Department of Health and Human Services: Wednesday, March 14, 2007

Wednesday,
March 14, 2007
Part III
Department of
Health and Human
Services
Food and Drug Administration
21 CFR Part 113

Temperature-Indicating Devices;
Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed
Containers; Proposed Rule
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11990 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules
DEPARTMENT OF HEALTH AND comments submitted to the agency by e- A. Preliminary Regulatory Impact
HUMAN SERVICES mail. FDA encourages you to continue Analysis: Flexibility in Permitting
to submit electronic comments by using Alternative Temperature-Indicating
Food and Drug Administration the Federal eRulemaking Portal or the Devices
agency Web site, as described
21 CFR Part 113 previously, in the ADDRESSES portion of B. Regulatory Flexibility Analysis
this document under Electronic C. Unfunded Mandate Analysis
[Docket No. 2007N–0026] V. Environmental Impact
Submissions.
Instructions: All submissions received VI. Paperwork Reduction Act
Temperature-Indicating Devices; VII. Federalism
Thermally Processed Low-Acid Foods must include the agency name and VIII. Comments
Packaged in Hermetically Sealed docket number for this rulemaking. All IX. References
Containers comments received may be posted
without change to http://www.fda.gov/ I. Background
AGENCY: Food and Drug Administration, ohrms/dockets/default.htm, including In the Federal Register of January 24,
HHS. any personal information provided. For 1973 (38 FR 2398), FDA (we) issued a
ACTION: Proposed rule. additional information on submitting final rule entitled ‘‘Thermally Processed
comments, see the ‘‘Comments’’ heading Low-Acid Food Packaged in
SUMMARY: The Food and Drug
of the SUPPLEMENTARY INFORMATION Hermetically Sealed Containers’’ (low-
Administration (FDA) is proposing to
section of this document. acid canned foods) (the 1973 final rule),
amend its regulations for thermally
Docket: For access to the docket to part 113 (21 CFR part 113)1, which,
processed low-acid foods packaged in
read background documents or among other things, provides for the use
hermetically sealed containers to allow
comments received, go to http:// of an ‘‘indicating mercury-in-glass
for use of other temperature-indicating
www.fda.gov/ohrms/dockets/ thermometer’’ for equipment and
devices, in addition to mercury-in-glass
default.htm and insert the docket procedures for the following: (1)
thermometers, during processing. FDA
number, found in brackets in the Pressure processing in steam in still
also is proposing to establish
heading of this document, into the retorts (§ 113.40(a)), (2) pressure
recordkeeping requirements relating to
‘‘Search’’ box and follow the prompts processing in water in still retorts
temperature-indicating devices and to
and/or go to the Division of Dockets (§ 113.40(b)), (3) pressure processing in
clarify other aspects of low-acid canned
Management, 5630 Fishers Lane, rm. steam in continuous agitating retorts
food processing such as FDA’s
1061, Rockville, MD 20852. (§ 113.40(c)), (4) pressure processing in
interpretation of some requirements of
Information Collection Provisions: steam in discontinuous agitating retorts
the current regulations that will, in part,
Submit written comments on the (§ 113.40(d)), (5) pressure processing in
allow the use of advanced technology
information collection provisions to the water in discontinuous agitating retorts
for measuring and recording
Office of Information and Regulatory (§ 113.40(e)), (6) pressure processing in
temperatures during processing. Finally,
Affairs, OMB. To ensure that comments steam in hydrostatic retorts (§ 113.40(f)),
FDA is proposing to include metric
on the information collection are and (7) aseptic processing and
equivalents of avoirdupois (U.S.)
received, OMB recommends that written packaging systems (§ 113.40(g)). In
measurements where appropriate.
comments be faxed to the Office of addition, aseptic processing systems
DATES: Submit written or electronic Information and Regulatory Affairs,
comments on the proposed rule by June (§ 113.40(g)) can be equipped with a
OMB, Attn: FDA Desk Officer, FAX: mercury-in-glass thermometer or an
12, 2007. Submit comments regarding 202–395–6974.
the information collection by April 13, equivalent temperature-indicating
FOR FURTHER INFORMATION CONTACT: device, such as a thermocouple-
2007, to the Office of Management and
Budget (OMB) (see ADDRESSES). Mischelle B. Ledet, Center for Food recorder.
Safety and Applied Nutrition (HFS– The 1973 final rule also established
ADDRESSES: You may submit comments,
615), Food and Drug Administration, requirements for containers (§ 113.60),
identified by Docket No. 2007N–0026, 5100 Paint Branch Pkwy., College Park, requirements for establishing scheduled
by any of the following methods: MD 20740, 301–436–2359. processes (§ 113.83), and requirements
Electronic Submissions for operations in the thermal processing
Submit electronic comments in the SUPPLEMENTARY INFORMATION:
room (§ 113.87). The 1973 final rule also
following ways: Table of Contents
• Federal eRulemaking Portal: http:// established requirements for processing
www.regulations.gov. Follow the I. Background and production records, which include
instructions for submitting comments. II. Legal Authority requirements for maintaining records of
• Agency Web site: http:// III. Proposed Rule mercury-in-glass thermometer and
www.fda.gov/dockets/ecomments. A. Equipment and Procedures recording thermometer readings
Follow the instructions for submitting (§ 113.40) (§ 113.100).
In the preamble to the 1973 final rule,
comments on the agency Web site.
Written Submissions B. Containers (§ 113.60) FDA stated that two comments on a
Submit written submissions in the C. Establishing Scheduled Processes tentative final order, published
following ways: (§ 113.83) November 14, 1972 (37 FR 24117),
• FAX: 301–827–6870. ‘‘recommended that provisions be made
• Mail/Hand delivery/Courier [For [in the final rule] for the use of
D. Operations in the Thermal

paper, disk, or CD–ROM submissions]: Processing Room (§ 113.87) temperature[-]indicating devices other
Division of Dockets Management (HFA– E. Processing and Production Records than mercury-in-glass thermometers.’’
305), Food and Drug Administration, (§ 113.100)
1The low-acid canned food regulations (21 CFR
5630 Fishers Lane, rm. 1061, Rockville, F. Minor Revisions in Regulations
part 128b) were recodified as part 113 on March 15,
MD 20852. G. Immediate Implementation of 1977 (42 FR 14302). The regulations were
To ensure more timely processing of Proposed Rule subsequently amended on March 16, 1979 (44 FR
comments, FDA is no longer accepting IV. Analysis of Impacts 16209) and June 11, 1997 (62 FR 31721).
Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 11991
FDA responded, ‘‘The Commissioner [of industry to take necessary and of reproducing under normal non-
Food and Drugs] has determined that appropriate steps to transition from refrigerated conditions of storage and
the mercury-in-glass thermometer is the mercury-in-glass thermometers to distribution and viable microorganisms
recognized standard against which all alternative temperature-indicating of public health significance (§ 113.3(e)).
other temperature[-]indicating devices devices, the agency also recognizes that Adhering to the scheduled process is
are checked and calibrated. The it may not be practical for all important for preventing growth in the
regulation * * * retains the requirement manufacturers to make this transition. food of microorganisms, such as
that all retorts be equipped with Accordingly, FDA is proposing to revise Clostridium botulinum. Clostridium
mercury-in-glass indicating regulations in part 113 to permit botulinum produces a neurotoxin that
thermometers. However, because of the industry use of temperature-indicating causes botulism, a communicable
speed of the thermal process, alternate devices, including mercury-in-glass disease that can result in paralysis and
temperature[-]indicating devices such as thermometers, and to require death (Ref. 1). The failure to use
thermocouples will be allowed in maintenance of records associated with accurate temperature-indicating devices,
aseptic processing and packaging ensuring that temperature-indicating and other measures clarified in this
systems’’ (38 FR 2398 at 2400). devices are accurate during processing. proposed rule, to ensure that low-acid
Since publication of the 1973 final FDA also is aware that the regulations foods are processed to achieve
rule, FDA has received various requests from the 1973 final rule include commercial sterility is an insanitary
to permit use of alternative temperature- outdated terminology and that some of condition and thus renders the food
indicating devices or to permit entry the provisions are unclear. FDA is adulterated under section 402(a)(4) of
into the United States of low-acid proposing to update and clarify these the act. In addition, such a food is unfit
canned foods that were processed in sections of the regulations. FDA also is for food under section 402(a)(3) of the
countries that permit alternative proposing to clarify and establish act based on health risks from
temperature-indicating devices to be recordkeeping requirements relating to insufficient processing.
used during processing. In responding ensuring the accuracy of temperature- Under section 701(a) of the act (21
to such requests, FDA expressed indicating devices. U.S.C. 371(a)), FDA is authorized to
concern about whether the devices were issue regulations for the act’s efficient
II. Legal Authority
reliable and maintained accuracy under enforcement. A regulation that requires
actual plant operation conditions. FDA FDA is proposing these regulations measures to prevent human food from
also requested additional information under sections 402(a)(3) and (a)(4) of the being unfit for food and from being held
relating to reliability and accuracy, Federal Food, Drug, and Cosmetic Act under insanitary conditions allows for
including evidence to show that, if the (the act) (21 U.S.C. 342(a)(3) and (a)(4)). the efficient enforcement of the act. This
device does not maintain its accuracy, In addition, FDA is proposing these proposed rule requires processors of
this fact would become immediately regulations under section 361 of the thermally processed low-acid food to
known by the operator and would not Public Health Service Act (the PHS Act) establish and maintain records of the
result in underprocessed food. (42 U.S.C. 264) that relates to accuracy of the temperature-indicating
FDA is aware that technological communicable disease. Under section device and reference device. Other
advancements in thermometry have 402(a)(3) of the act, a food is deemed records relating to processing and
been made since publication of the low- adulterated ‘‘if it consists in whole or in production are currently required in
acid canned food regulations in 1973 part of any filthy, putrid, or § 113.100. The proposed rule requires
and that temperature-indicating devices decomposed substance, or if it is that all records under part 113, whether
other than mercury-in-glass otherwise unfit for food.’’ Under section currently required or proposed to be
thermometers are now available that 402(a)(4) of the act, a food is adulterated required in this proposed rule, be made
may be appropriate for use in thermal ‘‘if it has been prepared, packed, or held available to FDA for inspection and
processing of low-acid foods. FDA also under insanitary conditions whereby it copying.
is aware, specifically for low-acid may have become contaminated with The proposed rule would require
canned food manufacturers, of filth, or whereby it may have been accuracy testing of temperature-
traditional concerns about ensuring that rendered injurious to health.’’ indicating devices against a calibrated
mercury from broken mercury-in-glass A commercial processor engaged in reference device by appropriate
thermometers does not contaminate the the thermal processing of low-acid foods standard procedures upon installation
food or the processing environment. packaged in hermetically sealed and at least once a year thereafter, or
FDA recognizes that the industry must containers must provide FDA with more frequently if necessary, to ensure
proceed cautiously to transition from information about its scheduled process accuracy during processing.
mercury-in-glass thermometers to that includes processing method, type of Documentation of accuracy of such
alternative technology to ensure that retort or other thermal processing devices is necessary to determine, over
accuracy and ability to function equipment employed, minimum initial time, whether each device complies
properly during processing are not temperatures, times and temperatures of with current requirements to be accurate
compromised by replacing mercury-in- processing, sterilizing value or other during processing and for verifying that
glass thermometers with alternative equivalent scientific evidence of temperatures required by the scheduled
temperature-indicating devices. As with processing adequacy, critical control process are met during processing.
mercury-in-glass thermometers, factors affecting heat penetration, and Further, such documentation is
manufacturers who use alternative source and date of the establishment of necessary for evaluating the
temperature-indicating devices must the process for each low-acid food in performance of temperature-indicating
conduct appropriate tests and each container size (21 CFR devices that are technologically and
implement procedures to ensure that the 108.35(c)(2)). The scheduled process is operationally different from mercury-in-
device is accurate during processing and designed to achieve commercial glass thermometers traditionally used in
does not result in underprocessed foods. sterility. Commercial sterility relates to processing low-acid canned food. The
Thus, although FDA supports conditions achieved through the records of accuracy testing for each
elimination of mercury from the application of heat to render the food temperature-indicating device and
processing environment and encourages free of certain microorganisms capable reference device will be linked to each
such device through the accuracy lead to death (Ref. 1). As explained processing and packaging. Processors
records so that the processor will be previously in this document, processing are responsible for ensuring that the
able to ensure that temperature- and production records required by part temperature-indicating device is
indicating devices and reference devices 113, and those proposed in this rule accurate during processing.
are tested as often as needed and will related to accuracy testing, are necessary FDA is proposing that temperature-
provide a means for the processor to to ensure that low-acid foods are indicating devices shall be tested for
quickly identify and correct problems prepared in a manner that will prevent accuracy against an ‘‘accurate calibrated
that may occur. Without records the spread of communicable disease. reference device’’ upon installation and
documenting accuracy testing of Section 361 of the PHS Act provides at least once a year thereafter, or more
temperature-indicating devices and FDA with the authority to institute frequently if necessary, to ensure
reference devices, processors would not recordkeeping requirements, including accuracy during processing. Currently,
know whether they are adulterating access to such records to enable FDA to mercury-in-glass thermometers must be
their products. Therefore, a failure of ensure that low-acid foods are being tested for accuracy against a ‘‘known
processors to establish and maintain processed in a manner to prevent the accurate standard thermometer’’ upon
these records results in thermally spread of communicable disease. For installation and at least once a year
processed low-acid canned food being these reasons, and for the reasons stated thereafter, or more frequently if
prepared under insanitary conditions previously in this document for access necessary. FDA is proposing to require
whereby the food may have been and copying of records to provide for an similar tests for accuracy for all
rendered injurious to health. enforceable regulation that will ensure temperature-indicating devices.
Because FDA cannot continuously public health protection, we have Traditionally, a ‘‘known accurate
observe processors’ operations, the tentatively concluded that the standard thermometer’’ was a mercury-
records for accuracy, and other records recordkeeping requirements are in-glass thermometer that had been
currently required for processing and necessary to prevent the spread of calibrated against an instrument that
production, are essential for FDA to communicable disease. was traceable to a National Institute of
know whether processors have Standards and Technology (NIST)
complied with the current good III. Proposed Rule standard or according to other standard
manufacturing practice requirements in A. Equipment and Procedures (§ 113.40) calibration procedures that assured
part 113. FDA may consider it necessary accuracy at the time the thermometer
to copy records when, for example, our 1. Temperature-Indicating Devices was used as the ‘‘standard.’’ These
investigator may need assistance in Current § 113.40(a)(1), (b)(1), (c)(1), thermometers are often referred to as
reviewing a certain record from relevant (d)(1), (e)(1), and (f)(1) require that ‘‘reference devices.’’ (NIST is a non-
experts in headquarters. If we are unable retorts used for processing low-acid regulatory Federal agency that develops
to copy the records, we would have to foods shall be equipped with at least and promotes measurement, standards,
rely solely on our investigator’s notes one mercury-in-glass thermometer. FDA and technology to enhance productivity,
and reports when drawing conclusions. is proposing to revise the regulations to facilitate trade, and improve the quality
In addition, copying records will provide for use of temperature- of life.) FDA is proposing to replace the
facilitate followup regulatory actions. indicating devices that accurately term ‘‘known accurate standard
We have tentatively concluded that the indicate the temperature during thermal thermometer’’ with the broader term
ability to access and copy the records is processing. Accordingly, FDA is ‘‘accurate calibrated reference device’’
necessary to provide FDA with an replacing the terms ‘‘mercury-in-glass to recognize that reference or
enforceable regulation that will ensure thermometer’’ and ‘‘thermometer’’ with ‘‘standard’’ devices other than mercury-
public health protection. Thus, the ‘‘temperature-indicating device,’’ as in-glass thermometers are available and
recordkeeping requirements and access appropriate. Current § 113.40(g)(1) may be used for determining accuracy.
to such records would be necessary to already allows for use of temperature- FDA is proposing that the design of
the efficient enforcement of the act. indicating devices for aseptic processing the temperature-indicating device shall
Under the proposed rule, the failure to of low-acid foods. However, FDA is ensure that the accuracy of the device is
comply with the recordkeeping proposing revisions in § 113.40(g)(1) not affected by electromagnetic
requirements would render the food similar to proposed § 113.40(a)(1), (b)(1), interference and environmental
adulterated under section 402(a)(4) of (c)(1), (d)(1), (e)(1), and (f)(1) to ensure conditions. Although electromagnetic
the act. consistency in terminology, energy does not affect the accuracy of
In addition, FDA has authority under interpretation, and application of all mercury-in-glass thermometers,
section 361 of the PHS Act to make and provisions of the regulation that allow temperature-indicating devices with
enforce such regulations as ‘‘are for use of temperature-indicating electronic or electromagnetic
necessary to prevent the introduction, devices. components are vulnerable and must be
transmission, or spread of The term ‘‘temperature-indicating designed to ensure that they are
communicable disease from foreign device’’ includes mercury-in-glass resistant to electromagnetic interference.
countries into the States * * * or from thermometers. The proposed rule Environmental conditions, such as
one State * * * into any other State’’ provides for use of temperature- humidity, vibrations, and air pressure,
(section 361(a) of the PHS Act). A low- indicating devices for the following which may affect the accuracy or
acid canned food that is not processed purposes: (1) Pressure processing in performance of the temperature-
to achieve commercial sterility may steam in still retorts, (2) pressure indicating device, also must be
become contaminated with processing in water in still retorts, (3) identified and controlled, to the extent
microorganisms such as Clostridium pressure processing in steam in necessary, to ensure that the
botulinum. Clostridium botulinum continuous agitating retorts, (4) pressure temperature-indicating device is
produces a neurotoxin which, when processing in steam in discontinuous accurate during processing. The current
ingested, causes botulism. Botulism is a agitating retorts, (5) pressure processing regulations indirectly address control of
communicable disease that is in water in discontinuous agitating the impact of environmental conditions
characterized by the rapid onset of retorts, (6) pressure processing in steam on mercury-in-glass thermometers by
paralysis. If untreated, this paralysis can in hydrostatic retorts, and (7) aseptic requiring calibration ‘‘at least once a
year * * * or more frequently if seal, or other means of identity that results of each accuracy test; (6) the
necessary, to ensure their accuracy’’ includes the date on which it was last name of the person or facility that
(§ 113.40(a)(1), (b)(1), (c)(1), (d)(1), tested for accuracy. Similar provisions performed the accuracy test and
(e)(1), (f)(1), and (g)(1)(i)(a)) and by in current § 113.40(g)(1)(i)(a) apply to adjusted or calibrated the temperature-
requiring that a mercury-in-glass maintenance of records of accuracy indicating device; and (7) the date of the
thermometer that has a ‘‘divided checks and to establishing a means of next scheduled accuracy test. Reference
mercury column or that cannot be identity for ‘‘thermometers and to the temperature-indicating device
adjusted to the standard shall be temperature-indicating devices.’’ identity in the record of accuracy
repaired or replaced before further use However, establishment and provides an essential link between each
of the retort’’ (§ 113.40(a)(1), (b)(1), maintenance of records of the accuracy temperature-indicating device and the
(c)(1), (d)(1), (e)(1), and (f)(1); similar of each temperature-indicating device specific record associated with that
requirement in § 113.40(g)(1)(i)(a)). The are essential for documenting accuracy device. The name of the manufacturer
design of the mercury-in-glass of temperature-indicating devices enables the processor to readily identify
thermometer makes it relatively easy to throughout time, for determining that the source of the defective or deficient
detect a malfunction, including those each temperature-indicating device device and to correct or replace the
caused by environmental conditions, complies with current requirements to device, as appropriate. Identification of
because most are associated with a be accurate during processing, and for the reference device used for the
broken thermometer, separated column, verifying that temperatures required by accuracy check and of the equipment
or scale slippage. However, malfunction the scheduled process are met. Further, and procedures used to adjust or
of other temperature-indicating devices such documentation is necessary for calibrate the temperature-indicating
may need to be detected by means other evaluating the performance of device provides an essential reference
than observation. For example, a temperature-indicating devices that are for additional followup in the event the
temperature-indicating device could be technologically and operationally reference device is subsequently
designed with a dual probe sensor that different from mercury-in-glass determined to be inaccurate.
would enable detection of loss of thermometers traditionally used in Documentation of the date and results of
accuracy of one of the probes when the processing low-acid canned food. accuracy tests provides evidence that
probe readings do not agree. FDA FDA is proposing to require that each scheduled tests were performed and is
recommends, but is not proposing to temperature-indicating device have a essential for evaluating performance of
require, a dual probe design. FDA tag, seal, or other means of identity that the temperature-indicating device over
recognizes that specific design will be used by the processor to identify time. This information can be used to
specifications for temperature- the temperature-indicating device and determine whether more frequent
indicating devices may limit the that each reference device have a tag, accuracy tests are needed and whether
flexibility of the regulation for current seal, or other means of identity that will a temperature-indicating device needs
and future technologies. Design be used by the processor to identify the to be replaced. Documentation of the
specificity in the regulation is not reference device. FDA is proposing to identification of the person or facility
practical because of the diversity of eliminate the current recommendation that performed the accuracy test and
technology associated with temperature- in § 113.40(a)(1), (b)(1), (c)(1), (d)(1), adjusted or recalibrated the
indicating devices that have been or (e)(1), (f)(1), and (g)(1)(i)(a) to include temperature-indicating device is
may be developed and because, for each on the tag or seal the date on which each essential for appropriate followup in the
type of temperature-indicating device, thermometer was last tested for event that the temperature-indicating
different factors or parameters may need accuracy. FDA does not object to device subsequently is determined to be
to be addressed by design. Rather, the recording the accuracy test date on the inaccurate.
proposed regulation would require that tag or seal. However, as discussed later These records are necessary to ensure
the design of the temperature-indicating in this document, FDA is proposing to that appropriate accuracy checks are
device ensure that the accuracy of the require that the date of the last accuracy performed for each temperature-
device is not affected by electromagnetic test be included as part of the record of indicating device, to establish the
interference and environmental accuracy for the temperature-indicating appropriate frequency for accuracy
conditions. Thus, the processor is device. FDA believes this proposed checks, to identify when there is a
responsible for ensuring that the change clarifies the process for assuring problem with a temperature-indicating
temperature-indicating device is that the written record of the accuracy device and, as necessary, to repair or
designed so that its accuracy during test can be linked to the appropriate replace the device, and to determine
processing is not compromised due to temperature-indicating device. and initiate appropriate followup to
electromagnetic interference or FDA is proposing that a written ensure that low-acid canned foods are
environmental conditions and that any record of accuracy for each temperature- appropriately processed. Because it is
malfunctions in the device that may indicating device shall be established not possible for FDA to continuously
affect accuracy will be immediately and maintained. Documentation of the observe processors’ operations, these
detectable. accuracy of each temperature-indicating records are essential to ensure that the
device shall include the following agency has the information needed to
2. Documentation and Records information: (1) A reference to the tag, identify noncompliance and to bring a
Current § 113.40(a)(1), (b)(1), (c)(1), seal, or other means of identity used by non-compliant processor into
(d)(1), (e)(1), and (f)(1) recommend, but the processor to identify the compliance. Thus, these records are
do not specifically require, maintenance temperature-indicating device; (2) the essential for FDA to have an enforceable
of records of accuracy checks. These name of the manufacturer of the regulation that will ensure public health
regulations indicate that the records temperature-indicating device; (3) the protection.
should specify the date, standard used, identity of the reference device used for Current § 113.40(a)(1), (b)(1), (c)(1),
method used, and person performing the accuracy test; (4) the identity of the (d)(1), (e)(1), and (f)(1) require that
the test. The regulations also equipment and procedures used to thermometers (and temperature-
recommend, but do not require, that adjust or calibrate the temperature- indicating devices in § 113.40(g)(1)(i)(a))
each thermometer should have a tag, indicating device; (5) the date and shall be tested for accuracy against a
known accurate standard thermometer. identity of temperature-indicating to paper charts and the paper charts
This requirement implies, but does not devices and reference devices, are served as the historical record of
explicitly state, that the processor must subject to the recordkeeping temperatures during processing. At that
be able to demonstrate, by appropriate requirements of § 113.100. See the time, the terms ‘‘temperature-recording
documentation, that the reference or discussion later in this document device’’ and ‘‘recording chart’’ were
standard device used to determine the relating to proposed revisions to used interchangeably. However, because
accuracy of the thermometers used to § 113.100. of advancements in technology,
measure temperature during processing FDA is proposing to revise temperatures may now be recorded in a
also is accurate. Thus, although the § 113.40(g)(1)(ii)(e) by removing the format other than the traditional chart
current regulations require requirement to observe and record the that has a pre-printed time and
documentation of the accuracy of the product temperature in the temperature temperature scale and may be recorded
standard thermometer, the specific recorder-controller at the final heater and maintained by mechanisms or
documentation FDA expects processors outlet in aseptic processing and devices other than recorders that use the
to maintain is not clear. FDA is packaging systems. The temperature in traditional recording charts. The
proposing to clarify this requirement by the final heater outlet may not be a permanent record of temperatures may
specifying that a written record of the critical factor in the scheduled process be in the form of an analog or graphical
accuracy of the reference device shall be and, therefore, may not require recording, such as a traditional chart
established and maintained. maintenance of records. However, if the with pre-printed time and temperature
Documentation of the accuracy of the final heater outlet temperature is scale. The permanent record also may
reference device must include the identified as a critical factor in the be an analog or graphical recording, for
following information: (1) A reference to scheduled process, the temperature which the chart design, continuous
the tag, seal, or other means of identity must be observed and recorded, as temperature recordings or tracings, and
used by the processor to identify the required in § 113.100(a). date and time notations may be
reference device; (2) the name of the 3. Metric Equivalents generated and printed by the
manufacturer of the reference device; (3) temperature-recording device onto a
FDA is proposing to revise
the identity of the equipment and blank paper, chart, or other medium as
§ 113.40(a), (b), (c), (d), (e), (f), and (g)
procedures used to test the accuracy and they are generated by the temperature-
to provide metric equivalents of
to adjust or calibrate the reference recording device. Processors also are
avoirdupois (U.S.) measurements.
device; (4) the identity of the person or using temperature-recording devices,
Currently, these regulations express
facility that performed the accuracy test such as data loggers, that record
temperature measurements in
and adjusted or calibrated the reference Fahrenheit (°F) units, length
numbers or create other digital
device; (5) the date and results of the measurements in inches and feet, and recordings at established intervals,
accuracy test; and (6) the traceability pressure measurements in pounds per rather than providing continuous
information. Traceability, as defined by square inch. The proposed metric recordings on a chart. Therefore, FDA
the International Vocabulary of Basic equivalents are provided in parenthesis recognizes that the term ‘‘temperature-
and General Terms in Metrology, means in the text of the proposed regulation, recording device’’ does not necessarily
a ‘‘property of the result of a immediately following the avoirdupois imply that temperatures are being
measurement or the value of a standard measurement. FDA is proposing to recorded to a ‘‘temperature-recording
whereby it can be related to stated modify the current regulations to not chart.’’ Thus, the ‘‘graduation’’ and
references, usually national or only provide the temperature ‘‘working scale’’ requirements in the
international standards, through an measurements in Fahrenheit, but to current regulation do not apply to all
unbroken chain of comparisons all follow the Fahrenheit (°F) measure with temperature-recording device records.
having stated uncertainties’’ (Ref. 2). the units in Celsius (°C). FDA is The general term ‘‘temperature-
Accordingly, records must be proposing to provide measurements recording device’’ should be used when
maintained to document that the currently in inches also in millimeters referring to the entire device that
accuracy of the reference device can be or centimeters, measurements currently records temperatures and the term
traced by comparison with a standard in feet also in centimeters or meters, and ‘‘temperature-recording chart’’ should
device, such as a NIST standard measurements in pounds per square be used when referring to an actual
temperature device. Documentation of inch of pressure also in kilopascals. chart that constitutes the mechanism by
the traceability information for the which the temperature-recording device
reference device may be in the form of 4. Temperature-Recording Devices records processing temperatures. The
a guaranty of accuracy from the Current § 113.40(a)(2), (b)(2), (c)(2), ‘‘graduation’’ and ‘‘working scale’’
manufacturer of the reference device or (d)(2), (e)(2), (f)(2), and (g)(1)(i)(b) states requirements specified in the current
a certificate of calibration from a that, ‘‘Graduations on the temperature- regulation are still applicable to the
laboratory. Information required in the recording devices shall not exceed 2 °F ‘‘temperature-recording chart,’’ when
record of accuracy for a reference device within a range of 10 °F of the processing used as the mechanism for recording
is essential for assuring that reference temperature. Each chart shall have a processing temperatures.
devices maintain their accuracy and working scale of not more than 55 °F per FDA, therefore, is proposing to revise
ensures that the processor can establish inch within a range of 20 °F of the § 113.40(a)(2), (b)(2), (c)(2), (d)(2), (e)(2),
an unbroken chain to trace the accuracy processing temperature. The (f)(2), and (g)(1)(i)(b) to provide
of the reference device to a standard
temperature chart shall be adjusted to flexibility for processors to use

device. agree as nearly as possible with, but to temperature-recording device advanced
The requirements in proposed be in no event higher than, the known technology, to update terminology to
§ 113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), accurate mercury-in-glass thermometer reflect current and appropriate use of
(f)(1), and (g)(1)(i)(a) to establish and during the process time.’’ When the terms such as ‘‘temperature-recording
maintain written records of accuracy of regulations were published in the 1973 device’’ and ‘‘temperature-recording
temperature-indicating devices and final rule, temperature-recording chart,’’ to replace the terms ‘‘mercury-
reference devices, which include the devices generally recorded temperatures in-glass thermometer’’ and
‘‘thermometer’’ with ‘‘temperature- retort systems that pressure process in controller sensor shall be located
indicating device,’’ to replace the term water and are equipped with between the water surface and the
‘‘bulb’’ with ‘‘sensor’’ (discussed later in combination recorder-controller sensors, horizontal plane passing through the
this document), and to clarify the the temperature recorder-controller center of the retort so that there is no
requirements for temperature-recording sensors shall be located where the opportunity for direct steam
devices and the records created by the recorded temperature is an accurate impingement on the sensor. For all still
devices as follows: measurement of the scheduled process retort systems that pressure process in
Temperature-recording device. Each temperature and is not affected by the water and are equipped with
retort, or product sterilizer, shall have heating media. Current § 113.40(b)(2) combination recorder-controllers, the
an accurate temperature-recording indicates specific requirements for temperature recorder-controller sensors
device that records temperatures to a placement of sensors for recorder- shall be located where the recorded
permanent record, such as a controllers, as follows: ‘‘The recording- temperature is an accurate measurement
temperature-recording chart. thermometer bulb should be located of the scheduled process temperature
Analog or graphical recordings. adjacent to the bulb of the mercury-in- and is not affected by the heating media.
Temperature-recording devices that glass thermometer, except in the case of Air-operated temperature controllers
create analog or graphical recordings a vertical retort equipped with a should have adequate filter systems to
may be used. Temperature-recording combination recorder-controller. In such ensure a supply of clean, dry air.
devices that record to charts shall be vertical retorts, the temperature FDA is proposing to clarify in
used only with the appropriate chart. recorder-control bulb shall be located at § 113.40(b)(9) that a sensor, in addition
Each chart shall have a working scale of the bottom of the retort below the lowest to a gage, water glass, or petcock, may
not more than 55 °F per inch (12 °C per crate rest in such a position that the be used to determine the water level in
centimeter) within a range of 20 °F (10 steam does not strike it directly. In the retort during operation. For some
°C) of the process temperature. Chart horizontal retorts, the temperature water level indictors, the term ‘‘sensor’’
graduations shall not exceed 2 °F (1 °C) recorder-control bulb shall be located may more appropriately describe the
within a range of 10 °F (5 °C) of the between the water surface and the mechanism that measures or detects the
process temperature. Temperature- horizontal plane passing through the water level.
recording devices that create multipoint center of the retort so that there is no
plottings of temperature readings shall FDA is proposing to revise
opportunity for direct steam § 113.40(e)(1) to clarify requirements for
record the temperature at intervals that impingement on the control bulb.’’
will assure that the parameters of the placement of sensors of temperature-
These requirements for placement of indicating devices in discontinuous
process time and process temperature combination recorder-controller sensors
have been met. agitating retorts used for pressure
were intended to ensure accurate processing in water, i.e., a water
Digital recordings. Temperature-
measurement of the scheduled process immersion processing system. Current
recording devices, such as data loggers,
temperature and were helpful specific § 113.40(e)(1) requires, ‘‘Bulbs of
that record numbers or create other
directives for sensor placement when indicating thermometers shall be
digital recordings may be used. Such a
the regulations were published in 1973, installed either within the retort shell or
device shall record the temperature at
based on retort designs at that time. in external wells attached to the retort.’’
intervals that will assure that the
However, it may be technologically However, this basic, unqualified
parameters of the process time and
feasible to comply with the specific requirement to place sensors in the
process temperature have been met.
requirements of the current regulation, retort shell or in external wells may not
5. Sensors but place the sensor in a location that be sufficient to ensure proper placement
FDA is proposing to revise does not accurately measure the of temperature-indicating device sensors
§ 113.40(a), (b), (c), (d), (e), (f), and (g)(1) scheduled process temperature. Thus, in discontinuous agitating retorts used
by replacing the term ‘‘bulb’’ or ‘‘bulb or although the specific sensor location for pressure processing in water.
sensor’’ with the general term ‘‘sensor’’ requirements of current § 113.40(b)(2) Current § 113.40(b)(1), relating to
when referring generally to the sensing are still valid, FDA believes further pressure processing in water in still
element of temperature-indicating clarification is needed to ensure that retorts, also a water immersion process,
devices, temperature-recording devices, combination recorder-controller sensors clarifies that, ‘‘Bulbs of indicating
and temperature-controlling devices. are located where the recorded thermometers shall be located in such a
The sensing element of a mercury-in- temperature is an accurate measurement position that they are beneath the
glass thermometer is called a ‘‘bulb’’ in of the scheduled process temperature surface of the water throughout the
the current regulations. The term and is not affected by the heating media. process * * * this entry should be
‘‘sensor’’ encompasses ‘‘bulb’’ as well as FDA is proposing to provide this made in the side at the center, and the
other types of temperature-indicating clarification in new § 113.40(b)(2)(iv) as thermometer bulb shall be inserted
device sensing elements, which are not follows: directly into the retort shell * * * the
bulbs. In the proposed regulation, the • The temperature-recording device thermometer bulbs shall extend directly
inclusive term ‘‘sensor’’ is used when may be combined with the steam into the water a minimum of at least 2
referring to the sensor portion of a controller and may be a combination inches without a separable well or
temperature-indicating device, which recording-controlling instrument. For a sleeve.’’ This type of clarification
may be the bulb of a mercury-in glass vertical retort equipped with a relating to placement of temperature-
thermometer, or to the sensing element combination recorder-controller, the indicating device sensors in still retorts
or probe of a temperature-recording temperature recorder-controller sensor used for pressure processing in water
device or temperature-controlling shall be located at the bottom of the also applies to discontinuous retorts for
device, which may include a mercury- retort below the lowest crate rest in such pressure processing in water. Thus, FDA
in-glass thermometer as a component of a position that the steam does not strike is proposing to revise § 113.40(e)(1)
the device. it directly. For a horizontal retort (proposed § 113.40(e)(1)(v)) by adding
FDA is proposing to revise equipped with a combination recorder- clarifying language relating to
§ 113.40(b)(2) to clarify that, for still controller, the temperature recorder- temperature-indicating device sensor
placement, similar to current • Some typical installations and equipped with a pilot light or other
§ 113.40(b)(1), as follows: operating procedures reflecting the signaling device to warn the operator
• Each temperature-indicating device requirements of this section for venting when it is not running, and with a
shall be installed where it can be still retorts without divider plates are bleeder to remove air when starting
accurately and easily read. The sensor of given in paragraph (a)(12)(i)(a) through operations. Alternative methods for
the temperature-indicating device shall (a)(12)(i)(d) and (a)(12)(ii)(a) and circulation of water in the retort may be
be installed either within the retort shell (a)(12)(ii)(b) of this section. used when established by a competent
or in an external well attached to the As required in current authority as adequate for even heat
retort. Sensors of temperature-indicating § 113.40(a)(12)(iii), other installations distribution.
devices shall be located in such a and operating procedures, such as still
retorts with divider plates, may be used 8. Air Supply and Controls and Water
position that they are beneath the Circulation
surface of the water throughout the if the processor has evidence, on file, in
process. This entry should be made in the form of heat distribution data that its FDA is proposing editorial changes to
installations and operating procedures § 113.40(e)(6). At the beginning of the
the side at the center, and the
accomplish adequate venting of air. first complete sentence, the word
temperature-indicating device sensor
Such documentation is likely to include ‘‘Means’’ is changed to ‘‘A means’’ and
shall be inserted directly into the retort
heat distribution studies conducted and the sentence was changed from a
shell. The temperature-indicating device
documented by the processor to show compound sentence to two simple
sensor shall extend directly into the
that the process temperature will be sentences. FDA also is proposing to
water a minimum of at least 2 inches
reached with the dividers in place. renumber § 113.40(e)(6) as
(5.1 centimeters) without a separable
§ 113.40(e)(6)(i), to read as follows:
well or sleeve. If a separate well or 7. Screens • Air supply and controls. A means
sleeve is used, there must be adequate Current § 113.40(b)(8) states, in part, shall be provided for introducing
circulation to ensure accurate ‘‘Screens should be installed over all compressed air at the proper pressure
temperature measurements. The drain openings.’’ Current and rate. The proper pressure shall be
temperature-indicating device—not the § 113.40(b)(10)(ii) states, in part, ‘‘The controlled by an automatic pressure
temperature-recording device—shall be suction outlets should be protected with control unit. A check valve shall be
the reference instrument for indicating nonclogging screens to keep debris from provided in the air supply line to
the processing temperature. entering the circulating system.’’ These prevent water from entering the system.
6. Vents provisions are intended to advise FDA is proposing to revise
processors that they are responsible for § 113.40(e)(6) to include requirements
FDA is proposing to revise evaluating their water circulation for water circulation pressure
§ 113.40(a)(12) to clarify that the systems and for ensuring that drain processing in water in discontinuous
‘‘installations and operating openings and suction outlets do not agitating water retorts, similar to the
procedures’’ in § 113.40(a)(12)(i)(a) become clogged and prevent proper requirements in current
through (a)(12)(i)(d) and (a)(12)(ii)(a) water circulation and proper heat § 113.40(b)(10)(ii) for pressure
and (a)(12)(ii)(b) do not apply to systems distribution. Although the current processing in water in still retorts.
that use dividers between layers of regulation is expressed as a Current § 113.40(b) and (e) both
containers. Current § 113.40(a)(12) recommendation, rather than a establish equipment and procedures for
states, in part, ‘‘Some typical requirement, processors are responsible pressure processing in water. Section
installations and operating procedures for ensuring proper heat distribution 113.40(b) applies to still retorts and
reflecting the requirements of this during processing and, therefore, must § 113.40(e) applies to discontinuous
section for venting still retorts are given ensure that heat distribution is not agitating retorts. The retort systems are
in paragraph (a)(12)(i)(a) through hampered by clogged drains or suction operationally similar in that they use
(a)(12)(i)(d) and (a)(12)(ii)(a) and outlets. FDA is proposing to revise water under pressure, which must be
(a)(12)(ii)(b) of this section.’’ However, § 113.40(b)(8) and 113.40(b)(10)(ii) to circulated to ensure appropriate heat
the placement of dividers between clarify the requirement, as follows: distribution. FDA considers the water
layers of containers in a still retort • Drain valve. A nonclogging, water- circulation requirements in § 113.40(b)
system was not a ‘‘typical installation or tight valve shall be used. A screen shall for still retorts also apply to
operating procedure’’ at the time the be installed or other suitable means discontinuous agitating retorts. Because
regulations were published in 1973. The shall be used on all drain openings to they are basic procedures for assuring
venting procedures in current prevent clogging. even heat distribution when pressure
§ 113.40(a)(12) were based on heat • Water circulation. When a water processing in water, FDA currently
penetration studies in retort systems circulating system is used for heat considers these requirements when
without dividers and may be inadequate distribution, it shall be installed in such evaluating scheduled processes for
when dividers are placed between a manner that water will be drawn from pressure processing in water in
layers of containers. The dividers may the bottom of the retort through a discontinuous agitating retorts. FDA is
interfere with heat distribution. suction manifold and discharged proposing to clarify the water
Therefore, use of venting schedules through a spreader which extends the circulation procedures for pressure
developed for retorts without dividers length of the top of the retort. The holes processing in water in discontinuous
may not be appropriate for retorts with in the water spreader shall be uniformly agitating retorts by adding new
dividers because such schedules may distributed and should have an § 113.40(e)(6)(ii) as follows:
not be adequate to ensure that all areas aggregate area not greater than the cross- • Water circulation. When a water
of the retort, and thus all containers in section area of the outlet line from the circulating system is used for heat
the retort, reach the required processing pump. The suction outlets shall be distribution, it shall be installed in such
temperature. FDA is proposing to add protected with nonclogging screens or a manner that water will be drawn from
the phrase ‘‘without divider plates’’ to other suitable means shall be used to the bottom of the retort through a
the last sentence of § 113.40(a)(12) as keep debris from entering the suction manifold and discharged
follows: circulating system. The pump shall be through a spreader which extends the
length of the top of the retort. The holes 10. Temperature-Recording Device B. Containers (§ 113.60)
in the water spreader shall be uniformly Sensors Current § 113.60(a) requires
distributed and should have an Current 113.40(g)(1)(i)(b) requires that processors to ensure proper closure and
aggregate area not greater than the cross- a temperature-recording device shall be to check for closure defects. This
section area of the outlet line from the installed in the product at the holding- responsibility should have extended to
pump. The suction outlets shall be tube outlet between the holding tube postprocess handling. However, current
protected with nonclogging screens or and the inlet to the cooler. In addition, § 113.60(a) does not specifically address
other suitable means shall be used to to comply with current § 113.40(g)(4), postprocess handling and current
keep debris from entering the processors must identify where § 113.60(d) relating to postprocess
circulating system. The pump shall be temperature is a critical factor in the handling recommends, but does not
equipped with a pilot light or other require, processors to design and
scheduled process and must measure
signaling device to warn the operator operate automatic equipment used in
and record the temperatures that are
when it is not running, and with a handling filled containers to preserve
critical factors. For example, when
bleeder to remove air when starting the can seam and container closure
processing a non-liquid product or a
operations. Alternative methods for integrity. Container handling
product that contains solid particles,
circulation of water in the retort may be equipment, including automated and
heat penetration of the solid and liquid
used when established by a competent non-automated equipment, must be of
portions may vary and the temperature
authority as adequate for even heat appropriate equipment design and
at locations other than the holding-tube
distribution.
outlet may be critical to ensure effective construction, operated to ensure
9. Drain Valve and Water Level heat penetration throughout the container closure integrity, and replaced
Indicator product. Processors must determine or repaired if defective to ensure proper
FDA is proposing to revise § 113.40(e) each point in the process where container closure. Otherwise, container
to include requirements for the drain temperature is a critical factor for either handling equipment may be the source
valve and water level indicator in the solid or liquid portion of the of damage to the can seam and may
discontinuous agitating water retorts, product and must place temperature- prevent proper seam closure. Improper
similar to the requirements in current recording device sensors at those seam closures may lead to
§ 113.40(b)(8) and (b)(9), respectively, locations. Thus, processors must contamination of the previously
for pressure processing in water in still determine where temperature sterilized product in the can. FDA is
retorts. As previously explained, the measurements are critical, based on the proposing to revise § 113.60(d) to
retort systems for which equipment and size and texture of particles in the food, change the term ‘‘automatic equipment’’
procedures are established § 113.40(b) and must locate sensors as necessary to to ‘‘container handling equipment,’’ to
and (e) are operationally similar in that ensure that the process temperature is clarify that container handling
they use water under pressure. The reached and maintained throughout the equipment used in handling filled
basic requirements for the drain valve process. FDA is proposing to clarify the containers shall be designed,
and water level indicator in § 113.40(b) requirement for temperature-recording constructed, and operated to preserve
for still retorts also should apply to device sensors by adding the following can seam or other container closure
discontinuous agitating retorts. FDA is statement to § 113.40(g)(1)(i)(b): integrity, and to clarify that processors
proposing to add new § 113.40(e)(7) for • Additional temperature-recording must check and, as necessary, repair or
drain valve, consistent with proposed, device sensors shall be located at each replace the container handling
revised § 113.40(b)(8), discussed point where temperature is specified as equipment, including conveyors and
previously in this document, and is a critical factor in the scheduled non-automated equipment, to ensure
proposing new § 113.40(e)(8) for water process. that they do not damage the containers
level indicator, consistent with and container closures as follows:
11. Flow Control • Postprocess handling. Container
proposed, revised § 113.40(b)(9), as
follows: FDA is proposing to revise handling equipment used in handling
• Drain valve. A nonclogging, water- terminology in § 113.40(g)(1)(i)(f) by filled containers shall be designed,
tight valve shall be used. A screen shall changing the title of the section from constructed, and operated to preserve
be installed or other suitable means ‘‘Metering pump’’ to ‘‘Flow control’’ by the can seam or other container closure
shall be used on all drain openings to replacing the terms ‘‘metering pump’’ integrity. Container handling
prevent clogging. and ‘‘speed adjusting device’’ with equipment, including automated and
• Water level indicator. There shall be ‘‘flow controlling device,’’ and by non-automated equipment, shall be
a means of determining the water level replacing the term ‘‘speed changes’’ checked at sufficient frequency and
in the retort during operation, e.g., by with ‘‘flow adjustments.’’ The broad repaired or replaced as necessary to
using a sensor, gage, water glass, or term ‘‘flow controlling device’’ prevent damage to containers and
petcock(s). Water shall cover the top encompasses ‘‘metering pump’’ and container closures. When cans are
layer of containers during the entire ‘‘speed adjusting device’’ as well as handled on belt conveyors, the
come-up-time and processing periods other terms that may be used, such as conveyors should be constructed to
and should cover the top layer of metering device or flow control meter, minimize contact by the belt with the
containers during the cooling periods. to describe or identify equipment used double seam, i.e., cans should not be
The operator shall check and record the to control product flow in the rolled on the double seam. All worn and
water level at intervals sufficient to processing system. Similarly, use of the frayed belting, can retarders, cushions,
ensure its adequacy. term ‘‘flow adjustments’’ is consistent etc. should be replaced with new
Because FDA is proposing new with and broadly describes the function nonporous material. All tracks and belts
§ 113.40(e)(7) and (e)(8), as discussed of flow controlling devices. The that come into contact with the can
previously in this document, we also are proposed revision of the title of the seams should be thoroughly scrubbed
proposing to renumber current section to ‘‘Flow control’’ is consistent and sanitized at intervals of sufficient
§ 113.40(e)(7), relating to critical factors, with the terminology changes within the frequency to avoid product
as § 113.40(e)(9). text of proposed § 113.40(g)(1)(i)(f). contamination.
C. Establishing Scheduled Processes initialed, dated, and maintained.’’ identified as a critical factor in the
(§ 113.83) Although FDA believes it should be scheduled process, the temperature
Current § 113.83 states, ‘‘The type, understood that initial temperature must be observed and recorded, as
range, and combination of variations measurements are expected to be required in § 113.100(a).
encountered in commercial production accurate when taken and, therefore, the FDA is proposing to revise
shall be adequately provided for in temperature-indicating device used for § 113.100(c) by adding the statement,
establishing the scheduled process.’’ initial temperatures must be accurate,
‘‘The records shall be signed or initialed
Reprocessing of a product and blending the proposed clarifications ensure
and dated by the reviewer.’’ The current
a previously processed product into a consistency in interpretation of the
regulation requires that containers
new formulation are variations that may requirements of § 113.87(c).
FDA is proposing to revise § 113.87(e) closure records shall be signed or
affect the adequacy of the scheduled initialed by the container closure
to replace the term ‘‘recording-
process and, therefore, must be carefully inspector and reviewed by management,
temperature charts’’ with ‘‘temperature-
evaluated and adequately addressed in recording device records’’ to ensure but it does not explicitly state that the
the scheduled process. For example, consistency with the changes in person in management who reviews the
because starch, when heated, is terminology relating to the use of the records must also sign or initial and
gelatinized, a processed starchy food term ‘‘charts,’’ discussed previously in date the records. FDA is proposing to
may have a different viscosity than the this document in changes to proposed add this requirement because such
same starchy food prior to processing. revised § 113.40. FDA also is proposing documentation is necessary to identify
When a previously processed starchy to change the recommendation for clock the manager who conducted the review
food is blended or reprocessed, because times to reasonably correspond to the and thus avoid any misunderstandings
of physical changes in the time of the day to a requirement by about who reviewed the record, to verify
characteristics of the food, the changing the word ‘‘should’’ to ‘‘shall.’’ that the review was conducted by an
scheduled process used for the starchy Correlation of records with the time the individual qualified by training and
food prior to processing may not be records were created and with the time expertise relating to container closures
adequate for the same food after of the processing cycle is essential for who can accept the records for the
processing. Thus, the scheduled process evaluating time and temperature processor, to identify the person
must be established based on the correlations of the scheduled process. responsible for ensuring following-up to
specific food used as the starting This revision also is consistent with the correct container closure defects, and to
material for each specific process, i.e., requirement of § 113.100(a), ‘‘Processing indicate that the records have been
when a reprocessed or a previously and production information shall be accepted by the processor.
processed product is blended into a new entered at the time it is observed by the
formulation, the scheduled process retort or processing system operator FDA is proposing to add a new
must be specific for that situation. FDA * * *.’’ Proposed revised § 113.87(e) § 113.100(f) to provide for the
is proposing to clarify this requirement would read as follows: maintenance of computerized records,
by revising § 113.83 to include the • Clock times on temperature- in accordance with part 11 (21 CFR part
statement, ‘‘When a product is recording device records shall 11). FDA regulations in part 11 set forth
reprocessed or a previously processed reasonably correspond to the time of FDA criteria for electronic records and
product is blended into a new day on the written processing records to signatures. Many low-acid canned food
formulation, this condition must be provide correlation of these records. processors currently maintain records
covered in the scheduled process.’’ on computers. The proposed addition of
E. Processing and Production Records new § 113.100(f) clarifies and
D. Operations in the Thermal Processing (§ 113.100) acknowledges that records relating to
Room (§ 113.87) Current § 113.100 identifies processing low-acid canned foods may
FDA is proposing to revise § 113.87(c) requirements for processing and be maintained electronically, provided
by inserting the term ‘‘accurately’’ in the production records. FDA is proposing in they are in compliance with part 11.
first sentence to clarify that ‘‘The initial § 113.100 to revise terminology,
temperature of the contents of the FDA is proposing to add a new
consistent with terminology used in
containers to be processed shall be § 113.100(g) to clarify that records
proposed § 113.40. FDA is proposing to
accurately determined and recorded required under part 113, or copies of
replace the term ‘‘mercury-in-glass
with sufficient frequency to ensure that thermometer’’ with ‘‘temperature- such records, must be readily available
the temperature of the product is no indicating device,’’ to replace during the retention period for
lower than the minimum initial ‘‘recording thermometer’’ with inspection and copying by FDA when
temperature specified in the scheduled ‘‘temperature-recording device,’’ to requested. Proposed § 113.100(g)
process.’’ FDA is adding this term to replace ‘‘metering pump’’ with ‘‘flow provides that, in part, ‘‘if reduction
emphasize that initial temperature controlling device,’’ and to replace techniques, such as microfilming, are
determinations must be accurate, as ‘‘recording thermometer charts’’ with used, a suitable reader and
determined by sufficiently frequent tests ‘‘temperature-recording device records.’’ photocopying equipment must be made
of the temperature-indicating device for FDA is proposing to revise readily available to FDA.’’ Access to
accuracy against an accurate calibrated § 113.100(a)(4) by removing the such records during inspections is
reference device. FDA also is proposing requirement to maintain records of the needed by FDA field investigators to
evaluate compliance with the
to add in § 113.87(c), ‘‘The temperature- product temperature in the final heater

indicating device used to determine the outlet as indicted by the temperature requirements of part 113. Copies of such
initial temperature shall be tested for recorder-controller in aseptic processing records are needed for review by FDA
accuracy against an accurate calibrated and packaging systems. The temperature headquarters staff experts who evaluate
reference device at sufficient frequency in the final heater outlet may not be complex scientific and technical issues
to ensure that initial temperature critical and, therefore, may not require associated with processing low-acid
measurements are accurate. Records of maintenance of records. However, if the canned foods and with compliance with
the accuracy tests shall be signed or final heater outlet temperature is the requirements of part 113.
F. Minor Revisions in Regulations with the proposed rule. The act’s available for the low-acid food industry.
FDA is proposing to correct enforcement provisions commit Moreover, NIST has developed
typographical errors, revise sentence complete discretion to the Secretary of standards for some alternative
structure, and make minor clarifying Health and Human Services (and by temperature-indicating devices and
edits in the regulations, as follows: delegation to FDA) to decide how and there is little reason to assume that
In proposed § 113.40(a)(4), (a)(8), when they should be exercised (see alternatives are any less accurate than
(b)(10)(i), (c)(5), and (e)(6)(i), we Heckler v. Chaney, 470 U.S. 821 at 835 mercury-in-glass thermometers, given
(1985); see also Shering Corp. v. an appropriate testing regime. We
changed compound sentences to simple
Heckler, 779 F.2d 683 at 685–86 (D.C. request comments on the possibility that
sentences.
Cir. 1985) (stating that the provisions of alternative temperature-indicating
In the first sentence of proposed
the act ‘‘authorize, but do not compel devices are at least as accurate as
§ 113.40(b)(10)(ii), we changed the word
the FDA to undertake enforcement mercury-in-glass thermometers, and also
‘‘is’’ to ‘‘it.’’
activity’’)). Until the agency issues a that there are appropriate and
In the third sentence of proposed
final rule for temperature-indicating established testing regimes to assure
§ 113.40(d)(2)(iv), we changed the
devices for thermally processed low- their accuracy.
phrase ‘‘bleeder opening emitting Correspondence with industry
steam’’ to ‘‘bleeder that emits steam.’’ acid foods packaged in hermetically
sealed containers, the agency believes representatives suggests that the current
In the second sentence of proposed regulation requiring mercury-in-glass
§ 113.40(e)(1)(v), we changed the phrase that its exercise of enforcement
discretion will provide the needed thermometers may be a barrier to
‘‘in external wells’’ to ‘‘in an external innovation (Ref. 3). By allowing the low-
well.’’ flexibility to manufacturers who desire
to transition to alternative temperature- acid food industry flexibility to choose
In the fifth sentence of proposed alternative temperature-indicating
§ 113.40(e)(9), we corrected the spelling indicating devices. Processors who
choose to use alternative temperature- devices, the proposed rule would allow
of ‘‘vacuum.’’ processors to select temperature-
In the first sentence of proposed indicating devices must comply with
any revised requirements established in indicating devices based on gains to
§ 113.40(g)(1)(i)(G), we corrected the labor productivity and technical
spelling of ‘‘continuous.’’ the final rule when the final rule
becomes effective. considerations. Clarifying provisions in
In the third sentence of proposed the current regulation would facilitate
§ 113.100(b), we changed the word IV. Analysis of Impacts the voluntary adoption and safe use of
‘‘that’’ to ‘‘than.’’ alternative temperature-indicating
A. Preliminary Regulatory Impact
G. Immediate Implementation of Analysis: Flexibility in Permitting technology, as well as replace outdated
Proposed Rule Alternative Temperature-Indicating terminology.
Devices The potential to improve productivity
FDA believes the proposed revisions may be one reason firms may choose to
to §§ 113.40, 113.60, 113.83, 113.87, and FDA has examined the impacts of the adopt alternatives to mercury-in-glass
113.100 will provide industry with proposed rule under Executive Order thermometers. Correspondence with the
flexibility to take advantage of 12866, the Regulatory Flexibility Act Food Products Association (FPA)
technological advancements associated (the RFA) (5 U.S.C. 601–612), and the (formerly, National Food Processors
with temperature-indicating devices and Unfunded Mandates Reform Act of 1995 Association) suggests that monitoring
temperature-recording devices, will (Public Law 104–4). Executive Order and analysis capabilities from using
clarify recordkeeping requirements for 12866 directs agencies to assess all costs alternative temperature-indicating
temperature-indicating devices and and benefits of available regulatory devices may be enhanced (Ref. 3). In
other aspects of processing low-acid alternatives and, when regulation is addition, the potential to avoid costly
canned foods, and will clarify necessary, to select regulatory remediation of hazardous mercury
provisions of the current regulations. approaches that maximize net benefits spills, and growing concerns by State
FDA believes that the proposed rule will (including potential economic, and local governments about the health
ensure that temperature-indicating environmental, public health and safety, effects from the accumulation of
devices that replace mercury-in-glass and other advantages; distributive mercury in the environment, have led to
thermometers are accurate during impacts; and equity). The agency legislation that restricts the sale,
processing. FDA also believes the believes that this proposed rule is not a manufacture, and distribution of
proposed rule allows industry to significant regulatory action as defined mercury-in-glass thermometers (Ref. 4).
voluntarily transition from mercury-in- by the Executive order. For these reasons, FPA correspondence
glass thermometers to other suggests that low-acid food processors
temperature-indicating devices and to 1. Need for the Regulation
are phasing out the use of mercury-in-
reduce potential sources of mercury Current regulations for thermally glass thermometers for all other
contamination in food processing processed low-acid foods in purposes except those necessary for
plants. hermetically sealed containers, except regulatory compliance.
FDA believes that some processors are for aseptic packaging and processing,
anxious to replace mercury-in-glass require the exclusive use of mercury-in- 2. Regulatory Options Considered
thermometers with alternative glass thermometers for indicating Regulatory options considered
temperature-indicating devices. temperatures during food processing. include:
Therefore, pending issuance of a final The requirement for exclusive use of Option 1—No new regulation.
rule, FDA intends to consider the mercury-in-glass thermometers reflects Option 2—Allow flexibility to use
exercise of its enforcement discretion on the absence of alternatives on the alternative temperature-indicating
a case-by-case basis when processors of market at the time current regulations devices, including mercury-in-glass
low-acid canned food elect to replace became effective in 1973. Because of thermometers, that can be tested against
mercury-in-glass thermometers with technological advances in thermometry an accurate calibrated reference device
alternative temperature-indicating since that time, alternatives to mercury- in processing low-acid canned foods
devices in a manner that is consistent in-glass thermometers may now be without an explicit record requirements.
Option 3 (the Proposed Rule)—All of Higher purchase prices and thermometers. FDA requests comments
the provisions in option 2 and include maintenance costs may influence a on the magnitude of the costs (if any)
explicit recordkeeping requirements for firm’s decision to use alternative associated with learning about and
test results and explicit records access temperature-indicating devices. adjusting to testing requirements for
requirements for required records. Correspondence with FPA suggests that alternative temperature-indicating
most digital alternatives are slightly devices, as well as our assumption that
3. Costs and Benefits of Option 1 (No
more expensive than mercury-in-glass testing costs for alternative temperature-
New Regulation)
thermometers (Ref. 3). According to indicating devices, subsequent to the
There are neither costs nor benefits FPA, after installation, there are no initial establishment of testing
from the option of no new regulation. significant differences in maintenance protocols, are comparable to those for
4. Costs and Benefits of Option 2 (Allow costs during normal operations between mercury-in-glass thermometers.
the Use of Alternative Temperature- mercury-in-glass thermometers and Finally, we assume that firms able to
Indicating Devices Without a Record alternative temperature-indicating achieve gains in labor productivity and
Requirement for Accuracy Tests) devices (Ref. 3). Thus, the higher cost reduce remediation costs will phase in
would be a one-time capital cost. FPA alternative temperature-indicating
The costs and benefits are estimated also suggests that many firms are using devices. One firm predicted that
separately for the proposed voluntary alternative temperature-indicating alternative temperature-indicating
and mandatory provisions of the rule. device technology for purposes that are devices will be chosen for all new
The voluntary provision allows low- beyond the scope of the low-acid food purchases immediately following
acid canned food manufacturers to use regulations (Ref. 3). This implies that issuance of the final rule, and that the
alternatives to mercury-in-glass the productivity gains from their total period for transition from mercury-
thermometers as temperature-indicating adoption are greater than the higher in-glass thermometers to alternative
devices. In option 2, the mandatory purchase prices. temperature-indicating devices will be 5
provisions are considered to be Temperature-indicating devices must years (Ref. 3). FDA assumes that all mid-
clarifications of the current regulation be tested against an accurate calibrated sized and large low-acid canned food
and are primarily intended to facilitate reference device, including tests relating manufacturers will adopt alternative
the voluntary adoption and safe use of to relevant factors such as temperature-indicating device
alternative temperature-indicating electromagnetic interference and technology within 5 years after issuance
technologies. Option 2 does not environmental conditions. of the final rule. We request comments
consider requirements for low-acid Environmental conditions may affect on this assumption.
canned food manufacturers to establish the accuracy of mercury-in-glass b. Benefits from permitting the use of
and maintain records on accuracy tests thermometers. Thus, low-acid food alternative temperature-indicating
necessary to ensure that each manufacturers have experience with devices.
temperature-indicating device, understanding and controlling these Changes in the Risk of Foodborne
including each mercury-in-glass factors to ensure that mercury-in-glass Illness
thermometer, and each reference device thermometers are accurate and function The Centers for Disease Control and
is accurate during processing. Nor does properly during processing. Tests to Prevention (CDC) report that there were
option 2 consider requirements for FDA ensure that alternative temperature- 20 cases of foodborne botulism and 76
access to such records upon inspection. indicating devices are not susceptible to cases of infant botulism in the United
There are no compliance costs from electromagnetic interference may result States in 2003 (Ref. 5). There have been
allowing alternative temperature- in higher costs for testing and no reported cases of foodborne botulism
indicating devices. The benefits from maintaining the devices. associated with commercially canned
allowing alternative temperature- FPA suggests that many companies low-acid food in recent years. CDC
indicating devices are from any already use alternative temperature- reported one case of botulism from food
reduction of the risk of foodborne indicating devices for unregulated eaten at a restaurant and one case from
illness that results from the use of purposes, and that the use of mercury- food eaten at an unknown location in
alternative temperature-indicating in-glass thermometers in these 1994, but home-canned food and Alaska
devices, the avoided cleanup and establishments is restricted to regulatory Native foods consisting of fermented
disposal costs resulting from breaking compliance purposes (Ref. 3). In the seafood are currently the principal
mercury-in-glass thermometers during event that alternative temperature- sources of foodborne botulism (Ref. 5).
non-production times, and the increase indicating devices currently used by The risk factors for infant botulism,
in labor productivity at low-acid canned industry for unregulated purposes are including from food and non-food
food manufacturers. tested against an accurate calibrated sources, remain largely unknown.
a. Costs from permitting the use of reference device, the experience of their Although cases of botulism are mostly
alternative temperature-indicating use for the unregulated purpose would associated with food prepared or canned
devices. The proposed regulation likely mitigate any additional learning, at home, a change to inaccurate or
permits, but does not require, low-acid or adjustment costs for their testing. improperly functioning temperature-
food manufacturers to adopt alternatives Nevertheless, one-time adjustment costs indicating devices by low-acid canned
to mercury-in-glass thermometers. Thus, are likely to be incurred by all low-acid food manufacturers could potentially
costs associated with choosing an canned food manufacturers that adopt increase the risk of foodborne botulism.
alternative to mercury-in-glass alternative temperature-indicating Increased risk of botulism associated
thermometers are voluntarily incurred. device technology—especially early with new technology could result from
These costs would be incurred only if adopters of such technology—as they increased risk of device errors for
the expected private benefits from doing adjust to new testing protocols and indicating and recording temperatures,
so are higher than the costs. To show appropriate testing frequencies. FDA or an increased risk of human errors in
our estimation method and solicit assumes that, after testing protocols and reading alternative temperature-
comments, we specify the determinants frequencies are established, the testing indicating devices. An increased risk of
of the costs of alternative temperature- costs will be comparable to those illness could accompany an increased
indicating devices. required for testing mercury-in-glass risk of such errors that lead to food
being processed at unsafe low indicating device technology by low- Based on the laboratory accident rates
temperatures. acid canned food manufacturers is the reported previously, we estimate that
To acknowledge the potential for reduced risk of cleanup and disposal there are approximately 390
increased risk associated with the costs resulting from breaking mercury- manufacturing process related accidents
adoption of alternative technologies in-glass thermometers during non- per year (i.e., (19,504 / 100) x an
mentioned previously in this document, production times (e.g., calibration, accident rate of 2) in the low-acid
this proposed rule requires alternative equipment maintenance, storage). canned food industry. We assume that
temperature-indicating devices to be Disposal and cleanup costs for mercury half of these accidents involve
tested for accuracy against an accurate spills and damaged mercury-in-glass equipment that comes directly in
calibrated reference device. The thermometers can be high. FPA contact with mercury-in-glass
proposed rule also requires tests relating estimates the cost of environmental thermometers, and half of those, or
to relevant factors such as disposal of mercury-in-glass approximately 100, involve mercury-in-
electromagnetic interference and thermometers to be about $500 (Ref. 3). glass thermometer breakage and require
environmental conditions. Alternatives Examples of cleanup costs provided by remediation in the form of cleanup and
to the mercury-in-glass thermometer the Northeast Waste Management disposal.
that meet NIST requirements are Officials’ Association include the $6,000 We estimate that all large and mid-
currently available to the industry and cleanup costs paid by a school following sized low-acid canned food
we assume that such technology is at the breakage of 12 thermometers (Ref. manufacturers will adopt alternative
least as accurate as mercury-in-glass 6), or approximately $500 per temperature-indicating device
thermometers given an appropriate thermometer. According to Harvard technology because of the potential
testing regime. University Operations Services, mercury savings in cleanup costs as well as the
There may be a period of learning and spills involving thermometer breakage potential for increased productivity
adjustment to the new temperature- are one of the most common accidents made possible from alternative
indicating technology for a short period involving laboratory equipment, with temperature-indicating devices. There
immediately following its adoption, cleanup costs of approximately $110 per currently are approximately 1,100
during which the risk of inaccurate thermometer (Ref. 7). domestic and 5,600 foreign-based low-
measurement may be temporarily Mercury-in-glass thermometer acid canned food manufacturers
elevated. We assume that the frequency breakage can occur within the registered with FDA that supply the
of testing for accuracy during this processing plant during calibration, domestic market (Ref. 10). Because that
adjustment period may increase for a equipment maintenance, storage, and data does not include firm size
short time to compensate for any other non-production times. Because we information, we estimate the proportion
increased risk of inaccurate do not have accident data from of large and mid-sized domestic low-
measurement from the new technology. processors, we estimate mercury-in- acid canned food manufacturers using
Consequently, we assume that any glass thermometer breakage rates using U.S. Economic Census data, and assume
increases in risk during the adjustment information on accident rates involving the same proportions of large and mid-
period will be fully mitigated through laboratory equipment. According to a sized foreign firms as well.
appropriate or increased testing. We 2004 bulletin published by the Based on the 2002 U.S. Economic
request comments on this assumption. Lawrence Berkeley Laboratory, the Census there were a total of 1,051 fruit
An increase in risk of illness could annual number of laboratory accident and vegetable, specialty canning, and
arise from an increase in human error in rates for 2002, 2003, and 2004 was 2.17, dry, condensed, and evaporated dairy
reading the alternative temperature- 2.51, and 1.25 per 100 employees product manufacturing establishments
indicating device. However, we assume (respectively), for an annual average of reported for NAICS codes 311421,
that the alternatives to the mercury-in- approximately 2 per 100 employees 311422, and 311514, and that large and
glass thermometer are likely to be no (Ref. 8). mid-sized establishments (i.e.,
more difficult to read than mercury-in- Using 2002 U.S. Economic Census establishments with more than 19
glass thermometers. Thus, we expect no data on the number of employees in the employees) comprise approximately
increase in the number of reading errors. low-acid canned food industry, we half of the total. Consequently, we
Some alternative temperature-indicating extrapolated the laboratory accident estimate that if half of the low-acid food
devices may have a digital display of the rates reported previously in this manufacturers were to discontinue use
temperature and may be easier to read document. There were reported to be of mercury-in-glass thermometers as
than mercury-in-glass thermometers. 78,016 employees in the canned food provided in the proposed rule,
However, there is also the possibility industry (North American Industry approximately 50 domestic accidents
that certain digital displays with poor Classification System (NAICS) codes per year involving mercury-in-glass
resolution may facilitate reading errors. 311421, 311422, and 311514 for fruits thermometers would be avoided (i.e.,
In addition, the magnitude of a reading and vegetables canning, specialty 100 accidents divided by 2 for large and
error from a digital display may be canning, and seafood canning) in 2002 mid-sized establishments) and 255
different than that from a mercury-in- (Ref. 9). We assume that half of all foreign-based accidents per year
glass thermometer. The relative risk of employees of canning manufacturers are involving mercury-in-glass
misreading a digit displayed in the involved in the manufacturing process. thermometers would be avoided (i.e.,
‘‘tens’’ and ‘‘ones’’ columns may be We further assume that half of the 100 accidents, scaled by the ratio of
different for digital displays compared employees involved in the foreign to domestic firms, 5,600 / 1,100,
to the conventional mercury-in-glass manufacturing process will come into and divided by 2 for large and mid-sized
thermometers. Although we assume no direct contact with mercury-in-glass firms) that would otherwise incur
increase in the risk of reading errors for thermometers at some point during the cleanup and disposal costs during non-
digital devices, we request comments on performance of their jobs. This yields an production times. Implicit in this
this assumption. estimate of 19,504 employees of low- estimate is the assumption that the
Avoided Cleanup Costs acid canned food manufacturers that accident rates for domestic and foreign-
The principal benefit from allowing come into direct contact with based manufacturers are the same. We
flexibility in the use of temperature- temperature-indicating devices. request comments on this assumption.
We assume that each accident sized establishments (i.e., 2.8 percent industry, and information that is
involves one mercury-in-glass divided by 2 x $27.10), and $0.19 per currently generated during accuracy
thermometer. In addition, we assume hour at small establishments (i.e., 2.8 tests may not be permanently recorded,
that cleanup and remediation costs per percent divided by 4 x $27.10). as required under this proposed rule.
accident are the same for foreign-based Thus, we assume there will be labor
5. Costs and Benefits of Option 3, the
and domestic low-acid canned food costs incurred from this proposed rule
Proposed Rule (Option 2 With Added
manufacturers. Consequently, we to record information that is currently
Recordkeeping and Records Access
estimate that after half of the low-acid generated, but not recorded. We assume
Requirements)
canned foods manufactures adopt that half of the industry currently does
alternative temperature-indicating a. Costs of the recordkeeping and not have sufficient incentive to track the
device technology, between $5,500 and records access requirements. The performance of the temperature-
$25,000 in remediation costs (i.e., 50 current low-acid food regulations indicating devices necessary to
accidents x $110, and 50 accidents x recommend, but do not require, that permanently record all of the required
$500) would be averted by domestic records of thermometer accuracy checks information. We further assume that
manufacturers, and between $25,000 that specify date, standard used, method current practice by these firms is to
and $127,000 in remediation costs (i.e., used, and person performing the test be leave unrecorded one to four separate
255 accidents x $110, and 255 accidents maintained. The proposed rule requires, pieces of information required under the
x $500, rounded to the nearest rather than recommends, maintenance proposed rule, and that each piece of
thousand) would be averted by foreign- of written documentation of the information takes between 10 and 15
based manufacturers. Total remediation accuracy of the temperature-indicating seconds to permanently record.
costs averted would be between $30,500 device, and also written documentation Consequently, we estimated that half of
and $152,000. of the accuracy of the reference device. all low-acid canned food manufacturers
Increased Productivity from Allowing The proposed rule also requires that would spend between 10 seconds and 1
Alternative Technologies each temperature-indicating device and minute (i.e., 1 x 10 seconds and 4 x 15
We use U.S. Department of Labor reference device have a tag, seal, or seconds) per device, recording
estimates of changes in labor other means of identity that can be information required in the proposed
productivity from 1995 to 2004 to referenced in the required records as the rule that is currently unrecorded.
estimate the savings to large, mid-sized, identity of the device. These proposed We estimated the number of
and small firms from improved recordkeeping requirements apply to temperature-indicating devices that
temperature monitoring and mercury-in-glass thermometers as well would be subject to recordkeeping
recordkeeping productivity that may as alternative temperature-indicating requirements using the results of a
result from using alternative devices and reference devices. survey of the low-acid canned food
temperature-indicating devices. We Additional costs associated with the industry conducted by FDA and
assume that cost savings and increases proposed revised recordkeeping published in 1994 (Ref. 13). Findings
in labor productivity from adopting requirements may be incurred for all from that survey indicate that the
alternative temperature-indicating temperature-indicating devices and number of mercury-in-glass
technology would be the same for reference devices. thermometers found at establishments
domestic and foreign-based firms of The costs of the requirement to ranged from 1 to 65, with only 4 percent
similar size. establish and maintain records are the of establishments having more than 30
We computed the average of the U.S. setup costs required to design and thermometers, and 67 percent having
Department of Labor quarterly estimates establish a form for recording the fewer than 10. Assuming the number of
of the percent change in quarterly required information, and the additional thermometers is uniformly distributed
output per hour (expressed in annual labor requirements needed to record the between 1 and 10 for 67 percent of
terms) in the non-farm business sector information. In addition, there will be establishments, between 11 and 30 for
over the 10-year period from 1996 one-time costs for training employees to 29 percent of establishments, and
through 2005 to be 2.8 percent (Ref. 11). comply with the requirement. We between 31 and 65 for 4 percent of
We estimated that productivity gains to assume that one to two accuracy tests establishments, we estimated a
labor engaged in monitoring will be performed per year per device weighted average of about 10
temperature sensitive processes by low- and that only a small number of forms thermometers per establishment (i.e., 67
acid canned food manufacturers that would need to be designed. Thus, the percent x 5.5 + 29 percent x 15.5 + 4
adopt alternative temperature-indicating setup costs for the recordkeeping percent x 48 rounded to the nearest
technology would be 2.8 percent as requirement would be minimal. integer).
well. Moreover, we assume that the current Based on the findings from this study,
We assume that monitoring recordkeeping practice is to maintain we estimated that low-acid canned food
temperature sensitive processes requires most, if not all, of these records and that establishments use an average of 10
the equivalent of one full time job at the additional one-time training costs devices annually, for a total number of
large establishments, half a full time job would be minimal as well. 33,500 thermometers with accuracy test
at mid-sized establishments, and one We assume that additional labor costs results that are currently not fully
quarter of a full time job at small to record the required information will recorded (i.e., 1/2 x 6,700
establishments. We doubled the mean be small because the current regulations establishments x 10 thermometers) as
hourly wage of $13.55 for production recommend maintaining similar required in the proposed rule. We
labor in 2002, obtained from the Bureau records. Thus, we assume that the assume that each device requires one to
of Labor Statistics (Ref. 12), to account current practice is to keep track of most, two tests per year (for a mean of 1.5),
for overhead costs and estimated that if not all, of the information required by and estimated the total burden for the
adopting new temperature-indicating the proposed rule. However, we request industry for recording the required test
technology could increase labor comments on this assumption. result information to be between 140
productivity by as much as $0.76 per Current incentives to track accuracy hours and 838 hours per year (i.e.,
hour (i.e., 2.8 percent x $27.10) at large and performance of mercury-in-glass 33,500 thermometers x 10 seconds x 1.5
establishments, $0.38 per hour at mid- thermometers may vary across the tests / 3,600 seconds per hour, and
33,500 thermometers x 60 seconds x 1.5 accuracy that might result due to substantial. We estimate that avoided
tests / 3,600 seconds per hour). concern by a manufacturer with being in cleanup costs from broken mercury-in-
Doubling the $13.55 mean hourly wage compliance with the testing glass thermometers will be between
for production labor for 2002 from the requirement. Additional incentives for $30,500 and $152,000 if all large and
Bureau of Labor Statistics (Ref. 11) to testing for accuracy may be particularly medium sized low-acid food firms adopt
account for overhead costs, we important during a transition period alternative temperature-indicating
computed the labor cost of recording when knowledge about alternative devices. Table 1 of this document
accuracy test information required in temperature-indicating device summarizes the costs and benefits of the
this proposal to be between $3,800 and performance characteristics may be proposed rule, rounded to the nearest
$22,700, rounded to the nearest uncertain. thousand.
hundred. In addition, there may be benefits
The costs of the requirement to allow from any increase in the degree of TABLE 1.—A SUMMARY OF THE COSTS
FDA access to records documenting the certainty that a manufacturer will AND BENEFITS OF THE PROPOSED
accuracy of both temperature-indicating comply with a records access request, RULE
devices and reference devices include particularly during an outbreak
the costs of document retrieval and investigation when records of test Description Impact
reproduction, as well as time spent with results may be essential to determine
FDA investigators prior to, and the cause of the outbreak. However, any One-time Costs
immediately following, these activities. increase in the incentives to test
We assume these costs would be alternative temperature-indicating Design of new record- minimal
incurred once per year with a regular devices for accuracy, and also in the keeping forms
facility inspection, as well as irregularly degree of certainty that a manufacturer Recordkeeping training minimal
during outbreak investigations. We will comply with a records access
assume the costs from the records access request, may be smaller for foreign- Recurring Costs
requirements would be incurred by a based manufacturers compared with
small number of firms that currently fail domestic manufacturers. This may be Recordkeeping $5,000–
to permit FDA access to records under true if foreign-based manufacturers $23,000
the current regulation. export their products to buyers based
Records access (incurred minimal
b. Benefits of the recordkeeping and not only in the United States, but also by a small number of
records access requirements. The in countries that do not require the firms that currently fail to
benefits from the proposed maintenance and access to records permit FDA access)
recordkeeping and records access documenting the accuracy of
requirements are derived from the temperature-indicating device Purchase and additional voluntarily in-
enhanced ability by manufacturers to technology. Under such circumstances testing of alternative de- curred
track critical accuracy and performance foreign-based low-acid canned food vices
data for temperature-indicating devices manufacturers may choose to sell their
Benefits
which may improve safety, as well as products in other countries rather than
the ability by FDA to determine comply with FDA records requirements. Change in risk from low- no change
compliance with the recordkeeping We request comments on the possibility acid canned foods
requirements. Although we believe that that the incentives for maintaining
maintenance of these records is the records by foreign-based low-acid Avoided mercury cleanup $31,000–
current industry practice, the explicit canned food manufacturers that export costs $152,000
requirement in this proposed rule may to the United States are smaller than
Enhanced labor produc- not quantified,
increase the incentive for industry those for domestic manufacturers. tivity but may be
compliance with records requirements, substantial
including those related to the testing of 6. Summary
temperature-indicating devices and In summary, the proposed rule
B. Regulatory Flexibility Analysis
reference devices, and may increase the provides flexibility by permitting
frequency with which testing occurs. alternative temperature-indicating The RFA requires agencies to analyze
The benefits from requiring devices without increasing public regulatory options that would minimize
maintenance of accuracy testing records health risks from low-acid foods. In any significant impact of a rule on small
may be particularly high during the addition, the proposed rule may result entities. The agency certifies that the
transition period following the adoption in additional or more frequent testing of proposed rule will not have a significant
of alternative temperature-indicating alternative temperature-indicating economic impact on a substantial
devices if they are useful for learning devices, which may be particularly number of small entities.
about the performance characteristics useful for evaluating device FDA has examined the economic
and required testing protocols. performance. The setup costs for implications of this proposed rule as
FDA’s experience is that most designing new forms for recording the required by the RFA. If a rule has a
manufacturers currently permit access required accuracy test information and significant economic impact on a
to temperature-indicating device test the one-time training costs are assumed substantial number of small entities, the
results and other records under the to be minimal. The recurring additional RFA requires agencies to analyze
regulatory options that would lessen the
current regulation, and we expect the labor costs are estimated to be between
benefits of the records access $3,800 and $22,700. economic effect of the rule on small
requirement from improving regular The avoided mercury cleanup costs entities. The voluntary provisions of
inspections to be small. However, the from broken mercury-in-glass this proposed rule would not generate
records access requirement may provide thermometers, and also the potential for any compliance costs for any small
benefits from any accompanying enhanced labor productivity from entities because they do not require
increase in incentives to test alternative adopting alternative temperature- small entities to undertake any new
temperature-indicating devices for indicating device technology, may be activity. A small business will not
choose alternative temperature- Paperwork Reduction Act of 1995 (the data, we estimate that there are
indicating device technology unless it PRA) (44 U.S.C. 3501–3520). A approximately 6,700 low-acid canned
believes that doing so will increase description of these provisions is given food processing establishments.
private benefits by more than it in the following paragraphs with an Burden: The costs of the
increases private costs. estimate of the annual recordkeeping recordkeeping requirement are the setup
The per-firm costs of the mandatory burden. Included in the estimate is the costs required to design and establish a
recordkeeping requirement of this time for reviewing instructions, form for recording the required
proposed rule will be small. The searching existing data sources, information, and the additional labor
additional labor costs from the gathering and maintaining the data requirements needed to record the
recordkeeping requirements are needed, and completing and reviewing information. The initial setup costs for
estimated to be between $3,800 and each collection of information. designing a new record form are
$22,700 or between approximately $1.00 FDA invites comments on the assumed to be minimal since only one
and $4.00 per firm (i.e., $3,800 / 6,700 following topics: (1) Whether the to two accuracy tests will be performed
firms and $22,700 / 6,700 firms, proposed collection of information is on an average of 10 devices per firm.
rounded up). Moreover, costs for small necessary for the proper performance of We assume that labor costs to record
firms will be at the lower end of this FDA’s functions, including whether the the required information will be small
range since they will have fewer information will have practical utility; because current practice is to keep track
temperature-indicating devices and (2) the accuracy of FDA’s estimate of the of most, if not all, of this information.
reference devices to test. We assume the burden of the proposed collection of Because current incentives to track
costs from the records access information, including the validity of accuracy of mercury-in-glass
requirement would be small and the methodology and assumptions used; thermometers may vary across the
incurred by a small number of firms that (3) ways to enhance the quality, utility, industry, information that is currently
currently fail to grant FDA access to and clarity of the information to be generated during accuracy tests may not
records under the current regulation. collected; and (4) ways to minimize the be permanently recorded as required
Accordingly, FDA certifies that this burden of the collection of information under the proposed rule. Thus, we
proposed rule will not have a significant on respondents, including through the assume there will be labor costs
impact on a substantial number of small use of automated collection techniques, incurred from this proposed rule to
entities. Under the RFA, no further when appropriate, and other forms of record information that is currently
analysis is required. information technology. generated, but not recorded.
C. Unfunded Mandate Analysis Title: Recordkeeping Requirements for We assume that half of the industry
Temperature-Indicating Devices currently does not have sufficient
Section 202(a) of the Unfunded
Description: The information incentive to track the performance of the
Mandates Reform Act of 1995 requires
proposed to be collected contains the temperature-indicating devices and
that agencies prepare a written
results of tests of the accuracy of reference devices necessary to
statement, which includes an
temperature-indicating devices used by permanently record all of the required
assessment of anticipated costs and
low-acid food firms. Much of this information. We further assume that
benefits, before proposing ‘‘any rule that
information is currently generated from current practice by these firms is to
includes any Federal mandate that may
the accuracy ‘‘checks’’ recommended leave unrecorded one to four separate
result in the expenditure by State, local,
under current regulations, and some of pieces of information required under the
and tribal governments, in the aggregate,
it may not be permanently recorded as proposed rule, and that each piece of
or by the private sector, of $100,000,000
required under this proposed rule. information takes between 10 and 15
or more (adjusted annually for inflation)
Current low-acid food regulations seconds to permanently record.
in any one year.’’ The current threshold
recommend that records of thermometer Consequently, we estimate that half of
after adjustment for inflation is $122
accuracy checks that specify date, all low-acid canned food manufacturers
million, using the most current (2005)
reference device used, method used, would spend between 10 seconds and 1
Implicit Price Deflator for the Gross
and person performing the test be minute (i.e., 1 x 10 seconds and 4 x 15
Domestic Product. FDA does not expect
maintained. The proposed rule requires seconds) per device, recording
this proposed rule, if finalized, to result
maintenance of written documentation information required in the proposed
in any 1-year expenditures that would
of the accuracy of the temperature- rule.
meet or exceed this amount and has
determined that this proposed rule does indicating device and also written Based on a survey conducted by FDA
not constitute a significant rule under documentation of the accuracy of the between 1992 and 1993, we estimate
the Unfunded Mandates Reform Act of reference device. The required that low-acid food firms use an average
1995. documentation of accuracy is necessary of 10 devices, including reference
to track the performance of devices, and devices. We estimate that 3,350 low-
V. Environmental Impact may be particularly important for new acid canned food manufacturers
The agency has determined under 21 temperature-indicating device currently do not fully record the
CFR 25.30(j) that this action is of a type technology during the transition period accuracy test results required by the
that does not individually or following its adoption. By requiring proposed rule. We assume that each
cumulatively have a significant effect on permanent records of the accuracy test device requires one to two tests per year
the human environment. Therefore, results, manufacturers may have (midpoint of 1.5 tests per year). We
neither an environmental assessment incentive to test temperature-indicating estimate the annual frequency per
nor an environmental impact statement devices for accuracy more frequently recordkeeping to be 15 (i.e., 10 devices
is required. than they would under the current x 1.5 tests per year). We estimate the
regulations. burden for recording the additional
VI. Paperwork Reduction Act Description of Respondents: All information to be between 10 and 60
This proposed rule contains commercial low-acid canned food seconds per device (midpoint of 35
information collection provisions that processors. Based on FDA low-acid seconds or 0.0097 hours per device).
are subject to review by OMB under the canned food manufacturers’ registration Table 2 of this document reports the
average annual burden described

previously in this document.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Recordkeepers per Recordkeeping Records Record
113.40(a)(1), (b)(1), (c)(1), (d)(1),

(e)(1), and (f)(1) 3,350 15 50,250 0.0097 487
1There are no capital costs or operating and maintenance costs associated with this collection of information.
In compliance with the PRA (44 Official Report of the American Public Health List of Subjects in 21 CFR Part 113
U.S.C. 3507(d)), the agency has Association, American Public Health
Association, Washington, DC, p. 612, 2001.
Food packaging, Foods, Reporting and
submitted the information collection recordkeeping requirements.
provisions of this proposed rule to OMB 2. International Vocabulary of Basic and
General Terms in Metrology (VIM), BIPM, Therefore, under the Federal Food,
for review. Interested persons are Drug, and Cosmetic Act and under
IEC, IFCC, ISO, IUPAC, IUPAP, OIML, 2d ed.,
requested to send comments regarding authority delegated to the Commissioner
p. 47, definition 6.10, 1993.
information collection to OMB (see 3. Letter from Sia Economides, FPA, to of Food and Drugs, it is proposed that
DATES and ADDRESSES). Mischelle Ledet, FDA, August 23, 2004. 21 CFR part 113 be amended as follows:
VII. Federalism 4. Smith, Brandie, King County Passes
Mercury Thermometer Sales Ban, PART 113—THERMALLY PROCESSED
We have analyzed this proposed rule Washington Free Press, #63, May/June 2003, LOW-ACID FOODS PACKAGED IN
in accordance with the principles set accessed online January 25, 2007, at http:// HERMETICALLY SEALED
forth in Executive Order 13132. We www.washingtonfreepress.org/63/ CONTAINERS
have determined that the proposed rule kingCountyPassesMercury.htm.
does not contain policies that have 5. CDC, ‘‘Summary of Notifiable Diseases— 1. The authority citation for 21 CFR
substantial direct effects on States, on United States, 2003,’’ Morbidity and part 113 continues to read as follows:
the relationship between the National Mortality Weekly Report, April 22, 2005, Authority: 21 U.S.C. 342, 371, 374; 42
Government and the States, or on the accessed online January 25, 2007, at http:// U.S.C. 264.
distribution of power and www.cdc.gov/mmwr/preview/mmwrhtml/ 2. Revise § 113.40 to read as follows:
responsibilities among the various mm5254a1.htm.
6. Great Lakes Regional Pollution § 113.40 Equipment and procedures.
levels of government. Accordingly, we
Prevention Roundtable, ‘‘Mercury- (a) Equipment and procedures for
have tentatively concluded that the Thermometers: Spills,’’ Mercury-
proposed rule does not contain policies pressure processing in steam in still
Thermometer Topic Hub, Northeast Waste retorts—(1) Temperature-indicating
that have federalism implications as Management Officials’ Association, accessed
defined in the Executive order and, device. Each retort shall be equipped
online January 25, 2007, at http:// with at least one temperature-indicating
consequently, a federalism summary www.glrppr.org/hubs/subsection.cfm?hub=
impact statement is not required. device that accurately indicates the
101&subsec=17&nav=17, last updated July
13, 2006.
temperature during processing.
VIII. Comments Temperature-indicating devices shall be
7. University Operations Services, Harvard
Interested persons may submit to the University Web site, accessed online January tested for accuracy against an accurate
Division of Dockets Management (see 25, 2007, at http://www.uos.harvard.edu/ehs/ calibrated reference device by
ADDRESSES) written or electronic onllfaclenvlmer.shtml. appropriate standard procedures, upon
comments regarding this document. 8. ‘‘Accident Prevention Urged for Final installation and at least once a year
Submit a single copy of electronic Weeks of Fiscal Year ‘04,’’ Today at Berkeley thereafter, or more frequently if
comments or two paper copies of any Lab—Friday, August 27, 2004, accessed necessary, to ensure accuracy during
mailed comments, except that online January 25, 2007, at http:// processing. Each temperature-indicating
www.lbl.gov/today/2004/Aug/27-Fri/ device and reference device shall have
individuals may submit one paper copy. safetylpage.html.
Comments are to be identified with the a tag, seal, or other means of identity.
9. U.S. Census Bureau, ‘‘2002 Economic (i) The design of the temperature-
docket number found in brackets in the Census’’, accessed online January 25, 2007, at
heading of this document. Received indicating device shall ensure that the
http://factfinder.census.gov/servlet/
comments may be seen in the Division IBQTable?lbm=y&-geolid=&- accuracy of the device is not affected by
of Dockets Management between 9 a.m. dslname=EC0231I3&-llang=en. electromagnetic interference and
and 4 p.m., Monday through Friday. 10. FDA/Center for Food Safety and environmental conditions.
Applied Nutrition, ‘‘Acidified and Low-Acid (ii) Written documentation of the
IX. References Canned Food Registration Data,’’ December accuracy of the temperature-indicating
The following references have been 2005. device and the reference device shall be
placed on display in the Division of 11. U.S. Department of Labor, Bureau of established and maintained.
Dockets Management (see ADDRESSES) Labor Statistics, Output Per Hour—Non-farm (A) Documentation of the accuracy of
Business Productivity—PRS85006092, the temperature-indicating device shall
and may be seen by interested persons
accessed online January 25, 2007, at http://
between 9 a.m. and 4 p.m., Monday include a reference to the tag, seal, or
data.bls.gov/cgi-bin/surveymost?bls. other means of identity used by the
through Friday. FDA has verified the 12. U.S. Department of Labor, Bureau of
Web site addresses, but is not processor to identify the temperature-
Labor Statistics, accessed online January 25,
responsible for subsequent changes to 2007, at ftp://ftp.bls.gov/pub/news.release/ indicating device, the name of the
the Web sites after this document History/ocwage.11192003.news. manufacturer of the temperature-
publishes in the Federal Register. 13. Stringer, L.W., Proceedings of indicating device, the identity of the
1. Heymann, David L., ‘‘Control of Advances in Instrumentation and Control, reference device used for the accuracy
Communicable Diseases,’’ 18th ed., 2004, An Vol. 49, part 2, pp. 715–723, 1994. test and of equipment and procedures
used to adjust or calibrate the (i) Analog or graphical recordings. sensor positioned near the temperature-
temperature-indicating device, the date Temperature-recording devices that indicating device in the retort. A steam
and results of each accuracy test, the create analog or graphical recordings controller activated by the steam
name of the person or facility that may be used. Temperature-recording pressure of the retort is acceptable if it
performed the accuracy test and devices that record to charts shall be is carefully maintained mechanically so
adjusted or calibrated the temperature- used only with the appropriate chart. that it operates satisfactorily.
indicating device, and the date of the Each chart shall have a working scale of (5) Steam inlet. The steam inlet to
next scheduled accuracy test. not more than 55 °F per inch (12 °C per each still retort shall be large enough to
(B) Documentation of the accuracy of centimeter) within a range of 20 °F (10 provide sufficient steam for proper
the reference device shall include a °C) of the process temperature. Chart operation of the retort. Steam may enter
reference to the tag, seal, or other means graduations shall not exceed 2 °F (1 °C) either the top portion or the bottom
of identity used by the processor to within a range of 10 °F (5 °C) of the portion of the retort but, in any case,
identify the reference device, the name process temperature. Temperature- shall enter the portion of the retort
of the manufacturer of the reference recording devices that create multipoint opposite the vent; for example, steam
device, the identity of the equipment plottings of temperature readings shall inlet in bottom portion and vent in top
and procedures used to test the accuracy record the temperature at intervals that portion.
and to adjust or calibrate the reference will assure that the parameters of the (6) Crate supports. A bottom crate
device, the identity of the person or process time and process temperature support shall be used in vertical still
facility that performed the accuracy test have been met. retorts. Baffle plates shall not be used in
and adjusted or calibrated the reference (ii) Digital recordings. Temperature- the bottom of still retorts.
recording devices, such as data loggers, (7) Steam spreaders. Steam spreaders
device, the date and results of the
that record numbers or create other are continuations of the steam inlet line
accuracy test, and the traceability
digital records may be used. Such a inside the retort. Horizontal still retorts
information. Documentation of the
device shall record the temperature at shall be equipped with steam spreaders
traceability information for the reference
intervals that will assure that the that extend the length of the retort. For
device may be in the form of a guaranty
parameters of the process time and steam spreaders along the bottom of the
of accuracy from the manufacturer of
process temperature have been met. retort, the perforations should be along
the reference device or a certificate of
(iii) Adjustments. The temperature- the top 90° of this pipe, that is, within
calibration from a laboratory.
recording device shall be adjusted to 45° on either side of the top center.
(iii) A temperature-indicating device Horizontal still retorts over 30 feet (9.1
agree as nearly as possible with, but to
that is defective or cannot be adjusted meters) long should have two steam
be in no event higher than, the
to the accurate calibrated reference inlets connected to the spreader. In
temperature-indicating device during
device shall be repaired or replaced vertical still retorts, the steam spreaders,
the process time. A means of preventing
before further use. unauthorized changes in adjustment if used, should be perforated along the
(iv) A temperature-indicating device shall be provided. A lock or a notice center line of the pipe facing the interior
shall be easily readable to 1 °F (0.5 °C). from management posted at or near the of the retort or along the sides of the
The temperature range of a mercury-in- temperature-recording device that pipe. The number of perforations should
glass thermometer shall not exceed 17 provides a warning that only authorized be such that the total cross-sectional
°F per inch (4 °C per centimeter) of persons are permitted to make area of the perforations is equal to 1.5
graduated scale. A mercury-in-glass adjustments is a satisfactory means of to 2 times the cross-sectional area of the
thermometer that has a divided mercury preventing unauthorized changes. smallest restriction in the steam inlet
column shall be considered defective. (iv) Temperature controller. The line.
(v) Each temperature-indicating temperature-recording device may be (8) Bleeders. Bleeders, except those
device shall be installed where it can be combined with the steam controller and for temperature-indicating device wells,
accurately and easily read. The sensor of may be a recording-controlling shall be 1/8-inch (3 millimeters) or
the temperature-indicating device shall instrument. The temperature-recording larger and shall be wide open during the
be installed either within the retort shell device sensor shall be installed either entire process, including the come-up-
or in external wells attached to the within the retort shell or in a well time. For horizontal still retorts,
retort. External wells or pipes shall be attached to the shell. Each temperature- bleeders shall be located within
connected to the retort through at least recording device sensor well shall have approximately 1 foot (30.5 centimeters)
a 3/4-inch (2 centimeters) diameter a 1/16-inch (1.5 millimeters) or larger of the outermost locations of containers
opening and equipped with a 1/16-inch bleeder which emits steam continuously at each end along the top of the retort.
(1.5 millimeters) or larger bleeder during the processing period. Air- Additional bleeders shall be located not
opening so located as to provide a full operated temperature controllers should more than 8 feet (2.4 meters) apart along
flow of steam past the length of the have adequate filter systems to ensure a the top. Bleeders may be installed at
temperature-indicating device sensor. supply of clean, dry air. positions other than those specified in
The bleeders for external wells shall (3) Pressure gages. Each retort should this paragraph, as long as there is
emit steam continuously during the be equipped with a pressure gage that evidence in the form of heat distribution
entire processing period. The should be graduated in divisions of 2 data that they accomplish adequate
temperature-indicating device—not the pounds per square inch (13.8 removal of air and circulation of steam
temperature-recording device—shall be kilopascals) or less. within the retort. Vertical retorts shall
the reference instrument for indicating (4) Steam controller. Each retort shall have at least one bleeder opening
the processing temperature. be equipped with an automatic steam located in that portion of the retort
(2) Temperature-recording device. controller to maintain the retort opposite the steam inlet. In retorts
Each retort shall have an accurate temperature. This may be a recording- having top steam inlet and bottom
temperature-recording device that controlling instrument when combined venting, a bleeder shall be installed in
records temperatures to a permanent with a temperature-recording device. the bottom of the retort to remove
record, such as a temperature-recording The steam controller may be air- condensate. All bleeders shall be
chart. operated and actuated by a temperature arranged so that the operator can
observe that they are functioning (12) Vents. Vents shall be installed in directly connected to a closed drain
properly. such a way that air is removed from the without an atmospheric break in the
(9) Stacking equipment and position retort before timing of the process is line. A manifold header connecting
of containers. Crates, trays, gondolas, started. Vents shall be controlled by vents or manifolds from several still
etc., for holding containers shall be gate, plug cock, or other adequate type retorts shall lead to the atmosphere. The
made of strap iron, adequately valves which shall be fully open to manifold header shall not be controlled
perforated sheet metal, or other suitable permit rapid discharge of air from the by a valve and shall be of a size that the
material. When perforated sheet metal is retort during the venting period. Vents cross-sectional area is at least equal to
used for the bottoms, the perforations shall not be connected directly to a the total cross-sectional area of all
should be approximately the equivalent closed drain system. If the overflow is connecting retort manifold pipes from
of 1-inch (2.5 centimeters) holes on 2- used as a vent, there shall be an all retorts venting simultaneously.
inch (5.1 centimeters) centers. If Timing of the process shall not begin
atmospheric break in the line before it
dividers are used between the layers of until the retort has been properly vented
connects to a closed drain. The vent
containers, they should be perforated as and the processing temperature has
shall be located in that portion of the
stated in this paragraph. The positioning been reached. Some typical installations
of containers in the retort, when retort opposite the steam inlet; for
example, steam inlet in bottom portion and operating procedures reflecting the
specified in the scheduled process, shall requirements of this section for venting
be in accordance with that process. and vent in top portion. Where a retort
manifold connects several vent pipes still retorts without divider plates are
(10) Air valves. Retorts using air for
from a single still retort, it shall be given in paragraph (a)(12)(i)(A) through
pressure cooling shall be equipped with
controlled by a gate, plug cock, or other (a)(12)(i)(D) and (a)(12)(ii)(A) and
a suitable valve to prevent air leakage
into the retort during processing. adequate type valve. The retort manifold (a)(12)(ii)(B) of this section.
(11) Water valves. Retorts using water shall be of a size that the cross-sectional (i) Venting horizontal retorts. (A)
for cooling shall be equipped with a area of the pipe is larger than the total Venting through multiple 1-inch (2.5
suitable valve to prevent leakage of cross-sectional area of all connecting centimeters) vents discharging directly
water into the retort during processing. vents. The discharge shall not be to atmosphere.
Specifications. One 1-inch (2.5 2.5 feet (76 centimeters) from ends of 7 minutes and to at least 220 °F (104.4
centimeters) vent for every 5 feet (1.5 retort. °C).
meters) of retort length equipped with a Venting method. Vent valves should (B) Venting through multiple 1-inch
gate or plug cock valve and discharging be wide open for at least 5 minutes and (2.5 centimeters) vents discharging
to atmosphere; end vents not more than to at least 225 °F (107.2 °C), or at least through a manifold to atmosphere.
EP14mr07.007</GPH>
Specifications. One 1-inch (2.5 2.5 inches (6.4 centimeters); for retorts °F (107.2 °C), or for at least 8 minutes
centimeters) vent for every 5 feet (1.5 15 feet (4.6 meters) and over in length, and to at least 220 °F (104.4 °C).
meters) of retort length; and vents not 3 inches (7.6 centimeters). (C) Venting through water spreaders.
over 2.5 feet (76 centimeters) from ends Venting method. Manifold vent gate
of retort: Size of manifold—for retorts or plug cock valve should be wide open
less than 15 feet (4.6 meters) in length, for at least 6 minutes and to at least 225
Size of vent and vent valve. For retorts inches (3.8 centimeters); for retorts 15 Venting method. Water spreader vent
less than 15 feet (4.6 meters) in length, feet (4.6 meters) and over in length, 2 gate or plug cock valve should be wide
EP14mr07.009</GPH>
2 inches (5.1 centimeters); for retorts 15 inches (5.1 centimeters). The number of open for at least 5 minutes and to at
feet (4.6 meters) and over in length, 2.5 holes should be such that their total least 225 °F (107.2 °C), or for at least 7
inches (3.8 centimeters). cross-sectional area is approximately minutes and to at least 220 °F (104.4 °C).
Size of water spreader. For retorts less equal to the cross-sectional area of the
than 15 feet (4.6 meters) in length, 1.5 vent pipe inlet.
EP14mr07.008</GPH>
(D) Venting through a single 2.5-inch

(6.4 centimeters) top vent (for retorts not
exceeding 15 feet (4.6 meters) in length).
Specifications: A 2.5-inch (6.4 Venting method: Vent gate or plug (ii) Venting vertical retorts. (A)
centimeters) vent equipped with a 2.5- cock valve should be wide open for at Venting through a 1.5-inch (3.8
inch (6.4 centimeters) gate or plug cock least 4 minutes and to at least 220 °F centimeters) overflow.
valve and located within 2 feet (61 (104.4 °C).
centimeters) of the center of the retort.
EP14mr07.010</GPH>
Specifications. A 1.5-inch (3.8 centimeters) pipe beyond the valve least 4 minutes and to at least 218 °F
centimeters) overflow pipe equipped before break to the atmosphere or to a (103.3 °C), or for at least 5 minutes and
with a 1.5-inch (3.8 centimeters) gate or manifold header. to at least 215 °F (101.7 °C).
plug cock valve and with not more than Venting method. Vent gate or plug (B) Venting through a single 1-inch
6 feet (1.8 meters) of 1.5-inch (3.8 cock valve should be wide open for at (2.5 centimeters) side or top vent.
EP14mr07.011</GPH>
Specifications. A 1-inch (2.5 (i) When maximum fill-in or drained retorts—(1) Temperature-indicating
centimeters) vent in lid or top side, weight is specified in the scheduled device. Each retort shall be equipped
equipped with a 1-inch (2.5 centimeters) process, it shall be measured and with at least one temperature-indicating
gate or plug cock valve and discharging recorded at intervals of sufficient device that accurately indicates the
directly into the atmosphere or to a frequency to ensure that the weight of temperature during processing.
manifold header. the product does not exceed the Temperature-indicating devices shall be
Venting method. Vent gate or plug maximum for the given container size tested for accuracy against an accurate
cock valve should be wide open for at specified in the scheduled process. calibrated reference device by
least 5 minutes and to at least 230 °F (ii) Closing machine vacuum in appropriate standard procedures, upon
(110.0 °C), or for at least 7 minutes and vacuum-packed products shall be installation and at least once a year
to at least 220 °F (104.4 °C). observed and recorded at intervals of thereafter, or more frequently if
(iii) Other procedures. Other sufficient frequency to ensure that the necessary, to ensure accuracy during
installations and operating procedures vacuum is as specified in the scheduled processing. Each temperature-indicating
that deviate from the above process. device and reference device shall have
specifications may be used if there is (iii) Such measurements and a tag, seal, or other means of identity.
evidence in the form of heat distribution recordings should be made at intervals
data, which shall be kept on file, that (i) The design of the temperature-
not to exceed 15 minutes.
indicating device shall ensure that the
they accomplish adequate venting of air. (iv) When the product style results in
(13) Critical factors. Critical factors stratification or layering of the primary accuracy of the device is not affected by
specified in the scheduled process shall product in the containers, the electromagnetic interference and
be measured and recorded on the positioning of containers in the retort environmental conditions.
processing record at intervals of shall be according to the scheduled (ii) Written documentation of the
sufficient frequency to ensure that the process. accuracy of the temperature-indicating
factors are within the limits specified in (b) Equipment and procedures for device and the reference device shall be
the scheduled process. pressure processing in water in still established and maintained.
EP14mr07.012</GPH>
(A) Documentation of the accuracy of measurements. The temperature- there is no opportunity for direct steam
the temperature-indicating device shall indicating device—not the temperature- impingement on the sensor. For all still
include a reference to the tag, seal, or recording device—shall be the reference retort systems that pressure process in
other means of identity used by the instrument for indicating the processing water and are equipped with
processor to identify the temperature- temperature. combination recorder-controllers, the
indicating device, the name of the (2) Temperature-recording device. temperature recorder-controller sensors
manufacturer of the temperature- Each retort shall have an accurate shall be located where the recorded
indicating device, the identity of the temperature-recording device that temperature is an accurate measurement
reference device used for the accuracy records temperatures to a permanent of the scheduled process temperature
test and of equipment and procedures record, such as a temperature-recording and is not affected by the heating media.
used to adjust or calibrate the chart. Air-operated temperature controllers
temperature-indicating device, the date (i) Analog or graphical recordings. should have adequate filter systems to
and results of each accuracy test, the Temperature-recording devices that ensure a supply of clean, dry air.
name of the person or facility that create analog or graphical recordings (3) Pressure gages. (i) Each retort
performed the accuracy test and may be used. Temperature-recording should be equipped with a pressure
adjusted or calibrated the temperature- devices that record to charts shall be gage that should be graduated in
indicating device, and the date of the used only with the appropriate chart. divisions of 2 pounds per square inch
next scheduled accuracy test. Each chart shall have a working scale of (13.8 kilopascals) or less.
(B) Documentation of the accuracy of not more than 55 °F per inch (12 °C per (ii) Each retort should have an
the reference device shall include a centimeter) within a range of 20 °F (10 adjustable pressure relief or control
reference to the tag, seal, or other means °C) of the process temperature. Chart valve of a capacity sufficient to prevent
of identity used by the processor to graduations shall not exceed 2 °F (1 °C) an undesired increase in retort pressure
identify the reference device, the name within a range of 10 °F (5 °C) of the when the water valve is wide open and
of the manufacturer of the reference process temperature. Temperature- should be installed in the overflow line.
device, the identity of the equipment recording devices that create multipoint (4) Steam controller. Each retort shall
and procedures used to test the accuracy plottings of temperature readings shall be equipped with an automatic steam
and to adjust or calibrate the reference record the temperature at intervals that controller to maintain the retort
device, the identity of the person or will assure that the parameters of the temperature. The steam controller may
facility that performed the accuracy test process time and process temperature be combined with a temperature-
and adjusted or calibrated the reference have been met. recording device and, thus, may be a
device, the date and results of the (ii) Digital recordings. Temperature- combination recorder-controller.
accuracy test, and the traceability recording devices, such as data loggers, (5) Steam introduction. Steam shall be
information. Documentation for the that record numbers or create other distributed in the bottom of the retort in
reference device may be in the form of digital records may be used. Such a a manner adequate to provide uniform
a guaranty of accuracy from the device shall record the temperature at heat distribution throughout the retort.
manufacturer or a certificate of intervals that will assure that the In vertical retorts, uniform steam
calibration from a laboratory. parameters of the process time and distribution can be achieved by any of
(iii) A temperature-indicating device process temperature have been met. several methods. In horizontal retorts,
that is defective or cannot be adjusted (iii) Adjustments. The temperature- the steam distributor shall run the
to the accurate calibrated reference recording device shall be adjusted to length of the bottom of the retort with
device shall be repaired or replaced agree as nearly as possible with, but to perforations distributed uniformly along
before further use. be in no event higher than, the the upper part of the pipe.
(iv) A temperature-indicating device temperature-indicating device during (6) Crate supports. A bottom crate
shall be easily readable to 1 °F (0.5 °C). the process time. A means of preventing support shall be used in vertical still
The temperature range of a mercury-in- unauthorized changes in adjustment retorts. Baffle plates shall not be used in
glass thermometer shall not exceed 17 shall be provided. A lock or a notice the bottom of the retort. Centering
°F per inch (4 °C per centimeter) of from management posted at or near the guides should be installed so as to
graduated scale. A mercury-in-glass temperature-recording device that ensure that there is about a 1.5-inch (3.8
thermometer that has a divided mercury provides a warning that only authorized centimeters) clearance between the side
column shall be considered defective. persons are permitted to make wall of the crate and the retort wall.
(v) Each temperature-indicating adjustments is a satisfactory means of (7) Stacking equipment and position
device shall be installed where it can be preventing unauthorized changes. of containers. Crates, trays, gondolas,
accurately and easily read. Sensors of (iv) Temperature controller. The etc., for holding containers shall be
temperature-indicating devices shall be temperature-recording device may be made of strap iron, adequately
located in such a position that they are combined with the steam controller and perforated sheet metal, or other suitable
beneath the surface of the water may be a combination recording- material. When perforated sheet metal is
throughout the process. On horizontal controlling instrument. For a vertical used for the bottoms, the perforations
retorts, this entry should be made in the retort equipped with a combination should be approximately the equivalent
side at the center, and the temperature- recorder-controller, the temperature of 1-inch (2.5 centimeters) holes on 2-
indicating device sensor shall be recorder-controller sensor shall be inch (5.1 centimeters) centers. If divider
inserted directly into the retort shell. In located at the bottom of the retort below plates are used between the layers of
both vertical and horizontal retorts, the the lowest crate rest in such a position containers, they should be perforated as
temperature-indicating device sensor that the steam does not strike it directly. stated in this paragraph. The positioning
shall extend directly into the water a For a horizontal retort equipped with a of containers in the retort, when
minimum of at least 2 inches (5.1 combination recorder-controller, the specified in the scheduled process, shall
centimeters) without a separable well or temperature recorder-controller sensor be in accordance with that process.
sleeve. If a separate well or sleeve is shall be located between the water Dividers, racks, trays, or other means of
used, there must be adequate circulation surface and the horizontal plane passing positioning of flexible containers shall
to ensure accurate temperature through the center of the retort so that be designed and employed to ensure
even circulation of heating medium and cooling periods. The adequacy of bleeder to remove air when starting
around all containers in the retort. the air or water circulation for uniform operations. Alternative methods for
(8) Drain valve. A nonclogging, water- heat distribution within the retort shall circulation of water in the retort may be
tight valve shall be used. A screen shall be established in accordance with used when established by a competent
be installed or other suitable means procedures recognized by a competent authority as adequate for even heat
shall be used on all drain openings to processing authority and records shall distribution.
prevent clogging. be kept on file. If air is used to promote (11) Cooling water supply. In vertical
(9) Water level indicator. There shall circulation, it shall be introduced into retorts the cooling water should be
be a means of determining the water the steam line at a point between the introduced at the top of the retort
level in the retort during operation, e.g., retort and the steam control valve at the between the water and container levels;
by using a sensor, gage, water glass, or bottom of the retort. in horizontal retorts the cooling water
petcock(s). Water shall cover the top should be introduced into the suction
layer of containers during the entire (ii) Water circulation. When a water
circulating system is used for heat side of the pump. A check valve should
come-up-time and processing periods
distribution, it shall be installed in such be included in the cooling water line.
and should cover the top layer of
containers during the cooling periods. a manner that water will be drawn from (12) Retort headspace. The headspace
The operator shall check and record the the bottom of the retort through a necessary to control the air pressure
water level at intervals sufficient to suction manifold and discharged should be maintained between the water
ensure its adequacy. through a spreader which extends the level and the top of the retort shell.
(10)(i) Air supply and controls. In length of the top of the retort. The holes (13) Vertical and horizontal still
both horizontal and vertical still retorts in the water spreader shall be uniformly retorts. Vertical and horizontal still
for pressure processing in water, a distributed and should have an retorts should follow the arrangements
means shall be provided for introducing aggregate area not greater than the cross- in the diagrams below in this paragraph.
compressed air at the proper pressure section area of the outlet line from the Other installation and operating
and rate. The proper pressure shall be pump. The suction outlets shall be procedures that deviate from these
controlled by an automatic pressure protected with nonclogging screens or arrangements may be used, as long as
control unit. A check valve shall be other suitable means shall be used to there is evidence in the form of heat
provided in the air supply line to keep debris from entering the distribution data or other suitable
prevent water from entering the system. circulating system. The pump shall be information, which shall be kept on file,
Air or water circulation shall be equipped with a pilot light or other which demonstrates that the heat
maintained continuously during the signaling device to warn the operator distribution is adequate.
come-up-time and during processing when it is not running, and with a BILLING CODE 4160–01–S
BILLING CODE 4160–01–C

EP14mr07.013</GPH>
Legend for Vertical and Horizontal Temperature-indicating device. Each glass thermometer shall not exceed 17
Still Retorts retort shall be equipped with at least °F per inch (4 °C per centimeter) of
A—Water line. one temperature-indicating device that graduated scale. A mercury-in-glass
B—Steam line. accurately indicates the temperature thermometer that has a divided mercury
C—Temperature control. during processing. Temperature- column shall be considered defective.
D—Overflow line. indicating devices shall be tested for (v) Each temperature-indicating
E1—Drain line. accuracy against an accurate calibrated device shall be installed where it can be
E2—Screens. reference device by appropriate accurately and easily read. The sensor of
F—Check valves. standard procedures, upon installation the temperature-indicating device shall
G—Line from hot water storage. and at least once a year thereafter, or be installed either within the retort shell
H—Suction line and manifold. more frequently if necessary, to ensure or in external wells attached to the
I—Circulating pump. accuracy during processing. Each retort. External wells or pipes shall be
J—Petcocks. temperature-indicating device and connected to the retort through at least
K—Recirculating line. reference device shall have a tag, seal, a 3/4-inch (2 centimeters) diameter
L—Steam distributor. or other means of identity. opening and equipped with a 1/16-inch
M—Temperature-controller sensor. (i) The design of the temperature- (1.5 millimeters) or larger bleeder
N—Temperature-indicating device indicating device shall ensure that the opening so located as to provide a full
sensor. accuracy of the device is not affected by flow of steam past the length of the
O—Water spreader. electromagnetic interference and temperature-indicating device sensor.
P—Safety valve. environmental conditions. The bleeders for external wells shall
Q—Vent valve for steam processing. (ii) Written documentation of the emit steam continuously during the
R—Pressure gage. accuracy of the temperature-indicating entire processing period. The
S—Inlet air control. device and the reference device shall be temperature-indicating device—not the
T—Pressure control. established and maintained. temperature-recording device—shall be
U—Air line. (A) Documentation of the accuracy of the reference instrument for indicating
V—To pressure control instrument. the temperature-indicating device shall the processing temperature.
W—To temperature control include a reference to the tag, seal, or (2) Temperature-recording device.
instrument. other means of identity used by the Each retort shall have an accurate
X—Wing nuts. processor to identify the temperature- temperature-recording device that
Y1—Crate support. indicating device, the name of the records temperatures to a permanent
Y2—Crate guides. manufacturer of the temperature- record, such as a temperature-recording
Z—Constant flow orifice valve. indicating device, the identity of the chart.
Z1—Constant flow orifice valve used reference device used for the accuracy (i) Analog or graphical recordings.
during come-up. test and of equipment and procedures Temperature-recording devices that
Z2—Constant flow orifice valve used used to adjust or calibrate the create analog or graphical recordings
during cook. temperature-indicating device, the date may be used. Temperature-recording
(14) Critical factors. Critical factors and results of each accuracy test, the devices that record to charts shall be
specified in the scheduled process shall name of the person or facility that used only with the appropriate chart.
be measured and recorded on the performed the accuracy test and Each chart shall have a working scale of
processing record at intervals of adjusted or calibrated the temperature- not more than 55 °F per inch (12 °C per
sufficient frequency to ensure that the indicating device, and the date of the centimeter) within a range of 20 °F (10
factors are within the limits specified in next scheduled accuracy test. °C) of the process temperature. Chart
the scheduled process. (B) Documentation of the accuracy of graduations shall not exceed 2 °F (1 °C)
(i) When maximum fill-in or drained the reference device shall include a within a range of 10 °F (5 °C) of the
weight is specified in the scheduled reference to the tag, seal, or other means process temperature. Temperature-
process, it shall be measured and of identity used by the processor to recording devices that create multipoint
recorded at intervals of sufficient identify the reference device, the name plottings of temperature readings shall
frequency to ensure that the weight of of the manufacturer of the reference record the temperature at intervals that
the product does not exceed the device, the identity of the equipment will assure that the parameters of the
maximum for the given container size and procedures used to test the accuracy process time and process temperature
specified in the scheduled process. and to adjust or calibrate the reference have been met.
(ii) Closing machine vacuum in device, the identity of the person or (ii) Digital recordings. Temperature-
vacuum-packed products shall be facility that performed the accuracy test recording devices, such as data loggers,
observed and recorded at intervals of and adjusted or calibrated the reference that record numbers or create other
sufficient frequency to ensure that the device, the date and results of the digital records may be used. Such a
vacuum is as specified in the scheduled accuracy test, and the traceability device shall record the temperature at
process. information. Documentation for the intervals that will assure that the
(iii) Such measurements and reference device may be in the form of parameters of the process time and
recordings should be made at intervals a guaranty of accuracy from the process temperature have been met.
not to exceed 15 minutes. manufacturer or a certificate of (iii) Adjustments. The temperature-
(iv) When the product style results in calibration from a laboratory. recording device shall be adjusted to
stratification or layering of the primary (iii) A temperature-indicating device agree as nearly as possible with, but to
product in the containers, the that is defective or cannot be adjusted be in no event higher than, the
positioning of containers in the retort to the accurate calibrated reference temperature-indicating device during
shall be according to the scheduled device shall be repaired or replaced the process time. A means of preventing
process. before further use. unauthorized changes in adjustment
(c) Equipment and procedures for (iv) A temperature-indicating device shall be provided. A lock or a notice
pressure processing in steam in shall be easily readable to 1 °F (0.5 °C). from management posted at or near the
continuous agitating retorts—(1) The temperature range of a mercury-in- temperature-recording device that
provides a warning that only authorized kept on file. At the time steam is turned drops below the temperature specified
persons are permitted to make on, the drain should be opened for a in the scheduled process while
adjustments is a satisfactory means of time sufficient to remove steam containers are in the retort, the retort
preventing unauthorized changes. condensate from the retort, and reel shall be stopped promptly. An
(iv) Temperature controller. The provision shall be made for continuing automatic device should be used to stop
temperature-recording device may be drainage of condensate during the retort the reel when the temperature drops
combined with the steam controller and operation. The condensate bleeder in below the specified process
may be a recording-controlling the bottom of the shell serves as an temperature. Before the reel is restarted,
instrument. The temperature-recording indicator of continuous condensate all containers in the retort shall be given
device sensor shall be installed either removal. a complete scheduled still retort process
within the retort shell or in a well (7) Retort speed timing. The rotational if the temperature drop was 10 °F (5 °C)
attached to the shell. Each temperature- speed of the retort shall be specified in or more below the specified
recording device sensor well shall have the scheduled process. The speed shall temperature, or alternatively, container
a 1/16-inch (1.5 millimeters) or larger be adjusted and recorded when the entry to the retort shall be stopped and
bleeder opening emitting steam retort is started, at any time a speed the reel restarted to empty the retort.
continuously during the processing change is made, and at intervals of The discharged containers shall be
period. Air-operated temperature sufficient frequency to ensure that the either reprocessed, repacked and
controllers should have adequate filter retort speed is maintained as specified reprocessed, or discarded. Both the time
systems to ensure a supply of clean, dry in the scheduled process. These at which the reel stopped and the time
air. adjustments and recordings should be the retort was used for a still retort
(3) Pressure gages. Each retort should made every 4 hours or less. process, if so used, shall be marked on
be equipped with a pressure gage, Alternatively, a recording tachometer the temperature-recording device record
which should be graduated in divisions may be used to provide a continuous and entered on the other production
of 2 pounds per square inch (13.8 record of the speed. A means of records required in this chapter. If the
kilopascals) or less. preventing unauthorized speed changes alternative procedure of emptying the
(4) Steam controller. Each retort shall on retorts shall be provided. A lock, or retort is followed, the subsequent
be equipped with an automatic steam a notice from management posted at or handling methods used for the
controller to maintain the retort near the speed adjustment device that containers in the retort at the time of the
temperature. This may be a recording- provides a warning that only authorized temperature drop shall be entered on
controlling instrument when combined persons are permitted to make the production records. If the
with a temperature-recording device. A adjustments, is a satisfactory means of temperature drop was less than 10 °F (5
steam controller activated by the steam preventing unauthorized changes. °C), a scheduled authorized emergency
pressure of the retort is acceptable if it (8) Emergency stops. If a retort jams or
still process approved by a qualified
is carefully maintained mechanically so breaks down during processing
person(s) having expert knowledge of
that it operates satisfactorily. operations, necessitating cooling the
(5) Bleeders. Bleeders, except those thermal processing requirements may be
retort for repairs, the retort shall be
for temperature-indicating device wells, used before restarting the retort reel.
operated in such a way that ensures that
shall be 1/8-inch (3 millimeters) or Alternatively, container entry to the
the product is commercially sterile, or
larger and shall be wide open during the retort shall be stopped and an
the retort is to be cooled promptly and
entire process, including the come-up- authorized emergency agitating process
all containers either reprocessed,
time. Bleeders shall be located within may be used before container entry to
repacked and reprocessed, or discarded.
approximately 1 foot (30.5 centimeters) the retort is restarted. When emergency
When operated as a still retort, all
of the outermost location of containers containers shall be given a full still procedures are used, no containers may
at each end along the top of the retort. retort process before the retort is cooled. enter the retort and the process and
Additional bleeders shall be located not If, in such an emergency, a scheduled procedures used shall be noted on the
more than 8 feet (2.4 meters) apart along still process or another process production records.
the top of the retort. All bleeders shall established to ensure commercial (10) Critical factors. Critical factors
be arranged so that the operator can sterility is to be used, it shall be made specified in the scheduled process shall
observe that they are functioning readily available to the retort operator. be measured and recorded on the
properly. The condensate bleeder shall (i) Any containers in the retort intake processing record at intervals of
be checked with sufficient frequency to valve or in transfer valves between sufficient frequency to ensure that the
ensure adequate removal of condensate cooker shells of a continuous retort at factors are within the limits specified in
or shall be equipped with an automatic the time of breakdown shall either be the scheduled process. The minimum
alarm system(s) that would serve as a reprocessed, repacked and reprocessed, headspace of containers, if specified in
continuous monitor of condensate- or discarded. the scheduled process, shall be
bleeder functioning. Visual checks (ii) Both the time at which the reel measured and recorded at intervals of
should be done at intervals of not more stopped and the time the retort was sufficient frequency to ensure that the
than 15 minutes. A record of such used for a still retort process, if so used, headspace is as specified in the
checks should be kept to show that the shall be marked on the recording chart scheduled process. The headspace of
bleeder is functioning properly. and entered on the other production solder-tipped, lapseam (vent hole) cans
(6) Venting and condensate removal. records required in this chapter. If the may be measured by net weight
Vents shall be located in that portion of alternative procedure of prompt cooling determinations. The headspace of
the retort opposite the steam inlet. Air is followed, the subsequent handling double seamed cans may also be
shall be removed before processing is methods used for the containers in the measured by net weight determinations
started. Heat distribution data or retort at the time of stopping and for homogenous liquids, taking into
documentary proof from the cooling shall be entered on the account the specific can end profile and
manufacturer or from a competent production records. other factors which affect the
processing authority, demonstrating that (9) Temperature drop. If the headspace, if proof of the accuracy of
adequate venting is achieved, shall be temperature of the continuous retort such measurements is maintained and
the procedure and resultant headspace reference to the tag, seal, or other means process temperature. Temperature-
is in accordance with the scheduled of identity used by the processor to recording devices that create multipoint
process. When the product consistency identify the reference device, the name plottings of temperature readings shall
is specified in the scheduled process, of the manufacturer of the reference record the temperature at intervals that
the consistency of the product shall be device, the identity of the equipment will assure that the parameters of the
determined by objective measurements and procedures used to test the accuracy process time and process temperature
on the product taken from the filler and to adjust or calibrate the reference have been met.
before processing and recorded at device, the identity of the person or (ii) Digital recordings. Temperature-
intervals of sufficient frequency to facility that performed the accuracy test recording devices, such as data loggers,
ensure that the consistency is as and adjusted or calibrated the reference that record numbers or create other
specified in the scheduled process. device, the date and results of the digital records may be used. Such a
Minimum closing machine vacuum in accuracy test, and the traceability device shall record the temperature at
vacuum-packed products, maximum information. Documentation for the intervals that will assure that the
fill-in or drained weight, minimum net reference device may be in the form of parameters of the process time and
weight, and percent solids shall be as a guaranty of accuracy from the process temperature have been met.
specified in the scheduled process for manufacturer or a certificate of (iii) Adjustments. The temperature-
all products when deviations from such calibration from a laboratory. recording device shall be adjusted to
specifications may affect the scheduled (iii) A temperature-indicating device agree as nearly as possible with, but to
process. All measurements and that is defective or cannot be adjusted be in no event higher than, the
recordings of critical factors should be to the accurate calibrated reference temperature-indicating device during
made at intervals not to exceed 15 device shall be repaired or replaced the process time. A means of preventing
minutes. before further use. unauthorized changes in adjustment
(d) Equipment and procedures for (iv) A temperature-indicating device shall be provided. A lock or a notice
pressure processing in steam in shall be easily readable to 1 °F (0.5 °C). from management posted at or near the
discontinuous agitating retorts—(1) The temperature range of a mercury-in- temperature-recording device that
Temperature-indicating device. Each glass thermometer shall not exceed 17 provides a warning that only authorized
retort shall be equipped with at least °F per inch (4 °C per centimeter) of persons are permitted to make
one temperature-indicating device that graduated scale. A mercury-in-glass adjustments is a satisfactory means of
accurately indicates the temperature thermometer that has a divided mercury preventing unauthorized changes.
during processing. Temperature- column shall be considered defective. (iv) Temperature controller. The
indicating devices shall be tested for (v) Each temperature-indicating temperature-recording device may be
accuracy against an accurate calibrated device shall be installed where it can be combined with the steam controller and
reference device by appropriate accurately and easily read. The sensor of may be a recording-controlling
standard procedures, upon installation the temperature-indicating device shall instrument. The temperature-recording
and at least once a year thereafter, or be installed either within the retort shell device sensor shall be installed either
more frequently if necessary, to ensure or in external wells attached to the within the retort shell or in a well
accuracy during processing. Each retort. External wells or pipes shall be attached to the shell. Each temperature-
temperature-indicating device and connected to the retort through at least recording device sensor well shall have
reference device shall have a tag, seal, a 3/4-inch (2 centimeters) diameter a 1/16-inch (1.5 millimeters) or larger
or other means of identity. opening and equipped with a 1/16-inch bleeder that emits steam continuously
(i) The design of the temperature- (1.5 millimeters) or larger bleeder during the processing period. Air-
indicating device shall ensure that the opening so located as to provide a full operated temperature controllers should
accuracy of the device is not affected by flow of steam past the length of the have adequate filter systems to ensure a
electromagnetic interference and temperature-indicating device sensor. supply of clean, dry air.
environmental conditions. The bleeders for external wells shall (3) Pressure gages. Each retort should
(ii) Written documentation of the emit steam continuously during the be equipped with a pressure gage that
accuracy of the temperature-indicating entire processing period. The should be graduated in divisions of 2
device and the reference device shall be temperature-indicating device—not the pounds per square inch (13.8
established and maintained. temperature-recording device—shall be kilopascals) or less.
(A) Documentation of the accuracy of the reference instrument for indicating (4) Steam controller. Each retort shall
the temperature-indicating device shall the processing temperature. be equipped with an automatic steam
include a reference to the tag, seal, or (2) Temperature-recording device. controller to maintain the retort
other means of identity used by the Each retort shall have an accurate temperature. This may be a recording-
processor to identify the temperature- temperature-recording device that controlling instrument when combined
indicating device, the name of the records temperatures to a permanent with a temperature-recording device. A
manufacturer of the temperature- record, such as a temperature-recording steam controller activated by the steam
indicating device, the identity of the chart. pressure of the retort is acceptable if it
reference device used for the accuracy (i) Analog or graphical recordings. is mechanically maintained so that it
test and of equipment and procedures Temperature-recording devices that operates satisfactorily.
used to adjust or calibrate the create analog or graphical recordings (5) Bleeders. Bleeders, except those
temperature-indicating device, the date may be used. Temperature-recording for temperature-indicating device wells,
and results of each accuracy test, the devices that record to charts shall be shall be 1/8-inch (3 millimeters) or
name of the person or facility that used only with the appropriate chart. larger and shall be wide open during the
performed the accuracy test and Each chart shall have a working scale of entire process, including the come-up-
adjusted or calibrated the temperature- not more than 55 °F per inch (12 °C per time. Bleeders shall be located within
indicating device, and the date of the centimeter) within a range of 20 °F (10 approximately 1 foot (30.5 centimeters)
next scheduled accuracy test. °C) of the process temperature. Chart of the outermost location of containers,
(B) Documentation of the accuracy of graduations shall not exceed 2 °F (1 °C) at each end along the top of the retort;
the reference device shall include a within a range of 10 °F (5 °C) of the additional bleeders shall be located not
more than 8 feet (2.4 meters) apart along frequency to ensure that the consistency and adjusted or calibrated the reference
the top. Bleeders may be installed at is as specified in the scheduled process. device, the date and results of the
positions other than those specified in Minimum closing machine vacuum in accuracy test, and the traceability
this paragraph, as long as there is vacuum-packed products, maximum information. Documentation for the
evidence in the form of heat distribution fill-in or drained weight, minimum net reference device may be in the form of
data that they accomplish adequate weight, and percent solids shall be as a guaranty of accuracy from the
removal of air and circulation of heat specified in the scheduled process for manufacturer or a certificate of
within the retort. In retorts having top all products for which deviations from calibration from a laboratory.
steam inlet and bottom venting, a such specifications may affect the (iii) A temperature-indicating device
bleeder shall be installed in the bottom scheduled process. All measurements that is defective or cannot be adjusted
of the retort to remove condensate. All and recordings of critical factors should to the accurate calibrated reference
bleeders shall be arranged in a way that be made at intervals not to exceed 15 device shall be repaired or replaced
enables the operator to observe that they minutes. before further use.
are functioning properly. (e) Equipment and procedures for (iv) A temperature-indicating device
(6) Venting and condensate removal. pressure processing in water in shall be easily readable to 1 °F (0.5 °C).
The air in each retort shall be removed discontinuous agitating retorts—(1) The temperature range of a mercury-in-
before processing is started. Heat Temperature-indicating device. Each glass thermometer shall not exceed 17
distribution data or documentary proof retort shall be equipped with at least °F per inch (4 °C per centimeter) of
from the manufacturer or from a one temperature-indicating device that graduated scale. A mercury-in-glass
competent processing authority, accurately indicates the temperature thermometer that has a divided mercury
demonstrating that adequate venting is during processing. Temperature- column shall be considered defective.
achieved, shall be kept on file. At the indicating devices shall be tested for (v) Each temperature-indicating
time steam is turned on, the drain accuracy against an accurate calibrated device shall be installed where it can be
should be opened for a time sufficient reference device by appropriate accurately and easily read. The sensor of
to remove steam condensate from the standard procedures, upon installation the temperature-indicating device shall
retort and provision should be made for and at least once a year thereafter, or be installed either within the retort shell
containing drainage of condensate more frequently if necessary, to ensure or in an external well attached to the
during the retort operation. accuracy during processing. Each retort. Sensors of temperature-indicating
(7) Retort speed timing. The rotational temperature-indicating device and devices shall be located in such a
speed of the retort shall be specified in reference device shall have a tag, seal, position that they are beneath the
the schedules process. The speed shall or other means of identity. surface of the water throughout the
be adjusted, as necessary, to ensure that (i) The design of the temperature- process. This entry should be made in
the speed is as specified in the indicating device shall ensure that the the side at the center, and the
scheduled process. The rotational speed accuracy of the device is not affected by temperature-indicating device sensor
as well as the process time shall be electromagnetic interference and shall be inserted directly into the retort
recorded for each retort load processed. environmental conditions. shell. The temperature-indicating device
Alternatively, a recording tachometer (ii) Written documentation of the sensor shall extend directly into the
may be used to provide a continuous accuracy of the temperature-indicating water a minimum of at least 2 inches
record of the speed. A means of device and the reference device shall be (5.1 centimeters) without a separable
preventing unauthorized speed changes established and maintained. well or sleeve. If a separate well or
on retorts shall be provided. A lock, or (A) Documentation of the accuracy of sleeve is used, there must be adequate
a notice from management posted at or the temperature-indicating device shall circulation to ensure accurate
near the speed-adjustment device that include a reference to the tag, seal, or temperature measurements. The
provides a warning that only authorized other means of identity used by the temperature-indicating device—not the
persons are permitted to make processor to identify the temperature- temperature-recording device—shall be
adjustments, is a satisfactory means of indicating device, the name of the the reference instrument for indicating
preventing unauthorized changes. manufacturer of the temperature- the processing temperature.
(8) Critical factors. Critical factors indicating device, the identity of the (2) Temperature-recording device.
specified in the schedules process shall reference device used for the accuracy Each retort shall have an accurate
be measured and recorded on the test and of equipment and procedures temperature-recording device that
processing record at intervals of used to adjust or calibrate the records temperatures to a permanent
sufficient frequency to ensure that the temperature-indicating device, the date record, such as a temperature-recording
factors are within the limits specified in and results of each accuracy test, the chart.
the scheduled process. The minimum name of the person or facility that (i) Analog or graphical recordings.
headspace of containers in each retort performed the accuracy test and Temperature-recording devices that
load to be processed, if specified in the adjusted or calibrated the temperature- create analog or graphical recordings
scheduled process, shall be measured indicating device, and the date of the may be used. Temperature-recording
and recorded at intervals of sufficient next scheduled accuracy test. devices that record to charts shall be
frequency to ensure that the headspace (B) Documentation of the accuracy of used only with the appropriate chart.
is as specified in the scheduled process. the reference device shall include a Each chart shall have a working scale of
The headspace of solder-tipped, lap reference to the tag, seal, or other means not more than 55 °F per inch (12 °C per
centimeter) within a range of 20 °F (10
seam (vent hole) cans may be measured of identity used by the processor to
by net weight determinations. When the identify the reference device, the name °C) of the process temperature. Chart
product consistency is specified in the of the manufacturer of the reference graduations shall not exceed 2 °F (1 °C)
scheduled process, the consistency of device, the identity of the equipment within a range of 10 °F (5 °C) of the
the product shall be determined by and procedures used to test the accuracy process temperature. Temperature-
objective measurements on the product and to adjust or calibrate the reference recording devices that create multipoint
taken from the filler before processing device, the identity of the person or plottings of temperature readings shall
and recorded at intervals of sufficient facility that performed the accuracy test record the temperature at intervals that
will assure that the parameters of the and rate. The proper pressure shall be and recorded at intervals of sufficient
process time and process temperature controlled by an automatic pressure frequency to ensure that the consistency
have been met. control unit. A check valve shall be is as specified in the scheduled process.
(ii) Digital recordings. Temperature- provided in the air supply line to Minimum closing machine vacuum in
recording devices, such as data loggers, prevent water from entering the system. vacuum-packed products, maximum
that record numbers or create other (ii) Water circulation. When a water fill-in or drained weight, minimum net
digital records may be used. Such a circulating system is used for heat weight, and percent solids shall be as
device shall record the temperature at distribution, it shall be installed in such specified in the scheduled process for
intervals that will assure that the a manner that water will be drawn from all products when deviations from such
parameters of the process time and the bottom of the retort through a specifications may affect the scheduled
process temperature have been met. suction manifold and discharged process. All measurements and
(iii) Adjustments. The temperature- through a spreader which extends the recordings of critical factors should be
recording device shall be adjusted to length of the top of the retort. The holes made at intervals not to exceed 15
agree as nearly as possible with, but to in the water spreader shall be uniformly minutes.
be in no event higher than, the distributed and should have an (f) Equipment and procedures for
temperature-indicating device during aggregate area not greater than the cross- pressure processing in steam in
the process time. A means of preventing section area of the outlet line from the hydrostatic retorts—(1) Temperature-
unauthorized changes in adjustment pump. The suction outlets shall be indicating device. Each retort shall be
shall be provided. A lock or a notice protected with nonclogging screens or equipped with at least one temperature-
from management posted at or near the other suitable means shall be used to indicating device that accurately
temperature-recording device that keep debris from entering the indicates the temperature during
provides a warning that only authorized circulating system. The pump shall be processing. Temperature-indicating
persons are permitted to make equipped with a pilot light or other devices shall be tested for accuracy
adjustments is a satisfactory means of signaling device to warn the operator against an accurate calibrated reference
preventing unauthorized changes. when it is not running, and with a device by appropriate standard
(iv) Temperature controller. The bleeder to remove air when starting procedures, upon installation and at
temperature-recording device may be operations. Alternative methods for least once a year thereafter, or more
combined with the steam controller and circulation of water in the retort may be frequently if necessary, to ensure
may be a recording-controlling used when established by a competent accuracy during processing. Each
instrument. The temperature-recording authority as adequate for even heat temperature-indicating device and
device sensor shall be installed either distribution. reference device shall have a tag, seal,
within the retort shell or in a well (7) Drain valve. A nonclogging, water- or other means of identity.
attached to the shell. Air-operated tight valve shall be used. A screen shall (i) The design of the temperature-
temperature controllers should have be installed or other suitable means indicating device shall ensure that the
adequate filter systems to ensure a shall be used on all drain openings to accuracy of the device is not affected by
supply of clean, dry air. prevent clogging. electromagnetic interference and
(3) Pressure gages. Each retort should (8) Water level indicator. There shall environmental conditions.
be equipped with a pressure gage that be a means of determining the water (ii) Written documentation of the
should be graduated in divisions of 2 level in the retort during operation, e.g., accuracy of the temperature-indicating
pounds per square inch (13.8 by using a sensor, gage, water glass, or device and the reference device shall be
kilopascals) or less. petcock(s). Water shall cover the top established and maintained.
(4) Steam controller. Each retort shall layer of containers during the entire (A) Documentation of the accuracy of
be equipped with an automatic steam come-up-time and processing periods the temperature-indicating device shall
controller to maintain the retort and should cover the top layer of include a reference to the tag, seal, or
temperature. This may be a recording- containers during the cooling periods. other means of identity used by the
controlling instrument when combined The operator shall check and record the processor to identify the temperature-
with a temperature-recording device. water level at intervals sufficient to indicating device, the name of the
(5) Retort speed timing. The rotational ensure its adequacy. manufacturer of the temperature-
speed of the retort shall be specified in (9) Critical factors. Critical factors indicating device, the identity of the
the scheduled process. The speed shall specified in the scheduled process shall reference device used for the accuracy
be adjusted, as necessary, to ensure that be measured and recorded on the test and of equipment and procedures
the speed is as specified in the processing record at intervals of used to adjust or calibrate the
scheduled process. The rotational speed sufficient frequency to ensure that the temperature-indicating device, the date
as well as the process time shall be factors are within the limits specified in and results of each accuracy test, the
recorded for each retort load processed. the scheduled process. The minimum name of the person or facility that
Alternatively, a recording tachometer headspace of containers, if specified in performed the accuracy test and
may be used to provide a continuous the scheduled process, shall be adjusted or calibrated the temperature-
record of the speed. A means of measured and recorded at intervals of indicating device, and the date of the
preventing unauthorized speed changes sufficient frequency to ensure that the next scheduled accuracy test.
shall be provided. A lock, or a notice headspace is as specified in the (B) Documentation of the accuracy of
from management posted at or near the scheduled process. The headspace of the reference device shall include a
speed adjustment device that provides a solder-tipped, lap seam (vent hole) cans reference to the tag, seal, or other means
warning that only authorized persons may be measured by net weight of identity used by the processor to
are permitted to make adjustment, is a determinations. When the product identify the reference device, the name
satisfactory means of preventing consistency is specified in the of the manufacturer of the reference
unauthorized changes. scheduled process, the consistency of device, the identity of the equipment
(6)(i) Air supply and controls. A the product shall be determined by and procedures used to test the accuracy
means shall be provided for introducing objective measurements on the product and to adjust or calibrate the reference
compressed air at the proper pressure taken from the filler before processing device, the identity of the person or
facility that performed the accuracy test intervals that will assure that the (6) Venting. Before the start of
and adjusted or calibrated the reference parameters of the process time and processing operations, the retort steam
device, the date and results of the process temperature have been met. chamber or chambers shall be vented to
accuracy test, and the traceability (iii) Adjustments. The temperature- ensure removal of air.
information. Documentation for the recording device shall be adjusted to (7) Bleeders. Bleeder openings 1/4-
reference device may be in the form of agree as nearly as possible with, but to inch (6 millimeters) or larger shall be
a guaranty of accuracy from the be in no event higher than, the located at the top of the steam chamber
manufacturer or a certificate of temperature-indicating device during or chambers opposite the point of steam
calibration from a laboratory. the process time. A means of preventing entry. Bleeders shall be wide open and
(iii) A temperature-indicating device unauthorized changes in adjustment shall emit steam continuously during
that is defective or cannot be adjusted shall be provided. A lock or a notice the entire process, including the come-
to the accurate calibrated reference from management posted at or near the up-time. All bleeders shall be arranged
device shall be repaired or replaced temperature-recording device that in such a way that the operator can
before further use. provides a warning that only authorized observe that they are functioning
(iv) A temperature-indicating device persons are permitted to make properly.
shall be easily readable to 1 °F (0.5 °C). adjustments is a satisfactory means of (8) Retort speed. The speed of the
The temperature range of a mercury-in- preventing unauthorized changes. container-conveyor chain shall be
glass thermometer shall not exceed 17 (iv) Temperature controller. The specified in the scheduled process and
°F per inch (4 °C per centimeter) of temperature-recording device may be shall be determined and recorded at the
graduated scale. A mercury-in-glass combined with the steam controller and start of processing and at intervals of
thermometer that has a divided mercury may be a recording-controlling sufficient frequency to ensure that the
column shall be considered defective. instrument. The temperature-recording retort speed is maintained as specified.
(v) Each temperature-indicating device sensor shall be installed either The speed should be determined and
device shall be installed where it can be within the steam dome or in a well recorded every 4 hours. An automatic
accurately and easily read. The attached to the dome. Each temperature- device should be used to stop the chain
temperature-indicating device shall be recording device sensor well shall have when the temperature drops below that
located in the steam dome near the a 1/16-inch (1.5 millimeters) or larger specified in the scheduled process. A
steam-water interface. When the bleeder which emits steam continuously means of preventing unauthorized
scheduled process specifies during the processing period. speed changes shall be provided. A
maintenance of particular temperatures Additional temperature-recording lock, or a notice from management
in the hydrostatic water legs, a device sensors shall be installed in the posted at or near the speed-adjusting
temperature-indicating device shall be hydrostatic water legs if the scheduled device that provides a warning that only
located in each hydrostatic water leg in process specified maintenance of authorized persons are permitted to
a position near the bottom temperature- particular temperatures in the make adjustments, is a satisfactory
recording device sensor. The hydrostatic water legs. Air-operated means of preventing unauthorized
temperature-indicating device—not the temperature controllers should have changes.
temperature-recording device—shall be adequate filter systems to ensure a (9) Critical factors. Critical factors
the reference instrument for indicating supply of clean, dry air. specified in the scheduled process shall
the processing temperature. (3) Pressure gages. Each retort should be measured and recorded on the
(2) Temperature-recording device. be equipped with a pressure gage that processing record at intervals of
Each retort shall have an accurate should be graduated in divisions of 2 sufficient frequency to ensure that the
temperature-recording device that pounds per square inch (13.8 factors are within the limits specified in
records temperatures to a permanent kilopascals) or less. the scheduled process.
record, such as a temperature-recording (4) Recording of temperatures. (i) When maximum fill-in or drained
chart. Temperatures indicated by the weight is specified in the scheduled
(i) Analog or graphical recordings. temperature-indicating device or process, it shall be measured and
Temperature-recording devices that devices shall be entered on a suitable recorded at intervals of sufficient
create analog or graphical recordings form during processing operations. frequency to ensure that the weight of
may be used. Temperature-recording Temperatures shall be recorded by an the product does not exceed the
devices that record to charts shall be accurate temperature-recording device maximum for the given container size
used only with the appropriate chart. or devices at the following points: specified in the scheduled process.
Each chart shall have a working scale of (i) In the steam chamber between the (ii) Closing machine vacuum in
not more than 55 °F per inch (12 °C per steam-water interface and the lowest vacuum-packed products shall be
centimeter) within a range of 20 °F (10 container position. observed and recorded at intervals of
°C) of the process temperature. Chart (ii) Near the top and the bottom of sufficient frequency to ensure that the
graduations shall not exceed 2 °F (1 °C) each hydrostatic water leg if the vacuum is as specified in the scheduled
within a range of 10 °F (5 °C) of the scheduled process specifies process.
process temperature. Temperature- maintenance of particular temperatures (iii) Such measurements and
recording devices that create multipoint in the legs. recordings should be made at intervals
plottings of temperature readings shall (5) Steam controller. Each retort shall not to exceed 15 minutes.
record the temperature at intervals that be equipped with an automatic steam (g) Aseptic processing and packaging
will assure that the parameters of the controller to maintain the retort systems—(1) Product sterilizer—(i)
process time and process temperature temperature. This may be a recording- Equipment—(A) Temperature-
have been met. controlling instrument when combined indicating device. Each product
(ii) Digital recordings. Temperature- with a temperature-recording device. A sterilizer shall be equipped with at least
recording devices, such as data loggers, steam controller activated by the steam one temperature-indicating device that
that record numbers or create other pressure of the retort is acceptable if it accurately indicates the temperature
digital recordings may be used. Such a is carefully mechanically maintained so during processing. Temperature-
device shall record the temperature at that it operates satisfactorily. indicating devices shall be tested for
accuracy against an accurate calibrated (5) Each temperature-indicating adequate filter systems to ensure a
reference device by appropriate device shall be installed where it can be supply of clean, dry air.
standard procedures, upon installation accurately and easily read. The (D) Product-to-product regenerators.
and at least once a year thereafter, or temperature-indicating device—not the When a product-to-product regenerator
more frequently if necessary, to ensure temperature-recording device—shall be is used to heat the cold unsterilized
accuracy during processing. Each the reference instrument for indicating product entering the sterilizer by means
temperature-indicating device and the processing temperature. of a heat exchange system, it shall be
reference device shall have a tag, seal, (B) Temperature-recording device. designed, operated, and controlled so
or other means of identity. Each product sterilizer shall have an that the pressure of the sterilized
(1) The design of the temperature- accurate temperature-recording device product in the regenerator is greater
indicating device shall ensure that the that records temperatures to a than the pressure of any unsterilized
accuracy of the device is not affected by permanent record, such as a product in the regenerator to ensure that
electromagnetic interference and temperature-recording chart. A any leakage in the regenerator is from
environmental conditions. temperature-recording device shall be the sterilized product into the
(2) Written documentation of the installed in the product at the holding- unsterilized product.
accuracy of the temperature-indicating tube outlet between the holding tube (E) Differential pressure recorder-
device and the reference device shall be and the inlet to the cooler. Additional controller. When a product-to-product
established and maintained. temperature-recording device sensors regenerator is used, there shall be an
(i) Documentation of the accuracy of shall be located at each point where accurate differential pressure recorder-
the temperature-indicating device shall temperature is specified as a critical controller installed on the regenerator.
factor in the scheduled process. The scale divisions shall not exceed 2
include a reference to the tag, seal, or
(1) Analog or graphical recordings. pounds per square inch (13.8
other means of identity used by the
Temperature-recording devices that kilopascals) on the working scale of not
processor to identify the temperature-
more than 20 pounds per square inch
indicating device, the name of the create analog or graphical recordings
per inch of scale (55 kilopascals per
manufacturer of the temperature- may be used. Temperature-recording
centimeter). The controller shall be
indicating device, the identity of the devices that record to charts shall be
tested for accuracy against a known
reference device used for the accuracy used only with the appropriate chart.
accurate standard pressure indicator
test and of equipment and procedures Each chart shall have a working scale of
upon installation and at least once every
used to adjust or calibrate the not more than 55 °F per inch (12 °C per
3 months of operation thereafter, or
temperature-indicating device, the date centimeter) within a range of 20 °F (10
more frequently if necessary, to ensure
and results of each accuracy test, the °C) of the desired-product sterilization
its accuracy. One pressure sensor shall
name of the person or facility that temperature. Chart graduations shall not
be installed at the sterilized product
performed the accuracy test and exceed 2 °F (1 °C) within a range of 10 regenerator outlet and the other pressure
adjusted or calibrated the temperature- °F (5 °C) of the process temperature. sensor shall be installed at the
indicating device, and the date of the Temperature-recording devices that unsterilized product regenerator inlet.
next scheduled accuracy test. create multipoint plottings of (F) Flow control. A flow controlling
(ii) Documentation of the accuracy of temperature readings shall record the device shall be located upstream from
the reference device shall include a temperature at intervals that will assure the holding tube and shall be operated
reference to the tag, seal, or other means that the parameters of the process time to maintain the required rate of product
of identity used by the processor to and process temperature have been met. flow. A means of preventing
identify the reference device, the name (2) Digital recordings. Temperature- unauthorized flow adjustments shall be
of the manufacturer of the reference recording devices, such as data loggers, provided. A lock or a notice from
device, the identity of the equipment that record numbers or create other management posted at or near the flow
and procedures used to test the accuracy digital recordings may be used. Such a controlling device that provides a
and to adjust or calibrate the reference device shall record the temperature at warning that only authorized persons
device, the identity of the person or intervals that will assure that the are permitted to make adjustments, is a
facility that performed the accuracy test parameters of the process time and satisfactory means of preventing
and adjusted or calibrated the reference process temperature have been met. unauthorized changes.
device, the date and results of the (3) Adjustments. The temperature- (G) Product holding tube. The
accuracy test, and the traceability recording device shall be adjusted to product-sterilizing holding tube shall be
information. Documentation for the agree as nearly as possible with, but to designed to give continuous holding of
reference device may be in the form of be in no event higher than, the every particle of food for at least the
a guaranty of accuracy from the temperature-indicating device during minimum holding time specified in the
manufacturer or a certificate of the process time. A means of preventing scheduled process. The holding tube
calibration from a laboratory. unauthorized changes in adjustment shall be designed so that no portion of
(3) A temperature-indicating device shall be provided. A lock or a notice the tube between the product inlet and
that is defective or cannot be adjusted from management posted at or near the the product outlet can be heated, and it
to the accurate calibrated reference temperature-recording device that must be sloped upward at least 1/4-inch
device shall be repaired or replaced provides a warning that only authorized per foot (2.1 centimeters per meter).
before further use. persons are permitted to make (H) Flow-diversion systems. If a
(4) A temperature-indicating device adjustments is a satisfactory means of processor elects to install a flow-
shall be easily readable to 1 °F (0.5 °C). preventing unauthorized changes. diversion system, it should be installed
The temperature range of a mercury-in- (C) Temperature controller. An in the product piping located between
glass thermometer shall not exceed 17 accurate temperature controller shall be the product cooler and the product filler
°F per inch (4 °C per centimeter) of installed and capable of ensuring that or aseptic surge tank and should be
graduated scale. A mercury-in-glass the desired product sterilization designed to divert flow away from the
thermometer that has a divided mercury temperature is maintained. Air-operated filler or aseptic surge tank
column shall be considered defective. temperature controllers should have automatically. Controls and/or warning
systems should be designed and shall not be resumed until the cause of satisfactory means of preventing
installed with necessary sensors and the improper pressure relationships in unauthorized changes.
actuators to operate whenever the the regenerator has been corrected and (ii) Operation—(A) Startup. Before the
sterilizing temperature in the holding the affected system(s) has been returned start of packaging operations, both the
tube or pressure differential in the to a condition of commercial sterility. container and closure sterilizing system
product regenerator drops below (D) Loss of sterile air pressure or other and the product filling and closing
specified limits. Flow-diversion systems protection level in the aseptic surge system shall be brought to a condition
should be designed and operated in tank. When an aseptic surge tank is of commercial sterility.
accordance with recommendations of an used, conditions of commercial sterility (B) Loss of sterility. A system shall be
aseptic processing and packaging may be lost when the sterile air provided to stop packaging operations,
authority. overpressure or other means of or alternatively to ensure segregation of
(I) Equipment downstream from the protection drops below the scheduled any product packaged when the
holding tube. Product coolers, aseptic process value. Product flow to and/or packaging conditions fall below
surge tanks, or any other equipment from the aseptic surge tank shall not be scheduled processes. Compliance with
downstream from the holding tube, with resumed until the potentially this requirement may be accomplished
rotating or reciprocating shafts, valve contaminated product in the tank is by diverting product away from the
stems, instrument connections, or other removed, and the aseptic surge tank has filler, by preventing containers from
such points, are subject to potential been returned to a condition of entering the filler, or by other suitable
entry of microorganisms into the commercial sterility. means. In the event product is packaged
product. Such locations in the system (E) Records. Readings at the following under conditions below those specified
should be equipped with steam seals or points shall be observed and recorded at in the scheduled process, all such
other effective barriers at the potential product shall be segregated and handled
the start of aseptic packaging operations
access points. Appropriate means in accordance with § 113.89. In the
and at intervals of sufficient frequency
should be provided to permit the event of loss of sterility, the system(s)
to ensure that these values are as
operator to monitor the performance of shall be returned to a condition of
specified in the scheduled process:
the seals or barriers during operations. commercial sterility before resuming
Temperature-indicating device in
(ii) Operation—(A) Startup. Before the packaging operations.
holding tube outlet; temperature- (C) Records. Observations and
start of aseptic processing operations the
recording device in holding tube outlet; measurements of operating conditions
product sterilizer and all product-
differential pressure recorder-controller, shall be made and recorded at intervals
contact surfaces downstream shall be
if a product-to-product regenerator is of sufficient frequency to ensure that
brought to a condition of commercial
used; product flow rate as established commercial sterility of the food product
sterility.
(B) Temperature drop in product- by the metering pump or as determined is being achieved; such measurements
sterilizing holding tube. When product by filling and closing rates and, if an shall include the sterilization media
temperature in the holding tube drops aseptic surge tank is used, sterile air flow rates, temperatures, the container
below the temperature specified in the pressure or other protection means; and and closure rates (if applicable) through
scheduled process, product flow should proper performance of steam seals or the sterilizing system, and the
be diverted away from the filler or other similar devices. The sterilization conditions if a batch system
aseptic surge tank by means of a flow- measurements and recordings should be is used for container sterilization. The
diversion system. If for any reason made at intervals not to exceed 1 hour. measurements and recordings should be
product subjected to a temperature drop (2) Container sterilizing, filling, and made at intervals not to exceed 1 hour.
below the scheduled process is filled closing operation—(i) Equipment—(A) (3) Incubation. Incubation tests
into containers, the product shall be Recording device. The container and should be conducted on a representative
segregated from product that received closure sterilization system and product sample of containers of product from
the scheduled process. The processing filling and closing system shall be each code; records of the test results
deviation shall be handled in instrumented to demonstrate that the should be maintained.
accordance with § 113.89. The product required sterilization is being (4) Critical factors. Critical factors
holding tube and any further system accomplished continuously. Recording specified in the scheduled process shall
portions affected shall be returned to a devices shall be used to record, when be measured and recorded on the
condition of commercial sterility before applicable, the sterilization media flow processing record at intervals of
product flow is resumed to the filler or rates, temperature, concentration, or sufficient frequency to ensure that the
to the aseptic surge tank. other factors. When a batch system is factors are within the limits specified in
(C) Loss of proper pressures in the used for container sterilization, the the scheduled process. Such
regenerator. When a regenerator is used, sterilization conditions shall be measurements and recordings should be
the product may lose sterility whenever recorded. done at intervals not to exceed 15
the pressure of sterilized product in the (B) Timing method(s). A method(s) minutes.
regenerator is less than 1 pound per shall be used either to give the retention (h) Equipment and procedures for
square inch (6.9 kilopascals) greater time of containers, and closures if flame sterilizers. The container
than the pressure of unsterilized applicable, in the sterilizing conveyor speed shall be specified in the
product in the regenerator. In this case, environment specified in the scheduled scheduled process. The container
product flow should be diverted away process, or to control the sterilization conveyor speed shall be measured and
from the filler or aseptic surge tank by cycle at the rate specified in the recorded at the start of operations and
means of the flow-diversion system. If scheduled process. A means of at intervals of sufficient frequency to
for any reason the product is filled into preventing unauthorized speed changes ensure that the conveyor speed is as
containers, the product shall be must be provided. A lock, or a notice specified in the scheduled process.
segregated from product that received from management posted at or near the Such measurements and recordings
the scheduled process and shall be speed adjusting device that provides a should be done at 1-hour intervals.
reprocessed or destroyed. Product flow warning that only authorized persons Alternatively, recording tachometer may
to the filler or to the aseptic surge tank are permitted to make adjustments, is a be used to provide a continuous record
of the speed. A means of preventing sterility is achieved. Critical factors recognized by competent processing
changes in flame intensity and specified in the scheduled process shall authorities. If incubation tests are
unauthorized speed changes on the be measured and recorded at intervals of necessary for process confirmation, they
conveyor shall be provided. A lock, or sufficient frequency to ensure that the shall include containers from test trials
a notice from management posted at or critical factors are within the limits and from actual commercial production
near the speed adjusting device that specified in the scheduled process. runs during the period of instituting the
provides a warning that only authorized 3. Amend § 113.60 by revising process. The incubation tests for
persons are permitted to make paragraph (d) to read as follows: confirmation of the scheduled processes
adjustments, is a satisfactory means of should include the containers from the
preventing unauthorized changes. The § 113.60 Containers. test trials and a number of containers
surface temperature of at least one * * * * * from each of four or more actual
container from each conveyor channel (d) Postprocess handling. Container commercial production runs. The
shall be measured and recorded at the handling equipment used in handling number of containers from actual
entry and at the end of the holding filled containers shall be designed, commercial production runs should be
period at intervals of sufficient constructed, and operated to preserve determined on the basis of recognized
frequency to ensure that the the can seam or other container closure scientific methods to be of a size
temperatures specified in the scheduled integrity. Container handling sufficient to ensure the adequacy of the
process are maintained. Such equipment, including automated and process. Complete records covering all
measurements and recordings should be non-automated equipment, shall be aspects of the establishment of the
done at intervals not to exceed 15 checked at sufficient frequency and process and associated incubation tests
minutes. repaired or replaced as necessary to shall be prepared and shall be
(1) Process interruption. In the event prevent damage to containers and permanently retained by the person or
of process interruption wherein the container closures. When cans are organization making the determination.
temperature of the product may have handled on belt conveyors, the 5. Amend § 113.87 by revising
dropped, an authorized, scheduled conveyors should be constructed to paragraphs (c) and (e) to read as follows:
emergency plan approved by a qualified minimize contact by the belt with the
person having expert knowledge of the double seam, i.e., cans should not be § 113.87 Operations in the thermal
process requirements may be used. rolled on the double seam. All worn and processing room.
(2) Critical factors. Critical factors frayed belting, can retarders, cushions, * * * * *
specified in the scheduled process shall etc. should be replaced with new (c) The initial temperature of the
be measured and recorded on the nonporous material. All tracks and belts contents of the containers to be
processing record at intervals of that come into contact with the can processed shall be accurately
sufficient frequency to ensure that the seams should be thoroughly scrubbed determined and recorded with sufficient
factors are within the limits specified in and sanitized at intervals of sufficient frequency to ensure that the temperature
the scheduled process. frequency to avoid product of the product is no lower than the
(i) Equipment and procedures for contamination. minimum initial temperature specified
thermal processing of foods wherein 4. Revise § 113.83 to read as follows: in the scheduled process. For those
critical factors such as water activity are operations that use water during the
used in conjunction with thermal § 113.83 Establishing scheduled filling of the retort or during processing,
processing. The methods and controls processes. provision shall be made to ensure that
used for the manufacture, processing, Scheduled processes for low-acid the water will not, before the start of
and packing of such foods shall be as foods shall be established by qualified each thermal process, lower the initial
established in the scheduled process persons having expert knowledge of temperature of the product below that
and shall be operated or administered in thermal processing requirements for specified in the scheduled process. The
a manner adequate to ensure that the low-acid foods in hermetically sealed temperature-indicating device used to
product is safe. The time and containers and having adequate determine the initial temperature shall
temperature of processing and other facilities for making such be tested for accuracy against an
critical factors specified in the determinations. The type, range, and accurate calibrated reference device at
scheduled process shall be measured combination of variations encountered sufficient frequency to ensure that
with instruments having the accuracy in commercial production shall be initial temperature measurements are
and dependability adequate to ensure adequately provided for in establishing accurate. Records of the accuracy tests
that the requirements of the scheduled the scheduled process. When a product shall be signed or initialed, dated, and
process are met. All measurements shall is reprocessed or a previously processed maintained.
be made and recorded at intervals of product is blended into a new * * * * *
sufficient frequency to ensure that the formulation, this condition must be (e) Clock times on temperature-
critical factors are within the limits covered in the scheduled process. recording device records shall
specified in the scheduled process. Critical factors, e.g., minimum reasonably correspond to the time of
(j) Other systems. All systems, headspace, consistency, maximum fill- day on the written processing records to
whether or not specifically mentioned in or drained weight, aw, etc., that may provide correlation of these records.
in this part, for the thermal processing affect the scheduled process, shall be
* * * * *
of low-acid foods in hermetically sealed specified in the scheduled process. 6. Amend § 113.100 by revising
containers shall conform to the Acceptable scientific methods of paragraphs (a) introductory text, (a)(4),
applicable requirements of this part and establishing heat sterilization processes (b), and (c) and by adding paragraphs (f)
the methods and controls used for the shall include, when necessary, but shall and (g) to read as follows:
manufacture, processing, and packing of not be limited to, microbial thermal
these foods shall be as established in the death time data, process calculations § 113.100 Processing and production
scheduled process. These systems shall based on product heat penetration data, records.
be operated or administered in a manner and inoculated packs. Calculation shall (a) Processing and production
adequate to ensure that commercial be performed according to procedures information shall be entered at the time
it is observed by the retort or processing sterilizing environment; and, when a product code, the date and time of
system operator, or other designated batch system is used for container and/ container closure inspections, the
person, on forms that include the or closure sterilization, sterilization measurements obtained, and all
product, the code number, the date, the cycle times and temperatures. corrective actions taken. Records shall
retort or processing system number, the * * * * * be signed or initialed by the container
size of container, the approximate (b) Temperature-recording device closure inspector and reviewed by
number of containers per coding records shall be identified by date, retort management with sufficient frequency
interval, the initial temperature, the number, and other data as necessary, so to ensure that the containers are
actual processing time, the temperature- they can be correlated with the written hermetically sealed. The records shall
indicating device and temperature- record of lots processed. Each entry on be signed or initialed and dated by the
recording device readings, and other the processing and production records reviewer.
appropriate processing data. Closing shall be made by the retort or processing
machine vacuum in vacuum-packed system operator, or other designated * * * * *
products, maximum fill-in or drained person, at the time the specific retort or (f) Records of this part may be
weight, or other critical factors specified processing system condition or maintained electronically, provided
in the scheduled process shall also be operation occurs, and this retort or they are in compliance with part 11 of
recorded. In addition, the following processing system operator or other this chapter.
records shall be maintained: designated person shall sign or initial
(g) All records required under this
* * * * * each record form. Not later than 1
(4) Aseptic processing and packaging part, or copies of such records, must be
working day after the actual process,
systems. Product temperature in the and before shipment or release for readily available during the retention
holding tube outlet as indicated by the distribution, a representative of plant period for inspection and copying by
temperature-indicating device and the management who is qualified by FDA when requested. If reduction
temperature-recording device; suitable training or experience shall techniques, such as microfilming, are
differential pressure as indicated by the review all processing and production used, a suitable reader and
differential pressure recorder-controller, records for completeness and to ensure photocopying equipment must be made
if a product-to-product regenerator is that the product received the scheduled readily available to FDA.
used; product flow rate, as determined process. The records, including Dated: March 4, 2007.
by the flow controlling device or by temperature-recording device records, Jeffrey Shuren,
filling and closing rates; sterilization shall be signed or initialed and dated by
media flow rate or temperature or both; Assistant Commissioner for Policy.
the reviewer.
retention time of containers, and (c) Written records of all container [FR Doc. 07–1172 Filed 3–13–07; 8:45 am]
closures when applicable, in the closure examinations shall specify the BILLING CODE 4160–01–S

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21 CFR Part 113

D. Operations in the Thermal

temperature chart shall be adjusted to flexibility for processors to use

to add in § 113.87(c), ‘‘The temperature- product temperature in the final heater

average annual burden described

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

113.40(a)(1), (b)(1), (c)(1), (d)(1),

(D) Venting through a single 2.5-inch

BILLING CODE 4160–01–C

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