Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, 11990-12024 [07-1172]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

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



[[Page 11989]]

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Part III





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 113



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

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

[[Page 11990]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 113

[Docket No. 2007N-0026]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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

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

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

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

I. Background

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

[[Page 11991]]

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

II. Legal Authority

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

[[Page 11992]]

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

III. Proposed Rule

A. Equipment and Procedures (Sec.  113.40)

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

[[Page 11993]]

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

[[Page 11994]]

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

[[Page 11995]]

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

[[Page 11996]]

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

[[Page 11997]]

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

B. Containers (Sec.  113.60)

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

[[Page 11998]]

C. Establishing Scheduled Processes (Sec.  113.83)

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

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

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