[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
