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A Generic HACCP Model for a Thermally Processed, Commercially Sterile Product

The United States Department of Agriculture (USDA) published the Pathogen Reduction/Hazard 

Analysis Critical Control Point (HACCP) Systems Final Rule in July 1996. The HACCP regulations 

(9 CFR Part 417) require establishments to develop and implement a system of controls designed 

to address safety hazards reasonably likely to occur in their production process. Therefore, this

HACCP model’s focus, and the focus of the other HACCP models, is on product safety, not 

product quality characteristics.

With the rule, FSIS made available a guidebook for the preparation of HACCP plans and a generic 

model for each food processing category defined in regulation 9 CFR 417.2(b)(1). The guidebook 

and the generic models have been updated since their initial publication to be consistent with 

current science and policy. FSIS recommends you use the updated Guidebook for the Preparation 

of HACCP Plans when developing an establishment-specific HACCP plan.

Generic models serve as useful examples of how to meet the regulatory requirements. Each 

model represents a food processing category. Each processing category may contain numerous 

products. Therefore, each single model represents a category of products and, as such, the 

models do not demonstrate unique products or novel processes. The generic models are 

not intended to be used “as is.” FSIS recommends that establishments tailor the model(s) to fit the 

establishment’s operations. 

Thermally processed, commercially sterile (TPCS) products are commonly referred to as canned 

products although the containers can be metal cans, glass jars, flexible pouches, paperboard, and 

other types of hermetically sealed containers. Processors of TPCS products must identify their 

biological, physical, and chemical food safety hazards when performing their hazard analysis. 

Under 9 CFR 417.2(b)(3) of the HACCP regulations, establishments do not have to address the 

microbiological food safety hazards identified in its hazard analysis if the product is produced in 

accordance with the requirements of 9 CFR Part 431. However, canning establishments that 

identify chemical or physical food safety hazards as reasonably likely to occur (RLTO) are to 

address those hazards in their HACCP plan.

The regulations provide that canning establishments do not have to address microbiological 

hazards in their HACCP plan because FSIS recognized that the canning regulations were based 

on HACCP concepts and provide for the analysis of thermal processing systems and controls to 

exclude biological food safety hazards. However, a canning establishment may choose to address 

the microbiological food safety hazards in its HACCP plan. In either case, the requirements in 9 

CFR parts 431 and 417 must be met through the establishment’s HACCP system.

This HACCP model illustrates the scenario when the establishment does not address 

microbiological hazards in a HACCP plan and does not identify chemical or physical food safety 

hazards as reasonably likely to occur. Thus, this model does not include any critical control points

(CCP). This model does contain the required product description, list of product ingredients and 

materials, flowchart, and hazard analysis. The model may not necessarily apply to all operations 

or products. Products or operations may require CCPs depending on the operation. The flow 

diagram demonstrates a general production process and should be modified to reflect the

processes used at the establishment.

The records produced while documenting a HACCP plan, including all documentation used to 

support the hazard analysis, are HACCP records (9 CFR 417.5(a)). Ensure you maintain the 

documents produced while developing a HACCP plan.

For further assistance with developing HACCP plans see the Guidebook for the Preparation of 

HACCP Plans and the guidance materials available on the FSIS HACCP webpage. 
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EXAMPLE PRODUCT DESCRIPTION1

Thermally Processed, Commercially Sterile: Beef Stew

Process or Product name Beef Stew

Important product characteristics 

(Aw, pH, Preservatives, etc.) None

Intended use2 Ready-to-eat; typically heated before 

consumption.

Packaging (durability and storage

conditions) 3-piece metal, double seamed (“Sanitary”) can.

Shelf life and at what temperature3 3 years under cool (e.g., 75 °F or lower) and dry 

conditions; Protected from freezing.

Where it will be sold (specify 

intended consumers, especially atrisk populations)4

Sold to household consumers through retail 

outlets or distributed to hotels, restaurants, and 

institutions (HRI).

Labeling instructions and 

requirements

Product name, inspection legend and 

establishment number, heating instructions, net 

weight statement, address line, nutrition facts, 

and ingredients list.

Special distribution control None

DATE: APPROVED BY: 

1 Prior to developing the HACCP plan please read the Guidebook for the Preparation of HACCP Plans for detailed descriptions of the 

worksheets and hazard analysis. The FSIS Guidebook for the Preparation of HACCP Plans and the generic HACCP models are 

intended for small and very small establishments seeking assistance in understanding the requirements in Title 9 Code of Federal 

Regulations (9 CFR) Part 417. The HACCP model is for demonstration purposes only. The model does not represent requirements 

that must be met. Establishments are required to develop HACCP plans specific to their facilities, production practices, and products. 2The intended use or consumer of the product must be identified in accordance with 9 CFR 417.2(a)(2). Identifying the product’s 

intended use in the product description is one way to meet the regulatory requirements specific to 417.2(a)(2). 3Each establishment’s products may have their own defined shelf life. Thermally Processed, Commercially Sterile products must be 

shelf stable per 9 CFR 431.1. 4 At-risk populations include young children, the elderly, and immunocompromised persons.
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EXAMPLE LIST OF PRODUCT INGREDIENTS AND INCOMING MATERIAL5

Thermally Processed, Commercially Sterile: Beef Stew

Meat and meat by-products Frozen beef

Non-meat food ingredients

Water, Frozen diced celery, Frozen sliced 

carrots, Frozen tomato puree, Modified food 

starch, Textured soy protein, Spice mix, Salt, 

Sugar.

Antimicrobial interventions6 and

processing aids None

Packaging material7 3-piece double seamed (“Sanitary”) cans with 

capacities of 7 oz, 11.5 oz, 12 oz and 20 oz.

Restricted ingredients or Allergens Texturized soy protein

Other None

DATE: APPROVED BY: 

5 List all meat, non-meat ingredients, restricted ingredients (for example, nitrites), processing aids, and packaging material used in 

production of this product. This is important to help identify any special ingredients or processes to address in the HACCP plan. See 

the FSIS Compliance Guideline Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and 

Declaration through Labeling for detailed information on allergens. 

6FSIS and the Food and Drug Administration (FDA) have a memorandum of understanding (MOU) that establishes the working 

relationship followed when responding to notifications for the use of food additives (including ingredients) intended for use in the 

production of FSIS regulated products. FSIS determines the suitability of the use of food ingredients used in the production of meat, 

poultry, and egg products. FSIS consults, as necessary, with FDA on the requirements under the Federal Food, Drug & Cosmetic Act 

and its implementing regulations. See FSIS Directive 7120.1, Safe and Suitable Ingredients Used in Meat Poultry and Egg Products for 

the list of suitable ingredients. 

7 Establishments will follow different process schedules developed by a processing authority for the product packaged in different 

container sizes.
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EXAMPLE PROCESS FLOW DIAGRAM8

Thermally Processed, Commercially Sterile: Beef Stew

18. Returned Product9

DATE: APPROVED BY: 

8This is an example flow diagram. Establishments’ flow diagrams for the same product may be different. Establishments determine 

which steps are included in their process. The steps must represent all relevant hazards in the hazard analysis. 9 The Returned Product step (18) is shown as not connected to another process step. Returned product may re-enter the 

production system at different process steps depending on condition or food safety concerns. Returned product may be relabeled,

repackaged, or discarded.

1. Receiving and Storage of 

Frozen Beef

3. Receiving and 

Storage of Cans and

Packaging Materials

9. Filling 

5. Pre-cooking Beef

10. Sealing

6. Pre-Weigh, 

Pre-mix and 

Prepare NonMeat Food 

7. Mixing Ingredients

11. Thermal Processing 

8. Cleaning Cans 

16. Labeling and Packaging

14. Storage 

17. Storage and Shipping

13. Sample Incubation

4. Cutting or Dicing Beef

12. Cooling

15. Defect Detection

2. Non-Meat Ingredients 

Receiving and Storage
EXAMPLE HAZARD ANALYSIS

Thermally Processed, Commercially Sterile: Beef Stew

Potential 

Hazards10

Is the 

Hazard 

Reasonably 

Likely to 

occur

(RLTO)?11

Justification or Basis for Decisioni

If yes in Column 2

(hazard RLTO), What 

Control Measures Can 

Be Applied to Prevent, 

Eliminate, or Reduce 

the Hazard to 

Acceptable Levelsii

Is this 

Step a 

Critical 

Control 

Point 

(CCP)?

10Hazards are grouped into three categories: Biological (B), Chemical (C), and Physical (P). Biological hazards are living organisms. Chemical hazards may be naturally

occurring in foods, used or added during the processing of foods, or administered to live animals. Physical hazards are a component of a food that is unexpected, such as 

plastic, glass, metal, or bone in a boneless product. See the Guidebook for the Preparation of HACCP Plans for more information about hazards identification.

11Place the justification for your decision in column 3. Control measures for hazards not reasonably likely to occur are entered in column 3. Control measures for 

hazards reasonably likely to occur are entered in column 4. If a hazard is reasonable likely to occur, then a CCP must be addressed at this step or a later step. See 

FSIS Meat and Poultry Hazards and Controls Guide for a list of frequently used controls.

1. Receiving and Storage of Frozen Beef 

B: Presence 

and outgrowth 

of pathogens, 

Shiga-toxin 

producing 

Escherichia 

coli (STEC) (E.

coli O157:H7, 

O26, O45, 

O103, O111, 

O121 and 

O145), 

Salmonella 

and

Clostridium 

botulinum

No Beef may be contaminated with Shiga-toxin producing Escherichia coli

(STEC) (E. coli O157:H7, O26, O45, O103, O111, O121 and O145), 

Salmonella and Clostridium botulinum.

9 CFR 417.2(b)(3) exempts establishment from having to address 

microbiological food safety hazards in the HACCP plan if the product is 

produced in accordance with the requirements in 9 CFR Part 431.

Written receiving program to ensure product specifications, temperature, 

and package integrity. 

Written Sanitation Standard Operating Procedure (SOP), including 

temperature control and maintenance of sanitary conditions.

The product is thermally processed during the thermal process step in 

accordance with 9 CFR Part 431.
Potential Hazard RLTO Justification or Basis Controls CCP

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12This Foreign Material SOP (prerequisite program) should have details on how this procedure (such as metal prevention controls) is preventing the hazard from occurring 

as well as the on-going verification procedures. These controls should be evident within the written document upon review. The Foreign Material SOP and plant data 

related to on-going verification activities then become part of recordkeeping and historical data. 

BSE (Prions) No Bovine Spongiform Encephalopathy (BSE) Prions associated with 

specified risk materials (SRM) is a potential hazard in beef products.

Only boneless beef received from approved suppliers according to 

company purchasing program. SRMs are required to be removed by 

supplier prior to release into commerce.

Letters of Guarantee (LOGs) from suppliers describing SRM controls.

C: Antibiotic 

and pesticide 

residues

No Letters of Guarantee (LOG) from suppliers describing quality controls and 

prevention procedures. The blanket LOG is updated annually. 

Approved supplier program and ongoing communication with suppliers to 

verify LOGs.

P: Foreign 

materials, i.e., 

metal, rubber, 

plastic, and 

wood.

No Visual examination procedures in the Foreign Material SOP.12

Establishment Foreign Material SOP records demonstrate no incidents of 

foreign materials detected in products received. 

2. Non-meat Ingredients Receiving and Storage

B: Presence 

and outgrowth 

of pathogens, 

e.g., STEC, 

Salmonella 

and

Clostridium

botulinum

No 9 CFR 417.2(b)(3) exempts establishment from having to address 

microbiological food safety hazards in the HACCP plan if the product is 

produced in accordance with the requirements in 9 CFR 431.

Written receiving program to ensure product specifications, temperatures, 

and package integrity. 

Purchasing program to ensure microbiological specifications for non-meat 

ingredients are met.

Written Sanitation SOP including storage temperature control and 
Potential Hazard RLTO Justification or Basis Controls CCP

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13Note: this “historical data” must be supported with evidence from the establishment through the establishment’s history or validation data with reference to the actual 

SOP or prerequisite program. When historical data is not available (for example, a HACCP plan for a new process or product), then system design must be supported by 

other documentary evidence, such as the FSIS Meat and Poultry Hazards and Controls Guide which states “letters of guarantee, certificate of analysis, approved supplier 

program and proper storage to prevent contamination of allergen-free products” as frequently used controls for the receiving and storage of pesticides and allergens.

maintenance of sanitary conditions.

C: Pesticide 

residues and 

undeclared 

allergens

No Written receiving program to ensure product specifications. 

Allergen Control SOP to verify proper identification of allergenic containing 

ingredients for each lot.

Approved supplier program and ongoing communication with suppliers to 

verify LOGs.

Establishment records demonstrate no incidents of chemical hazards 

detected in products received.13

Written Chemical Receiving, Storage, and Use SOP for mixing and 

determining concentration of chemicals to ensure the mixture is made per 

the manufacturer’s instructions and is within the allowable limits identified 

in Directive 7120.1.

P: Foreign 

materials, i.e., 

metal, rubber, 

plastic, and 

wood.

No Visual examination procedures in the Foreign Material SOP.

Approved supplier program and ongoing communication with suppliers to 

verify LOGs.

Establishment Foreign Material SOP records demonstrate no incidents of 

foreign materials detected in products received. 
Potential Hazard RLTO Justification or Basis Controls CCP

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3. Receiving and Storage of Cans & Packaging Materials

B: Postprocess 

contamination

due to 

container 

defects 

No Packaging materials are stored, handled, and conveyed according to SOP 

to prevent damage that could affect the hermetic condition of the sealed 

container (9 CFR 431.2).

C: Chemicals No LOGs for all packaging materials describing the material’s intended use 

complies with the Federal Food, Drug, and Cosmetic Act (FFDCA) and all 

applicable food additive regulations. 

Incoming packaging material examination procedures per 9 CFR 431.2.

Approved supplier program.

P: Foreign 

material

No Cans are inverted and washed with hot water at step 8 in accordance with

9 CFR 431.2

4. Cutting or Dicing Beef

B: Pathogen 

outgrowth

No Written Sanitation SOP to prevent or minimize cross-contamination.

Temperature control SOP in the processing area to prevent the outgrowth 

of pathogens.

Beef is cut into sizes in accordance with the process schedule developed 

by a processing authority (9 CFR 431.3(a) &(b)).

The product is thermally processed during the thermal process step in 

accordance with 9 CFR Part 431.

C: None

P: Foreign 

materials, i.e., 

metal from 

No Metal fragments could come from processing equipment.

Daily equipment examination and preventive maintenance SOP on 

equipment and conveyor to prevent foreign materials, i.e., metal, rubber, 
Potential Hazard RLTO Justification or Basis Controls CCP

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processing 

equipment

plastic from contaminating the product.

5. Pre-cooking Beef

B: Presence 

and outgrowth 

of pathogens: 

e.g., STEC, 

Salmonella 

and

Clostridium

botulinum

No Written Sanitation SOP to prevent or minimize cross-contamination.

Beef is pre-cooked according to the procedures defined by a processing 

authority (9 CFR 431.3).

The product is thermally processed during the thermal process step in 

accordance with 9 CFR Part 431.

C: None

P: None

6. Pre-Weigh, Pre-mix and Prepare Non-Meat Food Ingredients

B: Presence 

and outgrowth 

of pathogens 

No Written Sanitation SOP to prevent or minimize cross-contamination. 

Non-meat ingredients are pre-mixed according to the written formulation 

SOP.

Temperature control SOP to prevent the outgrowth of pathogens.

C: Undeclared 

allergen

No Formulation is conducted in accordance with established process 

schedules. 

Allergen Control SOP ensures ingredient statements on finished product 

labels match ingredient formulation.

Written Good Manufacturing Practices (GMPs) prevent and minimize the 

likelihood of cross-contamination with allergens and chemicals.
Potential Hazard RLTO Justification or Basis Controls CCP

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P: Foreign 

materials

No Daily equipment examination and preventive maintenance SOP on 

equipment and conveyor to prevent foreign materials, i.e., metal, rubber, 

plastic from contaminating the product.

7. Mixing

B: Clostridium 

botulinum

No 9 CFR 417.2(b)(3) exempts establishment from having to address 

microbiological food safety hazards in the HACCP plan if the product is 

produced in accordance with the requirements in 9 CFR Part 431.

Improper formulation may cause process deviation and survival of 

Clostridium botulinum spores.

Written formulation SOP defined by a processing authority.14

C: Undeclared 

allergens

No Formulation is conducted in accordance with established process 

schedules. 

Allergen Control SOP ensures ingredient statements on finished product 

labels match ingredient formulation.

Written Good Manufacturing Practices (GMPs) to prevent and minimize 

the likelihood of cross-contamination with allergens and chemicals. 

P: Metal 

fragments 

No Metal fragments could come from processing equipment.

Daily equipment examination and preventive maintenance SOP on 

equipment and conveyor to prevent foreign materials, i.e., metal, rubber, 

14 If an establishment implements a process consistent with the process specifications described in the scientific support, and the scientific support contains microbiological 

data specifying the level of pathogen reduction achieved by the intervention strategy for the target pathogen identified in the hazard analysis, the in-plant validation data 

collected during the 90 day initial validation period will consist of data on quantifiable characteristics of the critical operational parameters, such as pressure, temperature, 

and concentration. However, if an establishment implements different critical operational parameters in the process from the scientific support, or the scientific support 

identified does not contain microbiological data, then the establishment should collect in-plant data demonstrating the critical operational parameters that it has 

implemented can all be met AND should collect in-plant microbiological validation data or identify scientific support with microbiological data that demonstrates the 

effectiveness of those implemented critical operational parameter (FSIS Compliance Guideline HACCP Systems Validation, page 27).
Potential Hazard RLTO Justification or Basis Controls CCP

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plastic from contaminating the product.

8. Cleaning Cans

B: None

C: None

P: Foreign 

materials

No Cans are inverted and cleaned per 9 CFR 431.2

9. Filling

B: Clostridium

botulinum

No Improper fill may cause process deviation and survival of Clostridium 

botulinum spores.

Fill-in weight15 checked by inline scale monitoring SOP.

Written formulation and filling procedure defined by a processing authority

(9 CFR 431.3).

C: None

P: None

10. Sealing

B: Container 

defects causing 

spoilage of 

product due to 

defective 

No Routine visual and teardown examinations during the operation and 

seamer per 9 CFR 431.2.

Reject non-conforming products in accordance with closure and teardown 

examinations SOP.

15The process schedule developed by a processing authority determines whether the fill-in weight is a critical factor. Establishment is required to measure, control, and 

record the critical factors specified in the process schedule per 9 CFR 431.4. 
Potential Hazard RLTO Justification or Basis Controls CCP

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seaming

Formation of 

Staphylococcal

enterotoxins

No Daily equipment examination and preventive maintenance SOP.

The maximum time lapse between closure of containers and initiation of 

thermal processing is controlled to be less than 2 hours per 9 CFR 

431.2(f)(2).

C: None

P: None

11. Thermal Processing

B: Clostridium

botulinum

No Proper application of process schedule developed for the product by a 

processing authority (9 CFR 431.3).

Operation procedures in accordance with requirements in 9 CFR part 431.

C: None

P: None

12. Cooling

B: Post-process 

contamination

No Containers are cooled using potable water per 9 CFR 431.6(h) and cooling

water is not reused in the retort system.

C: None

P: None
Potential Hazard RLTO Justification or Basis Controls CCP

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13. Sample Incubation

B: Spoilage of 

product due to 

process 

deviation or 

post-process 

deviation 

No At least one container per load16 of product will be selected for 10 days 

incubation per 9 CFR 431.10(b).

C: None

P: None 

14. Storage 

B: Spoilage of 

product due to 

process 

deviation or 

post-process 

contamination

No The lot will be on hold during the 10 days incubation period.

Written SOP for the handling of abnormal containers to ensure only normalappearing safe and stable product are released per 9 CFR 431.10(a).

Written GMPs to prevent and minimize container defects due to rough 

handling (9 CFR 431.2(f)(1)).

C: None

P: None 

15. Defect Detection

B: Spoilage of 

product due to 

container 

No Visual examination of containers to ensure only normal appearing 

containers are labelled and released (9 CFR 431.10(c)).

Written Container Examination SOP including procedures for, and records 

16 In this HACCP model, the establishment is using a steam-still, batch-type retort. If the establishment is using a continuous-type retort system, such as continuous rotary 

retorts or hydrostatic retorts, it will select at least one container per 1000 for incubation per 9 CFR 431.10(b).
Potential Hazard RLTO Justification or Basis Controls CCP

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defects or 

process 

deviation

of, container examinations and handling of abnormal containers. 

C: None 

P: None 

16. Labeling and Packaging

B: None

C: Undeclared 

Allergens

No Formulation is conducted in accordance with established process 

schedules (9 CFR 431.3(a)). 

Allergen Control SOP ensures ingredient statements on finished product 

labels match ingredient formulation.

P: None

17. Storage and Shipping

B: None

C: None

P: None

18. Returned Product

B: None Reinspection SOP implemented before accepting returned product. 

Person(s) or business returning the product must demonstrate the product 

was held in the appropriate temperature range and in a sanitary manner. 

When such assurance is not available, returned product is rejected or 

destroyed. Opened packages are not accepted. Accepted product enters 
Potential Hazard RLTO Justification or Basis Controls CCP

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the appropriate step of the production system based on findings of product 

evaluation. Notify FSIS personnel when returned product has been 

accepted. 

C: None

P: None

DATE: APPROVED BY: 

i

Scientific references are important in making decisions, providing justifications, and validating the HACCP system. When scientific references are used for decisions, 

the referenced articles must be part of the HACCP records. If the scientific justification is from FSIS, then list the document name. If justification is not from an FSIS 

program, then HACCP system design must be supported by documentary evidence – that is, the theoretical principles, expert advice from processing authorities, 

scientific or technical data, peer-reviewed journal articles, pathogen modeling programs, or other information demonstrating that particular process control measures can 

adequately prevent, reduce, or eliminate specific hazards. These non-FSIS supporting documents must be kept for the life of the HACCP plan. 

ii Because the results obtained under prerequisite programs could affect decisions made in the hazard analysis, an establishment is required to maintain records 

associated with these programs as supporting documentation for its hazard analysis (9 CFR 417.5(a)). When an establishment determines that a potential hazard is 

not reasonably likely to occur because the implementation of a prerequisite program (e.g., Sanitation SOP, written sanitary dressing procedures incorporated into 

prerequisite programs, purchase specifications, or antimicrobial interventions) prevents conditions that make the potential hazard likely, that prerequisite program 

then becomes part of the HACCP system and as a result, must be validated. This means that establishments must maintain scientific or technical support for the 

design of those prerequisite programs used to support decisions in the hazard analysis and must collect in-plant validation data to support that the programs are 

implemented as designed (see FSIS Compliance Guideline HACCP Systems Validation, page 5).