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Ready-to-Eat/Shelf Stable Products Process Familiarization 

This document has been created to be used for reference purposes only. The 

information in this document is not all-inclusive. Please refer to the FSIS directives and 

notices for detailed policy and procedural information. 

FSIS Directive 5300.1 – identifies the HACCP categories that can include RTE products 

(Fully Cooked- Not Shelf Stable, Products with Secondary Inhibitors- Not Shelf Stable, 

Heat Treated – Shelf Stable, Heat Treated – Shelf Stable, Not Heat Treated – Shelf 

Stable). 

Fully Cooked-Not Shelf Stable 

This category applies to establishments that further process products by using a full 

lethality heat processing step (cooking) to achieve food safety. 

Examples: Fully cooked hams Hot dogs 

Meat loaves Cooked beef 

Meat and poultry salads Roast Beef 

Sliced luncheon meat Pastrami 

Poultry rolls Corned Beef 

The finished products are not shelf stable and must be frozen or refrigerated for food 

safety purposes. These products also meet the definition of Ready-to-Eat (RTE) as 

defined in 9 CFR 430.1. 

9 CFR 430.1 – a meat or poultry product that is in a form that is edible without additional 

preparation to achieve food safety and may receive additional preparation for 

palatability or aesthetic, epicurean, gastronomic, or culinary purposes. 

RTE product - a meat or poultry product that is in a form that is edible without 

additional preparation to achieve food safety and may receive additional preparation 

for palatability or aesthetic, epicurean, gastronomic, or culinary purposes. RTE product 

is not required to bear safe handling instructions or other labeling that directs that the 

product must be cooked or otherwise treated for safety and can include frozen meat and 

poultry products. 

The cooking step in these products kills the pathogens. However, there are other 

biological hazards of concern in some products as a result of the different process 

steps and procedures involved in the production of the finished products. 

There is also a concern with some common chemical hazards, including allergens such 

as soy or milk byproducts which may be included as non-meat ingredients in some 

products. Chemical accelerants, acidifiers and antioxidants may also be used as part of 

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the fermentation process or assist in the quality of some products. These could pose 

hazards if not used in proper quantities. 

Like non-intact raw products, metal contamination from equipment with small and 

moving parts could pose potential physical hazards as well. 

Heat Treated-Shelf Stable 

This category applies to establishments that further processing by using a heat 

treatment processing step as the primary means to achieve food safety, in combination 

with curing, drying, or fermenting processing steps. The finished products are shelf 

stable and are not required to be frozen or refrigerated for food safety purposes. 

Shelf Stable products -> free of microorganisms (pathogens and spoilage) capable of 

growing in the product at non-refrigerated conditions at which the product is intended to 

be held during distribution and storage. Shelf-stability is primarily achieved through 

drying or low water activity (aw). 

Examples: Meat Snacks/Jerky Popped pork skins 

Sliced whole muscle beef jerky Bacon Bits 

Beef nuggets Snack sticks 

Steak tenders Summer sausage 

Lebanon bologna Thuringer 

* Heat treated = cooked for lethality 

* Dried for Shelf Stable (No refrigeration necessary) 

Potential biological hazards include Listeria monocytogenes, which may contaminate 

the product after lethality. 

Common chemical hazards include allergens, such as soy or milk byproducts which 

may be used as ingredients. Chemical accelerants, acidifiers and antioxidants may be 

used as part of the fermentation process or assist in the quality. These could pose 

hazardous if not used in proper measurements. 

There are no notable physical hazards unique to this process category. However, like 

non- intact raw products, metal contamination from equipment with small and moving 

parts could pose potential physical hazards as well. 

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Not Heat Treated-Shelf Stable 

This process category applies to products that are further processed by a curing, drying, 

or fermenting step as the sole means by which product achieves food safety. A lowlevel heat treatment may be applied if the heat treatment is not used as the sole means 

to achieve food safety. The finished products produced are shelf stable. 

Examples: Dried sausage, such as Salami and Pepperoni 

Dried whole muscle products 

Dried hams, such as Prosciutto, Parma, and Country Ham 

Dried pork bellies (Pancetta) 

Dried pork shoulders (Copa) 

Dried beef rounds (Bresaola, Beef Prosciutto, Basturma) 

Cure – Salt lowers the water activity (makes water unavailable to microbes) 

Nitrite fixes the color of the product 

Inhibits outgrowth of spores (Clostridia) 

NOTE: Nitrate or Nitrite = restricted ingredients 

Proper usage and amounts are specified in the CFR 

Formulations must be carefully controlled to be effective and 

prevent toxicity. 

Biological hazards which are common to these products differ from raw products. The 

lethality step(s) in these products kills the pathogens (e.g., Salmonella, Campylobacter, 

Listeria monocytogenes, and E. coli O157:H7) which may otherwise be present in the 

raw materials. However, there are other biological hazards of concern as a result of the 

different ingredients and process steps these products may undergo. 

Listeria monocytogenes (Lm) is also a potential biological hazard that may recontaminate the product. This could happen after lethality if products are exposed to 

food contact surfaces, raw products, or contaminated ingredients prior to final 

packaging. 

Common chemical hazards include allergens, such as soy or milk byproducts which 

may be used as ingredients. Lactic acid or acetic acid may be used to speed acid 

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formation. Nitrites are commonly used as part of the curing process and phosphates 

might also be used for binding, flavor and/or color. 

Like non-intact raw products, metal contamination from equipment with small and 

moving parts could pose potential physical hazards as well. 

Amenable Fish Species 

Section 601(w)(2) was added to the FMIA and specified all fish of the order Siluriformes 

as amenable species under the act. FSIS has regulatory jurisdiction over all fish of the 

order Siluriformes produced for human food. 

The Siluriformes includes the family Ictaluridae (e.g., Channel Catfish and Blue Catfish) 

(historically grown in the United States) as well as other catfish-like fish species 

(historically imported). Common names for some of these other catfish-like species are 

Basa, Tra, and Swai. 

Organisms are classified according to the following hierarchy: Domain, Kingdom, 

Phylum, Class, Order, Family, Genus, and Species. 

• Siluriformes is an order of bony fish that includes all catfish and catfish-like 

species. 

• The name catfish refers to the long barbels, or feelers, which are present about 

the mouth of the fish and resemble cat whiskers. 

• The Order Siluriformes comprises nearly 2,900 species in about 35 Families. 

• Several species within the families Ictaluridae, Pangasiidae, and Clariidae are 

important food fish. 

• Products labelled as “catfish” must be of the family Ictaluridae. Other species 

may only be labeled by their common or usual name. All these fish are desirable 

food fish. 

• Once a fish has been de-headed, eviscerated, and skinned or filleted, it is difficult 

to accurately distinguish one family or species from another on visual exam. The 

agency has genetic-based species testing for that purpose. 

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