
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28069-28072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12783]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 August 21, 2017.

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 August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 21, 2017. 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.

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.fda.gov/regulatoryinformation/dockets/default.htm.
    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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the PRA (44 U.S.C. 3501-3520), 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,

[[Page 28070]]

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 
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 which 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)(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 Form FDA 2541a for all methods except 
aseptic processing, or Form FDA 2541c 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. Sec.  
113.60(c)) (thermally processed 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 our regulations, processors may obtain the paper 
versions of Forms FDA 2541, FDA 2541a, and FDA 2541c by contacting us 
at a particular address. 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 2541a, and FDA 2541c 
electronically (Ref. 1) (see also 76 FR 11783 at 11785; March 3, 2011).
    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 
pertain to a specific type of commercial processing and are available 
both on the electronic submission system and as a paper-based form. The 
electronic submission system and the 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) (Ref. 3);
     Form FDA 2541e (Food Process Filing for Acidified Method) 
(Ref. 4);
     Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 5); and
     Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems) (Ref. 6).
    At this time, the paper-based versions of the four proposed 
replacement forms and their instructions are all available for review 
as references to this document (Refs. 4 through 6) or 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 28071]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Number of
          21 CFR section                FDA Form No.        Number of     responses per   Total annual     Average burden per response      Total hours
                                                           respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   108.25(c)(1) and       2541...............             645               1             645  0.17 (10 minutes)..............             110
 108.35(c)(2); Food canning
 establishment registration.
Sec.   108.25(c)(2); Food process   2541e..............             726              11           7,986  0.333 (20 minutes).............           2,659
 filing for acidified method.
Sec.   108.35(c)(2); Food process   2541d..............             336              12           4,032  0.333 (20 minutes).............           1,343
 filing for low-acid retorted
 method.
Sec.   108.35(c)(2); Food process   2541f..............              37               6             222  0.333 (20 minutes).............              74
 filing for water activity/
 formulation control method.
Sec.   108.35(c)(2); Food process   2541g..............              42              22             924  0.75 (45 minutes)..............             693
 filing for low-acid aseptic
 systems.
Sec.  Sec.   108.25(d) and          N/A................               1               1               1  4..............................               4
 108.35(d) and (e); Report of 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.........................  ...................  ..............  ..............  ..............  ...............................           4,883
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate of the number of respondents in table 1 on 
registrations, process filings, and reports received over the past 3 
years. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                            21 CFR part                                 Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
108, 113, and 114..................................................          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.

    FDA bases its estimate of 10,392 recordkeepers in table 2 on its 
records of the number of registered firms, excluding firms that were 
inactive or out of business, yet still registered. To avoid double-
counting, we have not included estimates for Sec. Sec.  108.25(g), 
108.35(c)(2)(ii), and 108.35(h) because they merely cross-reference 
recordkeeping requirements contained in parts 113 and 114 and have been 
accounted for in the recordkeeping burden estimate. We estimate that 
10,392 firms will 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. We seek OMB 
approval of the third party disclosure requirements in Sec. Sec.  
113.60(c) and 114.80(b). However, we have not included a separate table 
to report the estimated burden of these regulations. 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.

II. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov/. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA 2016. ``Guidance for Industry: Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and Forms FDA 2541a and FDA 
2541c (Food Process Filing Forms) to FDA in Electronic or Paper 
Format.'' Available at https://www.fda.gov/Food/GuidanceRegulation/
Guidance

[[Page 28072]]

DocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541. Food Process Filing for All Methods Except Low-
Acid Aseptic. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076778.pdf.
3. Form 2541d. Food Process Filing for Low-Acid Retorted Method. 
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf.
4. Form 2541e. Food Process Filing for Acidified Method. Available 
at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf.
5. Form 2541f. Food Process Filing for Water Activity/Formulation 
Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf.
6. Form 2541g. Food Process Filing for Low-Acid Aseptic Systems. 
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf.


    Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12783 Filed 6-19-17; 8:45 am]
 BILLING CODE 4164-01-P


