
[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45293-45295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20791]


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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 or we) 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: Fax written comments on the collection of information by October 
30, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0037. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

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.

I. Background

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 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)(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,

[[Page 45294]]

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 
versions of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 
2541g by contacting us at a particular address or 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 (Ref. 1).
    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) (Ref. 2);
     Form FDA 2541e (Food Process Filing for Acidified Method) 
(Ref. 3);
     Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 4); and
     Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems) (Ref. 5).
    At this time, the paper-based versions of the four forms and their 
instructions are all available for review as references to this 
document (Refs. 2 through 5) 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.
    In the Federal Register of June 20, 2017 (82 FR 28069), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. While no comments were submitted to the 
docket, it was noted that the notice included an inadvertent reference 
to outdated forms. We regret this oversight and have made appropriate 
corrections in this notice. The forms developed in support of the 
information collection are intended to minimize burden on respondents 
while maximizing utility for FDA, and thus we are continuously open to 
suggestions on how they might be improved.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                              Average
                                                             FDA  form       Number of       Number of     Total  annual    burden per
                     21 CFR section                           number        respondents    responses per     responses       response       Total hours
                                                                                            respondent                       (minutes)
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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)
Sec.   108.25(c)(2); Food process filing for acidified             2541e             726              11           7,986           0.333           2,659
 method.................................................                                                                            (20)
Sec.   108.35(c)(2); Food process filing for low-acid              2541d             336              12           4,032           0.333           1,343
 retorted method........................................                                                                            (20)
Sec.   108.35(c)(2); Food process filing for water                 2541f              37               6             222           0.333              74
 activity/formulation control method....................                                                                            (20)
Sec.   108.35(c)(2); Food process filing for low-acid              2541g              42              22             924            0.75             693
 aseptic systems........................................                                                                            (45)

[[Page 45295]]

 
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 are therefore 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.

    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. The burden for this information collection has not changed 
since the last OMB approval.

II. References

    The following references are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 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 2541d, FDA 2541e, 
FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in 
Electronic or Paper Format.'' Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541d. Food Process Filing for Low-Acid Retorted Method. 
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf.
3. Form FDA 2541e. Food Process Filing for Acidified Method. 
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf.
4. Form FDA 2541f. Food Process Filing for Water Activity/
Formulation Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf.
5. Form FDA 2541g. Food Process Filing for Low-Acid Aseptic Systems. 
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20791 Filed 9-27-17; 8:45 am]
 BILLING CODE 4164-01-P


