[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
