11892 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 113 

[Docket No. FDA–2007–N–0265; Formerly 

Docket No. 2007P–0026] 

Temperature-Indicating Devices; 

Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed 

Containers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations for thermally processed lowacid foods packaged in hermetically 

sealed containers to allow for use of 

other temperature-indicating devices, in 

addition to mercury-in-glass 

thermometers, during processing. This 

final rule also establishes recordkeeping 

requirements relating to temperatureindicating devices and reference devices 

maintained by the processor and allows 

for the use of advanced technology for 

measuring and recording temperatures 

during processing. Finally, this final 

rule includes metric equivalents of 

avoirdupois (U.S.) measurements where 

appropriate. This final rule will allow 

low-acid canned food processors to 

transition from mercury-in-glass 

thermometers to alternative 

temperature-indicating devices. Use of 

temperature-indicating devices that do 

not contain mercury will eliminate 

concerns about potential contamination 

of the food or the processing 

environment from broken mercury-inglass thermometers. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a 30-day notice announcing 

that it has submitted the information 

collection provisions of this final rule to 

the Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). The notice also invites the 

public to submit comments on the 

information provisions to OMB. Prior to 

the effective date of this final rule, FDA 

will publish a notice in the Federal 

Register announcing OMB’s decision to 

approve, modify, or disapprove the 

information collection provisions of the 

final rule. 

DATES: This final rule is effective March 

5, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Mischelle B. Ledet, Center for Food 

Safety and Applied Nutrition (HFS– 

615), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2070. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Comments on the Proposed Rule 

III. Minor Revisions in Regulations 

IV. Analysis of Economic Impacts 

A. Final Regulatory Impact Analysis 

B. Regulatory Flexibility Analysis 

C. Unfunded Mandate Analysis 

V. Paperwork Reduction Act of 1995 

VI. Federalism 

VII. References 

I. Background 

In the Federal Register of March 14, 

2007 (72 FR 11990), FDA published a 

proposed rule entitled ‘‘TemperatureIndicating Devices; Thermally Processed 

Low-Acid Foods Packaged in 

Hermetically Sealed Containers’’ (the 

proposed rule). We proposed to revise 

§ 113.40 (21 CFR 113.40) to provide for 

use of temperature-indicating devices 

that accurately indicate the temperature 

during processing. We proposed that 

temperature-indicating devices shall be 

tested for accuracy against an accurate 

calibrated reference device upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

processing. We also proposed that the 

design of the temperature-indicating 

device shall ensure that the accuracy of 

the device is not affected by 

electromagnetic interference and 

environmental conditions. 

We proposed to require that each 

temperature-indicating device have a 

tag, seal, or other means of identity that 

will be used by the processor to identify 

the temperature-indicating device, and 

that each reference device have a tag, 

seal, or other means of identity that will 

be used by the processor to identify the 

reference device. We proposed the 

establishment and maintenance of 

written records to document the 

accuracy for each temperatureindicating device and each reference or 

standard device. 

We also proposed to provide for the 

use of metric equivalents of avoirdupois 

(U.S.) measurements for temperatureindicating devices, to provide for use of 

temperature-recording devices that 

create analog, graphical, or digital 

recordings, and to clarify various 

operational and record requirements of 

the regulations. 

In the preamble to the proposed rule, 

FDA stated that, pending issuance of a 

final rule, we intended to consider the 

exercise of our enforcement discretion 

on a case-by-case basis when processors 

of low-acid canned food elect to replace 

mercury-in-glass thermometers with 

alternative temperature-indicating 

devices in a manner that was consistent 

with the proposed rule (72 FR 11990 at 

11999, March 14, 2007). The Federal 

Food, Drug, and Cosmetic Act’s (the 

FD&C Act) enforcement provisions 

commit complete discretion to the 

Secretary of Health and Human Services 

(and by delegation to FDA) to decide 

how and when they should be exercised 

(see Heckler v. Chaney, 470 U.S. 821, 

835 (1985); see also Schering Corp. v. 

Heckler, 779 F.2d 683, 685–86 (DC Cir. 

1985) (stating that the provisions of the 

act ‘‘authorize, but do not compel FDA 

to undertake enforcement activity’’)). 

FDA will continue to consider the 

exercise of our enforcement discretion 

on a case-by-case basis when processors 

of low-acid canned food elect to replace 

mercury-in-glass thermometers with 

alternative temperature-indicating 

devices in a manner that is consistent 

with the proposed rule until the 

effective date of the final rule. In 

addition, we will consider the exercise 

of our enforcement discretion on a caseby-case basis for processors who comply 

with the provisions of this final rule 

prior to the effective date. All low-acid 

canned food processors must comply 

with the requirements of this final rule 

on and after the effective date. 

II. Comments on the Proposed Rule 

FDA received six letters, each 

containing one or more comments, to 

the proposed rule. The comments were 

from industry, a trade association, and 

individuals. Most of the letters generally 

supported the proposed rule, but 

provided some comments that suggested 

modifications to the proposed rule. 

Some of the comments addressed issues 

outside the scope of this rulemaking and 

will not be addressed in this document. 

A summary of the comments and FDA’s 

responses follows. 

(Comment 1) One comment requested 

that the effective date of this final rule 

be not less than 1 year from the date of 

publication. The comment indicated 

that companies that are continuing to 

use mercury-in-glass thermometers will 

need time to comply with the additional 

recordkeeping requirements for 

accuracy checks. Furthermore, 

companies with existing water retorts 

will need at least 1 year to comply with 

the additional equipment requirements 

of the regulation. The comment also 

indicated that firms that currently 

reprocess products or rework previously 

processed product into a new 

formulation need at least 1 year to 

review existing process schedules and 

conduct confirmatory testing if 

necessary, to comply with § 113.83 (21 

CFR 113.83). 

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(Response) We agree with the 

comment’s request to allow 1 year for 

processors to comply with 

recordkeeping requirements relating to 

use of mercury-in-glass thermometers 

and to other requirements relating to 

temperature-indicating devices 

established in this final rule. Thus, the 

effective date of this final rule is 1 year 

from the date of publication in the 

Federal Register. However, FDA does 

not agree with the comment’s suggestion 

that processors need a year to comply 

with § 113.83 for reprocessed or 

reworked product. As discussed in our 

response to comment 38, although we 

clarified the requirements in final 

§ 113.83, we did not propose new 

requirements for reprocessed or 

reworked products in the proposed rule 

or establish new requirements for 

reprocessed or reworked products in 

this final rule. 

(Comment 2) One comment 

recommended defining the term 

‘‘temperature-indicating device’’ as the 

entire system, including the sensor(s) 

and the temperature-indicating device 

display. The comment noted that 

separate references to the ‘‘temperatureindicating device’’ and the ‘‘sensor of the 

temperature-indicating device’’ could be 

interpreted to mean that the sensor is 

not part of the temperature-indicating 

device and thus does not have to be 

calibrated. The comment suggested 

using the term ‘‘temperature-indicating 

device display’’ to refer to the 

electronics/display portion only and to 

define ‘‘temperature-indicating device’’ 

to mean the entire system. 

(Response) We agree that the term 

‘‘temperature-indicating device’’ 

includes the temperature-indicating 

device sensor and the temperatureindicating device display. Accordingly, 

we revised the proposed requirements 

to clarify that each temperatureindicating device must have a sensor 

and a display (final § 113.40(a)(1), (b)(1), 

(c)(1), (d)(1), (e)(1), (f)(1), and 

(g)(1)(i)(A)). As appropriate, we replaced 

the terms ‘‘sensors of temperatureindicating devices’’ and ‘‘sensor of the 

temperature-indicating device’’ with 

‘‘temperature-indicating device sensor’’ 

(final § 113.40(a)(1)(v), (b)(1)(v), 

(c)(1)(v), (d)(1)(v), and (e)(1)(v)). In final 

§ 113.40(f)(1)(v), we clarified that the 

temperature-indicating device sensor, 

rather than the temperature-indicating 

device, must be located in the steam 

dome near the steam water interface or, 

when applicable, in each hydrostatic 

water leg. 

Although the comment did not 

request similar clarification for 

temperature-recording devices, in this 

final rule we also clarified that each 

temperature-recording device must have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart 

(final § 113.40(a)(2), (b)(2), (c)(2), (d)(2), 

(e)(2), (f)(2), and (g)(1)(i)(B)). 

(Comment 3) One comment indicated 

that the mercury-in-glass thermometer 

originally was used for three important 

reasons, i.e., permanent accuracy, no 

drift over time, and reliability. 

According to the comment, reliability 

means ‘‘it works or it doesn’t work and 

you know when it doesn’t work.’’ The 

comment suggested that these factors 

should be characteristics of any 

alternative temperature-indicating 

device. Another comment suggested 

revising proposed § 113.40(a)(1) to 

require alternative temperatureindicating devices to meet or exceed the 

accuracy and reliability of mercury-inglass thermometers. 

(Response) The Agency recognizes 

that accuracy, drift, and reliability are 

important considerations for any 

temperature-indicating device. 

However, the comment does not specify 

any unique problems that may be 

associated with these factors that were 

not addressed by the proposed codified 

language. Thus, the Agency is not 

making any changes to the proposed 

codified in response to this comment. 

The comment’s reference to 

‘‘permanent accuracy’’ is not clear. 

Perpetual and unfailing accuracy cannot 

be guaranteed for any temperatureindicating device, including mercury-inglass thermometers. Each temperatureindicating device must be tested for 

accuracy, as required in final 

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

(f)(1), and (g)(1)(i)(A) of this final rule. 

A temperature-indicating device that is 

defective or cannot be adjusted to the 

accurate calibrated reference device 

must be repaired before further use or 

replaced (final § 113.40(a)(1)(iii), 

(b)(1)(iii), (c)(1)(iii), (d)(1)(iii), (e)(1)(iii), 

(f)(1)(iii), and (g)(1)(i)(A)(3)). 

We use the terms ‘‘accurate’’ and 

‘‘accuracy’’ in this final rule to refer to 

‘‘measurement accuracy.’’ Measurement 

accuracy is defined in the International 

Vocabulary of Metrology as ‘‘closeness 

of agreement between a measured 

quantity value and a true quantity value 

of a measurand’’ (Ref. 1). For a 

temperature-indicating device, the 

temperature shown on the display is the 

‘‘measured quantity value’’ and the 

actual or true temperature is the ‘‘true 

quantity value.’’ As discussed in our 

response to Comment 9, this final rule 

provides that the measurement accuracy 

for a temperature-indicating device 

must be within 1 °F (0.5 °C) of the true 

quantity value, i.e., the temperatureindicating device must be accurate to 

1 °F (0.5 °C) (final § 113.40(a)(1)(iv), 

(b)(1)(iv), (c)(1)(iv), (d)(1)(iv), (e)(1)(iv), 

(f)(1)(iv), and (g)(1)(i)(A)(4)). 

We agree that ‘‘drift over time’’ is a 

factor that must be considered to assure 

that the temperature-indicating device is 

accurate during processing. However, 

because an absolute requirement for no 

drift over time may prevent use of an 

otherwise appropriate temperatureindicating device, we do not agree that 

this characteristic should be specified in 

this final rule. We believe the 

requirement of this final rule for the 

temperature-indicating device to be 

accurate encompasses considerations 

relating to drift. If the accuracy of the 

temperature-indicating device may be 

affected by drift, it is our expectation 

that an appropriate calibration interval 

(i.e., more frequently than once per 

year) or other appropriate mechanism 

will be established by the processor to 

ensure that the temperature-indicating 

device is accurate during processing. 

The reliability of a temperatureindicating device is determined based 

on evaluation of past performance of the 

specific temperature-indicating device 

or similar temperature-indicating 

devices. Past performance may be used 

as an indicator, but not as an absolute 

guarantee or predictor, of future 

performance. Although we agree that 

warranties and predictions of reliability 

are important considerations for 

processors when choosing a 

temperature-indicating device, they do 

not ensure accuracy during processing 

or alleviate the processors’ 

responsibility to ensure that the 

temperature-indicating device provides 

an accurate temperature reading during 

processing (final § 113.40(a)(1), (b)(1), 

(c)(1), (d)(1), (e)(1), (f)(1), and 

(g)(1)(i)(A)). A temperature-indicating 

device that does not accurately indicate 

the temperature during processing does 

not comply with the requirements of 

this final rule. 

We believe that the requirement in 

this final rule for the temperatureindicating device to accurately indicate 

the temperature during processing (final 

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

(f)(1), and (g)(1)(i)(A) is adequate to 

ensure the accuracy and reliability of 

the temperature-indicating device, and 

that it is not necessary to revise the 

regulation to require that alternate 

temperature-indicating devices meet or 

exceed the accuracy and reliability of 

mercury-in-glass thermometers, as 

suggested by the comment. 

(Comment 4) One comment 

recommended revising proposed 

§ 113.40(a)(1) to require temperatureindicating devices to be tested for 

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accuracy against a reference device for 

which the accuracy is traceable to a 

National Institute of Standards and 

Technology (NIST), or equivalent, 

standard reference device. 

(Response) We agree with the 

comment. We revised the applicable 

proposed requirements to clarify that 

each temperature-indicating device and 

each reference device that is maintained 

by the processor must be tested for 

accuracy against a reference device for 

which the accuracy is traceable to a 

NIST, or other national metrology 

institute, standard reference device 

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

(e)(1), (f)(1), and (g)(1)(i)(A)). The term 

‘‘reference device maintained by the 

processor’’ refers to the reference device 

used by a processor who performs the 

accuracy tests at the processor’s own 

facility or facility laboratory. For such 

reference device, the processor, rather 

than a third party laboratory, is 

responsible for ensuring accuracy of the 

reference device when it is used for the 

accuracy test and for ensuring that its 

accuracy is traceable to a NIST, or other 

national metrology institute, standard 

reference device. The term ‘‘traceable’’ 

refers to ‘‘metrological traceability,’’ 

which is defined in the International 

Vocabulary of Metrology as the 

‘‘property of a measurement result 

whereby the result can be related to a 

reference through a documented 

unbroken chain of calibrations, each 

contributing to the measurement 

uncertainty’’ (Ref. 2). ‘‘Measurement 

result’’ is defined as a ‘‘set of quantity 

values being attributed to a measurand 

together with any other available 

relevant information’’ (Ref. 3) and 

‘‘measurement uncertainty’’ is defined as 

‘‘the non-negative parameter 

characterizing the dispersion of the 

quantity values being attributed to a 

measurand, based on the information 

used’’ (Ref. 4). 

This final rule also clarifies that the 

record of the accuracy test for a 

temperature-indicating device or a 

reference device maintained by the 

processor must include documentation 

of the traceability of the accuracy of the 

reference device to a NIST, or other 

national metrology institute, standard 

reference device (final § 113.100(c) and 

(d) (21 CFR 113.100(c) and (d))). For an 

accuracy test performed by the 

processor and, thus, for which the 

processor maintains the reference 

device, the documentation of 

traceability must be a guarantee, 

certificate of accuracy, certificate of 

calibration, or other document from the 

manufacturer or other source of the 

reference device. For an accuracy test 

performed by an outside facility, the 

documentation of traceability must be a 

guarantee, certificate of accuracy, 

certificate of calibration, or other 

document from the facility that includes 

a statement or other documentation 

regarding the traceability of the 

accuracy to a NIST, or other national 

metrology institute, standard reference 

device. 

The information required to be 

included in the records of accuracy for 

temperature-indicating devices and 

reference devices was set forth in 

proposed § 113.40(a)(1)(ii), (b)(1)(ii), 

(c)(1)(ii), (d)(1)(ii), (e)(1)(ii), (f)(1)(ii), 

and (g)(1)(i)(A)(2). To eliminate 

redundancy, we moved the information 

requirements for the records of accuracy 

for temperature-indicating devices and 

reference devices maintained by the 

processor from each of these sections to 

final § 113.100(c) and (d) of Subpart F— 

Records and Reports. We redesignated 

proposed § 113.100(c), (d), and (e), as 

final § 113.100(e), (f), and (g), 

respectively. We also revised proposed 

§ 113.87(c) (21 CFR 113.87(c)) to clarify 

that the records of accuracy tests for 

temperature-indicating devices used to 

determine the initial product 

temperature and reference devices 

maintained by the processor must be 

maintained in accordance with 

§ 113.100(c) and (d). 

(Comment 5) One comment expressed 

concern about the proposed requirement 

that the design of the temperatureindicating device ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions (proposed 

§ 113.40(a)(1)(i), (b)(1)(i), (c)(1)(i), 

(d)(1)(i), (e)(1)(i), (f)(1)(i), and 

(g)(1)(i)(A)(1)). According to the 

comment, the proposed language 

focuses on only a few of the 

considerations that a processor must 

take into account when selecting a 

temperature-indicating device and the 

considerations in the proposed language 

may not be applicable to future 

temperature-indicating technologies. 

The comment pointed out that a 

temperature-indicating device that is 

very robust in terms of the 

electromagnetic interference and 

environmental conditions could provide 

unreliable temperature readings because 

of other aspects of the design and 

installation. However, a temperatureindicating device that is less robust in 

terms of electromagnetic interference 

and environmental conditions could 

provide reliable and accurate readings 

due to good design and installation 

practices. The comment stated that the 

end goal of any temperature-indicating 

device is reliable and accurate readings. 

The comment suggested that it would be 

more effective to state that: ‘‘The design, 

installation, and operation of the 

temperature-indicating device shall be 

such that the accuracy and reliability of 

the device is ensured.’’ 

(Response) We do not agree that the 

language recommended by the comment 

provides clarity or value to the 

regulation. The requirements in the 

regulation for the temperatureindicating device to be accurate upon 

installation and during processing (final 

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

(f)(1), and (g)(1)(i)(A)) encompass 

design, installation, operation, and 

reliability considerations traditionally 

associated with mercury-in-glass 

thermometers and that must be 

considered for other temperatureindicating devices. However, we believe 

it is necessary to emphasize in this final 

rule that the design of the temperatureindicating device must assure that 

accuracy is not affected by 

electromagnetic interference and 

environmental conditions because these 

factors are not traditionally associated 

with mercury-in-glass thermometers. As 

discussed in the preamble to the 

proposed final rule, although 

electromagnetic energy does not affect 

the accuracy of mercury-in-glass 

thermometers, temperature-indicating 

devices with electronic or 

electromagnetic components are 

vulnerable to electromagnetic 

interference. Electromagnetic energy 

may vary in the area where a 

temperature-indicating device is located 

as electronics are turned on and off, 

introduced into, and removed from the 

area. Electromagnetic energy exposure 

may also vary when a temperatureindicating device is moved from one 

location to another, e.g., from one retort 

to another. Thus, unlike a mercury-inglass thermometer, a temperatureindicating device that may be affected 

by electromagnetic energy must be 

designed based on consideration of that 

factor, i.e., the temperature-indicating 

device must be designed to ensure that 

its accuracy during processing is not 

compromised by exposure to electronics 

that generate or cause fluctuations in 

electromagnetic energy. Similarly, some 

environmental conditions, such as 

humidity, vibrations, and air pressure, 

that do not affect the accuracy or 

performance of mercury-in-glass 

thermometers must be considered and 

addressed in the design of other 

temperature-indicating devices. 

(Comment 6) One comment objected 

to the proposed requirement that the 

design of the temperature-indicating 

device ensure that accuracy is not 

affected by environmental conditions 

because it does not clearly state which 

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environmental conditions are important 

and which are not (proposed 

§ 113.40(a)(1)(i), (b)(1)(i), (c)(1)(i), 

(d)(1)(i), (e)(1)(i), (f)(1)(i), and 

(g)(1)(i)(A)(1)). The comment expressed 

concern that some important 

environmental factors may not be 

adequately considered. The comment 

noted that there is a difference between 

environmental considerations for 

mechanical and electronic instruments. 

According to the comment, moisture is 

an important environmental concern 

with electronic instruments. The 

comment noted that condensation on a 

computer board or wiring terminals can 

be detrimental to making a 

measurement and can cause errors. The 

comment suggested requiring the use of 

temperature-indicating devices with an 

Ingress Protection code suitable for the 

environment. The comment also 

indicated concern about ambient 

temperature and vibration, either or 

both of which may affect some 

electronic and mechanical technologies. 

According to the comment, the ambient 

temperature coefficient, which is 

usually expressed as degrees of error per 

degree of change from a specified 

ambient temperature, may not be 

specified for some temperatureindicating devices. The comment 

expressed concern that most users will 

not have the ability to evaluate the 

impact of ambient temperature and may 

not be aware that the ambient 

temperature coefficient is important. 

The comment emphasized that design 

and installation are essential 

components in vibration resistance. 

(Response) Processors are responsible 

for ensuring that environmental factors, 

including those expressed in the 

comment, are adequately considered. 

Processors must use temperatureindicating devices appropriate for the 

processing environment and take 

appropriate steps to evaluate 

environmental factors that may affect 

the accuracy of the temperatureindicating device. Processors who do 

not have specific expertise for 

evaluating the effect of environmental 

factors on temperature-indicating 

devices may need to obtain advice from 

a thermometry expert or obtain a 

manufacturer’s guaranty or warranty 

regarding use of a specific temperatureindicating device in their specific food 

processing environment. 

(Comment 7) One comment requested 

clarification of proposed 

§ 113.40(a)(1)(i), which requires that the 

design of the temperature-indicating 

device ensure that the accuracy of the 

device is not affected by electromagnetic 

interference and environmental 

conditions. The comment questioned 

whether mechanical thermometers are 

exempt from this requirement. The 

comment stated that most processors 

will have no way to determine the 

effects of electromagnetic interference 

on an electronic thermometer design. 

The comment suggested that the 

regulation should state that 

temperature-indicating devices should 

comply with an electromagnetic 

interference standard that is current at 

the time they are designed. According to 

the comment, this would eliminate 

issues associated with changes to 

standards that make existing 

temperature-indicating devices 

noncompliant. The comment suggested 

that temperature-indicating devices 

should comply with the European 

standards EN 61326–1:2006 Electrical 

equipment for measurement, control 

and laboratory use; EN 61000–4–2 

Personnel Electrostatic Discharge 

Immunity; EN 61000–4–3 

Electromagnetic compatibility (EMC); 

and EN 61000–4–6 Conducted 

disturbances immunity. 

(Response) This final rule does not 

exempt mechanical thermometers, e.g., 

mercury-in-glass thermometers, from 

the requirement that the design ensure 

that accuracy is not affected by 

electromagnetic interference and 

environmental conditions. However, 

although the accuracy of mechanical 

thermometers may be affected by 

environmental conditions, they 

generally are not susceptible to the 

affects of electromagnetic interference as 

are electronic devices. 

FDA is providing flexibility to 

processors with respect to this 

requirement and is not limiting 

processors to specific standards with 

which they must comply. Processors, in 

conjunction with temperatureindicating device manufacturers and 

appropriate thermometry experts, 

should ensure that the temperatureindicating devices that processors use 

are accurate during processing. A 

processor may elect to use an 

appropriate electronic standard, such as 

those established by the European 

Union, to ensure compliance with final 

§ 113.40(a)(1)(i), (b)(1)(i), (c)(1)(i), 

(d)(1)(i), (e)(1)(i), (f)(1)(i), and 

(g)(1)(i)(A)(1). 

(Comment 8) One comment stated 

that electronic thermometers are not 

capable of communicating that there is 

an accuracy problem. The comment 

stated that it is risky to rely on the 

history of calibration to prove an 

instrument’s accuracy because the 

temperature-indicating device may 

perform properly for years and then fail 

without warning. The comment pointed 

out that a failure that occurs between 

calibration cycles may not be detected 

for a significant period of time. The 

comment suggested that additional 

features are needed to ensure that a 

temperature-indicating device retains its 

accuracy, will not drift, and will report 

any potential errors. The comment 

indicated that a system with internal 

diagnostics and error reporting to the 

operator would be one way of providing 

this evidence. The comment suggested 

that FDA require that an electronic 

temperature-indicating device 

incorporate technology to alert the 

operator of measurement errors. 

(Response) Processors must ensure 

that temperature-indicating devices are 

accurate during processing (final 

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

(f)(1), and (g)(1)(i)(A)). Processors must 

test the temperature-indicating device 

for accuracy upon installation and at 

least once per year thereafter, or more 

frequently if necessary, to ensure 

accuracy (emphasis added) (see, e.g., 

final § 113.40(a)(1)). These requirements 

for accuracy for all temperatureindicating devices make it unnecessary 

for this final rule to require specific 

mechanisms to alert the operator of 

measurement errors. Processors should 

adopt whatever features or systems are 

appropriate to ensure the accuracy of a 

given temperature-indicating device, 

and to detect defects or failures that may 

cause a temperature-indicating device to 

be inaccurate. For mercury-in-glass 

thermometers, the process for detecting 

failure may include periodic visual 

examinations and appropriate followup 

based on findings of defects or potential 

for failure. Electronic devices may have 

hardware and software components 

with built-in diagnostic and alarm 

features. Processors also may use 

backup or duplicate devices to detect 

defects or failures. In addition, when 

adjustments are made to the 

temperature-recording device so that it 

agrees as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time, as required by this 

regulation (final § 113.40(a)(2)(iii), 

(b)(2)(iii), (c)(2)(iii), (d)(2)(iii), (e)(2)(iii), 

(f)(2)(iii), and (g)(1)(i)(B)(3)), the need 

for such adjustment may be used as a 

signal for determining whether a 

temperature-indicating device failure 

occurred. Thus, features or systems for 

ensuring accuracy or for detecting 

inaccuracies may be different for 

different types of temperature-indicating 

devices, as well as subject to 

technological advancements that we 

may not anticipate at this time. To 

ensure processors have flexibility to 

adopt future technologies to detect 

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defects or failures of temperatureindicating devices, we have not required 

in this final rule specific features or 

systems to detect such defects or 

failures. 

(Comment 9) One comment expressed 

concern that the proposed rule did not 

mention measurement uncertainties or 

test accuracy ratio, which are essential 

parameters for assuring an accurate 

calibration that are specified in 

standards issued by the American 

National Standards Institute (ANSI) and 

the International Organization for 

Standardization (ISO) for certification of 

calibration laboratories. The comment 

stated that the ANSI and ISO standards 

provide a limit for measurement 

uncertainty and establish a minimum 

test accuracy ratio that is commonly 

used by calibration facilities. According 

to the comment, although the proposed 

rule requires use of a calibrated accurate 

reference device, the lack of specific 

calibration parameters may lead to 

inaccurate calibrations for temperatureindicating devices. 

(Response) Measurement uncertainty 

is inherent in the proposed requirement 

that the temperature-indicating device 

be easily readable to 1 °F (0.5 °C), (i.e., 

the dispersion of the quantity values for 

the temperature must be within 1 °F 

(0.5 °C) of the actual temperature) 

(proposed § 113.40(a)(1)(iv), (b)(1)(iv), 

(c)(1)(iv), (d)(1)(iv), (e)(1)(iv), (f)(1)(iv), 

and (g)(1)(i)(A)(4)). However, we 

acknowledge that the term ‘‘easily 

readable’’ is readily understood for a 

mercury-in-glass thermometer, which 

has a visible scale of temperature 

gradations, but it may not be clear for 

other temperature-indicating devices, 

such as those that display a digital 

reading of the temperature. Therefore, 

we removed the term ‘‘easily readable’’ 

and clarified in this final rule that a 

temperature-indicating device must be 

accurate to 1 °F (0.5 °C) (final 

§ 113.40(a)(1)(iv), (b)(1)(iv), (c)(1)(iv), 

(d)(1)(iv), (e)(1)(iv), (f)(1)(iv), and 

(g)(1)(i)(A)(4)). 

We do not agree that the regulations 

should specify calibration parameters, 

such as those relating to measurement 

uncertainties or test accuracy ratio, or 

require use of specific calibration 

standards, such as the ANSI and ISO 

standards suggested by the comment. 

Metrology authorities, in addition to 

ANSI and ISO, issue calibration 

standards, which may be revised or 

replaced. It would be impractical for 

FDA to maintain in the regulations a 

current list of acceptable calibration 

standards. Processors are responsible for 

ensuring that the temperature-indicating 

device is accurate during processing and 

for testing each temperature-indicating 

device for accuracy against a reference 

device for which the accuracy is 

traceable to a NIST, or other national 

metrology institute, standard reference 

device by appropriate standard 

procedures, upon installation and at 

least once a year thereafter, or more 

frequently if necessary (final 

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

(f)(1), and (g)(1)(i)(A)). Thus, processors 

are responsible for ensuring that 

accuracy tests are performed by 

appropriate standard procedures or by 

calibration facilities that use appropriate 

standard procedures. 

(Comment 10) One comment 

recommended revising proposed 

§ 113.40(a)(1) to clarify that the identity 

of each temperature-indicating device 

and reference device must be ‘‘unique.’’ 

(Response) We do not agree that the 

term ‘‘unique’’ is necessary because each 

temperature-indicating device and each 

reference device that is maintained by 

the processor must have a tag, seal, or 

other means of identity (final 

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

(f)(1), and (g)(1)(i)(A)). The purpose of a 

tag, seal, or other means of identity is, 

in part, to uniquely identify each 

temperature-indicating device and each 

reference device that is maintained by 

the processor so that one temperatureindicating or reference device can be 

distinguished from another and so that 

appropriate records can be associated 

with each temperature-indicating device 

or reference device. 

(Comment 11) One comment 

expressed concern about the 

information required in proposed 

§ 113.40(a)(1)(ii)(A) and (a)(1)(ii)(B) for 

documentation of accuracy of 

temperature-indicating devices and 

reference devices. The comment 

suggested that the final rule should 

instead require documentation that 

conforms to the standards established 

by the American National Standards 

Institute, National Conference of 

Standards Laboratories (ANSI/NCSL) or 

the International Organization for 

Standardization, International 

Electrotechnical Commission (ISO/IEC) 

for accrediting calibration laboratories. 

The comment stated that the laboratory 

accreditation standards indicate 

acceptable reporting practices. The 

comment acknowledged that the 

standards may be too prescriptive for 

food processors who perform their own 

calibrations. 

(Response) We do not agree that the 

regulation should require the 

documentation of accuracy of 

temperature-indicating devices and 

reference devices to conform to the 

standards specified in the comment for 

accrediting calibration laboratories. 

Although FDA supports use of 

accredited calibration laboratories and 

recognizes that the laboratories must 

maintain certain documentation for the 

accreditation, the records required by 

this final rule are appropriately limited 

to those necessary to document that the 

temperature-indicating device was 

tested for accuracy at sufficient 

frequency to ensure accuracy during 

processing. As acknowledged by the 

comment, a requirement for processors 

to adhere to accreditation standards 

would impose an unnecessary burden 

on those who successfully perform their 

own calibrations but are not accredited 

by ANSI/NCSL or ISO/IEC. 

(Comment 12) One comment 

recommended revising proposed 

§ 113.40(a)(1)(ii)(A) and (a)(1)(ii)(B) to 

require that documentation of the 

results of the accuracy test include 

before and after data, i.e., the 

temperature reading of the temperatureindicating device compared to the 

accurate calibrated reference device, 

before and after the calibration. The 

comment indicated that the before data 

is needed because it is the basis for 

determining whether the device was 

accurate at the time of calibration and 

for documenting any adjustment that 

was made. 

(Response) Proposed 

§ 113.40(a)(1)(ii)(A) and (a)(1)(ii)(B) 

require that the results of each accuracy 

test be documented. Although not 

explicitly stated in the proposed rule, 

we would expect documentation of the 

results of the accuracy test to include 

information about the amount of 

calibration adjustment that was 

necessary. The ‘‘before and after data’’ 

suggested by the comment would be 

reflected in the amount of calibration 

adjustment. The amount of calibration 

adjustment is an indication of whether 

the temperature-indicating device was 

accurate at the time of the calibration. 

If an adjustment is required, the 

processor should evaluate the need for 

more frequent accuracy tests and also 

determine whether food processed prior 

to the adjustment is under processed. To 

provide clarity in the regulation 

regarding the requirement to record the 

amount of calibration adjustment that 

was necessary for a temperatureindicating device, we are revising final 

§ 113.100 ‘‘Processing and production 

records’’ to indicate that the record of 

each accuracy test for each temperatureindicating device and for each reference 

device that is maintained by the 

processor must include the results of 

each accuracy test, including the 

amount of calibration adjustment (final 

§ 113.100(c)(5) and (d)(5)). 

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Other information relating to the 

results of the accuracy test that should 

be recorded when it is relevant includes 

information about the condition of the 

temperature-indicating device (i.e., 

intact or broken mercury column, worn 

or broken components) and disposition 

of the temperature-indicating device if it 

cannot be calibrated (i.e., destroyed, 

repaired, or replaced). 

(Comment 13) One comment 

addressed the proposed requirement 

that records of the accuracy test for the 

temperature-indicating device include 

the date of the next scheduled accuracy 

test (proposed § 113.40(a)(1)(ii)(A), 

(b)(1)(ii)(A), (c)(1)(ii)(A), (d)(1)(ii)(A), 

(e)(1)(ii)(A), (f)(1)(ii)(A), and 

(g)(1)(i)(A)(2)(i)). One comment 

interpreted this requirement to imply 

that the test must be conducted on that 

specific date. The comment suggested 

removing the requirement or changing 

the language to ‘‘the date of the 

calibration expiration.’’ 

(Response) We acknowledge that the 

proposed requirement concerning the 

date of the next scheduled accuracy test 

may be misinterpreted to mean that the 

next accuracy test must be conducted on 

that specific date. However, we do not 

agree that the revised language 

recommended by the comment, i.e., the 

date of the calibration expiration, 

adequately clarifies that the next 

accuracy test must be conducted on or 

before the specified date. In this final 

rule, we require that the record of 

accuracy for a temperature-indicating 

device and a reference device 

maintained by the processor include the 

date on or before which the next 

accuracy test must be performed (final 

§ 113.100(c)(6) and (d)(6)). 

(Comment 14) One comment 

recommended placing on each 

temperature-indicating device a 

calibration sticker that indicates the 

date of the last calibration and the date 

the next calibration is due. According to 

the comment, the calibration standard 

ISO/IEC 17025 does not require the 

calibration due date to be recorded on 

the certificate issued by the calibration 

facility, which may have no knowledge 

of the calibration interval for the 

specific device. 

(Response) We recognize that outside 

calibration facilities are not responsible 

for determining the frequency of the 

accuracy tests for temperatureindicating devices and, thus, are not 

required to record the frequency on a 

calibration certificate. We do not agree 

with the comment’s recommendation to 

require a sticker on each temperatureindicating device with the date of the 

last calibration and date the next 

calibration is due. Although we do not 

object to processors using stickers or 

similar mechanisms on temperatureindicating devices to emphasize when 

the next accuracy test for a temperatureindicating device must be performed, 

we consider it sufficient to require that 

information relating to the accuracy test, 

such as the date on or before which the 

next accuracy test must be performed, 

be included in the processor’s records of 

the accuracy test (final § 113.100(c)). 

(Comment 15) One comment 

questioned why the documentation 

requirements for accuracy tests in 

proposed § 113.40(a)(1)(ii)(B) apply to 

reference devices. The comment pointed 

out that the reference device may be 

located in a third party calibration 

laboratory. 

(Response) Accuracy tests for 

temperature-indicating devices may be 

performed by the processor or by a third 

party calibration laboratory. Processors 

who perform their own accuracy test 

must ensure that the reference device 

they use is accurate and must maintain 

records to document that accuracy. In 

this final rule, we clarify that the 

required records of the accuracy tests for 

reference devices are for reference 

devices maintained by the processor 

(final §§ 113.40(a)(1), (b)(1), (c)(1), 

(d)(1), (e)(1), (f)(1), and (g)(1)(i)(A), 

113.87(c), and 113.100(d)). 

(Comment 16) One comment 

recommended that processors be 

required to implement a method or 

process for identifying when a 

temperature-indicating device needs to 

be calibrated. The comment pointed out 

that inexpensive software packages are 

readily available for this purpose. 

(Response) We recognize that 

processors may desire to establish a 

system to prompt them when scheduled 

activities, such as calibrations, need to 

be performed. Although available 

software may be appropriate for that 

purpose, we do not agree that the 

regulations should require processors to 

develop or use existing software or any 

other specific method or system to 

identify when a temperature-indicating 

device needs to be calibrated. Processors 

must test temperature-indicating 

devices for accuracy upon installation 

and at least once a year thereafter, or 

more frequently if necessary (final 

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

(f)(1), and (g)(1)(i)(A)). The appropriate 

frequency for the accuracy test should 

be determined based on previous 

accuracy test results, evidence of 

damage, and other factors or situations 

that cause the accuracy of the 

temperature-indicating device to be 

questionable. 

(Comment 17) One comment objected 

to the preamble statement, ‘‘FDA 

recommends, but is not proposing to 

require, a dual probe design.’’ (72 FR 

11989 at 11993). According to the 

comment, FDA’s recommendation for a 

dual probe design will lead companies 

to purchase a dual probe unit to reduce 

any potential conflict with FDA. The 

comment stated that the dual probe 

design is a patented technology and 

other designs or mechanisms may be 

used for detecting malfunctions. 

(Response) In the preamble to the 

proposed rule, FDA stated, ‘‘The design 

of the mercury-in-glass thermometer 

makes it relatively easy to detect a 

malfunction, including those caused by 

environmental conditions, because most 

are associated with a broken 

thermometer, separated column, or scale 

slippage. However, malfunction of other 

temperature-indicating devices may 

need to be detected by means other than 

observation. For example, a 

temperature-indicating device could be 

designed with a dual probe sensor that 

would enable detection of loss of 

accuracy of one of the probes when the 

probe readings do not agree. FDA 

recommends, but is not proposing to 

require, a dual probe design. FDA 

recognizes that specific design 

specifications for temperatureindicating devices may limit the 

flexibility of the regulation for current 

and future technologies’’ (72 FR 11990 at 

11993). Thus, in the preamble to the 

proposed rule, we discussed a dual 

probe sensor as one means to detect a 

malfunction of a temperature-indicating 

device. We agree that a dual probe 

sensor is not the only design, 

mechanism, or process that may help 

detect temperature-indicating device 

failures. Therefore, this final rule does 

not require a dual probe design to detect 

malfunctions or failures of a 

temperature-indicating device. 

(Comment 18) One comment objected 

to the requirement for ‘‘written 

documentation,’’ found in proposed 

§§ 113.40(a)(1)(ii), (b)(1)(ii), (c)(1)(ii), 

(d)(1)(ii), (e)(1)(ii), (f)(1)(ii), and 

(g)(1)(i)(A)(2). The comment indicated 

that the term ‘‘written’’ implies handwritten documentation and will limit 

new documentation technologies. The 

comment stated that the term ‘‘written’’ 

should be removed to allow for means 

of documentation other than just written 

records, especially since the Agency 

proposed in § 113.100(f) to allow 

electronic records. The comment also 

stated that the term ‘‘written’’ should be 

removed from other sections of the 

regulations that apply to records. 

(Response) We do not agree that the 

term ‘‘written’’ implies that the 

documents are hand-written. Written 

documentation may be generated 

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mechanically, such as when a stylus 

generates a tracing onto a paper chart, 

or electronically, including computer 

generated documents. However, we do 

agree that the term is not necessary for 

describing the requirements for 

establishing and maintaining records. 

Therefore, in this final rule, we used the 

term ‘‘record’’ or ‘‘records’’ without the 

qualifying term ‘‘written’’ (final 

§§ 113.87(e) and 113.100(b) and (e)). For 

consistency, we also removed the 

qualifying term ‘‘written’’ from 

§ 113.87(b). In addition, where the term 

‘‘written documentation’’ is intended to 

mean ‘‘records’’ that must be established 

and maintained, we changed the term 

‘‘written documentation’’ to ‘‘records’’ 

(final § 113.40(a)(1)(ii), (b)(1)(ii), 

(c)(1)(ii), (d)(1)(ii), (e)(1)(ii), (f)(1)(ii), 

and (g)(1)(i)(A)(2)). 

(Comment 19) One comment 

recommended that proposed 

§ 113.40(b)(6)(ii) on water circulation be 

redesignated as new § 113.40(b)(9). The 

comment suggested that it was 

inappropriate to place the requirements 

for water circulation and for air supply 

in the same section, specifically 

proposed § 113.40(b)(6)(i) and (b)(6)(ii), 

which, according to the comment, 

respectively addressed air supply and 

water control. The comment stated that, 

for discontinuous water retort, air 

supply and water circulation are not 

related functions as they are for vertical 

water retorts covered in § 113.40(b). 

(Response) The proposed rule does 

not have a § 113.40(b)(6)(ii). Because the 

comment was related to water 

circulation for discontinuous agitating 

retorts, we assume the comment was 

requesting redesignation of proposed 

§ 113.40(e)(6)(ii). We also assume the 

comment was comparing proposed 

§ 113.40(e)(6)(ii), related to water 

circulation in discontinuous agitating 

retorts, to proposed § 113.40(b)(10)(ii), 

related to water circulation in still 

retorts, including vertical still retorts. 

We reviewed the structure of proposed 

§ 113.40(b)(10) and (e)(6) and agree that 

separating the requirements for the air 

supply and controls and the water 

circulation functions into distinct 

paragraphs for both discontinuous 

agitating and still retorts enhances the 

clarity of the regulation. We also 

determined that, based on changes to 

proposed § 113.40(e)(8), as explained in 

response to Comment 20, proposed 

§ 113.40(b)(9) and (e)(8), relating to the 

water level indicator, should be 

redesignated to immediately precede 

proposed § 113.40(b)(10)(ii) and 

(e)(6)(ii), respectively, relating to water 

circulation. Thus, in this final rule, we 

redesignated proposed § 113.40(b)(9), 

(b)(10)(i), and (b)(10)(ii) as final 

§ 113.40(b)(10), (b)(9), and (b)(11), 

respectively. We redesignated proposed 

§ 113.40(e)(6)(ii) and (e)(8) as final 

§ 113.40(e)(7) and (e)(6)(ii), respectively. 

We made conforming changes to the 

numbering of proposed § 113.40(b)(11), 

(b)(12), (b)(13), and (b)(14), which is 

now final § 113.40(b)(12), (b)(13), 

(b)(14), and (b)(15), respectively. 

Similarly, we redesignated proposed 

§ 113.40(e)(6)(ii) and (e)(7), as final 

§ 113.40(e)(7) and (e)(8), respectively. 

(Comment 20) One comment 

suggested revising proposed 

§ 113.40(b)(6), relating to air supply and 

controls, to clarify that the requirements 

apply only if air is used for providing 

overpressure. The comment also 

suggested revising proposed 

§ 113.40(e)(8), which requires a water 

level indicator and operator checks of 

the water level to ensure that water 

covers the top layer of containers during 

the entire come-up time and processing 

periods. The comment requested 

revisions to clarify that the requirements 

of proposed § 113.40(e)(8) apply only if 

water level is determined to be a critical 

factor in the scheduled process or retort 

operating procedures. According to the 

comment, these revisions would 

accommodate current systems for 

pressure processing in discontinuous 

agitating retorts that utilize steam as the 

source of overpressure. The comment 

stated that for such systems, the 

processing authority may have 

determined that water level is not 

critical to the scheduled process 

because of the influences of steam in the 

retort headspace area and the 

continuous rotation of the retort baskets. 

(Response) Because proposed 

§ 113.40(b)(6) does not relate to air 

supply and controls, but is instead 

about crate supports, we assume here as 

we did in our response to Comment 19 

that the comment is referring to 

proposed § 113.40(e)(6)(i), relating to air 

supply and controls for pressure 

processing in water in discontinuous 

agitating retorts. Proposed 

§ 113.40(e)(6)(i) requires that a means be 

provided for introducing compressed air 

at the proper pressure and rate. We 

agree with the comment that the 

requirement of proposed 

§ 113.40(e)(6)(i) applies only if air is 

used for providing overpressure. We 

also agree that the requirement of 

proposed § 113.40(e)(6)(ii) for a water 

level indicator and recorded checks of 

the water level during processing 

should be revised to accommodate 

discontinuous agitating retorts that 

utilize steam as the source of 

overpressure. Accordingly, in final 

§ 113.40(e)(6)(i) and (e)(6)(ii), we 

clarified that the requirements relating 

to air supply and controls and to the 

water level indicator apply only if air is 

used for providing overpressure. 

(Comment 21) One comment 

suggested revising proposed 

§ 113.40(b)(10)(ii), which requires the 

water circulation pump to be equipped 

with a bleeder to remove air when 

starting operations. The comment 

suggested revising this requirement to 

allow for use of other suitable devices 

for air removal. 

(Response) We agree that proposed 

§ 113.40(b)(10)(ii), redesignated as 

§ 113.40(b)(11) in this final rule, should 

be revised to allow for use of water 

circulation pumps, other than a water 

circulation pump with a bleeder, 

designed to ensure proper heat 

distribution. To ensure proper heat 

distribution, the water circulation pump 

must be designed to properly start the 

flow of water and to maintain the flow 

of water at the appropriate flow rate. To 

obtain the appropriate flow rate, the 

water circulation pump must be 

designed or equipped with a suitable 

means, such as a bleeder, to remove air 

from the pump chamber or the pump 

must be self priming. In addition, the 

pumping system must ensure that it 

avoids cavitation, i.e., changes in water 

pressure caused by the formation of 

cavities or voids within the circulating 

water. Water circulation pumps that use 

mechanisms other than bleeders to 

remove air must be designed to ensure 

appropriate water circulation and to 

prevent cavitation. 

To clarify this requirement, in 

§ 113.40(b)(11) of this final rule we 

specify that the water circulation pump 

must be designed to provide proper flow 

on startup and during operation, such as 

with a bleeder or other suitable means 

to remove air during startup and with an 

appropriate device or design to prevent 

pump cavitation during operation. In 

addition, the pump must be equipped 

with a signaling device to warn the 

operator when it is not running. For 

consistency, we made similar changes to 

proposed § 113.40(e)(6)(ii) (redesignated 

as § 113.40(e)(7) in this final rule). In 

final § 113.40(b)(11) and (e)(7), we 

removed the reference to ‘‘pilot light’’ as 

the example of a signaling device to 

avoid the appearance of preference for 

a pilot light signaling device and to 

provide flexibility for processors to 

determine an appropriate signaling 

device. 

(Comment 22) One comment agreed 

with the provision of proposed 

§ 113.40(b)(1)(v) that allows a 

temperature-indicating device to be 

installed in a separate well or sleeve, 

i.e., ‘‘If a separate well or sleeve is used, 

there must be adequate circulation to 

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ensure accurate temperature 

measurement.’’ However, the comment 

indicated that the provision appears to 

conflict with another requirement in 

proposed § 113.40(b)(1)(v) for the 

temperature-indicating device sensor to 

extend directly into the water a 

minimum of at least 2 inches (5.1 

centimeters) without a separable well or 

sleeve. 

(Response) We agree that additional 

clarification is needed. In this final rule, 

we revised proposed § 113.40(b)(1)(v) 

and a similar requirement in proposed 

§ 113.40(e)(1)(v) to clarify that the 

temperature-indicating device sensor 

must be installed directly into the retort 

shell or in a separate well or sleeve 

attached to the retort. In addition, for all 

retorts covered by these sections, the 

temperature-indicating device sensor 

must be located so that it is beneath the 

surface of the water throughout the 

process and where there is adequate 

circulation to ensure accurate 

temperature measurement. We also 

removed the requirement for the 

temperature-indicating device sensor to 

extend at least 2 inches (5.1 centimeters) 

directly into the water when the 

temperature-indicating device sensor is 

not located in a separate well or sleeve. 

We believe the requirement for adequate 

water circulation to ensure accurate 

temperature measurement obviates the 

need to specify how far the temperatureindicating device sensor must extend 

into the water and allows for use of 

alternative technologies. 

(Comment 23) One comment noted 

that proposed § 113.40(f)(1)(v) should be 

revised to clarify that placement 

requirements in the steam dome and the 

hydrostatic water leg are for the 

temperature-indicating device sensor. 

(Response) We agree. In this final 

rule, we revised proposed 

§ 113.40(f)(1)(v) to clarify that the 

placement requirements in the steam 

dome and the hydrostatic water leg 

apply to the temperature-indicating 

device sensor, rather than the entire 

temperature-indicating device. 

(Comment 24) One comment stated 

that the requirement for the 

temperature-recording device sensor to 

be installed either within the retort shell 

or in a well attached to the shell is 

misplaced in the paragraph heading, 

Temperature controller (proposed 

§ 113.40(a)(2)(iv), (c)(2)(iv), (d)(2)(iv), 

(e)(2)(iv), and (f)(2)(iv)). The comment 

indicated that the statement applies to 

all temperature-recording device 

sensors, but its placement in the 

regulations implies that it applies only 

to combination recording-controlling 

devices. The comment suggested 

moving the statement relating to 

installation of the sensor, along with the 

requirement for the temperaturerecording device sensor well to have a 

1⁄16-inch (1.5 millimeters) or larger 

bleeder, to a separate paragraph. 

(Response) We agree. In this final 

rule, we moved the statements relating 

to installation of the sensor and, where 

relevant, the requirement for the 

temperature-recording device sensor 

well to have a 1⁄16-inch (1.5 millimeters) 

or larger bleeder to the paragraph 

heading, Temperature-recording device 

(final § 113.40(a)(2), (c)(2), (d)(2), (e)(2), 

and (f)(2)). 

(Comment 25) One comment objected 

to the requirement in proposed 

§ 113.40(e)(1)(v) for the temperatureindicating device sensor to be installed 

either within the retort shell or in an 

external well attached to the retort. The 

comment indicated that placement of 

the temperature-indicating device in the 

suction manifold shows good agreement 

with temperatures inside the retort once 

the Cook Hold step begins. According to 

the comment, this placement is an 

improvement over using a thermometer 

well, since the water line for a partial 

immersion process is normally below 

the feed leg of the thermometer well and 

the temperature at that location may not 

be representative of the retort 

temperature. The comment suggested 

revising § 113.40(e)(1)(v) by adding the 

following language to permit alternative 

sensor placement, if appropriately 

documented: ‘‘Other installations 

deviating from these sensor locations 

may be used if the processor has 

evidence, on file, in the form of heat 

distribution data that its installation 

accomplishes adequate heat 

distribution. Such documentation is 

likely to include heat distribution 

studies conducted and documented by 

the processor to show that the process 

temperature will be reached once the 

Cook Hold time begins.’’ 

(Response) We do not agree with the 

comment’s recommendation that 

§ 113.40(e)(1)(v) should state that 

process deviations relating to placement 

of temperature-indicating device sensors 

may be acceptable if supported by heat 

distribution data. Section 108.35 states 

the requirements for submitting 

information to demonstrate process 

adequacy for a system design that 

deviates from the requirements of the 

regulations. A change in the design of a 

system for processing in water in 

discontinuous agitating retorts, such as 

placement of a temperature-indicating 

device sensor in a suction manifold 

rather than within the retort shell or in 

an external well attached to the retort, 

would require substantiation by 

qualified scientific authority as to its 

adequacy, including, for example, heat 

distribution studies as suggested by the 

comment. Such information must be 

submitted to FDA (§ 108.35(c)(2)(ii) (21 

CFR 108.35(c)(2)(ii))). 

(Comment 26) One comment 

expressed concern that proposed 

§ 113.40(a)(2), which requires each 

retort to have an accurate temperaturerecording device, does not define the 

term ‘‘accurate’’ or state how to 

determine that a temperature-recording 

device is accurate. The comment 

suggested using the same calibration 

method for temperature-recording 

devices as used for temperatureindicating devices and reference devices 

by requiring annual calibrations of 

temperature-recording devices with 

NIST traceability. The comment stated 

that this would effectively allow the 

temperature-recording device to be used 

as a secondary component of a 

‘‘redundant system’’ to verify the 

accuracy of the temperature-indicating 

device. Accordingly, the temperatureindicating device would still be ‘‘the 

standard’’ device and should still be 

required to have the characteristics of 

high accuracy and reliability. The 

comment indicated that if the 

temperature-recording device is 

adjusted to the temperature-indicating 

device and the temperature-indicating 

device slowly drifts, this may not be 

known until the next calibration cycle, 

which could be up to a year later. 

However, according to the comment, if 

the devices are allowed to vary within 

their individual established calibration 

tolerances, it will be known if one 

device drifts out of its tolerance. The 

comment stated that adjusting the 

temperature-recording to the 

temperature-indicating device does not 

ensure the accuracy of the temperaturerecording device or the recorded data. 

(Response) This final rule requires the 

temperature-recording device to be 

adjusted to agree as nearly as possible 

with, but to be in no event higher than, 

the temperature-indicating device 

during the process time (final 

§ 113.40(a)(2)(iii), (b)(2)(iii), (c)(2)(iii), 

(d)(2)(iii), (e)(2)(iii), (f)(2)(iii), and 

(g)(1)(i)(B)(3)). Processors must ensure 

that the temperature-indicating device is 

accurate during processing and that the 

recording mechanism of the 

temperature-recording device is 

adjusted to and reflects the temperature 

indicated by the temperature-indicating 

device. For some temperature-recording 

devices, such as those that record to a 

chart, adjustments to the mechanism 

that draws onto the chart are made by 

hand based on visually determining 

where the mechanism should be placed 

in contact with the chart. Unavoidable 

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imprecision relating to, for example, 

manual placement of the recording 

mechanism onto a chart, must result in 

recording a temperature that is not 

greater than the actual processing 

temperature. A recorded temperature 

that is higher than the actual processing 

temperature may mean that the product 

was not processed at or above the 

required processing temperature (i.e., 

the product was under processed) and 

may pose a health hazard. However, if 

the temperature-recording device 

records a temperature that is lower than 

the actual processing temperature, 

although the quality of the product may 

be affected, processing at a higher 

temperature than recorded (i.e., over 

processing) does not create a health 

hazard. Thus, although the recorded 

temperature should reflect the actual 

processing temperature as precisely as 

possible, we believe the requirement to 

not record a temperature that is higher 

than the temperature-indicating device, 

which must be accurate, provides an 

appropriate parameter for ensuring that 

the product is not under processed. 

We believe processors should adjust 

the temperature-recording device 

mechanism for each batch at least at the 

beginning of the process and, as 

necessary, check the adjustment during 

the process time to ensure compliance 

with the regulation and to ensure that 

the batch is processed at or above the 

scheduled process temperature. To 

emphasize that the adjustment must 

occur with sufficient frequency to 

ensure that the temperature-recording 

device record reflects the temperature 

indicated by the temperature-indicating 

device, we revised the final rule to 

require the temperature-recording 

device to be adjusted with sufficient 

frequency to ensure agreement as nearly 

as possible with, but to be in no event 

higher than, the temperature-indicating 

device during processing (final 

§ 113.40(a)(2)(iii), (b)(2)(iii), (c)(2)(iii), 

(d)(2)(iii), (e)(2)(iii), (f)(2)(iii), and 

(g)(1)(i)(B)(3)). 

(Comment 27) One comment 

suggested replacing the term ‘‘recording 

chart’’ with ‘‘temperature-recording 

device record’’ in proposed 

§ 113.40(c)(8)(ii). 

(Response) We agree. In 

§ 113.40(c)(8)(ii) of this final rule, we 

replaced the term ‘‘recording chart’’ with 

‘‘temperature-recording device record.’’ 

Also, because the term ‘‘marked’’ may be 

interpreted to mean a manual action, for 

clarity and to allow for use of alternative 

technologies, we replaced the term 

‘‘marked’’ with ‘‘indicated’’ in 

§ 113.40(c)(8)(ii) and (c)(9). 

(Comment 28) One comment 

suggested that the statement that airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air is misplaced in 

the regulations (proposed 

§ 113.40(a)(2)(iv), (b)(2)(iv), (c)(2)(iv), 

(d)(2)(iv), (e)(2)(iv), and (f)(2)(iv)). The 

comment stated that, because this 

statement applies to all air-operated 

temperature or steam control systems, 

regardless of whether or not it is a 

combination recorder-controller, it 

should be moved to proposed 

§ 113.40(a)(4), (b)(4), (c)(4), (d)(4), (e)(4), 

and (f)(5), respectively, which set out 

the requirements for the steam 

controller. 

(Response) We agree. In this final 

rule, we moved the statement that airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air from proposed 

§ 113.40(a)(2)(iv), (b)(2)(iv), (c)(2)(iv), 

(d)(2)(iv), (e)(2)(iv), and (f)(2)(iv) to final 

§ 113.40(a)(4), (b)(4), (c)(4), (d)(4), (e)(4), 

and (f)(5). In addition, for consistency in 

terminology, we replaced the term 

‘‘recording-controlling instrument’’ with 

‘‘recorder-controller’’ in final 

§ 113.40(a)(2)(iv), (a)(4), (b)(2)(iv), (b)(4), 

(c)(2)(iv), (c)(4), (d)(2)(iv), (d)(4), 

(e)(2)(iv), (e)(4), (f)(2)(iv), and (f)(5). 

(Comment 29) One comment stated 

that the requirement in proposed 

§ 113.40(g)(1)(i)(E) for the differential 

pressure recorder-controller to be 

installed on the product-to-product 

regenerator is confusing because it 

implies that the recorder-controller 

needs to be physically attached to the 

product-to-product regenerator. Thus, 

according to the comment, the 

requirement does not accommodate 

operational practices where recording 

and control are done in remote systems. 

The comment stated that the pressure 

sensing device, rather than the recordercontroller, is installed on the 

regenerator. 

(Response) We agree with the 

comment’s suggestion to allow for use of 

alternative differential pressure 

recorder-controllers by eliminating the 

requirement for the differential pressure 

recorder-controller to be installed on the 

product-to-product regenerator. In this 

final rule, we clarify that when a 

product-to-product regenerator is used, 

it must be equipped with an accurate 

differential pressure recorder-controller 

(final § 113.40(g)(1)(i)(E)). 

(Comment 30) One comment stated 

that the scale division requirements for 

differential pressure recorder-controllers 

in proposed § 113.40(g)(1)(i)(E) do not 

allow for use of differential pressure 

recorder-controllers that incorporate 

alternative technologies, such as digital 

recordings, for recording and controlling 

differential pressure. 

(Response) We agree with the 

comment. In this final rule, we clarify 

that the requirements for scale divisions 

apply to graphical recordings and 

allowed for use of digital recordings, as 

well as analog or graphical recordings 

(final § 113.40(g)(1)(i)(E)(i) and 

(g)(1)(i)(E)(ii)). We also clarified that the 

differential pressure recorder-controller 

must be accurate to within 2 pounds per 

square inch (13.8 kilopascals) and that 

the sensor and the recorder of the 

differential pressure recorder-controller 

must be tested for accuracy against an 

accurate reference device (final 

§ 113.40(g)(1)(i)(E)). 

Although the comment did not 

request a similar change for pressure 

gages, in this final rule, for consistency, 

we changed the recommendation for 

each retort to be equipped with a 

pressure gage that is ‘‘graduated in 

divisions of 2 pounds per square inch 

(13.8 kilopascals) or less’’ to a 

recommendation that each retort be 

‘‘equipped with a pressure gage that is 

accurate to 2 pounds per square inch 

(13.8 kilopascals) or less’’ (§ 113.40(a)(3), 

(b)(3), (c)(3), (d)(3), (e)(3) and (f)(3)). 

(Comment 31) One comment stated 

that the requirement for the differential 

pressure recorder-controller to be tested 

for accuracy against a known accurate 

standard pressure indicator upon 

installation and at least once every 3 

months of operation, is confusing and 

not reflective of actual operating 

conditions (proposed 

§ 113.40(g)(1)(i)(E)). The comment 

indicated that the pressure sensors, 

rather than the controller, are tested for 

accuracy and that the controller should 

be tested for proper functioning. In 

addition, the comment stated that the 

required minimum frequency for testing 

the differential pressure recordercontroller after installation should be 

once per year, consistent with the 

requirement for testing temperatureindicating devices, instead of once every 

3 months. 

(Response) We do not agree with the 

comment’s suggestion to reduce the 

requirement to test for accuracy from at 

least once every 3 months to once every 

year. The requirement to test the 

differential pressure recorder-controller 

for accuracy at least once every 3 

months of operation is well established 

(current § 113.40(g)(1)(i)(E). The 

comment did not provide, and we do 

not have, data to support the adequacy 

of testing only once every year. 

Accordingly, we are making no changes 

in response to this comment. 

(Comment 32) One comment 

suggested revising proposed 

§ 113.40(g)(1)(ii)(C) and (g)(2)(ii)(B) to be 

consistent with § 113.40(g)(1)(ii)(B), 

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which states that a processing deviation 

must be handled in accordance with 

§ 113.89 (21 CFR 113.89). 

(Response) We agree that the 

suggested revision clarifies and provides 

consistency in the regulation. In this 

final rule, we clarify that the processing 

deviation must be handled in 

accordance with final § 113.89 

(§ 113.40(g)(1)(ii)(C) and (g)(2)(ii)(B)). 

(Comment 33) One comment objected 

to the way we expressed temperatures 

in Fahrenheit, followed by a 

parenthetical reference to the 

temperature expressed in Celsius. 

According to the comment, food 

chemists use only metric equivalents 

and their equipment is only calibrated 

in metric units. The comment suggested 

that we list the temperature in Celsius 

followed by a parenthetical reference in 

Fahrenheit, i.e., instead of 220 °F (104.4 

°C), use 105 °C (221 °F). The comment 

stated that the proposed temperature 

conversions do not follow the Omnibus 

Trade and Competitiveness Act of 1988. 

The comment also objected to 

expressing Celsius temperatures to four 

digits. 

(Response) We do not agree with the 

comments suggestion to first list the 

Celsius temperature, followed by a 

parenthetical reference to the 

Fahrenheit temperature. Thermal 

processing temperatures are expressed 

in Fahrenheit in the current low-acid 

canned food regulations (part 113 (21 

CFR part 113)) and many processors use 

temperature-indicating devices that 

express temperature in Fahrenheit. In 

the proposed rule, we added 

appropriate conversions to Celsius to 

ensure consistency in such conversions. 

Each conversion provided in the 

proposed rule was carefully evaluated to 

ensure that it appropriately expressed 

the required Fahrenheit temperature, or 

increments of temperature changes, and 

that any rounding did not significantly 

alter the intended temperature 

measurement established in the 

regulations in Fahrenheit. As 

demonstrated by the one degree 

Fahrenheit change in the comment’s 

example, the conversion and rounding 

of the Fahrenheit temperature, based on 

the converted and rounded Celsius 

temperature, may result in a change that 

could significantly impact scheduled 

processes established based on 

Fahrenheit temperatures in the 

regulation. The comment did not 

provide a basis for changing the 

required scheduled process 

temperatures or cite specific provisions 

of the Omnibus Trade and 

Competitiveness Act of 1988 that would 

be applicable to Fahrenheit conversions 

in this regulation. 

The comment also did not explain the 

basis for objecting to expressing Celsius 

temperatures to four digits. We interpret 

the comment to mean that, above 100 

°C, the temperature should be rounded 

to the nearest whole number, rather 

than to the nearest tenth, which adds a 

fourth digit to the temperature 

measurement. We agree that it is not 

necessary to convert the Fahrenheit 

temperatures to the nearest tenth degree 

Celsius. Rather, we believe rounding 

should be to the nearest 0.5 degree 

Celsius, consistent with the requirement 

for temperature-indicating devices to be 

accurate to 1 °F (0.5 °C) ((final 

§ 113.40(a)(1)(iv), (b)(1)(iv), (c)(1)(iv), 

(d)(1)(iv), (e)(1)(iv), (f)(1)(iv), and 

(g)(1)(i)(A)(4)). Accordingly, in this final 

rule we rounded the Celsius 

temperatures up to the nearest 0.5 

degree Celsius, i.e., we rounded 101.7 

°C to 102 °C, 103.3 °C to 103.5 °C, 104.4 

°C to 104.5 °C, and 107.2 °C to 107.5 °C 

(final § 113.40(a)(12)(i)(A), (a)(12)(i)(B), 

(a)(12)(i)(C), (a)(12)(i)(D), (a)(12)(ii)(A), 

and (a)(12)(ii)(B)). 

(Comment 34) One comment 

indicated that using kilopascals as the 

metric equivalent for pounds per square 

inch may cause confusion. According to 

the comment, many systems use other 

units for pressure, such as bar. The 

comment suggested that the 

parenthetical addition of ‘‘kilopascals’’ 

at various locations in the proposed rule 

be qualified with ‘‘or equivalent unit’’ to 

support the use of the different, but 

equivalent, ways of referring to 

pressure. 

(Response) We disagree with the 

comment. Each measurement in the 

regulations, including pounds per 

square inch, may be converted to the 

units appropriate for the equipment or 

system used by the processor, provided 

that the converted measurement does 

not differ significantly from the U.S. 

measurement in the regulation. 

Processors are responsible for ensuring 

that converted measurements are 

consistent with the requirements of the 

regulations, regardless of the unit of 

measure used. 

(Comment 35) One comment noted 

that, in proposed § 113.40(d)(7) and 

(d)(8), the word ‘‘schedules’’ should be 

‘‘scheduled.’’ 

(Response) We agree. We revised 

proposed § 113.40(d)(7) and (d)(8) 

accordingly. 

(Comment 36) One comment 

suggested revising proposed 

§ 113.40(g)(1)(ii)(E) to change the term 

‘‘metering pump’’ to ‘‘flow controlling 

device’’ to be consistent with changes in 

proposed § 113.40(g)(1)(i)(F). 

(Response) We agree that the term 

‘‘metering pump’’ should be replaced 

with a more current term. As noted by 

the comment, in proposed 

§ 113.40(g)(1)(i)(F), we used the term 

‘‘flow controlling device.’’ However, we 

believe the term ‘‘flow control device’’ is 

more consistent with current 

terminology. Thus, we replaced the 

terms ‘‘flow controlling device’’ and 

‘‘metering pump’’ with ‘‘flow control 

device’’ in § 113.40(g)(1)(i)(F) and 

(g)(1)(ii)(E) of this final rule. 

(Comment 37) One comment objected 

to the requirements in proposed 

§ 113.60(d) for container handling 

equipment to be designed, constructed, 

and operated to preserve the can seam 

or other container closure integrity and 

for container handling equipment to be 

checked with sufficient frequency and 

repaired or replaced to prevent damage 

to containers. The comment stated that 

these proposed changes will not provide 

greater public health protection than the 

current regulations. According to the 

comment, the proposed changes will not 

provide FDA with any additional 

enforcement tools because they do not 

specify what processors must do to 

comply with the requirements and, 

thus, are subject to interpretation. The 

comment requested that no change be 

made to § 113.60(d) in the current 

regulations. 

(Response) We do not agree with the 

comment’s request to make no change to 

previous § 113.60(d), relating to 

container handling equipment. Previous 

§ 113.60(d) recommends specific 

preventive measures that may be taken 

to prevent damage to containers and 

container closures, but does not clearly 

express that the measures are a few 

examples, rather than an exhaustive 

expression of the processor’s 

responsibility to ensure that the can 

seam and container closure are not 

compromised during post-process 

handling. The proposed revision to 

§ 113.60(d) was intended to clarify that 

processors are responsible for ensuring 

that container handling equipment used 

in handling filled containers, including 

automated and non-automated 

equipment, is designed and operated to 

preserve the can seam and container 

closure integrity. This proposal allows 

flexibility regarding appropriate design, 

construction, and operation of container 

handling equipment. We believe 

processors currently ensure can seam 

and container closure integrity without 

prescriptive instructions from the 

Agency. Also, we recognize that the 

proposed revision does not establish a 

new enforcement tool for FDA. The 

revised language is intended to clarify 

processors’ responsibilities relating to 

post-process handling. We believe 

consumer protection will be enhanced 

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11902 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

by processors who, as a result of the 

clarification to § 113.60(d), evaluate 

their post-process handling equipment 

and procedures and either confirm that 

they are adequate or correct 

deficiencies. 

(Comment 38) One comment 

encouraged FDA to develop guidance 

for processors and inspection personnel 

on how to verify compliance with the 

proposed revision to § 113.83, which 

indicates that when a product is 

reprocessed or a previously processed 

product is blended into a new 

formulation, this condition must be 

covered in the scheduled process. 

According to the comment, amending 

existing process filings for thousands of 

products that currently meet this new 

requirement will be burdensome to both 

the industry and FDA. The comment 

suggested that a note in the processor’s 

file from the processing authority 

should satisfy this requirement. 

(Response) Previous § 113.83 requires 

the type, range, and combination of 

variations encountered in commercial 

production to be adequately provided 

for in establishing the scheduled 

process. Variations may occur due to 

seasonal or growing fluctuations, variety 

differences, or supplier processes. 

Variations also may occur when a food 

is reprocessed or when a previously 

processed product is mixed with a batch 

of the same unprocessed product before 

it is processed. In proposed § 113.83 we 

clarified that variations that occur due 

to reprocessing or mixing processed and 

unprocessed batches must be provided 

for in the scheduled process. In this 

final rule, we clarify in § 113.83 that 

variations include those that occur due 

to seasonal or growing fluctuations, 

variety differences, supplier processes, 

reprocessing, and mixing a batch of 

processed product with the same 

unprocessed product before it is 

processed. Therefore, this clarification 

does not represent a change from what 

has already been required of processors. 

Consistent with current 

§ 108.35(c)(2)(ii), a processor who 

intentionally makes a change in a 

previously filed scheduled process by 

changing a condition that is basic to the 

adequacy of the scheduled process must 

obtain substantiation by a qualified 

scientific authority as to its adequacy, 

promptly record the substantiation, and 

obtain and file written verification from 

the authority for review by FDA. In 

addition, within 30 days after the first 

use, the processor must submit to FDA 

a copy of the file record showing the 

substantiation by a qualified scientific 

authority. 

(Comment 39) One comment stated 

that proposed § 113.100(g) duplicates, in 

part, the requirements of § 108.35(h). 

The comment recommended removing 

the requirement from § 113.100(g) or, if 

retained, making the language identical 

to the language in § 108.35(h). 

(Response) We agree with the 

comment and deleted § 113.100(g) from 

this final rule. 

III. Minor Revisions in Regulations 

We made minor revisions in this final 

rule, including the following: 

In final § 113.40(a)(12)(i)(C), we 

corrected the metric conversion for 2.5 

inches to 6.4 centimeters. 

In final § 113.40(d)(6), we changed the 

word ‘‘containing’’ to ‘‘continuing.’’ 

In final § 113.40(e)(7), we changed the 

word ‘‘cross-section’’ to ‘‘crosssectional,’’ for consistency with use of 

the term in final § 113.40(a)(7) and 

(a)(12). 

IV. Analysis of Economic Impacts 

A. Final Regulatory Impact Analysis 

FDA has examined the impacts of this 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

the Executive Order. 

1. Need for Regulation 

This final rule is needed to address 

inflexibility in the current regulations 

with regard to the requirement to use 

mercury-in-glass thermometry in lowacid canned food manufacturing, as well 

as to update and clarify current 

regulations. Previous regulations for 

thermally processed low-acid foods in 

hermetically sealed containers, except 

for aseptic packaging and processing, 

required the exclusive use of mercuryin-glass thermometers for indicating 

temperatures during food processing. 

The requirement for exclusive use of 

mercury-in-glass thermometers reflects 

the absence of alternatives on the 

market at the time current regulations 

became effective in 1973. Because of 

technological advances in thermometry 

since that time, alternatives to mercuryin-glass thermometers may now be 

available for the low-acid canned food 

industry. 

Moreover, the number and variety of 

low-acid canned food products, the 

technologies, and the countries where 

they are processed have changed 

substantially since 1973 when the lowacid canned food regulations became 

effective. Data on imported foods 

obtained from FDA’s ‘‘Consumption of 

Imported Foods’’ model indicates that 

approximately 15 billion pounds of lowacid canned food were imported from 

more than 100 countries in 2006 (Ref. 

5). Provisions in the regulations issued 

in 1973 that were targeted toward 

technologies at that time may be less 

clear when applied to technologies 

being used today. 

2. Costs and Benefits of Revisions 

Suggested by Comments 

There were no comments that directly 

addressed the economic sections in the 

proposed regulatory impact analysis. 

We evaluated the revisions to the 

proposed rule to determine whether 

they may have implications for costs 

and benefits of this final rule. We 

identify each revision to the proposed 

rule that may have implications for the 

costs and benefits of this final rule as 

belonging to one of three categories of 

provisions, each category distinguished 

by the way it contributes to the costs 

and benefits. The categories of 

provisions are: Revisions to proposed 

recordkeeping requirements reported in 

table 1 of this document, revisions to 

the proposed non-recordkeeping 

requirements that may facilitate 

adoption of alternative technologies 

reported in table 2 of this document, 

and other minor revisions. Even though 

many of the revisions lie outside the 

framework of the economic analysis in 

the proposed rule, their categorization 

may help identify any potential costs 

and benefits. The costs and benefits of 

this final rule are reported in table 3 of 

this document. 

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TABLE 1—REVISIONS TO PROPOSED RECORDKEEPING REQUIREMENTS

Proposed 21 CFR Section Final 21 CFR Section Revision 

113.40(a)(1)(ii)(A) and (a)(1)(ii)(B), 113.40(b)(1)(ii)(A) 

and (b)(1)(ii)(B), 113.40(c)(1)(ii)(A) and (c)(1)(ii)(B), 

113.40(d)(1)(ii)(A) and (d)(1)(ii)(B), 113.40(e)(1)(ii)(A) 

and (e)(1)(ii)(B), 113.40(f)(1)(ii)(A) and (f)(1)(ii)(B), 

113.40(g)(1)(i)(A)(2)(i) and (g)(1)(i)(A)(2)(ii).

113.100(c)(3) and (d)(3) ..... Make explicit the records requirements that apply when 

an accuracy test for a temperature-indicating device 

and for a reference device that is maintained by the 

processor is conducted by an outside facility. 

113.40(a)(1)(ii)(A) and (a)(1)(ii)(B), 113.40(b)(1)(ii)(A) 

and (b)(1)(ii)(B), 113.40(c)(1)(ii)(A) and (c)(1)(ii)(B), 

113.40(d)(1)(ii)(A) and (d)(1)(ii)(B), 113.40(e)(1)(ii)(A) 

and (e)(1)(ii)(B), 113.40(f)(1)(ii)(A) and (f)(1)(ii)(B), 

113.40(g)(1)(i)(A)(2)(i) and (g)(1)(i)(A)(2)(ii).

113.100(c)(5) and (d)(5) ..... Clarify that records of the accuracy of a temperature-indicating device and a reference device maintained by 

the processor must include the date and results of 

each accuracy test, including the amount of calibration adjustment. 

113.40(a)(1)(ii)(A) and (a)(1)(ii)(B), 113.40(b)(1)(ii)(A) 

and (b)(1)(ii)(B), 113.40(c)(1)(ii)(A) and (c)(1)(ii)(B), 

113.40(d)(1)(ii)(A) and (d)(1)(ii)(B), 113.40(e)(1)(ii)(A) 

and (e)(1)(ii)(B), 113.40(f)(1)(ii)(A) and (f)(1)(ii)(B), 

113.40(g)(1)(i)(A)(2)(i) and (g)(1)(i)(A)(2)(ii).

113.100(c)(6) and (d)(6) ..... Indicate ‘‘[t]he date on or before which the next accuracy test must be performed’’ instead of the proposed 

‘‘the date of the next scheduled accuracy test.’’ 

FDA believes that the information 

required by this final rule to be 

established and maintained for accuracy 

tests is currently generated even though 

it may not currently be permanently 

recorded. We estimate that the revisions 

to the proposed records requirements 

reported in table 1 of this document will 

add very little or no additional costs to 

the recordkeeping costs estimated in the 

analysis of the proposed rule. Thus, the 

estimated costs of the records of the 

accuracy tests for this final rule are not 

different than those estimated for the 

analysis of the proposed rule (72 FR 

11990 at 11999, March 14, 2007). 

TABLE 2—REVISIONS TO PROPOSED NON-RECORDKEEPING REQUIREMENTS THAT MAY FACILITATE ADOPTION OF

ALTERNATIVE TECHNOLOGIES

Revised 21 CFR Section Revision 

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

113.40(d)(1), 113.40(e)(1), 113.40(f)(1) and 

(g)(1)(i)(A), 113.87(c).

Replace ‘‘an accurate calibrated reference device’’ with ‘‘a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device.’’ 

113.40(a)(1)(iv), 113.40(b)(1)(iv), 

113.40(c)(1)(iv), 113.40(e)(1)(iv) and (f)(1)(iv), 

113.40(g)(1)(i)(A)(4).

Replace ‘‘easily readable to’’ with ‘‘accurate to’’ to describe the measurement uncertainty allowed for temperature-indicating devices. 

Proposed 113.40(b)(10)(ii): Final 113.40(b)(11)

Proposed 113.40(e)(6)(ii): Final 113.40(e)(7) 

Change the term ‘‘pilot light or other signaling device’’ to ‘‘signaling device’’ on the pump that 

controls water circulation to allow for the use of alternative signaling devices. 

113.40(g)(1)(i)(E) ................................................ Clarify that recordings for differential pressure recorder-controllers may be analog or graphical 

or digital. 

130.40(g)(1)(i)(F) and (g)(1)(ii)(E) ...................... Replace ‘‘metering pump’’ with ‘‘flow control device‘‘. 

The costs for the revisions to the 

proposed rule of non-recordkeeping 

requirements that may facilitate 

adoption of alternative technologies are 

estimated to be zero since the adoption 

of alternative technologies is voluntary 

and there would be no additional health 

risks from their adoption. The benefits 

of these revisions are estimated to be 

positive since they would allow 

additional flexibility for adopting 

alternative thermometry and other 

technologies that, consistent with the 

framework in the analysis of the 

proposed rule, could slightly improve 

labor productivity in the manufacture of 

low-acid canned food. 

Other revisions in this final rule 

include those that are editorial in nature 

and clarifications of existing regulations 

that have neither additional costs nor 

additional benefits to those considered 

in the analysis of the proposed rule (72 

FR 11990 at 11999, March 14, 2007). 

3. Regulatory Options 

This section reports estimates of the 

costs and benefits of several regulatory 

options. The regulatory options include: 

(a) No new regulation; (b) allow 

flexibility to use temperature-indicating 

devices, including mercury-in-glass 

thermometers, without explicit 

recordkeeping requirements; and (c) 

final rule—Option (b), with explicit 

recordkeeping requirements for 

accuracy tests for temperatureindicating devices and reference devices 

maintained by the processor. 

• Option (a)—No new regulation. 

There would be neither costs nor 

benefits from this option. 

• Option (b)—Allow flexibility to use 

temperature-indicating devices, 

including mercury-in-glass 

thermometers, without explicit 

recordkeeping requirements. 

There would be neither costs nor 

benefits from this option. 

• Option (c)—Final rule—Option (b), 

with explicit recordkeeping 

requirements for accuracy tests for 

temperature-indicating devices and 

reference devices maintained by the 

processor. 

Tables 3 and 4 of this document 

report the costs and benefits of this final 

rule based on estimates derived in the 

analysis of the proposed rule and 

modified in accordance with changes to 

the final rule, as indicated in the tables. 

In the analysis of the proposed rule, we 

estimated the costs to be from the 

recordkeeping provisions that involved 

one-time and recurring costs. The 

benefits from the proposed rule were 

from the reduced presence of mercury 

in food processing facilities, the reduced 

mercury cleanup and remediation costs, 

and improved labor productivity due to 

the voluntary adoption of alternative 

temperature device technologies. In 

addition, benefits from the 

recordkeeping provisions were from the 

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11904 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

enhanced ability to track critical 

accuracy test data, particularly during 

the transition from mercury-in-glass 

thermometers to alternative 

temperature-indicating devices (72 FR 

11990 at 11999, March 14, 2007). 

TABLE 3—COSTS OF THE FINAL RULE

One-time recordkeeping costs 

Design of new recordkeeping forms ........................................................ Minimal. 

Recordkeeping training ............................................................................. Minimal. 

Recurring Costs (annual) 

Recordkeeping 1 ....................................................................................... $5,000–$23,000 plus a minimal amount in accordance to the changes 

to the recordkeeping language. 

Purchase and additional testing of alternative devices ............................ Voluntarily incurred. 

1Estimates based on those reported in the analysis for the proposed rule. 

TABLE 4—BENEFITS OF THE FINAL RULE

Benefits (annual) 

Change in risk from low-acid canned foods ................................................................................................................... No change. 

Clarification of existing processor’s responsibilities ....................................................................................................... Not quantified. 

Avoided mercury cleanup costs 1 ................................................................................................................................... $31,000–$152,000. 

Enhanced labor productivity from adopting alternative temperature-indicating devices and other processing technologies.Not quantified. 

Enhanced ability to track critical accuracy performance data—especially during the transition period following the 

adoption of alternative temperature indicating devices.

Not quantified. 

1Estimates based on those reported in the analysis for the proposed rule. 

B. Regulatory Flexibility Analysis 

The Regulatory Flexibility Act (RFA) 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. An estimate of the cost of the 

proposed rule on small entities was 

made in the proposed rule. For firms of 

all sizes, the per-firm costs were 

estimated to be between $1 and $4 per 

year for each of the estimated 6,700 

firms. The per-firm costs for small firms 

were estimated to be on the lower end 

of that range. Based on these estimates, 

FDA certified that the proposed rule 

would not have a significant impact on 

a substantial number of small entities. 

Under the RFA, no further analysis is 

required. For the complete discussion, 

see the Regulatory Flexibility Analysis 

of the proposed rule (72 FR 11990 at 

11999 and 12003 to 12004, March 14, 

2007). No comments objected to or 

suggested significant modifications to 

the estimates of the per-firm costs in the 

regulatory flexibility analysis in the 

proposed rule. 

C. Unfunded Mandate Analysis 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, for ‘‘any rule that includes any 

Federal mandate that may result in the 

expenditure by State, local, and Tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

1 year.’’ The current threshold after 

adjustment for inflation is $135 million, 

using the most current (2009) Implicit 

Price Deflator for the Gross Domestic 

Product. FDA does not expect this final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount. 

V. Paperwork Reduction Act of 1995 

This final rule contains information 

collection provisions that are subject to 

review by OMB under the PRA (44 

U.S.C. 3501–3520). The final rule 

revises information collection 

requirements in part 113 that are 

currently approved under OMB control 

number 0910–0037 (expires August 31, 

2011). Comments on the information 

collection requirements currently 

approved under OMB control number 

0910–0037, as amended by the 

information collection provisions of this 

final rule, are being solicited in a 

separate notice published elsewhere in 

this issue of the Federal Register. That 

notice also announces that FDA has 

submitted the information collection 

provisions of the final rule to OMB for 

approval, along with a request for 

extension of the related information 

collection provisions already approved 

under OMB control number 0910–0037, 

as revised by the final rule. Prior to the 

effective date of this final rule, FDA will 

publish a notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in this final rule. 

An Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

In compliance with the PRA (44 

U.S.C. 3506(c)(2)(B)), the Agency 

requested public comment on the 

information collection provisions of the 

proposed rule (72 FR 11990 at 12004). 

The proposed rule also stated that FDA 

had submitted the information 

collection provisions to OMB for review 

(72 FR 11990 at 12005). However, due 

to an administrative error, the Agency 

did not actually do so, and therefore is 

submitting them to OMB now. No 

public comments to the analysis of the 

information collection provisions in the 

proposed rule suggested that we modify 

our burden estimates. Thus, we have not 

changed our estimates of the annual 

frequency per recordkeeping or the 

hours per record. We have, however, 

increased the estimated number of 

recordkeepers to reflect growth in the 

low-acid canned food processing 

industry since the 2007 proposed rule. 

Title: Recordkeeping Requirements 

for Temperature-Indicating Devices. 

Description: The information to be 

collected is related to accuracy tests of 

temperature-indicating devices and 

reference devices maintained by 

processors of low-acid canned foods. 

These tests must be performed to ensure 

the accuracy of the devices during the 

processing of these foods. If these 

devices are not accurate, the processor 

cannot ensure that the low-acid canned 

foods it produces are safe to eat, and 

consumers may be harmed. The 

recordkeeping requirements of the rule 

are necessary to document that 

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appropriate accuracy tests have been 

performed with the appropriate 

frequencies for each temperatureindicating device and each reference 

device maintained by the processor. 

Records of accuracy tests for these 

devices also help processors determine 

how frequently the devices should be 

tested for accuracy. Much of the 

information is currently generated for 

accuracy tests performed under current 

regulations. However, the information 

may not be recorded as required under 

the final rule. 

Current low-acid canned food 

regulations recommend, but do not 

require, that processors keep records of 

accuracy tests for mercury-in-glass 

thermometers, including test date, 

standard used, method used, and person 

performing the test. This final rule 

requires processors to keep records 

documenting the accuracy of 

temperature-indicating devices 

(including but not limited to mercuryin-glass thermometers) and of reference 

devices that are maintained by the 

processor. These records include: The 

identifier of the device being tested, 

such as its tag or seal; the name of the 

manufacturer of the device; the identity 

of the reference device, equipment, and 

procedures used for the accuracy test 

and to adjust the device or, if an outside 

facility conducts the accuracy test, 

documentation tracing the accuracy to a 

NIST or other national metrology 

institute standard; the identity of the 

person or facility that performed the 

accuracy test and adjusted or calibrated 

the device; the date and results of each 

accuracy test, including the amount of 

adjustment; and the date on or before 

which the next accuracy test must be 

performed. 

Description of Respondents: The 

respondents to this information 

collection are commercial low-acid 

canned food processors. Based on FDA’s 

low-acid canned food manufacturers’ 

registration database as of September 

2009, we estimate that there are 

approximately 8,450 foreign and 

domestic low-acid canned food 

processing establishments. 

Burden: The burden of the 

recordkeeping requirement consists of 

the setup time required to design and 

establish a form for recording the 

required information, and the additional 

hours of labor needed to record the 

information. The setup time required for 

designing a new recordkeeping form is 

assumed to be minimal since we 

estimate that only a few data elements 

required in the final rule are currently 

unreported by some processors and that 

only small modifications to a 

processor’s recordkeeping form would 

be required to accommodate the 

additional data elements. 

We estimate that the time needed to 

comply with the recordkeeping 

requirements of the final rule will be 

small because current industry practice 

is to keep track of most, if not all, of this 

information. Because current incentives 

to track accuracy of mercury-in-glass 

thermometers may vary across the 

industry, however, some information 

that is currently generated during 

accuracy tests may not be recorded as 

required under the final rule. Thus, we 

assume there will be a burden incurred 

from the final rule to record information 

that is currently generated, but not 

recorded. 

We assume that half of the industry 

currently does not record all of the 

device accuracy testing information that 

the final rule requires. We further 

assume that current practice by these 

firms is to leave unrecorded 1 to 4 

separate pieces of information required 

under the final rule, and that each piece 

of information takes between 10 and 15 

seconds to record. Consequently, we 

estimate that half of all low-acid canned 

food manufacturers will spend between 

10 seconds and 1 minute (i.e., 1 × 10 

seconds and 4 × 15 seconds) per device 

to record information required in the 

final rule. 

Based on a survey conducted by FDA 

between 1992 and 1993 of mercury-inglass thermometer calibration in the 

low-acid canned food industry, we 

estimate that low-acid food firms use an 

average of 10 temperature-indicating 

devices, including reference devices. 

We estimate that 4,225 low-acid canned 

food manufacturers (half of the 

industry) currently do not fully record 

the accuracy test results required by the 

final rule. Because the regulations 

specify that each device must be tested 

upon installation and at least once a 

year thereafter, or more frequently if 

necessary to ensure accuracy, we 

estimate that each device requires 1 to 

2 tests per year (midpoint of 1.5 tests 

per year). We therefore estimate the 

annual frequency per recordkeeping to 

be 15 (i.e., 10 devices × 1.5 tests per 

year). We estimate the burden for 

recording the additional information to 

be between 10 and 60 seconds per 

device (midpoint of 35 seconds or 

0.0097 hours per device). Therefore, the 

estimated total annual burden in hours 

for the recordkeeping requirements of 

the final rule is approximately 615 

hours (63,375 × 0.0097 = 614.7 hours, 

rounded to 615 hours). Table 5 of this 

document reports the average annual 

recordkeeping burden described 

previously in this section of the 

document. 

TABLE 5–ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records Hours per record Total hours 

113.100(c) and (d) ........................................... 4,225 15 63,375 0.0097 615 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

VI. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. References 

We have placed the following 

references on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20857. 

You may see them between 9 a.m. and 

4 p.m., Monday through Friday. FDA 

has verified the Web site addresses, but 

FDA is not responsible for any 

subsequent changes to the Web sites 

after this document publishes in the 

Federal Register. 

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11906 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

1. International Vocabulary of 

Metrology—Basic and General Concepts 

and Associated Terms (VIM), BIPM, IEC, 

IFCC, ILAC, ISO, IUPAC, IUPAP, OIML, 

3d ed., p. 21, definition 2.13, 2008; 

accessed online October 20, 2010, at 

http://www.bipm.org/utils/common/ 

documents/jcgm/JCGM_200_2008.pdf. 

2. International Vocabulary of 

Metrology—Basic and General Concepts 

and Associated Terms (VIM), BIPM, IEC, 

IFCC, ILAC, ISO, IUPAC, IUPAP, OIML, 

3d ed., p. 29, definition 2.41, 2008; 

accessed online October 20, 2010, at 

http://www.bipm.org/utils/common/ 

documents/jcgm/JCGM_200_2008.pdf. 

3. International Vocabulary of 

Metrology—Basic and General Concepts 

and Associated Terms (VIM), BIPM, IEC, 

IFCC, ILAC, ISO, IUPAC, IUPAP, OIML, 

3d ed., p. 19, definition 2.9, 2008; 

accessed online October 20, 2010, at 

http://www.bipm.org/utils/common/ 

documents/jcgm/JCGM_200_2008.pdf. 

4. International Vocabulary of 

Metrology—Basic and General Concepts 

and Associated Terms (VIM), BIPM, IEC, 

IFCC, ILAC, ISO, IUPAC, IUPAP, OIML, 

3d ed., p. 25, definition 2.26, 2008; 

accessed online October 20, 2010, at 

http://www.bipm.org/utils/common/ 

documents/jcgm/JCGM_200_2008.pdf. 

5. U.S. FDA, Consumption of 

Imported Foods, Final Report. RTI 

International, Contract 223–01–2466, 

Task Order 11, RTI Project Number 

0208184.011, August 2008. 

List of Subjects in 21 CFR Part 113 

Food packaging, Foods, Reporting and 

recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 113 is 

amended as follows: 

PART 113—THERMALLY PROCESSED 

LOW-ACID FOODS PACKAGED IN 

HERMETICALLY SEALED 

CONTAINERS 

■ 1. The authority citation for 21 CFR 

part 113 continues to read as follows: 

Authority: 21 U.S.C. 342, 371, 374; 

42 U.S.C. 264. 

■ 2. Revise § 113.40 to read as follows: 

§ 113.40 Equipment and procedures. 

(a) Equipment and procedures for 

pressure processing in steam in still 

retorts—(1) Temperature-indicating 

device. Each retort shall be equipped 

with at least one temperature-indicating 

device that accurately indicates the 

temperature during processing. Each 

temperature-indicating device shall 

have a sensor and a display. Each 

temperature-indicating device and each 

reference device that is maintained by 

the processor shall be tested for 

accuracy against a reference device for 

which the accuracy is traceable to a 

National Institute of Standards and 

Technology (NIST), or other national 

metrology institute, standard reference 

device by appropriate standard 

procedures, upon installation and at 

least once a year thereafter, or more 

frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and each 

reference device that is maintained by 

the processor shall have a tag, seal, or 

other means of identity. 

(i) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(iv) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(v) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. The 

temperature-indicating device sensor 

shall be installed either within the retort 

shell or in external wells attached to the 

retort. External wells or pipes shall be 

connected to the retort through at least 

a 3⁄4-inch (2 centimeters) diameter 

opening and equipped with a 1⁄16-inch 

(1.5 millimeters) or larger bleeder 

opening so located as to provide a full 

flow of steam past the length of the 

temperature-indicating device sensor. 

The bleeders for external wells shall 

emit steam continuously during the 

entire processing period. The 

temperature-indicating device—not the 

temperature recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device. Each 

temperature-recording device shall have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart. 

The temperature-recording device 

sensor shall be installed either within 

the retort shell or in a well attached to 

the shell. Each temperature-recording 

device sensor well shall have a 1⁄16-inch 

(1.5 millimeters) or larger bleeder that 

emits steam continuously during the 

processing period. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F (10 

°C) of the process temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(ii) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital records may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(iii) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recorder-controller. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that is 

accurate to 2 pounds per square inch 

(13.8 kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordercontroller when combined with a 

temperature-recording device. The 

steam controller may be air-operated 

and actuated by a temperature sensor 

positioned near the temperatureindicating device in the retort. Airoperated temperature controllers should 

have adequate filter systems to ensure a 

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supply of clean, dry air. A steam 

controller activated by the steam 

pressure of the retort is acceptable if it 

is carefully maintained mechanically so 

that it operates satisfactorily. 

(5) Steam inlet. The steam inlet to 

each still retort shall be large enough to 

provide sufficient steam for proper 

operation of the retort. Steam may enter 

either the top portion or the bottom 

portion of the retort but, in any case, 

shall enter the portion of the retort 

opposite the vent; for example, steam 

inlet in bottom portion and vent in top 

portion. 

(6) Crate supports. A bottom crate 

support shall be used in vertical still 

retorts. Baffle plates shall not be used in 

the bottom of still retorts. 

(7) Steam spreaders. Steam spreaders 

are continuations of the steam inlet line 

inside the retort. Horizontal still retorts 

shall be equipped with steam spreaders 

that extend the length of the retort. For 

steam spreaders along the bottom of the 

retort, the perforations should be along 

the top 90° of the pipe, that is, within 

45° on either side of the top center. 

Horizontal still retorts over 30 feet (9.1 

meters) long should have two steam 

inlets connected to the spreader. In 

vertical still retorts, the steam spreaders, 

if used, should be perforated along the 

center line of the pipe facing the interior 

of the retort or along the sides of the 

pipe. The number of perforations should 

be such that the total cross-sectional 

area of the perforations is equal to 1.5 

to 2 times the cross-sectional area of the 

smallest restriction in the steam inlet 

line. 

(8) Bleeders. Bleeders, except those 

for temperature-indicating device wells, 

shall be 1/8-inch (3 millimeters) or 

larger and shall be wide open during the 

entire process, including the come-up 

time. For horizontal still retorts, 

bleeders shall be located within 

approximately 1 foot (30.5 centimeters) 

of the outermost locations of containers 

at each end along the top of the retort. 

Additional bleeders shall be located not 

more than 8 feet (2.4 meters) apart along 

the top. Bleeders may be installed at 

positions other than those specified in 

this paragraph, as long as there is 

evidence in the form of heat distribution 

data that they accomplish adequate 

removal of air and circulation of steam 

within the retort. Vertical retorts shall 

have at least one bleeder opening 

located in that portion of the retort 

opposite the steam inlet. In retorts 

having top steam inlet and bottom 

venting, a bleeder shall be installed in 

the bottom of the retort to remove 

condensate. All bleeders shall be 

arranged so that the operator can 

observe that they are functioning 

properly. 

(9) Stacking equipment and position 

of containers. Crates, trays, gondolas, 

etc., for holding containers shall be 

made of strap iron, adequately 

perforated sheet metal, or other suitable 

material. When perforated sheet metal is 

used for the bottoms, the perforations 

should be approximately the equivalent 

of 1-inch (2.5 centimeters) holes on 2- 

inch (5.1 centimeters) centers. If 

dividers are used between the layers of 

containers, they should be perforated as 

stated in this paragraph. The positioning 

of containers in the retort, when 

specified in the scheduled process, shall 

be in accordance with that process. 

(10) Air valves. Retorts using air for 

pressure cooling shall be equipped with 

a suitable valve to prevent air leakage 

into the retort during processing. 

(11) Water valves. Retorts using water 

for cooling shall be equipped with a 

suitable valve to prevent leakage of 

water into the retort during processing. 

(12) Vents. Vents shall be installed in 

such a way that air is removed from the 

retort before timing of the process is 

started. Vents shall be controlled by 

gate, plug cock, or other adequate type 

valves which shall be fully open to 

permit rapid discharge of air from the 

retort during the venting period. Vents 

shall not be connected directly to a 

closed drain system. If the overflow is 

used as a vent, there shall be an 

atmospheric break in the line before it 

connects to a closed drain. The vent 

shall be located in that portion of the 

retort opposite the steam inlet; for 

example, steam inlet in bottom portion 

and vent in top portion. Where a retort 

manifold connects several vent pipes 

from a single still retort, it shall be 

controlled by a gate, plug cock, or other 

adequate type of valve. The retort 

manifold shall be of a size that the 

cross-sectional area of the pipe is larger 

than the total cross-sectional area of all 

connecting vents. The discharge shall 

not be directly connected to a closed 

drain without an atmospheric break in 

the line. A manifold header connecting 

vents or manifolds from several still 

retorts shall lead to the atmosphere. The 

manifold header shall not be controlled 

by a valve and shall be of a size that the 

cross-sectional area is at least equal to 

the total cross-sectional area of all 

connecting retort manifold pipes from 

all retorts venting simultaneously. 

Timing of the process shall not begin 

until the retort has been properly vented 

and the processing temperature has 

been reached. Some typical installations 

and operating procedures reflecting the 

requirements of this section for venting 

still retorts without divider plates are 

given in paragraphs (a)(12)(i)(A) through 

(a)(12)(i)(D) and (a)(12)(ii)(A) and 

(a)(12)(ii)(B) of this section. 

(i) Venting horizontal retorts. (A) 

Venting through multiple 1-inch (2.5 

centimeters) vents discharging directly 

to atmosphere. 


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11908 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

(1) Specifications. One 1-inch (2.5 

centimeters) vent for every 5 feet (1.5 

meters) of retort length equipped with a 

gate or plug cock valve and discharging 

to atmosphere; end vents not more than 

2.5 feet (76 centimeters) from ends of 

retort. 

(2) Venting method. Vent valves 

should be wide open for at least 5 

minutes and to at least 225 °F (107 °C), 

or at least 7 minutes and to at least 220 

°F (104.5 °C). 

(B) Venting through multiple 1-inch 

(2.5 centimeters) vents discharging 

through a manifold to atmosphere. 

(1) Specifications. One 1-inch (2.5 

centimeters) vent for every 5 feet (1.5 

meters) of retort length; and vents not 

over 2.5 feet (76 centimeters) from ends 

of retort. Size of manifold—for retorts 

less than 15 feet (4.6 meters) in length, 

2.5 inches (6.4 centimeters); for retorts 

15 feet (4.6 meters) and over in length, 

3 inches (7.6 centimeters). 

(2) Venting method. Manifold vent 

gate or plug cock valve should be wide 

open for at least 6 minutes and to at 

least 225 °F (107 °C), or for at least 8 

minutes and to at least 220 °F (104.5 °C). 

(C) Venting through water spreaders. 

(1) Size of vent and vent valve. For 

retorts less than 15 feet (4.6 meters) in 

length, 2 inches (5.1 centimeters); for 

retorts 15 feet (4.6 meters) and over in 

length, 2.5 inches (6.4 centimeters). 

(2) Size of water spreader. For retorts 

less than 15 feet (4.6 meters) in length, 

1.5 inches (3.8 centimeters); for retorts 

15 feet (4.6 meters) and over in length, 

2 inches (5.1 centimeters). The number 

of holes should be such that their total 

cross-sectional area is approximately 

equal to the cross-sectional area of the 

vent pipe inlet. 

(3) Venting method. Water spreader 

vent gate or plug cock valve should be 

wide open for at least 5 minutes and to 

at least 225 °F (107 °C), or for at least 

7 minutes and to at least 220 °F (104.5 

°C). 


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(D) Venting through a single 2.5-inch 

(6.4 centimeters) top vent (for retorts not 

exceeding 15 feet (4.6 meters) in length). 

(1) Specifications. A 2.5-inch (6.4 

centimeters) vent equipped with a 2.5- 

inch (6.4 centimeters) gate or plug cock 

valve and located within 2 feet (61 

centimeters) of the center of the retort. 

(2) Venting method. Vent gate or plug 

cock valve should be wide open for at 

least 4 minutes and to at least 220 °F 

(104.5 °C). 

(ii) Venting vertical retorts. (A) 

Venting through a 1.5-inch (3.8 

centimeters) overflow. 


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11910 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

(1) Specifications. A 1.5-inch (3.8 

centimeters) overflow pipe equipped 

with a 1.5-inch (3.8 centimeters) gate or 

plug cock valve and with not more than 

6 feet (1.8 meters) of 1.5-inch (3.8 

centimeters) pipe beyond the valve 

before break to the atmosphere or to a 

manifold header. 

(2) Venting method. Vent gate or plug 

cock valve should be wide open for at 

least 4 minutes and to at least 218 °F 

(103.5 °C), or for at least 5 minutes and 

to at least 215 °F (102 °C). 

(B) Venting through a single 1-inch 

(2.5 centimeters) side or top vent. 


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(1) Specifications. A 1-inch (2.5 

centimeters) vent in lid or top side, 

equipped with a 1-inch (2.5 centimeters) 

gate or plug cock valve and discharging 

directly into the atmosphere or to a 

manifold header. 

(2) Venting method. Vent gate or plug 

cock valve should be wide open for at 

least 5 minutes and to at least 230 °F 

(110 °C), or for at least 7 minutes and 

to at least 220 °F (104.5 °C). 

(iii) Other procedures. Other 

installations and operating procedures 

that deviate from the requirements in 

paragraph (a)(12) of this section may be 

used if there is evidence in the form of 

heat distribution data, which shall be 

kept on file, that they accomplish 

adequate venting of air. 

(13) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. 

(i) When maximum fill-in or drained 

weight is specified in the scheduled 

process, it shall be measured and 

recorded at intervals of sufficient 

frequency to ensure that the weight of 

the product does not exceed the 

maximum for the given container size 

specified in the scheduled process. 

(ii) Closing machine vacuum in 

vacuum-packed products shall be 

observed and recorded at intervals of 

sufficient frequency to ensure that the 

vacuum is as specified in the scheduled 

process. 

(iii) Such measurements and 

recordings should be made at intervals 

not to exceed 15 minutes. 

(iv) When the product style results in 

stratification or layering of the primary 

product in the containers, the 

positioning of containers in the retort 

shall be according to the scheduled 

process. 

(b) Equipment and procedures for 

pressure processing in water in still 

retorts—(1) Temperature-indicating 

device. Each retort shall be equipped 

with at least one temperature-indicating 

device that accurately indicates the 

temperature during processing. Each 

temperature-indicating device shall 

have a sensor and a display. Each 

temperature-indicating device and each 

reference device that is maintained by 

the processor shall be tested for 

accuracy against a reference device for 

which the accuracy is traceable to a 

National Institute of Standards and 

Technology (NIST), or other national 

metrology institute, standard reference 

device by appropriate standard 

procedures, upon installation and at 

least once a year thereafter, or more 

frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and each 

reference device that is maintained by 

the processor shall have a tag, seal, or 

other means of identity. 

(i) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 


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maintained in accordance with 

§ 113.100(c) and (d). 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(iv) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(v) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. In both 

horizontal and vertical retorts, the 

temperature-indicating device sensor 

shall be inserted directly into the retort 

shell or in a separate well or sleeve 

attached to the retort. The temperatureindicating device sensor shall be located 

so that it is beneath the surface of the 

water throughout the process and where 

there is adequate circulation to ensure 

accurate temperature measurement. On 

horizontal retorts, the temperatureindicating device sensor should be 

located in the side at the center of the 

retort. The temperature-indicating 

device—not the temperature-recording 

device—shall be the reference 

instrument for indicating the processing 

temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device. Each 

temperature-recording device shall have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F (10 

°C) of the process temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(ii) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital records may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(iii) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a combination recordercontroller. For a vertical retort equipped 

with a combination recorder-controller, 

the temperature recorder-controller 

sensor shall be located at the bottom of 

the retort below the lowest crate rest in 

such a position that the steam does not 

strike it directly. For a horizontal retort 

equipped with a combination recordercontroller, the temperature recordercontroller sensor shall be located 

between the water surface and the 

horizontal plane passing through the 

center of the retort so that there is no 

opportunity for direct steam 

impingement on the sensor. For all still 

retort systems that pressure process in 

water and are equipped with 

combination recorder-controllers, the 

temperature recorder-controller sensors 

shall be located where the recorded 

temperature is an accurate measurement 

of the scheduled process temperature 

and is not affected by the heating media. 

(3) Pressure gages. (i) Each retort 

should be equipped with a pressure 

gage that is accurate to 2 pounds per 

square inch (13.8 kilopascals) or less. 

(ii) Each retort should have an 

adjustable pressure relief or control 

valve of a capacity sufficient to prevent 

an undesired increase in retort pressure 

when the water valve is wide open and 

should be installed in the overflow line. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. The steam controller may 

be combined with a temperaturerecording device and, thus, may be a 

combination recorder-controller. Airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air. 

(5) Steam introduction. Steam shall be 

distributed in the bottom of the retort in 

a manner adequate to provide uniform 

heat distribution throughout the retort. 

In vertical retorts, uniform steam 

distribution can be achieved by any of 

several methods. In horizontal retorts, 

the steam distributor shall run the 

length of the bottom of the retort with 

perforations distributed uniformly along 

the upper part of the pipe. 

(6) Crate supports. A bottom crate 

support shall be used in vertical still 

retorts. Baffle plates shall not be used in 

the bottom of the retort. Centering 

guides should be installed so as to 

ensure that there is about a 1.5-inch (3.8 

centimeters) clearance between the side 

wall of the crate and the retort wall. 

(7) Stacking equipment and position 

of containers. Crates, trays, gondolas, 

etc., for holding containers shall be 

made of strap iron, adequately 

perforated sheet metal, or other suitable 

material. When perforated sheet metal is 

used for the bottoms, the perforations 

should be approximately the equivalent 

of 1-inch (2.5 centimeters) holes on 2- 

inch (5.1 centimeters) centers. If divider 

plates are used between the layers of 

containers, they should be perforated as 

stated in this paragraph. The positioning 

of containers in the retort, when 

specified in the scheduled process, shall 

be in accordance with that process. 

Dividers, racks, trays, or other means of 

positioning of flexible containers shall 

be designed and employed to ensure 

even circulation of heating medium 

around all containers in the retort. 

(8) Drain valve. A nonclogging, watertight valve shall be used. A screen shall 

be installed or other suitable means 

shall be used on all drain openings to 

prevent clogging. 

(9) Air supply and controls. In both 

horizontal and vertical still retorts for 

pressure processing in water, a means 

shall be provided for introducing 

compressed air at the proper pressure 

and rate. The proper pressure shall be 

controlled by an automatic pressure 

control unit. A check valve shall be 

provided in the air supply line to 

prevent water from entering the system. 

Air or water circulation shall be 

maintained continuously during the 

come-up time and during processing 

and cooling periods. The adequacy of 

the air or water circulation for uniform 

heat distribution within the retort shall 

be established in accordance with 

procedures recognized by a competent 

processing authority and records shall 

be kept on file. If air is used to promote 

circulation, it shall be introduced into 

the steam line at a point between the 

retort and the steam control valve at the 

bottom of the retort. 

(10) Water level indicator. There shall 

be a means of determining the water 

level in the retort during operation, e.g., 

by using a sensor, gage, water glass, or 

petcock(s). Water shall cover the top 

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layer of containers during the entire 

come-up time and processing periods 

and should cover the top layer of 

containers during the cooling periods. 

The operator shall check and record the 

water level at intervals sufficient to 

ensure its adequacy. 

(11) Water circulation. When a water 

circulating system is used for heat 

distribution, it shall be installed in such 

a manner that water will be drawn from 

the bottom of the retort through a 

suction manifold and discharged 

through a spreader which extends the 

length of the top of the retort. The holes 

in the water spreader shall be uniformly 

distributed and should have an 

aggregate area not greater than the crosssectional area of the outlet line from the 

pump. The suction outlets shall be 

protected with nonclogging screens or 

other suitable means shall be used to 

keep debris from entering the 

circulating system. The pump shall be 

designed to provide proper flow on 

startup and during operation, such as 

with a bleeder or other suitable means 

to remove air during startup and with an 

appropriate device or design to prevent 

pump cavitation during operation. The 

pump shall be equipped with a 

signaling device to warn the operator 

when it is not running. Alternative 

methods for circulation of water in the 

retort may be used when established by 

a competent authority as adequate for 

even heat distribution. 

(12) Cooling water supply. In vertical 

retorts, the cooling water should be 

introduced at the top of the retort 

between the water and container levels. 

In horizontal retorts the cooling water 

should be introduced into the suction 

side of the pump. A check valve should 

be included in the cooling water line. 

(13) Retort headspace. The headspace 

necessary to control the air pressure 

should be maintained between the water 

level and the top of the retort shell. 

(14) Vertical and horizontal still 

retorts. Vertical and horizontal still 

retorts should follow the arrangements 

in the diagrams in this paragraph. Other 

installation and operating procedures 

that deviate from these arrangements 

may be used, as long as there is 

evidence in the form of heat distribution 

data or other suitable information, 

which shall be kept on file, which 

demonstrates that the heat distribution 

is adequate. 

BILLING CODE 4160–01–P 

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BILLING CODE 4160–01–C 

Legend for Vertical and Horizontal Still 

Retorts 

A—Water line. 

B—Steam line. 

C—Temperature control. 

D—Overflow line. 

E1—Drain line. 

E2—Screens. 

F—Check valves. 

G—Line from hot water storage. 

H—Suction line and manifold. 

I—Circulating pump. 

J—Petcocks. 


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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 11915 

K—Recirculating line. 

L—Steam distributor. 

M—Temperature-controller sensor. 

N—Temperature-indicating device sensor. 

O—Water spreader. 

P—Safety valve. 

Q—Vent valve for steam processing. 

R—Pressure gage. 

S—Inlet air control. 

T—Pressure control. 

U—Air line. 

V—To pressure control instrument. 

W—To temperature control instrument. 

X—Wing nuts. 

Y1—Crate support. 

Y2—Crate guides. 

Z—Constant flow orifice valve. 

Z1—Constant flow orifice valve used during 

come-up. 

Z2—Constant flow orifice valve used during 

cook. 

(15) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. 

(i) When maximum fill-in or drained 

weight is specified in the scheduled 

process, it shall be measured and 

recorded at intervals of sufficient 

frequency to ensure that the weight of 

the product does not exceed the 

maximum for the given container size 

specified in the scheduled process. 

(ii) Closing machine vacuum in 

vacuum-packed products shall be 

observed and recorded at intervals of 

sufficient frequency to ensure that the 

vacuum is as specified in the scheduled 

process. 

(iii) Such measurements and 

recordings should be made at intervals 

not to exceed 15 minutes. 

(iv) When the product style results in 

stratification or layering of the primary 

product in the containers, the 

positioning of containers in the retort 

shall be according to the scheduled 

process. 

(c) Equipment and procedures for 

pressure processing in steam in 

continuous agitating retorts—(1) 

Temperature-indicating device. Each 

retort shall be equipped with at least 

one temperature-indicating device that 

accurately indicates the temperature 

during processing. Each temperatureindicating device shall have a sensor 

and a display. Each temperatureindicating device and each reference 

device that is maintained by the 

processor shall be tested for accuracy 

against a reference device for which the 

accuracy is traceable to a National 

Institute of Standards and Technology 

(NIST), or other national metrology 

institute, standard reference device by 

appropriate standard procedures, upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

processing. Each temperature-indicating 

device and each reference device that is 

maintained by the processor shall have 

a tag, seal, or other means of identity. 

(i) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(iv) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(v) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. The 

temperature-indicating device sensor 

shall be installed either within the retort 

shell or in external wells attached to the 

retort. External wells or pipes shall be 

connected to the retort through at least 

a 3⁄4-inch (2 centimeters) diameter 

opening and equipped with a 1⁄16-inch 

(1.5 millimeters) or larger bleeder 

opening so located as to provide a full 

flow of steam past the length of the 

temperature-indicating device sensor. 

The bleeders for external wells shall 

emit steam continuously during the 

entire processing period. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device. Each 

temperature-recording device shall have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart. 

The temperature-recording device 

sensor shall be installed either within 

the retort shell or in a well attached to 

the shell. Each temperature-recording 

device sensor well shall have a 1⁄16-inch 

(1.5 millimeters) or larger bleeder that 

emits steam continuously during the 

processing period. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F (10 

°C) of the process temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(ii) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital records may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(iii) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recorder-controller. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that is 

accurate to 2 pounds per square inch 

(13.8 kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordercontroller when combined with a 

temperature-recording device. A steam 

controller activated by the steam 

pressure of the retort is acceptable if it 

is carefully maintained mechanically so 

that it operates satisfactorily. Airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air. 

(5) Bleeders. Bleeders, except those 

for temperature-indicating device wells, 

shall be 1⁄8-inch (3 millimeters) or larger 

and shall be wide open during the entire 

process, including the come-up time. 

Bleeders shall be located within 

approximately 1 foot (30.5 centimeters) 

of the outermost location of containers 

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at each end along the top of the retort. 

Additional bleeders shall be located not 

more than 8 feet (2.4 meters) apart along 

the top of the retort. All bleeders shall 

be arranged so that the operator can 

observe that they are functioning 

properly. The condensate bleeder shall 

be checked with sufficient frequency to 

ensure adequate removal of condensate 

or shall be equipped with an automatic 

alarm system(s) that would serve as a 

continuous monitor of condensatebleeder functioning. Visual checks 

should be done at intervals of not more 

than 15 minutes. A record of such 

checks should be kept to show that the 

bleeder is functioning properly. 

(6) Venting and condensate removal. 

Vents shall be located in that portion of 

the retort opposite the steam inlet. Air 

shall be removed before processing is 

started. Heat distribution data or 

documentary proof from the 

manufacturer or from a competent 

processing authority, demonstrating that 

adequate venting is achieved, shall be 

kept on file. At the time steam is turned 

on, the drain should be opened for a 

time sufficient to remove steam 

condensate from the retort, and 

provision shall be made for continuing 

drainage of condensate during the retort 

operation. The condensate bleeder in 

the bottom of the shell serves as an 

indicator of continuous condensate 

removal. 

(7) Retort speed timing. The rotational 

speed of the retort shall be specified in 

the scheduled process. The speed shall 

be adjusted and recorded when the 

retort is started, at any time a speed 

change is made, and at intervals of 

sufficient frequency to ensure that the 

retort speed is maintained as specified 

in the scheduled process. These 

adjustments and recordings should be 

made every 4 hours or less. 

Alternatively, a recording tachometer 

may be used to provide a continuous 

record of the speed. A means of 

preventing unauthorized speed changes 

on retorts shall be provided. A lock or 

a notice from management posted at or 

near the speed adjustment device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(8) Emergency stops. If a retort jams or 

breaks down during processing 

operations, necessitating cooling the 

retort for repairs, the retort shall be 

operated in such a way that ensures that 

the product is commercially sterile, or 

the retort is to be cooled promptly and 

all containers either reprocessed, 

repacked and reprocessed, or discarded. 

When operated as a still retort, all 

containers shall be given a full still 

retort process before the retort is cooled. 

If, in such an emergency, a scheduled 

still process or another process 

established to ensure commercial 

sterility is to be used, it shall be made 

readily available to the retort operator. 

(i) Any containers in the retort intake 

valve or in transfer valves between 

cooker shells of a continuous retort at 

the time of breakdown shall either be 

reprocessed, repacked and reprocessed, 

or discarded. 

(ii) Both the time at which the reel 

stopped and the time the retort was 

used for a still retort process, if so used, 

shall be indicated on the temperaturerecording device record and entered on 

the other production records required in 

this chapter. If the alternative procedure 

of prompt cooling is followed, the 

subsequent handling methods used for 

the containers in the retort at the time 

of stopping and cooling shall be entered 

on the production records. 

(9) Temperature drop. If the 

temperature of the continuous retort 

drops below the temperature specified 

in the scheduled process while 

containers are in the retort, the retort 

reel shall be stopped promptly. An 

automatic device should be used to stop 

the reel when the temperature drops 

below the specified process 

temperature. Before the reel is restarted, 

all containers in the retort shall be given 

a complete scheduled still retort process 

if the temperature drop was 10 °F (5 °C) 

or more below the specified 

temperature, or alternatively, container 

entry to the retort shall be stopped and 

the reel restarted to empty the retort. 

The discharged containers shall be 

either reprocessed, repacked and 

reprocessed, or discarded. Both the time 

at which the reel stopped and the time 

the retort was used for a still retort 

process, if so used, shall be indicated on 

the temperature-recording device record 

and entered on the other production 

records required in this chapter. If the 

alternative procedure of emptying the 

retort is followed, the subsequent 

handling methods used for the 

containers in the retort at the time of the 

temperature drop shall be entered on 

the production records. If the 

temperature drop was less than 10 °F (5 

°C), a scheduled authorized emergency 

still process approved by a qualified 

person(s) having expert knowledge of 

thermal processing requirements may be 

used before restarting the retort reel. 

Alternatively, container entry to the 

retort shall be stopped and an 

authorized emergency agitating process 

may be used before container entry to 

the retort is restarted. When emergency 

procedures are used, no containers may 

enter the retort and the process and 

procedures used shall be noted on the 

production records. 

(10) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. The minimum 

headspace of containers, if specified in 

the scheduled process, shall be 

measured and recorded at intervals of 

sufficient frequency to ensure that the 

headspace is as specified in the 

scheduled process. The headspace of 

solder-tipped, lapseam (vent hole) cans 

may be measured by net weight 

determinations. The headspace of 

double seamed cans may also be 

measured by net weight determinations 

for homogenous liquids, taking into 

account the specific can end profile and 

other factors which affect the 

headspace, if proof of the accuracy of 

such measurements is maintained and 

the procedure and resultant headspace 

is in accordance with the scheduled 

process. When the product consistency 

is specified in the scheduled process, 

the consistency of the product shall be 

determined by objective measurements 

on the product taken from the filler 

before processing and recorded at 

intervals of sufficient frequency to 

ensure that the consistency is as 

specified in the scheduled process. 

Minimum closing machine vacuum in 

vacuum-packed products, maximum 

fill-in or drained weight, minimum net 

weight, and percent solids shall be as 

specified in the scheduled process for 

all products when deviations from such 

specifications may affect the scheduled 

process. All measurements and 

recordings of critical factors should be 

made at intervals not to exceed 15 

minutes. 

(d) Equipment and procedures for 

pressure processing in steam in 

discontinuous agitating retorts—(1) 

Temperature-indicating device. Each 

retort shall be equipped with at least 

one temperature-indicating device that 

accurately indicates the temperature 

during processing. Each temperatureindicating device shall have a sensor 

and a display. Each temperatureindicating device and each reference 

device that is maintained by the 

processor shall be tested for accuracy 

against a reference device for which the 

accuracy is traceable to a National 

Institute of Standards and Technology 

(NIST), or other national metrology 

institute, standard reference device by 

appropriate standard procedures, upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

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processing. Each temperature-indicating 

device and each reference device that is 

maintained by the processor shall have 

a tag, seal, or other means of identity. 

(i) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(iv) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(v) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. The 

temperature-indicating device sensor 

shall be installed either within the retort 

shell or in external wells attached to the 

retort. External wells or pipes shall be 

connected to the retort through at least 

a 3⁄4-inch (2 centimeters) diameter 

opening and equipped with a 1⁄16-inch 

(1.5 millimeters) or larger bleeder 

opening so located as to provide a full 

flow of steam past the length of the 

temperature-indicating device sensor. 

The bleeders for external wells shall 

emit steam continuously during the 

entire processing period. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device. Each 

temperature-recording device shall have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart. 

The temperature-recording device 

sensor shall be installed either within 

the retort shell or in a well attached to 

the shell. Each temperature-recording 

device sensor well shall have a 1⁄16-inch 

(1.5 millimeters) or larger bleeder that 

emits steam continuously during the 

processing period. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F (10 

°C) of the process temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(ii) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital records may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(iii) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recorder-controller. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that is 

accurate to 2 pounds per square inch 

(13.8 kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordercontroller when combined with a 

temperature-recording device. A steam 

controller activated by the steam 

pressure of the retort is acceptable if it 

is mechanically maintained so that it 

operates satisfactorily. Air-operated 

temperature controllers should have 

adequate filter systems to ensure a 

supply of clean, dry air. 

(5) Bleeders. Bleeders, except those 

for temperature-indicating device wells, 

shall be 1⁄8-inch (3 millimeters) or larger 

and shall be wide open during the entire 

process, including the come-up time. 

Bleeders shall be located within 

approximately 1 foot (30.5 centimeters) 

of the outermost location of containers, 

at each end along the top of the retort; 

additional bleeders shall be located not 

more than 8 feet (2.4 meters) apart along 

the top. Bleeders may be installed at 

positions other than those specified in 

this paragraph, as long as there is 

evidence in the form of heat distribution 

data that they accomplish adequate 

removal of air and circulation of heat 

within the retort. In retorts having top 

steam inlet and bottom venting, a 

bleeder shall be installed in the bottom 

of the retort to remove condensate. All 

bleeders shall be arranged in a way that 

enables the operator to observe that they 

are functioning properly. 

(6) Venting and condensate removal. 

The air in each retort shall be removed 

before processing is started. Heat 

distribution data or documentary proof 

from the manufacturer or from a 

competent processing authority, 

demonstrating that adequate venting is 

achieved, shall be kept on file. At the 

time steam is turned on, the drain 

should be opened for a time sufficient 

to remove steam condensate from the 

retort and provision should be made for 

continuing drainage of condensate 

during the retort operation. 

(7) Retort speed timing. The rotational 

speed of the retort shall be specified in 

the scheduled process. The speed shall 

be adjusted, as necessary, to ensure that 

the speed is as specified in the 

scheduled process. The rotational speed 

as well as the process time shall be 

recorded for each retort load processed. 

Alternatively, a recording tachometer 

may be used to provide a continuous 

record of the speed. A means of 

preventing unauthorized speed changes 

on retorts shall be provided. A lock or 

a notice from management posted at or 

near the speed-adjustment device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(8) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. The minimum 

headspace of containers in each retort 

load to be processed, if specified in the 

scheduled process, shall be measured 

and recorded at intervals of sufficient 

frequency to ensure that the headspace 

is as specified in the scheduled process. 

The headspace of solder-tipped, lap 

seam (vent hole) cans may be measured 

by net weight determinations. When the 

product consistency is specified in the 

scheduled process, the consistency of 

the product shall be determined by 

objective measurements on the product 

taken from the filler before processing 

and recorded at intervals of sufficient 

frequency to ensure that the consistency 

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is as specified in the scheduled process. 

Minimum closing machine vacuum in 

vacuum-packed products, maximum 

fill-in or drained weight, minimum net 

weight, and percent solids shall be as 

specified in the scheduled process for 

all products for which deviations from 

such specifications may affect the 

scheduled process. All measurements 

and recordings of critical factors should 

be made at intervals not to exceed 15 

minutes. 

(e) Equipment and procedures for 

pressure processing in water in 

discontinuous agitating retorts—(1) 

Temperature-indicating device. Each 

retort shall be equipped with at least 

one temperature-indicating device that 

accurately indicates the temperature 

during processing. Each temperatureindicating device shall have a sensor 

and a display. Each temperatureindicating device and each reference 

device that is maintained by the 

processor shall be tested for accuracy 

against a reference device for which the 

accuracy is traceable to a National 

Institute of Standards and Technology 

(NIST), or other national metrology 

institute, standard reference device by 

appropriate standard procedures, upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

processing. Each temperature-indicating 

device and each reference device that is 

maintained by the processor shall have 

a tag, seal, or other means of identity. 

(i) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(iv) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(v) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. In both 

horizontal and vertical retorts, the 

temperature-indicating device sensor 

shall be inserted directly into the retort 

shell or in a separate well or sleeve 

attached to the retort. The temperatureindicating device sensor shall be located 

so that it is beneath the surface of the 

water throughout the process and where 

there is adequate circulation to ensure 

accurate temperature measurement. On 

horizontal retorts, the temperatureindicating device sensor should be 

located in the side at the center of the 

retort. The temperature-indicating 

device—not the temperature-recording 

device—shall be the reference 

instrument for indicating the processing 

temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device. Each 

temperature-recording device shall have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart. 

The temperature-recording device 

sensor shall be installed either within 

the retort shell or in a well attached to 

the shell. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F (10 

°C) of the process temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(ii) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital records may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(iii) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recorder-controller. Airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that is 

accurate to 2 pounds per square inch 

(13.8 kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordercontroller when combined with a 

temperature-recording device. Airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air. 

(5) Retort speed timing. The rotational 

speed of the retort shall be specified in 

the scheduled process. The speed shall 

be adjusted, as necessary, to ensure that 

the speed is as specified in the 

scheduled process. The rotational speed 

as well as the process time shall be 

recorded for each retort load processed. 

Alternatively, a recording tachometer 

may be used to provide a continuous 

record of the speed. A means of 

preventing unauthorized speed changes 

shall be provided. A lock or a notice 

from management posted at or near the 

speed adjustment device that provides a 

warning that only authorized persons 

are permitted to make adjustment is a 

satisfactory means of preventing 

unauthorized changes. 

(6) Air supply and controls. When air 

is used to provide overpressure: 

(i) A means shall be provided for 

introducing compressed air at the 

proper pressure and rate. The proper 

pressure shall be controlled by an 

automatic pressure control unit. A 

check valve shall be provided in the air 

supply line to prevent water from 

entering the system. 

(ii) A water level indicator, e.g., 

sensor, gage, water glass, or petcock(s), 

shall be used for determining the water 

level in the retort during operation. 

Water shall cover the top layer of 

containers during the entire come-up 

time and processing periods and should 

also cover the top layer of containers 

during the cooling periods. The operator 

shall check and record the water level 

at intervals sufficient to ensure its 

adequacy. 

(7) Water circulation. When a water 

circulating system is used for heat 

distribution, it shall be installed in such 

a manner that water will be drawn from 

the bottom of the retort through a 

suction manifold and discharged 

through a spreader which extends the 

length of the top of the retort. The holes 

in the water spreader shall be uniformly 

distributed and should have an 

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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 11919 

aggregate area not greater than the crosssectional area of the outlet line from the 

pump. The suction outlets shall be 

protected with nonclogging screens or 

other suitable means shall be used to 

keep debris from entering the 

circulating system. The pump shall be 

designed to provide proper flow on 

startup and during operation, such as 

with a bleeder or other suitable means 

to remove air during startup and with an 

appropriate device or design to prevent 

pump cavitation during operation. The 

pump shall be equipped with a 

signaling device to warn the operator 

when it is not running. Alternative 

methods for circulation of water in the 

retort may be used when established by 

a competent authority as adequate for 

even heat distribution. 

(8) Drain valve. A nonclogging, watertight valve shall be used. A screen shall 

be installed or other suitable means 

shall be used on all drain openings to 

prevent clogging. 

(9) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. The minimum 

headspace of containers, if specified in 

the scheduled process, shall be 

measured and recorded at intervals of 

sufficient frequency to ensure that the 

headspace is as specified in the 

scheduled process. The headspace of 

solder-tipped, lap seam (vent hole) cans 

may be measured by net weight 

determinations. When the product 

consistency is specified in the 

scheduled process, the consistency of 

the product shall be determined by 

objective measurements on the product 

taken from the filler before processing 

and recorded at intervals of sufficient 

frequency to ensure that the consistency 

is as specified in the scheduled process. 

Minimum closing machine vacuum in 

vacuum-packed products, maximum 

fill-in or drained weight, minimum net 

weight, and percent solids shall be as 

specified in the scheduled process for 

all products when deviations from such 

specifications may affect the scheduled 

process. All measurements and 

recordings of critical factors should be 

made at intervals not to exceed 15 

minutes. 

(f) Equipment and procedures for 

pressure processing in steam in 

hydrostatic retorts—(1) Temperatureindicating device. Each retort shall be 

equipped with at least one temperatureindicating device that accurately 

indicates the temperature during 

processing. Each temperature-indicating 

device shall have a sensor and a display. 

Each temperature-indicating device and 

each reference device that is maintained 

by the processor shall be tested for 

accuracy against a reference device for 

which the accuracy is traceable to a 

National Institute of Standards and 

Technology (NIST), or other national 

metrology institute, standard reference 

device by appropriate standard 

procedures, upon installation and at 

least once a year thereafter, or more 

frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and each 

reference device that is maintained by 

the processor shall have a tag, seal, or 

other means of identity. 

(i) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(iv) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(v) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. The 

temperature-indicating device sensor 

shall be located in the steam dome near 

the steam-water interface. When the 

scheduled process specifies 

maintenance of particular temperatures 

in the hydrostatic water legs, a 

temperature-indicating device sensor 

shall be located in each hydrostatic 

water leg in a position near the bottom 

temperature-recording device sensor. 

The temperature-indicating device—not 

the temperature-recording device—shall 

be the reference instrument for 

indicating the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device. Each 

temperature-recording device shall have 

a sensor and a mechanism for recording 

temperatures to a permanent record, 

such as a temperature-recording chart. 

The temperature-recording device 

sensor shall be installed either within 

the steam dome or in a well attached to 

the dome. Each temperature-recording 

device sensor well shall have a 1⁄16-inch 

(1.5 millimeters) or larger bleeder that 

emits steam continuously during the 

processing period. Additional 

temperature-recording device sensors 

shall be installed in the hydrostatic 

water legs in situations where the 

scheduled process specifies 

maintenance of particular temperatures 

in the hydrostatic water legs. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F 

(10 °C) of the process temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(ii) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital recordings may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(iii) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recorder-controller. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that is 

accurate to 2 pounds per square inch 

(13.8 kilopascals) or less. 

(4) Recording of temperatures. 

Temperatures indicated by the 

temperature-indicating device or 

devices shall be entered on a suitable 

form during processing operations. 

Temperatures shall be recorded by an 

accurate temperature-recording device 

or devices at the following points: 

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11920 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 

(i) In the steam chamber between the 

steam-water interface and the lowest 

container position. 

(ii) Near the top and the bottom of 

each hydrostatic water leg if the 

scheduled process specifies 

maintenance of particular temperatures 

in the legs. 

(5) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordercontroller when combined with a 

temperature-recording device. A steam 

controller activated by the steam 

pressure of the retort is acceptable if it 

is carefully mechanically maintained so 

that it operates satisfactorily. Airoperated temperature controllers should 

have adequate filter systems to ensure a 

supply of clean, dry air. 

(6) Venting. Before the start of 

processing operations, the retort steam 

chamber or chambers shall be vented to 

ensure removal of air. 

(7) Bleeders. Bleeder openings 1⁄4-inch 

(6 millimeters) or larger shall be located 

at the top of the steam chamber or 

chambers opposite the point of steam 

entry. Bleeders shall be wide open and 

shall emit steam continuously during 

the entire process, including the comeup time. All bleeders shall be arranged 

in such a way that the operator can 

observe that they are functioning 

properly. 

(8) Retort speed. The speed of the 

container-conveyor chain shall be 

specified in the scheduled process and 

shall be determined and recorded at the 

start of processing and at intervals of 

sufficient frequency to ensure that the 

retort speed is maintained as specified. 

The speed should be determined and 

recorded every 4 hours. An automatic 

device should be used to stop the chain 

when the temperature drops below that 

specified in the scheduled process. A 

means of preventing unauthorized 

speed changes shall be provided. A lock 

or a notice from management posted at 

or near the speed-adjusting device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(9) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. 

(i) When maximum fill-in or drained 

weight is specified in the scheduled 

process, it shall be measured and 

recorded at intervals of sufficient 

frequency to ensure that the weight of 

the product does not exceed the 

maximum for the given container size 

specified in the scheduled process. 

(ii) Closing machine vacuum in 

vacuum-packed products shall be 

observed and recorded at intervals of 

sufficient frequency to ensure that the 

vacuum is as specified in the scheduled 

process. 

(iii) Such measurements and 

recordings should be made at intervals 

not to exceed 15 minutes. 

(g) Aseptic processing and packaging 

systems—(1) Product sterilizer—(i) 

Equipment—(A) Temperatureindicating device. Each product 

sterilizer shall be equipped with at least 

one temperature-indicating device that 

accurately indicates the temperature 

during processing. Each temperatureindicating device shall have a sensor 

and a display. Each temperatureindicating device and each reference 

device that is maintained by the 

processor shall be tested for accuracy 

against a reference device for which the 

accuracy is traceable to a National 

Institute of Standards and Technology 

(NIST), or other national metrology 

institute, standard reference device by 

appropriate standard procedures, upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

processing. Each temperature-indicating 

device and each reference device that is 

maintained by the processor shall have 

a tag, seal, or other means of identity. 

(1) The design of the temperatureindicating device shall ensure that the 

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(2) Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

(3) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired before further 

use or replaced. 

(4) A temperature-indicating device 

shall be accurate to 1 °F (0.5 °C). The 

temperature range of a mercury-in-glass 

thermometer shall not exceed 17 °F per 

inch (4 °C per centimeter) of graduated 

scale. A mercury-in-glass thermometer 

that has a divided mercury column shall 

be considered defective. 

(5) Each temperature-indicating 

device shall be installed where it can be 

accurately and easily read. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(B) Temperature-recording device. 

Each product sterilizer shall have an 

accurate temperature-recording device. 

Each temperature-recording device shall 

have a sensor and a mechanism for 

recording temperatures to a permanent 

record, such as a temperature-recording 

chart. A temperature-recording device 

sensor shall be installed in the product 

at the holding-tube outlet between the 

holding tube and the inlet to the cooler. 

Additional temperature-recording 

device sensors shall be located at each 

point where temperature is specified as 

a critical factor in the scheduled 

process. 

(1) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °F per inch (12 °C per 

centimeter) within a range of 20 °F 

(10 °C) of the desired product 

sterilization temperature. Chart 

graduations shall not exceed 2 °F (1 °C) 

within a range of 10 °F (5 °C) of the 

process temperature. Temperaturerecording devices that create multipoint 

plottings of temperature readings shall 

record the temperature at intervals that 

will assure that the parameters of the 

process time and process temperature 

have been met. 

(2) Digital recordings. Temperaturerecording devices, such as data loggers, 

that record numbers or create other 

digital recordings may be used. Such a 

device shall record the temperature at 

intervals that will assure that the 

parameters of the process time and 

process temperature have been met. 

(3) Adjustments. The temperaturerecording device shall be adjusted with 

sufficient frequency to ensure agreement 

as nearly as possible with, but to be in 

no event higher than, the temperatureindicating device during processing. A 

means of preventing unauthorized 

changes in adjustment shall be 

provided. A lock or a notice from 

management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(C) Temperature controller. An 

accurate temperature controller shall be 

installed and capable of ensuring that 

the desired product sterilization 

temperature is maintained. Air-operated 

temperature controllers should have 

adequate filter systems to ensure a 

supply of clean, dry air. 

(D) Product-to-product regenerators. 

When a product-to-product regenerator 

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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Rules and Regulations 11921 

is used to heat the cold unsterilized 

product entering the sterilizer by means 

of a heat exchange system, it shall be 

designed, operated, and controlled so 

that the pressure of the sterilized 

product in the regenerator is greater 

than the pressure of any unsterilized 

product in the regenerator to ensure that 

any leakage in the regenerator is from 

the sterilized product into the 

unsterilized product. 

(E) Differential pressure recordercontroller. When a product-to-product 

regenerator is used, it shall be equipped 

with an accurate differential pressure 

recorder-controller. The differential 

pressure recorder-controller shall be 

accurate to within 2 pounds per square 

inch (13.8 kilopascals). One pressure 

sensor shall be installed at the sterilized 

product regenerator outlet and the other 

pressure sensor shall be installed at the 

unsterilized product regenerator inlet. 

The sensor and recorder of the 

differential pressure recorder-controller 

shall be tested for accuracy against an 

accurate reference device upon 

installation and at least once every 3 

months of operation thereafter, or more 

frequently if necessary, to ensure its 

accuracy. 

(1) Analog or graphical recordings. 

Differential pressure recordercontrollers that create analog or 

graphical recordings may be used. 

Differential pressure recordercontrollers that record to charts shall be 

used only with the appropriate chart. 

The scale divisions of the chart shall not 

exceed 2 pounds per square inch (13.8 

kilopascals) on a working scale of not 

more than 20 pounds per square inch 

per inch of scale (55 kilopascals per 

centimeter). 

(2) Digital recordings. Differential 

pressure recorder-controllers, such as 

data loggers, that record numbers or 

create other digital recordings may be 

used. Such differential pressure 

recorder-controllers shall record the 

differential pressure at intervals that 

will assure that the minimum 

differential pressure is maintained. 

(F) Flow control. A flow control 

device shall be located upstream from 

the holding tube and shall be operated 

to maintain the required rate of product 

flow. A means of preventing 

unauthorized flow adjustments shall be 

provided. A lock or a notice from 

management posted at or near the flow 

controlling device that provides a 

warning that only authorized persons 

are permitted to make adjustments is a 

satisfactory means of preventing 

unauthorized changes. 

(G) Product holding tube. The 

product-sterilizing holding tube shall be 

designed to give continuous holding of 

every particle of food for at least the 

minimum holding time specified in the 

scheduled process. The holding tube 

shall be designed so that no portion of 

the tube between the product inlet and 

the product outlet can be heated, and it 

must be sloped upward at least 1⁄4-inch 

per foot (2.1 centimeters per meter). 

(H) Flow-diversion systems. If a 

processor elects to install a flowdiversion system, it should be installed 

in the product piping located between 

the product cooler and the product filler 

or aseptic surge tank and should be 

designed to divert flow away from the 

filler or aseptic surge tank 

automatically. Controls and/or warning 

systems should be designed and 

installed with necessary sensors and 

actuators to operate whenever the 

sterilizing temperature in the holding 

tube or pressure differential in the 

product regenerator drops below 

specified limits. Flow-diversion systems 

should be designed and operated in 

accordance with recommendations of an 

aseptic processing and packaging 

authority. 

(I) Equipment downstream from the 

holding tube. Product coolers, aseptic 

surge tanks, or any other equipment 

downstream from the holding tube, with 

rotating or reciprocating shafts, valve 

stems, instrument connections, or other 

such points, are subject to potential 

entry of microorganisms into the 

product. Such locations in the system 

should be equipped with steam seals or 

other effective barriers at the potential 

access points. Appropriate means 

should be provided to permit the 

operator to monitor the performance of 

the seals or barriers during operations. 

(ii) Operation—(A) Startup. Before the 

start of aseptic processing operations the 

product sterilizer and all productcontact surfaces downstream shall be 

brought to a condition of commercial 

sterility. 

(B) Temperature drop in productsterilizing holding tube. When product 

temperature in the holding tube drops 

below the temperature specified in the 

scheduled process, product flow should 

be diverted away from the filler or 

aseptic surge tank by means of a flowdiversion system. If for any reason 

product subjected to a temperature drop 

below the scheduled process is filled 

into containers, the product shall be 

segregated from product that received 

the scheduled process. The processing 

deviation shall be handled in 

accordance with § 113.89. The product 

holding tube and any further system 

portions affected shall be returned to a 

condition of commercial sterility before 

product flow is resumed to the filler or 

to the aseptic surge tank. 

(C) Loss of proper pressures in the 

regenerator. When a regenerator is used, 

the product may lose sterility whenever 

the pressure of sterilized product in the 

regenerator is less than 1 pound per 

square inch (6.9 kilopascals) greater 

than the pressure of unsterilized 

product in the regenerator. In this case, 

product flow should be diverted away 

from the filler or aseptic surge tank by 

means of the flow-diversion system. If 

for any reason the product is filled into 

containers, the product shall be 

segregated from product that received 

the scheduled process. The processing 

deviation shall be handled in 

accordance with § 113.89. Product flow 

to the filler or to the aseptic surge tank 

shall not be resumed until the cause of 

the improper pressure relationships in 

the regenerator has been corrected and 

the affected system(s) has been returned 

to a condition of commercial sterility. 

(D) Loss of sterile air pressure or other 

protection level in the aseptic surge 

tank. When an aseptic surge tank is 

used, conditions of commercial sterility 

may be lost when the sterile air 

overpressure or other means of 

protection drops below the scheduled 

process value. Product flow to and/or 

from the aseptic surge tank shall not be 

resumed until the potentially 

contaminated product in the tank is 

removed, and the aseptic surge tank has 

been returned to a condition of 

commercial sterility. 

(E) Records. Readings at the following 

points shall be observed and recorded at 

the start of aseptic packaging operations 

and at intervals of sufficient frequency 

to ensure that these values are as 

specified in the scheduled process: 

Temperature-indicating device in 

holding tube outlet; temperaturerecording device in holding tube outlet; 

differential pressure recorder-controller, 

if a product-to-product regenerator is 

used; product flow rate as established 

by the flow control device or as 

determined by filling and closing rates 

and, if an aseptic surge tank is used, 

sterile air pressure or other protection 

means; and proper performance of 

steam seals or other similar devices. The 

measurements and recordings should be 

made at intervals not to exceed 1 hour. 

(2) Container sterilizing, filling, and 

closing operation—(i) Equipment—(A) 

Recording device. The container and 

closure sterilization system and product 

filling and closing system shall be 

implemented to demonstrate that the 

required sterilization is being 

accomplished continuously. Recording 

devices shall be used to record, when 

applicable, the sterilization media flow 

rates, temperature, concentration, or 

other factors. When a batch system is 

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used for container sterilization, the 

sterilization conditions shall be 

recorded. 

(B) Timing method(s). A method(s) 

shall be used either to give the retention 

time of containers, and closures if 

applicable, in the sterilizing 

environment specified in the scheduled 

process, or to control the sterilization 

cycle at the rate specified in the 

scheduled process. A means of 

preventing unauthorized speed changes 

must be provided. A lock or a notice 

from management posted at or near the 

speed adjusting device that provides a 

warning that only authorized persons 

are permitted to make adjustments is a 

satisfactory means of preventing 

unauthorized changes. 

(ii) Operation—(A) Startup. Before the 

start of packaging operations, both the 

container and closure sterilizing system 

and the product filling and closing 

system shall be brought to a condition 

of commercial sterility. 

(B) Loss of sterility. A system shall be 

provided to stop packaging operations, 

or alternatively to ensure segregation of 

any product packaged when the 

packaging conditions fall below 

scheduled processes. Compliance with 

this requirement may be accomplished 

by diverting product away from the 

filler, by preventing containers from 

entering the filler, or by other suitable 

means. In the event product is packaged 

under conditions below those specified 

in the scheduled process, all such 

product shall be segregated from 

product that received the scheduled 

process. The processing deviation shall 

be handled in accordance with § 113.89. 

In the event of loss of sterility, the 

system(s) shall be returned to a 

condition of commercial sterility before 

resuming packaging operations. 

(C) Records. Observations and 

measurements of operating conditions 

shall be made and recorded at intervals 

of sufficient frequency to ensure that 

commercial sterility of the food product 

is being achieved; such measurements 

shall include the sterilization media 

flow rates, temperatures, the container 

and closure rates (if applicable) through 

the sterilizing system, and the 

sterilization conditions if a batch system 

is used for container sterilization. The 

measurements and recordings should be 

made at intervals not to exceed 1 hour. 

(3) Incubation. Incubation tests 

should be conducted on a representative 

sample of containers of product from 

each code; records of the test results 

should be maintained. 

(4) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. Such 

measurements and recordings should be 

done at intervals not to exceed 15 

minutes. 

(h) Equipment and procedures for 

flame sterilizers. The container 

conveyor speed shall be specified in the 

scheduled process. The container 

conveyor speed shall be measured and 

recorded at the start of operations and 

at intervals of sufficient frequency to 

ensure that the conveyor speed is as 

specified in the scheduled process. 

Such measurements and recordings 

should be done at 1-hour intervals. 

Alternatively, a recording tachometer 

may be used to provide a continuous 

record of the speed. A means of 

preventing changes in flame intensity 

and unauthorized speed changes on the 

conveyor shall be provided. A lock or a 

notice from management posted at or 

near the speed adjusting device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. The 

surface temperature of at least one 

container from each conveyor channel 

shall be measured and recorded at the 

entry and at the end of the holding 

period at intervals of sufficient 

frequency to ensure that the 

temperatures specified in the scheduled 

process are maintained. Such 

measurements and recordings should be 

done at intervals not to exceed 15 

minutes. 

(1) Process interruption. In the event 

of process interruption wherein the 

temperature of the product may have 

dropped, an authorized, scheduled 

emergency plan approved by a qualified 

person having expert knowledge of the 

process requirements may be used. 

(2) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. 

(i) Equipment and procedures for 

thermal processing of foods wherein 

critical factors such as water activity are 

used in conjunction with thermal 

processing. The methods and controls 

used for the manufacture, processing, 

and packing of such foods shall be as 

established in the scheduled process 

and shall be operated or administered in 

a manner adequate to ensure that the 

product is safe. The time and 

temperature of processing and other 

critical factors specified in the 

scheduled process shall be measured 

with instruments having the accuracy 

and dependability adequate to ensure 

that the requirements of the scheduled 

process are met. All measurements shall 

be made and recorded at intervals of 

sufficient frequency to ensure that the 

critical factors are within the limits 

specified in the scheduled process. 

(j) Other systems. All systems, 

whether or not specifically mentioned 

in this part, for the thermal processing 

of low-acid foods in hermetically sealed 

containers shall conform to the 

applicable requirements of this part and 

the methods and controls used for the 

manufacture, processing, and packing of 

these foods shall be as established in the 

scheduled process. These systems shall 

be operated or administered in a manner 

adequate to ensure that commercial 

sterility is achieved. Critical factors 

specified in the scheduled process shall 

be measured and recorded at intervals of 

sufficient frequency to ensure that the 

critical factors are within the limits 

specified in the scheduled process. 

■ 3. Amend § 113.60 by revising 

paragraph (d) to read as follows: 

§ 113.60 Containers. 

* * * * * 

(d) Postprocess handling. Container 

handling equipment used in handling 

filled containers shall be designed, 

constructed, and operated to preserve 

the can seam or other container closure 

integrity. Container handling 

equipment, including automated and 

non-automated equipment, shall be 

checked with sufficient frequency and 

repaired or replaced as necessary to 

prevent damage to containers and 

container closures. When cans are 

handled on belt conveyors, the 

conveyors should be constructed to 

minimize contact by the belt with the 

double seam, i.e., cans should not be 

rolled on the double seam. All worn and 

frayed belting, can retarders, cushions, 

etc. should be replaced with new 

nonporous material. All tracks and belts 

that come into contact with the can 

seams should be thoroughly scrubbed 

and sanitized at intervals of sufficient 

frequency to avoid product 

contamination. 

■ 4. Revise § 113.83 to read as follows: 

§ 113.83 Establishing scheduled 

processes. 

Scheduled processes for low-acid 

foods shall be established by qualified 

persons having expert knowledge of 

thermal processing requirements for 

low-acid foods in hermetically sealed 

containers and having adequate 

facilities for making such 

determinations. The type, range, and 

combination of variations encountered 

in commercial production shall be 

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adequately provided for in establishing 

the scheduled process. Variations 

include those that occur due to seasonal 

or growing fluctuations, variety 

differences, supplier processes, 

reprocessing, and mixing a batch of 

processed product with the same 

unprocessed product before it is 

processed. Critical factors, e.g., 

minimum headspace, consistency, 

maximum fill-in or drained weight, aw, 

etc., that may affect the scheduled 

process, shall be specified in the 

scheduled process. Acceptable scientific 

methods of establishing heat 

sterilization processes shall include, 

when necessary, but shall not be limited 

to, the use of microbial thermal death 

time data, process calculations based on 

product heat penetration data, and 

inoculated packs. Calculation shall be 

performed according to procedures 

recognized by competent processing 

authorities. If incubation tests are 

necessary for process confirmation, they 

shall include containers from test trials 

and from actual commercial production 

runs during the period of instituting the 

process. The incubation tests for 

confirmation of the scheduled processes 

should include the containers from the 

test trials and a number of containers 

from each of four or more actual 

commercial production runs. The 

number of containers from actual 

commercial production runs should be 

determined on the basis of recognized 

scientific methods to be of a size 

sufficient to ensure the adequacy of the 

process. Complete records covering all 

aspects of the establishment of the 

process and associated incubation tests 

shall be prepared and shall be 

permanently retained by the person or 

organization making the determination. 

■ 5. Amend § 113.87 by revising 

paragraphs (b), (c), and (e) to read as 

follows: 

§ 113.87 Operations in the thermal 

processing room. 

* * * * * 

(b) A system for product traffic 

control in the retort room shall be 

established to prevent unretorted 

product from bypassing the retort 

process. Each retort basket, truck, car, or 

crate used to hold containers in a retort, 

or one or more containers therein, shall, 

if it contains any retorted food product, 

be plainly and conspicuously marked 

with a heat-sensitive indicator, or by 

other effective means that will indicate 

visually, to thermal processing 

personnel, those units that have been 

retorted. A visual check shall be 

performed to determine whether or not 

the appropriate change has occurred in 

the heat-sensitive indicator as a result of 

retorting for all retort baskets, trucks, 

cars, or crates, to ensure that each unit 

of product has been retorted. A record 

of these checks should be made. 

(c) The initial temperature of the 

contents of the containers to be 

processed shall be accurately 

determined and recorded with sufficient 

frequency to ensure that the temperature 

of the product is no lower than the 

minimum initial temperature specified 

in the scheduled process. For those 

operations that use water during the 

filling of the retort or during processing, 

provision shall be made to ensure that 

the water will not, before the start of 

each thermal process, lower the initial 

temperature of the product below that 

specified in the scheduled process. The 

temperature-indicating device used to 

determine the initial temperature shall 

be tested for accuracy against a 

reference device for which the accuracy 

is traceable to a National Institute of 

Standards and Technology (NIST), or 

other national metrology institute, 

standard reference device, by 

appropriate standard procedures, with 

sufficient frequency to ensure that 

initial temperature measurements are 

accurate. Records of the accuracy of the 

temperature-indicating device and of a 

reference device that is maintained by 

the processor shall be established and 

maintained in accordance with 

§ 113.100(c) and (d). 

* * * * * 

(e) Clock times on temperaturerecording device records shall 

reasonably correspond to the time of 

day on the processing records to provide 

correlation of these records. 

* * * * * 

■ 6. Section 113.100 is amended by: 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b); 

■ b. Redesignating paragraphs (c), (d), 

and (e), as paragraphs (e), (f), and (g), 

respectively; 

■ c. Adding new paragraphs (c), (d), and 

(h); and 

■ d. Revising newly redesignated 

paragraph (e). 

The revisions and additions read as 

follows: 

§ 113.100 Processing and production 

records. 

(a) Processing and production 

information shall be entered at the time 

it is observed by the retort or processing 

system operator, or other designated 

person, on forms that include the 

product, the code number, the date, the 

retort or processing system number, the 

size of container, the approximate 

number of containers per coding 

interval, the initial temperature, the 

actual processing time, the temperatureindicating device and temperaturerecording device readings, and other 

appropriate processing data. Closing 

machine vacuum in vacuum-packed 

products, maximum fill-in or drained 

weight, or other critical factors specified 

in the scheduled process shall also be 

recorded. In addition, the following 

records shall be maintained: 

* * * * * 

(4) Aseptic processing and packaging 

systems. Product temperature in the 

holding tube outlet as indicated by the 

temperature-indicating device and the 

temperature-recording device; 

differential pressure as indicated by the 

differential pressure recorder-controller, 

if a product-to-product regenerator is 

used; product flow rate, as determined 

by the flow controlling device or by 

filling and closing rates; sterilization 

media flow rate or temperature or both; 

retention time of containers, and 

closures when applicable, in the 

sterilizing environment; and, when a 

batch system is used for container and/ 

or closure sterilization, sterilization 

cycle times and temperatures. 

* * * * * 

(b) Temperature-recording device 

records shall be identified by date, retort 

number, and other data as necessary, so 

they can be correlated with the record 

of lots processed. Each entry on the 

processing and production records shall 

be made by the retort or processing 

system operator, or other designated 

person, at the time the specific retort or 

processing system condition or 

operation occurs, and this retort or 

processing system operator or other 

designated person shall sign or initial 

each record form. Not later than 1 

working day after the actual process, 

and before shipment or release for 

distribution, a representative of plant 

management who is qualified by 

suitable training or experience shall 

review all processing and production 

records for completeness and to ensure 

that the product received the scheduled 

process. The records, including 

temperature-recording device records, 

shall be signed or initialed and dated by 

the reviewer. 

(c) Records of the accuracy of a 

temperature-indicating device shall 

include: 

(1) A reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device; 

(2) The name of the manufacturer of 

the temperature-indicating device; 

(3) The identity of the reference 

device, equipment, and procedures used 

for the accuracy test and to adjust the 

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temperature-indicating device or, if an 

outside facility is used to conduct the 

accuracy test for the temperatureindicating device, a guarantee, 

certificate of accuracy, certificate of 

calibration, or other document from the 

facility that includes a statement or 

other documentation regarding the 

traceability of the accuracy to a National 

Institute of Standards and Technology 

(NIST) or other national metrology 

institute standard; 

(4) The identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the 

temperature-indicating device; 

(5) The date and results of each 

accuracy test, including the amount of 

calibration adjustment; and 

(6) The date on or before which the 

next accuracy test must be performed. 

(d) Records of the accuracy of a 

reference device maintained by the 

processor shall include: 

(1) A reference to the tag, seal, or 

other means of identity used by the 

processor to identify the reference 

device; 

(2) The name of the manufacturer of 

the reference device; 

(3) The identity of the equipment and 

reference to procedures used for the 

accuracy test and to adjust or calibrate 

the reference device or, if an outside 

facility is used to conduct the accuracy 

test for the reference device, a 

guarantee, certificate of accuracy, 

certificate of calibration, or other 

document from the facility that includes 

a statement or other documentation 

regarding the traceability of the 

accuracy to a NIST or other national 

metrology institute standard; 

(4) The identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device; 

(5) The date and results of each 

accuracy test, including the amount of 

calibration adjustment; and 

(6) The date on or before which the 

next accuracy test must be performed. 

(e) Records of all container closure 

examinations shall specify the product 

code, the date and time of container 

closure inspections, the measurements 

obtained, and all corrective actions 

taken. Records shall be signed or 

initialed by the container closure 

inspector and reviewed by management 

with sufficient frequency to ensure that 

the containers are hermetically sealed. 

The records shall be signed or initialed 

and dated by the reviewer. 

* * * * * 

(h) Records of this part may be 

maintained electronically, provided 

they are in compliance with part 11 of 

this chapter. 

Dated: February 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–4475 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

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