[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Notices]
[Pages 23334-23336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0780]


Agency Information Collection Activities: Proposed Collection; 
Comment Request for 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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[[Page 23335]]

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 comments on the collection of information by June 
29, 1999.
ADDRESSES: 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 below.
     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.

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(c)(1) and 
(c)(2), (d), (e), (g); 108.35(c)(1), (c)(2), (d), (e), (f), (h); 
113.60(c); 113.83; 113.87; 113.89; 113.100; 114.80(b); 114.89; 
114.100(a) through (d)) (OMB Control Number 0910-0037--Extension).

     Under section 402 of 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 (21 U.S.C. 342). Under the authority granted to FDA by 
section 404 of the act (21 U.S.C. 344), FDA's 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's 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 
the agency 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 of information as follows:

                                                      Table 1.--Estimated Annual Reporting Burden1
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                                                                                              Annual
              Form No.                           CFR Section                  No. of       Frequency per   Total Annual      Hours per      Total Hours
                                                                            Respondents      Response        Responses       Response
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Form FDA 2541 (Registration)         108.25 (c)(1) and 108.35(c)(1)           300               1             300                .17           51

[[Page 23336]]

 
Form FDA 2541a (Process Filing)      108.25 (c)(2) and 108.35(c)(2)         1,000               6.5         6,500                .333       2,165
Form FDA 2541c (Process Filing)      108.35(c)(2)                           1,000                .50          500                .75          375
Total                                                                                                                                       2,591
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                Annual
        21 CFR Part             No. of       Frequency per   Total Annual      Hours per         Total Hours
                             Recordkeepers   Recordkeeping      Records      Recordkeeper
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 108, 113, and 114            5,865               1           5,865             250           1,466,250
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\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, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10797 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F