[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Rules and Regulations]
[Pages 11892-11924]
[FR Doc No: 2011-4475]

Vol. 76

Thursday,

No. 42

March 3, 2011

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; Final Rule

Federal Register / Vol. 76 , No. 42 / Thursday, March 3, 2011 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 113

[Docket No. FDA-2007-N-0265; Formerly Docket No. 2007P-0026]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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. This final rule also establishes recordkeeping
requirements relating to temperature-indicating devices and reference
devices maintained by the processor and allows for the use of advanced
technology for measuring and recording temperatures during processing.
Finally, this final rule includes metric equivalents of avoirdupois
(U.S.) measurements where appropriate. This final rule will allow low-
acid canned food processors to transition from mercury-in-glass
thermometers to alternative temperature-indicating devices. Use of
temperature-indicating devices that do not contain mercury will
eliminate concerns about potential contamination of the food or the
processing environment from broken mercury-in-glass thermometers.
Elsewhere in this issue of the Federal Register, FDA is publishing a
30-day notice announcing that it has submitted the information
collection provisions of this final rule to the Office of Management
and Budget (OMB) for review and clearance under the Paperwork Reduction
Act of 1995 (the PRA). The notice also invites the public to submit
comments on the information provisions to OMB. Prior to the effective
date of this final rule, FDA will publish a notice in the Federal
Register announcing OMB's decision to approve, modify, or disapprove
the information collection provisions of the final rule.

DATES: This final rule is effective March 5, 2012.

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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Comments on the Proposed Rule
III. Minor Revisions in Regulations
IV. Analysis of Economic Impacts
    A. Final Regulatory Impact Analysis
    B. Regulatory Flexibility Analysis
    C. Unfunded Mandate Analysis
V. Paperwork Reduction Act of 1995
VI. Federalism
VII. References

I. Background

    In the Federal Register of March 14, 2007 (72 FR 11990), FDA
published a proposed rule entitled ``Temperature-Indicating Devices;
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers'' (the proposed rule). We proposed to revise Sec.  113.40
(21 CFR 113.40) to provide for use of temperature-indicating devices
that accurately indicate the temperature during processing. We proposed
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. We also proposed 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.
    We proposed 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. We proposed
the establishment and maintenance of written records to document the
accuracy for each temperature-indicating device and each reference or
standard device.
    We also proposed to provide for the use of metric equivalents of
avoirdupois (U.S.) measurements for temperature-indicating devices, to
provide for use of temperature-recording devices that create analog,
graphical, or digital recordings, and to clarify various operational
and record requirements of the regulations.
    In the preamble to the proposed rule, FDA stated that, pending
issuance of a final rule, we intended to consider the exercise of our
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 was
consistent with the proposed rule (72 FR 11990 at 11999, March 14,
2007). The Federal Food, Drug, and Cosmetic Act's (the FD&C Act)
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, 835
(1985); see also Schering Corp. v. Heckler, 779 F.2d 683, 685-86 (DC
Cir. 1985) (stating that the provisions of the act ``authorize, but do
not compel FDA to undertake enforcement activity'')). FDA will continue
to consider the exercise of our 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 until the
effective date of the final rule. In addition, we will consider the
exercise of our enforcement discretion on a case-by-case basis for
processors who comply with the provisions of this final rule prior to
the effective date. All low-acid canned food processors must comply
with the requirements of this final rule on and after the effective
date.

II. Comments on the Proposed Rule

    FDA received six letters, each containing one or more comments, to
the proposed rule. The comments were from industry, a trade
association, and individuals. Most of the letters generally supported
the proposed rule, but provided some comments that suggested
modifications to the proposed rule. Some of the comments addressed
issues outside the scope of this rulemaking and will not be addressed
in this document. A summary of the comments and FDA's responses
follows.
    (Comment 1) One comment requested that the effective date of this
final rule be not less than 1 year from the date of publication. The
comment indicated that companies that are continuing to use mercury-in-
glass thermometers will need time to comply with the additional
recordkeeping requirements for accuracy checks. Furthermore, companies
with existing water retorts will need at least 1 year to comply with
the additional equipment requirements of the regulation. The comment
also indicated that firms that currently reprocess products or rework
previously processed product into a new formulation need at least 1
year to review existing process schedules and conduct confirmatory
testing if necessary, to comply with Sec.  113.83 (21 CFR 113.83).

    (Response) We agree with the comment's request to allow 1 year for
processors to comply with recordkeeping requirements relating to use of
mercury-in-glass thermometers and to other requirements relating to
temperature-indicating devices established in this final rule. Thus,
the effective date of this final rule is 1 year from the date of
publication in the Federal Register. However, FDA does not agree with
the comment's suggestion that processors need a year to comply with
Sec.  113.83 for reprocessed or reworked product. As discussed in our
response to comment 38, although we clarified the requirements in final
Sec.  113.83, we did not propose new requirements for reprocessed or
reworked products in the proposed rule or establish new requirements
for reprocessed or reworked products in this final rule.
    (Comment 2) One comment recommended defining the term
``temperature-indicating device'' as the entire system, including the
sensor(s) and the temperature-indicating device display. The comment
noted that separate references to the ``temperature-indicating device''
and the ``sensor of the temperature-indicating device'' could be
interpreted to mean that the sensor is not part of the temperature-
indicating device and thus does not have to be calibrated. The comment
suggested using the term ``temperature-indicating device display'' to
refer to the electronics/display portion only and to define
``temperature-indicating device'' to mean the entire system.
    (Response) We agree that the term ``temperature-indicating device''
includes the temperature-indicating device sensor and the temperature-
indicating device display. Accordingly, we revised the proposed
requirements to clarify that each temperature-indicating device must
have a sensor and a display (final Sec.  113.40(a)(1), (b)(1), (c)(1),
(d)(1), (e)(1), (f)(1), and (g)(1)(i)(A)). As appropriate, we replaced
the terms ``sensors of temperature-indicating devices'' and ``sensor of
the temperature-indicating device'' with ``temperature-indicating
device sensor'' (final Sec.  113.40(a)(1)(v), (b)(1)(v), (c)(1)(v),
(d)(1)(v), and (e)(1)(v)). In final Sec.  113.40(f)(1)(v), we clarified
that the temperature-indicating device sensor, rather than the
temperature-indicating device, must be located in the steam dome near
the steam water interface or, when applicable, in each hydrostatic
water leg.
    Although the comment did not request similar clarification for
temperature-recording devices, in this final rule we also clarified
that each temperature-recording device must have a sensor and a
mechanism for recording temperatures to a permanent record, such as a
temperature-recording chart (final Sec.  113.40(a)(2), (b)(2), (c)(2),
(d)(2), (e)(2), (f)(2), and (g)(1)(i)(B)).
    (Comment 3) One comment indicated that the mercury-in-glass
thermometer originally was used for three important reasons, i.e.,
permanent accuracy, no drift over time, and reliability. According to
the comment, reliability means ``it works or it doesn't work and you
know when it doesn't work.'' The comment suggested that these factors
should be characteristics of any alternative temperature-indicating
device. Another comment suggested revising proposed Sec.  113.40(a)(1)
to require alternative temperature-indicating devices to meet or exceed
the accuracy and reliability of mercury-in-glass thermometers.
    (Response) The Agency recognizes that accuracy, drift, and
reliability are important considerations for any temperature-indicating
device. However, the comment does not specify any unique problems that
may be associated with these factors that were not addressed by the
proposed codified language. Thus, the Agency is not making any changes
to the proposed codified in response to this comment.
    The comment's reference to ``permanent accuracy'' is not clear.
Perpetual and unfailing accuracy cannot be guaranteed for any
temperature-indicating device, including mercury-in-glass thermometers.
Each temperature-indicating device must be tested for accuracy, as
required in final Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1),
(f)(1), and (g)(1)(i)(A) of this final rule. A temperature-indicating
device that is defective or cannot be adjusted to the accurate
calibrated reference device must be repaired before further use or
replaced (final Sec.  113.40(a)(1)(iii), (b)(1)(iii), (c)(1)(iii),
(d)(1)(iii), (e)(1)(iii), (f)(1)(iii), and (g)(1)(i)(A)(3)).
    We use the terms ``accurate'' and ``accuracy'' in this final rule
to refer to ``measurement accuracy.'' Measurement accuracy is defined
in the International Vocabulary of Metrology as ``closeness of
agreement between a measured quantity value and a true quantity value
of a measurand'' (Ref. 1). For a temperature-indicating device, the
temperature shown on the display is the ``measured quantity value'' and
the actual or true temperature is the ``true quantity value.'' As
discussed in our response to Comment 9, this final rule provides that
the measurement accuracy for a temperature-indicating device must be
within 1 [deg]F (0.5 [deg]C) of the true quantity value, i.e., the
temperature-indicating device must be accurate to 1 [deg]F (0.5 [deg]C)
(final Sec.  113.40(a)(1)(iv), (b)(1)(iv), (c)(1)(iv), (d)(1)(iv),
(e)(1)(iv), (f)(1)(iv), and (g)(1)(i)(A)(4)).
    We agree that ``drift over time'' is a factor that must be
considered to assure that the temperature-indicating device is accurate
during processing. However, because an absolute requirement for no
drift over time may prevent use of an otherwise appropriate
temperature-indicating device, we do not agree that this characteristic
should be specified in this final rule. We believe the requirement of
this final rule for the temperature-indicating device to be accurate
encompasses considerations relating to drift. If the accuracy of the
temperature-indicating device may be affected by drift, it is our
expectation that an appropriate calibration interval (i.e., more
frequently than once per year) or other appropriate mechanism will be
established by the processor to ensure that the temperature-indicating
device is accurate during processing.
    The reliability of a temperature-indicating device is determined
based on evaluation of past performance of the specific temperature-
indicating device or similar temperature-indicating devices. Past
performance may be used as an indicator, but not as an absolute
guarantee or predictor, of future performance. Although we agree that
warranties and predictions of reliability are important considerations
for processors when choosing a temperature-indicating device, they do
not ensure accuracy during processing or alleviate the processors'
responsibility to ensure that the temperature-indicating device
provides an accurate temperature reading during processing (final Sec.
113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and
(g)(1)(i)(A)). A temperature-indicating device that does not accurately
indicate the temperature during processing does not comply with the
requirements of this final rule.
    We believe that the requirement in this final rule for the
temperature-indicating device to accurately indicate the temperature
during processing (final Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1),
(e)(1), (f)(1), and (g)(1)(i)(A) is adequate to ensure the accuracy and
reliability of the temperature-indicating device, and that it is not
necessary to revise the regulation to require that alternate
temperature-indicating devices meet or exceed the accuracy and
reliability of mercury-in-glass thermometers, as suggested by the
comment.
    (Comment 4) One comment recommended revising proposed Sec.
113.40(a)(1) to require temperature-indicating devices to be tested for

accuracy against a reference device for which the accuracy is traceable
to a National Institute of Standards and Technology (NIST), or
equivalent, standard reference device.
    (Response) We agree with the comment. We revised the applicable
proposed requirements to clarify that each temperature-indicating
device and each reference device that is maintained by the processor
must be tested for accuracy against a reference device for which the
accuracy is traceable to a NIST, or other national metrology institute,
standard reference device (final Sec.  113.40(a)(1), (b)(1), (c)(1),
(d)(1), (e)(1), (f)(1), and (g)(1)(i)(A)). The term ``reference device
maintained by the processor'' refers to the reference device used by a
processor who performs the accuracy tests at the processor's own
facility or facility laboratory. For such reference device, the
processor, rather than a third party laboratory, is responsible for
ensuring accuracy of the reference device when it is used for the
accuracy test and for ensuring that its accuracy is traceable to a
NIST, or other national metrology institute, standard reference device.
The term ``traceable'' refers to ``metrological traceability,'' which
is defined in the International Vocabulary of Metrology as the
``property of a measurement result whereby the result can be related to
a reference through a documented unbroken chain of calibrations, each
contributing to the measurement uncertainty'' (Ref. 2). ``Measurement
result'' is defined as a ``set of quantity values being attributed to a
measurand together with any other available relevant information''
(Ref. 3) and ``measurement uncertainty'' is defined as ``the non-
negative parameter characterizing the dispersion of the quantity values
being attributed to a measurand, based on the information used'' (Ref.
4).
    This final rule also clarifies that the record of the accuracy test
for a temperature-indicating device or a reference device maintained by
the processor must include documentation of the traceability of the
accuracy of the reference device to a NIST, or other national metrology
institute, standard reference device (final Sec.  113.100(c) and (d)
(21 CFR 113.100(c) and (d))). For an accuracy test performed by the
processor and, thus, for which the processor maintains the reference
device, the documentation of traceability must be a guarantee,
certificate of accuracy, certificate of calibration, or other document
from the manufacturer or other source of the reference device. For an
accuracy test performed by an outside facility, the documentation of
traceability must be a guarantee, certificate of accuracy, certificate
of calibration, or other document from the facility that includes a
statement or other documentation regarding the traceability of the
accuracy to a NIST, or other national metrology institute, standard
reference device.
    The information required to be included in the records of accuracy
for temperature-indicating devices and reference devices was set forth
in proposed Sec.  113.40(a)(1)(ii), (b)(1)(ii), (c)(1)(ii), (d)(1)(ii),
(e)(1)(ii), (f)(1)(ii), and (g)(1)(i)(A)(2). To eliminate redundancy,
we moved the information requirements for the records of accuracy for
temperature-indicating devices and reference devices maintained by the
processor from each of these sections to final Sec.  113.100(c) and (d)
of Subpart F--Records and Reports. We redesignated proposed Sec.
113.100(c), (d), and (e), as final Sec.  113.100(e), (f), and (g),
respectively. We also revised proposed Sec.  113.87(c) (21 CFR
113.87(c)) to clarify that the records of accuracy tests for
temperature-indicating devices used to determine the initial product
temperature and reference devices maintained by the processor must be
maintained in accordance with Sec.  113.100(c) and (d).
    (Comment 5) One comment expressed concern about the proposed
requirement that the design of the temperature-indicating device ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions (proposed Sec.
113.40(a)(1)(i), (b)(1)(i), (c)(1)(i), (d)(1)(i), (e)(1)(i), (f)(1)(i),
and (g)(1)(i)(A)(1)). According to the comment, the proposed language
focuses on only a few of the considerations that a processor must take
into account when selecting a temperature-indicating device and the
considerations in the proposed language may not be applicable to future
temperature-indicating technologies. The comment pointed out that a
temperature-indicating device that is very robust in terms of the
electromagnetic interference and environmental conditions could provide
unreliable temperature readings because of other aspects of the design
and installation. However, a temperature-indicating device that is less
robust in terms of electromagnetic interference and environmental
conditions could provide reliable and accurate readings due to good
design and installation practices. The comment stated that the end goal
of any temperature-indicating device is reliable and accurate readings.
The comment suggested that it would be more effective to state that:
``The design, installation, and operation of the temperature-indicating
device shall be such that the accuracy and reliability of the device is
ensured.''
    (Response) We do not agree that the language recommended by the
comment provides clarity or value to the regulation. The requirements
in the regulation for the temperature-indicating device to be accurate
upon installation and during processing (final Sec.  113.40(a)(1),
(b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and (g)(1)(i)(A)) encompass
design, installation, operation, and reliability considerations
traditionally associated with mercury-in-glass thermometers and that
must be considered for other temperature-indicating devices. However,
we believe it is necessary to emphasize in this final rule that the
design of the temperature-indicating device must assure that accuracy
is not affected by electromagnetic interference and environmental
conditions because these factors are not traditionally associated with
mercury-in-glass thermometers. As discussed in the preamble to the
proposed final rule, although electromagnetic energy does not affect
the accuracy of mercury-in-glass thermometers, temperature-indicating
devices with electronic or electromagnetic components are vulnerable to
electromagnetic interference. Electromagnetic energy may vary in the
area where a temperature-indicating device is located as electronics
are turned on and off, introduced into, and removed from the area.
Electromagnetic energy exposure may also vary when a temperature-
indicating device is moved from one location to another, e.g., from one
retort to another. Thus, unlike a mercury-in-glass thermometer, a
temperature-indicating device that may be affected by electromagnetic
energy must be designed based on consideration of that factor, i.e.,
the temperature-indicating device must be designed to ensure that its
accuracy during processing is not compromised by exposure to
electronics that generate or cause fluctuations in electromagnetic
energy. Similarly, some environmental conditions, such as humidity,
vibrations, and air pressure, that do not affect the accuracy or
performance of mercury-in-glass thermometers must be considered and
addressed in the design of other temperature-indicating devices.
    (Comment 6) One comment objected to the proposed requirement that
the design of the temperature-indicating device ensure that accuracy is
not affected by environmental conditions because it does not clearly
state which

environmental conditions are important and which are not (proposed
Sec.  113.40(a)(1)(i), (b)(1)(i), (c)(1)(i), (d)(1)(i), (e)(1)(i),
(f)(1)(i), and (g)(1)(i)(A)(1)). The comment expressed concern that
some important environmental factors may not be adequately considered.
The comment noted that there is a difference between environmental
considerations for mechanical and electronic instruments. According to
the comment, moisture is an important environmental concern with
electronic instruments. The comment noted that condensation on a
computer board or wiring terminals can be detrimental to making a
measurement and can cause errors. The comment suggested requiring the
use of temperature-indicating devices with an Ingress Protection code
suitable for the environment. The comment also indicated concern about
ambient temperature and vibration, either or both of which may affect
some electronic and mechanical technologies. According to the comment,
the ambient temperature coefficient, which is usually expressed as
degrees of error per degree of change from a specified ambient
temperature, may not be specified for some temperature-indicating
devices. The comment expressed concern that most users will not have
the ability to evaluate the impact of ambient temperature and may not
be aware that the ambient temperature coefficient is important. The
comment emphasized that design and installation are essential
components in vibration resistance.
    (Response) Processors are responsible for ensuring that
environmental factors, including those expressed in the comment, are
adequately considered. Processors must use temperature-indicating
devices appropriate for the processing environment and take appropriate
steps to evaluate environmental factors that may affect the accuracy of
the temperature-indicating device. Processors who do not have specific
expertise for evaluating the effect of environmental factors on
temperature-indicating devices may need to obtain advice from a
thermometry expert or obtain a manufacturer's guaranty or warranty
regarding use of a specific temperature-indicating device in their
specific food processing environment.
    (Comment 7) One comment requested clarification of proposed Sec.
113.40(a)(1)(i), which requires that the design of the temperature-
indicating device ensure that the accuracy of the device is not
affected by electromagnetic interference and environmental conditions.
The comment questioned whether mechanical thermometers are exempt from
this requirement. The comment stated that most processors will have no
way to determine the effects of electromagnetic interference on an
electronic thermometer design. The comment suggested that the
regulation should state that temperature-indicating devices should
comply with an electromagnetic interference standard that is current at
the time they are designed. According to the comment, this would
eliminate issues associated with changes to standards that make
existing temperature-indicating devices noncompliant. The comment
suggested that temperature-indicating devices should comply with the
European standards EN 61326-1:2006 Electrical equipment for
measurement, control and laboratory use; EN 61000-4-2 Personnel
Electrostatic Discharge Immunity; EN 61000-4-3 Electromagnetic
compatibility (EMC); and EN 61000-4-6 Conducted disturbances immunity.
    (Response) This final rule does not exempt mechanical thermometers,
e.g., mercury-in-glass thermometers, from the requirement that the
design ensure that accuracy is not affected by electromagnetic
interference and environmental conditions. However, although the
accuracy of mechanical thermometers may be affected by environmental
conditions, they generally are not susceptible to the affects of
electromagnetic interference as are electronic devices.
    FDA is providing flexibility to processors with respect to this
requirement and is not limiting processors to specific standards with
which they must comply. Processors, in conjunction with temperature-
indicating device manufacturers and appropriate thermometry experts,
should ensure that the temperature-indicating devices that processors
use are accurate during processing. A processor may elect to use an
appropriate electronic standard, such as those established by the
European Union, to ensure compliance with final Sec.  113.40(a)(1)(i),
(b)(1)(i), (c)(1)(i), (d)(1)(i), (e)(1)(i), (f)(1)(i), and
(g)(1)(i)(A)(1).
    (Comment 8) One comment stated that electronic thermometers are not
capable of communicating that there is an accuracy problem. The comment
stated that it is risky to rely on the history of calibration to prove
an instrument's accuracy because the temperature-indicating device may
perform properly for years and then fail without warning. The comment
pointed out that a failure that occurs between calibration cycles may
not be detected for a significant period of time. The comment suggested
that additional features are needed to ensure that a temperature-
indicating device retains its accuracy, will not drift, and will report
any potential errors. The comment indicated that a system with internal
diagnostics and error reporting to the operator would be one way of
providing this evidence. The comment suggested that FDA require that an
electronic temperature-indicating device incorporate technology to
alert the operator of measurement errors.
    (Response) Processors must ensure that temperature-indicating
devices are accurate during processing (final Sec.  113.40(a)(1),
(b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and (g)(1)(i)(A)). Processors
must test the temperature-indicating device for accuracy upon
installation and at least once per year thereafter, or more frequently
if necessary, to ensure accuracy (emphasis added) (see, e.g., final
Sec.  113.40(a)(1)). These requirements for accuracy for all
temperature-indicating devices make it unnecessary for this final rule
to require specific mechanisms to alert the operator of measurement
errors. Processors should adopt whatever features or systems are
appropriate to ensure the accuracy of a given temperature-indicating
device, and to detect defects or failures that may cause a temperature-
indicating device to be inaccurate. For mercury-in-glass thermometers,
the process for detecting failure may include periodic visual
examinations and appropriate followup based on findings of defects or
potential for failure. Electronic devices may have hardware and
software components with built-in diagnostic and alarm features.
Processors also may use backup or duplicate devices to detect defects
or failures. In addition, when adjustments are made to the temperature-
recording device so that it agrees as nearly as possible with, but to
be in no event higher than, the temperature-indicating device during
the process time, as required by this regulation (final Sec.
113.40(a)(2)(iii), (b)(2)(iii), (c)(2)(iii), (d)(2)(iii), (e)(2)(iii),
(f)(2)(iii), and (g)(1)(i)(B)(3)), the need for such adjustment may be
used as a signal for determining whether a temperature-indicating
device failure occurred. Thus, features or systems for ensuring
accuracy or for detecting inaccuracies may be different for different
types of temperature-indicating devices, as well as subject to
technological advancements that we may not anticipate at this time. To
ensure processors have flexibility to adopt future technologies to
detect

defects or failures of temperature-indicating devices, we have not
required in this final rule specific features or systems to detect such
defects or failures.
    (Comment 9) One comment expressed concern that the proposed rule
did not mention measurement uncertainties or test accuracy ratio, which
are essential parameters for assuring an accurate calibration that are
specified in standards issued by the American National Standards
Institute (ANSI) and the International Organization for Standardization
(ISO) for certification of calibration laboratories. The comment stated
that the ANSI and ISO standards provide a limit for measurement
uncertainty and establish a minimum test accuracy ratio that is
commonly used by calibration facilities. According to the comment,
although the proposed rule requires use of a calibrated accurate
reference device, the lack of specific calibration parameters may lead
to inaccurate calibrations for temperature-indicating devices.
    (Response) Measurement uncertainty is inherent in the proposed
requirement that the temperature-indicating device be easily readable
to 1 [deg]F (0.5 [deg]C), (i.e., the dispersion of the quantity values
for the temperature must be within 1 [deg]F (0.5 [deg]C) of the actual
temperature) (proposed Sec.  113.40(a)(1)(iv), (b)(1)(iv), (c)(1)(iv),
(d)(1)(iv), (e)(1)(iv), (f)(1)(iv), and (g)(1)(i)(A)(4)). However, we
acknowledge that the term ``easily readable'' is readily understood for
a mercury-in-glass thermometer, which has a visible scale of
temperature gradations, but it may not be clear for other temperature-
indicating devices, such as those that display a digital reading of the
temperature. Therefore, we removed the term ``easily readable'' and
clarified in this final rule that a temperature-indicating device must
be accurate to 1 [deg]F (0.5 [deg]C) (final Sec.  113.40(a)(1)(iv),
(b)(1)(iv), (c)(1)(iv), (d)(1)(iv), (e)(1)(iv), (f)(1)(iv), and
(g)(1)(i)(A)(4)).
    We do not agree that the regulations should specify calibration
parameters, such as those relating to measurement uncertainties or test
accuracy ratio, or require use of specific calibration standards, such
as the ANSI and ISO standards suggested by the comment. Metrology
authorities, in addition to ANSI and ISO, issue calibration standards,
which may be revised or replaced. It would be impractical for FDA to
maintain in the regulations a current list of acceptable calibration
standards. Processors are responsible for ensuring that the
temperature-indicating device is accurate during processing and for
testing each temperature-indicating device for accuracy against a
reference device for which the accuracy is traceable to a NIST, or
other national metrology institute, standard reference device by
appropriate standard procedures, upon installation and at least once a
year thereafter, or more frequently if necessary (final Sec.
113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and
(g)(1)(i)(A)). Thus, processors are responsible for ensuring that
accuracy tests are performed by appropriate standard procedures or by
calibration facilities that use appropriate standard procedures.
    (Comment 10) One comment recommended revising proposed Sec.
113.40(a)(1) to clarify that the identity of each temperature-
indicating device and reference device must be ``unique.''
    (Response) We do not agree that the term ``unique'' is necessary
because each temperature-indicating device and each reference device
that is maintained by the processor must have a tag, seal, or other
means of identity (final Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1),
(e)(1), (f)(1), and (g)(1)(i)(A)). The purpose of a tag, seal, or other
means of identity is, in part, to uniquely identify each temperature-
indicating device and each reference device that is maintained by the
processor so that one temperature-indicating or reference device can be
distinguished from another and so that appropriate records can be
associated with each temperature-indicating device or reference device.
    (Comment 11) One comment expressed concern about the information
required in proposed Sec.  113.40(a)(1)(ii)(A) and (a)(1)(ii)(B) for
documentation of accuracy of temperature-indicating devices and
reference devices. The comment suggested that the final rule should
instead require documentation that conforms to the standards
established by the American National Standards Institute, National
Conference of Standards Laboratories (ANSI/NCSL) or the International
Organization for Standardization, International Electrotechnical
Commission (ISO/IEC) for accrediting calibration laboratories. The
comment stated that the laboratory accreditation standards indicate
acceptable reporting practices. The comment acknowledged that the
standards may be too prescriptive for food processors who perform their
own calibrations.
    (Response) We do not agree that the regulation should require the
documentation of accuracy of temperature-indicating devices and
reference devices to conform to the standards specified in the comment
for accrediting calibration laboratories. Although FDA supports use of
accredited calibration laboratories and recognizes that the
laboratories must maintain certain documentation for the accreditation,
the records required by this final rule are appropriately limited to
those necessary to document that the temperature-indicating device was
tested for accuracy at sufficient frequency to ensure accuracy during
processing. As acknowledged by the comment, a requirement for
processors to adhere to accreditation standards would impose an
unnecessary burden on those who successfully perform their own
calibrations but are not accredited by ANSI/NCSL or ISO/IEC.
    (Comment 12) One comment recommended revising proposed Sec.
113.40(a)(1)(ii)(A) and (a)(1)(ii)(B) to require that documentation of
the results of the accuracy test include before and after data, i.e.,
the temperature reading of the temperature-indicating device compared
to the accurate calibrated reference device, before and after the
calibration. The comment indicated that the before data is needed
because it is the basis for determining whether the device was accurate
at the time of calibration and for documenting any adjustment that was
made.
    (Response) Proposed Sec.  113.40(a)(1)(ii)(A) and (a)(1)(ii)(B)
require that the results of each accuracy test be documented. Although
not explicitly stated in the proposed rule, we would expect
documentation of the results of the accuracy test to include
information about the amount of calibration adjustment that was
necessary. The ``before and after data'' suggested by the comment would
be reflected in the amount of calibration adjustment. The amount of
calibration adjustment is an indication of whether the temperature-
indicating device was accurate at the time of the calibration. If an
adjustment is required, the processor should evaluate the need for more
frequent accuracy tests and also determine whether food processed prior
to the adjustment is under processed. To provide clarity in the
regulation regarding the requirement to record the amount of
calibration adjustment that was necessary for a temperature-indicating
device, we are revising final Sec.  113.100 ``Processing and production
records'' to indicate that the record of each accuracy test for each
temperature-indicating device and for each reference device that is
maintained by the processor must include the results of each accuracy
test, including the amount of calibration adjustment (final Sec.
113.100(c)(5) and (d)(5)).

    Other information relating to the results of the accuracy test that
should be recorded when it is relevant includes information about the
condition of the temperature-indicating device (i.e., intact or broken
mercury column, worn or broken components) and disposition of the
temperature-indicating device if it cannot be calibrated (i.e.,
destroyed, repaired, or replaced).
    (Comment 13) One comment addressed the proposed requirement that
records of the accuracy test for the temperature-indicating device
include the date of the next scheduled accuracy test (proposed Sec.
113.40(a)(1)(ii)(A), (b)(1)(ii)(A), (c)(1)(ii)(A), (d)(1)(ii)(A),
(e)(1)(ii)(A), (f)(1)(ii)(A), and (g)(1)(i)(A)(2)(i)). One comment
interpreted this requirement to imply that the test must be conducted
on that specific date. The comment suggested removing the requirement
or changing the language to ``the date of the calibration expiration.''
    (Response) We acknowledge that the proposed requirement concerning
the date of the next scheduled accuracy test may be misinterpreted to
mean that the next accuracy test must be conducted on that specific
date. However, we do not agree that the revised language recommended by
the comment, i.e., the date of the calibration expiration, adequately
clarifies that the next accuracy test must be conducted on or before
the specified date. In this final rule, we require that the record of
accuracy for a temperature-indicating device and a reference device
maintained by the processor include the date on or before which the
next accuracy test must be performed (final Sec.  113.100(c)(6) and
(d)(6)).
    (Comment 14) One comment recommended placing on each temperature-
indicating device a calibration sticker that indicates the date of the
last calibration and the date the next calibration is due. According to
the comment, the calibration standard ISO/IEC 17025 does not require
the calibration due date to be recorded on the certificate issued by
the calibration facility, which may have no knowledge of the
calibration interval for the specific device.
    (Response) We recognize that outside calibration facilities are not
responsible for determining the frequency of the accuracy tests for
temperature-indicating devices and, thus, are not required to record
the frequency on a calibration certificate. We do not agree with the
comment's recommendation to require a sticker on each temperature-
indicating device with the date of the last calibration and date the
next calibration is due. Although we do not object to processors using
stickers or similar mechanisms on temperature-indicating devices to
emphasize when the next accuracy test for a temperature-indicating
device must be performed, we consider it sufficient to require that
information relating to the accuracy test, such as the date on or
before which the next accuracy test must be performed, be included in
the processor's records of the accuracy test (final Sec.  113.100(c)).
    (Comment 15) One comment questioned why the documentation
requirements for accuracy tests in proposed Sec.  113.40(a)(1)(ii)(B)
apply to reference devices. The comment pointed out that the reference
device may be located in a third party calibration laboratory.
    (Response) Accuracy tests for temperature-indicating devices may be
performed by the processor or by a third party calibration laboratory.
Processors who perform their own accuracy test must ensure that the
reference device they use is accurate and must maintain records to
document that accuracy. In this final rule, we clarify that the
required records of the accuracy tests for reference devices are for
reference devices maintained by the processor (final Sec. Sec.
113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and (g)(1)(i)(A),
113.87(c), and 113.100(d)).
    (Comment 16) One comment recommended that processors be required to
implement a method or process for identifying when a temperature-
indicating device needs to be calibrated. The comment pointed out that
inexpensive software packages are readily available for this purpose.
    (Response) We recognize that processors may desire to establish a
system to prompt them when scheduled activities, such as calibrations,
need to be performed. Although available software may be appropriate
for that purpose, we do not agree that the regulations should require
processors to develop or use existing software or any other specific
method or system to identify when a temperature-indicating device needs
to be calibrated. Processors must test temperature-indicating devices
for accuracy upon installation and at least once a year thereafter, or
more frequently if necessary (final Sec.  113.40(a)(1), (b)(1), (c)(1),
(d)(1), (e)(1), (f)(1), and (g)(1)(i)(A)). The appropriate frequency
for the accuracy test should be determined based on previous accuracy
test results, evidence of damage, and other factors or situations that
cause the accuracy of the temperature-indicating device to be
questionable.
    (Comment 17) One comment objected to the preamble statement, ``FDA
recommends, but is not proposing to require, a dual probe design.'' (72
FR 11989 at 11993). According to the comment, FDA's recommendation for
a dual probe design will lead companies to purchase a dual probe unit
to reduce any potential conflict with FDA. The comment stated that the
dual probe design is a patented technology and other designs or
mechanisms may be used for detecting malfunctions.
    (Response) In the preamble to the proposed rule, FDA stated, ``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'' (72 FR 11990 at 11993). Thus, in the
preamble to the proposed rule, we discussed a dual probe sensor as one
means to detect a malfunction of a temperature-indicating device. We
agree that a dual probe sensor is not the only design, mechanism, or
process that may help detect temperature-indicating device failures.
Therefore, this final rule does not require a dual probe design to
detect malfunctions or failures of a temperature-indicating device.
    (Comment 18) One comment objected to the requirement for ``written
documentation,'' found in proposed Sec. Sec.  113.40(a)(1)(ii),
(b)(1)(ii), (c)(1)(ii), (d)(1)(ii), (e)(1)(ii), (f)(1)(ii), and
(g)(1)(i)(A)(2). The comment indicated that the term ``written''
implies hand-written documentation and will limit new documentation
technologies. The comment stated that the term ``written'' should be
removed to allow for means of documentation other than just written
records, especially since the Agency proposed in Sec.  113.100(f) to
allow electronic records. The comment also stated that the term
``written'' should be removed from other sections of the regulations
that apply to records.
    (Response) We do not agree that the term ``written'' implies that
the documents are hand-written. Written documentation may be generated

mechanically, such as when a stylus generates a tracing onto a paper
chart, or electronically, including computer generated documents.
However, we do agree that the term is not necessary for describing the
requirements for establishing and maintaining records. Therefore, in
this final rule, we used the term ``record'' or ``records'' without the
qualifying term ``written'' (final Sec. Sec.  113.87(e) and 113.100(b)
and (e)). For consistency, we also removed the qualifying term
``written'' from Sec.  113.87(b). In addition, where the term ``written
documentation'' is intended to mean ``records'' that must be
established and maintained, we changed the term ``written
documentation'' to ``records'' (final Sec.  113.40(a)(1)(ii),
(b)(1)(ii), (c)(1)(ii), (d)(1)(ii), (e)(1)(ii), (f)(1)(ii), and
(g)(1)(i)(A)(2)).
    (Comment 19) One comment recommended that proposed Sec.
113.40(b)(6)(ii) on water circulation be redesignated as new Sec.
113.40(b)(9). The comment suggested that it was inappropriate to place
the requirements for water circulation and for air supply in the same
section, specifically proposed Sec.  113.40(b)(6)(i) and (b)(6)(ii),
which, according to the comment, respectively addressed air supply and
water control. The comment stated that, for discontinuous water retort,
air supply and water circulation are not related functions as they are
for vertical water retorts covered in Sec.  113.40(b).
    (Response) The proposed rule does not have a Sec.
113.40(b)(6)(ii). Because the comment was related to water circulation
for discontinuous agitating retorts, we assume the comment was
requesting redesignation of proposed Sec.  113.40(e)(6)(ii). We also
assume the comment was comparing proposed Sec.  113.40(e)(6)(ii),
related to water circulation in discontinuous agitating retorts, to
proposed Sec.  113.40(b)(10)(ii), related to water circulation in still
retorts, including vertical still retorts. We reviewed the structure of
proposed Sec.  113.40(b)(10) and (e)(6) and agree that separating the
requirements for the air supply and controls and the water circulation
functions into distinct paragraphs for both discontinuous agitating and
still retorts enhances the clarity of the regulation. We also
determined that, based on changes to proposed Sec.  113.40(e)(8), as
explained in response to Comment 20, proposed Sec.  113.40(b)(9) and
(e)(8), relating to the water level indicator, should be redesignated
to immediately precede proposed Sec.  113.40(b)(10)(ii) and (e)(6)(ii),
respectively, relating to water circulation. Thus, in this final rule,
we redesignated proposed Sec.  113.40(b)(9), (b)(10)(i), and
(b)(10)(ii) as final Sec.  113.40(b)(10), (b)(9), and (b)(11),
respectively. We redesignated proposed Sec.  113.40(e)(6)(ii) and
(e)(8) as final Sec.  113.40(e)(7) and (e)(6)(ii), respectively. We
made conforming changes to the numbering of proposed Sec.
113.40(b)(11), (b)(12), (b)(13), and (b)(14), which is now final Sec.
113.40(b)(12), (b)(13), (b)(14), and (b)(15), respectively. Similarly,
we redesignated proposed Sec.  113.40(e)(6)(ii) and (e)(7), as final
Sec.  113.40(e)(7) and (e)(8), respectively.
    (Comment 20) One comment suggested revising proposed Sec.
113.40(b)(6), relating to air supply and controls, to clarify that the
requirements apply only if air is used for providing overpressure. The
comment also suggested revising proposed Sec.  113.40(e)(8), which
requires a water level indicator and operator checks of the water level
to ensure that water covers the top layer of containers during the
entire come-up time and processing periods. The comment requested
revisions to clarify that the requirements of proposed Sec.
113.40(e)(8) apply only if water level is determined to be a critical
factor in the scheduled process or retort operating procedures.
According to the comment, these revisions would accommodate current
systems for pressure processing in discontinuous agitating retorts that
utilize steam as the source of overpressure. The comment stated that
for such systems, the processing authority may have determined that
water level is not critical to the scheduled process because of the
influences of steam in the retort headspace area and the continuous
rotation of the retort baskets.
    (Response) Because proposed Sec.  113.40(b)(6) does not relate to
air supply and controls, but is instead about crate supports, we assume
here as we did in our response to Comment 19 that the comment is
referring to proposed Sec.  113.40(e)(6)(i), relating to air supply and
controls for pressure processing in water in discontinuous agitating
retorts. Proposed Sec.  113.40(e)(6)(i) requires that a means be
provided for introducing compressed air at the proper pressure and
rate. We agree with the comment that the requirement of proposed Sec.
113.40(e)(6)(i) applies only if air is used for providing overpressure.
We also agree that the requirement of proposed Sec.  113.40(e)(6)(ii)
for a water level indicator and recorded checks of the water level
during processing should be revised to accommodate discontinuous
agitating retorts that utilize steam as the source of overpressure.
Accordingly, in final Sec.  113.40(e)(6)(i) and (e)(6)(ii), we
clarified that the requirements relating to air supply and controls and
to the water level indicator apply only if air is used for providing
overpressure.
    (Comment 21) One comment suggested revising proposed Sec.
113.40(b)(10)(ii), which requires the water circulation pump to be
equipped with a bleeder to remove air when starting operations. The
comment suggested revising this requirement to allow for use of other
suitable devices for air removal.
    (Response) We agree that proposed Sec.  113.40(b)(10)(ii),
redesignated as Sec.  113.40(b)(11) in this final rule, should be
revised to allow for use of water circulation pumps, other than a water
circulation pump with a bleeder, designed to ensure proper heat
distribution. To ensure proper heat distribution, the water circulation
pump must be designed to properly start the flow of water and to
maintain the flow of water at the appropriate flow rate. To obtain the
appropriate flow rate, the water circulation pump must be designed or
equipped with a suitable means, such as a bleeder, to remove air from
the pump chamber or the pump must be self priming. In addition, the
pumping system must ensure that it avoids cavitation, i.e., changes in
water pressure caused by the formation of cavities or voids within the
circulating water. Water circulation pumps that use mechanisms other
than bleeders to remove air must be designed to ensure appropriate
water circulation and to prevent cavitation.
    To clarify this requirement, in Sec.  113.40(b)(11) of this final
rule we specify that the water circulation pump must be designed to
provide proper flow on startup and during operation, such as with a
bleeder or other suitable means to remove air during startup and with
an appropriate device or design to prevent pump cavitation during
operation. In addition, the pump must be equipped with a signaling
device to warn the operator when it is not running. For consistency, we
made similar changes to proposed Sec.  113.40(e)(6)(ii) (redesignated
as Sec.  113.40(e)(7) in this final rule). In final Sec.  113.40(b)(11)
and (e)(7), we removed the reference to ``pilot light'' as the example
of a signaling device to avoid the appearance of preference for a pilot
light signaling device and to provide flexibility for processors to
determine an appropriate signaling device.
    (Comment 22) One comment agreed with the provision of proposed
Sec.  113.40(b)(1)(v) that allows a temperature-indicating device to be
installed in a separate well or sleeve, i.e., ``If a separate well or
sleeve is used, there must be adequate circulation to

ensure accurate temperature measurement.'' However, the comment
indicated that the provision appears to conflict with another
requirement in proposed Sec.  113.40(b)(1)(v) for the temperature-
indicating device sensor to extend directly into the water a minimum of
at least 2 inches (5.1 centimeters) without a separable well or sleeve.
    (Response) We agree that additional clarification is needed. In
this final rule, we revised proposed Sec.  113.40(b)(1)(v) and a
similar requirement in proposed Sec.  113.40(e)(1)(v) to clarify that
the temperature-indicating device sensor must be installed directly
into the retort shell or in a separate well or sleeve attached to the
retort. In addition, for all retorts covered by these sections, the
temperature-indicating device sensor must be located so that it is
beneath the surface of the water throughout the process and where there
is adequate circulation to ensure accurate temperature measurement. We
also removed the requirement for the temperature-indicating device
sensor to extend at least 2 inches (5.1 centimeters) directly into the
water when the temperature-indicating device sensor is not located in a
separate well or sleeve. We believe the requirement for adequate water
circulation to ensure accurate temperature measurement obviates the
need to specify how far the temperature-indicating device sensor must
extend into the water and allows for use of alternative technologies.
    (Comment 23) One comment noted that proposed Sec.  113.40(f)(1)(v)
should be revised to clarify that placement requirements in the steam
dome and the hydrostatic water leg are for the temperature-indicating
device sensor.
    (Response) We agree. In this final rule, we revised proposed Sec.
113.40(f)(1)(v) to clarify that the placement requirements in the steam
dome and the hydrostatic water leg apply to the temperature-indicating
device sensor, rather than the entire temperature-indicating device.
    (Comment 24) One comment stated that the requirement for the
temperature-recording device sensor to be installed either within the
retort shell or in a well attached to the shell is misplaced in the
paragraph heading, Temperature controller (proposed Sec.
113.40(a)(2)(iv), (c)(2)(iv), (d)(2)(iv), (e)(2)(iv), and (f)(2)(iv)).
The comment indicated that the statement applies to all temperature-
recording device sensors, but its placement in the regulations implies
that it applies only to combination recording-controlling devices. The
comment suggested moving the statement relating to installation of the
sensor, along with the requirement for the temperature-recording device
sensor well to have a \1/16\-inch (1.5 millimeters) or larger bleeder,
to a separate paragraph.
    (Response) We agree. In this final rule, we moved the statements
relating to installation of the sensor and, where relevant, the
requirement for the temperature-recording device sensor well to have a
\1/16\-inch (1.5 millimeters) or larger bleeder to the paragraph
heading, Temperature-recording device (final Sec.  113.40(a)(2),
(c)(2), (d)(2), (e)(2), and (f)(2)).
    (Comment 25) One comment objected to the requirement in proposed
Sec.  113.40(e)(1)(v) for the temperature-indicating device sensor to
be installed either within the retort shell or in an external well
attached to the retort. The comment indicated that placement of the
temperature-indicating device in the suction manifold shows good
agreement with temperatures inside the retort once the Cook Hold step
begins. According to the comment, this placement is an improvement over
using a thermometer well, since the water line for a partial immersion
process is normally below the feed leg of the thermometer well and the
temperature at that location may not be representative of the retort
temperature. The comment suggested revising Sec.  113.40(e)(1)(v) by
adding the following language to permit alternative sensor placement,
if appropriately documented: ``Other installations deviating from these
sensor locations may be used if the processor has evidence, on file, in
the form of heat distribution data that its installation accomplishes
adequate heat distribution. Such documentation is likely to include
heat distribution studies conducted and documented by the processor to
show that the process temperature will be reached once the Cook Hold
time begins.''
    (Response) We do not agree with the comment's recommendation that
Sec.  113.40(e)(1)(v) should state that process deviations relating to
placement of temperature-indicating device sensors may be acceptable if
supported by heat distribution data. Section 108.35 states the
requirements for submitting information to demonstrate process adequacy
for a system design that deviates from the requirements of the
regulations. A change in the design of a system for processing in water
in discontinuous agitating retorts, such as placement of a temperature-
indicating device sensor in a suction manifold rather than within the
retort shell or in an external well attached to the retort, would
require substantiation by qualified scientific authority as to its
adequacy, including, for example, heat distribution studies as
suggested by the comment. Such information must be submitted to FDA
(Sec.  108.35(c)(2)(ii) (21 CFR 108.35(c)(2)(ii))).
    (Comment 26) One comment expressed concern that proposed Sec.
113.40(a)(2), which requires each retort to have an accurate
temperature-recording device, does not define the term ``accurate'' or
state how to determine that a temperature-recording device is accurate.
The comment suggested using the same calibration method for
temperature-recording devices as used for temperature-indicating
devices and reference devices by requiring annual calibrations of
temperature-recording devices with NIST traceability. The comment
stated that this would effectively allow the temperature-recording
device to be used as a secondary component of a ``redundant system'' to
verify the accuracy of the temperature-indicating device. Accordingly,
the temperature-indicating device would still be ``the standard''
device and should still be required to have the characteristics of high
accuracy and reliability. The comment indicated that if the
temperature-recording device is adjusted to the temperature-indicating
device and the temperature-indicating device slowly drifts, this may
not be known until the next calibration cycle, which could be up to a
year later. However, according to the comment, if the devices are
allowed to vary within their individual established calibration
tolerances, it will be known if one device drifts out of its tolerance.
The comment stated that adjusting the temperature-recording to the
temperature-indicating device does not ensure the accuracy of the
temperature-recording device or the recorded data.
    (Response) This final rule requires the temperature-recording
device to 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 (final Sec.  113.40(a)(2)(iii), (b)(2)(iii), (c)(2)(iii),
(d)(2)(iii), (e)(2)(iii), (f)(2)(iii), and (g)(1)(i)(B)(3)). Processors
must ensure that the temperature-indicating device is accurate during
processing and that the recording mechanism of the temperature-
recording device is adjusted to and reflects the temperature indicated
by the temperature-indicating device. For some temperature-recording
devices, such as those that record to a chart, adjustments to the
mechanism that draws onto the chart are made by hand based on visually
determining where the mechanism should be placed in contact with the
chart. Unavoidable

imprecision relating to, for example, manual placement of the recording
mechanism onto a chart, must result in recording a temperature that is
not greater than the actual processing temperature. A recorded
temperature that is higher than the actual processing temperature may
mean that the product was not processed at or above the required
processing temperature (i.e., the product was under processed) and may
pose a health hazard. However, if the temperature-recording device
records a temperature that is lower than the actual processing
temperature, although the quality of the product may be affected,
processing at a higher temperature than recorded (i.e., over
processing) does not create a health hazard. Thus, although the
recorded temperature should reflect the actual processing temperature
as precisely as possible, we believe the requirement to not record a
temperature that is higher than the temperature-indicating device,
which must be accurate, provides an appropriate parameter for ensuring
that the product is not under processed.
    We believe processors should adjust the temperature-recording
device mechanism for each batch at least at the beginning of the
process and, as necessary, check the adjustment during the process time
to ensure compliance with the regulation and to ensure that the batch
is processed at or above the scheduled process temperature. To
emphasize that the adjustment must occur with sufficient frequency to
ensure that the temperature-recording device record reflects the
temperature indicated by the temperature-indicating device, we revised
the final rule to require the temperature-recording device to be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing (final Sec.  113.40(a)(2)(iii),
(b)(2)(iii), (c)(2)(iii), (d)(2)(iii), (e)(2)(iii), (f)(2)(iii), and
(g)(1)(i)(B)(3)).
    (Comment 27) One comment suggested replacing the term ``recording
chart'' with ``temperature-recording device record'' in proposed Sec.
113.40(c)(8)(ii).
    (Response) We agree. In Sec.  113.40(c)(8)(ii) of this final rule,
we replaced the term ``recording chart'' with ``temperature-recording
device record.'' Also, because the term ``marked'' may be interpreted
to mean a manual action, for clarity and to allow for use of
alternative technologies, we replaced the term ``marked'' with
``indicated'' in Sec.  113.40(c)(8)(ii) and (c)(9).
    (Comment 28) One comment suggested that the statement that air-
operated temperature controllers should have adequate filter systems to
ensure a supply of clean, dry air is misplaced in the regulations
(proposed Sec.  113.40(a)(2)(iv), (b)(2)(iv), (c)(2)(iv), (d)(2)(iv),
(e)(2)(iv), and (f)(2)(iv)). The comment stated that, because this
statement applies to all air-operated temperature or steam control
systems, regardless of whether or not it is a combination recorder-
controller, it should be moved to proposed Sec.  113.40(a)(4), (b)(4),
(c)(4), (d)(4), (e)(4), and (f)(5), respectively, which set out the
requirements for the steam controller.
    (Response) We agree. In this final rule, we moved the statement
that air-operated temperature controllers should have adequate filter
systems to ensure a supply of clean, dry air from proposed Sec.
113.40(a)(2)(iv), (b)(2)(iv), (c)(2)(iv), (d)(2)(iv), (e)(2)(iv), and
(f)(2)(iv) to final Sec.  113.40(a)(4), (b)(4), (c)(4), (d)(4), (e)(4),
and (f)(5). In addition, for consistency in terminology, we replaced
the term ``recording-controlling instrument'' with ``recorder-
controller'' in final Sec.  113.40(a)(2)(iv), (a)(4), (b)(2)(iv),
(b)(4), (c)(2)(iv), (c)(4), (d)(2)(iv), (d)(4), (e)(2)(iv), (e)(4),
(f)(2)(iv), and (f)(5).
    (Comment 29) One comment stated that the requirement in proposed
Sec.  113.40(g)(1)(i)(E) for the differential pressure recorder-
controller to be installed on the product-to-product regenerator is
confusing because it implies that the recorder-controller needs to be
physically attached to the product-to-product regenerator. Thus,
according to the comment, the requirement does not accommodate
operational practices where recording and control are done in remote
systems. The comment stated that the pressure sensing device, rather
than the recorder-controller, is installed on the regenerator.
    (Response) We agree with the comment's suggestion to allow for use
of alternative differential pressure recorder-controllers by
eliminating the requirement for the differential pressure recorder-
controller to be installed on the product-to-product regenerator. In
this final rule, we clarify that when a product-to-product regenerator
is used, it must be equipped with an accurate differential pressure
recorder-controller (final Sec.  113.40(g)(1)(i)(E)).
    (Comment 30) One comment stated that the scale division
requirements for differential pressure recorder-controllers in proposed
Sec.  113.40(g)(1)(i)(E) do not allow for use of differential pressure
recorder-controllers that incorporate alternative technologies, such as
digital recordings, for recording and controlling differential
pressure.
    (Response) We agree with the comment. In this final rule, we
clarify that the requirements for scale divisions apply to graphical
recordings and allowed for use of digital recordings, as well as analog
or graphical recordings (final Sec.  113.40(g)(1)(i)(E)(i) and
(g)(1)(i)(E)(ii)). We also clarified that the differential pressure
recorder-controller must be accurate to within 2 pounds per square inch
(13.8 kilopascals) and that the sensor and the recorder of the
differential pressure recorder-controller must be tested for accuracy
against an accurate reference device (final Sec.  113.40(g)(1)(i)(E)).
    Although the comment did not request a similar change for pressure
gages, in this final rule, for consistency, we changed the
recommendation for each retort to be equipped with a pressure gage that
is ``graduated in divisions of 2 pounds per square inch (13.8
kilopascals) or less'' to a recommendation that each retort be
``equipped with a pressure gage that is accurate to 2 pounds per square
inch (13.8 kilopascals) or less'' (Sec.  113.40(a)(3), (b)(3), (c)(3),
(d)(3), (e)(3) and (f)(3)).
    (Comment 31) One comment stated that the requirement for the
differential pressure recorder-controller to be tested for accuracy
against a known accurate standard pressure indicator upon installation
and at least once every 3 months of operation, is confusing and not
reflective of actual operating conditions (proposed Sec.
113.40(g)(1)(i)(E)). The comment indicated that the pressure sensors,
rather than the controller, are tested for accuracy and that the
controller should be tested for proper functioning. In addition, the
comment stated that the required minimum frequency for testing the
differential pressure recorder-controller after installation should be
once per year, consistent with the requirement for testing temperature-
indicating devices, instead of once every 3 months.
    (Response) We do not agree with the comment's suggestion to reduce
the requirement to test for accuracy from at least once every 3 months
to once every year. The requirement to test the differential pressure
recorder-controller for accuracy at least once every 3 months of
operation is well established (current Sec.  113.40(g)(1)(i)(E). The
comment did not provide, and we do not have, data to support the
adequacy of testing only once every year. Accordingly, we are making no
changes in response to this comment.
    (Comment 32) One comment suggested revising proposed Sec.
113.40(g)(1)(ii)(C) and (g)(2)(ii)(B) to be consistent with Sec.
113.40(g)(1)(ii)(B),

which states that a processing deviation must be handled in accordance
with Sec.  113.89 (21 CFR 113.89).
    (Response) We agree that the suggested revision clarifies and
provides consistency in the regulation. In this final rule, we clarify
that the processing deviation must be handled in accordance with final
Sec.  113.89 (Sec.  113.40(g)(1)(ii)(C) and (g)(2)(ii)(B)).
    (Comment 33) One comment objected to the way we expressed
temperatures in Fahrenheit, followed by a parenthetical reference to
the temperature expressed in Celsius. According to the comment, food
chemists use only metric equivalents and their equipment is only
calibrated in metric units. The comment suggested that we list the
temperature in Celsius followed by a parenthetical reference in
Fahrenheit, i.e., instead of 220 [deg]F (104.4 [deg]C), use 105 [deg]C
(221 [deg]F). The comment stated that the proposed temperature
conversions do not follow the Omnibus Trade and Competitiveness Act of
1988. The comment also objected to expressing Celsius temperatures to
four digits.
    (Response) We do not agree with the comments suggestion to first
list the Celsius temperature, followed by a parenthetical reference to
the Fahrenheit temperature. Thermal processing temperatures are
expressed in Fahrenheit in the current low-acid canned food regulations
(part 113 (21 CFR part 113)) and many processors use temperature-
indicating devices that express temperature in Fahrenheit. In the
proposed rule, we added appropriate conversions to Celsius to ensure
consistency in such conversions. Each conversion provided in the
proposed rule was carefully evaluated to ensure that it appropriately
expressed the required Fahrenheit temperature, or increments of
temperature changes, and that any rounding did not significantly alter
the intended temperature measurement established in the regulations in
Fahrenheit. As demonstrated by the one degree Fahrenheit change in the
comment's example, the conversion and rounding of the Fahrenheit
temperature, based on the converted and rounded Celsius temperature,
may result in a change that could significantly impact scheduled
processes established based on Fahrenheit temperatures in the
regulation. The comment did not provide a basis for changing the
required scheduled process temperatures or cite specific provisions of
the Omnibus Trade and Competitiveness Act of 1988 that would be
applicable to Fahrenheit conversions in this regulation.
    The comment also did not explain the basis for objecting to
expressing Celsius temperatures to four digits. We interpret the
comment to mean that, above 100 [deg]C, the temperature should be
rounded to the nearest whole number, rather than to the nearest tenth,
which adds a fourth digit to the temperature measurement. We agree that
it is not necessary to convert the Fahrenheit temperatures to the
nearest tenth degree Celsius. Rather, we believe rounding should be to
the nearest 0.5 degree Celsius, consistent with the requirement for
temperature-indicating devices to be accurate to 1 [deg]F (0.5 [deg]C)
((final Sec.  113.40(a)(1)(iv), (b)(1)(iv), (c)(1)(iv), (d)(1)(iv),
(e)(1)(iv), (f)(1)(iv), and (g)(1)(i)(A)(4)). Accordingly, in this
final rule we rounded the Celsius temperatures up to the nearest 0.5
degree Celsius, i.e., we rounded 101.7 [deg]C to 102 [deg]C, 103.3
[deg]C to 103.5 [deg]C, 104.4 [deg]C to 104.5 [deg]C, and 107.2 [deg]C
to 107.5 [deg]C (final Sec.  113.40(a)(12)(i)(A), (a)(12)(i)(B),
(a)(12)(i)(C), (a)(12)(i)(D), (a)(12)(ii)(A), and (a)(12)(ii)(B)).
    (Comment 34) One comment indicated that using kilopascals as the
metric equivalent for pounds per square inch may cause confusion.
According to the comment, many systems use other units for pressure,
such as bar. The comment suggested that the parenthetical addition of
``kilopascals'' at various locations in the proposed rule be qualified
with ``or equivalent unit'' to support the use of the different, but
equivalent, ways of referring to pressure.
    (Response) We disagree with the comment. Each measurement in the
regulations, including pounds per square inch, may be converted to the
units appropriate for the equipment or system used by the processor,
provided that the converted measurement does not differ significantly
from the U.S. measurement in the regulation. Processors are responsible
for ensuring that converted measurements are consistent with the
requirements of the regulations, regardless of the unit of measure
used.
    (Comment 35) One comment noted that, in proposed Sec.  113.40(d)(7)
and (d)(8), the word ``schedules'' should be ``scheduled.''
    (Response) We agree. We revised proposed Sec.  113.40(d)(7) and
(d)(8) accordingly.
    (Comment 36) One comment suggested revising proposed Sec.
113.40(g)(1)(ii)(E) to change the term ``metering pump'' to ``flow
controlling device'' to be consistent with changes in proposed Sec.
113.40(g)(1)(i)(F).
    (Response) We agree that the term ``metering pump'' should be
replaced with a more current term. As noted by the comment, in proposed
Sec.  113.40(g)(1)(i)(F), we used the term ``flow controlling device.''
However, we believe the term ``flow control device'' is more consistent
with current terminology. Thus, we replaced the terms ``flow
controlling device'' and ``metering pump'' with ``flow control device''
in Sec.  113.40(g)(1)(i)(F) and (g)(1)(ii)(E) of this final rule.
    (Comment 37) One comment objected to the requirements in proposed
Sec.  113.60(d) for container handling equipment to be designed,
constructed, and operated to preserve the can seam or other container
closure integrity and for container handling equipment to be checked
with sufficient frequency and repaired or replaced to prevent damage to
containers. The comment stated that these proposed changes will not
provide greater public health protection than the current regulations.
According to the comment, the proposed changes will not provide FDA
with any additional enforcement tools because they do not specify what
processors must do to comply with the requirements and, thus, are
subject to interpretation. The comment requested that no change be made
to Sec.  113.60(d) in the current regulations.
    (Response) We do not agree with the comment's request to make no
change to previous Sec.  113.60(d), relating to container handling
equipment. Previous Sec.  113.60(d) recommends specific preventive
measures that may be taken to prevent damage to containers and
container closures, but does not clearly express that the measures are
a few examples, rather than an exhaustive expression of the processor's
responsibility to ensure that the can seam and container closure are
not compromised during post-process handling. The proposed revision to
Sec.  113.60(d) was intended to clarify that processors are responsible
for ensuring that container handling equipment used in handling filled
containers, including automated and non-automated equipment, is
designed and operated to preserve the can seam and container closure
integrity. This proposal allows flexibility regarding appropriate
design, construction, and operation of container handling equipment. We
believe processors currently ensure can seam and container closure
integrity without prescriptive instructions from the Agency. Also, we
recognize that the proposed revision does not establish a new
enforcement tool for FDA. The revised language is intended to clarify
processors' responsibilities relating to post-process handling. We
believe consumer protection will be enhanced

by processors who, as a result of the clarification to Sec.  113.60(d),
evaluate their post-process handling equipment and procedures and
either confirm that they are adequate or correct deficiencies.
    (Comment 38) One comment encouraged FDA to develop guidance for
processors and inspection personnel on how to verify compliance with
the proposed revision to Sec.  113.83, which indicates that 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. According to the comment, amending existing process filings
for thousands of products that currently meet this new requirement will
be burdensome to both the industry and FDA. The comment suggested that
a note in the processor's file from the processing authority should
satisfy this requirement.
    (Response) Previous Sec.  113.83 requires the type, range, and
combination of variations encountered in commercial production to be
adequately provided for in establishing the scheduled process.
Variations may occur due to seasonal or growing fluctuations, variety
differences, or supplier processes. Variations also may occur when a
food is reprocessed or when a previously processed product is mixed
with a batch of the same unprocessed product before it is processed. In
proposed Sec.  113.83 we clarified that variations that occur due to
reprocessing or mixing processed and unprocessed batches must be
provided for in the scheduled process. In this final rule, we clarify
in Sec.  113.83 that variations include those that occur due to
seasonal or growing fluctuations, variety differences, supplier
processes, reprocessing, and mixing a batch of processed product with
the same unprocessed product before it is processed. Therefore, this
clarification does not represent a change from what has already been
required of processors. Consistent with current Sec.  108.35(c)(2)(ii),
a processor who intentionally makes a change in a previously filed
scheduled process by changing a condition that is basic to the adequacy
of the scheduled process must obtain substantiation by a qualified
scientific authority as to its adequacy, promptly record the
substantiation, and obtain and file written verification from the
authority for review by FDA. In addition, within 30 days after the
first use, the processor must submit to FDA a copy of the file record
showing the substantiation by a qualified scientific authority.
    (Comment 39) One comment stated that proposed Sec.  113.100(g)
duplicates, in part, the requirements of Sec.  108.35(h). The comment
recommended removing the requirement from Sec.  113.100(g) or, if
retained, making the language identical to the language in Sec.
108.35(h).
    (Response) We agree with the comment and deleted Sec.  113.100(g)
from this final rule.

III. Minor Revisions in Regulations

    We made minor revisions in this final rule, including the
following:
    In final Sec.  113.40(a)(12)(i)(C), we corrected the metric
conversion for 2.5 inches to 6.4 centimeters.
    In final Sec.  113.40(d)(6), we changed the word ``containing'' to
``continuing.''
    In final Sec.  113.40(e)(7), we changed the word ``cross-section''
to ``cross-sectional,'' for consistency with use of the term in final
Sec.  113.40(a)(7) and (a)(12).

IV. Analysis of Economic Impacts

A. Final Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 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 final rule is not a significant regulatory action under the
Executive Order.
1. Need for Regulation
    This final rule is needed to address inflexibility in the current
regulations with regard to the requirement to use mercury-in-glass
thermometry in low-acid canned food manufacturing, as well as to update
and clarify current regulations. Previous regulations for thermally
processed low-acid foods in hermetically sealed containers, except for
aseptic packaging and processing, required 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
canned food industry.
    Moreover, the number and variety of low-acid canned food products,
the technologies, and the countries where they are processed have
changed substantially since 1973 when the low-acid canned food
regulations became effective. Data on imported foods obtained from
FDA's ``Consumption of Imported Foods'' model indicates that
approximately 15 billion pounds of low-acid canned food were imported
from more than 100 countries in 2006 (Ref. 5). Provisions in the
regulations issued in 1973 that were targeted toward technologies at
that time may be less clear when applied to technologies being used
today.
2. Costs and Benefits of Revisions Suggested by Comments
    There were no comments that directly addressed the economic
sections in the proposed regulatory impact analysis. We evaluated the
revisions to the proposed rule to determine whether they may have
implications for costs and benefits of this final rule. We identify
each revision to the proposed rule that may have implications for the
costs and benefits of this final rule as belonging to one of three
categories of provisions, each category distinguished by the way it
contributes to the costs and benefits. The categories of provisions
are: Revisions to proposed recordkeeping requirements reported in table
1 of this document, revisions to the proposed non-recordkeeping
requirements that may facilitate adoption of alternative technologies
reported in table 2 of this document, and other minor revisions. Even
though many of the revisions lie outside the framework of the economic
analysis in the proposed rule, their categorization may help identify
any potential costs and benefits. The costs and benefits of this final
rule are reported in table 3 of this document.

        Table 1--Revisions to Proposed Recordkeeping Requirements
------------------------------------------------------------------------
                                   Final 21 CFR
    Proposed 21 CFR Section          Section              Revision
------------------------------------------------------------------------
113.40(a)(1)(ii)(A) and         113.100(c)(3) and  Make explicit the
 (a)(1)(ii)(B),                  (d)(3).            records requirements
 113.40(b)(1)(ii)(A) and                            that apply when an
 (b)(1)(ii)(B),                                     accuracy test for a
 113.40(c)(1)(ii)(A) and                            temperature-
 (c)(1)(ii)(B),                                     indicating device
 113.40(d)(1)(ii)(A) and                            and for a reference
 (d)(1)(ii)(B),                                     device that is
 113.40(e)(1)(ii)(A) and                            maintained by the
 (e)(1)(ii)(B),                                     processor is
 113.40(f)(1)(ii)(A) and                            conducted by an
 (f)(1)(ii)(B),                                     outside facility.
 113.40(g)(1)(i)(A)(2)(i) and
 (g)(1)(i)(A)(2)(ii).
113.40(a)(1)(ii)(A) and         113.100(c)(5) and  Clarify that records
 (a)(1)(ii)(B),                  (d)(5).            of the accuracy of a
 113.40(b)(1)(ii)(A) and                            temperature-
 (b)(1)(ii)(B),                                     indicating device
 113.40(c)(1)(ii)(A) and                            and a reference
 (c)(1)(ii)(B),                                     device maintained by
 113.40(d)(1)(ii)(A) and                            the processor must
 (d)(1)(ii)(B),                                     include the date and
 113.40(e)(1)(ii)(A) and                            results of each
 (e)(1)(ii)(B),                                     accuracy test,
 113.40(f)(1)(ii)(A) and                            including the amount
 (f)(1)(ii)(B),                                     of calibration
 113.40(g)(1)(i)(A)(2)(i) and                       adjustment.
 (g)(1)(i)(A)(2)(ii).
113.40(a)(1)(ii)(A) and         113.100(c)(6) and  Indicate ``[t]he date
 (a)(1)(ii)(B),                  (d)(6).            on or before which
 113.40(b)(1)(ii)(A) and                            the next accuracy
 (b)(1)(ii)(B),                                     test must be
 113.40(c)(1)(ii)(A) and                            performed'' instead
 (c)(1)(ii)(B),                                     of the proposed
 113.40(d)(1)(ii)(A) and                            ``the date of the
 (d)(1)(ii)(B),                                     next scheduled
 113.40(e)(1)(ii)(A) and                            accuracy test.''
 (e)(1)(ii)(B),
 113.40(f)(1)(ii)(A) and
 (f)(1)(ii)(B),
 113.40(g)(1)(i)(A)(2)(i) and
 (g)(1)(i)(A)(2)(ii).
------------------------------------------------------------------------

    FDA believes that the information required by this final rule to be
established and maintained for accuracy tests is currently generated
even though it may not currently be permanently recorded. We estimate
that the revisions to the proposed records requirements reported in
table 1 of this document will add very little or no additional costs to
the recordkeeping costs estimated in the analysis of the proposed rule.
Thus, the estimated costs of the records of the accuracy tests for this
final rule are not different than those estimated for the analysis of
the proposed rule (72 FR 11990 at 11999, March 14, 2007).

 Table 2--Revisions to Proposed Non-Recordkeeping Requirements That May
             Facilitate Adoption of Alternative Technologies
------------------------------------------------------------------------
    Revised 21 CFR Section                      Revision
------------------------------------------------------------------------
113.40(a)(1), 113.40(b)(1),    Replace ``an accurate calibrated
 113.40(c)(1), 113.40(d)(1),    reference device'' with ``a reference
 113.40(e)(1), 113.40(f)(1)     device for which the accuracy is
 and (g)(1)(i)(A), 113.87(c).   traceable to a National Institute of
                                Standards and Technology (NIST), or
                                other national metrology institute,
                                standard reference device.''
113.40(a)(1)(iv),              Replace ``easily readable to'' with
 113.40(b)(1)(iv),              ``accurate to'' to describe the
 113.40(c)(1)(iv),              measurement uncertainty allowed for
 113.40(e)(1)(iv) and           temperature-indicating devices.
 (f)(1)(iv),
 113.40(g)(1)(i)(A)(4).
Proposed 113.40(b)(10)(ii):    Change the term ``pilot light or other
 Final 113.40(b)(11).           signaling device'' to ``signaling
Proposed 113.40(e)(6)(ii):      device'' on the pump that controls water
 Final 113.40(e)(7).            circulation to allow for the use of
                                alternative signaling devices.
113.40(g)(1)(i)(E)...........  Clarify that recordings for differential
                                pressure recorder-controllers may be
                                analog or graphical or digital.
130.40(g)(1)(i)(F) and         Replace ``metering pump'' with ``flow
 (g)(1)(ii)(E).                 control device``.
------------------------------------------------------------------------

    The costs for the revisions to the proposed rule of non-
recordkeeping requirements that may facilitate adoption of alternative
technologies are estimated to be zero since the adoption of alternative
technologies is voluntary and there would be no additional health risks
from their adoption. The benefits of these revisions are estimated to
be positive since they would allow additional flexibility for adopting
alternative thermometry and other technologies that, consistent with
the framework in the analysis of the proposed rule, could slightly
improve labor productivity in the manufacture of low-acid canned food.
    Other revisions in this final rule include those that are editorial
in nature and clarifications of existing regulations that have neither
additional costs nor additional benefits to those considered in the
analysis of the proposed rule (72 FR 11990 at 11999, March 14, 2007).
3. Regulatory Options
    This section reports estimates of the costs and benefits of several
regulatory options. The regulatory options include: (a) No new
regulation; (b) allow flexibility to use temperature-indicating
devices, including mercury-in-glass thermometers, without explicit
recordkeeping requirements; and (c) final rule--Option (b), with
explicit recordkeeping requirements for accuracy tests for temperature-
indicating devices and reference devices maintained by the processor.
     Option (a)--No new regulation.
    There would be neither costs nor benefits from this option.
     Option (b)--Allow flexibility to use temperature-
indicating devices, including mercury-in-glass thermometers, without
explicit recordkeeping requirements.
    There would be neither costs nor benefits from this option.
     Option (c)--Final rule--Option (b), with explicit
recordkeeping requirements for accuracy tests for temperature-
indicating devices and reference devices maintained by the processor.
    Tables 3 and 4 of this document report the costs and benefits of
this final rule based on estimates derived in the analysis of the
proposed rule and modified in accordance with changes to the final
rule, as indicated in the tables. In the analysis of the proposed rule,
we estimated the costs to be from the recordkeeping provisions that
involved one-time and recurring costs. The benefits from the proposed
rule were from the reduced presence of mercury in food processing
facilities, the reduced mercury cleanup and remediation costs, and
improved labor productivity due to the voluntary adoption of
alternative temperature device technologies. In addition, benefits from
the recordkeeping provisions were from the

enhanced ability to track critical accuracy test data, particularly
during the transition from mercury-in-glass thermometers to alternative
temperature-indicating devices (72 FR 11990 at 11999, March 14, 2007).

                    Table 3--Costs of the Final Rule
------------------------------------------------------------------------
      One-time recordkeeping costs
------------------------------------------------------------------------
Design of new recordkeeping forms......  Minimal.
Recordkeeping training.................  Minimal.
Recurring Costs (annual)
Recordkeeping \1\......................  $5,000-$23,000 plus a minimal
                                          amount in accordance to the
                                          changes to the recordkeeping
                                          language.
Purchase and additional testing of       Voluntarily incurred.
 alternative devices.
------------------------------------------------------------------------
\1\ Estimates based on those reported in the analysis for the proposed
  rule.

                   Table 4--Benefits of the Final Rule
------------------------------------------------------------------------
        Benefits (annual)
------------------------------------------------------------------------
Change in risk from low-acid       No change.
 canned foods.
Clarification of existing          Not quantified.
 processor's responsibilities.
Avoided mercury cleanup costs \1\  $31,000-$152,000.
Enhanced labor productivity from   Not quantified.
 adopting alternative temperature-
 indicating devices and other
 processing technologies.
Enhanced ability to track          Not quantified.
 critical accuracy performance
 data--especially during the
 transition period following the
 adoption of alternative
 temperature indicating devices.
------------------------------------------------------------------------
\1\ Estimates based on those reported in the analysis for the proposed
  rule.

B. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (RFA) requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. An estimate of the cost of the proposed rule on
small entities was made in the proposed rule. For firms of all sizes,
the per-firm costs were estimated to be between $1 and $4 per year for
each of the estimated 6,700 firms. The per-firm costs for small firms
were estimated to be on the lower end of that range. Based on these
estimates, FDA certified that the proposed rule would not have a
significant impact on a substantial number of small entities. Under the
RFA, no further analysis is required. For the complete discussion, see
the Regulatory Flexibility Analysis of the proposed rule (72 FR 11990
at 11999 and 12003 to 12004, March 14, 2007). No comments objected to
or suggested significant modifications to the estimates of the per-firm
costs in the regulatory flexibility analysis in the proposed rule.

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, for ``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 1 year.''
The current threshold after adjustment for inflation is $135 million,
using the most current (2009) Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect this final rule to result in any
1-year expenditure that would meet or exceed this amount.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The final
rule revises information collection requirements in part 113 that are
currently approved under OMB control number 0910-0037 (expires August
31, 2011). Comments on the information collection requirements
currently approved under OMB control number 0910-0037, as amended by
the information collection provisions of this final rule, are being
solicited in a separate notice published elsewhere in this issue of the
Federal Register. That notice also announces that FDA has submitted the
information collection provisions of the final rule to OMB for
approval, along with a request for extension of the related information
collection provisions already approved under OMB control number 0910-
0037, as revised by the final rule. Prior to the effective date of this
final rule, FDA will publish a notice in the Federal Register
announcing OMB's decision to approve, modify, or disapprove the
information collection provisions in this final rule. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
    In compliance with the PRA (44 U.S.C. 3506(c)(2)(B)), the Agency
requested public comment on the information collection provisions of
the proposed rule (72 FR 11990 at 12004). The proposed rule also stated
that FDA had submitted the information collection provisions to OMB for
review (72 FR 11990 at 12005). However, due to an administrative error,
the Agency did not actually do so, and therefore is submitting them to
OMB now. No public comments to the analysis of the information
collection provisions in the proposed rule suggested that we modify our
burden estimates. Thus, we have not changed our estimates of the annual
frequency per recordkeeping or the hours per record. We have, however,
increased the estimated number of recordkeepers to reflect growth in
the low-acid canned food processing industry since the 2007 proposed
rule.
    Title: Recordkeeping Requirements for Temperature-Indicating
Devices.
    Description: The information to be collected is related to accuracy
tests of temperature-indicating devices and reference devices
maintained by processors of low-acid canned foods. These tests must be
performed to ensure the accuracy of the devices during the processing
of these foods. If these devices are not accurate, the processor cannot
ensure that the low-acid canned foods it produces are safe to eat, and
consumers may be harmed. The recordkeeping requirements of the rule are
necessary to document that

appropriate accuracy tests have been performed with the appropriate
frequencies for each temperature-indicating device and each reference
device maintained by the processor. Records of accuracy tests for these
devices also help processors determine how frequently the devices
should be tested for accuracy. Much of the information is currently
generated for accuracy tests performed under current regulations.
However, the information may not be recorded as required under the
final rule.
    Current low-acid canned food regulations recommend, but do not
require, that processors keep records of accuracy tests for mercury-in-
glass thermometers, including test date, standard used, method used,
and person performing the test. This final rule requires processors to
keep records documenting the accuracy of temperature-indicating devices
(including but not limited to mercury-in-glass thermometers) and of
reference devices that are maintained by the processor. These records
include: The identifier of the device being tested, such as its tag or
seal; the name of the manufacturer of the device; the identity of the
reference device, equipment, and procedures used for the accuracy test
and to adjust the device or, if an outside facility conducts the
accuracy test, documentation tracing the accuracy to a NIST or other
national metrology institute standard; the identity of the person or
facility that performed the accuracy test and adjusted or calibrated
the device; the date and results of each accuracy test, including the
amount of adjustment; and the date on or before which the next accuracy
test must be performed.
    Description of Respondents: The respondents to this information
collection are commercial low-acid canned food processors. Based on
FDA's low-acid canned food manufacturers' registration database as of
September 2009, we estimate that there are approximately 8,450 foreign
and domestic low-acid canned food processing establishments.
    Burden: The burden of the recordkeeping requirement consists of the
setup time required to design and establish a form for recording the
required information, and the additional hours of labor needed to
record the information. The setup time required for designing a new
recordkeeping form is assumed to be minimal since we estimate that only
a few data elements required in the final rule are currently unreported
by some processors and that only small modifications to a processor's
recordkeeping form would be required to accommodate the additional data
elements.
    We estimate that the time needed to comply with the recordkeeping
requirements of the final rule will be small because current industry
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, however, some information
that is currently generated during accuracy tests may not be recorded
as required under the final rule. Thus, we assume there will be a
burden incurred from the final rule to record information that is
currently generated, but not recorded.
    We assume that half of the industry currently does not record all
of the device accuracy testing information that the final rule
requires. We further assume that current practice by these firms is to
leave unrecorded 1 to 4 separate pieces of information required under
the final rule, and that each piece of information takes between 10 and
15 seconds to record. Consequently, we estimate that half of all low-
acid canned food manufacturers will spend between 10 seconds and 1
minute (i.e., 1 x 10 seconds and 4 x 15 seconds) per device to record
information required in the final rule.
    Based on a survey conducted by FDA between 1992 and 1993 of
mercury-in-glass thermometer calibration in the low-acid canned food
industry, we estimate that low-acid food firms use an average of 10
temperature-indicating devices, including reference devices. We
estimate that 4,225 low-acid canned food manufacturers (half of the
industry) currently do not fully record the accuracy test results
required by the final rule. Because the regulations specify that each
device must be tested upon installation and at least once a year
thereafter, or more frequently if necessary to ensure accuracy, we
estimate that each device requires 1 to 2 tests per year (midpoint of
1.5 tests per year). We therefore 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). Therefore, the estimated total annual burden in
hours for the recordkeeping requirements of the final rule is
approximately 615 hours (63,375 x 0.0097 = 614.7 hours, rounded to 615
hours). Table 5 of this document reports the average annual
recordkeeping burden described previously in this section of the
document.

                                                    Table 5-Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Annual  frequency
                      21 CFR Section                           Number of             per            Total annual     Hours per record     Total hours
                                                             recordkeepers      recordkeeping         records
--------------------------------------------------------------------------------------------------------------------------------------------------------
113.100(c) and (d).......................................             4,225                 15             63,375             0.0097                615
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
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, the Agency has concluded
that the 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.

VII. References

    We have placed the following references on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20857. You may see them between 9
a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site
addresses, but FDA is not responsible for any subsequent changes to the
Web sites after this document publishes in the Federal Register.

    1. International Vocabulary of Metrology--Basic and General
Concepts and Associated Terms (VIM), BIPM, IEC, IFCC, ILAC, ISO, IUPAC,
IUPAP, OIML, 3d ed., p. 21, definition 2.13, 2008; accessed online
October 20, 2010, at http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2008.pdf.
    2. International Vocabulary of Metrology--Basic and General
Concepts and Associated Terms (VIM), BIPM, IEC, IFCC, ILAC, ISO, IUPAC,
IUPAP, OIML, 3d ed., p. 29, definition 2.41, 2008; accessed online
October 20, 2010, at http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2008.pdf.
    3. International Vocabulary of Metrology--Basic and General
Concepts and Associated Terms (VIM), BIPM, IEC, IFCC, ILAC, ISO, IUPAC,
IUPAP, OIML, 3d ed., p. 19, definition 2.9, 2008; accessed online
October 20, 2010, at http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2008.pdf.
    4. International Vocabulary of Metrology--Basic and General
Concepts and Associated Terms (VIM), BIPM, IEC, IFCC, ILAC, ISO, IUPAC,
IUPAP, OIML, 3d ed., p. 25, definition 2.26, 2008; accessed online
October 20, 2010, at http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2008.pdf.
    5. U.S. FDA, Consumption of Imported Foods, Final Report. RTI
International, Contract 223-01-2466, Task Order 11, RTI Project Number
0208184.011, August 2008.

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, 21 CFR part
113 is amended as follows:

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

0
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.

0
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. Each
temperature-indicating device shall have a sensor and a display. Each
temperature-indicating device and each reference device that is
maintained by the processor shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device by appropriate standard
procedures, upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure accuracy during processing.
Each temperature-indicating device and each reference device that is
maintained by the processor shall have a tag, seal, or other means of
identity.
    (i) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and maintained in accordance with Sec.  113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it
can be accurately and easily read. The temperature-indicating device
sensor shall be installed either within the retort shell or in external
wells attached to the retort. External wells or pipes shall be
connected to the retort through at least a \3/4\-inch (2 centimeters)
diameter opening and equipped with a \1/16\-inch (1.5 millimeters) or
larger bleeder opening so located as to provide a full flow of steam
past the length of the temperature-indicating device sensor. The
bleeders for external wells shall emit steam continuously during the
entire processing period. The temperature-indicating device--not the
temperature recording device--shall be the reference instrument for
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an
accurate temperature-recording device. Each temperature-recording
device shall have a sensor and a mechanism for recording temperatures
to a permanent record, such as a temperature-recording chart. The
temperature-recording device sensor shall be installed either within
the retort shell or in a well attached to the shell. Each temperature-
recording device sensor well shall have a \1/16\-inch (1.5 millimeters)
or larger bleeder that emits steam continuously during the processing
period.
    (i) Analog or graphical recordings. Temperature-recording devices
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the
appropriate chart. Each chart shall have a working scale of not more
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C)
of the process temperature. Temperature-recording devices that create
multipoint plottings of temperature readings shall record the
temperature at intervals that will assure that the parameters of the
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as
data loggers, that record numbers or create other digital records may
be used. Such a device shall record the temperature at intervals that
will assure that the parameters of the process time and process
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized
changes in adjustment shall be provided. A lock or a notice from
management posted at or near the temperature-recording device that
provides a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may
be combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or
less.
    (4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recorder-controller when combined with a temperature-recording
device. The steam controller may be air-operated and actuated by a
temperature sensor positioned near the temperature-indicating device in
the retort. Air-operated temperature controllers should have adequate
filter systems to ensure a

supply of clean, dry air. 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 the 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 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 of 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 paragraphs
(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] TR03MR11.000

    (1) 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.
    (2) Venting method. Vent valves should be wide open for at least 5
minutes and to at least 225 [deg]F (107 [deg]C), or at least 7 minutes
and to at least 220 [deg]F (104.5 [deg]C).
    (B) Venting through multiple 1-inch (2.5 centimeters) vents
discharging through a manifold to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR03MR11.001

    (1) 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).
    (2) 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
[deg]C), or for at least 8 minutes and to at least 220 [deg]F (104.5
[deg]C).
    (C) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TR03MR11.002

    (1) 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 (6.4 centimeters).
    (2) 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.
    (3) 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 [deg]C), or for at least 7 minutes and to at least 220 [deg]F
(104.5 [deg]C).

    (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] TR03MR11.003

    (1) 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.
    (2) Venting method. Vent gate or plug cock valve should be wide
open for at least 4 minutes and to at least 220 [deg]F (104.5 [deg]C).
    (ii) Venting vertical retorts. (A) Venting through a 1.5-inch (3.8
centimeters) overflow.

[GRAPHIC] [TIFF OMITTED] TR03MR11.004

    (1) 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.
    (2) Venting method. Vent gate or plug cock valve should be wide
open for at least 4 minutes and to at least 218 [deg]F (103.5 [deg]C),
or for at least 5 minutes and to at least 215 [deg]F (102 [deg]C).
    (B) Venting through a single 1-inch (2.5 centimeters) side or top
vent.

[GRAPHIC] [TIFF OMITTED] TR03MR11.005

    (1) 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.
    (2) 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 [deg]C), or
for at least 7 minutes and to at least 220 [deg]F (104.5 [deg]C).
    (iii) Other procedures. Other installations and operating
procedures that deviate from the requirements in paragraph (a)(12) of
this section 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. Each
temperature-indicating device shall have a sensor and a display. Each
temperature-indicating device and each reference device that is
maintained by the processor shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device by appropriate standard
procedures, upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure accuracy during processing.
Each temperature-indicating device and each reference device that is
maintained by the processor shall have a tag, seal, or other means of
identity.
    (i) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and

maintained in accordance with Sec.  113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it
can be accurately and easily read. In both horizontal and vertical
retorts, the temperature-indicating device sensor shall be inserted
directly into the retort shell or in a separate well or sleeve attached
to the retort. The temperature-indicating device sensor shall be
located so that it is beneath the surface of the water throughout the
process and where there is adequate circulation to ensure accurate
temperature measurement. On horizontal retorts, the temperature-
indicating device sensor should be located in the side at the center of
the retort. The temperature-indicating device--not the temperature-
recording device--shall be the reference instrument for indicating the
processing temperature.
    (2) Temperature-recording device. Each retort shall have an
accurate temperature-recording device. Each temperature-recording
device shall have a sensor and a mechanism for recording temperatures
to a permanent record, such as a temperature-recording chart.
    (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