[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44905-44907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16037]


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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) 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 August 24, 2020.

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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

[[Page 44906]]

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 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 our regulations, processors may obtain the paper 
version of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 
2541g by contacting us at a particular address by visiting 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 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).
    At this time, the paper-based versions of the four forms and their 
instructions are all available for review at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm.
    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 April 3, 2020 (85 FR 18995), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate 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              FDA Form No.      Number of      responses per     Total annual    Average  burden per     Total hours
                                                                 respondents       respondent       responses           response 2
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108.25(c)(1) and 108.35(c)(1); Food canning             2541              645                1              645      0.17 (10 minutes)              110
 establishment registration.................
108.25(c)(2); Food process filing for                  2541e              726               11            7,986      0.33 (20 minutes)            2,659
 acidified method...........................
108.35(c)(2); Food process filing for low-             2541d              336               12            4,032      0.33 (20 minutes)            1,343
 acid retorted method.......................
108.35(c)(2); Food process filing for water            2541f               37                6              222      0.33 (20 minutes)               74
 activity/formulation control method........
108.35(c)(2); Food process filing for low-             2541g               42               22              924      0.75 (45 minutes)              693
 acid aseptic systems.......................
108.25(d); 108.35(d) and (e); Report of any              N/A                1                1                1                      4                4
 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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[[Page 44907]]

 
    Total...................................  ...............  ...............  ...............  ...............  .....................           4,883
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The calculation for 20 minutes uses 0.333 hour.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. We base our estimate of the number of respondents in table 1 
on registrations, process filings, and reports received. The hours per 
response reporting estimates are based on our experience with similar 
programs and information received from industry. The reporting burden 
for Sec. Sec.  108.25(d) and 108.35(d) and (e) is minimal because 
notification of spoilage, process deviation, or contamination of 
product in distribution occurs less than once a year. Most firms 
discover these problems before the product is distributed and, 
therefore, are not required to report the occurrence. We estimate that 
we will receive one report annually under Sec. Sec.  108.25(d) and 
108.35(d) and (e). The report is expected to take 4 hours per response, 
for a total of 4 hours.

                                                    Table 2--Estimated Annual Recordkeeping Burden 1
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                                                                                         Number of                      Average  burden
                            21 CFR part                                 Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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108, 113, and 114..................................................          10,392                1           10,392              250        2,598,000
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\1\ here are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate of 10,392 recordkeepers in table 2 on the 
number of registered firms, excluding firms that were inactive or out 
of business, yet still registered. We estimate that 10,392 firms will 
each expend approximately 250 hours per year to fully satisfy the 
recordkeeping requirements in parts 108, 113 and 114, for a total of 
2,598,000 hours.
    Finally, 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.

    Dated: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16037 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P