11990 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 

1The low-acid canned food regulations (21 CFR 

part 128b) were recodified as part 113 on March 15, 

1977 (42 FR 14302). The regulations were 

subsequently amended on March 16, 1979 (44 FR 

16209) and June 11, 1997 (62 FR 31721). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 113 

[Docket No. 2007N–0026] 

Temperature-Indicating Devices; 

Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed 

Containers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulations for thermally 

processed low-acid foods packaged in 

hermetically sealed containers to allow 

for use of other temperature-indicating 

devices, in addition to mercury-in-glass 

thermometers, during processing. FDA 

also is proposing to establish 

recordkeeping requirements relating to 

temperature-indicating devices and to 

clarify other aspects of low-acid canned 

food processing such as FDA’s 

interpretation of some requirements of 

the current regulations that will, in part, 

allow the use of advanced technology 

for measuring and recording 

temperatures during processing. Finally, 

FDA is proposing to include metric 

equivalents of avoirdupois (U.S.) 

measurements where appropriate. 

DATES: Submit written or electronic 

comments on the proposed rule by June 

12, 2007. Submit comments regarding 

the information collection by April 13, 

2007, to the Office of Management and 

Budget (OMB) (see ADDRESSES). 

ADDRESSES: You may submit comments, 

identified by Docket No. 2007N–0026, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described 

previously, in the ADDRESSES portion of 

this document under Electronic 

Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

Information Collection Provisions: 

Submit written comments on the 

information collection provisions to the 

Office of Information and Regulatory 

Affairs, OMB. To ensure that comments 

on the information collection are 

received, OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Mischelle B. Ledet, Center for Food 

Safety and Applied Nutrition (HFS– 

615), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2359. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Legal Authority 

III. Proposed Rule 

A. Equipment and Procedures 

(§ 113.40) 

B. Containers (§ 113.60) 

C. Establishing Scheduled Processes 

(§ 113.83) 

D. Operations in the Thermal 

Processing Room (§ 113.87) 

E. Processing and Production Records 

(§ 113.100) 

F. Minor Revisions in Regulations 

G. Immediate Implementation of 

Proposed Rule 

IV. Analysis of Impacts 

A. Preliminary Regulatory Impact 

Analysis: Flexibility in Permitting 

Alternative Temperature-Indicating 

Devices 

B. Regulatory Flexibility Analysis 

C. Unfunded Mandate Analysis 

V. Environmental Impact 

VI. Paperwork Reduction Act 

VII. Federalism 

VIII. Comments 

IX. References 

I. Background 

In the Federal Register of January 24, 

1973 (38 FR 2398), FDA (we) issued a 

final rule entitled ‘‘Thermally Processed 

Low-Acid Food Packaged in 

Hermetically Sealed Containers’’ (lowacid canned foods) (the 1973 final rule), 

part 113 (21 CFR part 113)1, which, 

among other things, provides for the use 

of an ‘‘indicating mercury-in-glass 

thermometer’’ for equipment and 

procedures for the following: (1) 

Pressure processing in steam in still 

retorts (§ 113.40(a)), (2) pressure 

processing in water in still retorts 

(§ 113.40(b)), (3) pressure processing in 

steam in continuous agitating retorts 

(§ 113.40(c)), (4) pressure processing in 

steam in discontinuous agitating retorts 

(§ 113.40(d)), (5) pressure processing in 

water in discontinuous agitating retorts 

(§ 113.40(e)), (6) pressure processing in 

steam in hydrostatic retorts (§ 113.40(f)), 

and (7) aseptic processing and 

packaging systems (§ 113.40(g)). In 

addition, aseptic processing systems 

(§ 113.40(g)) can be equipped with a 

mercury-in-glass thermometer or an 

equivalent temperature-indicating 

device, such as a thermocouplerecorder. 

The 1973 final rule also established 

requirements for containers (§ 113.60), 

requirements for establishing scheduled 

processes (§ 113.83), and requirements 

for operations in the thermal processing 

room (§ 113.87). The 1973 final rule also 

established requirements for processing 

and production records, which include 

requirements for maintaining records of 

mercury-in-glass thermometer and 

recording thermometer readings 

(§ 113.100). 

In the preamble to the 1973 final rule, 

FDA stated that two comments on a 

tentative final order, published 

November 14, 1972 (37 FR 24117), 

‘‘recommended that provisions be made 

[in the final rule] for the use of 

temperature[-]indicating devices other 

than mercury-in-glass thermometers.’’ 


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FDA responded, ‘‘The Commissioner [of 

Food and Drugs] has determined that 

the mercury-in-glass thermometer is the 

recognized standard against which all 

other temperature[-]indicating devices 

are checked and calibrated. The 

regulation * * * retains the requirement 

that all retorts be equipped with 

mercury-in-glass indicating 

thermometers. However, because of the 

speed of the thermal process, alternate 

temperature[-]indicating devices such as 

thermocouples will be allowed in 

aseptic processing and packaging 

systems’’ (38 FR 2398 at 2400). 

Since publication of the 1973 final 

rule, FDA has received various requests 

to permit use of alternative temperatureindicating devices or to permit entry 

into the United States of low-acid 

canned foods that were processed in 

countries that permit alternative 

temperature-indicating devices to be 

used during processing. In responding 

to such requests, FDA expressed 

concern about whether the devices were 

reliable and maintained accuracy under 

actual plant operation conditions. FDA 

also requested additional information 

relating to reliability and accuracy, 

including evidence to show that, if the 

device does not maintain its accuracy, 

this fact would become immediately 

known by the operator and would not 

result in underprocessed food. 

FDA is aware that technological 

advancements in thermometry have 

been made since publication of the lowacid canned food regulations in 1973 

and that temperature-indicating devices 

other than mercury-in-glass 

thermometers are now available that 

may be appropriate for use in thermal 

processing of low-acid foods. FDA also 

is aware, specifically for low-acid 

canned food manufacturers, of 

traditional concerns about ensuring that 

mercury from broken mercury-in-glass 

thermometers does not contaminate the 

food or the processing environment. 

FDA recognizes that the industry must 

proceed cautiously to transition from 

mercury-in-glass thermometers to 

alternative technology to ensure that 

accuracy and ability to function 

properly during processing are not 

compromised by replacing mercury-inglass thermometers with alternative 

temperature-indicating devices. As with 

mercury-in-glass thermometers, 

manufacturers who use alternative 

temperature-indicating devices must 

conduct appropriate tests and 

implement procedures to ensure that the 

device is accurate during processing and 

does not result in underprocessed foods. 

Thus, although FDA supports 

elimination of mercury from the 

processing environment and encourages 

industry to take necessary and 

appropriate steps to transition from 

mercury-in-glass thermometers to 

alternative temperature-indicating 

devices, the agency also recognizes that 

it may not be practical for all 

manufacturers to make this transition. 

Accordingly, FDA is proposing to revise 

regulations in part 113 to permit 

industry use of temperature-indicating 

devices, including mercury-in-glass 

thermometers, and to require 

maintenance of records associated with 

ensuring that temperature-indicating 

devices are accurate during processing. 

FDA also is aware that the regulations 

from the 1973 final rule include 

outdated terminology and that some of 

the provisions are unclear. FDA is 

proposing to update and clarify these 

sections of the regulations. FDA also is 

proposing to clarify and establish 

recordkeeping requirements relating to 

ensuring the accuracy of temperatureindicating devices. 

II. Legal Authority 

FDA is proposing these regulations 

under sections 402(a)(3) and (a)(4) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 342(a)(3) and (a)(4)). 

In addition, FDA is proposing these 

regulations under section 361 of the 

Public Health Service Act (the PHS Act) 

(42 U.S.C. 264) that relates to 

communicable disease. Under section 

402(a)(3) of the act, a food is deemed 

adulterated ‘‘if it consists in whole or in 

part of any filthy, putrid, or 

decomposed substance, or if it is 

otherwise unfit for food.’’ Under section 

402(a)(4) of the act, a food is adulterated 

‘‘if it has been prepared, packed, or held 

under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health.’’

A commercial processor engaged in 

the thermal processing of low-acid foods 

packaged in hermetically sealed 

containers must provide FDA with 

information about its scheduled process 

that includes processing method, type of 

retort or other thermal processing 

equipment employed, minimum initial 

temperatures, times and temperatures of 

processing, sterilizing value or other 

equivalent scientific evidence of 

processing adequacy, critical control 

factors affecting heat penetration, and 

source and date of the establishment of 

the process for each low-acid food in 

each container size (21 CFR 

108.35(c)(2)). The scheduled process is 

designed to achieve commercial 

sterility. Commercial sterility relates to 

conditions achieved through the 

application of heat to render the food 

free of certain microorganisms capable 

of reproducing under normal nonrefrigerated conditions of storage and 

distribution and viable microorganisms 

of public health significance (§ 113.3(e)). 

Adhering to the scheduled process is 

important for preventing growth in the 

food of microorganisms, such as 

Clostridium botulinum. Clostridium 

botulinum produces a neurotoxin that 

causes botulism, a communicable 

disease that can result in paralysis and 

death (Ref. 1). The failure to use 

accurate temperature-indicating devices, 

and other measures clarified in this 

proposed rule, to ensure that low-acid 

foods are processed to achieve 

commercial sterility is an insanitary 

condition and thus renders the food 

adulterated under section 402(a)(4) of 

the act. In addition, such a food is unfit 

for food under section 402(a)(3) of the 

act based on health risks from 

insufficient processing. 

Under section 701(a) of the act (21 

U.S.C. 371(a)), FDA is authorized to 

issue regulations for the act’s efficient 

enforcement. A regulation that requires 

measures to prevent human food from 

being unfit for food and from being held 

under insanitary conditions allows for 

the efficient enforcement of the act. This 

proposed rule requires processors of 

thermally processed low-acid food to 

establish and maintain records of the 

accuracy of the temperature-indicating 

device and reference device. Other 

records relating to processing and 

production are currently required in 

§ 113.100. The proposed rule requires 

that all records under part 113, whether 

currently required or proposed to be 

required in this proposed rule, be made 

available to FDA for inspection and 

copying. 

The proposed rule would require 

accuracy testing of temperatureindicating devices against a calibrated 

reference device by appropriate 

standard procedures upon installation 

and at least once a year thereafter, or 

more frequently if necessary, to ensure 

accuracy during processing. 

Documentation of accuracy of such 

devices is necessary to determine, over 

time, whether each device complies 

with current requirements to be accurate 

during processing and for verifying that 

temperatures required by the scheduled 

process are met during processing. 

Further, such documentation is 

necessary for evaluating the 

performance of temperature-indicating 

devices that are technologically and 

operationally different from mercury-inglass thermometers traditionally used in 

processing low-acid canned food. The 

records of accuracy testing for each 

temperature-indicating device and 

reference device will be linked to each 


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such device through the accuracy 

records so that the processor will be 

able to ensure that temperatureindicating devices and reference devices 

are tested as often as needed and will 

provide a means for the processor to 

quickly identify and correct problems 

that may occur. Without records 

documenting accuracy testing of 

temperature-indicating devices and 

reference devices, processors would not 

know whether they are adulterating 

their products. Therefore, a failure of 

processors to establish and maintain 

these records results in thermally 

processed low-acid canned food being 

prepared under insanitary conditions 

whereby the food may have been 

rendered injurious to health. 

Because FDA cannot continuously 

observe processors’ operations, the 

records for accuracy, and other records 

currently required for processing and 

production, are essential for FDA to 

know whether processors have 

complied with the current good 

manufacturing practice requirements in 

part 113. FDA may consider it necessary 

to copy records when, for example, our 

investigator may need assistance in 

reviewing a certain record from relevant 

experts in headquarters. If we are unable 

to copy the records, we would have to 

rely solely on our investigator’s notes 

and reports when drawing conclusions. 

In addition, copying records will 

facilitate followup regulatory actions. 

We have tentatively concluded that the 

ability to access and copy the records is 

necessary to provide FDA with an 

enforceable regulation that will ensure 

public health protection. Thus, the 

recordkeeping requirements and access 

to such records would be necessary to 

the efficient enforcement of the act. 

Under the proposed rule, the failure to 

comply with the recordkeeping 

requirements would render the food 

adulterated under section 402(a)(4) of 

the act. 

In addition, FDA has authority under 

section 361 of the PHS Act to make and 

enforce such regulations as ‘‘are 

necessary to prevent the introduction, 

transmission, or spread of 

communicable disease from foreign 

countries into the States * * * or from 

one State*** into any other State’’

(section 361(a) of the PHS Act). A lowacid canned food that is not processed 

to achieve commercial sterility may 

become contaminated with 

microorganisms such as Clostridium 

botulinum. Clostridium botulinum 

produces a neurotoxin which, when 

ingested, causes botulism. Botulism is a 

communicable disease that is 

characterized by the rapid onset of 

paralysis. If untreated, this paralysis can 

lead to death (Ref. 1). As explained 

previously in this document, processing 

and production records required by part 

113, and those proposed in this rule 

related to accuracy testing, are necessary 

to ensure that low-acid foods are 

prepared in a manner that will prevent 

the spread of communicable disease. 

Section 361 of the PHS Act provides 

FDA with the authority to institute 

recordkeeping requirements, including 

access to such records to enable FDA to 

ensure that low-acid foods are being 

processed in a manner to prevent the 

spread of communicable disease. For 

these reasons, and for the reasons stated 

previously in this document for access 

and copying of records to provide for an 

enforceable regulation that will ensure 

public health protection, we have 

tentatively concluded that the 

recordkeeping requirements are 

necessary to prevent the spread of 

communicable disease. 

III. Proposed Rule 

A. Equipment and Procedures (§ 113.40) 

1. Temperature-Indicating Devices 

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

(d)(1), (e)(1), and (f)(1) require that 

retorts used for processing low-acid 

foods shall be equipped with at least 

one mercury-in-glass thermometer. FDA 

is proposing to revise the regulations to 

provide for use of temperatureindicating devices that accurately 

indicate the temperature during thermal 

processing. Accordingly, FDA is 

replacing the terms ‘‘mercury-in-glass 

thermometer’’ and ‘‘thermometer’’ with 

‘‘temperature-indicating device,’’ as 

appropriate. Current § 113.40(g)(1) 

already allows for use of temperatureindicating devices for aseptic processing 

of low-acid foods. However, FDA is 

proposing revisions in § 113.40(g)(1) 

similar to proposed § 113.40(a)(1), (b)(1), 

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

consistency in terminology, 

interpretation, and application of all 

provisions of the regulation that allow 

for use of temperature-indicating 

devices. 

The term ‘‘temperature-indicating 

device’’ includes mercury-in-glass 

thermometers. The proposed rule 

provides for use of temperatureindicating devices for the following 

purposes: (1) Pressure processing in 

steam in still retorts, (2) pressure 

processing in water in still retorts, (3) 

pressure processing in steam in 

continuous agitating retorts, (4) pressure 

processing in steam in discontinuous 

agitating retorts, (5) pressure processing 

in water in discontinuous agitating 

retorts, (6) pressure processing in steam 

in hydrostatic retorts, and (7) aseptic 

processing and packaging. Processors 

are responsible for ensuring that the 

temperature-indicating device is 

accurate during processing. 

FDA is proposing that temperatureindicating devices shall be tested for 

accuracy against an ‘‘accurate calibrated 

reference device’’ upon installation and 

at least once a year thereafter, or more 

frequently if necessary, to ensure 

accuracy during processing. Currently, 

mercury-in-glass thermometers must be 

tested for accuracy against a ‘‘known 

accurate standard thermometer’’ upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary. FDA is proposing to require 

similar tests for accuracy for all 

temperature-indicating devices. 

Traditionally, a ‘‘known accurate 

standard thermometer’’ was a mercuryin-glass thermometer that had been 

calibrated against an instrument that 

was traceable to a National Institute of 

Standards and Technology (NIST) 

standard or according to other standard 

calibration procedures that assured 

accuracy at the time the thermometer 

was used as the ‘‘standard.’’ These 

thermometers are often referred to as 

‘‘reference devices.’’ (NIST is a nonregulatory Federal agency that develops 

and promotes measurement, standards, 

and technology to enhance productivity, 

facilitate trade, and improve the quality 

of life.) FDA is proposing to replace the 

term ‘‘known accurate standard 

thermometer’’ with the broader term 

‘‘accurate calibrated reference device’’

to recognize that reference or 

‘‘standard’’ devices other than mercuryin-glass thermometers are available and 

may be used for determining accuracy. 

FDA is proposing that the design of 

the temperature-indicating device shall 

ensure that the accuracy of the device is 

not affected by electromagnetic 

interference and environmental 

conditions. Although electromagnetic 

energy does not affect the accuracy of 

mercury-in-glass thermometers, 

temperature-indicating devices with 

electronic or electromagnetic 

components are vulnerable and must be 

designed to ensure that they are 

resistant to electromagnetic interference. 

Environmental conditions, such as 

humidity, vibrations, and air pressure, 

which may affect the accuracy or 

performance of the temperatureindicating device, also must be 

identified and controlled, to the extent 

necessary, to ensure that the 

temperature-indicating device is 

accurate during processing. The current 

regulations indirectly address control of 

the impact of environmental conditions 

on mercury-in-glass thermometers by 

requiring calibration ‘‘at least once a 


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year * * * or more frequently if 

necessary, to ensure their accuracy’’

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

(e)(1), (f)(1), and (g)(1)(i)(a)) and by 

requiring that a mercury-in-glass 

thermometer that has a ‘‘divided 

mercury column or that cannot be 

adjusted to the standard shall be 

repaired or replaced before further use 

of the retort’’ (§ 113.40(a)(1), (b)(1), 

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

requirement in § 113.40(g)(1)(i)(a)). The 

design of the mercury-in-glass 

thermometer makes it relatively easy to 

detect a malfunction, including those 

caused by environmental conditions, 

because most are associated with a 

broken thermometer, separated column, 

or scale slippage. However, malfunction 

of other temperature-indicating devices 

may need to be detected by means other 

than observation. For example, a 

temperature-indicating device could be 

designed with a dual probe sensor that 

would enable detection of loss of 

accuracy of one of the probes when the 

probe readings do not agree. FDA 

recommends, but is not proposing to 

require, a dual probe design. FDA 

recognizes that specific design 

specifications for temperatureindicating devices may limit the 

flexibility of the regulation for current 

and future technologies. Design 

specificity in the regulation is not 

practical because of the diversity of 

technology associated with temperatureindicating devices that have been or 

may be developed and because, for each 

type of temperature-indicating device, 

different factors or parameters may need 

to be addressed by design. Rather, the 

proposed regulation would require that 

the design of the temperature-indicating 

device ensure that the accuracy of the 

device is not affected by electromagnetic 

interference and environmental 

conditions. Thus, the processor is 

responsible for ensuring that the 

temperature-indicating device is 

designed so that its accuracy during 

processing is not compromised due to 

electromagnetic interference or 

environmental conditions and that any 

malfunctions in the device that may 

affect accuracy will be immediately 

detectable. 

2. Documentation and Records 

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

(d)(1), (e)(1), and (f)(1) recommend, but 

do not specifically require, maintenance 

of records of accuracy checks. These 

regulations indicate that the records 

should specify the date, standard used, 

method used, and person performing 

the test. The regulations also 

recommend, but do not require, that 

each thermometer should have a tag, 

seal, or other means of identity that 

includes the date on which it was last 

tested for accuracy. Similar provisions 

in current § 113.40(g)(1)(i)(a) apply to 

maintenance of records of accuracy 

checks and to establishing a means of 

identity for ‘‘thermometers and 

temperature-indicating devices.’’

However, establishment and 

maintenance of records of the accuracy 

of each temperature-indicating device 

are essential for documenting accuracy 

of temperature-indicating devices 

throughout time, for determining that 

each temperature-indicating device 

complies with current requirements to 

be accurate during processing, and for 

verifying that temperatures required by 

the scheduled process are met. Further, 

such documentation is necessary for 

evaluating the performance of 

temperature-indicating devices that are 

technologically and operationally 

different from mercury-in-glass 

thermometers traditionally used in 

processing low-acid canned food. 

FDA is proposing to require that each 

temperature-indicating device have a 

tag, seal, or other means of identity that 

will be used by the processor to identify 

the temperature-indicating device and 

that each reference device have a tag, 

seal, or other means of identity that will 

be used by the processor to identify the 

reference device. FDA is proposing to 

eliminate the current recommendation 

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

(e)(1), (f)(1), and (g)(1)(i)(a) to include 

on the tag or seal the date on which each 

thermometer was last tested for 

accuracy. FDA does not object to 

recording the accuracy test date on the 

tag or seal. However, as discussed later 

in this document, FDA is proposing to 

require that the date of the last accuracy 

test be included as part of the record of 

accuracy for the temperature-indicating 

device. FDA believes this proposed 

change clarifies the process for assuring 

that the written record of the accuracy 

test can be linked to the appropriate 

temperature-indicating device. 

FDA is proposing that a written 

record of accuracy for each temperatureindicating device shall be established 

and maintained. Documentation of the 

accuracy of each temperature-indicating 

device shall include the following 

information: (1) A reference to the tag, 

seal, or other means of identity used by 

the processor to identify the 

temperature-indicating device; (2) the 

name of the manufacturer of the 

temperature-indicating device; (3) the 

identity of the reference device used for 

the accuracy test; (4) the identity of the 

equipment and procedures used to 

adjust or calibrate the temperatureindicating device; (5) the date and 

results of each accuracy test; (6) the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device; and (7) the date of the 

next scheduled accuracy test. Reference 

to the temperature-indicating device 

identity in the record of accuracy 

provides an essential link between each 

temperature-indicating device and the 

specific record associated with that 

device. The name of the manufacturer 

enables the processor to readily identify 

the source of the defective or deficient 

device and to correct or replace the 

device, as appropriate. Identification of 

the reference device used for the 

accuracy check and of the equipment 

and procedures used to adjust or 

calibrate the temperature-indicating 

device provides an essential reference 

for additional followup in the event the 

reference device is subsequently 

determined to be inaccurate. 

Documentation of the date and results of 

accuracy tests provides evidence that 

scheduled tests were performed and is 

essential for evaluating performance of 

the temperature-indicating device over 

time. This information can be used to 

determine whether more frequent 

accuracy tests are needed and whether 

a temperature-indicating device needs 

to be replaced. Documentation of the 

identification of the person or facility 

that performed the accuracy test and 

adjusted or recalibrated the 

temperature-indicating device is 

essential for appropriate followup in the 

event that the temperature-indicating 

device subsequently is determined to be 

inaccurate. 

These records are necessary to ensure 

that appropriate accuracy checks are 

performed for each temperatureindicating device, to establish the 

appropriate frequency for accuracy 

checks, to identify when there is a 

problem with a temperature-indicating 

device and, as necessary, to repair or 

replace the device, and to determine 

and initiate appropriate followup to 

ensure that low-acid canned foods are 

appropriately processed. Because it is 

not possible for FDA to continuously 

observe processors’ operations, these 

records are essential to ensure that the 

agency has the information needed to 

identify noncompliance and to bring a 

non-compliant processor into 

compliance. Thus, these records are 

essential for FDA to have an enforceable 

regulation that will ensure public health 

protection. 

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

(d)(1), (e)(1), and (f)(1) require that 

thermometers (and temperatureindicating devices in § 113.40(g)(1)(i)(a)) 

shall be tested for accuracy against a 


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known accurate standard thermometer. 

This requirement implies, but does not 

explicitly state, that the processor must 

be able to demonstrate, by appropriate 

documentation, that the reference or 

standard device used to determine the 

accuracy of the thermometers used to 

measure temperature during processing 

also is accurate. Thus, although the 

current regulations require 

documentation of the accuracy of the 

standard thermometer, the specific 

documentation FDA expects processors 

to maintain is not clear. FDA is 

proposing to clarify this requirement by 

specifying that a written record of the 

accuracy of the reference device shall be 

established and maintained. 

Documentation of the accuracy of the 

reference device must include the 

following information: (1) A reference to 

the tag, seal, or other means of identity 

used by the processor to identify the 

reference device; (2) the name of the 

manufacturer of the reference device; (3) 

the identity of the equipment and 

procedures used to test the accuracy and 

to adjust or calibrate the reference 

device; (4) the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device; (5) the date and results of the 

accuracy test; and (6) the traceability 

information. Traceability, as defined by 

the International Vocabulary of Basic 

and General Terms in Metrology, means 

a ‘‘property of the result of a 

measurement or the value of a standard 

whereby it can be related to stated 

references, usually national or 

international standards, through an 

unbroken chain of comparisons all 

having stated uncertainties’’ (Ref. 2). 

Accordingly, records must be 

maintained to document that the 

accuracy of the reference device can be 

traced by comparison with a standard 

device, such as a NIST standard 

temperature device. Documentation of 

the traceability information for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer of the reference device or 

a certificate of calibration from a 

laboratory. Information required in the 

record of accuracy for a reference device 

is essential for assuring that reference 

devices maintain their accuracy and 

ensures that the processor can establish 

an unbroken chain to trace the accuracy 

of the reference device to a standard 

device. 

The requirements in proposed 

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

(f)(1), and (g)(1)(i)(a) to establish and 

maintain written records of accuracy of 

temperature-indicating devices and 

reference devices, which include the 

identity of temperature-indicating 

devices and reference devices, are 

subject to the recordkeeping 

requirements of § 113.100. See the 

discussion later in this document 

relating to proposed revisions to 

§ 113.100. 

FDA is proposing to revise 

§ 113.40(g)(1)(ii)(e) by removing the 

requirement to observe and record the 

product temperature in the temperature 

recorder-controller at the final heater 

outlet in aseptic processing and 

packaging systems. The temperature in 

the final heater outlet may not be a 

critical factor in the scheduled process 

and, therefore, may not require 

maintenance of records. However, if the 

final heater outlet temperature is 

identified as a critical factor in the 

scheduled process, the temperature 

must be observed and recorded, as 

required in § 113.100(a). 

3. Metric Equivalents 

FDA is proposing to revise 

§ 113.40(a), (b), (c), (d), (e), (f), and (g) 

to provide metric equivalents of 

avoirdupois (U.S.) measurements. 

Currently, these regulations express 

temperature measurements in 

Fahrenheit (°F) units, length 

measurements in inches and feet, and 

pressure measurements in pounds per 

square inch. The proposed metric 

equivalents are provided in parenthesis 

in the text of the proposed regulation, 

immediately following the avoirdupois 

measurement. FDA is proposing to 

modify the current regulations to not 

only provide the temperature 

measurements in Fahrenheit, but to 

follow the Fahrenheit (°F) measure with 

the units in Celsius (°C). FDA is 

proposing to provide measurements 

currently in inches also in millimeters 

or centimeters, measurements currently 

in feet also in centimeters or meters, and 

measurements in pounds per square 

inch of pressure also in kilopascals. 

4. Temperature-Recording Devices 

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

(d)(2), (e)(2), (f)(2), and (g)(1)(i)(b) states 

that, ‘‘Graduations on the temperaturerecording devices shall not exceed 2 °F 

within a range of 10 °F of the processing 

temperature. Each chart shall have a 

working scale of not more than 55 °F per 

inch within a range of 20 °F of the 

processing temperature. The 

temperature chart shall be adjusted to 

agree as nearly as possible with, but to 

be in no event higher than, the known 

accurate mercury-in-glass thermometer 

during the process time.’’ When the 

regulations were published in the 1973 

final rule, temperature-recording 

devices generally recorded temperatures 

to paper charts and the paper charts 

served as the historical record of 

temperatures during processing. At that 

time, the terms ‘‘temperature-recording 

device’’ and ‘‘recording chart’’ were 

used interchangeably. However, because 

of advancements in technology, 

temperatures may now be recorded in a 

format other than the traditional chart 

that has a pre-printed time and 

temperature scale and may be recorded 

and maintained by mechanisms or 

devices other than recorders that use the 

traditional recording charts. The 

permanent record of temperatures may 

be in the form of an analog or graphical 

recording, such as a traditional chart 

with pre-printed time and temperature 

scale. The permanent record also may 

be an analog or graphical recording, for 

which the chart design, continuous 

temperature recordings or tracings, and 

date and time notations may be 

generated and printed by the 

temperature-recording device onto a 

blank paper, chart, or other medium as 

they are generated by the temperaturerecording device. Processors also are 

using temperature-recording devices, 

such as data loggers, that record 

numbers or create other digital 

recordings at established intervals, 

rather than providing continuous 

recordings on a chart. Therefore, FDA 

recognizes that the term ‘‘temperaturerecording device’’ does not necessarily 

imply that temperatures are being 

recorded to a ‘‘temperature-recording 

chart.’’ Thus, the ‘‘graduation’’ and 

‘‘working scale’’ requirements in the 

current regulation do not apply to all 

temperature-recording device records. 

The general term ‘‘temperaturerecording device’’ should be used when 

referring to the entire device that 

records temperatures and the term 

‘‘temperature-recording chart’’ should 

be used when referring to an actual 

chart that constitutes the mechanism by 

which the temperature-recording device 

records processing temperatures. The 

‘‘graduation’’ and ‘‘working scale’’

requirements specified in the current 

regulation are still applicable to the 

‘‘temperature-recording chart,’’ when 

used as the mechanism for recording 

processing temperatures. 

FDA, therefore, is proposing to revise 

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

(f)(2), and (g)(1)(i)(b) to provide 

flexibility for processors to use 

temperature-recording device advanced 

technology, to update terminology to 

reflect current and appropriate use of 

terms such as ‘‘temperature-recording 

device’’ and ‘‘temperature-recording 

chart,’’ to replace the terms ‘‘mercuryin-glass thermometer’’ and 


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‘‘thermometer’’ with ‘‘temperatureindicating device,’’ to replace the term 

‘‘bulb’’ with ‘‘sensor’’ (discussed later in 

this document), and to clarify the 

requirements for temperature-recording 

devices and the records created by the 

devices as follows: 

Temperature-recording device. Each 

retort, or product sterilizer, shall have 

an accurate temperature-recording 

device that records temperatures to a 

permanent record, such as a 

temperature-recording chart. 

Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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. 

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. 

5. Sensors 

FDA is proposing to revise 

§ 113.40(a), (b), (c), (d), (e), (f), and (g)(1) 

by replacing the term ‘‘bulb’’ or ‘‘bulb or 

sensor’’ with the general term ‘‘sensor’’

when referring generally to the sensing 

element of temperature-indicating 

devices, temperature-recording devices, 

and temperature-controlling devices. 

The sensing element of a mercury-inglass thermometer is called a ‘‘bulb’’ in 

the current regulations. The term 

‘‘sensor’’ encompasses ‘‘bulb’’ as well as 

other types of temperature-indicating 

device sensing elements, which are not 

bulbs. In the proposed regulation, the 

inclusive term ‘‘sensor’’ is used when 

referring to the sensor portion of a 

temperature-indicating device, which 

may be the bulb of a mercury-in glass 

thermometer, or to the sensing element 

or probe of a temperature-recording 

device or temperature-controlling 

device, which may include a mercuryin-glass thermometer as a component of 

the device. 

FDA is proposing to revise 

§ 113.40(b)(2) to clarify that, for still 

retort systems that pressure process in 

water and are equipped with 

combination recorder-controller sensors, 

the temperature recorder-controller 

sensors shall be located where the 

recorded temperature is an accurate 

measurement of the scheduled process 

temperature and is not affected by the 

heating media. Current § 113.40(b)(2) 

indicates specific requirements for 

placement of sensors for recordercontrollers, as follows: ‘‘The recordingthermometer bulb should be located 

adjacent to the bulb of the mercury-inglass thermometer, except in the case of 

a vertical retort equipped with a 

combination recorder-controller. In such 

vertical retorts, the temperature 

recorder-control bulb shall be located at 

the bottom of the retort below the lowest 

crate rest in such a position that the 

steam does not strike it directly. In 

horizontal retorts, the temperature 

recorder-control bulb shall be located 

between the water surface and the 

horizontal plane passing through the 

center of the retort so that there is no 

opportunity for direct steam 

impingement on the control bulb.’’

These requirements for placement of 

combination recorder-controller sensors 

were intended to ensure accurate 

measurement of the scheduled process 

temperature and were helpful specific 

directives for sensor placement when 

the regulations were published in 1973, 

based on retort designs at that time. 

However, it may be technologically 

feasible to comply with the specific 

requirements of the current regulation, 

but place the sensor in a location that 

does not accurately measure the 

scheduled process temperature. Thus, 

although the specific sensor location 

requirements of current § 113.40(b)(2) 

are still valid, FDA believes further 

clarification is needed to ensure that 

combination recorder-controller sensors 

are located where the recorded 

temperature is an accurate measurement 

of the scheduled process temperature 

and is not affected by the heating media. 

FDA is proposing to provide this 

clarification in new § 113.40(b)(2)(iv) as 

follows: 

• The temperature-recording device 

may be combined with the steam 

controller and may be a combination 

recording-controlling instrument. For a 

vertical retort equipped with a 

combination recorder-controller, the 

temperature recorder-controller sensor 

shall be located at the bottom of the 

retort below the lowest crate rest in such 

a position that the steam does not strike 

it directly. For a horizontal retort 

equipped with a combination 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. 

Air-operated temperature controllers 

should have adequate filter systems to 

ensure a supply of clean, dry air. 

FDA is proposing to clarify in 

§ 113.40(b)(9) that a sensor, in addition 

to a gage, water glass, or petcock, may 

be used to determine the water level in 

the retort during operation. For some 

water level indictors, the term ‘‘sensor’’

may more appropriately describe the 

mechanism that measures or detects the 

water level. 

FDA is proposing to revise 

§ 113.40(e)(1) to clarify requirements for 

placement of sensors of temperatureindicating devices in discontinuous 

agitating retorts used for pressure 

processing in water, i.e., a water 

immersion processing system. Current 

§ 113.40(e)(1) requires, ‘‘Bulbs of 

indicating thermometers shall be 

installed either within the retort shell or 

in external wells attached to the retort.’’

However, this basic, unqualified 

requirement to place sensors in the 

retort shell or in external wells may not 

be sufficient to ensure proper placement 

of temperature-indicating device sensors 

in discontinuous agitating retorts used 

for pressure processing in water. 

Current § 113.40(b)(1), relating to 

pressure processing in water in still 

retorts, also a water immersion process, 

clarifies that, ‘‘Bulbs of indicating 

thermometers shall be located in such a 

position that they are beneath the 

surface of the water throughout the 

process * * * this entry should be 

made in the side at the center, and the 

thermometer bulb shall be inserted 

directly into the retort shell * * * the 

thermometer bulbs shall extend directly 

into the water a minimum of at least 2 

inches without a separable well or 

sleeve.’’ This type of clarification 

relating to placement of temperatureindicating device sensors in still retorts 

used for pressure processing in water 

also applies to discontinuous retorts for 

pressure processing in water. Thus, FDA 

is proposing to revise § 113.40(e)(1) 

(proposed § 113.40(e)(1)(v)) by adding 

clarifying language relating to 

temperature-indicating device sensor 


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placement, similar to current 

§ 113.40(b)(1), as follows: 

• Each temperature-indicating device 

shall be installed where it can be 

accurately and easily read. The sensor of 

the temperature-indicating device shall 

be installed either within the retort shell 

or in an external well attached to the 

retort. Sensors of temperature-indicating 

devices shall be located in such a 

position that they are beneath the 

surface of the water throughout the 

process. This entry should be made in 

the side at the center, and the 

temperature-indicating device sensor 

shall be inserted directly into the retort 

shell. The temperature-indicating device 

sensor shall extend directly into the 

water a minimum of at least 2 inches 

(5.1 centimeters) without a separable 

well or sleeve. If a separate well or 

sleeve is used, there must be adequate 

circulation to ensure accurate 

temperature measurements. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

6. Vents 

FDA is proposing to revise 

§ 113.40(a)(12) to clarify that the 

‘‘installations and operating 

procedures’’ in § 113.40(a)(12)(i)(a) 

through (a)(12)(i)(d) and (a)(12)(ii)(a) 

and (a)(12)(ii)(b) do not apply to systems 

that use dividers between layers of 

containers. Current § 113.40(a)(12) 

states, in part, ‘‘Some typical 

installations and operating procedures 

reflecting the requirements of this 

section for venting still retorts are given 

in paragraph (a)(12)(i)(a) through 

(a)(12)(i)(d) and (a)(12)(ii)(a) and 

(a)(12)(ii)(b) of this section.’’ However, 

the placement of dividers between 

layers of containers in a still retort 

system was not a ‘‘typical installation or 

operating procedure’’ at the time the 

regulations were published in 1973. The 

venting procedures in current 

§ 113.40(a)(12) were based on heat 

penetration studies in retort systems 

without dividers and may be inadequate 

when dividers are placed between 

layers of containers. The dividers may 

interfere with heat distribution. 

Therefore, use of venting schedules 

developed for retorts without dividers 

may not be appropriate for retorts with 

dividers because such schedules may 

not be adequate to ensure that all areas 

of the retort, and thus all containers in 

the retort, reach the required processing 

temperature. FDA is proposing to add 

the phrase ‘‘without divider plates’’ to 

the last sentence of § 113.40(a)(12) as 

follows: 

• Some typical installations and 

operating procedures reflecting the 

requirements of this section for venting 

still retorts without divider plates are 

given in paragraph (a)(12)(i)(a) through 

(a)(12)(i)(d) and (a)(12)(ii)(a) and 

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

As required in current 

§ 113.40(a)(12)(iii), other installations 

and operating procedures, such as still 

retorts with divider plates, may be used 

if the processor has evidence, on file, in 

the form of heat distribution data that its 

installations and operating procedures 

accomplish adequate venting of air. 

Such documentation is likely to include 

heat distribution studies conducted and 

documented by the processor to show 

that the process temperature will be 

reached with the dividers in place. 

7. Screens 

Current § 113.40(b)(8) states, in part, 

‘‘Screens should be installed over all 

drain openings.’’ Current 

§ 113.40(b)(10)(ii) states, in part, ‘‘The 

suction outlets should be protected with 

nonclogging screens to keep debris from 

entering the circulating system.’’ These 

provisions are intended to advise 

processors that they are responsible for 

evaluating their water circulation 

systems and for ensuring that drain 

openings and suction outlets do not 

become clogged and prevent proper 

water circulation and proper heat 

distribution. Although the current 

regulation is expressed as a 

recommendation, rather than a 

requirement, processors are responsible 

for ensuring proper heat distribution 

during processing and, therefore, must 

ensure that heat distribution is not 

hampered by clogged drains or suction 

outlets. FDA is proposing to revise 

§ 113.40(b)(8) and 113.40(b)(10)(ii) to 

clarify the requirement, as follows: 

• 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. 

• 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 crosssection area of the outlet line from the 

pump. The suction outlets shall be 

protected with nonclogging screens or 

other suitable means shall be used to 

keep debris from entering the 

circulating system. The pump shall be 

equipped with a pilot light or other 

signaling device to warn the operator 

when it is not running, and with a 

bleeder to remove air when starting 

operations. Alternative methods for 

circulation of water in the retort may be 

used when established by a competent 

authority as adequate for even heat 

distribution. 

8. Air Supply and Controls and Water 

Circulation 

FDA is proposing editorial changes to 

§ 113.40(e)(6). At the beginning of the 

first complete sentence, the word 

‘‘Means’’ is changed to ‘‘A means’’ and 

the sentence was changed from a 

compound sentence to two simple 

sentences. FDA also is proposing to 

renumber § 113.40(e)(6) as 

§ 113.40(e)(6)(i), to read as follows: 

• Air supply and controls. A means 

shall be provided for introducing 

compressed air at the proper pressure 

and rate. The proper pressure shall be 

controlled by an automatic pressure 

control unit. A check valve shall be 

provided in the air supply line to 

prevent water from entering the system. 

FDA is proposing to revise 

§ 113.40(e)(6) to include requirements 

for water circulation pressure 

processing in water in discontinuous 

agitating water retorts, similar to the 

requirements in current 

§ 113.40(b)(10)(ii) for pressure 

processing in water in still retorts. 

Current § 113.40(b) and (e) both 

establish equipment and procedures for 

pressure processing in water. Section 

113.40(b) applies to still retorts and 

§ 113.40(e) applies to discontinuous 

agitating retorts. The retort systems are 

operationally similar in that they use 

water under pressure, which must be 

circulated to ensure appropriate heat 

distribution. FDA considers the water 

circulation requirements in § 113.40(b) 

for still retorts also apply to 

discontinuous agitating retorts. Because 

they are basic procedures for assuring 

even heat distribution when pressure 

processing in water, FDA currently 

considers these requirements when 

evaluating scheduled processes for 

pressure processing in water in 

discontinuous agitating retorts. FDA is 

proposing to clarify the water 

circulation procedures for pressure 

processing in water in discontinuous 

agitating retorts by adding new 

§ 113.40(e)(6)(ii) as follows: 

• Water circulation. When a water 

circulating system is used for heat 

distribution, it shall be installed in such 

a manner that water will be drawn from 

the bottom of the retort through a 

suction manifold and discharged 

through a spreader which extends the 


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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 crosssection area of the outlet line from the 

pump. The suction outlets shall be 

protected with nonclogging screens or 

other suitable means shall be used to 

keep debris from entering the 

circulating system. The pump shall be 

equipped with a pilot light or other 

signaling device to warn the operator 

when it is not running, and with a 

bleeder to remove air when starting 

operations. Alternative methods for 

circulation of water in the retort may be 

used when established by a competent 

authority as adequate for even heat 

distribution. 

9. Drain Valve and Water Level 

Indicator 

FDA is proposing to revise § 113.40(e) 

to include requirements for the drain 

valve and water level indicator in 

discontinuous agitating water retorts, 

similar to the requirements in current 

§ 113.40(b)(8) and (b)(9), respectively, 

for pressure processing in water in still 

retorts. As previously explained, the 

retort systems for which equipment and 

procedures are established § 113.40(b) 

and (e) are operationally similar in that 

they use water under pressure. The 

basic requirements for the drain valve 

and water level indicator in § 113.40(b) 

for still retorts also should apply to 

discontinuous agitating retorts. FDA is 

proposing to add new § 113.40(e)(7) for 

drain valve, consistent with proposed, 

revised § 113.40(b)(8), discussed 

previously in this document, and is 

proposing new § 113.40(e)(8) for water 

level indicator, consistent with 

proposed, revised § 113.40(b)(9), as 

follows: 

• 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. 

• Water level indicator. There shall be 

a means of determining the water level 

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

using a sensor, gage, water glass, or 

petcock(s). Water shall cover the top 

layer of containers during the entire 

come-up-time and processing periods 

and should cover the top layer of 

containers during the cooling periods. 

The operator shall check and record the 

water level at intervals sufficient to 

ensure its adequacy. 

Because FDA is proposing new 

§ 113.40(e)(7) and (e)(8), as discussed 

previously in this document, we also are 

proposing to renumber current 

§ 113.40(e)(7), relating to critical factors, 

as § 113.40(e)(9). 

10. Temperature-Recording Device 

Sensors 

Current 113.40(g)(1)(i)(b) requires that 

a temperature-recording device shall be 

installed in the product at the holdingtube outlet between the holding tube 

and the inlet to the cooler. In addition, 

to comply with current § 113.40(g)(4), 

processors must identify where 

temperature is a critical factor in the 

scheduled process and must measure 

and record the temperatures that are 

critical factors. For example, when 

processing a non-liquid product or a 

product that contains solid particles, 

heat penetration of the solid and liquid 

portions may vary and the temperature 

at locations other than the holding-tube 

outlet may be critical to ensure effective 

heat penetration throughout the 

product. Processors must determine 

each point in the process where 

temperature is a critical factor for either 

the solid or liquid portion of the 

product and must place temperaturerecording device sensors at those 

locations. Thus, processors must 

determine where temperature 

measurements are critical, based on the 

size and texture of particles in the food, 

and must locate sensors as necessary to 

ensure that the process temperature is 

reached and maintained throughout the 

process. FDA is proposing to clarify the 

requirement for temperature-recording 

device sensors by adding the following 

statement to § 113.40(g)(1)(i)(b): 

• Additional temperature-recording 

device sensors shall be located at each 

point where temperature is specified as 

a critical factor in the scheduled 

process. 

11. Flow Control 

FDA is proposing to revise 

terminology in § 113.40(g)(1)(i)(f) by 

changing the title of the section from 

‘‘Metering pump’’ to ‘‘Flow control’’ by 

replacing the terms ‘‘metering pump’’

and ‘‘speed adjusting device’’ with 

‘‘flow controlling device,’’ and by 

replacing the term ‘‘speed changes’’

with ‘‘flow adjustments.’’ The broad 

term ‘‘flow controlling device’’

encompasses ‘‘metering pump’’ and 

‘‘speed adjusting device’’ as well as 

other terms that may be used, such as 

metering device or flow control meter, 

to describe or identify equipment used 

to control product flow in the 

processing system. Similarly, use of the 

term ‘‘flow adjustments’’ is consistent 

with and broadly describes the function 

of flow controlling devices. The 

proposed revision of the title of the 

section to ‘‘Flow control’’ is consistent 

with the terminology changes within the 

text of proposed § 113.40(g)(1)(i)(f). 

B. Containers (§ 113.60) 

Current § 113.60(a) requires 

processors to ensure proper closure and 

to check for closure defects. This 

responsibility should have extended to 

postprocess handling. However, current 

§ 113.60(a) does not specifically address 

postprocess handling and current 

§ 113.60(d) relating to postprocess 

handling recommends, but does not 

require, processors to design and 

operate automatic equipment used in 

handling filled containers to preserve 

the can seam and container closure 

integrity. Container handling 

equipment, including automated and 

non-automated equipment, must be of 

appropriate equipment design and 

construction, operated to ensure 

container closure integrity, and replaced 

or repaired if defective to ensure proper 

container closure. Otherwise, container 

handling equipment may be the source 

of damage to the can seam and may 

prevent proper seam closure. Improper 

seam closures may lead to 

contamination of the previously 

sterilized product in the can. FDA is 

proposing to revise § 113.60(d) to 

change the term ‘‘automatic equipment’’

to ‘‘container handling equipment,’’ to 

clarify that container handling 

equipment used in handling filled 

containers shall be designed, 

constructed, and operated to preserve 

can seam or other container closure 

integrity, and to clarify that processors 

must check and, as necessary, repair or 

replace the container handling 

equipment, including conveyors and 

non-automated equipment, to ensure 

that they do not damage the containers 

and container closures as follows: 

• Postprocess handling. Container 

handling equipment used in handling 

filled containers shall be designed, 

constructed, and operated to preserve 

the can seam or other container closure 

integrity. Container handling 

equipment, including automated and 

non-automated equipment, shall be 

checked at sufficient frequency and 

repaired or replaced as necessary to 

prevent damage to containers and 

container closures. When cans are 

handled on belt conveyors, the 

conveyors should be constructed to 

minimize contact by the belt with the 

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

rolled on the double seam. All worn and 

frayed belting, can retarders, cushions, 

etc. should be replaced with new 

nonporous material. All tracks and belts 

that come into contact with the can 

seams should be thoroughly scrubbed 

and sanitized at intervals of sufficient 

frequency to avoid product 

contamination. 


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C. Establishing Scheduled Processes 

(§ 113.83) 

Current § 113.83 states, ‘‘The type, 

range, and combination of variations 

encountered in commercial production 

shall be adequately provided for in 

establishing the scheduled process.’’

Reprocessing of a product and blending 

a previously processed product into a 

new formulation are variations that may 

affect the adequacy of the scheduled 

process and, therefore, must be carefully 

evaluated and adequately addressed in 

the scheduled process. For example, 

because starch, when heated, is 

gelatinized, a processed starchy food 

may have a different viscosity than the 

same starchy food prior to processing. 

When a previously processed starchy 

food is blended or reprocessed, because 

of physical changes in the 

characteristics of the food, the 

scheduled process used for the starchy 

food prior to processing may not be 

adequate for the same food after 

processing. Thus, the scheduled process 

must be established based on the 

specific food used as the starting 

material for each specific process, i.e., 

when a reprocessed or a previously 

processed product is blended into a new 

formulation, the scheduled process 

must be specific for that situation. FDA 

is proposing to clarify this requirement 

by revising § 113.83 to include the 

statement, ‘‘When a product is 

reprocessed or a previously processed 

product is blended into a new 

formulation, this condition must be 

covered in the scheduled process.’’

D. Operations in the Thermal Processing 

Room (§ 113.87) 

FDA is proposing to revise § 113.87(c) 

by inserting the term ‘‘accurately’’ in the 

first sentence to clarify that ‘‘The initial 

temperature of the contents of the 

containers to be processed shall be 

accurately determined and recorded 

with sufficient frequency to ensure that 

the temperature of the product is no 

lower than the minimum initial 

temperature specified in the scheduled 

process.’’ FDA is adding this term to 

emphasize that initial temperature 

determinations must be accurate, as 

determined by sufficiently frequent tests 

of the temperature-indicating device for 

accuracy against an accurate calibrated 

reference device. FDA also is proposing 

to add in § 113.87(c), ‘‘The temperatureindicating device used to determine the 

initial temperature shall be tested for 

accuracy against an accurate calibrated 

reference device at sufficient frequency 

to ensure that initial temperature 

measurements are accurate. Records of 

the accuracy tests shall be signed or 

initialed, dated, and maintained.’’

Although FDA believes it should be 

understood that initial temperature 

measurements are expected to be 

accurate when taken and, therefore, the 

temperature-indicating device used for 

initial temperatures must be accurate, 

the proposed clarifications ensure 

consistency in interpretation of the 

requirements of § 113.87(c). 

FDA is proposing to revise § 113.87(e) 

to replace the term ‘‘recordingtemperature charts’’ with ‘‘temperaturerecording device records’’ to ensure 

consistency with the changes in 

terminology relating to the use of the 

term ‘‘charts,’’ discussed previously in 

this document in changes to proposed 

revised § 113.40. FDA also is proposing 

to change the recommendation for clock 

times to reasonably correspond to the 

time of the day to a requirement by 

changing the word ‘‘should’’ to ‘‘shall.’’

Correlation of records with the time the 

records were created and with the time 

of the processing cycle is essential for 

evaluating time and temperature 

correlations of the scheduled process. 

This revision also is consistent with the 

requirement of § 113.100(a), ‘‘Processing 

and production information shall be 

entered at the time it is observed by the 

retort or processing system operator 

* * *.’’ Proposed revised § 113.87(e) 

would read as follows: 

• Clock times on temperaturerecording device records shall 

reasonably correspond to the time of 

day on the written processing records to 

provide correlation of these records. 

E. Processing and Production Records 

(§ 113.100) 

Current § 113.100 identifies 

requirements for processing and 

production records. FDA is proposing in 

§ 113.100 to revise terminology, 

consistent with terminology used in 

proposed § 113.40. FDA is proposing to 

replace the term ‘‘mercury-in-glass 

thermometer’’ with ‘‘temperatureindicating device,’’ to replace 

‘‘recording thermometer’’ with 

‘‘temperature-recording device,’’ to 

replace ‘‘metering pump’’ with ‘‘flow 

controlling device,’’ and to replace 

‘‘recording thermometer charts’’ with 

‘‘temperature-recording device records.’’

FDA is proposing to revise 

§ 113.100(a)(4) by removing the 

requirement to maintain records of the 

product temperature in the final heater 

outlet as indicted by the temperature 

recorder-controller in aseptic processing 

and packaging systems. The temperature 

in the final heater outlet may not be 

critical and, therefore, may not require 

maintenance of records. However, if the 

final heater outlet temperature is 

identified as a critical factor in the 

scheduled process, the temperature 

must be observed and recorded, as 

required in § 113.100(a). 

FDA is proposing to revise 

§ 113.100(c) by adding the statement, 

‘‘The records shall be signed or initialed 

and dated by the reviewer.’’ The current 

regulation requires that containers 

closure records shall be signed or 

initialed by the container closure 

inspector and reviewed by management, 

but it does not explicitly state that the 

person in management who reviews the 

records must also sign or initial and 

date the records. FDA is proposing to 

add this requirement because such 

documentation is necessary to identify 

the manager who conducted the review 

and thus avoid any misunderstandings 

about who reviewed the record, to verify 

that the review was conducted by an 

individual qualified by training and 

expertise relating to container closures 

who can accept the records for the 

processor, to identify the person 

responsible for ensuring following-up to 

correct container closure defects, and to 

indicate that the records have been 

accepted by the processor. 

FDA is proposing to add a new 

§ 113.100(f) to provide for the 

maintenance of computerized records, 

in accordance with part 11 (21 CFR part 

11). FDA regulations in part 11 set forth 

FDA criteria for electronic records and 

signatures. Many low-acid canned food 

processors currently maintain records 

on computers. The proposed addition of 

new § 113.100(f) clarifies and 

acknowledges that records relating to 

processing low-acid canned foods may 

be maintained electronically, provided 

they are in compliance with part 11. 

FDA is proposing to add a new 

§ 113.100(g) to clarify that records 

required under part 113, or copies of 

such records, must be readily available 

during the retention period for 

inspection and copying by FDA when 

requested. Proposed § 113.100(g) 

provides that, in part, ‘‘if reduction 

techniques, such as microfilming, are 

used, a suitable reader and 

photocopying equipment must be made 

readily available to FDA.’’ Access to 

such records during inspections is 

needed by FDA field investigators to 

evaluate compliance with the 

requirements of part 113. Copies of such 

records are needed for review by FDA 

headquarters staff experts who evaluate 

complex scientific and technical issues 

associated with processing low-acid 

canned foods and with compliance with 

the requirements of part 113. 


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F. Minor Revisions in Regulations 

FDA is proposing to correct 

typographical errors, revise sentence 

structure, and make minor clarifying 

edits in the regulations, as follows: 

In proposed § 113.40(a)(4), (a)(8), 

(b)(10)(i), (c)(5), and (e)(6)(i), we 

changed compound sentences to simple 

sentences. 

In the first sentence of proposed 

§ 113.40(b)(10)(ii), we changed the word 

‘‘is’’ to ‘‘it.’’

In the third sentence of proposed 

§ 113.40(d)(2)(iv), we changed the 

phrase ‘‘bleeder opening emitting 

steam’’ to ‘‘bleeder that emits steam.’’

In the second sentence of proposed 

§ 113.40(e)(1)(v), we changed the phrase 

‘‘in external wells’’ to ‘‘in an external 

well.’’

In the fifth sentence of proposed 

§ 113.40(e)(9), we corrected the spelling 

of ‘‘vacuum.’’

In the first sentence of proposed 

§ 113.40(g)(1)(i)(G), we corrected the 

spelling of ‘‘continuous.’’

In the third sentence of proposed 

§ 113.100(b), we changed the word 

‘‘that’’ to ‘‘than.’’

G. Immediate Implementation of 

Proposed Rule 

FDA believes the proposed revisions 

to §§ 113.40, 113.60, 113.83, 113.87, and 

113.100 will provide industry with 

flexibility to take advantage of 

technological advancements associated 

with temperature-indicating devices and 

temperature-recording devices, will 

clarify recordkeeping requirements for 

temperature-indicating devices and 

other aspects of processing low-acid 

canned foods, and will clarify 

provisions of the current regulations. 

FDA believes that the proposed rule will 

ensure that temperature-indicating 

devices that replace mercury-in-glass 

thermometers are accurate during 

processing. FDA also believes the 

proposed rule allows industry to 

voluntarily transition from mercury-inglass thermometers to other 

temperature-indicating devices and to 

reduce potential sources of mercury 

contamination in food processing 

plants. 

FDA believes that some processors are 

anxious to replace mercury-in-glass 

thermometers with alternative 

temperature-indicating devices. 

Therefore, pending issuance of a final 

rule, FDA intends to consider the 

exercise of its enforcement discretion on 

a case-by-case basis when processors of 

low-acid canned food elect to replace 

mercury-in-glass thermometers with 

alternative temperature-indicating 

devices in a manner that is consistent 

with the proposed rule. The act’s 

enforcement provisions commit 

complete discretion to the Secretary of 

Health and Human Services (and by 

delegation to FDA) to decide how and 

when they should be exercised (see 

Heckler v. Chaney, 470 U.S. 821 at 835 

(1985); see also Shering Corp. v. 

Heckler, 779 F.2d 683 at 685–86 (D.C. 

Cir. 1985) (stating that the provisions of 

the act ‘‘authorize, but do not compel 

the FDA to undertake enforcement 

activity’’)). Until the agency issues a 

final rule for temperature-indicating 

devices for thermally processed lowacid foods packaged in hermetically 

sealed containers, the agency believes 

that its exercise of enforcement 

discretion will provide the needed 

flexibility to manufacturers who desire 

to transition to alternative temperatureindicating devices. Processors who 

choose to use alternative temperatureindicating devices must comply with 

any revised requirements established in 

the final rule when the final rule 

becomes effective. 

IV. Analysis of Impacts 

A. Preliminary Regulatory Impact 

Analysis: Flexibility in Permitting 

Alternative Temperature-Indicating 

Devices 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, the Regulatory Flexibility Act 

(the RFA) (5 U.S.C. 601–612), and the 

Unfunded Mandates Reform Act of 1995 

(Public Law 104–4). Executive Order 

12866 directs agencies to assess all costs 

and benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this proposed rule is not a 

significant regulatory action as defined 

by the Executive order. 

1. Need for the Regulation 

Current regulations for thermally 

processed low-acid foods in 

hermetically sealed containers, except 

for aseptic packaging and processing, 

require the exclusive use of mercury-inglass 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 food industry. 

Moreover, NIST has developed 

standards for some alternative 

temperature-indicating devices and 

there is little reason to assume that 

alternatives are any less accurate than 

mercury-in-glass thermometers, given 

an appropriate testing regime. We 

request comments on the possibility that 

alternative temperature-indicating 

devices are at least as accurate as 

mercury-in-glass thermometers, and also 

that there are appropriate and 

established testing regimes to assure 

their accuracy. 

Correspondence with industry 

representatives suggests that the current 

regulation requiring mercury-in-glass 

thermometers may be a barrier to 

innovation (Ref. 3). By allowing the lowacid food industry flexibility to choose 

alternative temperature-indicating 

devices, the proposed rule would allow 

processors to select temperatureindicating devices based on gains to 

labor productivity and technical 

considerations. Clarifying provisions in 

the current regulation would facilitate 

the voluntary adoption and safe use of 

alternative temperature-indicating 

technology, as well as replace outdated 

terminology. 

The potential to improve productivity 

may be one reason firms may choose to 

adopt alternatives to mercury-in-glass 

thermometers. Correspondence with the 

Food Products Association (FPA) 

(formerly, National Food Processors 

Association) suggests that monitoring 

and analysis capabilities from using 

alternative temperature-indicating 

devices may be enhanced (Ref. 3). In 

addition, the potential to avoid costly 

remediation of hazardous mercury 

spills, and growing concerns by State 

and local governments about the health 

effects from the accumulation of 

mercury in the environment, have led to 

legislation that restricts the sale, 

manufacture, and distribution of 

mercury-in-glass thermometers (Ref. 4). 

For these reasons, FPA correspondence 

suggests that low-acid food processors 

are phasing out the use of mercury-inglass thermometers for all other 

purposes except those necessary for 

regulatory compliance. 

2. Regulatory Options Considered 

Regulatory options considered 

include: 

Option 1—No new regulation. 

Option 2—Allow flexibility to use 

alternative temperature-indicating 

devices, including mercury-in-glass 

thermometers, that can be tested against 

an accurate calibrated reference device 

in processing low-acid canned foods 

without an explicit record requirements. 


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Option 3 (the Proposed Rule)—All of 

the provisions in option 2 and include 

explicit recordkeeping requirements for 

test results and explicit records access 

requirements for required records. 

3. Costs and Benefits of Option 1 (No 

New Regulation) 

There are neither costs nor benefits 

from the option of no new regulation. 

4. Costs and Benefits of Option 2 (Allow 

the Use of Alternative TemperatureIndicating Devices Without a Record 

Requirement for Accuracy Tests) 

The costs and benefits are estimated 

separately for the proposed voluntary 

and mandatory provisions of the rule. 

The voluntary provision allows lowacid canned food manufacturers to use 

alternatives to mercury-in-glass 

thermometers as temperature-indicating 

devices. In option 2, the mandatory 

provisions are considered to be 

clarifications of the current regulation 

and are primarily intended to facilitate 

the voluntary adoption and safe use of 

alternative temperature-indicating 

technologies. Option 2 does not 

consider requirements for low-acid 

canned food manufacturers to establish 

and maintain records on accuracy tests 

necessary to ensure that each 

temperature-indicating device, 

including each mercury-in-glass 

thermometer, and each reference device 

is accurate during processing. Nor does 

option 2 consider requirements for FDA 

access to such records upon inspection. 

There are no compliance costs from 

allowing alternative temperatureindicating devices. The benefits from 

allowing alternative temperatureindicating devices are from any 

reduction of the risk of foodborne 

illness that results from the use of 

alternative temperature-indicating 

devices, the avoided cleanup and 

disposal costs resulting from breaking 

mercury-in-glass thermometers during 

non-production times, and the increase 

in labor productivity at low-acid canned 

food manufacturers. 

a. Costs from permitting the use of 

alternative temperature-indicating 

devices. The proposed regulation 

permits, but does not require, low-acid 

food manufacturers to adopt alternatives 

to mercury-in-glass thermometers. Thus, 

costs associated with choosing an 

alternative to mercury-in-glass 

thermometers are voluntarily incurred. 

These costs would be incurred only if 

the expected private benefits from doing 

so are higher than the costs. To show 

our estimation method and solicit 

comments, we specify the determinants 

of the costs of alternative temperatureindicating devices. 

Higher purchase prices and 

maintenance costs may influence a 

firm’s decision to use alternative 

temperature-indicating devices. 

Correspondence with FPA suggests that 

most digital alternatives are slightly 

more expensive than mercury-in-glass 

thermometers (Ref. 3). According to 

FPA, after installation, there are no 

significant differences in maintenance 

costs during normal operations between 

mercury-in-glass thermometers and 

alternative temperature-indicating 

devices (Ref. 3). Thus, the higher cost 

would be a one-time capital cost. FPA 

also suggests that many firms are using 

alternative temperature-indicating 

device technology for purposes that are 

beyond the scope of the low-acid food 

regulations (Ref. 3). This implies that 

the productivity gains from their 

adoption are greater than the higher 

purchase prices. 

Temperature-indicating devices must 

be tested against an accurate calibrated 

reference device, including tests relating 

to relevant factors such as 

electromagnetic interference and 

environmental conditions. 

Environmental conditions may affect 

the accuracy of mercury-in-glass 

thermometers. Thus, low-acid food 

manufacturers have experience with 

understanding and controlling these 

factors to ensure that mercury-in-glass 

thermometers are accurate and function 

properly during processing. Tests to 

ensure that alternative temperatureindicating devices are not susceptible to 

electromagnetic interference may result 

in higher costs for testing and 

maintaining the devices. 

FPA suggests that many companies 

already use alternative temperatureindicating devices for unregulated 

purposes, and that the use of mercuryin-glass thermometers in these 

establishments is restricted to regulatory 

compliance purposes (Ref. 3). In the 

event that alternative temperatureindicating devices currently used by 

industry for unregulated purposes are 

tested against an accurate calibrated 

reference device, the experience of their 

use for the unregulated purpose would 

likely mitigate any additional learning, 

or adjustment costs for their testing. 

Nevertheless, one-time adjustment costs 

are likely to be incurred by all low-acid 

canned food manufacturers that adopt 

alternative temperature-indicating 

device technology—especially early 

adopters of such technology—as they 

adjust to new testing protocols and 

appropriate testing frequencies. FDA 

assumes that, after testing protocols and 

frequencies are established, the testing 

costs will be comparable to those 

required for testing mercury-in-glass 

thermometers. FDA requests comments 

on the magnitude of the costs (if any) 

associated with learning about and 

adjusting to testing requirements for 

alternative temperature-indicating 

devices, as well as our assumption that 

testing costs for alternative temperatureindicating devices, subsequent to the 

initial establishment of testing 

protocols, are comparable to those for 

mercury-in-glass thermometers. 

Finally, we assume that firms able to 

achieve gains in labor productivity and 

reduce remediation costs will phase in 

alternative temperature-indicating 

devices. One firm predicted that 

alternative temperature-indicating 

devices will be chosen for all new 

purchases immediately following 

issuance of the final rule, and that the 

total period for transition from mercuryin-glass thermometers to alternative 

temperature-indicating devices will be 5 

years (Ref. 3). FDA assumes that all midsized and large low-acid canned food 

manufacturers will adopt alternative 

temperature-indicating device 

technology within 5 years after issuance 

of the final rule. We request comments 

on this assumption. 

b. Benefits from permitting the use of 

alternative temperature-indicating 

devices. 

Changes in the Risk of Foodborne 

Illness 

The Centers for Disease Control and 

Prevention (CDC) report that there were 

20 cases of foodborne botulism and 76 

cases of infant botulism in the United 

States in 2003 (Ref. 5). There have been 

no reported cases of foodborne botulism 

associated with commercially canned 

low-acid food in recent years. CDC 

reported one case of botulism from food 

eaten at a restaurant and one case from 

food eaten at an unknown location in 

1994, but home-canned food and Alaska 

Native foods consisting of fermented 

seafood are currently the principal 

sources of foodborne botulism (Ref. 5). 

The risk factors for infant botulism, 

including from food and non-food 

sources, remain largely unknown. 

Although cases of botulism are mostly 

associated with food prepared or canned 

at home, a change to inaccurate or 

improperly functioning temperatureindicating devices by low-acid canned 

food manufacturers could potentially 

increase the risk of foodborne botulism. 

Increased risk of botulism associated 

with new technology could result from 

increased risk of device errors for 

indicating and recording temperatures, 

or an increased risk of human errors in 

reading alternative temperatureindicating devices. An increased risk of 

illness could accompany an increased 

risk of such errors that lead to food 


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being processed at unsafe low 

temperatures. 

To acknowledge the potential for 

increased risk associated with the 

adoption of alternative technologies 

mentioned previously in this document, 

this proposed rule requires alternative 

temperature-indicating devices to be 

tested for accuracy against an accurate 

calibrated reference device. The 

proposed rule also requires tests relating 

to relevant factors such as 

electromagnetic interference and 

environmental conditions. Alternatives 

to the mercury-in-glass thermometer 

that meet NIST requirements are 

currently available to the industry and 

we assume that such technology is at 

least as accurate as mercury-in-glass 

thermometers given an appropriate 

testing regime. 

There may be a period of learning and 

adjustment to the new temperatureindicating technology for a short period 

immediately following its adoption, 

during which the risk of inaccurate 

measurement may be temporarily 

elevated. We assume that the frequency 

of testing for accuracy during this 

adjustment period may increase for a 

short time to compensate for any 

increased risk of inaccurate 

measurement from the new technology. 

Consequently, we assume that any 

increases in risk during the adjustment 

period will be fully mitigated through 

appropriate or increased testing. We 

request comments on this assumption. 

An increase in risk of illness could 

arise from an increase in human error in 

reading the alternative temperatureindicating device. However, we assume 

that the alternatives to the mercury-inglass thermometer are likely to be no 

more difficult to read than mercury-inglass thermometers. Thus, we expect no 

increase in the number of reading errors. 

Some alternative temperature-indicating 

devices may have a digital display of the 

temperature and may be easier to read 

than mercury-in-glass thermometers. 

However, there is also the possibility 

that certain digital displays with poor 

resolution may facilitate reading errors. 

In addition, the magnitude of a reading 

error from a digital display may be 

different than that from a mercury-inglass thermometer. The relative risk of 

misreading a digit displayed in the 

‘‘tens’’ and ‘‘ones’’ columns may be 

different for digital displays compared 

to the conventional mercury-in-glass 

thermometers. Although we assume no 

increase in the risk of reading errors for 

digital devices, we request comments on 

this assumption. 

Avoided Cleanup Costs 

The principal benefit from allowing 

flexibility in the use of temperatureindicating device technology by lowacid canned food manufacturers is the 

reduced risk of cleanup and disposal 

costs resulting from breaking mercuryin-glass thermometers during nonproduction times (e.g., calibration, 

equipment maintenance, storage). 

Disposal and cleanup costs for mercury 

spills and damaged mercury-in-glass 

thermometers can be high. FPA 

estimates the cost of environmental 

disposal of mercury-in-glass 

thermometers to be about $500 (Ref. 3). 

Examples of cleanup costs provided by 

the Northeast Waste Management 

Officials’ Association include the $6,000 

cleanup costs paid by a school following 

the breakage of 12 thermometers (Ref. 

6), or approximately $500 per 

thermometer. According to Harvard 

University Operations Services, mercury 

spills involving thermometer breakage 

are one of the most common accidents 

involving laboratory equipment, with 

cleanup costs of approximately $110 per 

thermometer (Ref. 7). 

Mercury-in-glass thermometer 

breakage can occur within the 

processing plant during calibration, 

equipment maintenance, storage, and 

other non-production times. Because we 

do not have accident data from 

processors, we estimate mercury-inglass thermometer breakage rates using 

information on accident rates involving 

laboratory equipment. According to a 

2004 bulletin published by the 

Lawrence Berkeley Laboratory, the 

annual number of laboratory accident 

rates for 2002, 2003, and 2004 was 2.17, 

2.51, and 1.25 per 100 employees 

(respectively), for an annual average of 

approximately 2 per 100 employees 

(Ref. 8). 

Using 2002 U.S. Economic Census 

data on the number of employees in the 

low-acid canned food industry, we 

extrapolated the laboratory accident 

rates reported previously in this 

document. There were reported to be 

78,016 employees in the canned food 

industry (North American Industry 

Classification System (NAICS) codes 

311421, 311422, and 311514 for fruits 

and vegetables canning, specialty 

canning, and seafood canning) in 2002 

(Ref. 9). We assume that half of all 

employees of canning manufacturers are 

involved in the manufacturing process. 

We further assume that half of the 

employees involved in the 

manufacturing process will come into 

direct contact with mercury-in-glass 

thermometers at some point during the 

performance of their jobs. This yields an 

estimate of 19,504 employees of lowacid canned food manufacturers that 

come into direct contact with 

temperature-indicating devices. 

Based on the laboratory accident rates 

reported previously, we estimate that 

there are approximately 390 

manufacturing process related accidents 

per year (i.e., (19,504 / 100) x an 

accident rate of 2) in the low-acid 

canned food industry. We assume that 

half of these accidents involve 

equipment that comes directly in 

contact with mercury-in-glass 

thermometers, and half of those, or 

approximately 100, involve mercury-inglass thermometer breakage and require 

remediation in the form of cleanup and 

disposal. 

We estimate that all large and midsized low-acid canned food 

manufacturers will adopt alternative 

temperature-indicating device 

technology because of the potential 

savings in cleanup costs as well as the 

potential for increased productivity 

made possible from alternative 

temperature-indicating devices. There 

currently are approximately 1,100 

domestic and 5,600 foreign-based lowacid canned food manufacturers 

registered with FDA that supply the 

domestic market (Ref. 10). Because that 

data does not include firm size 

information, we estimate the proportion 

of large and mid-sized domestic lowacid canned food manufacturers using 

U.S. Economic Census data, and assume 

the same proportions of large and midsized foreign firms as well. 

Based on the 2002 U.S. Economic 

Census there were a total of 1,051 fruit 

and vegetable, specialty canning, and 

dry, condensed, and evaporated dairy 

product manufacturing establishments 

reported for NAICS codes 311421, 

311422, and 311514, and that large and 

mid-sized establishments (i.e., 

establishments with more than 19 

employees) comprise approximately 

half of the total. Consequently, we 

estimate that if half of the low-acid food 

manufacturers were to discontinue use 

of mercury-in-glass thermometers as 

provided in the proposed rule, 

approximately 50 domestic accidents 

per year involving mercury-in-glass 

thermometers would be avoided (i.e., 

100 accidents divided by 2 for large and 

mid-sized establishments) and 255 

foreign-based accidents per year 

involving mercury-in-glass 

thermometers would be avoided (i.e., 

100 accidents, scaled by the ratio of 

foreign to domestic firms, 5,600 / 1,100, 

and divided by 2 for large and mid-sized 

firms) that would otherwise incur 

cleanup and disposal costs during nonproduction times. Implicit in this 

estimate is the assumption that the 

accident rates for domestic and foreignbased manufacturers are the same. We 

request comments on this assumption. 


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We assume that each accident 

involves one mercury-in-glass 

thermometer. In addition, we assume 

that cleanup and remediation costs per 

accident are the same for foreign-based 

and domestic low-acid canned food 

manufacturers. Consequently, we 

estimate that after half of the low-acid 

canned foods manufactures adopt 

alternative temperature-indicating 

device technology, between $5,500 and 

$25,000 in remediation costs (i.e., 50 

accidents x $110, and 50 accidents x 

$500) would be averted by domestic 

manufacturers, and between $25,000 

and $127,000 in remediation costs (i.e., 

255 accidents x $110, and 255 accidents 

x $500, rounded to the nearest 

thousand) would be averted by foreignbased manufacturers. Total remediation 

costs averted would be between $30,500 

and $152,000. 

Increased Productivity from Allowing 

Alternative Technologies 

We use U.S. Department of Labor 

estimates of changes in labor 

productivity from 1995 to 2004 to 

estimate the savings to large, mid-sized, 

and small firms from improved 

temperature monitoring and 

recordkeeping productivity that may 

result from using alternative 

temperature-indicating devices. We 

assume that cost savings and increases 

in labor productivity from adopting 

alternative temperature-indicating 

technology would be the same for 

domestic and foreign-based firms of 

similar size. 

We computed the average of the U.S. 

Department of Labor quarterly estimates 

of the percent change in quarterly 

output per hour (expressed in annual 

terms) in the non-farm business sector 

over the 10-year period from 1996 

through 2005 to be 2.8 percent (Ref. 11). 

We estimated that productivity gains to 

labor engaged in monitoring 

temperature sensitive processes by lowacid canned food manufacturers that 

adopt alternative temperature-indicating 

technology would be 2.8 percent as 

well. 

We assume that monitoring 

temperature sensitive processes requires 

the equivalent of one full time job at 

large establishments, half a full time job 

at mid-sized establishments, and one 

quarter of a full time job at small 

establishments. We doubled the mean 

hourly wage of $13.55 for production 

labor in 2002, obtained from the Bureau 

of Labor Statistics (Ref. 12), to account 

for overhead costs and estimated that 

adopting new temperature-indicating 

technology could increase labor 

productivity by as much as $0.76 per 

hour (i.e., 2.8 percent x $27.10) at large 

establishments, $0.38 per hour at midsized establishments (i.e., 2.8 percent 

divided by 2 x $27.10), and $0.19 per 

hour at small establishments (i.e., 2.8 

percent divided by 4 x $27.10). 

5. Costs and Benefits of Option 3, the 

Proposed Rule (Option 2 With Added 

Recordkeeping and Records Access 

Requirements) 

a. Costs of the recordkeeping and 

records access requirements. The 

current low-acid food regulations 

recommend, but do not require, that 

records of thermometer accuracy checks 

that specify date, standard used, method 

used, and person performing the test be 

maintained. The proposed rule requires, 

rather than recommends, maintenance 

of written documentation of the 

accuracy of the temperature-indicating 

device, and also written documentation 

of the accuracy of the reference device. 

The proposed rule also requires that 

each temperature-indicating device and 

reference device have a tag, seal, or 

other means of identity that can be 

referenced in the required records as the 

identity of the device. These proposed 

recordkeeping requirements apply to 

mercury-in-glass thermometers as well 

as alternative temperature-indicating 

devices and reference devices. 

Additional costs associated with the 

proposed revised recordkeeping 

requirements may be incurred for all 

temperature-indicating devices and 

reference devices. 

The costs of the requirement to 

establish and maintain records are the 

setup costs required to design and 

establish a form for recording the 

required information, and the additional 

labor requirements needed to record the 

information. In addition, there will be 

one-time costs for training employees to 

comply with the requirement. We 

assume that one to two accuracy tests 

will be performed per year per device 

and that only a small number of forms 

would need to be designed. Thus, the 

setup costs for the recordkeeping 

requirement would be minimal. 

Moreover, we assume that the current 

recordkeeping practice is to maintain 

most, if not all, of these records and that 

the additional one-time training costs 

would be minimal as well. 

We assume that additional labor costs 

to record the required information will 

be small because the current regulations 

recommend maintaining similar 

records. Thus, we assume that the 

current practice is to keep track of most, 

if not all, of the information required by 

the proposed rule. However, we request 

comments on this assumption. 

Current incentives to track accuracy 

and performance of mercury-in-glass 

thermometers may vary across the 

industry, and information that is 

currently generated during accuracy 

tests may not be permanently recorded, 

as required under this proposed rule. 

Thus, we assume there will be labor 

costs incurred from this proposed rule 

to record information that is currently 

generated, but not recorded. We assume 

that half of the industry currently does 

not have sufficient incentive to track the 

performance of the temperatureindicating devices necessary to 

permanently record all of the required 

information. We further assume that 

current practice by these firms is to 

leave unrecorded one to four separate 

pieces of information required under the 

proposed rule, and that each piece of 

information takes between 10 and 15 

seconds to permanently record. 

Consequently, we estimated that half of 

all low-acid canned food manufacturers 

would spend between 10 seconds and 1 

minute (i.e., 1 x 10 seconds and 4 x 15 

seconds) per device, recording 

information required in the proposed 

rule that is currently unrecorded. 

We estimated the number of 

temperature-indicating devices that 

would be subject to recordkeeping 

requirements using the results of a 

survey of the low-acid canned food 

industry conducted by FDA and 

published in 1994 (Ref. 13). Findings 

from that survey indicate that the 

number of mercury-in-glass 

thermometers found at establishments 

ranged from 1 to 65, with only 4 percent 

of establishments having more than 30 

thermometers, and 67 percent having 

fewer than 10. Assuming the number of 

thermometers is uniformly distributed 

between 1 and 10 for 67 percent of 

establishments, between 11 and 30 for 

29 percent of establishments, and 

between 31 and 65 for 4 percent of 

establishments, we estimated a 

weighted average of about 10 

thermometers per establishment (i.e., 67 

percent x 5.5 + 29 percent x 15.5 + 4 

percent x 48 rounded to the nearest 

integer). 

Based on the findings from this study, 

we estimated that low-acid canned food 

establishments use an average of 10 

devices annually, for a total number of 

33,500 thermometers with accuracy test 

results that are currently not fully 

recorded (i.e., 1/2 x 6,700 

establishments x 10 thermometers) as 

required in the proposed rule. We 

assume that each device requires one to 

two tests per year (for a mean of 1.5), 

and estimated the total burden for the 

industry for recording the required test 

result information to be between 140 

hours and 838 hours per year (i.e., 

33,500 thermometers x 10 seconds x 1.5 

tests / 3,600 seconds per hour, and 


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33,500 thermometers x 60 seconds x 1.5 

tests / 3,600 seconds per hour). 

Doubling the $13.55 mean hourly wage 

for production labor for 2002 from the 

Bureau of Labor Statistics (Ref. 11) to 

account for overhead costs, we 

computed the labor cost of recording 

accuracy test information required in 

this proposal to be between $3,800 and 

$22,700, rounded to the nearest 

hundred. 

The costs of the requirement to allow 

FDA access to records documenting the 

accuracy of both temperature-indicating 

devices and reference devices include 

the costs of document retrieval and 

reproduction, as well as time spent with 

FDA investigators prior to, and 

immediately following, these activities. 

We assume these costs would be 

incurred once per year with a regular 

facility inspection, as well as irregularly 

during outbreak investigations. We 

assume the costs from the records access 

requirements would be incurred by a 

small number of firms that currently fail 

to permit FDA access to records under 

the current regulation. 

b. Benefits of the recordkeeping and 

records access requirements. The 

benefits from the proposed 

recordkeeping and records access 

requirements are derived from the 

enhanced ability by manufacturers to 

track critical accuracy and performance 

data for temperature-indicating devices 

which may improve safety, as well as 

the ability by FDA to determine 

compliance with the recordkeeping 

requirements. Although we believe that 

maintenance of these records is the 

current industry practice, the explicit 

requirement in this proposed rule may 

increase the incentive for industry 

compliance with records requirements, 

including those related to the testing of 

temperature-indicating devices and 

reference devices, and may increase the 

frequency with which testing occurs. 

The benefits from requiring 

maintenance of accuracy testing records 

may be particularly high during the 

transition period following the adoption 

of alternative temperature-indicating 

devices if they are useful for learning 

about the performance characteristics 

and required testing protocols. 

FDA’s experience is that most 

manufacturers currently permit access 

to temperature-indicating device test 

results and other records under the 

current regulation, and we expect the 

benefits of the records access 

requirement from improving regular 

inspections to be small. However, the 

records access requirement may provide 

benefits from any accompanying 

increase in incentives to test alternative 

temperature-indicating devices for 

accuracy that might result due to 

concern by a manufacturer with being in 

compliance with the testing 

requirement. Additional incentives for 

testing for accuracy may be particularly 

important during a transition period 

when knowledge about alternative 

temperature-indicating device 

performance characteristics may be 

uncertain. 

In addition, there may be benefits 

from any increase in the degree of 

certainty that a manufacturer will 

comply with a records access request, 

particularly during an outbreak 

investigation when records of test 

results may be essential to determine 

the cause of the outbreak. However, any 

increase in the incentives to test 

alternative temperature-indicating 

devices for accuracy, and also in the 

degree of certainty that a manufacturer 

will comply with a records access 

request, may be smaller for foreignbased manufacturers compared with 

domestic manufacturers. This may be 

true if foreign-based manufacturers 

export their products to buyers based 

not only in the United States, but also 

in countries that do not require the 

maintenance and access to records 

documenting the accuracy of 

temperature-indicating device 

technology. Under such circumstances 

foreign-based low-acid canned food 

manufacturers may choose to sell their 

products in other countries rather than 

comply with FDA records requirements. 

We request comments on the possibility 

that the incentives for maintaining 

records by foreign-based low-acid 

canned food manufacturers that export 

to the United States are smaller than 

those for domestic manufacturers. 

6. Summary 

In summary, the proposed rule 

provides flexibility by permitting 

alternative temperature-indicating 

devices without increasing public 

health risks from low-acid foods. In 

addition, the proposed rule may result 

in additional or more frequent testing of 

alternative temperature-indicating 

devices, which may be particularly 

useful for evaluating device 

performance. The setup costs for 

designing new forms for recording the 

required accuracy test information and 

the one-time training costs are assumed 

to be minimal. The recurring additional 

labor costs are estimated to be between 

$3,800 and $22,700. 

The avoided mercury cleanup costs 

from broken mercury-in-glass 

thermometers, and also the potential for 

enhanced labor productivity from 

adopting alternative temperatureindicating device technology, may be 

substantial. We estimate that avoided 

cleanup costs from broken mercury-inglass thermometers will be between 

$30,500 and $152,000 if all large and 

medium sized low-acid food firms adopt 

alternative temperature-indicating 

devices. Table 1 of this document 

summarizes the costs and benefits of the 

proposed rule, rounded to the nearest 

thousand. 

TABLE 1.—A SUMMARY OF THE COSTS

AND BENEFITS OF THE PROPOSED

RULE

Description Impact 

One-time Costs 

Design of new recordkeeping forms minimal 

Recordkeeping training minimal 

Recurring Costs 

Recordkeeping $5,000– 

$23,000 

Records access (incurred 

by a small number of 

firms that currently fail to 

permit FDA access) 

minimal 

Purchase and additional 

testing of alternative devices 

voluntarily incurred 

Benefits 

Change in risk from lowacid canned foods no change 

Avoided mercury cleanup 

costs 

$31,000– 

$152,000 

Enhanced labor productivity not quantified, 

but may be 

substantial 

B. Regulatory Flexibility Analysis 

The RFA requires agencies to analyze 

regulatory options that would minimize 

any significant impact of a rule on small 

entities. The agency certifies that the 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities. 

FDA has examined the economic 

implications of this proposed rule as 

required by the RFA. If a rule has a 

significant economic impact on a 

substantial number of small entities, the 

RFA requires agencies to analyze 

regulatory options that would lessen the 

economic effect of the rule on small 

entities. The voluntary provisions of 

this proposed rule would not generate 

any compliance costs for any small 

entities because they do not require 

small entities to undertake any new 

activity. A small business will not 


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choose alternative temperatureindicating device technology unless it 

believes that doing so will increase 

private benefits by more than it 

increases private costs. 

The per-firm costs of the mandatory 

recordkeeping requirement of this 

proposed rule will be small. The 

additional labor costs from the 

recordkeeping requirements are 

estimated to be between $3,800 and 

$22,700 or between approximately $1.00 

and $4.00 per firm (i.e., $3,800 / 6,700 

firms and $22,700 / 6,700 firms, 

rounded up). Moreover, costs for small 

firms will be at the lower end of this 

range since they will have fewer 

temperature-indicating devices and 

reference devices to test. We assume the 

costs from the records access 

requirement would be small and 

incurred by a small number of firms that 

currently fail to grant FDA access to 

records under the current regulation. 

Accordingly, FDA certifies that this 

proposed rule will not have a significant 

impact on a substantial number of small 

entities. Under the RFA, no further 

analysis is required. 

C. Unfunded Mandate Analysis 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule, if finalized, to result 

in any 1-year expenditures that would 

meet or exceed this amount and has 

determined that this proposed rule does 

not constitute a significant rule under 

the Unfunded Mandates Reform Act of 

1995. 

V. Environmental Impact 

The agency has determined under 21 

CFR 25.30(j) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. Paperwork Reduction Act 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

Paperwork Reduction Act of 1995 (the 

PRA) (44 U.S.C. 3501–3520). A 

description of these provisions is given 

in the following paragraphs with an 

estimate of the annual recordkeeping 

burden. Included in the estimate is the 

time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. 

FDA invites comments on the 

following topics: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Recordkeeping Requirements for 

Temperature-Indicating Devices 

Description: The information 

proposed to be collected contains the 

results of tests of the accuracy of 

temperature-indicating devices used by 

low-acid food firms. Much of this 

information is currently generated from 

the accuracy ‘‘checks’’ recommended 

under current regulations, and some of 

it may not be permanently recorded as 

required under this proposed rule. 

Current low-acid food regulations 

recommend that records of thermometer 

accuracy checks that specify date, 

reference device used, method used, 

and person performing the test be 

maintained. The proposed rule requires 

maintenance of written documentation 

of the accuracy of the temperatureindicating device and also written 

documentation of the accuracy of the 

reference device. The required 

documentation of accuracy is necessary 

to track the performance of devices, and 

may be particularly important for new 

temperature-indicating device 

technology during the transition period 

following its adoption. By requiring 

permanent records of the accuracy test 

results, manufacturers may have 

incentive to test temperature-indicating 

devices for accuracy more frequently 

than they would under the current 

regulations. 

Description of Respondents: All 

commercial low-acid canned food 

processors. Based on FDA low-acid 

canned food manufacturers’ registration 

data, we estimate that there are 

approximately 6,700 low-acid canned 

food processing establishments. 

Burden: The costs of the 

recordkeeping requirement are the setup 

costs required to design and establish a 

form for recording the required 

information, and the additional labor 

requirements needed to record the 

information. The initial setup costs for 

designing a new record form are 

assumed to be minimal since only one 

to two accuracy tests will be performed 

on an average of 10 devices per firm. 

We assume that labor costs to record 

the required information will be small 

because current practice is to keep track 

of most, if not all, of this information. 

Because current incentives to track 

accuracy of mercury-in-glass 

thermometers may vary across the 

industry, information that is currently 

generated during accuracy tests may not 

be permanently recorded as required 

under the proposed rule. Thus, we 

assume there will be labor costs 

incurred from this proposed rule to 

record information that is currently 

generated, but not recorded. 

We assume that half of the industry 

currently does not have sufficient 

incentive to track the performance of the 

temperature-indicating devices and 

reference devices necessary to 

permanently record all of the required 

information. We further assume that 

current practice by these firms is to 

leave unrecorded one to four separate 

pieces of information required under the 

proposed rule, and that each piece of 

information takes between 10 and 15 

seconds to permanently record. 

Consequently, we estimate that half of 

all low-acid canned food manufacturers 

would spend between 10 seconds and 1 

minute (i.e., 1 x 10 seconds and 4 x 15 

seconds) per device, recording 

information required in the proposed 

rule. 

Based on a survey conducted by FDA 

between 1992 and 1993, we estimate 

that low-acid food firms use an average 

of 10 devices, including reference 

devices. We estimate that 3,350 lowacid canned food manufacturers 

currently do not fully record the 

accuracy test results required by the 

proposed rule. We assume that each 

device requires one to two tests per year 

(midpoint of 1.5 tests per year). We 

estimate the annual frequency per 

recordkeeping to be 15 (i.e., 10 devices 

x 1.5 tests per year). We estimate the 

burden for recording the additional 

information to be between 10 and 60 

seconds per device (midpoint of 35 

seconds or 0.0097 hours per device). 

Table 2 of this document reports the 


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average annual burden described 

previously in this document. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

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

(e)(1), and (f)(1) 3,350 15 50,250 0.0097 487 

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

In compliance with the PRA (44 

U.S.C. 3507(d)), the agency has 

submitted the information collection 

provisions of this proposed rule to OMB 

for review. Interested persons are 

requested to send comments regarding 

information collection to OMB (see 

DATES and ADDRESSES). 

VII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule 

does not contain policies that have 

substantial direct effects on States, on 

the relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

have tentatively concluded that the 

proposed rule does not contain policies 

that have federalism implications as 

defined in the Executive order and, 

consequently, a federalism summary 

impact statement is not required. 

VIII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. FDA has verified the 

Web site addresses, but is not 

responsible for subsequent changes to 

the Web sites after this document 

publishes in the Federal Register. 1. Heymann, David L., ‘‘Control of 

Communicable Diseases,’’ 18th ed., 2004, An 

Official Report of the American Public Health 

Association, American Public Health 

Association, Washington, DC, p. 612, 2001. 

2. International Vocabulary of Basic and 

General Terms in Metrology (VIM), BIPM, 

IEC, IFCC, ISO, IUPAC, IUPAP, OIML, 2d ed., 

p. 47, definition 6.10, 1993. 

3. Letter from Sia Economides, FPA, to 

Mischelle Ledet, FDA, August 23, 2004. 

4. Smith, Brandie, King County Passes 

Mercury Thermometer Sales Ban, 

Washington Free Press, #63, May/June 2003, 

accessed online January 25, 2007, at http:// 

www.washingtonfreepress.org/63/ 

kingCountyPassesMercury.htm. 

5. CDC, ‘‘Summary of Notifiable Diseases—

United States, 2003,’’ Morbidity and 

Mortality Weekly Report, April 22, 2005, 

accessed online January 25, 2007, at http:// 

www.cdc.gov/mmwr/preview/mmwrhtml/ 

mm5254a1.htm. 

6. Great Lakes Regional Pollution 

Prevention Roundtable, ‘‘MercuryThermometers: Spills,’’ MercuryThermometer Topic Hub, Northeast Waste 

Management Officials’ Association, accessed 

online January 25, 2007, at http:// 

www.glrppr.org/hubs/subsection.cfm?hub= 

101&subsec=17&nav=17, last updated July 

13, 2006. 

7. University Operations Services, Harvard 

University Web site, accessed online January 

25, 2007, at http://www.uos.harvard.edu/ehs/ 

onllfaclenvlmer.shtml. 

8. ‘‘Accident Prevention Urged for Final 

Weeks of Fiscal Year ‘04,’’ Today at Berkeley 

Lab—Friday, August 27, 2004, accessed 

online January 25, 2007, at http:// 

www.lbl.gov/today/2004/Aug/27-Fri/ 

safetylpage.html. 

9. U.S. Census Bureau, ‘‘2002 Economic 

Census’’, accessed online January 25, 2007, at 

http://factfinder.census.gov/servlet/ 

IBQTable?lbm=y&-geolid=&- 

dslname=EC0231I3&-llang=en. 

10. FDA/Center for Food Safety and 

Applied Nutrition, ‘‘Acidified and Low-Acid 

Canned Food Registration Data,’’ December 

2005. 

11. U.S. Department of Labor, Bureau of 

Labor Statistics, Output Per Hour—Non-farm 

Business Productivity—PRS85006092, 

accessed online January 25, 2007, at http:// 

data.bls.gov/cgi-bin/surveymost?bls. 

12. U.S. Department of Labor, Bureau of 

Labor Statistics, accessed online January 25, 

2007, at ftp://ftp.bls.gov/pub/news.release/ 

History/ocwage.11192003.news. 

13. Stringer, L.W., Proceedings of 

Advances in Instrumentation and Control, 

Vol. 49, part 2, pp. 715–723, 1994. 

List of Subjects in 21 CFR Part 113 

Food packaging, Foods, Reporting and 

recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 113 be amended as follows: 

PART 113—THERMALLY PROCESSED 

LOW-ACID FOODS PACKAGED IN 

HERMETICALLY SEALED 

CONTAINERS 

1. The authority citation for 21 CFR 

part 113 continues to read as follows: 

Authority: 21 U.S.C. 342, 371, 374; 42 

U.S.C. 264. 

2. Revise § 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. 

Temperature-indicating devices shall be 

tested for accuracy against an accurate 

calibrated reference device by 

appropriate standard procedures, upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

processing. Each temperature-indicating 

device and reference device shall have 

a tag, seal, or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 

(A) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 


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used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(B) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation of the 

traceability information for the reference 

device may be in the form of a guaranty 

of accuracy from the manufacturer of 

the reference device or a certificate of 

calibration from a laboratory. 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(iv) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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 sensor of 

the temperature-indicating device shall 

be installed either within the retort shell 

or in external wells attached to the 

retort. External wells or pipes shall be 

connected to the retort through at least 

a 3/4-inch (2 centimeters) diameter 

opening and equipped with a 1/16-inch 

(1.5 millimeters) or larger bleeder 

opening so located as to provide a full 

flow of steam past the length of the 

temperature-indicating device sensor. 

The bleeders for external wells shall 

emit steam continuously during the 

entire processing period. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device that 

records temperatures to a permanent 

record, such as a temperature-recording 

chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recording-controlling 

instrument. The temperature-recording 

device sensor shall be installed either 

within the retort shell or in a well 

attached to the shell. Each temperaturerecording device sensor well shall have 

a 1/16-inch (1.5 millimeters) or larger 

bleeder which emits steam continuously 

during the processing period. 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 

should be graduated in divisions of 2 

pounds per square inch (13.8 

kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordingcontrolling instrument when combined 

with a temperature-recording device. 

The steam controller may be airoperated and actuated by a temperature 

sensor positioned near the temperatureindicating device in the retort. A steam 

controller activated by the steam 

pressure of the retort is acceptable if it 

is carefully maintained mechanically so 

that it operates satisfactorily. 

(5) Steam inlet. The steam inlet to 

each still retort shall be large enough to 

provide sufficient steam for proper 

operation of the retort. Steam may enter 

either the top portion or the bottom 

portion of the retort but, in any case, 

shall enter the portion of the retort 

opposite the vent; for example, steam 

inlet in bottom portion and vent in top 

portion. 

(6) Crate supports. A bottom crate 

support shall be used in vertical still 

retorts. Baffle plates shall not be used in 

the bottom of still retorts. 

(7) Steam spreaders. Steam spreaders 

are continuations of the steam inlet line 

inside the retort. Horizontal still retorts 

shall be equipped with steam spreaders 

that extend the length of the retort. For 

steam spreaders along the bottom of the 

retort, the perforations should be along 

the top 90° of this 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-uptime. 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 


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observe that they are functioning 

properly. 

(9) Stacking equipment and position 

of containers. Crates, trays, gondolas, 

etc., for holding containers shall be 

made of strap iron, adequately 

perforated sheet metal, or other suitable 

material. When perforated sheet metal is 

used for the bottoms, the perforations 

should be approximately the equivalent 

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

inch (5.1 centimeters) centers. If 

dividers are used between the layers of 

containers, they should be perforated as 

stated in this paragraph. The positioning 

of containers in the retort, when 

specified in the scheduled process, shall 

be in accordance with that process. 

(10) Air valves. Retorts using air for 

pressure cooling shall be equipped with 

a suitable valve to prevent air leakage 

into the retort during processing. 

(11) Water valves. Retorts using water 

for cooling shall be equipped with a 

suitable valve to prevent leakage of 

water into the retort during processing. 

(12) Vents. Vents shall be installed in 

such a way that air is removed from the 

retort before timing of the process is 

started. Vents shall be controlled by 

gate, plug cock, or other adequate type 

valves which shall be fully open to 

permit rapid discharge of air from the 

retort during the venting period. Vents 

shall not be connected directly to a 

closed drain system. If the overflow is 

used as a vent, there shall be an 

atmospheric break in the line before it 

connects to a closed drain. The vent 

shall be located in that portion of the 

retort opposite the steam inlet; for 

example, steam inlet in bottom portion 

and vent in top portion. Where a retort 

manifold connects several vent pipes 

from a single still retort, it shall be 

controlled by a gate, plug cock, or other 

adequate type valve. The retort manifold 

shall be of a size that the cross-sectional 

area of the pipe is larger than the total 

cross-sectional area of all connecting 

vents. The discharge shall not be 

directly connected to a closed drain 

without an atmospheric break in the 

line. A manifold header connecting 

vents or manifolds from several still 

retorts shall lead to the atmosphere. The 

manifold header shall not be controlled 

by a valve and shall be of a size that the 

cross-sectional area is at least equal to 

the total cross-sectional area of all 

connecting retort manifold pipes from 

all retorts venting simultaneously. 

Timing of the process shall not begin 

until the retort has been properly vented 

and the processing temperature has 

been reached. Some typical installations 

and operating procedures reflecting the 

requirements of this section for venting 

still retorts without divider plates are 

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

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

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

(i) Venting horizontal retorts. (A) 

Venting through multiple 1-inch (2.5 

centimeters) vents discharging directly 

to atmosphere. 

Specifications. One 1-inch (2.5 

centimeters) vent for every 5 feet (1.5 

meters) of retort length equipped with a 

gate or plug cock valve and discharging 

to atmosphere; end vents not more than 

2.5 feet (76 centimeters) from ends of 

retort. 

Venting method. Vent valves should 

be wide open for at least 5 minutes and 

to at least 225 °F (107.2 °C), or at least 

7 minutes and to at least 220 °F (104.4 

°C). 

(B) Venting through multiple 1-inch 

(2.5 centimeters) vents discharging 

through a manifold to atmosphere. 


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Specifications. One 1-inch (2.5 

centimeters) vent for every 5 feet (1.5 

meters) of retort length; and vents not 

over 2.5 feet (76 centimeters) from ends 

of retort: Size of manifold—for retorts 

less than 15 feet (4.6 meters) in length, 

2.5 inches (6.4 centimeters); for retorts 

15 feet (4.6 meters) and over in length, 

3 inches (7.6 centimeters). 

Venting method. Manifold vent gate 

or plug cock valve should be wide open 

for at least 6 minutes and to at least 225 

°F (107.2 °C), or for at least 8 minutes 

and to at least 220 °F (104.4 °C). 

(C) Venting through water spreaders. 

Size of vent and vent valve. For retorts 

less than 15 feet (4.6 meters) in length, 

2 inches (5.1 centimeters); for retorts 15 

feet (4.6 meters) and over in length, 2.5 

inches (3.8 centimeters). 

Size of water spreader. For retorts less 

than 15 feet (4.6 meters) in length, 1.5 

inches (3.8 centimeters); for retorts 15 

feet (4.6 meters) and over in length, 2 

inches (5.1 centimeters). The number of 

holes should be such that their total 

cross-sectional area is approximately 

equal to the cross-sectional area of the 

vent pipe inlet. 

Venting method. Water spreader vent 

gate or plug cock valve should be wide 

open for at least 5 minutes and to at 

least 225 °F (107.2 °C), or for at least 7 

minutes and to at least 220 °F (104.4 °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). 

Specifications: A 2.5-inch (6.4 

centimeters) vent equipped with a 2.5- 

inch (6.4 centimeters) gate or plug cock 

valve and located within 2 feet (61 

centimeters) of the center of the retort. 

Venting method: Vent gate or plug 

cock valve should be wide open for at 

least 4 minutes and to at least 220 °F 

(104.4 °C). 

(ii) Venting vertical retorts. (A) 

Venting through a 1.5-inch (3.8 

centimeters) overflow. 


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12010 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 

Specifications. A 1.5-inch (3.8 

centimeters) overflow pipe equipped 

with a 1.5-inch (3.8 centimeters) gate or 

plug cock valve and with not more than 

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

centimeters) pipe beyond the valve 

before break to the atmosphere or to a 

manifold header. 

Venting method. Vent gate or plug 

cock valve should be wide open for at 

least 4 minutes and to at least 218 °F 

(103.3 °C), or for at least 5 minutes and 

to at least 215 °F (101.7 °C). 

(B) Venting through a single 1-inch 

(2.5 centimeters) side or top vent. 


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Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 12011 

Specifications. A 1-inch (2.5 

centimeters) vent in lid or top side, 

equipped with a 1-inch (2.5 centimeters) 

gate or plug cock valve and discharging 

directly into the atmosphere or to a 

manifold header. 

Venting method. Vent gate or plug 

cock valve should be wide open for at 

least 5 minutes and to at least 230 °F 

(110.0 °C), or for at least 7 minutes and 

to at least 220 °F (104.4 °C). 

(iii) Other procedures. Other 

installations and operating procedures 

that deviate from the above 

specifications may be used if there is 

evidence in the form of heat distribution 

data, which shall be kept on file, that 

they accomplish adequate venting of air. 

(13) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. 

(i) When maximum fill-in or drained 

weight is specified in the scheduled 

process, it shall be measured and 

recorded at intervals of sufficient 

frequency to ensure that the weight of 

the product does not exceed the 

maximum for the given container size 

specified in the scheduled process. 

(ii) Closing machine vacuum in 

vacuum-packed products shall be 

observed and recorded at intervals of 

sufficient frequency to ensure that the 

vacuum is as specified in the scheduled 

process. 

(iii) Such measurements and 

recordings should be made at intervals 

not to exceed 15 minutes. 

(iv) When the product style results in 

stratification or layering of the primary 

product in the containers, the 

positioning of containers in the retort 

shall be according to the scheduled 

process. 

(b) Equipment and procedures for 

pressure processing in water in still 

retorts—(1) Temperature-indicating 

device. Each retort shall be equipped 

with at least one temperature-indicating 

device that accurately indicates the 

temperature during processing. 

Temperature-indicating devices shall be 

tested for accuracy against an accurate 

calibrated reference device by 

appropriate standard procedures, upon 

installation and at least once a year 

thereafter, or more frequently if 

necessary, to ensure accuracy during 

processing. Each temperature-indicating 

device and reference device shall have 

a tag, seal, or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 


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12012 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 

(A) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 

used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(B) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer or a certificate of 

calibration from a laboratory. 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(iv) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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. Sensors of 

temperature-indicating devices shall be 

located in such a position that they are 

beneath the surface of the water 

throughout the process. On horizontal 

retorts, this entry should be made in the 

side at the center, and the temperatureindicating device sensor shall be 

inserted directly into the retort shell. In 

both vertical and horizontal retorts, the 

temperature-indicating device sensor 

shall extend directly into the water a 

minimum of at least 2 inches (5.1 

centimeters) without a separable well or 

sleeve. If a separate well or sleeve is 

used, there must be adequate circulation 

to ensure accurate temperature 

measurements. The temperatureindicating device—not the temperaturerecording device—shall be the reference 

instrument for indicating the processing 

temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device that 

records temperatures to a permanent 

record, such as a temperature-recording 

chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a combination recordingcontrolling instrument. For a vertical 

retort equipped with a combination 

recorder-controller, the temperature 

recorder-controller sensor shall be 

located at the bottom of the retort below 

the lowest crate rest in such a position 

that the steam does not strike it directly. 

For a horizontal retort equipped with a 

combination recorder-controller, the 

temperature recorder-controller sensor 

shall be located between the water 

surface and the horizontal plane passing 

through the center of the retort so that 

there is no opportunity for direct steam 

impingement on the sensor. For all still 

retort systems that pressure process in 

water and are equipped with 

combination recorder-controllers, the 

temperature recorder-controller sensors 

shall be located where the recorded 

temperature is an accurate measurement 

of the scheduled process temperature 

and is not affected by the heating media. 

Air-operated temperature controllers 

should have adequate filter systems to 

ensure a supply of clean, dry air. 

(3) Pressure gages. (i) Each retort 

should be equipped with a pressure 

gage that should be graduated in 

divisions of 2 pounds per square inch 

(13.8 kilopascals) or less. 

(ii) Each retort should have an 

adjustable pressure relief or control 

valve of a capacity sufficient to prevent 

an undesired increase in retort pressure 

when the water valve is wide open and 

should be installed in the overflow line. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. The steam controller may 

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

combination recorder-controller. 

(5) Steam introduction. Steam shall be 

distributed in the bottom of the retort in 

a manner adequate to provide uniform 

heat distribution throughout the retort. 

In vertical retorts, uniform steam 

distribution can be achieved by any of 

several methods. In horizontal retorts, 

the steam distributor shall run the 

length of the bottom of the retort with 

perforations distributed uniformly along 

the upper part of the pipe. 

(6) Crate supports. A bottom crate 

support shall be used in vertical still 

retorts. Baffle plates shall not be used in 

the bottom of the retort. Centering 

guides should be installed so as to 

ensure that there is about a 1.5-inch (3.8 

centimeters) clearance between the side 

wall of the crate and the retort wall. 

(7) Stacking equipment and position 

of containers. Crates, trays, gondolas, 

etc., for holding containers shall be 

made of strap iron, adequately 

perforated sheet metal, or other suitable 

material. When perforated sheet metal is 

used for the bottoms, the perforations 

should be approximately the equivalent 

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

inch (5.1 centimeters) centers. If divider 

plates are used between the layers of 

containers, they should be perforated as 

stated in this paragraph. The positioning 

of containers in the retort, when 

specified in the scheduled process, shall 

be in accordance with that process. 

Dividers, racks, trays, or other means of 

positioning of flexible containers shall 

be designed and employed to ensure 


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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) Water level indicator. There shall 

be a means of determining the water 

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

by using a sensor, gage, water glass, or 

petcock(s). Water shall cover the top 

layer of containers during the entire 

come-up-time and processing periods 

and should cover the top layer of 

containers during the cooling periods. 

The operator shall check and record the 

water level at intervals sufficient to 

ensure its adequacy. 

(10)(i) Air supply and controls. In 

both horizontal and vertical still retorts 

for pressure processing in water, a 

means shall be provided for introducing 

compressed air at the proper pressure 

and rate. The proper pressure shall be 

controlled by an automatic pressure 

control unit. A check valve shall be 

provided in the air supply line to 

prevent water from entering the system. 

Air or water circulation shall be 

maintained continuously during the 

come-up-time and during processing 

and cooling periods. The adequacy of 

the air or water circulation for uniform 

heat distribution within the retort shall 

be established in accordance with 

procedures recognized by a competent 

processing authority and records shall 

be kept on file. If air is used to promote 

circulation, it shall be introduced into 

the steam line at a point between the 

retort and the steam control valve at the 

bottom of the retort. 

(ii) Water circulation. When a water 

circulating system is used for heat 

distribution, it shall be installed in such 

a manner that water will be drawn from 

the bottom of the retort through a 

suction manifold and discharged 

through a spreader which extends the 

length of the top of the retort. The holes 

in the water spreader shall be uniformly 

distributed and should have an 

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

pump. The suction outlets shall be 

protected with nonclogging screens or 

other suitable means shall be used to 

keep debris from entering the 

circulating system. The pump shall be 

equipped with a pilot light or other 

signaling device to warn the operator 

when it is not running, and with a 

bleeder to remove air when starting 

operations. Alternative methods for 

circulation of water in the retort may be 

used when established by a competent 

authority as adequate for even heat 

distribution. 

(11) Cooling water supply. In vertical 

retorts the cooling water should be 

introduced at the top of the retort 

between the water and container levels; 

in horizontal retorts the cooling water 

should be introduced into the suction 

side of the pump. A check valve should 

be included in the cooling water line. 

(12) Retort headspace. The headspace 

necessary to control the air pressure 

should be maintained between the water 

level and the top of the retort shell. 

(13) Vertical and horizontal still 

retorts. Vertical and horizontal still 

retorts should follow the arrangements 

in the diagrams below in this paragraph. 

Other installation and operating 

procedures that deviate from these 

arrangements may be used, as long as 

there is evidence in the form of heat 

distribution data or other suitable 

information, which shall be kept on file, 

which demonstrates that the heat 

distribution is adequate. 

BILLING CODE 4160–01–S 


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BILLING CODE 4160–01–C 


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Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 12015 

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. 

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. 

(14) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. 

(i) When maximum fill-in or drained 

weight is specified in the scheduled 

process, it shall be measured and 

recorded at intervals of sufficient 

frequency to ensure that the weight of 

the product does not exceed the 

maximum for the given container size 

specified in the scheduled process. 

(ii) Closing machine vacuum in 

vacuum-packed products shall be 

observed and recorded at intervals of 

sufficient frequency to ensure that the 

vacuum is as specified in the scheduled 

process. 

(iii) Such measurements and 

recordings should be made at intervals 

not to exceed 15 minutes. 

(iv) When the product style results in 

stratification or layering of the primary 

product in the containers, the 

positioning of containers in the retort 

shall be according to the scheduled 

process. 

(c) Equipment and procedures for 

pressure processing in steam in 

continuous agitating retorts—(1) 

Temperature-indicating device. Each 

retort shall be equipped with at least 

one temperature-indicating device that 

accurately indicates the temperature 

during processing. Temperatureindicating devices shall be tested for 

accuracy against an accurate calibrated 

reference device by appropriate 

standard procedures, upon installation 

and at least once a year thereafter, or 

more frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and 

reference device shall have a tag, seal, 

or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 

(A) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 

used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(B) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer or a certificate of 

calibration from a laboratory. 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(iv) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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 sensor of 

the temperature-indicating device shall 

be installed either within the retort shell 

or in external wells attached to the 

retort. External wells or pipes shall be 

connected to the retort through at least 

a 3/4-inch (2 centimeters) diameter 

opening and equipped with a 1/16-inch 

(1.5 millimeters) or larger bleeder 

opening so located as to provide a full 

flow of steam past the length of the 

temperature-indicating device sensor. 

The bleeders for external wells shall 

emit steam continuously during the 

entire processing period. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device that 

records temperatures to a permanent 

record, such as a temperature-recording 

chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 


cprice-sewell on PROD1PC66 with PROPOSALS3
12016 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recording-controlling 

instrument. The temperature-recording 

device sensor shall be installed either 

within the retort shell or in a well 

attached to the shell. Each temperaturerecording device sensor well shall have 

a 1/16-inch (1.5 millimeters) or larger 

bleeder opening emitting steam 

continuously during the processing 

period. Air-operated temperature 

controllers should have adequate filter 

systems to ensure a supply of clean, dry 

air. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage, 

which should be graduated in divisions 

of 2 pounds per square inch (13.8 

kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordingcontrolling instrument when combined 

with a temperature-recording device. A 

steam controller activated by the steam 

pressure of the retort is acceptable if it 

is carefully maintained mechanically so 

that it operates satisfactorily. 

(5) Bleeders. Bleeders, except those 

for temperature-indicating device wells, 

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

larger and shall be wide open during the 

entire process, including the come-uptime. Bleeders shall be located within 

approximately 1 foot (30.5 centimeters) 

of the outermost location of containers 

at each end along the top of the retort. 

Additional bleeders shall be located not 

more than 8 feet (2.4 meters) apart along 

the top of the retort. All bleeders shall 

be arranged so that the operator can 

observe that they are functioning 

properly. The condensate bleeder shall 

be checked with sufficient frequency to 

ensure adequate removal of condensate 

or shall be equipped with an automatic 

alarm system(s) that would serve as a 

continuous monitor of 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 marked on the recording chart 

and entered on the other production 

records required in this chapter. If the 

alternative procedure of prompt cooling 

is followed, the subsequent handling 

methods used for the containers in the 

retort at the time of stopping and 

cooling shall be entered on the 

production records. 

(9) Temperature drop. If the 

temperature of the continuous retort 

drops below the temperature specified 

in the scheduled process while 

containers are in the retort, the retort 

reel shall be stopped promptly. An 

automatic device should be used to stop 

the reel when the temperature drops 

below the specified process 

temperature. Before the reel is restarted, 

all containers in the retort shall be given 

a complete scheduled still retort process 

if the temperature drop was 10 °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 marked on 

the temperature-recording device record 

and entered on the other production 

records required in this chapter. If the 

alternative procedure of emptying the 

retort is followed, the subsequent 

handling methods used for the 

containers in the retort at the time of the 

temperature drop shall be entered on 

the production records. If the 

temperature drop was less than 10 °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 


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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. Temperatureindicating devices shall be tested for 

accuracy against an accurate calibrated 

reference device by appropriate 

standard procedures, upon installation 

and at least once a year thereafter, or 

more frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and 

reference device shall have a tag, seal, 

or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 

(A) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 

used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(B) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer or a certificate of 

calibration from a laboratory. 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(iv) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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 sensor of 

the temperature-indicating device shall 

be installed either within the retort shell 

or in external wells attached to the 

retort. External wells or pipes shall be 

connected to the retort through at least 

a 3/4-inch (2 centimeters) diameter 

opening and equipped with a 1/16-inch 

(1.5 millimeters) or larger bleeder 

opening so located as to provide a full 

flow of steam past the length of the 

temperature-indicating device sensor. 

The bleeders for external wells shall 

emit steam continuously during the 

entire processing period. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device that 

records temperatures to a permanent 

record, such as a temperature-recording 

chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recording-controlling 

instrument. The temperature-recording 

device sensor shall be installed either 

within the retort shell or in a well 

attached to the shell. Each temperaturerecording device sensor well shall have 

a 1/16-inch (1.5 millimeters) or larger 

bleeder that emits steam continuously 

during the processing period. 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 

should be graduated in divisions of 2 

pounds per square inch (13.8 

kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordingcontrolling instrument when combined 

with a temperature-recording device. A 

steam controller activated by the steam 

pressure of the retort is acceptable if it 

is mechanically maintained so that it 

operates satisfactorily. 

(5) Bleeders. Bleeders, except those 

for temperature-indicating device wells, 

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

larger and shall be wide open during the 

entire process, including the come-uptime. 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 


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12018 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 

more than 8 feet (2.4 meters) apart along 

the top. Bleeders may be installed at 

positions other than those specified in 

this paragraph, as long as there is 

evidence in the form of heat distribution 

data that they accomplish adequate 

removal of air and circulation of heat 

within the retort. In retorts having top 

steam inlet and bottom venting, a 

bleeder shall be installed in the bottom 

of the retort to remove condensate. All 

bleeders shall be arranged in a way that 

enables the operator to observe that they 

are functioning properly. 

(6) Venting and condensate removal. 

The air in each retort shall be removed 

before processing is started. Heat 

distribution data or documentary proof 

from the manufacturer or from a 

competent processing authority, 

demonstrating that adequate venting is 

achieved, shall be kept on file. At the 

time steam is turned on, the drain 

should be opened for a time sufficient 

to remove steam condensate from the 

retort and provision should be made for 

containing drainage of condensate 

during the retort operation. 

(7) Retort speed timing. The rotational 

speed of the retort shall be specified in 

the schedules process. The speed shall 

be adjusted, as necessary, to ensure that 

the speed is as specified in the 

scheduled process. The rotational speed 

as well as the process time shall be 

recorded for each retort load processed. 

Alternatively, a recording tachometer 

may be used to provide a continuous 

record of the speed. A means of 

preventing unauthorized speed changes 

on retorts shall be provided. A lock, or 

a notice from management posted at or 

near the speed-adjustment device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments, is a satisfactory means of 

preventing unauthorized changes. 

(8) Critical factors. Critical factors 

specified in the schedules process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. The minimum 

headspace of containers in each retort 

load to be processed, if specified in the 

scheduled process, shall be measured 

and recorded at intervals of sufficient 

frequency to ensure that the headspace 

is as specified in the scheduled process. 

The headspace of solder-tipped, lap 

seam (vent hole) cans may be measured 

by net weight determinations. When the 

product consistency is specified in the 

scheduled process, the consistency of 

the product shall be determined by 

objective measurements on the product 

taken from the filler before processing 

and recorded at intervals of sufficient 

frequency to ensure that the consistency 

is as specified in the scheduled process. 

Minimum closing machine vacuum in 

vacuum-packed products, maximum 

fill-in or drained weight, minimum net 

weight, and percent solids shall be as 

specified in the scheduled process for 

all products for which deviations from 

such specifications may affect the 

scheduled process. All measurements 

and recordings of critical factors should 

be made at intervals not to exceed 15 

minutes. 

(e) Equipment and procedures for 

pressure processing in water in 

discontinuous agitating retorts—(1) 

Temperature-indicating device. Each 

retort shall be equipped with at least 

one temperature-indicating device that 

accurately indicates the temperature 

during processing. Temperatureindicating devices shall be tested for 

accuracy against an accurate calibrated 

reference device by appropriate 

standard procedures, upon installation 

and at least once a year thereafter, or 

more frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and 

reference device shall have a tag, seal, 

or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 

(A) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 

used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(B) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer or a certificate of 

calibration from a laboratory. 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(iv) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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 sensor of 

the temperature-indicating device shall 

be installed either within the retort shell 

or in an external well attached to the 

retort. Sensors of temperature-indicating 

devices shall be located in such a 

position that they are beneath the 

surface of the water throughout the 

process. This entry should be made in 

the side at the center, and the 

temperature-indicating device sensor 

shall be inserted directly into the retort 

shell. The temperature-indicating device 

sensor shall extend directly into the 

water a minimum of at least 2 inches 

(5.1 centimeters) without a separable 

well or sleeve. If a separate well or 

sleeve is used, there must be adequate 

circulation to ensure accurate 

temperature measurements. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device that 

records temperatures to a permanent 

record, such as a temperature-recording 

chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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 


cprice-sewell on PROD1PC66 with PROPOSALS3
Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 12019 

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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recording-controlling 

instrument. The temperature-recording 

device sensor shall be installed either 

within the retort shell or in a well 

attached to the shell. Air-operated 

temperature controllers should have 

adequate filter systems to ensure a 

supply of clean, dry air. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that 

should be graduated in divisions of 2 

pounds per square inch (13.8 

kilopascals) or less. 

(4) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordingcontrolling instrument when combined 

with a temperature-recording device. 

(5) Retort speed timing. The rotational 

speed of the retort shall be specified in 

the scheduled process. The speed shall 

be adjusted, as necessary, to ensure that 

the speed is as specified in the 

scheduled process. The rotational speed 

as well as the process time shall be 

recorded for each retort load processed. 

Alternatively, a recording tachometer 

may be used to provide a continuous 

record of the speed. A means of 

preventing unauthorized speed changes 

shall be provided. A lock, or a notice 

from management posted at or near the 

speed adjustment device that provides a 

warning that only authorized persons 

are permitted to make adjustment, is a 

satisfactory means of preventing 

unauthorized changes. 

(6)(i) Air supply and controls. A 

means shall be provided for introducing 

compressed air at the proper pressure 

and rate. The proper pressure shall be 

controlled by an automatic pressure 

control unit. A check valve shall be 

provided in the air supply line to 

prevent water from entering the system. 

(ii) Water circulation. When a water 

circulating system is used for heat 

distribution, it shall be installed in such 

a manner that water will be drawn from 

the bottom of the retort through a 

suction manifold and discharged 

through a spreader which extends the 

length of the top of the retort. The holes 

in the water spreader shall be uniformly 

distributed and should have an 

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

pump. The suction outlets shall be 

protected with nonclogging screens or 

other suitable means shall be used to 

keep debris from entering the 

circulating system. The pump shall be 

equipped with a pilot light or other 

signaling device to warn the operator 

when it is not running, and with a 

bleeder to remove air when starting 

operations. Alternative methods for 

circulation of water in the retort may be 

used when established by a competent 

authority as adequate for even heat 

distribution. 

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

be installed or other suitable means 

shall be used on all drain openings to 

prevent clogging. 

(8) Water level indicator. There shall 

be a means of determining the water 

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

by using a sensor, gage, water glass, or 

petcock(s). Water shall cover the top 

layer of containers during the entire 

come-up-time and processing periods 

and should cover the top layer of 

containers during the cooling periods. 

The operator shall check and record the 

water level at intervals sufficient to 

ensure its adequacy. 

(9) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. The minimum 

headspace of containers, if specified in 

the scheduled process, shall be 

measured and recorded at intervals of 

sufficient frequency to ensure that the 

headspace is as specified in the 

scheduled process. The headspace of 

solder-tipped, lap seam (vent hole) cans 

may be measured by net weight 

determinations. When the product 

consistency is specified in the 

scheduled process, the consistency of 

the product shall be determined by 

objective measurements on the product 

taken from the filler before processing 

and recorded at intervals of sufficient 

frequency to ensure that the consistency 

is as specified in the scheduled process. 

Minimum closing machine vacuum in 

vacuum-packed products, maximum 

fill-in or drained weight, minimum net 

weight, and percent solids shall be as 

specified in the scheduled process for 

all products when deviations from such 

specifications may affect the scheduled 

process. All measurements and 

recordings of critical factors should be 

made at intervals not to exceed 15 

minutes. 

(f) Equipment and procedures for 

pressure processing in steam in 

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

equipped with at least one temperatureindicating device that accurately 

indicates the temperature during 

processing. Temperature-indicating 

devices shall be tested for accuracy 

against an accurate calibrated reference 

device by appropriate standard 

procedures, upon installation and at 

least once a year thereafter, or more 

frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and 

reference device shall have a tag, seal, 

or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(ii) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 

(A) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 

used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(B) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 


cprice-sewell on PROD1PC66 with PROPOSALS3
12020 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Proposed Rules 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer or a certificate of 

calibration from a laboratory. 

(iii) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(iv) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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 shall be 

located in the steam dome near the 

steam-water interface. When the 

scheduled process specifies 

maintenance of particular temperatures 

in the hydrostatic water legs, a 

temperature-indicating device shall be 

located in each hydrostatic water leg in 

a position near the bottom temperaturerecording device sensor. The 

temperature-indicating device—not the 

temperature-recording device—shall be 

the reference instrument for indicating 

the processing temperature. 

(2) Temperature-recording device. 

Each retort shall have an accurate 

temperature-recording device that 

records temperatures to a permanent 

record, such as a temperature-recording 

chart. 

(i) Analog or graphical recordings. 

Temperature-recording devices that 

create analog or graphical recordings 

may be used. Temperature-recording 

devices that record to charts shall be 

used only with the appropriate chart. 

Each chart shall have a working scale of 

not more than 55 °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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(iv) Temperature controller. The 

temperature-recording device may be 

combined with the steam controller and 

may be a recording-controlling 

instrument. The temperature-recording 

device sensor shall be installed either 

within the steam dome or in a well 

attached to the dome. Each temperaturerecording device sensor well shall have 

a 1/16-inch (1.5 millimeters) or larger 

bleeder which emits steam continuously 

during the processing period. 

Additional temperature-recording 

device sensors shall be installed in the 

hydrostatic water legs if the scheduled 

process specified maintenance of 

particular temperatures in the 

hydrostatic water legs. Air-operated 

temperature controllers should have 

adequate filter systems to ensure a 

supply of clean, dry air. 

(3) Pressure gages. Each retort should 

be equipped with a pressure gage that 

should be graduated in divisions of 2 

pounds per square inch (13.8 

kilopascals) or less. 

(4) Recording of temperatures. 

Temperatures indicated by the 

temperature-indicating device or 

devices shall be entered on a suitable 

form during processing operations. 

Temperatures shall be recorded by an 

accurate temperature-recording device 

or devices at the following points: 

(i) In the steam chamber between the 

steam-water interface and the lowest 

container position. 

(ii) Near the top and the bottom of 

each hydrostatic water leg if the 

scheduled process specifies 

maintenance of particular temperatures 

in the legs. 

(5) Steam controller. Each retort shall 

be equipped with an automatic steam 

controller to maintain the retort 

temperature. This may be a recordingcontrolling instrument when combined 

with a temperature-recording device. A 

steam controller activated by the steam 

pressure of the retort is acceptable if it 

is carefully mechanically maintained so 

that it operates satisfactorily. 

(6) Venting. Before the start of 

processing operations, the retort steam 

chamber or chambers shall be vented to 

ensure removal of air. 

(7) Bleeders. Bleeder openings 1/4- 

inch (6 millimeters) or larger shall be 

located at the top of the steam chamber 

or chambers opposite the point of steam 

entry. Bleeders shall be wide open and 

shall emit steam continuously during 

the entire process, including the 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. Temperatureindicating devices shall be tested for 


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accuracy against an accurate calibrated 

reference device by appropriate 

standard procedures, upon installation 

and at least once a year thereafter, or 

more frequently if necessary, to ensure 

accuracy during processing. Each 

temperature-indicating device and 

reference device shall have a tag, seal, 

or other means of identity. 

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

accuracy of the device is not affected by 

electromagnetic interference and 

environmental conditions. 

(2) Written documentation of the 

accuracy of the temperature-indicating 

device and the reference device shall be 

established and maintained. 

(i) Documentation of the accuracy of 

the temperature-indicating device shall 

include a reference to the tag, seal, or 

other means of identity used by the 

processor to identify the temperatureindicating device, the name of the 

manufacturer of the temperatureindicating device, the identity of the 

reference device used for the accuracy 

test and of equipment and procedures 

used to adjust or calibrate the 

temperature-indicating device, the date 

and results of each accuracy test, the 

name of the person or facility that 

performed the accuracy test and 

adjusted or calibrated the temperatureindicating device, and the date of the 

next scheduled accuracy test. 

(ii) Documentation of the accuracy of 

the reference device shall include a 

reference to the tag, seal, or other means 

of identity used by the processor to 

identify the reference device, the name 

of the manufacturer of the reference 

device, the identity of the equipment 

and procedures used to test the accuracy 

and to adjust or calibrate the reference 

device, the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the reference 

device, the date and results of the 

accuracy test, and the traceability 

information. Documentation for the 

reference device may be in the form of 

a guaranty of accuracy from the 

manufacturer or a certificate of 

calibration from a laboratory. 

(3) A temperature-indicating device 

that is defective or cannot be adjusted 

to the accurate calibrated reference 

device shall be repaired or replaced 

before further use. 

(4) A temperature-indicating device 

shall be easily readable to 1 °F (0.5 °C). 

The temperature range of a mercury-inglass 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 

that records temperatures to a 

permanent record, such as a 

temperature-recording chart. A 

temperature-recording device shall be 

installed in the product at the holdingtube 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. 

Temperature-recording devices that 

create multipoint plottings of 

temperature readings shall record the 

temperature at intervals that will assure 

that the parameters of the process time 

and process temperature have been met. 

(2) Digital recordings. 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 to 

agree as nearly as possible with, but to 

be in no event higher than, the 

temperature-indicating device during 

the process time. A means of preventing 

unauthorized changes in adjustment 

shall be provided. A lock or a notice 

from management posted at or near the 

temperature-recording device that 

provides a warning that only authorized 

persons are permitted to make 

adjustments is a satisfactory means of 

preventing unauthorized changes. 

(C) Temperature controller. An 

accurate temperature controller shall be 

installed and capable of ensuring that 

the desired product sterilization 

temperature is maintained. Air-operated 

temperature controllers should have 

adequate filter systems to ensure a 

supply of clean, dry air. 

(D) Product-to-product regenerators. 

When a product-to-product regenerator 

is used to heat the cold unsterilized 

product entering the sterilizer by means 

of a heat exchange system, it shall be 

designed, operated, and controlled so 

that the pressure of the sterilized 

product in the regenerator is greater 

than the pressure of any unsterilized 

product in the regenerator to ensure that 

any leakage in the regenerator is from 

the sterilized product into the 

unsterilized product. 

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

regenerator is used, there shall be an 

accurate differential pressure recordercontroller installed on the regenerator. 

The scale divisions shall not exceed 2 

pounds per square inch (13.8 

kilopascals) on the working scale of not 

more than 20 pounds per square inch 

per inch of scale (55 kilopascals per 

centimeter). The controller shall be 

tested for accuracy against a known 

accurate standard pressure indicator 

upon installation and at least once every 

3 months of operation thereafter, or 

more frequently if necessary, to ensure 

its accuracy. One pressure sensor shall 

be installed at the sterilized product 

regenerator outlet and the other pressure 

sensor shall be installed at the 

unsterilized product regenerator inlet. 

(F) Flow control. A flow controlling 

device shall be located upstream from 

the holding tube and shall be operated 

to maintain the required rate of product 

flow. A means of preventing 

unauthorized flow adjustments shall be 

provided. A lock or a notice from 

management posted at or near the flow 

controlling device that provides a 

warning that only authorized persons 

are permitted to make adjustments, is a 

satisfactory means of preventing 

unauthorized changes. 

(G) Product holding tube. The 

product-sterilizing holding tube shall be 

designed to give continuous holding of 

every particle of food for at least the 

minimum holding time specified in the 

scheduled process. The holding tube 

shall be designed so that no portion of 

the tube between the product inlet and 

the product outlet can be heated, and it 

must be sloped upward at least 1/4-inch 

per foot (2.1 centimeters per meter). 

(H) Flow-diversion systems. If a 

processor elects to install a 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 


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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 and shall be 

reprocessed or destroyed. Product flow 

to the filler or to the aseptic surge tank 

shall not be resumed until the cause of 

the improper pressure relationships in 

the regenerator has been corrected and 

the affected system(s) has been returned 

to a condition of commercial sterility. 

(D) Loss of sterile air pressure or other 

protection level in the aseptic surge 

tank. When an aseptic surge tank is 

used, conditions of commercial sterility 

may be lost when the sterile air 

overpressure or other means of 

protection drops below the scheduled 

process value. Product flow to and/or 

from the aseptic surge tank shall not be 

resumed until the potentially 

contaminated product in the tank is 

removed, and the aseptic surge tank has 

been returned to a condition of 

commercial sterility. 

(E) Records. Readings at the following 

points shall be observed and recorded at 

the start of aseptic packaging operations 

and at intervals of sufficient frequency 

to ensure that these values are as 

specified in the scheduled process: 

Temperature-indicating device in 

holding tube outlet; 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 metering pump or as determined 

by filling and closing rates and, if an 

aseptic surge tank is used, sterile air 

pressure or other protection means; and 

proper performance of steam seals or 

other similar devices. The 

measurements and recordings should be 

made at intervals not to exceed 1 hour. 

(2) Container sterilizing, filling, and 

closing operation—(i) Equipment—(A) 

Recording device. The container and 

closure sterilization system and product 

filling and closing system shall be 

instrumented to demonstrate that the 

required sterilization is being 

accomplished continuously. Recording 

devices shall be used to record, when 

applicable, the sterilization media flow 

rates, temperature, concentration, or 

other factors. When a batch system is 

used for container sterilization, the 

sterilization conditions shall be 

recorded. 

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

shall be used either to give the retention 

time of containers, and closures if 

applicable, in the sterilizing 

environment specified in the scheduled 

process, or to control the sterilization 

cycle at the rate specified in the 

scheduled process. A means of 

preventing unauthorized speed changes 

must be provided. A lock, or a notice 

from management posted at or near the 

speed adjusting device that provides a 

warning that only authorized persons 

are permitted to make adjustments, is a 

satisfactory means of preventing 

unauthorized changes. 

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

start of packaging operations, both the 

container and closure sterilizing system 

and the product filling and closing 

system shall be brought to a condition 

of commercial sterility. 

(B) Loss of sterility. A system shall be 

provided to stop packaging operations, 

or alternatively to ensure segregation of 

any product packaged when the 

packaging conditions fall below 

scheduled processes. Compliance with 

this requirement may be accomplished 

by diverting product away from the 

filler, by preventing containers from 

entering the filler, or by other suitable 

means. In the event product is packaged 

under conditions below those specified 

in the scheduled process, all such 

product shall be segregated and handled 

in accordance with § 113.89. In the 

event of loss of sterility, the system(s) 

shall be returned to a condition of 

commercial sterility before resuming 

packaging operations. 

(C) Records. Observations and 

measurements of operating conditions 

shall be made and recorded at intervals 

of sufficient frequency to ensure that 

commercial sterility of the food product 

is being achieved; such measurements 

shall include the sterilization media 

flow rates, temperatures, the container 

and closure rates (if applicable) through 

the sterilizing system, and the 

sterilization conditions if a batch system 

is used for container sterilization. The 

measurements and recordings should be 

made at intervals not to exceed 1 hour. 

(3) Incubation. Incubation tests 

should be conducted on a representative 

sample of containers of product from 

each code; records of the test results 

should be maintained. 

(4) Critical factors. Critical factors 

specified in the scheduled process shall 

be measured and recorded on the 

processing record at intervals of 

sufficient frequency to ensure that the 

factors are within the limits specified in 

the scheduled process. Such 

measurements and recordings should be 

done at intervals not to exceed 15 

minutes. 

(h) Equipment and procedures for 

flame sterilizers. The container 

conveyor speed shall be specified in the 

scheduled process. The container 

conveyor speed shall be measured and 

recorded at the start of operations and 

at intervals of sufficient frequency to 

ensure that the conveyor speed is as 

specified in the scheduled process. 

Such measurements and recordings 

should be done at 1-hour intervals. 

Alternatively, recording tachometer may 

be used to provide a continuous record 


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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 at sufficient frequency and 

repaired or replaced as necessary to 

prevent damage to containers and 

container closures. When cans are 

handled on belt conveyors, the 

conveyors should be constructed to 

minimize contact by the belt with the 

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

rolled on the double seam. All worn and 

frayed belting, can retarders, cushions, 

etc. should be replaced with new 

nonporous material. All tracks and belts 

that come into contact with the can 

seams should be thoroughly scrubbed 

and sanitized at intervals of sufficient 

frequency to avoid product 

contamination. 

4. Revise § 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 

adequately provided for in establishing 

the scheduled process. When a product 

is reprocessed or a previously processed 

product is blended into a new 

formulation, this condition must be 

covered in the scheduled process. 

Critical factors, e.g., minimum 

headspace, consistency, maximum fillin 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, 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 (c) and (e) to read as follows: 

§ 113.87 Operations in the thermal 

processing room. 

* * * * * 

(c) The initial temperature of the 

contents of the containers to be 

processed shall be accurately 

determined and recorded with sufficient 

frequency to ensure that the temperature 

of the product is no lower than the 

minimum initial temperature specified 

in the scheduled process. For those 

operations that use water during the 

filling of the retort or during processing, 

provision shall be made to ensure that 

the water will not, before the start of 

each thermal process, lower the initial 

temperature of the product below that 

specified in the scheduled process. The 

temperature-indicating device used to 

determine the initial temperature shall 

be tested for accuracy against an 

accurate calibrated reference device at 

sufficient frequency to ensure that 

initial temperature measurements are 

accurate. Records of the accuracy tests 

shall be signed or initialed, dated, and 

maintained. 

* * * * * 

(e) Clock times on temperaturerecording device records shall 

reasonably correspond to the time of 

day on the written processing records to 

provide correlation of these records. 

* * * * * 

6. Amend § 113.100 by revising 

paragraphs (a) introductory text, (a)(4), 

(b), and (c) and by adding paragraphs (f) 

and (g) to read as follows: 

§ 113.100 Processing and production 

records. 

(a) Processing and production 

information shall be entered at the time 


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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 written 

record of lots processed. Each entry on 

the processing and production records 

shall be made by the retort or processing 

system operator, or other designated 

person, at the time the specific retort or 

processing system condition or 

operation occurs, and this retort or 

processing system operator or other 

designated person shall sign or initial 

each record form. Not later than 1 

working day after the actual process, 

and before shipment or release for 

distribution, a representative of plant 

management who is qualified by 

suitable training or experience shall 

review all processing and production 

records for completeness and to ensure 

that the product received the scheduled 

process. The records, including 

temperature-recording device records, 

shall be signed or initialed and dated by 

the reviewer. 

(c) Written records of all container 

closure examinations shall specify the 

product code, the date and time of 

container closure inspections, the 

measurements obtained, and all 

corrective actions taken. Records shall 

be signed or initialed by the container 

closure inspector and reviewed by 

management with sufficient frequency 

to ensure that the containers are 

hermetically sealed. The records shall 

be signed or initialed and dated by the 

reviewer. 

* * * * * 

(f) Records of this part may be 

maintained electronically, provided 

they are in compliance with part 11 of 

this chapter. 

(g) All records required under this 

part, or copies of such records, must be 

readily available during the retention 

period for inspection and copying by 

FDA when requested. If reduction 

techniques, such as microfilming, are 

used, a suitable reader and 

photocopying equipment must be made 

readily available to FDA. 

Dated: March 4, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1172 Filed 3–13–07; 8:45 am] 

BILLING CODE 4160–01–S 


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