[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18995-18998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions of 
reporting and recordkeeping requirements for firms that process 
acidified foods and thermally processed low-acid foods in hermetically 
sealed containers.

DATES: Submit either electronic or written comments on the collection 
of information by June 2, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 2, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

[[Page 18996]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-1119 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Canning Establishment 
Registration, Process Filing, and Recordkeeping for Acidified Foods and 
Thermally Processed Low-Acid Foods in Hermetically Sealed Containers.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these 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.

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 (the 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

[[Page 18997]]

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)(2) 
(21 CFR 108.25(c)(1) and 108.35(c)(2)). 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, 
Sec.  108.35, or both, 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.
    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 response    Total hours
                                                              respondents     respondent       responses                 \2\
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108.25(c)(1) and 108.35(c)(1); Food                   2541             645               1             645  0.17 (10 mins.).............             110
 canning establishment registration.
108.25(c)(2); Food process filing for                2541e             726              11           7,986  0.33 (20 mins.).............           2,659
 acidified method.
108.35(c)(2); Food process filing for low-           2541d             336              12           4,032  0.33 (20 mins.).............           1,343
 acid retorted method.
108.35(c)(2); Food process filing for                2541f              37               6             222  0.33 (20 mins.).............              74
 water activity/formulation control method.
108.35(c)(2); Food process filing for low-           2541g              42              22             924  0.75 (45 mins.).............             693
 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.................................  ..............  ..............  ..............  ..............  ............................           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.


[[Page 18998]]

    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\ There 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: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07007 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P