Post on 27-Dec-2015
USFDA Canned Food Regulations
Thermal Processing Deviations
Registration and Process Filing
William W. Deckert Jr.
Low-acid canned foodsAcidified foods
• A compilation of title 21 code of federal regulations, parts 108, 113, and 114
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
§ 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.
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.
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
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)
§ 113.5- Current good manufacturing practice.
§ 113.10- Personnel
Subpart C - Equipment
§ 113.40- Equipment and procedures.
(figure page 220, 221, 224)
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)
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.
Subpart F - Records and Reports
§ 113.100- Processing and production records.
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)
§ 114.5- Current good manufacturing
practice.
§ 114.10- Personnel.
Subpart E - Production and Process Controls
§ 114.80- Processes and controls.
§ 114.83- Establishing scheduled
processes.
§ 114.90- Methodology.
Subpart F - Records and Reports
§ 114.100- Records.
Thermal Processing Deviations
Regulatory ReviewFDA
Federal Food, Drug, and Cosmetic Act
• Adulterated food
• Emergency permit control
• Imports and Exports
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
§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)
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
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
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
AW, Ph List, Container conversion chart
CFSAN HOME PAGE
Http://www.cfsan.fda.gov/
Acidified and Low Acid Canned Foods
Imports and Exports
Industry Assistance
International/Codex/Other Languages