USFDA Canned Food Regulations Thermal Processing Deviations Registration and Process Filing

1. USFDA Canned Food RegulationsThermal Processing DeviationsRegistration and Process Filing William W. Deckert Jr.

2. Low-acid canned foodsAcidified foods • A compilation of title 21 code of federal regulations, parts 108, 113, and 114

3. Part 108 - 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

4. 108.5- Determination of the need for a permit. • 108.6- Revocation of determination of need for permit. • 108.7- Issuance or denial of permit. • 108.10- Suspension and reinstatement of permit. • 108.12- Manufacturing, processing, or packing without a permit, or in violation of a permit. • 108.19- Establishment of requirements for exemption from section 404 of the act.

5. Subpart B - Specific requirements and conditions for exemption from or compliance with an emergency permit • 108.25- Acidified foods. • 108.35- Thermal processing of low-acid foods packaged in hermetically sealed containers.

6. Part 113 - Thermally processed low-acid foods packaged in hermetically sealed containers • Subpart A- General provisions • 113.3- 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

7. 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 (aw)

8. 113.5- Current good manufacturing practice. • 113.10- Personnel

9. Subpart C - Equipment • 113.40- Equipment and procedures. (figure page 220, 221, 224)

10. Subpart D - Control of components, food product containers, closures, and in-process materials • 113.60- Containers. a) Closures b) Cooling water c) Coding d) Post process handling (figure page 236)

11. Subpart E - Production and Process Control • 113.81- Product preparation. • 113.87- Operations in the thermal processing room. • 113.89- Deviations in processing, venting, or control of critical factors.

12. Subpart F - Records and Reports • 113.100- Processing and production records.

13. Part 114 - Acidified Foods • Subpart A- General Provisions • 114.3- Definitions. A) Acid foods b) Acidified foods c) Lot d) Low-acid foods e) Scheduled process f) Shall g) Should h) Water activity (aw)

14. 114.5- Current good manufacturing practice. • 114.10- Personnel.

15. Subpart E - Production and Process Controls • 114.80- Processes and controls. • 114.83- Establishing scheduled processes. • 114.90- Methodology.

16. Subpart F - Records and Reports • 114.100- Records.

17. Thermal Processing DeviationsRegulatory ReviewFDA

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

19. 21 CFR Code of Federal RegulationPart 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (Thermal processing deviations (LACF)) • 113.89- Deviations in processing, venting, or control of critical factors. (Thermal processing deviations (Acidified Foods) 21CFR$114.89 Deviations from scheduled processes

20. Title 21Food and DrugsChapter IFood and Drug AdministrationDepartment of Health and Human ServicesPart 108- Emergency Permit ControlTable of contents Subpart B- Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit • 108.35 Thermal processing of low-acid foods packaged in hermetically • sealed container • 108.35(a)

21. Title 21Food and Drugs AdministrationDepartment of Health and Human ServicesPart 108- Emergency Permit Control Table of Contents Subpart B - Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit Sec.108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers • 108.35 - (k) imports

22. Foreign and Domestic Low-acid Canned Food (LACF) and Acidified Food Establishment Inspection Report (EIR)Regulatory Review Considerations for Detention Without PhysicalExamination (DWPE) or Emergency PermitControl by FDA Compliance Officersin Order of Importance

23. 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?

24. 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

25. Issues pertaining to evaluation Reporting evaluation results to the processor

26. Emergency permit DWPE

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

28. CFSAN HOME PAGE Http://www.cfsan.fda.gov/ Acidified and Low Acid Canned Foods Imports and Exports Industry Assistance International/Codex/Other Languages