[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57391-57394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22674]


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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 we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 invites 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, and provides notice of and invites 
comments on our proposed revisions to the

[[Page 57392]]

electronic submission system and paper-based forms for this collection.

DATES: Submit either electronic or written comments concerning the 
collection of information by November 18, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, we are publishing this notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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)--Revision

    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) (21 CFR 
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) (21 CFR 113.60(c) (thermally 
processed foods) and 114.80(b) (21 CFR 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, 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).
    In this document, we are providing notice that we are updating the 
process filing portion of the electronic submission system to 
incorporate ``smart form'' technology. The updated process filing 
portion of the electronic submission system will query the processor 
about the processes used to produce the food and present only those 
data entry fields that are applicable. This will reduce the burden on 
processors and reduce errors in process filing because processors will 
no longer need to evaluate whether particular data entry fields are 
applicable to their products. For example, when a processor submits a 
process filing for a

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product that is processed using a low-acid retorted method with a 
process mode of ``agitating'', ``smart form'' technology would bypass 
questions that are not applicable to this process mode option.
    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 
proposing to eliminate Forms FDA 2541a (Ref. 2) and FDA 2541c (Ref. 3) 
and replace these two forms with a total of four forms. Each of the 
four proposed replacement forms will pertain to a specific type of 
commercial processing and will be available both on the electronic 
submission system and as a paper-based form. The electronic submission 
system and the paper-based form will ``mirror'' each other to the 
extent practicable. The four proposed replacement process filing forms 
are as follows:
     Form FDA 2541d (Food Process Filing for Low-Acid Retorted 
Method) (Ref.4);
     Form FDA 2541e (Food Process Filing for Acidified Method) 
(Ref. 5);
     Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 6); and
     Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems) (Ref. 7).
    Some of the data entry fields on the four proposed replacement 
process filing forms are not on current Forms FDA 2541a and FDA 2541c. 
We added certain data entry fields to improve the efficiency of our 
review of the process filings. For example, the four proposed 
replacement forms include data entry fields for the ``food product 
group'' (such as liquid, ready-to-eat ``breakfast foods''). We estimate 
that any time it would take to provide such information not already on 
Form FDA 2541a or FDA 2541c would be offset by the time processors will 
save by not having to evaluate whether certain data entry fields on 
Form FDA 2541a or FDA 2541c are applicable to their products. 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 11) or at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. After we review the comments received in response to 
this notice, we will determine what, if any, changes will be made to 
the paper-based versions of the forms. We will then complete the 
development of the electronic submission system to mirror the revised 
paper forms. The draft electronic versions of the forms will be made 
available for review on OMB's Web site when we publish a second notice 
in the Federal Register announcing the submission of the information 
collection request to OMB. That notice will have a 30-day public 
comment period.
    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:

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

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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.

    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 have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (We 
have verified the Web site addresses in this reference section, but we 
are not responsible for any subsequent changes to Web sites after this 
document publishes in the Federal Register.)
    1. FDA 2012. ``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 http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
    2. Form FDA 2541a. Food Process Filing for All Methods Except Low-
Acid Aseptic. Available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076784.pdf.
    3. Form FDA 2541c. Food Process Filing for Low-Acid Aseptic 
Systems. Available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM123687.pdf.
    4. Draft Form 2541d. Food Process Filing for Low-Acid Retorted 
Method. Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365066.pdf.
    5. Draft Form 2541e. Food Process Filing for Acidified Method. 
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365058.pdf.
    6. Draft Form 2541f. Food Process Filing for Water Activity/
Formulation Control Method. Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365059.pdf.
    7. Draft Form 2541g. Food Process Filing for Low-Acid Aseptic 
Systems. Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365060.pdf.
    8. Draft Instructions for Paper Submission of Form FDA 2541d. 
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366881.pdf.
    9. Draft Instructions for Paper Submission of Form FDA 2541e. 
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366882.pdf.
    10. Draft Instructions for Paper Submission of Form FDA 2541f. 
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366884.pdf
    11. Draft Instructions for Paper Submission of Form FDA 2541g. 
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366885.pdf.

    Dated: September 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22674 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P