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Transcript of USFDA Canned Food Regulations Thermal Processing Deviations Registration and Process Filing William...
![Page 1: USFDA Canned Food Regulations Thermal Processing Deviations Registration and Process Filing William W. Deckert Jr.](https://reader030.fdocuments.in/reader030/viewer/2022033107/56649e2e5503460f94b1e238/html5/thumbnails/1.jpg)
USFDA Canned Food Regulations
Thermal Processing Deviations
Registration and Process Filing
William W. Deckert Jr.
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Low-acid canned foodsAcidified foods
• A compilation of title 21 code of federal regulations, parts 108, 113, and 114
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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
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§ 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.
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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.
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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
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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)
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§ 113.5- Current good manufacturing practice.
§ 113.10- Personnel
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Subpart C - Equipment
§ 113.40- Equipment and procedures.
(figure page 220, 221, 224)
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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)
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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.
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Subpart F - Records and Reports
§ 113.100- Processing and production records.
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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)
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§ 114.5- Current good manufacturing
practice.
§ 114.10- Personnel.
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Subpart E - Production and Process Controls
§ 114.80- Processes and controls.
§ 114.83- Establishing scheduled
processes.
§ 114.90- Methodology.
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Subpart F - Records and Reports
§ 114.100- Records.
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Thermal Processing Deviations
Regulatory ReviewFDA
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Federal Food, Drug, and Cosmetic Act
• Adulterated food
• Emergency permit control
• Imports and Exports
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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
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§Title 21Food and Drugs
Chapter IFood and Drug Administration
Department 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
§ 108.35 Thermal processing of low-acid foods packaged in hermeticallysealed container§108.35(a)
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Title 21Food and Drugs Administration
Department 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
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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 Permit
Control by FDA Compliance Officersin Order of Importance
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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?
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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
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Issues pertaining to evaluation
Reporting evaluation results to the processor
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Emergency permit
DWPE
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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
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CFSAN HOME PAGE
Http://www.cfsan.fda.gov/
Acidified and Low Acid Canned Foods
Imports and Exports
Industry Assistance
International/Codex/Other Languages