[Federal Register Volume 67, Number 140 (Monday, July 22, 2002)]
[Notices]
[Pages 47820-47821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18319]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0123]


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.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
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: Submit written comments on the collection of information by 
August 21, 2002.

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: 
Stuart Shapiro, 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 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 (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 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

[[Page 47821]]

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 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\
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                                                                             Annual
                                                                 No. of    Frequency    Total      Hours   Total
             Form No.                    21 CFR Section       Respondents      of       Annual      per    Hours
                                                                            Response  Responses  Response
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FDA 2541 (registration)            108.25 and 108.35              500           1        500         .17     85
FDA 2541a (process filing)         108.25 and 108.35            1,000           7      7,000        .333   2,331
FDA 2541c (process filing)         108.35                         275           2        550         .75    412
Total                                                                                  8,050               2,828
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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 Frequency per                               Hours per
             21 CFR Part                No. of Recordkeepers      Recordkeeping       Total Annual Records       Recordkeeper           Total Hours
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108, 113, and 114                                     6,000                      1                  6,000                    250              1,500,000
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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 
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requirements contained in parts 113 and 114.

    Dated: July 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18319 Filed 7-19-02; 8:45 am]
BILLING CODE 4160-01-S