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