70 FR 67 pgs. 18034-18035 - Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Food Canning EstablishmentRegistration, Process Filing, and Recordkeeping for Acidified Foods andThermally Processed Low-Acid Foods in Hermetically SealedContainers
Type: NOTICEVolume: 70Number: 67Pages: 18034 - 18035
Docket number: [Docket No. 2005N-0032]
FR document: [FR Doc. 05-7028 Filed 4-7-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0032]
Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Food Canning EstablishmentRegistration, Process Filing, and Recordkeeping for Acidified Foods andThermally Processed Low-Acid Foods in Hermetically SealedContainers
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing that a proposed collection of information has been submitted tothe Office of Management and Budget (OMB) for review and clearance underthe Paperwork Reduction Act of 1995.
DATES:
Fax written comments on the collection ofinformation by May 9, 2005.
ADDRESSES:
OMB is still experiencing significant delaysin the regular mail, including first class and express mail, and messengerdeliveries are not being accepted. To ensure that comments on theinformation collection are received, OMB recommends that written commentsbe faxed to the Office of Information and Regulatory Affairs, OMB, Attn:Fumie Yokota, Desk Officer for FDA, FAX:202-395-6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins,Office of Management Programs (HFA-250), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the followingproposed collection of information to OMB for review and clearance.
Food Canning Establishment Registration, Process Filing, andRecordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods inHermetically Sealed Containers (OMB Control Number0910-0037)-Extension
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA isauthorized to prevent the interstate distribution of food products that maybe injurious to health or that are otherwise adulterated, as defined insection 402 of the act (21 U.S.C. 342). Under the authority granted to FDAby section 404 of the act (21 U.S.C. 344), FDA regulations requireregistration of food processing establishments, filing of process or otherdata, and maintenance of processing and production records for acidifiedfoods and thermally processed low-acid foods in hermetically sealedcontainers. These requirements are intended to ensure safe manufacturing,processing, and packing procedures and to permit FDA to verify that theseprocedures are being followed. Improperly processed low-acid foods presentlife-threatening hazards if contaminated with foodborne microorganisms,especially Clostridium botulinum . The spores of C.botulinum must be destroyed or inhibited to avoid production of thedeadly toxin that causes botulism. This is accomplished with goodmanufacturing procedures, which must include the use of adequate heatprocesses or other means of preservation.
To protect the public health, FDA regulations require that each firmthat manufactures, processes, or packs acidified foods or thermallyprocessed low-acid foods in hermetically sealed containers for introductioninto interstate commerce register the establishment with FDA using Form FDA2541 (§§ 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 isrequired to provide data on the processes used to produce these foods,using Form FDA 2541a for all methods except aseptic processing, or Form FDA2541c for aseptic processing of low-acid foods in hermetically sealedcontainers (§§ 108.25(c)(2) and 108.35(c)(2)). Plantregistration and process filing may be accomplished simultaneously. Processdata must be filed prior to packing any new product, and operatingprocesses and procedures must be posted near the processing equipment ormade available to the operator (§ 13.87(a) (21 CFR113.87(a))).
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 114)require firms to maintain records showing adherence to the substantiverequirements of the regulations. These records must be made available toFDA on request. Firms are also required to document corrective actions whenprocess controls and procedures do not fall within specified limits(§§ 113.89, 114.89, and 114.100(c)); to report any instanceof potential health-endangering spoilage, process deviation, orcontamination with microorganisms where any lot of the food has entereddistribution in commerce (§§ 108.25(d) and 108.35(d) and(e)); and to develop and keep on file plans for recalling products thatmay endanger the public health (§§ 108.25(e) and108.35(f)). To permit lots to be traced after distribution, acidified foodsand thermally processed low-acid foods in hermetically sealed containersmust be marked with an identifying code (§§ 113.60(c)(thermally processed foods) and 114.80(b) (acidified foods)).
In the Federal Register of February 7, 2005 (70 FR 6445),FDA published a 60-day notice requesting public comment on the informationcollection provisions. No comments were received.
FDA estimates the burden of the collection of information asfollows:
| Form No. | 21 CFR Section | No. of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Response | Total Hours | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA 2541 (registration) | 108.25 and 108.35 | 585 | 1 | 585 | 0.17 | 99 | |||||
| FDA 2541a (process filing) | 108.25 and 108.35 | 1,778 | 9 | 16,002 | 0.333 | 5,329 | |||||
| FDA 2541(c) | 108.35 | 124 | 10 | 1,240 | 0.75 | 930 | |||||
| Total | 6,358 | ||||||||||
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||||||||
| 21 CFR Part | No. of Recordkeepers | Annual Frequency per Record | Total Annual Records | Hours per Recordkeeper | Total Hours |
|---|---|---|---|---|---|
| Parts 113 and114 | 7,915 | 1 | 7,915 | 250 | 1,978,750 |
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||
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 avoiddouble-counting, estimates for §§ 108.25(g) and 108.35(h)have not been included because they merely cross reference recordkeepingrequirements contained in parts 113 and 114.
There are approximately 7,915 food processing establishments, bothforeign and domestic, registered as processors of acidified foods orthermally processed low-acid foods in hermetically sealed containers. FourFDA staff persons who are experienced in actual food processing plantoperations and familiar with the regulations reviewed the recordkeepingprocedures used by the industry.
Standardized timeframe requirements for conducting the recordkeepingprocedures do not exist but it is estimated to take 250 hours perestablishment to comply with the recordkeeping requirements in parts 108,113, and 114. This compares satisfactorily when based upon firsthand foodprocessing plant experience, individual estimates of the timeframes, andthe frequency of recordkeeping.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7028 Filed 4-7-05; 8:45 am]
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