Agency information collection activities: Submission for OMB review; comment request,
[Federal Register: July 22, 2002 (Volume 67, Number 140)]
[Notices]
[Page 47820-47821]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy02-91]
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.
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 filedprior 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\
Annual No. of Frequency Total Hours Total Form No.
21 CFR Section Respondents of Annual per Hours Response Responses Response
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
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
Annual Frequency per
Hours per 21 CFR Part
No. of Recordkeepers Recordkeeping Total Annual Records Recordkeeper
Total Hours
108, 113, and 114
6,000
1
6,000
250
1,500,000
\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: July 15, 2002. Margaret M. Dotzel, Associate Commissioner for Policy.
[FR Doc. 02-18319Filed7-19-02; 8:45 am]
BILLING CODE 4160-01-S
