Notice2023-22461
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70663-70664]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#b1e1e3f0e2c5d0d7d7f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="91c1c3d0c2e5f0f7f7d1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a>.
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 <a href="https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm">https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm</a>.
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:
<bullet> Form FDA 2541d (Food Process Filing for Low-Acid Retorted
Method);
<bullet> Form FDA 2541e (Food Process Filing for Acidified Method);
<bullet> Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method); and
<bullet> 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
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