Source: https://www.federalregister.gov/documents/2002/05/06/02-11132/agency-information-collection-activities-proposed-collection-comment-request-food-canning
Timestamp: 2017-08-23 01:04:08
Document Index: 769257665

Matched Legal Cases: ['§\u2009108', '§\u2009108', 'arts 108', 'arts 108', '§\u2009113', '§\u2009108', '§\u2009108', '§\u2009113', '§\u2009108', '§\u2009108', 'arts 113']

Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
A Notice by the Food and Drug Administration on 05/06/2002
Submit written or electronic comments on the collection of information by July 5, 2002.
67 FR 30391
02-11132
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
https://www.federalregister.gov/d/02-11132 https://www.federalregister.gov/d/02-11132
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 (§§ 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 (§§ 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 (§§ 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 (§§ 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 (§§ 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 (§§ 113.60(c) (thermally processed foods) and 114.80(b) (acidified foods)).
Form FDA 2541 (Registration) 108.25(c)(1) and 108.35(c)(1) 500 1 500 .17 85
Form FDA 2541a (Process Filing) 108.25(c)(2) and 108.35(c)(2) 1,000 7 7,000 .333 2,331
Form FDA 2541c (Process Filing) 108.35(c)(2) 275 2 550 .75 412
Total 8,050 2,828
108, 113, and 114 6,000 1 6,000 250 1,500,000
The reporting burden for §§ 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 §§ 108.25(g) and 108.35(h) have not been included because they merely cross-reference recordkeeping requirements contained in parts 113 and 114.
[FR Doc. 02-11132 Filed 5-3-02; 8:45 am]