# 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.
**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 July 3, 2008.
**ADDRESSES:**
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: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *[email protected]* . All comments should be identified with the OMB control number 0910-0037. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
**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 (§§ 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 (§ 113.87(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 (§§ 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 108.35(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)).
In the *Federal Register* of March 4, 2008 (73 FR 11649), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
| Form No. | 21 CFR | No. of | Annual Frequency | Total Annual | Hours per | Total Hours |
| --- | --- | --- | --- | --- | --- | --- |
| Form FDA 2541 (Registration) | 108.25 and 108.35 | 515 | 1 | 515 | .17 | 88 |
| Form FDA 2541a (Process Filing) | 108.25 and 108.35 | 1,489 | 8.62 | 12,835 | .333 | 4,274 |
| Form FDA 2541c (Process Filing) | 108.35 | 84 | 7.77 | 653 | .75 | 490 |
| Total | 4,852 | | | | | |
| 21 CFR Part | No. of | Annual Frequency | Total Annual | Hours per | Total Hours |
| --- | --- | --- | --- | --- | --- |
| 113 and 114 | 7,454 | 1 | 7,454 | 250 | 1,863,500 |
FDA based its estimate on registrations and process filings received over the past 3 years. FDA has changed its estimate of the number of recordkeepers in table 2 of this document, reducing the figure from 8,950 to 7,454. The agency reexamined the figure and excluded firms that were inactive or out of business, yet still registered. Thus, the lower figure is a more accurate estimate of the number of recordkeepers. The reporting burden for §§ 108.25(d) and 108.35(d) and 108.35(e) is minimal 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.
Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.