[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18034-18035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0032]


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) 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 May 9, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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 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 (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 Form FDA 2541a for all methods except 
aseptic processing, or Form FDA 2541c 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 
(Sec.  13.87(a) (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 (Sec. Sec.  113.89, 114.89, and 114.100(c)); to 
report any

[[Page 18035]]

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. Sec.  
113.60(c) (thermally processed foods) and 114.80(b) (acidified foods)).
    In the Federal Register of February 7, 2005 (70 FR 6445), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of the collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                     21 CFR         No. of       Annual Frequency   Total Annual     Hours per
    Form No.         Section      Respondents      per Response       Responses       Response      Total Hours
----------------------------------------------------------------------------------------------------------------
FDA 2541          108.25 and               585                  1             585          0.17               99
 (registration)    108.35
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FDA 2541a         108.25 and             1,778                  9          16,002          0.333           5,329
 (process          108.35
 filing)
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FDA 2541(c)       108.35                   124                 10           1,240          0.75              930
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Total                                                                                                     6,358
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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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                         No. of        Annual Frequency     Total Annual        Hours per
   21 CFR Part       Recordkeepers        per Record          Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
Parts 113 and 114              7,915                  1              7,915                250         1,978,750
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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 Sec. Sec.  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 Sec. Sec.  108.25(g) and 
108.35(h) have not been included because they merely cross reference 
recordkeeping requirements contained in parts 113 and 114.
    There are approximately 7,915 food processing establishments, both 
foreign and domestic, registered as processors of acidified foods or 
thermally processed low-acid foods in hermetically sealed containers. 
Four FDA staff persons who are experienced in actual food processing 
plant operations and familiar with the regulations reviewed the 
recordkeeping procedures used by the industry.
    Standardized timeframe requirements for conducting the 
recordkeeping procedures do not exist but it is estimated to take 250 
hours per establishment to comply with the recordkeeping requirements 
in parts 108, 113, and 114. This compares satisfactorily when based 
upon firsthand food processing plant experience, individual estimates 
of the timeframes, and the frequency of recordkeeping.

    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7028 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S