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, 70663-70664 [2023-22461]
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
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
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 LowAcid Foods in Hermetically Sealed
Containers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by November
13, 2023.
DATES:
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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
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 (§§ 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
(§§ 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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
70663
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 (§§ 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 (§§ 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 (§§ 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
(§ 113.60(c) (thermally processed lowacid foods) and § 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/Guidance
Regulation/FoodFacilityRegistration/
AcidifiedLACFRegistration/
ucm2007436.htm. Processors mail
completed paper forms to us. However,
processors who are subject to § 108.25
and/or § 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
E:\FR\FM\12OCN1.SGM
12OCN1
70664
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
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
21 CFR section; activity
Form FDA No.
108.25(c)(1) and 108.35(c)(2); Food
canning establishment registration.
108.25(c)(2); Food process filing for
acidified method.
108.35(c)(2); Food process filing for
low-acid retorted method.
108.35(c)(2); Food process filing for
water activity/formulation control
method.
108.35(c)(2); Food process filing for
low-acid aseptic systems.
108.25(d), 108.35(d) and (e); Report
of any instance of potential healthendangering spoilage, process deviation, or contamination with
microorganisms where any lot of
the food has entered distribution in
commerce.
Total ............................................
1 There
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours
2541
1,218
1
1,218
0.17 (10 minutes)
207
2541e
2,078
7
14,546
0.33 (20 minutes)
4,800
2541d
842
7
5,894
0.33 (20 minutes)
1,945
2541f
111
4
444
0.33 (20 minutes)
147
2541g
168
11
1,848
0.75 (45 minutes)
1,386
N/A
1
1
1
4 ...........................
4
........................
........................
........................
........................
..............................
8,489
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
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
113.100 and 114.100 ...........................................................
10,392
1
10,392
250
2,598,000
ddrumheller on DSK120RN23PROD with NOTICES1
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 (§ 113.60(c)) and acidified
foods (§ 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 §§ 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
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
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.
PO 00000
Frm 00027
Fmt 4703
Sfmt 9990
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
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. .............. ............................ 8,489
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
113.100 and 114.100................................................ 10,392 1 10,392 250 2,598,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
