[Federal Register Volume 64, Number 142 (Monday, July 26, 1999)]
[Notices]
[Pages 40377-40379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
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.


[[Page 40378]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
August 25, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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) (21 U.S.C. 342), FDA is authorized to prevent the interstate 
distribution of food products that may be injurious to health or that 
are otherwise adulterated. 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)).
    In the Federal Register of April 30, 1999 (64 FR 23334), the agency 
requested comments on the proposed collections of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
    Form No.      21 CFR Section      No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Form FDA 2541    108.25(c)(1)         300               1             300                .17           51
 (Registration)   and
                  108.35(c)(1)
Form FDA 2541a   108.25(c)(2)       1,000               6.5         6,500                .333       2,165
 (Process         and
 Filing)          108.35(c)(2)
Form FDA         108.35(c)(2)       1,000                .50          500                .75          375
 2541(c)
 (Process
 Filing)
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 Burden\1\
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                                                   Annual
        21 CFR Section             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.


[[Page 40379]]

    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: July 19, 1999
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-18925 Filed 7-23-99; 8:45 am]
BILLING CODE 4160-01-F