
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70663-70664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22461]



[[Page 70663]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1119]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Canning 
Establishment Registration, Process Filing, and Recordkeeping for 
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically 
Sealed Containers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, we, or us) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by November 13, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0037. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Canning Establishment Registration, Process Filing, and 
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid 
Foods in Hermetically Sealed Containers--21 CFR 108.25 and 108.35, and 
21 CFR Parts 113 and 114

OMB Control Number 0910-0037--Extension

    Section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 342) deems a food to be adulterated, in part, if the food 
bears or contains any poisonous or deleterious substance that may 
render it injurious to health. Section 301(a) of the FD&C Act (21 
U.S.C. 331(a)) prohibits the introduction or delivery for introduction 
into interstate commerce of adulterated food. Under section 404 of the 
FD&C Act (21 U.S.C. 344), our regulations require registration of food 
processing establishments, filing of process or other data, and 
maintenance of processing and production records for acidified foods 
and thermally processed low-acid foods in hermetically sealed 
containers. These requirements are intended to ensure safe 
manufacturing, processing, and packing procedures and to permit us to 
verify that these procedures are being followed. Improperly processed 
low-acid foods present life-threatening hazards if contaminated with 
foodborne microorganisms, especially Clostridium botulinum. The spores 
of C. botulinum need to be destroyed or inhibited to avoid production 
of the deadly toxin that causes botulism. This is accomplished with 
good manufacturing procedures, which must include the use of adequate 
heat processes or other means of preservation.
    To protect the public health, our regulations require that each 
firm that manufactures, processes, or packs acidified foods or 
thermally processed low-acid foods in hermetically sealed containers 
for introduction into interstate commerce register the establishment 
with us using Form FDA 2541 (Sec. Sec.  108.25(c)(1) and 108.35(c)(1) 
(21 CFR 108.25(c)(1) and 108.35(c)(1)). In addition to registering the 
plant, each firm is required to provide data on the processes used to 
produce these foods, using Forms FDA 2541d, FDA 2541e, and FDA 2541f 
for all methods except aseptic processing, or Form FDA 2541g for 
aseptic processing of low-acid foods in hermetically sealed containers 
(Sec. Sec.  108.25(c)(2) and 108.35(c)(2)). Plant registration and 
process filing may be accomplished simultaneously. Process data must be 
filed prior to packing any new product, and operating processes and 
procedures must be posted near the processing equipment or made 
available to the operator (21 CFR 113.87(a)).
    Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 
114) require firms to maintain records showing adherence to the 
substantive requirements of the regulations. These records must be made 
available to FDA on request. Firms also must document corrective 
actions when process controls and procedures do not fall within 
specified limits (Sec. Sec.  113.89, 114.89, and 114.100(c)); to report 
any instance of potential health-endangering spoilage, process 
deviation, or contamination with microorganisms where any lot of the 
food has entered distribution in commerce (Sec. Sec.  108.25(d) and 
108.35(d) and (e)); and to develop and keep on file plans for recalling 
products that may endanger the public health (Sec. Sec.  108.25(e) and 
108.35(f)). To permit lots to be traced after distribution, acidified 
foods and thermally processed low-acid foods in hermetically sealed 
containers must be marked with an identifying code (Sec.  113.60(c) 
(thermally processed low-acid foods) and Sec.  114.80(b) (acidified 
foods)).
    The records of processing information are periodically reviewed 
during factory inspections by FDA to verify fulfillment of the 
requirements in parts 113 or 114. Scheduled thermal processes are 
examined and reviewed to determine their adequacy to protect public 
health. In the event of a public health emergency, records are used to 
pinpoint potentially hazardous foods rapidly and thus limit recall 
activity to affected lots.
    As described in FDA regulations, processors may obtain the paper 
version of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 
2541g at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. 
Processors mail completed paper forms to us. However, processors who 
are subject to Sec.  108.25 and/or Sec.  108.35 have an option to 
submit Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g 
electronically.
    Although we encourage commercial processors to use the electronic 
submission system for plant registration and process filing, we will 
continue to make paper-based forms available. To standardize the burden 
associated with process filing, regardless of whether the process 
filing is submitted electronically or using a paper form, we are 
offering the public the opportunity to use four forms, each of which 
pertains to a specific type of commercial processing and is available 
both on the electronic submission system and as a paper-based form. The 
electronic submission system

[[Page 70664]]

and paper-based form ``mirror'' each other to the extent practicable. 
The four process filing forms are as follows:
     Form FDA 2541d (Food Process Filing for Low-Acid Retorted 
Method);
     Form FDA 2541e (Food Process Filing for Acidified Method);
     Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method); and
     Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems).
    Description of Respondents: The respondents to this information 
collection are commercial processors and packers of acidified foods and 
thermally processed low-acid foods in hermetically sealed containers.
    In the Federal Register of March 21, 2023 (88 FR 16990), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
         21 CFR section; activity            Form FDA No.      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
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108.25(c)(1) and 108.35(c)(2); Food                   2541           1,218               1           1,218  0.17 (10 minutes)...........             207
 canning establishment registration.
108.25(c)(2); Food process filing for                2541e           2,078               7          14,546  0.33 (20 minutes)...........           4,800
 acidified method.
108.35(c)(2); Food process filing for low-           2541d             842               7           5,894  0.33 (20 minutes)...........           1,945
 acid retorted method.
108.35(c)(2); Food process filing for                2541f             111               4             444  0.33 (20 minutes)...........             147
 water activity/formulation control method.
108.35(c)(2); Food process filing for low-           2541g             168              11           1,848  0.75 (45 minutes)...........           1,386
 acid aseptic systems.
108.25(d), 108.35(d) and (e); Report of                N/A               1               1               1  4...........................               4
 any instance of potential health-
 endangering spoilage, process deviation,
 or contamination with microorganisms
 where any lot of the food has entered
 distribution in commerce.
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    Total.................................  ..............  ..............  ..............  ..............  ............................           8,489
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates in table 1 on registrations, process filings, 
and reports received. The estimates for hours per response are based on 
our experience with similar programs and information received from 
industry.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                           21 CFR section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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113.100 and 114.100................................................          10,392                1           10,392              250        2,598,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our regulations require that processors mark thermally processed 
low-acid foods in hermetically sealed containers (Sec.  113.60(c)) and 
acidified foods (Sec.  114.80(b)) with an identifying code to permit 
lots to be traced after distribution. No burden has been estimated for 
the third-party disclosure requirements in Sec. Sec.  113.60(c) and 
114.80(b) because the coding process is done as a usual and customary 
part of normal business activities. Coding is a business practice in 
foods for liability purposes, inventory control, and process control in 
the event of a problem. Under 5 CFR 1320.3(b)(2), the time, effort, and 
financial resources necessary to comply with a collection of 
information are excluded from the burden estimate if the reporting, 
recordkeeping, or disclosure activities needed to comply are usual and 
customary because they would occur in the normal course of activities.
    Since the publication of the 60-day notice we have adjusted our 
burden estimate. Our estimated burden for the information collection 
reflects an increase of 3,606 total burden hours and a corresponding 
increase of 10,141 total annual responses. This increase corresponds 
with data obtained from past submissions.

    Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22461 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P


