USFDA Canned Food Regulations Thermal Processing Deviations Registration and Process Filing William W. Deckert Jr.

Low-acid canned foods Acidified foods A compilation of title 21 code of federal regulations, parts 108, 113, and 114

Part Emergency permit control Subpart A - General Provisions §108.3 Definitions a- the definitions contained in section 201 of the Federal Food, Drug, and cosmetic Act are applicable to such terms when used in this part. b- Commissioner c- Act Permit Manufacture, processing, or packing of food in any locality

§ Determination of the need for a permit. § Revocation of determination of need for permit. § Issuance or denial of permit. § Suspension and reinstatement of permit. § Manufacturing, processing, or packing without a permit, or in violation of a permit. § Establishment of requirements for exemption from section 404 of the act.

Subpart B - Specific requirements and conditions for exemption from or compliance with an emergency permit § Acidified foods. § Thermal processing of low-acid foods packaged in hermetically sealed containers.

Part Thermally processed low-acid foods packaged in hermetically sealed containers Subpart A- General provisions § Definitions: a) Aseptic processing and packaging b) Bleeders c) Come-up-time d) Commercial processor e) Commercial sterility f) Critical factor g) Flame sterilizer h) Headspace, gross

I) Headspace, net j) Hermetically sealed containers k) Incubation l) Initial temperature m) Lot n) Low-acid foods o) Minimum thermal process p) Operating process q) Retort r) Scheduled process s) Shall t) Should u) Vacuum-packed products v) Vents w) Water activity (a w )

§ Current good manufacturing practice. § Personnel

Subpart C - Equipment § Equipment and procedures. (figure page 220, 221, 224)

Subpart D - Control of components, food product containers, closures, and in-process materials § Containers. a) Closures b) Cooling water c) Coding d) Post process handling (figure page 236)

Subpart E - Production and Process Control § Product preparation. § Operations in the thermal processing room. § Deviations in processing, venting, or control of critical factors.

Subpart F - Records and Reports § Processing and production records.

Part Acidified Foods Subpart A- General Provisions § Definitions. A) Acid foods b) Acidified foods c) Lot d) Low-acid foods e) Scheduled process f) Shall g) Should h) Water activity (a w )

§ Current good manufacturing practice. § Personnel.

Subpart E - Production and Process Controls § Processes and controls. § Establishing scheduled processes. § Methodology.

Subpart F - Records and Reports § Records.

Thermal Processing Deviations Regulatory Review FDA

Federal Food, Drug, and Cosmetic Act Adulterated food Emergency permit control Imports and Exports

21 CFR Code of Federal Regulation Part Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (Thermal processing deviations (LACF)) § Deviations in processing, venting, or control of critical factors. (Thermal processing deviations (Acidified Foods) 21CFR$ Deviations from scheduled processes

§Title 21 Food and Drugs Chapter I Food and Drug Administration Department of Health and Human Services Part 108- Emergency Permit Control Table of contents Subpart B- Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit § Thermal processing of low-acid foods packaged in hermetically sealed container §108.35(a)

Title 21 Food and Drugs Administration Department of Health and Human Services Part 108- Emergency Permit Control Table of Contents Subpart B - Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit Sec Thermal processing of low-acid foods packaged in hermetically sealed containers § (k) imports

Foreign and Domestic Low-acid Canned Food (LACF) and Acidified Food Establishment Inspection Report (EIR) Regulatory Review Considerations for Detention Without Physical Examination (DWPE) or Emergency Permit Control by FDA Compliance Officers in Order of Importance

1- How are process deviations handled ? 2- Are scheduled processes properly delivered? 3- Were schedule processes properly developed? 4- Does documentation exist to confirm that uniform heat distribution is achieved in the firm’s processing system? 5- Does the firm follow its established schedule process? 6- Does the firm have necessary procedures in place to ensure container integrity?

How are process deviations handled ? Guide to inspections of low acid canned food manufacturers Part 1- Administrative procedures/scheduled process Process deviations Detection and correction in-process Reprocessing Isolation of affected prodution Sumissions to process authorities Incomplete records

Issues pertaining to evaluation Reporting evaluation results to the processor

Emergency permit DWPE

CANNING INDUSTRY FDA 2541 Registration form FDA 2541(A) Food process filing for all methods except low-acid aseptic FDA CFSAN WEB SITE A W, Ph List, Container conversion chart

CFSAN HOME PAGE Acidified and Low Acid Canned Foods Imports and Exports Industry Assistance International/Codex/Other Languages