[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Rules and Regulations]
[Pages 11892-11924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4475]



[[Page 11891]]

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  

[[Page 11892]]


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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, 301-436-2070.

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).

[[Page 11893]]

    (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

[[Page 11894]]

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

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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

[[Page 11896]]

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)).

[[Page 11897]]

    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

[[Page 11898]]

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

[[Page 11899]]

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

[[Page 11900]]

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),

[[Page 11901]]

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

[[Page 11902]]

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.

[[Page 11903]]



        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

[[Page 11904]]

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

[[Page 11905]]

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.

[[Page 11906]]

    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

[[Page 11907]]

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


[[Page 11908]]


    (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).

[[Page 11909]]

    (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.

[[Page 11910]]

[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.

[[Page 11911]]

[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

[[Page 11912]]

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

[[Page 11913]]

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

[[Page 11914]]

[GRAPHIC] [TIFF OMITTED] TR03MR11.006

BILLING CODE 4160-01-C

Legend for Vertical and Horizontal Still Retorts

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

[[Page 11915]]

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

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

[[Page 11916]]

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

[[Page 11917]]

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

[[Page 11918]]

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

[[Page 11919]]

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

[[Page 11920]]

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

[[Page 11921]]

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

[[Page 11922]]

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

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


Sec.  113.60  Containers.

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

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


Sec.  113.83  Establishing scheduled processes.

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

[[Page 11923]]

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

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


Sec.  113.87  Operations in the thermal processing room.

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

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


Sec.  113.100  Processing and production records.

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

[[Page 11924]]

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

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