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



[[Page 11989]]

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Part III





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 113



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

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

[[Page 11990]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 113

[Docket No. 2007N-0026]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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

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

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

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

I. Background

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

[[Page 11991]]

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

II. Legal Authority

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

[[Page 11992]]

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

III. Proposed Rule

A. Equipment and Procedures (Sec.  113.40)

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

[[Page 11993]]

year * * * or more frequently if necessary, to ensure their accuracy'' 
(Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and 
(g)(1)(i)(a)) and by requiring that a mercury-in-glass thermometer that 
has a ``divided mercury column or that cannot be adjusted to the 
standard shall be repaired or replaced before further use of the 
retort'' (Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and 
(f)(1); similar requirement in Sec.  113.40(g)(1)(i)(a)). The design of 
the mercury-in-glass thermometer makes it relatively easy to detect a 
malfunction, including those caused by environmental conditions, 
because most are associated with a broken thermometer, separated 
column, or scale slippage. However, malfunction of other temperature-
indicating devices may need to be detected by means other than 
observation. For example, a temperature-indicating device could be 
designed with a dual probe sensor that would enable detection of loss 
of accuracy of one of the probes when the probe readings do not agree. 
FDA recommends, but is not proposing to require, a dual probe design. 
FDA recognizes that specific design specifications for temperature-
indicating devices may limit the flexibility of the regulation for 
current and future technologies. Design specificity in the regulation 
is not practical because of the diversity of technology associated with 
temperature-indicating devices that have been or may be developed and 
because, for each type of temperature-indicating device, different 
factors or parameters may need to be addressed by design. Rather, the 
proposed regulation would require that the design of the temperature-
indicating device ensure that the accuracy of the device is not 
affected by electromagnetic interference and environmental conditions. 
Thus, the processor is responsible for ensuring that the temperature-
indicating device is designed so that its accuracy during processing is 
not compromised due to electromagnetic interference or environmental 
conditions and that any malfunctions in the device that may affect 
accuracy will be immediately detectable.
2. Documentation and Records
    Current Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and 
(f)(1) recommend, but do not specifically require, maintenance of 
records of accuracy checks. These regulations indicate that the records 
should specify the date, standard used, method used, and person 
performing the test. The regulations also recommend, but do not 
require, that each thermometer should have a tag, seal, or other means 
of identity that includes the date on which it was last tested for 
accuracy. Similar provisions in current Sec.  113.40(g)(1)(i)(a) apply 
to maintenance of records of accuracy checks and to establishing a 
means of identity for ``thermometers and temperature-indicating 
devices.'' However, establishment and maintenance of records of the 
accuracy of each temperature-indicating device are essential for 
documenting accuracy of temperature-indicating devices throughout time, 
for determining that each temperature-indicating device complies with 
current requirements to be accurate during processing, and for 
verifying that temperatures required by the scheduled process are met. 
Further, such documentation is necessary for evaluating the performance 
of temperature-indicating devices that are technologically and 
operationally different from mercury-in-glass thermometers 
traditionally used in processing low-acid canned food.
    FDA is proposing to require that each temperature-indicating device 
have a tag, seal, or other means of identity that will be used by the 
processor to identify the temperature-indicating device and that each 
reference device have a tag, seal, or other means of identity that will 
be used by the processor to identify the reference device. FDA is 
proposing to eliminate the current recommendation in Sec.  
113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and (g)(1)(i)(a) 
to include on the tag or seal the date on which each thermometer was 
last tested for accuracy. FDA does not object to recording the accuracy 
test date on the tag or seal. However, as discussed later in this 
document, FDA is proposing to require that the date of the last 
accuracy test be included as part of the record of accuracy for the 
temperature-indicating device. FDA believes this proposed change 
clarifies the process for assuring that the written record of the 
accuracy test can be linked to the appropriate temperature-indicating 
device.
    FDA is proposing that a written record of accuracy for each 
temperature-indicating device shall be established and maintained. 
Documentation of the accuracy of each temperature-indicating device 
shall include the following information: (1) A reference to the tag, 
seal, or other means of identity used by the processor to identify the 
temperature-indicating device; (2) the name of the manufacturer of the 
temperature-indicating device; (3) the identity of the reference device 
used for the accuracy test; (4) the identity of the equipment and 
procedures used to adjust or calibrate the temperature-indicating 
device; (5) the date and results of each accuracy test; (6) the name of 
the person or facility that performed the accuracy test and adjusted or 
calibrated the temperature-indicating device; and (7) the date of the 
next scheduled accuracy test. Reference to the temperature-indicating 
device identity in the record of accuracy provides an essential link 
between each temperature-indicating device and the specific record 
associated with that device. The name of the manufacturer enables the 
processor to readily identify the source of the defective or deficient 
device and to correct or replace the device, as appropriate. 
Identification of the reference device used for the accuracy check and 
of the equipment and procedures used to adjust or calibrate the 
temperature-indicating device provides an essential reference for 
additional followup in the event the reference device is subsequently 
determined to be inaccurate. Documentation of the date and results of 
accuracy tests provides evidence that scheduled tests were performed 
and is essential for evaluating performance of the temperature-
indicating device over time. This information can be used to determine 
whether more frequent accuracy tests are needed and whether a 
temperature-indicating device needs to be replaced. Documentation of 
the identification of the person or facility that performed the 
accuracy test and adjusted or recalibrated the temperature-indicating 
device is essential for appropriate followup in the event that the 
temperature-indicating device subsequently is determined to be 
inaccurate.
    These records are necessary to ensure that appropriate accuracy 
checks are performed for each temperature-indicating device, to 
establish the appropriate frequency for accuracy checks, to identify 
when there is a problem with a temperature-indicating device and, as 
necessary, to repair or replace the device, and to determine and 
initiate appropriate followup to ensure that low-acid canned foods are 
appropriately processed. Because it is not possible for FDA to 
continuously observe processors' operations, these records are 
essential to ensure that the agency has the information needed to 
identify noncompliance and to bring a non-compliant processor into 
compliance. Thus, these records are essential for FDA to have an 
enforceable regulation that will ensure public health protection.
    Current Sec.  113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and 
(f)(1) require that thermometers (and temperature-indicating devices in 
Sec.  113.40(g)(1)(i)(a)) shall be tested for accuracy against a

[[Page 11994]]

known accurate standard thermometer. This requirement implies, but does 
not explicitly state, that the processor must be able to demonstrate, 
by appropriate documentation, that the reference or standard device 
used to determine the accuracy of the thermometers used to measure 
temperature during processing also is accurate. Thus, although the 
current regulations require documentation of the accuracy of the 
standard thermometer, the specific documentation FDA expects processors 
to maintain is not clear. FDA is proposing to clarify this requirement 
by specifying that a written record of the accuracy of the reference 
device shall be established and maintained. Documentation of the 
accuracy of the reference device must include the following 
information: (1) A reference to the tag, seal, or other means of 
identity used by the processor to identify the reference device; (2) 
the name of the manufacturer of the reference device; (3) the identity 
of the equipment and procedures used to test the accuracy and to adjust 
or calibrate the reference device; (4) the identity of the person or 
facility that performed the accuracy test and adjusted or calibrated 
the reference device; (5) the date and results of the accuracy test; 
and (6) the traceability information. Traceability, as defined by the 
International Vocabulary of Basic and General Terms in Metrology, means 
a ``property of the result of a measurement or the value of a standard 
whereby it can be related to stated references, usually national or 
international standards, through an unbroken chain of comparisons all 
having stated uncertainties'' (Ref. 2). Accordingly, records must be 
maintained to document that the accuracy of the reference device can be 
traced by comparison with a standard device, such as a NIST standard 
temperature device. Documentation of the traceability information for 
the reference device may be in the form of a guaranty of accuracy from 
the manufacturer of the reference device or a certificate of 
calibration from a laboratory. Information required in the record of 
accuracy for a reference device is essential for assuring that 
reference devices maintain their accuracy and ensures that the 
processor can establish an unbroken chain to trace the accuracy of the 
reference device to a standard device.
    The requirements in proposed Sec.  113.40(a)(1), (b)(1), (c)(1), 
(d)(1), (e)(1), (f)(1), and (g)(1)(i)(a) to establish and maintain 
written records of accuracy of temperature-indicating devices and 
reference devices, which include the identity of temperature-indicating 
devices and reference devices, are subject to the recordkeeping 
requirements of Sec.  113.100. See the discussion later in this 
document relating to proposed revisions to Sec.  113.100.
    FDA is proposing to revise Sec.  113.40(g)(1)(ii)(e) by removing 
the requirement to observe and record the product temperature in the 
temperature recorder-controller at the final heater outlet in aseptic 
processing and packaging systems. The temperature in the final heater 
outlet may not be a critical factor in the scheduled process and, 
therefore, may not require maintenance of records. However, if the 
final heater outlet temperature is identified as a critical factor in 
the scheduled process, the temperature must be observed and recorded, 
as required in Sec.  113.100(a).
3. Metric Equivalents
    FDA is proposing to revise Sec.  113.40(a), (b), (c), (d), (e), 
(f), and (g) to provide metric equivalents of avoirdupois (U.S.) 
measurements. Currently, these regulations express temperature 
measurements in Fahrenheit ([deg]F) units, length measurements in 
inches and feet, and pressure measurements in pounds per square inch. 
The proposed metric equivalents are provided in parenthesis in the text 
of the proposed regulation, immediately following the avoirdupois 
measurement. FDA is proposing to modify the current regulations to not 
only provide the temperature measurements in Fahrenheit, but to follow 
the Fahrenheit ([deg]F) measure with the units in Celsius ([deg]C). FDA 
is proposing to provide measurements currently in inches also in 
millimeters or centimeters, measurements currently in feet also in 
centimeters or meters, and measurements in pounds per square inch of 
pressure also in kilopascals.
4. Temperature-Recording Devices
    Current Sec.  113.40(a)(2), (b)(2), (c)(2), (d)(2), (e)(2), (f)(2), 
and (g)(1)(i)(b) states that, ``Graduations on the temperature-
recording devices shall not exceed 2 [deg]F within a range of 10 [deg]F 
of the processing temperature. Each chart shall have a working scale of 
not more than 55 [deg]F per inch within a range of 20 [deg]F of the 
processing temperature. The temperature chart shall be adjusted to 
agree as nearly as possible with, but to be in no event higher than, 
the known accurate mercury-in-glass thermometer during the process 
time.'' When the regulations were published in the 1973 final rule, 
temperature-recording devices generally recorded temperatures to paper 
charts and the paper charts served as the historical record of 
temperatures during processing. At that time, the terms ``temperature-
recording device'' and ``recording chart'' were used interchangeably. 
However, because of advancements in technology, temperatures may now be 
recorded in a format other than the traditional chart that has a pre-
printed time and temperature scale and may be recorded and maintained 
by mechanisms or devices other than recorders that use the traditional 
recording charts. The permanent record of temperatures may be in the 
form of an analog or graphical recording, such as a traditional chart 
with pre-printed time and temperature scale. The permanent record also 
may be an analog or graphical recording, for which the chart design, 
continuous temperature recordings or tracings, and date and time 
notations may be generated and printed by the temperature-recording 
device onto a blank paper, chart, or other medium as they are generated 
by the temperature-recording device. Processors also are using 
temperature-recording devices, such as data loggers, that record 
numbers or create other digital recordings at established intervals, 
rather than providing continuous recordings on a chart. Therefore, FDA 
recognizes that the term ``temperature-recording device'' does not 
necessarily imply that temperatures are being recorded to a 
``temperature-recording chart.'' Thus, the ``graduation'' and ``working 
scale'' requirements in the current regulation do not apply to all 
temperature-recording device records. The general term ``temperature-
recording device'' should be used when referring to the entire device 
that records temperatures and the term ``temperature-recording chart'' 
should be used when referring to an actual chart that constitutes the 
mechanism by which the temperature-recording device records processing 
temperatures. The ``graduation'' and ``working scale'' requirements 
specified in the current regulation are still applicable to the 
``temperature-recording chart,'' when used as the mechanism for 
recording processing temperatures.
    FDA, therefore, is proposing to revise Sec.  113.40(a)(2), (b)(2), 
(c)(2), (d)(2), (e)(2), (f)(2), and (g)(1)(i)(b) to provide flexibility 
for processors to use temperature-recording device advanced technology, 
to update terminology to reflect current and appropriate use of terms 
such as ``temperature-recording device'' and ``temperature-recording 
chart,'' to replace the terms ``mercury-in-glass thermometer'' and

[[Page 11995]]

``thermometer'' with ``temperature-indicating device,'' to replace the 
term ``bulb'' with ``sensor'' (discussed later in this document), and 
to clarify the requirements for temperature-recording devices and the 
records created by the devices as follows:
    Temperature-recording device. Each retort, or product sterilizer, 
shall have an accurate temperature-recording device that records 
temperatures to a permanent record, such as a temperature-recording 
chart.
    Analog or graphical recordings. Temperature-recording devices that 
create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital recordings may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
5. Sensors
    FDA is proposing to revise Sec.  113.40(a), (b), (c), (d), (e), 
(f), and (g)(1) by replacing the term ``bulb'' or ``bulb or sensor'' 
with the general term ``sensor'' when referring generally to the 
sensing element of temperature-indicating devices, temperature-
recording devices, and temperature-controlling devices. The sensing 
element of a mercury-in-glass thermometer is called a ``bulb'' in the 
current regulations. The term ``sensor'' encompasses ``bulb'' as well 
as other types of temperature-indicating device sensing elements, which 
are not bulbs. In the proposed regulation, the inclusive term 
``sensor'' is used when referring to the sensor portion of a 
temperature-indicating device, which may be the bulb of a mercury-in 
glass thermometer, or to the sensing element or probe of a temperature-
recording device or temperature-controlling device, which may include a 
mercury-in-glass thermometer as a component of the device.
    FDA is proposing to revise Sec.  113.40(b)(2) to clarify that, for 
still retort systems that pressure process in water and are equipped 
with combination recorder-controller sensors, the temperature recorder-
controller sensors shall be located where the recorded temperature is 
an accurate measurement of the scheduled process temperature and is not 
affected by the heating media. Current Sec.  113.40(b)(2) indicates 
specific requirements for placement of sensors for recorder-
controllers, as follows: ``The recording-thermometer bulb should be 
located adjacent to the bulb of the mercury-in-glass thermometer, 
except in the case of a vertical retort equipped with a combination 
recorder-controller. In such vertical retorts, the temperature 
recorder-control bulb shall be located at the bottom of the retort 
below the lowest crate rest in such a position that the steam does not 
strike it directly. In horizontal retorts, the temperature recorder-
control bulb shall be located between the water surface and the 
horizontal plane passing through the center of the retort so that there 
is no opportunity for direct steam impingement on the control bulb.'' 
These requirements for placement of combination recorder-controller 
sensors were intended to ensure accurate measurement of the scheduled 
process temperature and were helpful specific directives for sensor 
placement when the regulations were published in 1973, based on retort 
designs at that time. However, it may be technologically feasible to 
comply with the specific requirements of the current regulation, but 
place the sensor in a location that does not accurately measure the 
scheduled process temperature. Thus, although the specific sensor 
location requirements of current Sec.  113.40(b)(2) are still valid, 
FDA believes further clarification is needed to ensure that combination 
recorder-controller sensors are located where the recorded temperature 
is an accurate measurement of the scheduled process temperature and is 
not affected by the heating media. FDA is proposing to provide this 
clarification in new Sec.  113.40(b)(2)(iv) as follows:
    <bullet> The temperature-recording device may be combined with the 
steam controller and may be a combination recording-controlling 
instrument. For a vertical retort equipped with a combination recorder-
controller, the temperature recorder-controller sensor shall be located 
at the bottom of the retort below the lowest crate rest in such a 
position that the steam does not strike it directly. For a horizontal 
retort equipped with a combination recorder-controller, the temperature 
recorder-controller sensor shall be located between the water surface 
and the horizontal plane passing through the center of the retort so 
that there is no opportunity for direct steam impingement on the 
sensor. For all still retort systems that pressure process in water and 
are equipped with combination recorder-controllers, the temperature 
recorder-controller sensors shall be located where the recorded 
temperature is an accurate measurement of the scheduled process 
temperature and is not affected by the heating media. Air-operated 
temperature controllers should have adequate filter systems to ensure a 
supply of clean, dry air.
    FDA is proposing to clarify in Sec.  113.40(b)(9) that a sensor, in 
addition to a gage, water glass, or petcock, may be used to determine 
the water level in the retort during operation. For some water level 
indictors, the term ``sensor'' may more appropriately describe the 
mechanism that measures or detects the water level.
    FDA is proposing to revise Sec.  113.40(e)(1) to clarify 
requirements for placement of sensors of temperature-indicating devices 
in discontinuous agitating retorts used for pressure processing in 
water, i.e., a water immersion processing system. Current Sec.  
113.40(e)(1) requires, ``Bulbs of indicating thermometers shall be 
installed either within the retort shell or in external wells attached 
to the retort.'' However, this basic, unqualified requirement to place 
sensors in the retort shell or in external wells may not be sufficient 
to ensure proper placement of temperature-indicating device sensors in 
discontinuous agitating retorts used for pressure processing in water. 
Current Sec.  113.40(b)(1), relating to pressure processing in water in 
still retorts, also a water immersion process, clarifies that, ``Bulbs 
of indicating thermometers shall be located in such a position that 
they are beneath the surface of the water throughout the process * * * 
this entry should be made in the side at the center, and the 
thermometer bulb shall be inserted directly into the retort shell * * * 
the thermometer bulbs shall extend directly into the water a minimum of 
at least 2 inches without a separable well or sleeve.'' This type of 
clarification relating to placement of temperature-indicating device 
sensors in still retorts used for pressure processing in water also 
applies to discontinuous retorts for pressure processing in water. 
Thus, FDA is proposing to revise Sec.  113.40(e)(1) (proposed Sec.  
113.40(e)(1)(v)) by adding clarifying language relating to temperature-
indicating device sensor

[[Page 11996]]

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

[[Page 11997]]

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

B. Containers (Sec.  113.60)

    Current Sec.  113.60(a) requires processors to ensure proper 
closure and to check for closure defects. This responsibility should 
have extended to postprocess handling. However, current Sec.  113.60(a) 
does not specifically address postprocess handling and current Sec.  
113.60(d) relating to postprocess handling recommends, but does not 
require, processors to design and operate automatic equipment used in 
handling filled containers to preserve the can seam and container 
closure integrity. Container handling equipment, including automated 
and non-automated equipment, must be of appropriate equipment design 
and construction, operated to ensure container closure integrity, and 
replaced or repaired if defective to ensure proper container closure. 
Otherwise, container handling equipment may be the source of damage to 
the can seam and may prevent proper seam closure. Improper seam 
closures may lead to contamination of the previously sterilized product 
in the can. FDA is proposing to revise Sec.  113.60(d) to change the 
term ``automatic equipment'' to ``container handling equipment,'' to 
clarify that container handling equipment used in handling filled 
containers shall be designed, constructed, and operated to preserve can 
seam or other container closure integrity, and to clarify that 
processors must check and, as necessary, repair or replace the 
container handling equipment, including conveyors and non-automated 
equipment, to ensure that they do not damage the containers and 
container closures as follows:
    <bullet> Postprocess handling. Container handling equipment used in 
handling filled containers shall be designed, constructed, and operated 
to preserve the can seam or other container closure integrity. 
Container handling equipment, including automated and non-automated 
equipment, shall be checked at sufficient frequency and repaired or 
replaced as necessary to prevent damage to containers and container 
closures. When cans are handled on belt conveyors, the conveyors should 
be constructed to minimize contact by the belt with the double seam, 
i.e., cans should not be rolled on the double seam. All worn and frayed 
belting, can retarders, cushions, etc. should be replaced with new 
nonporous material. All tracks and belts that come into contact with 
the can seams should be thoroughly scrubbed and sanitized at intervals 
of sufficient frequency to avoid product contamination.

[[Page 11998]]

C. Establishing Scheduled Processes (Sec.  113.83)

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

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

    FDA is proposing to revise Sec.  113.87(c) by inserting the term 
``accurately'' in the first sentence to clarify that ``The initial 
temperature of the contents of the containers to be processed shall be 
accurately determined and recorded with sufficient frequency to ensure 
that the temperature of the product is no lower than the minimum 
initial temperature specified in the scheduled process.'' FDA is adding 
this term to emphasize that initial temperature determinations must be 
accurate, as determined by sufficiently frequent tests of the 
temperature-indicating device for accuracy against an accurate 
calibrated reference device. FDA also is proposing to add in Sec.  
113.87(c), ``The temperature-indicating device used to determine the 
initial temperature shall be tested for accuracy against an accurate 
calibrated reference device at sufficient frequency to ensure that 
initial temperature measurements are accurate. Records of the accuracy 
tests shall be signed or initialed, dated, and maintained.'' Although 
FDA believes it should be understood that initial temperature 
measurements are expected to be accurate when taken and, therefore, the 
temperature-indicating device used for initial temperatures must be 
accurate, the proposed clarifications ensure consistency in 
interpretation of the requirements of Sec.  113.87(c).
    FDA is proposing to revise Sec.  113.87(e) to replace the term 
``recording-temperature charts'' with ``temperature-recording device 
records'' to ensure consistency with the changes in terminology 
relating to the use of the term ``charts,'' discussed previously in 
this document in changes to proposed revised Sec.  113.40. FDA also is 
proposing to change the recommendation for clock times to reasonably 
correspond to the time of the day to a requirement by changing the word 
``should'' to ``shall.'' Correlation of records with the time the 
records were created and with the time of the processing cycle is 
essential for evaluating time and temperature correlations of the 
scheduled process. This revision also is consistent with the 
requirement of Sec.  113.100(a), ``Processing and production 
information shall be entered at the time it is observed by the retort 
or processing system operator * * *.'' Proposed revised Sec.  113.87(e) 
would read as follows:
    <bullet> Clock times on temperature-recording device records shall 
reasonably correspond to the time of day on the written processing 
records to provide correlation of these records.

E. Processing and Production Records (Sec.  113.100)

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

[[Page 11999]]

F. Minor Revisions in Regulations

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

G. Immediate Implementation of Proposed Rule

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

IV. Analysis of Impacts

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

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

[[Page 12000]]

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

[[Page 12001]]

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

[[Page 12002]]

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

[[Page 12003]]

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

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

B. Regulatory Flexibility Analysis

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

[[Page 12004]]

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

C. Unfunded Mandate Analysis

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

V. Environmental Impact

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

VI. Paperwork Reduction Act

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

Title: Recordkeeping Requirements for Temperature-Indicating Devices

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

[[Page 12005]]

average annual burden described previously in this document.

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

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

VII. Federalism

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

VIII. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IX. References

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

List of Subjects in 21 CFR Part 113

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

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

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

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


Sec.  113.40  Equipment and procedures.

    (a) Equipment and procedures for pressure processing in steam in 
still retorts--(1) Temperature-indicating device. Each retort shall be 
equipped with at least one temperature-indicating device that 
accurately indicates the temperature during processing. Temperature-
indicating devices shall be tested for accuracy against an accurate 
calibrated reference device by appropriate standard procedures, upon 
installation and at least once a year thereafter, or more frequently if 
necessary, to ensure accuracy during processing. Each temperature-
indicating device and reference device shall have a tag, seal, or other 
means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.
    (A) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures

[[Page 12006]]

used to adjust or calibrate the temperature-indicating device, the date 
and results of each accuracy test, the name of the person or facility 
that performed the accuracy test and adjusted or calibrated the 
temperature-indicating device, and the date of the next scheduled 
accuracy test.
    (B) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or facility that performed 
the accuracy test and adjusted or calibrated the reference device, the 
date and results of the accuracy test, and the traceability 
information. Documentation of the traceability information for the 
reference device may be in the form of a guaranty of accuracy from the 
manufacturer of the reference device or a certificate of calibration 
from a laboratory.
    (iii) A temperature-indicating device that is defective or cannot 
be adjusted to the accurate calibrated reference device shall be 
repaired or replaced before further use.
    (iv) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The sensor of the temperature-
indicating device shall be installed either within the retort shell or 
in external wells attached to the retort. External wells or pipes shall 
be connected to the retort through at least a 3/4-inch (2 centimeters) 
diameter opening and equipped with a 1/16-inch (1.5 millimeters) or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the temperature-indicating device sensor. The 
bleeders for external wells shall emit steam continuously during the 
entire processing period. The temperature-indicating device--not the 
temperature-recording device--shall be the reference instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an 
accurate temperature-recording device that records temperatures to a 
permanent record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as 
data loggers, that record numbers or create other digital records may 
be used. Such a device shall record the temperature at intervals that 
will assure that the parameters of the process time and process 
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted to agree as nearly as possible with, but to be in no event 
higher than, the temperature-indicating device during the process time. 
A means of preventing unauthorized changes in adjustment shall be 
provided. A lock or a notice from management posted at or near the 
temperature-recording device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may 
be combined with the steam controller and may be a recording-
controlling instrument. The temperature-recording device sensor shall 
be installed either within the retort shell or in a well attached to 
the shell. Each temperature-recording device sensor well shall have a 
1/16-inch (1.5 millimeters) or larger bleeder which emits steam 
continuously during the processing period. Air-operated temperature 
controllers should have adequate filter systems to ensure a supply of 
clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that should be graduated in divisions of 2 pounds per square inch 
(13.8 kilopascals) or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a temperature-
recording device. The steam controller may be air-operated and actuated 
by a temperature sensor positioned near the temperature-indicating 
device in the retort. A steam controller activated by the steam 
pressure of the retort is acceptable if it is carefully maintained 
mechanically so that it operates satisfactorily.
    (5) Steam inlet. The steam inlet to each still retort shall be 
large enough to provide sufficient steam for proper operation of the 
retort. Steam may enter either the top portion or the bottom portion of 
the retort but, in any case, shall enter the portion of the retort 
opposite the vent; for example, steam inlet in bottom portion and vent 
in top portion.
    (6) Crate supports. A bottom crate support shall be used in 
vertical still retorts. Baffle plates shall not be used in the bottom 
of still retorts.
    (7) Steam spreaders. Steam spreaders are continuations of the steam 
inlet line inside the retort. Horizontal still retorts shall be 
equipped with steam spreaders that extend the length of the retort. For 
steam spreaders along the bottom of the retort, the perforations should 
be along the top 90[deg] of this pipe, that is, within 45[deg] on 
either side of the top center. Horizontal still retorts over 30 feet 
(9.1 meters) long should have two steam inlets connected to the 
spreader. In vertical still retorts, the steam spreaders, if used, 
should be perforated along the center line of the pipe facing the 
interior of the retort or along the sides of the pipe. The number of 
perforations should be such that the total cross-sectional area of the 
perforations is equal to 1.5 to 2 times the cross-sectional area of the 
smallest restriction in the steam inlet line.
    (8) Bleeders. Bleeders, except those for temperature-indicating 
device wells, shall be 1/8-inch (3 millimeters) or larger and shall be 
wide open during the entire process, including the come-up-time. For 
horizontal still retorts, bleeders shall be located within 
approximately 1 foot (30.5 centimeters) of the outermost locations of 
containers at each end along the top of the retort. Additional bleeders 
shall be located not more than 8 feet (2.4 meters) apart along the top. 
Bleeders may be installed at positions other than those specified in 
this paragraph, as long as there is evidence in the form of heat 
distribution data that they accomplish adequate removal of air and 
circulation of steam within the retort. Vertical retorts shall have at 
least one bleeder opening located in that portion of the retort 
opposite the steam inlet. In retorts having top steam inlet and bottom 
venting, a bleeder shall be installed in the bottom of the retort to 
remove condensate. All bleeders shall be arranged so that the operator 
can

[[Page 12007]]

observe that they are functioning properly.
    (9) Stacking equipment and position of containers. Crates, trays, 
gondolas, etc., for holding containers shall be made of strap iron, 
adequately perforated sheet metal, or other suitable material. When 
perforated sheet metal is used for the bottoms, the perforations should 
be approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-
inch (5.1 centimeters) centers. If dividers are used between the layers 
of containers, they should be perforated as stated in this paragraph. 
The positioning of containers in the retort, when specified in the 
scheduled process, shall be in accordance with that process.
    (10) Air valves. Retorts using air for pressure cooling shall be 
equipped with a suitable valve to prevent air leakage into the retort 
during processing.
    (11) Water valves. Retorts using water for cooling shall be 
equipped with a suitable valve to prevent leakage of water into the 
retort during processing.
    (12) Vents. Vents shall be installed in such a way that air is 
removed from the retort before timing of the process is started. Vents 
shall be controlled by gate, plug cock, or other adequate type valves 
which shall be fully open to permit rapid discharge of air from the 
retort during the venting period. Vents shall not be connected directly 
to a closed drain system. If the overflow is used as a vent, there 
shall be an atmospheric break in the line before it connects to a 
closed drain. The vent shall be located in that portion of the retort 
opposite the steam inlet; for example, steam inlet in bottom portion 
and vent in top portion. Where a retort manifold connects several vent 
pipes from a single still retort, it shall be controlled by a gate, 
plug cock, or other adequate type valve. The retort manifold shall be 
of a size that the cross-sectional area of the pipe is larger than the 
total cross-sectional area of all connecting vents. The discharge shall 
not be directly connected to a closed drain without an atmospheric 
break in the line. A manifold header connecting vents or manifolds from 
several still retorts shall lead to the atmosphere. The manifold header 
shall not be controlled by a valve and shall be of a size that the 
cross-sectional area is at least equal to the total cross-sectional 
area of all connecting retort manifold pipes from all retorts venting 
simultaneously. Timing of the process shall not begin until the retort 
has been properly vented and the processing temperature has been 
reached. Some typical installations and operating procedures reflecting 
the requirements of this section for venting still retorts without 
divider plates are given in paragraph (a)(12)(i)(A) through 
(a)(12)(i)(D) and (a)(12)(ii)(A) and (a)(12)(ii)(B) of this section.
    (i) Venting horizontal retorts. (A) Venting through multiple 1-inch 
(2.5 centimeters) vents discharging directly to atmosphere.
[GRAPHIC] [TIFF OMITTED] TP14MR07.007

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

[[Page 12008]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.008

    Specifications. One 1-inch (2.5 centimeters) vent for every 5 feet 
(1.5 meters) of retort length; and vents not over 2.5 feet (76 
centimeters) from ends of retort: Size of manifold--for retorts less 
than 15 feet (4.6 meters) in length, 2.5 inches (6.4 centimeters); for 
retorts 15 feet (4.6 meters) and over in length, 3 inches (7.6 
centimeters).
    Venting method. Manifold vent gate or plug cock valve should be 
wide open for at least 6 minutes and to at least 225 [deg]F (107.2 
[deg]C), or for at least 8 minutes and to at least 220 [deg]F (104.4 
[deg]C).
    (C) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TP14MR07.009
    
    Size of vent and vent valve. For retorts less than 15 feet (4.6 
meters) in length, 2 inches (5.1 centimeters); for retorts 15 feet (4.6 
meters) and over in length, 2.5 inches (3.8 centimeters).
    Size of water spreader. For retorts less than 15 feet (4.6 meters) 
in length, 1.5 inches (3.8 centimeters); for retorts 15 feet (4.6 
meters) and over in length, 2 inches (5.1 centimeters). The number of 
holes should be such that their total cross-sectional area is 
approximately equal to the cross-sectional area of the vent pipe inlet.
    Venting method. Water spreader vent gate or plug cock valve should 
be wide open for at least 5 minutes and to at least 225 [deg]F (107.2 
[deg]C), or for at least 7 minutes and to at least 220 [deg]F (104.4 
[deg]C).

[[Page 12009]]

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

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

[[Page 12010]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.011

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

[[Page 12011]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.012

    Specifications. A 1-inch (2.5 centimeters) vent in lid or top side, 
equipped with a 1-inch (2.5 centimeters) gate or plug cock valve and 
discharging directly into the atmosphere or to a manifold header.
    Venting method. Vent gate or plug cock valve should be wide open 
for at least 5 minutes and to at least 230 [deg]F (110.0 [deg]C), or 
for at least 7 minutes and to at least 220 [deg]F (104.4 [deg]C).
    (iii) Other procedures. Other installations and operating 
procedures that deviate from the above specifications may be used if 
there is evidence in the form of heat distribution data, which shall be 
kept on file, that they accomplish adequate venting of air.
    (13) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (iv) When the product style results in stratification or layering 
of the primary product in the containers, the positioning of containers 
in the retort shall be according to the scheduled process.
    (b) Equipment and procedures for pressure processing in water in 
still retorts--(1) Temperature-indicating device. Each retort shall be 
equipped with at least one temperature-indicating device that 
accurately indicates the temperature during processing. Temperature-
indicating devices shall be tested for accuracy against an accurate 
calibrated reference device by appropriate standard procedures, upon 
installation and at least once a year thereafter, or more frequently if 
necessary, to ensure accuracy during processing. Each temperature-
indicating device and reference device shall have a tag, seal, or other 
means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.

[[Page 12012]]

    (A) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures used to adjust or calibrate the 
temperature-indicating device, the date and results of each accuracy 
test, the name of the person or facility that performed the accuracy 
test and adjusted or calibrated the temperature-indicating device, and 
the date of the next scheduled accuracy test.
    (B) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or facility that performed 
the accuracy test and adjusted or calibrated the reference device, the 
date and results of the accuracy test, and the traceability 
information. Documentation for the reference device may be in the form 
of a guaranty of accuracy from the manufacturer or a certificate of 
calibration from a laboratory.
    (iii) A temperature-indicating device that is defective or cannot 
be adjusted to the accurate calibrated reference device shall be 
repaired or replaced before further use.
    (iv) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. Sensors of temperature-indicating 
devices shall be located in such a position that they are beneath the 
surface of the water throughout the process. On horizontal retorts, 
this entry should be made in the side at the center, and the 
temperature-indicating device sensor shall be inserted directly into 
the retort shell. In both vertical and horizontal retorts, the 
temperature-indicating device sensor shall extend directly into the 
water a minimum of at least 2 inches (5.1 centimeters) without a 
separable well or sleeve. If a separate well or sleeve is used, there 
must be adequate circulation to ensure accurate temperature 
measurements. The temperature-indicating device--not the temperature-
recording device--shall be the reference instrument for indicating the 
processing temperature.
    (2) Temperature-recording device. Each retort shall have an 
accurate temperature-recording device that records temperatures to a 
permanent record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as 
data loggers, that record numbers or create other digital records may 
be used. Such a device shall record the temperature at intervals that 
will assure that the parameters of the process time and process 
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted to agree as nearly as possible with, but to be in no event 
higher than, the temperature-indicating device during the process time. 
A means of preventing unauthorized changes in adjustment shall be 
provided. A lock or a notice from management posted at or near the 
temperature-recording device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may 
be combined with the steam controller and may be a combination 
recording-controlling instrument. For a vertical retort equipped with a 
combination recorder-controller, the temperature recorder-controller 
sensor shall be located at the bottom of the retort below the lowest 
crate rest in such a position that the steam does not strike it 
directly. For a horizontal retort equipped with a combination recorder-
controller, the temperature recorder-controller sensor shall be located 
between the water surface and the horizontal plane passing through the 
center of the retort so that there is no opportunity for direct steam 
impingement on the sensor. For all still retort systems that pressure 
process in water and are equipped with combination recorder-
controllers, the temperature recorder-controller sensors shall be 
located where the recorded temperature is an accurate measurement of 
the scheduled process temperature and is not affected by the heating 
media. Air-operated temperature controllers should have adequate filter 
systems to ensure a supply of clean, dry air.
    (3) Pressure gages. (i) Each retort should be equipped with a 
pressure gage that should be graduated in divisions of 2 pounds per 
square inch (13.8 kilopascals) or less.
    (ii) Each retort should have an adjustable pressure relief or 
control valve of a capacity sufficient to prevent an undesired increase 
in retort pressure when the water valve is wide open and should be 
installed in the overflow line.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. The 
steam controller may be combined with a temperature-recording device 
and, thus, may be a combination recorder-controller.
    (5) Steam introduction. Steam shall be distributed in the bottom of 
the retort in a manner adequate to provide uniform heat distribution 
throughout the retort. In vertical retorts, uniform steam distribution 
can be achieved by any of several methods. In horizontal retorts, the 
steam distributor shall run the length of the bottom of the retort with 
perforations distributed uniformly along the upper part of the pipe.
    (6) Crate supports. A bottom crate support shall be used in 
vertical still retorts. Baffle plates shall not be used in the bottom 
of the retort. Centering guides should be installed so as to ensure 
that there is about a 1.5-inch (3.8 centimeters) clearance between the 
side wall of the crate and the retort wall.
    (7) Stacking equipment and position of containers. Crates, trays, 
gondolas, etc., for holding containers shall be made of strap iron, 
adequately perforated sheet metal, or other suitable material. When 
perforated sheet metal is used for the bottoms, the perforations should 
be approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-
inch (5.1 centimeters) centers. If divider plates are used between the 
layers of containers, they should be perforated as stated in this 
paragraph. The positioning of containers in the retort, when specified 
in the scheduled process, shall be in accordance with that process. 
Dividers, racks, trays, or other means of positioning of flexible 
containers shall be designed and employed to ensure

[[Page 12013]]

even circulation of heating medium around all containers in the retort.
    (8) Drain valve. A nonclogging, water-tight valve shall be used. A 
screen shall be installed or other suitable means shall be used on all 
drain openings to prevent clogging.
    (9) Water level indicator. There shall be a means of determining 
the water level in the retort during operation, e.g., by using a 
sensor, gage, water glass, or petcock(s). Water shall cover the top 
layer of containers during the entire come-up-time and processing 
periods and should cover the top layer of containers during the cooling 
periods. The operator shall check and record the water level at 
intervals sufficient to ensure its adequacy.
    (10)(i) Air supply and controls. In both horizontal and vertical 
still retorts for pressure processing in water, a means shall be 
provided for introducing compressed air at the proper pressure and 
rate. The proper pressure shall be controlled by an automatic pressure 
control unit. A check valve shall be provided in the air supply line to 
prevent water from entering the system. Air or water circulation shall 
be maintained continuously during the come-up-time and during 
processing and cooling periods. The adequacy of the air or water 
circulation for uniform heat distribution within the retort shall be 
established in accordance with procedures recognized by a competent 
processing authority and records shall be kept on file. If air is used 
to promote circulation, it shall be introduced into the steam line at a 
point between the retort and the steam control valve at the bottom of 
the retort.
    (ii) Water circulation. When a water circulating system is used for 
heat distribution, it shall be installed in such a manner that water 
will be drawn from the bottom of the retort through a suction manifold 
and discharged through a spreader which extends the length of the top 
of the retort. The holes in the water spreader shall be uniformly 
distributed and should have an aggregate area not greater than the 
cross-section area of the outlet line from the pump. The suction 
outlets shall be protected with nonclogging screens or other suitable 
means shall be used to keep debris from entering the circulating 
system. The pump shall be equipped with a pilot light or other 
signaling device to warn the operator when it is not running, and with 
a bleeder to remove air when starting operations. Alternative methods 
for circulation of water in the retort may be used when established by 
a competent authority as adequate for even heat distribution.
    (11) Cooling water supply. In vertical retorts the cooling water 
should be introduced at the top of the retort between the water and 
container levels; in horizontal retorts the cooling water should be 
introduced into the suction side of the pump. A check valve should be 
included in the cooling water line.
    (12) Retort headspace. The headspace necessary to control the air 
pressure should be maintained between the water level and the top of 
the retort shell.
    (13) Vertical and horizontal still retorts. Vertical and horizontal 
still retorts should follow the arrangements in the diagrams below in 
this paragraph. Other installation and operating procedures that 
deviate from these arrangements may be used, as long as there is 
evidence in the form of heat distribution data or other suitable 
information, which shall be kept on file, which demonstrates that the 
heat distribution is adequate.
BILLING CODE 4160-01-S

[[Page 12014]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.013

BILLING CODE 4160-01-C

[[Page 12015]]

    Legend for Vertical and Horizontal Still Retorts
    A--Water line.
    B--Steam line.
    C--Temperature control.
    D--Overflow line.
    E<INF>1</INF>--Drain line.
    E<INF>2</INF>--Screens.
    F--Check valves.
    G--Line from hot water storage.
    H--Suction line and manifold.
    I--Circulating pump.
    J--Petcocks.
    K--Recirculating line.
    L--Steam distributor.
    M--Temperature-controller sensor.
    N--Temperature-indicating device sensor.
    O--Water spreader.
    P--Safety valve.
    Q--Vent valve for steam processing.
    R--Pressure gage.
    S--Inlet air control.
    T--Pressure control.
    U--Air line.
    V--To pressure control instrument.
    W--To temperature control instrument.
    X--Wing nuts.
    Y<INF>1</INF>--Crate support.
    Y<INF>2</INF>--Crate guides.
    Z--Constant flow orifice valve.
    Z<INF>1</INF>--Constant flow orifice valve used during come-up.
    Z<INF>2</INF>--Constant flow orifice valve used during cook.
    (14) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (iv) When the product style results in stratification or layering 
of the primary product in the containers, the positioning of containers 
in the retort shall be according to the scheduled process.
    (c) Equipment and procedures for pressure processing in steam in 
continuous agitating retorts--(1) Temperature-indicating device. Each 
retort shall be equipped with at least one temperature-indicating 
device that accurately indicates the temperature during processing. 
Temperature-indicating devices shall be tested for accuracy against an 
accurate calibrated reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. 
Each temperature-indicating device and reference device shall have a 
tag, seal, or other means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.
    (A) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures used to adjust or calibrate the 
temperature-indicating device, the date and results of each accuracy 
test, the name of the person or facility that performed the accuracy 
test and adjusted or calibrated the temperature-indicating device, and 
the date of the next scheduled accuracy test.
    (B) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or facility that performed 
the accuracy test and adjusted or calibrated the reference device, the 
date and results of the accuracy test, and the traceability 
information. Documentation for the reference device may be in the form 
of a guaranty of accuracy from the manufacturer or a certificate of 
calibration from a laboratory.
    (iii) A temperature-indicating device that is defective or cannot 
be adjusted to the accurate calibrated reference device shall be 
repaired or replaced before further use.
    (iv) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The sensor of the temperature-
indicating device shall be installed either within the retort shell or 
in external wells attached to the retort. External wells or pipes shall 
be connected to the retort through at least a 3/4-inch (2 centimeters) 
diameter opening and equipped with a 1/16-inch (1.5 millimeters) or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the temperature-indicating device sensor. The 
bleeders for external wells shall emit steam continuously during the 
entire processing period. The temperature-indicating device--not the 
temperature-recording device--shall be the reference instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an 
accurate temperature-recording device that records temperatures to a 
permanent record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as 
data loggers, that record numbers or create other digital records may 
be used. Such a device shall record the temperature at intervals that 
will assure that the parameters of the process time and process 
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted to agree as nearly as possible with, but to be in no event 
higher than, the temperature-indicating device during the process time. 
A means of preventing unauthorized changes in adjustment shall be 
provided. A lock or a notice from management posted at or near the 
temperature-recording device that

[[Page 12016]]

provides a warning that only authorized persons are permitted to make 
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may 
be combined with the steam controller and may be a recording-
controlling instrument. The temperature-recording device sensor shall 
be installed either within the retort shell or in a well attached to 
the shell. Each temperature-recording device sensor well shall have a 
1/16-inch (1.5 millimeters) or larger bleeder opening emitting steam 
continuously during the processing period. Air-operated temperature 
controllers should have adequate filter systems to ensure a supply of 
clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage, which should be graduated in divisions of 2 pounds per square 
inch (13.8 kilopascals) or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a temperature-
recording device. A steam controller activated by the steam pressure of 
the retort is acceptable if it is carefully maintained mechanically so 
that it operates satisfactorily.
    (5) Bleeders. Bleeders, except those for temperature-indicating 
device wells, shall be 1/8-inch (3 millimeters) or larger and shall be 
wide open during the entire process, including the come-up-time. 
Bleeders shall be located within approximately 1 foot (30.5 
centimeters) of the outermost location of containers at each end along 
the top of the retort. Additional bleeders shall be located not more 
than 8 feet (2.4 meters) apart along the top of the retort. All 
bleeders shall be arranged so that the operator can observe that they 
are functioning properly. The condensate bleeder shall be checked with 
sufficient frequency to ensure adequate removal of condensate or shall 
be equipped with an automatic alarm system(s) that would serve as a 
continuous monitor of condensate-bleeder functioning. Visual checks 
should be done at intervals of not more than 15 minutes. A record of 
such checks should be kept to show that the bleeder is functioning 
properly.
    (6) Venting and condensate removal. Vents shall be located in that 
portion of the retort opposite the steam inlet. Air shall be removed 
before processing is started. Heat distribution data or documentary 
proof from the manufacturer or from a competent processing authority, 
demonstrating that adequate venting is achieved, shall be kept on file. 
At the time steam is turned on, the drain should be opened for a time 
sufficient to remove steam condensate from the retort, and provision 
shall be made for continuing drainage of condensate during the retort 
operation. The condensate bleeder in the bottom of the shell serves as 
an indicator of continuous condensate removal.
    (7) Retort speed timing. The rotational speed of the retort shall 
be specified in the scheduled process. The speed shall be adjusted and 
recorded when the retort is started, at any time a speed change is 
made, and at intervals of sufficient frequency to ensure that the 
retort speed is maintained as specified in the scheduled process. These 
adjustments and recordings should be made every 4 hours or less. 
Alternatively, a recording tachometer may be used to provide a 
continuous record of the speed. A means of preventing unauthorized 
speed changes on retorts shall be provided. A lock, or a notice from 
management posted at or near the speed adjustment device that provides 
a warning that only authorized persons are permitted to make 
adjustments, is a satisfactory means of preventing unauthorized 
changes.
    (8) Emergency stops. If a retort jams or breaks down during 
processing operations, necessitating cooling the retort for repairs, 
the retort shall be operated in such a way that ensures that the 
product is commercially sterile, or the retort is to be cooled promptly 
and all containers either reprocessed, repacked and reprocessed, or 
discarded. When operated as a still retort, all containers shall be 
given a full still retort process before the retort is cooled. If, in 
such an emergency, a scheduled still process or another process 
established to ensure commercial sterility is to be used, it shall be 
made readily available to the retort operator.
    (i) Any containers in the retort intake valve or in transfer valves 
between cooker shells of a continuous retort at the time of breakdown 
shall either be reprocessed, repacked and reprocessed, or discarded.
    (ii) Both the time at which the reel stopped and the time the 
retort was used for a still retort process, if so used, shall be marked 
on the recording chart and entered on the other production records 
required in this chapter. If the alternative procedure of prompt 
cooling is followed, the subsequent handling methods used for the 
containers in the retort at the time of stopping and cooling shall be 
entered on the production records.
    (9) Temperature drop. If the temperature of the continuous retort 
drops below the temperature specified in the scheduled process while 
containers are in the retort, the retort reel shall be stopped 
promptly. An automatic device should be used to stop the reel when the 
temperature drops below the specified process temperature. Before the 
reel is restarted, all containers in the retort shall be given a 
complete scheduled still retort process if the temperature drop was 10 
[deg]F (5 [deg]C) or more below the specified temperature, or 
alternatively, container entry to the retort shall be stopped and the 
reel restarted to empty the retort. The discharged containers shall be 
either reprocessed, repacked and reprocessed, or discarded. Both the 
time at which the reel stopped and the time the retort was used for a 
still retort process, if so used, shall be marked on the temperature-
recording device record and entered on the other production records 
required in this chapter. If the alternative procedure of emptying the 
retort is followed, the subsequent handling methods used for the 
containers in the retort at the time of the temperature drop shall be 
entered on the production records. If the temperature drop was less 
than 10 [deg]F (5 [deg]C), a scheduled authorized emergency still 
process approved by a qualified person(s) having expert knowledge of 
thermal processing requirements may be used before restarting the 
retort reel. Alternatively, container entry to the retort shall be 
stopped and an authorized emergency agitating process may be used 
before container entry to the retort is restarted. When emergency 
procedures are used, no containers may enter the retort and the process 
and procedures used shall be noted on the production records.
    (10) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers, if specified in the scheduled process, shall be measured 
and recorded at intervals of sufficient frequency to ensure that the 
headspace is as specified in the scheduled process. The headspace of 
solder-tipped, lapseam (vent hole) cans may be measured by net weight 
determinations. The headspace of double seamed cans may also be 
measured by net weight determinations for homogenous liquids, taking 
into account the specific can end profile and other factors which 
affect the headspace, if proof of the accuracy of such measurements is 
maintained and

[[Page 12017]]

the procedure and resultant headspace is in accordance with the 
scheduled process. When the product consistency is specified in the 
scheduled process, the consistency of the product shall be determined 
by objective measurements on the product taken from the filler before 
processing and recorded at intervals of sufficient frequency to ensure 
that the consistency is as specified in the scheduled process. Minimum 
closing machine vacuum in vacuum-packed products, maximum fill-in or 
drained weight, minimum net weight, and percent solids shall be as 
specified in the scheduled process for all products when deviations 
from such specifications may affect the scheduled process. All 
measurements and recordings of critical factors should be made at 
intervals not to exceed 15 minutes.
    (d) Equipment and procedures for pressure processing in steam in 
discontinuous agitating retorts--(1) Temperature-indicating device. 
Each retort shall be equipped with at least one temperature-indicating 
device that accurately indicates the temperature during processing. 
Temperature-indicating devices shall be tested for accuracy against an 
accurate calibrated reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. 
Each temperature-indicating device and reference device shall have a 
tag, seal, or other means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.
    (A) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures used to adjust or calibrate the 
temperature-indicating device, the date and results of each accuracy 
test, the name of the person or facility that performed the accuracy 
test and adjusted or calibrated the temperature-indicating device, and 
the date of the next scheduled accuracy test.
    (B) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or facility that performed 
the accuracy test and adjusted or calibrated the reference device, the 
date and results of the accuracy test, and the traceability 
information. Documentation for the reference device may be in the form 
of a guaranty of accuracy from the manufacturer or a certificate of 
calibration from a laboratory.
    (iii) A temperature-indicating device that is defective or cannot 
be adjusted to the accurate calibrated reference device shall be 
repaired or replaced before further use.
    (iv) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The sensor of the temperature-
indicating device shall be installed either within the retort shell or 
in external wells attached to the retort. External wells or pipes shall 
be connected to the retort through at least a 3/4-inch (2 centimeters) 
diameter opening and equipped with a 1/16-inch (1.5 millimeters) or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the temperature-indicating device sensor. The 
bleeders for external wells shall emit steam continuously during the 
entire processing period. The temperature-indicating device--not the 
temperature-recording device--shall be the reference instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an 
accurate temperature-recording device that records temperatures to a 
permanent record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as 
data loggers, that record numbers or create other digital records may 
be used. Such a device shall record the temperature at intervals that 
will assure that the parameters of the process time and process 
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted to agree as nearly as possible with, but to be in no event 
higher than, the temperature-indicating device during the process time. 
A means of preventing unauthorized changes in adjustment shall be 
provided. A lock or a notice from management posted at or near the 
temperature-recording device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may 
be combined with the steam controller and may be a recording-
controlling instrument. The temperature-recording device sensor shall 
be installed either within the retort shell or in a well attached to 
the shell. Each temperature-recording device sensor well shall have a 
1/16-inch (1.5 millimeters) or larger bleeder that emits steam 
continuously during the processing period. Air-operated temperature 
controllers should have adequate filter systems to ensure a supply of 
clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that should be graduated in divisions of 2 pounds per square inch 
(13.8 kilopascals) or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a temperature-
recording device. A steam controller activated by the steam pressure of 
the retort is acceptable if it is mechanically maintained so that it 
operates satisfactorily.
    (5) Bleeders. Bleeders, except those for temperature-indicating 
device wells, shall be 1/8-inch (3 millimeters) or larger and shall be 
wide open during the entire process, including the come-up-time. 
Bleeders shall be located within approximately 1 foot (30.5 
centimeters) of the outermost location of containers, at each end along 
the top of the retort; additional bleeders shall be located not

[[Page 12018]]

more than 8 feet (2.4 meters) apart along the top. Bleeders may be 
installed at positions other than those specified in this paragraph, as 
long as there is evidence in the form of heat distribution data that 
they accomplish adequate removal of air and circulation of heat within 
the retort. In retorts having top steam inlet and bottom venting, a 
bleeder shall be installed in the bottom of the retort to remove 
condensate. All bleeders shall be arranged in a way that enables the 
operator to observe that they are functioning properly.
    (6) Venting and condensate removal. The air in each retort shall be 
removed before processing is started. Heat distribution data or 
documentary proof from the manufacturer or from a competent processing 
authority, demonstrating that adequate venting is achieved, shall be 
kept on file. At the time steam is turned on, the drain should be 
opened for a time sufficient to remove steam condensate from the retort 
and provision should be made for containing drainage of condensate 
during the retort operation.
    (7) Retort speed timing. The rotational speed of the retort shall 
be specified in the schedules process. The speed shall be adjusted, as 
necessary, to ensure that the speed is as specified in the scheduled 
process. The rotational speed as well as the process time shall be 
recorded for each retort load processed. Alternatively, a recording 
tachometer may be used to provide a continuous record of the speed. A 
means of preventing unauthorized speed changes on retorts shall be 
provided. A lock, or a notice from management posted at or near the 
speed-adjustment device that provides a warning that only authorized 
persons are permitted to make adjustments, is a satisfactory means of 
preventing unauthorized changes.
    (8) Critical factors. Critical factors specified in the schedules 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers in each retort load to be processed, if specified in the 
scheduled process, shall be measured and recorded at intervals of 
sufficient frequency to ensure that the headspace is as specified in 
the scheduled process. The headspace of solder-tipped, lap seam (vent 
hole) cans may be measured by net weight determinations. When the 
product consistency is specified in the scheduled process, the 
consistency of the product shall be determined by objective 
measurements on the product taken from the filler before processing and 
recorded at intervals of sufficient frequency to ensure that the 
consistency is as specified in the scheduled process. Minimum closing 
machine vacuum in vacuum-packed products, maximum fill-in or drained 
weight, minimum net weight, and percent solids shall be as specified in 
the scheduled process for all products for which deviations from such 
specifications may affect the scheduled process. All measurements and 
recordings of critical factors should be made at intervals not to 
exceed 15 minutes.
    (e) Equipment and procedures for pressure processing in water in 
discontinuous agitating retorts--(1) Temperature-indicating device. 
Each retort shall be equipped with at least one temperature-indicating 
device that accurately indicates the temperature during processing. 
Temperature-indicating devices shall be tested for accuracy against an 
accurate calibrated reference device by appropriate standard 
procedures, upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure accuracy during processing. 
Each temperature-indicating device and reference device shall have a 
tag, seal, or other means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.
    (A) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures used to adjust or calibrate the 
temperature-indicating device, the date and results of each accuracy 
test, the name of the person or facility that performed the accuracy 
test and adjusted or calibrated the temperature-indicating device, and 
the date of the next scheduled accuracy test.
    (B) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or facility that performed 
the accuracy test and adjusted or calibrated the reference device, the 
date and results of the accuracy test, and the traceability 
information. Documentation for the reference device may be in the form 
of a guaranty of accuracy from the manufacturer or a certificate of 
calibration from a laboratory.
    (iii) A temperature-indicating device that is defective or cannot 
be adjusted to the accurate calibrated reference device shall be 
repaired or replaced before further use.
    (iv) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The sensor of the temperature-
indicating device shall be installed either within the retort shell or 
in an external well attached to the retort. Sensors of temperature-
indicating devices shall be located in such a position that they are 
beneath the surface of the water throughout the process. This entry 
should be made in the side at the center, and the temperature-
indicating device sensor shall be inserted directly into the retort 
shell. The temperature-indicating device sensor shall extend directly 
into the water a minimum of at least 2 inches (5.1 centimeters) without 
a separable well or sleeve. If a separate well or sleeve is used, there 
must be adequate circulation to ensure accurate temperature 
measurements. The temperature-indicating device--not the temperature-
recording device--shall be the reference instrument for indicating the 
processing temperature.
    (2) Temperature-recording device. Each retort shall have an 
accurate temperature-recording device that records temperatures to a 
permanent record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that

[[Page 12019]]

will assure that the parameters of the process time and process 
temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as 
data loggers, that record numbers or create other digital records may 
be used. Such a device shall record the temperature at intervals that 
will assure that the parameters of the process time and process 
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted to agree as nearly as possible with, but to be in no event 
higher than, the temperature-indicating device during the process time. 
A means of preventing unauthorized changes in adjustment shall be 
provided. A lock or a notice from management posted at or near the 
temperature-recording device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may 
be combined with the steam controller and may be a recording-
controlling instrument. The temperature-recording device sensor shall 
be installed either within the retort shell or in a well attached to 
the shell. Air-operated temperature controllers should have adequate 
filter systems to ensure a supply of clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that should be graduated in divisions of 2 pounds per square inch 
(13.8 kilopascals) or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a temperature-
recording device.
    (5) Retort speed timing. The rotational speed of the retort shall 
be specified in the scheduled process. The speed shall be adjusted, as 
necessary, to ensure that the speed is as specified in the scheduled 
process. The rotational speed as well as the process time shall be 
recorded for each retort load processed. Alternatively, a recording 
tachometer may be used to provide a continuous record of the speed. A 
means of preventing unauthorized speed changes shall be provided. A 
lock, or a notice from management posted at or near the speed 
adjustment device that provides a warning that only authorized persons 
are permitted to make adjustment, is a satisfactory means of preventing 
unauthorized changes.
    (6)(i) Air supply and controls. A means shall be provided for 
introducing compressed air at the proper pressure and rate. The proper 
pressure shall be controlled by an automatic pressure control unit. A 
check valve shall be provided in the air supply line to prevent water 
from entering the system.
    (ii) Water circulation. When a water circulating system is used for 
heat distribution, it shall be installed in such a manner that water 
will be drawn from the bottom of the retort through a suction manifold 
and discharged through a spreader which extends the length of the top 
of the retort. The holes in the water spreader shall be uniformly 
distributed and should have an aggregate area not greater than the 
cross-section area of the outlet line from the pump. The suction 
outlets shall be protected with nonclogging screens or other suitable 
means shall be used to keep debris from entering the circulating 
system. The pump shall be equipped with a pilot light or other 
signaling device to warn the operator when it is not running, and with 
a bleeder to remove air when starting operations. Alternative methods 
for circulation of water in the retort may be used when established by 
a competent authority as adequate for even heat distribution.
    (7) Drain valve. A nonclogging, water-tight valve shall be used. A 
screen shall be installed or other suitable means shall be used on all 
drain openings to prevent clogging.
    (8) Water level indicator. There shall be a means of determining 
the water level in the retort during operation, e.g., by using a 
sensor, gage, water glass, or petcock(s). Water shall cover the top 
layer of containers during the entire come-up-time and processing 
periods and should cover the top layer of containers during the cooling 
periods. The operator shall check and record the water level at 
intervals sufficient to ensure its adequacy.
    (9) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers, if specified in the scheduled process, shall be measured 
and recorded at intervals of sufficient frequency to ensure that the 
headspace is as specified in the scheduled process. The headspace of 
solder-tipped, lap seam (vent hole) cans may be measured by net weight 
determinations. When the product consistency is specified in the 
scheduled process, the consistency of the product shall be determined 
by objective measurements on the product taken from the filler before 
processing and recorded at intervals of sufficient frequency to ensure 
that the consistency is as specified in the scheduled process. Minimum 
closing machine vacuum in vacuum-packed products, maximum fill-in or 
drained weight, minimum net weight, and percent solids shall be as 
specified in the scheduled process for all products when deviations 
from such specifications may affect the scheduled process. All 
measurements and recordings of critical factors should be made at 
intervals not to exceed 15 minutes.
    (f) Equipment and procedures for pressure processing in steam in 
hydrostatic retorts--(1) Temperature-indicating device. Each retort 
shall be equipped with at least one temperature-indicating device that 
accurately indicates the temperature during processing. Temperature-
indicating devices shall be tested for accuracy against an accurate 
calibrated reference device by appropriate standard procedures, upon 
installation and at least once a year thereafter, or more frequently if 
necessary, to ensure accuracy during processing. Each temperature-
indicating device and reference device shall have a tag, seal, or other 
means of identity.
    (i) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (ii) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.
    (A) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures used to adjust or calibrate the 
temperature-indicating device, the date and results of each accuracy 
test, the name of the person or facility that performed the accuracy 
test and adjusted or calibrated the temperature-indicating device, and 
the date of the next scheduled accuracy test.
    (B) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or

[[Page 12020]]

facility that performed the accuracy test and adjusted or calibrated 
the reference device, the date and results of the accuracy test, and 
the traceability information. Documentation for the reference device 
may be in the form of a guaranty of accuracy from the manufacturer or a 
certificate of calibration from a laboratory.
    (iii) A temperature-indicating device that is defective or cannot 
be adjusted to the accurate calibrated reference device shall be 
repaired or replaced before further use.
    (iv) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device 
shall be located in the steam dome near the steam-water interface. When 
the scheduled process specifies maintenance of particular temperatures 
in the hydrostatic water legs, a temperature-indicating device shall be 
located in each hydrostatic water leg in a position near the bottom 
temperature-recording device sensor. The temperature-indicating 
device--not the temperature-recording device--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an 
accurate temperature-recording device that records temperatures to a 
permanent record, such as a temperature-recording chart.
    (i) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall 
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C) 
of the process temperature. Temperature-recording devices that create 
multipoint plottings of temperature readings shall record the 
temperature at intervals that will assure that the parameters of the 
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as 
data loggers, that record numbers or create other digital recordings 
may be used. Such a device shall record the temperature at intervals 
that will assure that the parameters of the process time and process 
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be 
adjusted to agree as nearly as possible with, but to be in no event 
higher than, the temperature-indicating device during the process time. 
A means of preventing unauthorized changes in adjustment shall be 
provided. A lock or a notice from management posted at or near the 
temperature-recording device that provides a warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may 
be combined with the steam controller and may be a recording-
controlling instrument. The temperature-recording device sensor shall 
be installed either within the steam dome or in a well attached to the 
dome. Each temperature-recording device sensor well shall have a 1/16-
inch (1.5 millimeters) or larger bleeder which emits steam continuously 
during the processing period. Additional temperature-recording device 
sensors shall be installed in the hydrostatic water legs if the 
scheduled process specified maintenance of particular temperatures in 
the hydrostatic water legs. Air-operated temperature controllers should 
have adequate filter systems to ensure a supply of clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that should be graduated in divisions of 2 pounds per square inch 
(13.8 kilopascals) or less.
    (4) Recording of temperatures. Temperatures indicated by the 
temperature-indicating device or devices shall be entered on a suitable 
form during processing operations. Temperatures shall be recorded by an 
accurate temperature-recording device or devices at the following 
points:
    (i) In the steam chamber between the steam-water interface and the 
lowest container position.
    (ii) Near the top and the bottom of each hydrostatic water leg if 
the scheduled process specifies maintenance of particular temperatures 
in the legs.
    (5) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a temperature-
recording device. A steam controller activated by the steam pressure of 
the retort is acceptable if it is carefully mechanically maintained so 
that it operates satisfactorily.
    (6) Venting. Before the start of processing operations, the retort 
steam chamber or chambers shall be vented to ensure removal of air.
    (7) Bleeders. Bleeder openings 1/4-inch (6 millimeters) or larger 
shall be located at the top of the steam chamber or chambers opposite 
the point of steam entry. Bleeders shall be wide open and shall emit 
steam continuously during the entire process, including the come-up-
time. All bleeders shall be arranged in such a way that the operator 
can observe that they are functioning properly.
    (8) Retort speed. The speed of the container-conveyor chain shall 
be specified in the scheduled process and shall be determined and 
recorded at the start of processing and at intervals of sufficient 
frequency to ensure that the retort speed is maintained as specified. 
The speed should be determined and recorded every 4 hours. An automatic 
device should be used to stop the chain when the temperature drops 
below that specified in the scheduled process. A means of preventing 
unauthorized speed changes shall be provided. A lock, or a notice from 
management posted at or near the speed-adjusting device that provides a 
warning that only authorized persons are permitted to make adjustments, 
is a satisfactory means of preventing unauthorized changes.
    (9) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (g) Aseptic processing and packaging systems--(1) Product 
sterilizer--(i) Equipment--(A) Temperature-indicating device. Each 
product sterilizer shall be equipped with at least one temperature-
indicating device that accurately indicates the temperature during 
processing. Temperature-indicating devices shall be tested for

[[Page 12021]]

accuracy against an accurate calibrated reference device by appropriate 
standard procedures, upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure accuracy during 
processing. Each temperature-indicating device and reference device 
shall have a tag, seal, or other means of identity.
    (1) The design of the temperature-indicating device shall ensure 
that the accuracy of the device is not affected by electromagnetic 
interference and environmental conditions.
    (2) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and 
maintained.
    (i) Documentation of the accuracy of the temperature-indicating 
device shall include a reference to the tag, seal, or other means of 
identity used by the processor to identify the temperature-indicating 
device, the name of the manufacturer of the temperature-indicating 
device, the identity of the reference device used for the accuracy test 
and of equipment and procedures used to adjust or calibrate the 
temperature-indicating device, the date and results of each accuracy 
test, the name of the person or facility that performed the accuracy 
test and adjusted or calibrated the temperature-indicating device, and 
the date of the next scheduled accuracy test.
    (ii) Documentation of the accuracy of the reference device shall 
include a reference to the tag, seal, or other means of identity used 
by the processor to identify the reference device, the name of the 
manufacturer of the reference device, the identity of the equipment and 
procedures used to test the accuracy and to adjust or calibrate the 
reference device, the identity of the person or facility that performed 
the accuracy test and adjusted or calibrated the reference device, the 
date and results of the accuracy test, and the traceability 
information. Documentation for the reference device may be in the form 
of a guaranty of accuracy from the manufacturer or a certificate of 
calibration from a laboratory.
    (3) A temperature-indicating device that is defective or cannot be 
adjusted to the accurate calibrated reference device shall be repaired 
or replaced before further use.
    (4) A temperature-indicating device shall be easily readable to 1 
[deg]F (0.5 [deg]C). The temperature range of a mercury-in-glass 
thermometer shall not exceed 17 [deg]F per inch (4 [deg]C per 
centimeter) of graduated scale. A mercury-in-glass thermometer that has 
a divided mercury column shall be considered defective.
    (5) Each temperature-indicating device shall be installed where it 
can be accurately and easily read. The temperature-indicating device--
not the temperature-recording device--shall be the reference instrument 
for indicating the processing temperature.
    (B) Temperature-recording device. Each product sterilizer shall 
have an accurate temperature-recording device that records temperatures 
to a permanent record, such as a temperature-recording chart. A 
temperature-recording device shall be installed in the product at the 
holding-tube outlet between the holding tube and the inlet to the 
cooler. Additional temperature-recording device sensors shall be 
located at each point where temperature is specified as a critical 
factor in the scheduled process.
    (1) Analog or graphical recordings. Temperature-recording devices 
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the 
appropriate chart. Each chart shall have a working scale of not more 
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20 
[deg]F (10 [deg]C) of the desired-product sterilization temperature. 
Chart graduations shall not exceed 2 [deg]F (1 [deg]C) within a range 
of 10 [deg]F (5 [deg]C) of the process temperature. Temperature-
recording devices that create multipoint plottings of temperature 
readings shall record the temperature at intervals that will assure 
that the parameters of the process time and process temperature have 
been met.
    (2) Digital recordings. Temperature-recording devices, such as data 
loggers, that record numbers or create other digital recordings may be 
used. Such a device shall record the temperature at intervals that will 
assure that the parameters of the process time and process temperature 
have been met.
    (3) Adjustments. The temperature-recording device shall be adjusted 
to agree as nearly as possible with, but to be in no event higher than, 
the temperature-indicating device during the process time. A means of 
preventing unauthorized changes in adjustment shall be provided. A lock 
or a notice from management posted at or near the temperature-recording 
device that provides a warning that only authorized persons are 
permitted to make adjustments is a satisfactory means of preventing 
unauthorized changes.
    (C) Temperature controller. An accurate temperature controller 
shall be installed and capable of ensuring that the desired product 
sterilization temperature is maintained. Air-operated temperature 
controllers should have adequate filter systems to ensure a supply of 
clean, dry air.
    (D) Product-to-product regenerators. When a product-to-product 
regenerator is used to heat the cold unsterilized product entering the 
sterilizer by means of a heat exchange system, it shall be designed, 
operated, and controlled so that the pressure of the sterilized product 
in the regenerator is greater than the pressure of any unsterilized 
product in the regenerator to ensure that any leakage in the 
regenerator is from the sterilized product into the unsterilized 
product.
    (E) Differential pressure recorder-controller. When a product-to-
product regenerator is used, there shall be an accurate differential 
pressure recorder-controller installed on the regenerator. The scale 
divisions shall not exceed 2 pounds per square inch (13.8 kilopascals) 
on the working scale of not more than 20 pounds per square inch per 
inch of scale (55 kilopascals per centimeter). The controller shall be 
tested for accuracy against a known accurate standard pressure 
indicator upon installation and at least once every 3 months of 
operation thereafter, or more frequently if necessary, to ensure its 
accuracy. One pressure sensor shall be installed at the sterilized 
product regenerator outlet and the other pressure sensor shall be 
installed at the unsterilized product regenerator inlet.
    (F) Flow control. A flow controlling device shall be located 
upstream from the holding tube and shall be operated to maintain the 
required rate of product flow. A means of preventing unauthorized flow 
adjustments shall be provided. A lock or a notice from management 
posted at or near the flow controlling device that provides a warning 
that only authorized persons are permitted to make adjustments, is a 
satisfactory means of preventing unauthorized changes.
    (G) Product holding tube. The product-sterilizing holding tube 
shall be designed to give continuous holding of every particle of food 
for at least the minimum holding time specified in the scheduled 
process. The holding tube shall be designed so that no portion of the 
tube between the product inlet and the product outlet can be heated, 
and it must be sloped upward at least 1/4-inch per foot (2.1 
centimeters per meter).
    (H) Flow-diversion systems. If a processor elects to install a 
flow-diversion system, it should be installed in the product piping 
located between the product cooler and the product filler or aseptic 
surge tank and should be designed to divert flow away from the filler 
or aseptic surge tank automatically. Controls and/or warning

[[Page 12022]]

systems should be designed and installed with necessary sensors and 
actuators to operate whenever the sterilizing temperature in the 
holding tube or pressure differential in the product regenerator drops 
below specified limits. Flow-diversion systems should be designed and 
operated in accordance with recommendations of an aseptic processing 
and packaging authority.
    (I) Equipment downstream from the holding tube. Product coolers, 
aseptic surge tanks, or any other equipment downstream from the holding 
tube, with rotating or reciprocating shafts, valve stems, instrument 
connections, or other such points, are subject to potential entry of 
microorganisms into the product. Such locations in the system should be 
equipped with steam seals or other effective barriers at the potential 
access points. Appropriate means should be provided to permit the 
operator to monitor the performance of the seals or barriers during 
operations.
    (ii) Operation--(A) Startup. Before the start of aseptic processing 
operations the product sterilizer and all product-contact surfaces 
downstream shall be brought to a condition of commercial sterility.
    (B) Temperature drop in product-sterilizing holding tube. When 
product temperature in the holding tube drops below the temperature 
specified in the scheduled process, product flow should be diverted 
away from the filler or aseptic surge tank by means of a flow-diversion 
system. If for any reason product subjected to a temperature drop below 
the scheduled process is filled into containers, the product shall be 
segregated from product that received the scheduled process. The 
processing deviation shall be handled in accordance with Sec.  113.89. 
The product holding tube and any further system portions affected shall 
be returned to a condition of commercial sterility before product flow 
is resumed to the filler or to the aseptic surge tank.
    (C) Loss of proper pressures in the regenerator. When a regenerator 
is used, the product may lose sterility whenever the pressure of 
sterilized product in the regenerator is less than 1 pound per square 
inch (6.9 kilopascals) greater than the pressure of unsterilized 
product in the regenerator. In this case, product flow should be 
diverted away from the filler or aseptic surge tank by means of the 
flow-diversion system. If for any reason the product is filled into 
containers, the product shall be segregated from product that received 
the scheduled process and shall be reprocessed or destroyed. Product 
flow to the filler or to the aseptic surge tank shall not be resumed 
until the cause of the improper pressure relationships in the 
regenerator has been corrected and the affected system(s) has been 
returned to a condition of commercial sterility.
    (D) Loss of sterile air pressure or other protection level in the 
aseptic surge tank. When an aseptic surge tank is used, conditions of 
commercial sterility may be lost when the sterile air overpressure or 
other means of protection drops below the scheduled process value. 
Product flow to and/or from the aseptic surge tank shall not be resumed 
until the potentially contaminated product in the tank is removed, and 
the aseptic surge tank has been returned to a condition of commercial 
sterility.
    (E) Records. Readings at the following points shall be observed and 
recorded at the start of aseptic packaging operations and at intervals 
of sufficient frequency to ensure that these values are as specified in 
the scheduled process: Temperature-indicating device in holding tube 
outlet; temperature-recording device in holding tube outlet; 
differential pressure recorder-controller, if a product-to-product 
regenerator is used; product flow rate as established by the metering 
pump or as determined by filling and closing rates and, if an aseptic 
surge tank is used, sterile air pressure or other protection means; and 
proper performance of steam seals or other similar devices. The 
measurements and recordings should be made at intervals not to exceed 1 
hour.
    (2) Container sterilizing, filling, and closing operation--(i) 
Equipment--(A) Recording device. The container and closure 
sterilization system and product filling and closing system shall be 
instrumented to demonstrate that the required sterilization is being 
accomplished continuously. Recording devices shall be used to record, 
when applicable, the sterilization media flow rates, temperature, 
concentration, or other factors. When a batch system is used for 
container sterilization, the sterilization conditions shall be 
recorded.
    (B) Timing method(s). A method(s) shall be used either to give the 
retention time of containers, and closures if applicable, in the 
sterilizing environment specified in the scheduled process, or to 
control the sterilization cycle at the rate specified in the scheduled 
process. A means of preventing unauthorized speed changes must be 
provided. A lock, or a notice from management posted at or near the 
speed adjusting device that provides a warning that only authorized 
persons are permitted to make adjustments, is a satisfactory means of 
preventing unauthorized changes.
    (ii) Operation--(A) Startup. Before the start of packaging 
operations, both the container and closure sterilizing system and the 
product filling and closing system shall be brought to a condition of 
commercial sterility.
    (B) Loss of sterility. A system shall be provided to stop packaging 
operations, or alternatively to ensure segregation of any product 
packaged when the packaging conditions fall below scheduled processes. 
Compliance with this requirement may be accomplished by diverting 
product away from the filler, by preventing containers from entering 
the filler, or by other suitable means. In the event product is 
packaged under conditions below those specified in the scheduled 
process, all such product shall be segregated and handled in accordance 
with Sec.  113.89. In the event of loss of sterility, the system(s) 
shall be returned to a condition of commercial sterility before 
resuming packaging operations.
    (C) Records. Observations and measurements of operating conditions 
shall be made and recorded at intervals of sufficient frequency to 
ensure that commercial sterility of the food product is being achieved; 
such measurements shall include the sterilization media flow rates, 
temperatures, the container and closure rates (if applicable) through 
the sterilizing system, and the sterilization conditions if a batch 
system is used for container sterilization. The measurements and 
recordings should be made at intervals not to exceed 1 hour.
    (3) Incubation. Incubation tests should be conducted on a 
representative sample of containers of product from each code; records 
of the test results should be maintained.
    (4) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. Such measurements and 
recordings should be done at intervals not to exceed 15 minutes.
    (h) Equipment and procedures for flame sterilizers. The container 
conveyor speed shall be specified in the scheduled process. The 
container conveyor speed shall be measured and recorded at the start of 
operations and at intervals of sufficient frequency to ensure that the 
conveyor speed is as specified in the scheduled process. Such 
measurements and recordings should be done at 1-hour intervals. 
Alternatively, recording tachometer may be used to provide a continuous 
record

[[Page 12023]]

of the speed. A means of preventing changes in flame intensity and 
unauthorized speed changes on the conveyor shall be provided. A lock, 
or a notice from management posted at or near the speed adjusting 
device that provides a warning that only authorized persons are 
permitted to make adjustments, is a satisfactory means of preventing 
unauthorized changes. The surface temperature of at least one container 
from each conveyor channel shall be measured and recorded at the entry 
and at the end of the holding period at intervals of sufficient 
frequency to ensure that the temperatures specified in the scheduled 
process are maintained. Such measurements and recordings should be done 
at intervals not to exceed 15 minutes.
    (1) Process interruption. In the event of process interruption 
wherein the temperature of the product may have dropped, an authorized, 
scheduled emergency plan approved by a qualified person having expert 
knowledge of the process requirements may be used.
    (2) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) Equipment and procedures for thermal processing of foods 
wherein critical factors such as water activity are used in conjunction 
with thermal processing. The methods and controls used for the 
manufacture, processing, and packing of such foods shall be as 
established in the scheduled process and shall be operated or 
administered in a manner adequate to ensure that the product is safe. 
The time and temperature of processing and other critical factors 
specified in the scheduled process shall be measured with instruments 
having the accuracy and dependability adequate to ensure that the 
requirements of the scheduled process are met. All measurements shall 
be made and recorded at intervals of sufficient frequency to ensure 
that the critical factors are within the limits specified in the 
scheduled process.
    (j) Other systems. All systems, whether or not specifically 
mentioned in this part, for the thermal processing of low-acid foods in 
hermetically sealed containers shall conform to the applicable 
requirements of this part and the methods and controls used for the 
manufacture, processing, and packing of these foods shall be as 
established in the scheduled process. These systems shall be operated 
or administered in a manner adequate to ensure that commercial 
sterility is achieved. Critical factors specified in the scheduled 
process shall be measured and recorded at intervals of sufficient 
frequency to ensure that the critical factors are within the limits 
specified in the scheduled process.
    3. Amend Sec.  113.60 by revising paragraph (d) to read as follows:


Sec.  113.60  Containers.

* * * * *
    (d) Postprocess handling. Container handling equipment used in 
handling filled containers shall be designed, constructed, and operated 
to preserve the can seam or other container closure integrity. 
Container handling equipment, including automated and non-automated 
equipment, shall be checked at sufficient frequency and repaired or 
replaced as necessary to prevent damage to containers and container 
closures. When cans are handled on belt conveyors, the conveyors should 
be constructed to minimize contact by the belt with the double seam, 
i.e., cans should not be rolled on the double seam. All worn and frayed 
belting, can retarders, cushions, etc. should be replaced with new 
nonporous material. All tracks and belts that come into contact with 
the can seams should be thoroughly scrubbed and sanitized at intervals 
of sufficient frequency to avoid product contamination.
    4. Revise Sec.  113.83 to read as follows:


Sec.  113.83  Establishing scheduled processes.

    Scheduled processes for low-acid foods shall be established by 
qualified persons having expert knowledge of thermal processing 
requirements for low-acid foods in hermetically sealed containers and 
having adequate facilities for making such determinations. The type, 
range, and combination of variations encountered in commercial 
production shall be adequately provided for in establishing the 
scheduled process. When a product is reprocessed or a previously 
processed product is blended into a new formulation, this condition 
must be covered in the scheduled process. Critical factors, e.g., 
minimum headspace, consistency, maximum fill-in or drained weight, 
a<INF>w</INF>, etc., that may affect the scheduled process, shall be 
specified in the scheduled process. Acceptable scientific methods of 
establishing heat sterilization processes shall include, when 
necessary, but shall not be limited to, microbial thermal death time 
data, process calculations based on product heat penetration data, and 
inoculated packs. Calculation shall be performed according to 
procedures recognized by competent processing authorities. If 
incubation tests are necessary for process confirmation, they shall 
include containers from test trials and from actual commercial 
production runs during the period of instituting the process. The 
incubation tests for confirmation of the scheduled processes should 
include the containers from the test trials and a number of containers 
from each of four or more actual commercial production runs. The number 
of containers from actual commercial production runs should be 
determined on the basis of recognized scientific methods to be of a 
size sufficient to ensure the adequacy of the process. Complete records 
covering all aspects of the establishment of the process and associated 
incubation tests shall be prepared and shall be permanently retained by 
the person or organization making the determination.
    5. Amend Sec.  113.87 by revising paragraphs (c) and (e) to read as 
follows:


Sec.  113.87  Operations in the thermal processing room.

* * * * *
    (c) The initial temperature of the contents of the containers to be 
processed shall be accurately determined and recorded with sufficient 
frequency to ensure that the temperature of the product is no lower 
than the minimum initial temperature specified in the scheduled 
process. For those operations that use water during the filling of the 
retort or during processing, provision shall be made to ensure that the 
water will not, before the start of each thermal process, lower the 
initial temperature of the product below that specified in the 
scheduled process. The temperature-indicating device used to determine 
the initial temperature shall be tested for accuracy against an 
accurate calibrated reference device at sufficient frequency to ensure 
that initial temperature measurements are accurate. Records of the 
accuracy tests shall be signed or initialed, dated, and maintained.
* * * * *
    (e) Clock times on temperature-recording device records shall 
reasonably correspond to the time of day on the written processing 
records to provide correlation of these records.
* * * * *
    6. Amend Sec.  113.100 by revising paragraphs (a) introductory 
text, (a)(4), (b), and (c) and by adding paragraphs (f) and (g) to read 
as follows:


Sec.  113.100  Processing and production records.

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

[[Page 12024]]

it is observed by the retort or processing system operator, or other 
designated person, on forms that include the product, the code number, 
the date, the retort or processing system number, the size of 
container, the approximate number of containers per coding interval, 
the initial temperature, the actual processing time, the temperature-
indicating device and temperature-recording device readings, and other 
appropriate processing data. Closing machine vacuum in vacuum-packed 
products, maximum fill-in or drained weight, or other critical factors 
specified in the scheduled process shall also be recorded. In addition, 
the following records shall be maintained:
* * * * *
    (4) Aseptic processing and packaging systems. Product temperature 
in the holding tube outlet as indicated by the temperature-indicating 
device and the temperature-recording device; differential pressure as 
indicated by the differential pressure recorder-controller, if a 
product-to-product regenerator is used; product flow rate, as 
determined by the flow controlling device or by filling and closing 
rates; sterilization media flow rate or temperature or both; retention 
time of containers, and closures when applicable, in the sterilizing 
environment; and, when a batch system is used for container and/or 
closure sterilization, sterilization cycle times and temperatures.
* * * * *
    (b) Temperature-recording device records shall be identified by 
date, retort number, and other data as necessary, so they can be 
correlated with the written record of lots processed. Each entry on the 
processing and production records shall be made by the retort or 
processing system operator, or other designated person, at the time the 
specific retort or processing system condition or operation occurs, and 
this retort or processing system operator or other designated person 
shall sign or initial each record form. Not later than 1 working day 
after the actual process, and before shipment or release for 
distribution, a representative of plant management who is qualified by 
suitable training or experience shall review all processing and 
production records for completeness and to ensure that the product 
received the scheduled process. The records, including temperature-
recording device records, shall be signed or initialed and dated by the 
reviewer.
    (c) Written records of all container closure examinations shall 
specify the product code, the date and time of container closure 
inspections, the measurements obtained, and all corrective actions 
taken. Records shall be signed or initialed by the container closure 
inspector and reviewed by management with sufficient frequency to 
ensure that the containers are hermetically sealed. The records shall 
be signed or initialed and dated by the reviewer.
* * * * *
    (f) Records of this part may be maintained electronically, provided 
they are in compliance with part 11 of this chapter.
    (g) All records required under this part, or copies of such 
records, must be readily available during the retention period for 
inspection and copying by FDA when requested. If reduction techniques, 
such as microfilming, are used, a suitable reader and photocopying 
equipment must be made readily available to FDA.

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