[Federal Register Volume 67, Number 87 (Monday, May 6, 2002)]
[Notices]
[Pages 30391-30392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11132]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0123]


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) 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 solicits comments on reporting and recordkeeping 
requirements for firms that process acidified foods and thermally 
processed low-acid foods in hermetically sealed containers.

DATES: Submit written or electronic comments on the collection of 
information by July 5, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: 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, 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: (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.

[[Page 30392]]

Food Canning Establishment Registration, Process Filing and 
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid 
Foods in Hermetically Sealed Containers (OMB Control Number 0910-
0037)--Extension

    Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is 
authorized to prevent the interstate distribution of food products that 
may be injurious to health or that are otherwise adulterated, as 
defined in section 402 of the act (21 U.S.C. 342). Under the authority 
granted to FDA by section 404 of the act (21 U.S.C. 344), FDA 
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 FDA 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 must 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, FDA 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 FDA using Form FDA 2541 (Secs. 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 (Secs. 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 are also required to document 
corrective actions when process controls and procedures do not fall 
within specified limits (Secs. 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 (Secs. 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 (Secs. 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 (Secs. 113.60(c) 
(thermally processed foods) and 114.80(b) (acidified foods)).
    FDA estimates the burden of complying with the information 
collection provisions of the agency's regulations for acidified foods 
and thermally processed low-acid foods in hermetically sealed 
containers as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                               Annual
               Form No.                          21 CFR Section                No. of       Frequency per   Total Annual     Hours per      Total Hours
                                                                             Respondents      Response        Responses       Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541 (Registration)           108.25(c)(1) and 108.35(c)(1)              500               1             500            .17              85
Form FDA 2541a (Process Filing)        108.25(c)(2) and 108.35(c)(2)            1,000               7           7,000            .333          2,331
Form FDA 2541c (Process Filing)        108.35(c)(2)                               275               2             550            .75             412
Total                                                                                                           8,050                          2,828
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of         Annual Frequency      Total Annual          Hours per
                     21 CFR Part                         Recordkeepers     per Recordkeeping        Records          Recordkeeper         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
108, 113, and 114                                           6,000                   1               6,000                 250           1,500,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Secs. 108.25(d) and 108.35(d) and (e) is 
insignificant 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. To avoid 
double-counting, estimates for Secs. 108.25(g) and 108.35(h) have not 
been included because they merely cross-reference recordkeeping 
requirements contained in parts 113 and 114.

    Dated: April 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11132 Filed 5-3-02; 8:45 am]
BILLING CODE 4160-01-S