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Listeria monocytogenes Regulations 

Objectives 

Upon completion of this training module, Inspection Program Personnel (IPP) will 

be able to: 

1. Identify reasons Listeria monocytogenes (Lm) is a public health threat for 

ready-to eat (RTE) meat and poultry products. 

2. Verify compliance with the regulations in 9 CFR 430 by following instructions 

in FSIS Directive 10,240.4, Rev. 3 Verification Procedures for Consumer 

Safety Inspectors for the Listeria monocytogenes (Lm) Regulation and Lm 

Sampling Programs 

Listeria monocytogenes 

Listeria monocytogenes (Lm) is a pathogen that is considered to be ubiquitous, 

which literally means to exist everywhere. In practical terms, this means Lm is 

widespread in the environment. It can be found in the soil, on plant materials, 

animal feedstuffs, and the intestinal tract of various mammals and birds. Some 

humans may be intestinal carriers of the organism. This microbe is so 

widespread in part because it is capable of surviving under a variety of 

environmental conditions. It is very tolerant of freezing, drying, salt, and heat. It is 

capable of reproducing (i.e., growing) at temperatures as low as 31.3°F or as 

high as 113°F. It can adapt to significant changes in pH values, having 

demonstrated the capacity to reproduce at a pH as low as 4.39 and as high as 

9.4. It can also reproduce with a water activity (aw) as low as 0.92. 

In susceptible individuals, Lm can produce a disease called listeriosis. The 

Centers for Disease Control and Prevention has estimated that there are 

annually approximately 1,600 cases of foodborne listeriosis with 1,500 

hospitalizations and 260 deaths in the United States. Most healthy adults are 

generally not susceptible to infection with Lm. Groups that are considered to be 

at high risk for infection are pregnant women and their unborn children, young 

children, the elderly, and persons whose immunity might be compromised by 

treatment with certain medications or because of certain diseases. The infective 

dose of Lm probably varies with the pathogenicity of different strains of the 

organism present and an individual’s susceptibility, but is believed to be fewer 

than 1,000 organisms. With mild infections, an individual may have general flulike symptoms, including nausea, vomiting, and diarrhea. However, more severe 

infections can lead to septicemia, meningitis, encephalitis, and death. Infections 

during pregnancy generally do not lead to death of the mother, but the unborn 

child typically will not survive through the second or third trimester, resulting in a 

miscarriage or stillbirth. Those that do make it to term often do not survive the 

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early neonatal period. If a child does survive the early neonatal period, he or she 

may have severe, ongoing medical and developmental problems. 

Foodborne listeriosis has been linked to a wide variety of foods, including certain 

meat and poultry products. Here are some examples of outbreaks that have been 

tied to meat and poultry products: 

• A multistate outbreak occurring between 1998 and 1999 caused 101 

cases and 21 deaths. It was linked to the contamination of hotdogs and 

deli meats by Lm. Thirty million pounds of hotdogs and deli-meats were 

recalled. 

• In 2000, RTE turkey deli meat contaminated with Lm caused 29 illnesses 

across 10 states. There were 4 deaths. 

• In 2002, a multi-state outbreak caused 54 illnesses, 8 deaths, and 3 fetal 

deaths. The outbreak was associated with contaminated turkey deli meat. 

Over 27 million pounds of fresh and frozen RTE turkey and chicken 

products were recalled. 

• In 2017 and 2018, fully cooked ham products were recalled. Listeria 

specimens from 4 people were collected. All four people were 

hospitalized. One death was reported. 

The common link with these outbreaks was the contamination of product with Lm 

in the post-lethality environment prior to packaging. Lm can contaminate a food 

processing environment in a variety of ways. Lm may be present in slaughter 

animals and subsequently in raw meat and poultry products. Therefore, the 

organisms can be continuously introduced into the processing environment by 

incoming raw product. In addition, pallets, equipment, personnel, or other 

ingredients may serve as vehicles for bringing Lm into a processing environment 

or spreading the organism throughout processing areas and storage areas. Once 

it contaminates the processing environment, Lm can become established, 

growing in drains, on processing equipment, and on refrigeration units. The 

organism can also form durable biofilms on surfaces of facilities and equipment. 

Inadequate sanitation practices may allow Lm to come into contact with product 

exposed to the post-lethality environment. The dust and movement of personnel 

and equipment associated with construction projects (e.g., repairs to air handling 

systems, removal of walls, or repairs to plumbing systems.) create opportune 

times for Lm to ultimately contaminate post-lethality exposed product. An 

establishment may need to consider whether additional sanitation practices and 

containment procedures are necessary when doing any construction projects in 

or around processing areas where post-lethality exposed products are handled 

and packaged. 

As you can see, Lm is a significant foodborne pathogen with great potential to 

impact public health. Because of this, Lm is considered by FSIS to be a hazard 

which establishments producing post-lethality exposed ready-to-eat products 

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must control. FSIS has developed regulatory requirements specifically for 

controlling Lm in the production of post-lethality exposed RTE products. In 

addition, the agency has developed Lm sampling programs as part of its public 

health strategy for protecting consumers against this important pathogen. The 

next section of this module discusses how in plant inspection personnel (IPP) 

verify compliance with regulatory requirements for control of Lm. 

Listeria monocytogenes Verification 

Introduction 

On June 6, 2003, FSIS published an interim final rule requiring establishments 

producing post-lethality exposed RTE products to prevent product adulteration by 

Lm. Lm is a bacterial pathogen and environmental contaminant in the postlethality processing environment. The regulation, 9 CFR 430.4(a), states that Lm 

is a hazard that an establishment producing an RTE product exposed to the postlethality environment must control through its HACCP plan or prevent in the 

processing environment through a Sanitation SOP or other prerequisite program. 

It also states that RTE product is adulterated if it contains Lm or if it comes into 

direct contact with a food contact surface that is contaminated with Lm. 9 CFR 

430.4(b) sets out three alternatives that establishments producing post-lethality 

exposed RTE product are to choose from in order to meet the requirements of 9 

CFR 430.4(a). In-plant inspection personnel (IPP) are responsible for verifying 

that establishments are in compliance with 9 CFR 430.4(b). The appropriate 

HACCP, or SSOP, task will be used to perform and document the verification. 

Definitions (9 CFR 430.1) 

9 CFR 430.1 defines a ready-to-eat (RTE) product as a meat or poultry product 

that is in an edible form without additional preparation to achieve food safety and 

may receive additional preparation for palatability or aesthetic, epicurean, 

gastronomic, or culinary purposes. As we have discussed, RTE products are not 

labeled with the Safe Handling Instructions required for NRTE products. While 

some RTE product labels may include some instruction on reheating the product, 

these products do not need to be cooked to a level necessary to ensure food 

safety. It is important to note that even if RTE products are sold frozen, they are 

still considered RTE. 

Two particular RTE products defined in 9 CFR 430.1 are deli products and 

hotdog products. A deli product is an RTE meat or poultry product that is 

typically sliced, either in an official establishment or after distribution from an 

official establishment, and assembled in a sandwich for consumption. A hotdog 

product is an RTE meat or poultry frank, frankfurter, or wiener, such as a 

product defined in 9 CFR 319.180 and 319.181 (cheesefurters). It is important to 

note that a risk assessment performed jointly by FSIS and the FDA indicated that 

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on a per serving basis deli meats and hotdogs (not reheated) posed the greatest 

risk of illness and death from Lm. 

RTE meat and poultry products have undergone some lethality treatment. A 

lethality treatment is a process that eliminates or reduces the number of 

pathogenic microorganisms on or in a product to make the product safe for 

human consumption. Examples of lethality treatments include cooking or the 

application of an antimicrobial agent or process that eliminates or reduces 

pathogenic microorganisms. As described in the NRTE/RTE module, FSIS 

regulations specify levels of pathogen reduction for particular RTE product types. 

The following three terms are important with respect to understanding the 

distinction among different approaches for controlling or preventing Lm in an RTE 

product: 

• An antimicrobial agent is a substance in or added to an RTE product that 

has the effect of suppressing or limiting growth of Lm in the product 

throughout the shelf life of the product. Common examples of antimicrobial 

agents added to RTE products are potassium lactate and sodium 

diacetate. FSIS Directive 7120.1, Rev. 56, Safe and Suitable Ingredients 

Used in the Production of Meat, Poultry and Egg Products, identifies more 

antimicrobial agents used in the production of meat and poultry products. 

Note that some antimicrobial agents may have the effect of reducing the 

level of Lm on a product and suppressing growth of Lm throughout the 

shelf life of the product. 

• An antimicrobial process is an operation, such as freezing, applied to an 

RTE product that has the effect of suppressing or limiting the growth of Lm 

in the product throughout the shelf life of the product. Drying and 

fermenting are operations that may be applied to a product to make it RTE 

and subsequently suppress or limit the growth of Lm. 

• A post-lethality treatment (PLT) is an additional lethality treatment that is 

applied or is effective after post-lethality exposure of the product. It is 

applied to the final product or sealed package of product in order to reduce 

or eliminate Lm should contamination occur during post-lethality exposure. 

Some examples of post-lethality treatments include steam pasteurization, 

hot water pasteurization, radiant heating, and high pressure processing. 

Some antimicrobial agents may also serve as post-lethality treatments. 

The term post-lethality processing environment refers to the area of an 

establishment into which product is routed after having been subjected to an 

initial lethality treatment. The product may be exposed to the environment in this 

area as a result of slicing, peeling, re-bagging, cooling semi-permeable encased 

product with a brine solution, or other procedures. 

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A post-lethality exposed product is an RTE product that comes into direct 

contact with a food contact surface after the lethality treatment in a post-lethality 

processing environment. Remember that only post-lethality exposed RTE 

products are subject to 9 CFR 430. 

Prerequisite program is an important term defined in 9 CFR 430.1 as a 

procedure or set of procedures designed to provide basic environmental or 

operating conditions necessary for the production of safe, wholesome food. It is 

called “prerequisite'' because it is considered to be necessary condition for an 

effective HACCP system. For example, an establishment formulates a hotdog 

product to include an antimicrobial agent that will suppress the growth of Lm over 

the usual shelf life of the product. For this establishment, addition of this 

antimicrobial agent is carried out through a prerequisite program. Failure of the 

establishment to adequately design or implement this prerequisite program 

permits conditions whereby the product may become adulterated with Lm. 

While not defined in 9 CFR 430.1, the term indicator organism is used in 9 CFR 

430. Indicator organisms are bacteria used to determine objectionable microbial 

conditions of food, such as the presence of potential pathogens, as well as the 

sanitary conditions of food processing, production areas, or storage rooms. Lm 

belongs to the genus Listeria and the species is monocytogenes. The genus 

Listeria includes other nonpathogenic species (spp.) in addition to the pathogenic 

species monocytogenes. A positive test for Listeria spp. on a food contact 

surface would indicate the potential presence of Lm. However, the product is 

only considered adulterated if Lm is found on a food contact surface or product. 

If Listeria spp. is found, the product is not considered adulterated, however the 

establishment is expected to take corrective action, according to their control 

alternative, to address Listeria spp. positives so that the product does not 

become adulterated. If a test is negative for Lm or Listeria spp., this indicates Lm 

is not present. Note that tests for other indicator organisms, like aerobic plate 

counts (APC), total plate counts (TPC), and total coliforms are not appropriate 

indicators for Lm. Although such tests could provide a measure of general 

sanitation, they do not indicate the potential presence or absence of the 

pathogen of concern. 

IPP Responsibilities for Verifying Compliance with 9 CFR part 430.4 

You must be familiar with the establishment products and processes that must 

comply with 9 CFR 430.4 in order to verify compliance. If necessary, you can ask 

establishment management whether they produce any RTE product that is 

exposed to the environment after the initial lethality step. 

Note: the establishment is not required to comply with 9 CFR 430.4 if the RTE 

products produced are not exposed to the environment after the lethality step. 

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Examples: 

 Hotdogs exposed to the environment after peeling. 

− Establishment is required to comply with 9 CFR 430 

− Must choose one of 3 alternatives 

 Cooked ham sliced and film wrapped in retail packages. 

− Establishment is required to comply with 9 CFR 430 

− Must choose one of the 3 alternatives 

 Bologna cooked in an impermeable plastic casing. The casing is not removed 

prior to packing, and the product is not sliced at the official establishment. 

− Establishment is not required to comply with 9 CFR 430 

Ready to Eat (RTE) vs Not Ready to Eat (NRTE) 

The fully cooked not shelf stable HACCP processing category applies to 

establishments that further process products by using a lethality process, which 

includes a full cook step to achieve food safety. The term lethality is used to refer 

to the process step(s) that achieve food safety through the reduction or 

elimination of pathogenic microbes. The lethality process is expected to achieve 

at least a 7 log reduction for Salmonella in poultry products, a 6.5 log reduction 

for cooked beef, roast beef and corned beef, and at least a 5 log reduction in 

other products. Finished products produced in this category are not shelf stable 

(NSS), and must be kept frozen or refrigerated to maintain food safety. Products 

in this category are expected to meet the definition of ready-to-eat (RTE), which 

is defined in 9 CFR 430.1 as 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. However, only certain RTE products are required by 

standards of identity to be fully cooked (e.g. hot dogs, fully cooked sausages, 

barbecued meats, and cooked beef and roast beef) or by a common or usual 

identity (e.g., pate) as fully cooked. 

Some establishments may produce products that are fully-cooked (e.g., 

casserole, meat balls, and ham); however, the products may be considered 

NRTE by the establishment because they are not required to meet a fully cooked 

standard of identity, or common or usual identity, and the establishment chooses 

to label the product as NRTE (e.g., includes safe handling instructions). These 

products should be classified under the Heat Treated but Not Fully Cooked –Not 

Shelf Stable Category. The FSIS expectation is that products in the Fully-Cooked 

Not Shelf Stable processing category are RTE, therefore, categorizing the 

product in a Fully-Cooked Not Shelf Stable HACCP processing category would 

not be consistent with a NRTE product. 

If establishments consider a fully cooked product as NRTE, then it is FSIS 

expectation that they have safe handling instructions, and a statement such as 

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“must be cooked” on the label. A prudent establishment would include validated 

cooking instructions on the label. In addition, the establishment would need to 

ensure that the following are consistent with a NRTE product: 

• Labeling. Use of the terms “Baked” or “Broiled” in the label (e.g., 

“baked chicken”) would not be consistent with a NRTE product. 

• HACCP category. The FSIS expectation is that products in the 

Fully-Cooked Not Shelf Stable processing category are RTE, 

therefore, categorizing the product in a Fully-Cooked Not Shelf 

Stable HACCP processing category would not be consistent with a 

NRTE product. 

• Intended use statement. In order to be consistent with a NRTE 

product, the intended use statement should include how the 

product is expected to be cooked or otherwise treated for safety 

before consumption. 

Note: Only RTE products that are post-lethality exposed are required to meet the 

9 CFR 430.4 regulations. 

If the establishment is producing post-lethality exposed RTE products, you 

should ask establishment management which alternative they have chosen for 

each of the post-lethality exposed RTE products. You should inform them that, as 

set out in 9 CFR 430.4(c)(7), verification results that demonstrate the 

effectiveness of the measures they employ are to be made available upon 

request. 

You should verify that the establishment is meeting the requirements of the 

alternative that it has chosen by using the appropriate SSOP or HACCP tasks. If 

the establishment decides to produce different products using different 

alternatives, you should verify that they meet the requirements for each of the 

alternatives selected, for each of the post-lethality exposed RTE products. 

As you become familiar with the three alternatives, keep in mind that all 

establishments are required to maintain sanitary conditions sufficient to prevent 

direct product contamination including Lm. Sanitation is the foundation for 

controlling Lm and without it no alternative will be successful in controlling the 

organism. 

Note: See Attachment 1 and 2 for graphic summaries of the 3 alternatives and 

their requirements. The Listeria Compliance Guidelines have additional 

resources that help with determining whether a product is RTE or NRTE. 

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Alternative1 

9 CFR 430.4(b)(1) Use of a post-lethality treatment (which may also be the 

antimicrobial agent or process) that reduces or eliminates microorganisms on the 

product AND an antimicrobial agent or process that suppresses or limits the 

growth of L. monocytogenes. 

The thought process you should use when verifying regulatory requirements 

includes: 

 Gathering information by asking questions; 

 Assessing the information; and 

 Determining regulatory compliance. 

Gather information by asking questions 

When verifying compliance with the requirements in Alternative 1, seek answers 

to the following questions: 

1. Is the post-lethality treatment (PLT) (which may be an antimicrobial agent) 

incorporated in the HACCP plan? 

2. Does the establishment have scientific supporting documentation for the 

effectiveness of its post-lethality treatment in accordance with 9 CFR 

417.5(a)(2)? 

3. Does the establishment have validation data for the post-lethality 

treatment in accordance with 9 CFR 417.4? 

4. Is the establishment implementing the post-lethality treatment as 

described in the HACCP plan? 

5. Has the establishment incorporated the use of the antimicrobial agent or 

process to suppress or limit the growth of Lm in its HACCP plan, its 

Sanitation SOPs, or a prerequisite program? 

6. Is the establishment using the antimicrobial agent or process as described 

in its HACCP plan, its Sanitation SOPs, or a prerequisite program, and 

can it scientifically support how the antimicrobial agent or process is being 

used? 

Note: According to the Listeria Guidelines, the post lethality treatment should 

demonstrate at least 1-log decrease before the product is released into 

commerce and the antimicrobial agent or process should demonstrate no more 

than 2-logs of growth over the shelf life of the product. 

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Assess the information 

To answer these questions you should: 

 Review the HACCP plan, 

 Review validation data (supporting documentation) for the post-lethality 

treatment, 

 Review HACCP records, 

 Review the Sanitation SOP and/or prerequisite programs associated 

with the use of the antimicrobial agent or process (as necessary), and 

 Review Sanitation SOP and/or prerequisite program records (as 

necessary). 

Alternative 1 Examples: 

Example 1: You are verifying that the establishment is meeting the requirements 

of Part 430 and Alternative 1. You review the establishment’s hazard analysis for 

sliced semi-dry sausage products such as Genoa salami, sandwich pepperoni, 

cervelat, thuringer, etc., and find that the fermentation, heating, drying, and 

packaging steps have been identified as CCPs in the hazard analysis and have 

been incorporated into the HACCP plan. The hazard analysis and HACCP plan 

identify lowered acidity (pH) through the use of bacterial starter cultures and 

lowered water activity due to drying as measures to limit the growth of Lm in the 

finished product throughout the shelf life of the product. A steam pasteurization 

process after the product has been vacuum packaged has been identified as the 

treatment to reduce or eliminate post-lethality Lm contamination. There are 

critical limits at the respective steps in the plan for pH, water activity, and time 

and temperature exposure for the steam pasteurization process. You request the 

supporting documentation for the critical limits. The establishment provides 

scientific literature and the results of challenge studies conducted by a 

processing authority that show that the pH and water activity (achieved in the 

product) allows no more than a 2-log increase of Lm during its refrigerated shelf 

life and that the surface steam pasteurization treatment is effective in achieving 

at least a 1-log decrease of Lm resulting from the post-lethality contamination. 

Based upon your review, you determine that the establishment is in compliance 

with 9 CFR 430.4(b)(1). 

Example 2: You are verifying that an establishment complies with 9 CFR 

430.4(b)(1) in its deli products, which include sliced and unsliced roast beef, 

ham, turkey breast, and bologna. Because of concerns the establishment had 

with the flavor of some of its deli products, it decided to move away from 

incorporating the antimicrobial agents sodium lactate and sodium diacetate into 

the formulation for each of its deli products (i.e., prior to cooking). The 

establishment had previously supported that it met Alternative 2, Choice 2 

through the incorporation of these antimicrobial agents to limit the growth of Lm 

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in its deli products. Now the establishment is applying a post-lethality surface 

treatment to its deli products. The surface treatment is a solution containing an 

Lm-specific bacteriophage (ListexT P100) and a combination of sodium lactate 

and sodium diacetate. For the deli products that are sold unsliced, this solution is 

sprayed directly on the surface of each deli product loaf just before the vacuum 

packaging step. For the sliced deli products, the solution is sprayed on each slice 

as part of the slicing and vacuum packaging steps. You review the 

establishment's hazard analyses and HACCP plans for its deli products. You 

note that the establishment has identified the bacteriophage application as its 

post-lethality treatment to reduce or eliminate Lm on the product and the 

application of sodium lactate and sodium diacetate as antimicrobial agents to 

limit or suppress the growth of Lm throughout the shelf life of the product. Both 

elements are incorporated into the establishment's deli meat HACCP plans as 

CCPs. You review supporting documentation for the location of these CCPs, 

critical limits, and monitoring and verification procedures. Supporting documents 

include published research studies supporting the effectiveness of the 

bacteriophage as a post-lethality treatment and of the antimicrobial agents as 

inhibitors of the growth of Lm in deli products throughout their shelf life, technical 

information from the manufacturer of the bacteriophage product on its use, 

establishment decision making documents, and the results of challenge studies 

performed at a university-based food research and development laboratory on 

each of the establishment's deli products. You discuss some questions about the 

establishment's Lm controls with your supervisor. Based upon your review, you 

and your supervisor conclude that the establishment is in compliance with 9 CFR 

430.4(b)(1). 

Determine compliance 

After you have gathered and assessed all available information pertaining to 

Alternative 1, you must determine regulatory compliance. If you find that the 

establishment has met all regulatory requirements, then there is no regulatory 

noncompliance. If you find that the establishment has not met all regulatory 

requirements, i.e., the answer to any of the questions was “no”, there is 

noncompliance. You document a noncompliance on an NR under the appropriate 

PHIS task as described in FSIS Directive 5000.1, Rev. 6 and reference 9 CFR 

430.4(b)(1) and the appropriate section of §417 (for HACCP and prerequisite 

programs) or §416 (for Sanitation SOP). You should verify that the establishment 

takes corrective and preventive action to bring itself into compliance with 9 CFR 

430. Such actions may include a reassessment of the HACCP plan and the 

establishment’s choice of another alternative. You will receive more information 

about making compliance determinations in a later section. 

Noncompliance with Alternative 1 

The following are examples of noncompliance with Alternative 1. 

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1. The establishment has a post-lethality treatment to reduce or eliminate Lm 

incorporated into the HACCP plan, but does not have the use of the 

antimicrobial agent or process to suppress or limit the growth of Lm 

incorporated into its HACCP plan, its Sanitation SOP, or a prerequisite 

program. (Cite §430.4(b)(1) and §417.5(a)(1) & (2)) 

2. The establishment has the use of the antimicrobial agent or process to 

suppress or limit the growth of Lm incorporated into its HACCP plan, its 

Sanitation SOP, or a prerequisite program, but does not have a post-lethality 

treatment to reduce or eliminate Lm incorporated into the HACCP plan. (Cite 

§430.4(b)(1) and §417.5(a)(1) & (2)) 

3. The establishment is testing food contact surfaces in the post-lethality 

processing environment to ensure that the surfaces are sanitary and free of 

Lm or of an indicator organism, but does not have a post-lethality treatment to 

reduce or eliminate Lm incorporated into the HACCP plan OR the use of the 

antimicrobial agent or process to suppress or limit the growth of Lm 

incorporated into its HACCP plan, its Sanitation SOP, or a prerequisite 

program. (Cite §430.4(b)(1) and §417.5(a)(1) & (2)) 

4. The establishment has included a post-lethality treatment to reduce or 

eliminate Lm in its HACCP plan, but has not validated the effectiveness of the 

treatment. (Cite §430.4(b)(1) and §417.4.) 

You will document any noncompliance in accordance with our discussion of 

documentation and enforcement in a later section. 

Alternative2 

9 CFR 430.4(b)(2) Use of either a post-lethality treatment (which may be the 

antimicrobial agent or process) that reduces or eliminates microorganisms on the 

product OR an antimicrobial agent or process that suppresses or limits the 

growth of L. monocytogenes. 

Under Alternative 2, an establishment may select either Choice 1 or Choice 2 as 

follows. 

Alternative 2, Choice 1 - The establishment chooses to use a post-lethality 

treatment (which may be an antimicrobial agent) that reduces or eliminates Lm 

on the product. 

Alternative 2, Choice 2 - The establishment chooses to use an antimicrobial 

agent or process that suppresses or limits the growth of Lm. 

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The thought process you should use when verifying regulatory requirements 

includes: 

 Gathering information by asking questions; 

 Assessing the information; and 

 Determining regulatory compliance. 

Gather information by asking questions 

When verifying compliance with the requirements in Alternative 2, seek answers 

to the following questions. Alternative 2 is based on the same requirements as 

Alternative 1, except that the establishment can choose to just have a postlethality treatment that meets Choice 1, or an antimicrobial agent or process that 

meets Choice 2. 

Choice 1 

1. Is the post-lethality treatment (which may be an antimicrobial agent) 

incorporated in the HACCP plan? 

2. Does the establishment have validation data for the post-lethality 

treatment in accordance with 9 CFR 417.4? 

3. Is the establishment implementing the post-lethality treatment as 

described in the HACCP plan? 

Choice 2 

1. Has the establishment incorporated the use of the antimicrobial agent or 

process to suppress or limit the growth of Lm in its HACCP plan, its 

Sanitation SOPs, or a prerequisite program? 

2. Is the establishment using the antimicrobial agent or process as described 

in its HACCP plan, its Sanitation SOPs, or a prerequisite program? 

Also, if the establishment chooses Choice 2, you should seek answers to these 

additional questions, regarding the establishment’s sanitation procedures. 

Does the establishment’s testing for verifying the on-going effectiveness of their 

sanitation procedures: 

1. Provide for testing of food contact surfaces in the post-lethality processing 

environment to ensure that the surfaces are sanitary and free of Lm or of 

an indicator organism? 

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2. Identify the conditions under which the establishment will implement holdand-test procedures following a positive test of a food-contact surface for 

Lm or an indicator organism? 

3. State the frequency with which testing will be done? 

4. Identify the size and location of the sites that will be sampled? Note that 

establishments should identify all possible sites (see AskFSIS QA dated 2- 

17-12) 

5. Include an explanation of why the testing frequency is sufficient to ensure 

that effective control of Lm, or an indicator organism, is maintained? 

Assess the information 

To answer these questions you should: 

 Review the HACCP plan, 

 Review validation data for the post-lethality treatment, 

 Review HACCP records, 

 Review the Sanitation SOP and/or prerequisite programs associated 

with the use of the antimicrobial agent or process (as necessary), 

 Review the Sanitation SOP and/or prerequisite programs associated 

with the testing program for verification of effectiveness of sanitation 

procedures (as necessary), and 

 Review Sanitation SOP and/or prerequisite program records (as 

necessary). 

Alternative 2 Examples: 

Example 1: An establishment's product line includes wet salads, like chicken 

salad and ham salad. It hermetically seals containers filled with these ready-toeat salad products, the containers are batch loaded into cylinders, the cylinders 

enter a chamber, and the products undergo high pressure processing. You are 

reviewing the establishment's hazard analysis and HACCP plan for these 

products to verify compliance with the requirements for Alternative 2, Choice 1 as 

specified in 9 CFR 430. In its hazard analysis, the establishment concluded that 

Lm was a hazard reasonably likely to occur in the post-lethality processing steps. 

The establishment identified the high pressure processing as its post-lethality 

treatment and included it in its HACCP plan as a CCP. The critical limit is time at 

a specific pressure level. In reviewing supporting documents for the CCP, you 

discover there are other critical parameters associated with this type of 

treatment, including product temperature before high pressure processing and 

water fill level of the pressure chamber. You request additional documentation 

supporting that the establishment achieves these additional critical parameters. 

The establishment provides documents that show the product temperature is 

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consistently 40 degrees F or less at the packaging step and that the pressure 

chamber water level is monitored to ensure that the required level of pressure 

can consistently be achieved in the process. You conclude that the establishment 

is in compliance with 9 CFR 430.4(b)(2). 

Example 2: You are verifying that the establishment is meeting the requirements 

of Part 430 and Alternative 2, Choice 2. You review the establishment’s hazard 

analysis for fully cooked frozen breaded chicken products and find that the 

cooking and chilling steps have been identified as CCPs in the hazard analysis 

and have been incorporated into the HACCP plan. In addition to these CCPs, Lm 

was considered a potential hazard at the packaging step but was not likely to 

occur because the establishment has Listeria control measures in its SSOP to 

prevent Lm in the post-lethality processing environment. You decide to request 

the supporting documentation for the decision made in the hazard analysis that 

Lm is not likely to occur in the post-lethality environment. The establishment 

provides a scientific document that identifies the temperature that would inhibit 

Lm growth in the finished product throughout the shelf life of the product. The 

establishment also provides the procedures (verification activities) and the 

associated records it uses to demonstrate that products are frozen below the 

level that the scientific validation document establishes as preventing the growth 

of Lm. The records for the past several months show that the product is 

achieving the frozen temperature needed to suppress the growth of Lm and is 

labeled with the instructions “Keep Frozen.” You review the establishment’s 

SSOP and records and find that the establishment is testing food contact 

surfaces in the post-lethality processing environment to ensure that the surfaces 

are sanitary and free of Listeria spp. The establishment has identified the 

conditions under which the establishment will implement hold-and-test 

procedures following a positive test of a food contact surface for Listeria spp., the 

size and location of the sample sites, and the testing frequency. It also provided 

a thought process as to why the testing frequency it selected is sufficient to 

ensure that effective control of Lm, or an indicator organism, is maintained. 

Based upon your review, you determine that the establishment is in compliance 

with 9 CFR 430.4(b)(2). 

Determine compliance 

After you have gathered and assessed all available information pertaining to 

Alternative 2, you must determine regulatory compliance. If you find that the 

establishment has met all regulatory requirements, then there is no regulatory 

noncompliance. If you find that the establishment has not met all regulatory 

requirements, i.e., the answer to any of the questions was “no”, there is 

noncompliance. You should document the noncompliance on an NR under the 

appropriate PHIS task as described in FSIS Directive 5000.1 and reference 9 

CFR 430.4(b)(2) and, depending where the use of the antimicrobial agent or 

process is addressed, either the appropriate section of §417 (for HACCP and 

prerequisite programs) or the appropriate section of §416 (Sanitation SOP). 

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You should verify that the establishment takes corrective and preventive action to 

bring itself into compliance with 9 CFR 430. Such actions may include a 

reassessment of the HACCP plan and the establishment’s choice of another 

alternative. You will receive more information about making compliance 

determinations in a later section. 

Noncompliance with Alternative 2 

The following are examples of noncompliance with Alternative 2. 

1. The establishment is testing food contact surfaces in the post-lethality 

processing environment to ensure that the surfaces are sanitary and free of 

Lm or of an indicator organism but does not have a post-lethality treatment to 

reduce or eliminate Lm incorporated into the HACCP plan OR the use of the 

antimicrobial agent or process to suppress or limit the growth of Lm 

incorporated into its HACCP plan, its Sanitation SOP, or a prerequisite 

program. (Cite §430.4(b)(2), §417.2, and §417.5(a)(1) & (2)) 

2. The written sanitation procedures the establishment is using to meet the 

requirements of Choice 2 only addresses the testing of non-food contact 

surfaces in the post-lethality processing environment to ensure that the 

surfaces are sanitary and free of Lm or of an indicator organism. (Cite 

§430.4(b)(2), §416, and §417.5(a)(1) & (2)) 

3. The written sanitation procedures the establishment is using to meet the 

requirements of Choice 2 do not identify the conditions under which or at what 

point hold-and-test procedures following a positive test of a food-contact 

surface for Lm or an indicator organism will be initiated. (Cite §430.4(b)(2) 

and §417.5(a)(1) & (2)) 

4. The written sanitation procedures the establishment is using to meet the 

requirements of Choice 2 do not identify the size of the site to be sampled. 

(Cite §430.4(b)(2) and §417.5(a)(1) & (2)) 

5. The written sanitation procedures the establishment is using to meet the 

requirements of Choice 2 do not articulate its explanation as to why the 

testing frequency it selected is sufficient to ensure that effective control of Lm, 

or an indicator organism, is maintained. (Cite §430.4(b)(2) and §417.5(a)(1) & 

(2)) 

You will document any noncompliance in accordance with our discussion of 

documentation and enforcement in a later section. 

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Alternative3 

9 CFR 430.4(b)(3) Use of sanitation measures only 

The thought process you should use when verifying regulatory requirements 

includes: 

 Gathering information by asking questions; 

 Assessing the information; and 

 Determining regulatory compliance. 

Gather information by asking questions 

When verifying compliance with the requirements in Alternative 3, seek answers 

to the following questions. 

Does the establishment that produces post-lethality exposed product and that 

selects this alternative have on-going verification testing procedures that are 

designed to: 

1. Have sanitation measures incorporated in its HACCP, Sanitation SOP, or 

other prerequisite program? 

2. Test food contact surfaces in the post-lethality processing environment to 

ensure that the surfaces are sanitary and free of Lm or of an indicator 

organism? 

3. Identify the conditions under which the establishment will implement holdand-test procedures following a positive test of a food-contact surface for 

Lm or an indicator organism? 

4. State the frequency with which testing will be done? 

5. Identify the size and location of the sites that will be sampled? Note that 

establishments should identify all possible sites (see AskFSIS QA dated 2-

17-12) 

6. Include an explanation of why the testing frequency is sufficient to ensure 

that effective control of Lm, or an indicator organism, is maintained? 

Also, does an establishment producing a deli product or a hot dog product: 

1. Verify that the implemented corrective actions (with respect to sanitation 

after an initial positive result on a food contact surface in the post-lethality 

processing environment) are effective by follow-up testing that includes 

targeted testing of the specific site on the food contact surface area and 

other sites as necessary to ensure effectiveness of the corrective actions? 

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2. Hold lots of product (that may have become contaminated by contact with 

the food contact surface when the establishment obtains a second positive 

test for Lm, or an indicator organism, during this follow-up testing) until the 

establishment corrects the problem as indicated by follow-up test 

(negative) results? 

3. Sample and test the lots for Lm or an indicator organism, using a sampling 

method and frequency that will provide a level of statistical confidence that 

ensures that each lot is not adulterated with Lm, in order to be able to 

release into commerce the lots of product that may have been 

contaminated with Lm? 

4. Document the results of the testing? 

5. Rework the held product using a process that is destructive of Lm? 

Assess the information 

To answer these questions you should: 

 Review the HACCP plan, Sanitation SOP, and/or prerequisite 

programs associated with the testing program for verification of 

effectiveness of sanitation procedures. 

 Review HACCP records, SSOP records, or the records associated with 

the prerequisite program 

Alternative 3 Examples: 

Example 1: You are verifying that the establishment is meeting the requirements 

of Part 430 and Alternative 3. You review the establishment’s hazard analysis for 

fully cooked breakfast type products such as bacon, sausage patties, sausage 

links, etc., packaged and sold refrigerated. You find that the cooking and chilling 

steps have been identified as CCPs in the hazard analysis and have been 

incorporated into the HACCP plan. Lm was considered a potential hazard at the 

packaging step but the establishment concluded that it was a hazard not likely to 

occur because it has Listeria control measures in a prerequisite program to 

prevent Lm in the post-lethality processing environment. You request the 

supporting documentation for the decision that Lm is not likely to occur in the 

post-lethality environment. You review the establishment’s prerequisite program 

and records and find that the establishment is testing food contact surfaces in the 

post-lethality processing environment to ensure that the surfaces are sanitary 

and free of Listeria spp. It also has identified the conditions under which it will 

implement hold-and-test procedures following a positive test of a food contact 

surface for Listeria spp., the size and location of the sample sites, and testing 

frequency. The establishment provided a thought process as to why the testing 

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Listeria monocytogenes Regulations 

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frequency it selected is sufficient to ensure that effective control of Lm, or an 

indicator organism, is maintained. Based upon your review, you determine that 

the establishment is in compliance with 9 CFR 430.4(b)(3). 

Example 2: You are verifying that the establishment is meeting the requirements 

of Part 430 and Alternative 3. You review the establishment’s hazard analysis for 

fully cooked deli and hot dog type products such as franks, sliced ham, sliced 

bologna, sliced roast beef, sliced turkey breast, etc., packaged and sold 

refrigerated. You find that the cooking and chilling steps have been identified as 

CCPs in the hazard analysis and are incorporated into the HACCP plan. Lm was 

considered a potential hazard at the packaging step but the establishment 

concluded that it was a hazard not likely to occur because it has Listeria control 

measures in its SSOP to prevent Lm in the post-lethality processing environment. 

You request the supporting documentation for the decision that Lm is not likely to 

occur in the post-lethality environment. You review the establishment’s SSOP 

and records and find that the establishment is testing food contact surfaces in the 

post-lethality processing environment to ensure that the surfaces are sanitary 

and free of Listeria spp. The establishment has identified the conditions under 

which it will implement hold-and-test procedures following a positive test of a 

food-contact surface for Listeria spp., the size and location of the sample sites, 

and the testing frequency. It also provided a thought process as to why the 

testing frequency it selected is sufficient to ensure that effective control of Lm, or 

an indicator organism, is maintained. 

You find that the establishment verifies the effectiveness of the corrective actions 

it takes with respect to sanitation after an initial positive test on a food contact 

surface in the post-lethality processing environment through follow-up testing, 

including a targeted test of the specific site that is the most likely source of 

contamination by the organism, and other additional tests in the surrounding food 

contact surface area. When the establishment obtains a second positive test 

during this follow-up testing, it holds the lots of product that may have become 

contaminated by contact with the food contact surface until a test result indicates 

that the sanitation problem is corrected. The establishment only releases into 

commerce the lots of product that may have become contaminated with Lm from 

the food contact surface after it has sampled and tested the lots for Lm using a 

sampling method and frequency that will provide a level of statistical confidence 

that ensures that each lot is not adulterated with Lm. The establishment 

considers sampled product lots that test positive for Lm as adulterated and 

withholds them from entering commerce. The establishment destroys the held 

product, or reworks the held product using a process that is destructive of Lm. 

The establishment documents the test results and the disposition of the product. 

Based upon your review, you determine that the establishment is in compliance 

with 9 CFR 430.4(b)(3). 

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Listeria monocytogenes Regulations 

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Determine compliance 

After you have gathered and assessed all available information pertaining to 

Alternative 3, you must determine regulatory compliance. If you find that the 

establishment has met all regulatory requirements, then there is no regulatory 

noncompliance. If you find that the establishment has not met all regulatory 

requirements (i.e., the answer to any of the questions was “no”), there is 

noncompliance. You should issue an NR under the appropriate PHIS task as 

described in FSIS Directive 5000.1 and reference 9 CFR 430.4(b)(3) and, 

depending where the use of the sanitation measures are addressed, either the 

appropriate section of §417 (for HACCP and prerequisite programs) or the 

appropriate section of §416 (Sanitation SOP). You should verify that the 

establishment takes corrective and preventive action to bring itself into 

compliance with 9 CFR 430. Such actions may include a reassessment of the 

HACCP plan to determine whether the decisions made in the hazard analysis 

regarding the use of the prerequisite program remain valid, and the 

establishment’s choice of another alternative. You will receive more information 

about making compliance determinations in a later section. 

Noncompliance with Alternative 3 

The following are examples of noncompliance with Alternative 3. 

1. The establishment does not have sanitation measures incorporated in its 

HACCP, Sanitation SOP, or other prerequisite program. (Cite §430.4(b)(3), 

and §417.5(a)1&2.) 

2. The written sanitation procedures the establishment is using to meet the 

requirements of this alternative only address the testing of non-food contact 

surfaces in the post-lethality processing environment to ensure that the 

surfaces are sanitary and free of Lm or of an indicator organism. (Cite 

§430.4(b)(3), and §417.5(a)(1) and (2).) 

3. An establishment that produces deli and hot dog products does not conduct 

follow-up testing of target sites on the food contact surface area that is the 

most likely source of contamination after an initial positive test for Lm, or its 

indicator organisms, to verify the effectiveness of its sanitation corrective 

actions. (Cite §430.4(b)(3), and §417.5(a)(1) and (2).) 

4. An establishment that produces deli and hot dog products does not holdand-test lots of product for Lm, or an indicator organism, that may have 

become contaminated by contact with the food contact surface when it 

obtains a second positive test for Lm, or an indicator organism, during its 

follow-up testing. (Cite §430.4(b)(3), and §417.5(a)(1) and (2).) 

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Documentationand Enforcement 

If noncompliance with the Lm regulations is found, IPP are to issue a 

Noncompliance Record (NR) under the appropriate HACCP, or SSOP, task as 

described in FSIS Directive 5000.1 and reference 9 CFR 430.4(b)(1), (2), or (3) 

and the appropriate sections of 9 CFR 417 or §416, if applicable. CSIs are to 

verify that the establishment takes action to bring itself into compliance with 9 

CFR 430. Such actions may include, but are not limited to, a reassessment of the 

HACCP plan and the establishment’s choosing of another alternative or 

determining that the decisions it made in the hazard analysis regarding the use of 

a prerequisite program remain valid. 

If an establishment is producing post-lethality exposed products and has failed to 

meet any of the requirements of 9 CFR 430, you should contact the District 

Office through supervisory channels. A NOIE may be issued if the establishment 

HACCP system and/or SSOP is inadequate due to failure to meet the §430 

"Listeria Rule" regulations. 

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Listeria monocytogenes Regulations 

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ATTACHMENT 1: CONTROL REQUIREMENTS for LISTERIA MONOCYTOGENES 

Requirements 

 Increasing Risk Levels and Frequency of FSIS Verification Testing 

ALTERNATIVE 1 ALTERNATIVE 2 ALTERNATIVE 3 

Post-lethality

Treatment AND 

Antimicrobial agent or 

Process 

Post-lethality Treatment OR 

Antimicrobial agent or Process 

Sanitation and Testing Program 

Choice 1: 

Post-lethality 

Treatment 

Choice 2: 

Antimicrobial 

Agent or Process 

Non-deli, 

Non-hotdog 

Deli or hotdog product 

Validate effectiveness of post-lethality treatment (PLT). Must be 

included as a CCP in the establishment’s HACCP Plan and should 

show at least a 1-log reduction in Lm prior to distribution of the 

product into commerce 

X X 

Document effectiveness of antim icrobial agent or process: Must 

be included as part of the establishment’s HACCP, Sanitation SOP, 

or Pre-requisite Program and should demonstrate no more than 2-

logs grow th of Lm over the estimated shelf life. 

X X 

Sanitation Program Requirements X X X 

Testing food contact surfaces (FCS) in the post-lethality processing 

environment for Lm or an indicator organism. 

X X X 

State testing frequency. X X X 

Identify size and location of sites to be sampled. X X X 

Explain w hy testing frequency is sufficient to control Lm or an 

indicator organism. 

X X X 

Identify conditions for Hold-and-Test, w hen FCS (+) for Lm or an 

indicator organism. 

X X X 

Additional Sanitation Program Requirem ents 

Follow -up testing to verify corrective actions are 

effective after 1st FCS (+) for Lm or an indicator organism. Includes 

testing of targeted FCS as most likely source and additional testing of 

the surrounding area. 

X 

If follow -up testing yields 2nd FCS (+), hold products that may be 

contaminated until problem is corrected as show n by FCS (-) in 

follow -up testing. X 

Hold and test product lots using a sampling plan that provides 

statistical confidence that the lots are not contaminated w ith Lm or an 

indicator organism. Release, rew ork or condemn products based on 

results. Document results and product disposition. X 

Establishments in all three alternatives must maintain sanitation in 

accordance w ith 9 CFR 416. 

X X X X X 

Inspection Methods 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Listeria monocytogenes Regulations 

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ATTACHMENT 2: CHART OF RTE VS NRTE PRODUCTS 

TYPE CLASS PROCESSING 

CATEGORY 

REG REQUIRED 

SAFETY 

LABELING 

WHAT THE HAZARD ANALYSIS OR HACCP PLAN MAY 

ADDRESS 

A meat/poultry product (in w hole or Not- • Raw Product Nonintact Product must be • Use of SHI labeling (Some establishments may have a 

in part) w hich has not received an ready- • Raw Product Intact labeled w ith CCP for SHI labeling application). 

adequate lethality treatment for to-eat • Not Heat Treated Shelf statements such as If it is not obvious that the product is raw and needs to be 

Salmonella (i.e., raw or partially Stable keep refrigerated, cooked: 

cooked product). May include cuts • Heat Treated –shelf keep frozen, or • Features on labeling are conspicuous so that intended user 

of meat and poultry, cured pork stable refrigerate is fully aw are that product must be cooked for safety. This 

products, and NRTE sausage • Heat Treated but not leftovers, if not is best conveyed through the product name (e.g., “Cook 

Or Fully Cooked Not Shelf shelf stable. Use of and Serve”) but may also be conveyed by the use of an 

A meat/poultry product (in w hole or Stable Safe Handling asterisk on the product name that is associated w ith a 

in part) w hich has received an • Products w ith secondary Instruction (SHI) statement on the principle display panel or by a burst 

adequate lethality treatment for inhibitors Not Shelf labeling required. stating such things as “needs to be fully cooked,” “see 

Salmonella, that is not defined by a 

standard of identity or common or 

usual name that consumer 

Stable cooking instructions,” or “cook before eating.” 

• Validation that: 

a. Cooking and preparation instructions on the product are 

understand to refer to RTE product sufficient to destroy pathogens. and does not meet the definition of b. Instructions are realistic for the intended consumer. 

RTE in 9 CFR 430.1.May include 

NRTE ham, casseroles, and other 

meat or poultry dishes 

A product containing a meat/poultry Not- • Heat Treated but not Product must be • Validation that: 

component that is RTE in ready- Fully Cooked Not Shelf labeled w ith a. The meat/poultry component received an adequate lethality 

combination w ith nonmeat/poutry to-eat Stable statements such as treatment for pathogens. 

components that needs to receive a keep refrigerated or b. Cooking and preparation instructions on the product are 

lethality treatment by the intended frozen. Use of SHI sufficient to destroy pathogens. 

user. The final product does not labeling is c. Instructions are realistic for the intended consumer. 

meet the definition of RTE in 9 CFR recommended. • Features on labeling are conspicuous so that intended user 

430.1 because it contains raw is fully aw are that product must be cooked for safety. This 

components. May include meals, Note: SHI are not is best conveyed through the product name (e.g., “Cook 

dinners, and frozen entrees. required because and Serve”) but may also be conveyed by the use of an

the meat or poultry asterisk on the product name that is associated w ith a 

component is RTE. statement on the principle display panel, or by a burst 

How ever, FSIS stating such things as “needs to be fully cooked”, “see 

recommends SHI cooking instructions”, or “cook before eating.” 

for these products • If necessary, hazard analysis should address w hether 

because raw non instructions on the label are needed related to cross- meat ingredients contamination (e.g., avoid contact of contents) and 

are added. prevention of pathogenic grow th (e.g., promptly refrigerate 

leftovers). 

NOTE: Inspection program personnel are to collect samples as 

RTE if the establishment does not follow the guidance above. 

Inspection Methods 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Listeria monocytogenes Regulations 

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TYPE CLASS PROCESSING 

CATEGORY 

REG REQUIRED 

SAFETY 

LABELING 

WHAT THE HAZARD ANALYSIS OR HACCP PLAN MAY 

ADDRESS 

A meat/poultry component that has 

received an adequate lethality 

treatment for Salmonella that m ay 

or may not be defined by a 

standard of identity or common or 

usual name that consumer 

understand to refer to RTE product 

and meets the definition of 9 CFR 

430.1. RTE products that are post 

lethality exposed must meet the 

requirements of 9 CFR 430. May 

include hotdogs, deli meat, and 

RTE sausages. 

Readyto-eat 

• Not Heat Treated Shelf 

Stable 

• Heat Treated Shelf 

Stable 

• Fully Cooked Not Shelf 

Stable 

• Products w ith secondary 

inhibitors Not Shelf 

Stable 

If the product is not 

shelf stable, 

labeling such as 

keep refrigerated or 

frozen is required. 

SHI are not 

required and should 

not be used 

because they could 

be misleading to 

consumers 

• Validation that the meat or poultry component received an 

adequate lethality treatment for pathogens (e.g., a 5-log 

reduction of Salmonella). 

• The establishment meets the requirements of 9 CFR 430 if 

the product is post-lethality exposed. 

• Heating (not cooking) instructions may be included. 

• Statements on the principle display panel may indicate that 

the product is RTE and does not have to be cooked for 

safety (e.g., “fully cooked”, “heat and serve”). . 

Inspection Methods 
1 

Listeria monocytogenes (L.m.) 

I 

Control 

I 

Post-Lethally Anti-Microbial 

Treatment Agent/Process 

Of Product That Suppresses/Limits Gr

i i 

,- 

Lm

_ is a Hazard May Not Rewce Lm_ 

~Reamnahly Likely h Occur' Btt i is stl Effechre Thro

i Limi&lg lhe Outgn,w9I of O(!J8flismS 

MUST be ~eluded in HA.CCP Pim Suwilfe the Post-lethally Pro

VWh Pon: ofTrealment as CCP '- I 

(9 CFR 417_1) i i 

i SSOP ® Pn- ® 

Validated ' (9 CFR 416) Requisite 

as Effed:ilfe 11 Rewcng/Bimmmg Lm_ Prc9an 

(9 CFR 417_4) I I 

i 

[ Records //lust Be Made Avalable ID FSIS 

Nole: 

lan~~s isJtn,iei!asPmtaltle Cai SelVe asbolh 

llilill Ll6aRy MD Sil Has a Cmnmg Baden:idal I-------+ JW-LelhaMyTn!3bnenl: H .llml-twe ~

Eied: oo Lm Tia Palilts JW-lelhaMy Alm FE Gmwfi--liHihw 

Inspection Methods 
2 

Usteria monocytogenes (L.m.) 

Control ,.;-

Post-Lethally 

a 

Anli-lkrobial '\ Sanita

Treabnent Agentf Process A T

N Of Product Thal Suppresses/Limits Growth j\V 

I 

Lm_ ii a Hazanll 

"-Reamnab/y I.Jkely to Oa:ur' • Provide testi

sufaces 

May Not Rewce Lm_ ' • ldently hold 

MUST be Included in HACCP Plan Bu: i is stil Effed:ife Thmu~ posiive 

Wih Poit ofTreatmert as CCP Limi&lg fnd.ig of Lm

(9 cm 417

_1) lhe outgn,w8I of Organisms that orgar&n Suivive the Post-lethally Process • Stae fie!JEn

'-

• ldently size/

Validaled as Effective in sies 

Rewcing/Elininatilg Lm_ 

(9Cffi417

_4) l l ~0 Pre- 0 y- (9CFR416) Requisite HACCPPlan Pras,wn (9 CFR 417) 

I 

Recanls /llust Be Made Available ID FSIS Upon Request j 

Inspection Methods 
3 

Listeria monocytogenes (L.m.) 

Control 

Sanitation Program 

ThatMUST: 

For RTE PnHlucts: For Hotdag & Odi-Type Producfs

• • • 

• 

• 

Provide testmg of food coriad 

sgfaces 

ldently hold and test for 

posiive 

finding of Lm_ or .idicator 

Olgarert 

st* fieq1Ency ofte~.ig 

ldently size/locmon of 

safl1)1ing sies 

Support test.lg fie(J.lency 

AND 

• 

• 

• 

Verify corrective actions mler 

.iilial posiive sa~ of food 

coriact ru1face 

Te~ and hold .i the case of a 

second po9tive 

~le and te~ lots to releas

OR rewmk to de~my Lm_ 

Records lllust Be Made Available ID FSIS Upon Request 

Inspection Methods 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Listeria monocytogenes Regulations 

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Workshop: Listeria monocytogenes Regulations 

1. Establishments are required to comply with section 9 CFR 430.4 (Control of 

Listeria monocytogenes) if they produce: 

a. Ready-to-eat products processed and sold in impermeable packaging. 

b. Not ready-to-eat products with secondary inhibitors. 

c. Ready-to eat products. 

d. Ready-to-eat products exposed to the environment after the lethality step. 

2. Fill in the blanks with one of the following: 

Alternative 1 

Alternative 2, Choice 1 

Alternative 2, Choice 2 

Alternative 3 

a. Use of only a post-lethality treatment (which may be 

the antimicrobial agent or process) that reduces or 

eliminates microorganisms on the product 

b. Use of a post-lethality treatment (which may also be 

the antimicrobial agent or process) that reduces or 

eliminates microorganisms on the product AND an 

antimicrobial agent or process that suppresses or 

limits the growth of L. monocytogenes 

c. Sanitation measures only, in the HACCP plan, SSOP, 

or prerequisite program, including testing of food 

contact surfaces to verify the effectiveness of the 

sanitation procedures 

d. Use of an antimicrobial agent or process that 

suppresses or limits the growth of L. monocytogenes, 

along with a sanitation program addressing the testing 

of food contact surfaces to verify the effectiveness of 

the sanitation procedures 

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3. An establishment MUST implement hold and test procedures when a positive 

result for an indicator organism is found on a food-contact surface during 

follow-up testing (second consecutive food contact surface positive) if the 

establishment is producing: 

a. RTE products exposed to the environment after the lethality treatment 

using Alternative 1, 2, or 3. 

b. Non-deli and hot dog type RTE products exposed to the environment after 

the lethality treatment using Alternative 3. 

c. Deli and hot dog type RTE products exposed to the environment after the 

lethality treatment using Alternative 3. 

d. Deli and hot dog type RTE products exposed to the environment after the 

lethality treatment using Alternative 2, Choice 2 

4. An establishment MUST identify the conditions under which it will implement 

hold and test procedures after a positive result for an indicator organism is 

found on a food-contact surface if the establishment is producing: 

a. Non-deli and hot dog type or deli or hot dog type RTE products exposed to 

the environment after the lethality treatment using either Alternative 2 

(Choice 2) or Alternative 3. 

b. Deli and hot dog type RTE products exposed to the environment after the 

lethality treatment using either Alternatives 1, 2, or 3. 

c. Deli and hot dog type RTE products exposed to the environment after the 

lethality treatment using Alternative 1 or Alternative 2, Choice 1. 

d. Non-deli and hot dog type RTE products exposed to the environment after 

the lethality treatment using Alternative 2, Choice 1 

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5. Case Study. (Please note: This is a simplified training example only.) You are 

assigned to an establishment that makes smoked turkey for slicing at delis. 

The establishment has chosen to produce this product under Alternative 2, 

Choice 2. In order to comply with Part 430.4(b)(2), the establishment’s 

sanitation program must provide for testing of food contact surfaces in the 

post-lethality processing environment to ensure that the surfaces are sanitary 

and free of Listeria monocytogenes. The establishment includes sanitation 

measures to prevent Listeria monocytogenes in processing environment in 

the Sanitation SOP. The sanitation program targets the packaging room, 

where product is taken off of smokehouse racks, cut into halves, and vacuum 

packaged. The establishment conducts routine, random food contact surface 

testing as follows: 

• It has identified 20 food contact surface sites, such as table tops, packaging 

equipment, and knife blades. These represent all possible sites. 

• Each month 5 sites are randomly selected and tested for Listeria spp. The sites

are tested twice weekly, at the end of production before cleaning. Testing 

frequency is based on past data. For 6 months testing was done weekly, and 

data showed that the process ensured control of Lm. Additionally, they are 

testing more frequently than recommended by FSIS in the Compliance 

Guidelines to Control Listeria monocytogenes in Post-lethality Exposed Ready to 

Eat Meat and Poultry Products. 

• Sample size is 1 square foot for each surface. 

• Sample sites are recorded, along with visual observation of each site. Test 

results are recorded on the same form. 

• If a positive food contact surface sample result is detected, that site is given 

intensified cleaning and sanitizing during the next sanitation, and re-swabbed 

daily for 5 days. 

• If the site is again positive for Listeria spp. during this 5-day period, the food 

contact surface is taken out of production and subjected to intensive cleaning 

and sanitizing, holding product, and retesting, as follows. 

 Equipment is completely disassembled. 

 The food contact surface and surrounding areas receive intensified cleaning 

and sanitizing, and the item is re-assembled and placed back into production. 

 Corrective actions are recorded. 

 Food contact surface swabs are then taken every two hours during 

production. 

 All product is placed on hold until results are received. 

 If all food contact surface swabs are negative, product is released. 

 If any swab tests positive for Listeria spp., product from that 2-hour time 

period and from each period on either side of the positive result is tested for 

Listeria monocytogenes. 

o Testing will be done following a statistically derived sampling plan. 

o Product that tests negative for Lm is released. 

o Product that tests positive for Lm is destroyed. 

 The process of intensified sanitation, holding product, and testing food 

contact surfaces is repeated daily until test results are negative for Listeria 

spp. 

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a. At what point during production are the random food contact surface samples 

taken? 

b. Does this program identify conditions under which the establishment will 

implement hold-and-test procedures following a positive test of a food contact 

surface? If so, what are those conditions? 

c. Does this program identify the frequency with which testing will be done? If 

so, what is that frequency? 

d. Does this program identify the size and location of the sites that will be 

sampled? If so, what is the size and location? 

e. When are product samples for Listeria monocytogenes taken? 

f. Would you review records associated with this program? If so, when? Please 

explain your answer. 

g. Would you observe employees performing the sampling procedures? If so, 

when? Please explain your answer. 

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Regulations 

9 CFR 430.1, Definitions. 

Antimicrobial agent. A substance in or added to an RTE product that has the effect of 

reducing or eliminating a microorganism, including a pathogen such as L. 

monocytogenes, or that has the effect of suppressing or limiting growth of L. 

monocytogenes in the product throughout the shelf life of the product. Examples of 

antimicrobial agents added to RTE products are potassium lactate and sodium

diacetate. 

Antimicrobial process. An operation, such as freezing, applied to an RTE product that 

has the effect of suppressing or limiting the growth of a microorganism, such as L. 

monocytogenes, in the product throughout the shelf life of the product. 

Deli product. A ready-to-eat meat or poultry product that typically is sliced, either in an 

official establishment or after distribution from an official establishment, and typically is 

assembled in a sandwich for consumption. 

Hotdog product. A ready-to-eat meat or poultry frank, frankfurter, or wiener, such as a

product defined in 9 CFR 319.180 and 319.181. 

Lethality treatment. A process, including the application of an antimicrobial agent, that 

eliminates or reduces the number of pathogenic microorganisms on or in a product to 

make the product safe for human consumption. Examples of lethality treatments are 

cooking or the application of an antimicrobial agent or process that eliminates or reduces

pathogenic microorganisms. 

Post-lethality exposed product. Ready-to-eat product that comes into direct contact 

with a food contact surface after the lethality treatment in a post-lethality processing 

environment. 

Post-lethality processing environment. The area of an establishment into which 

product is routed after having been subjected to an initial lethality treatment. The product 

may be exposed to the environment in this area as a result of slicing, peeling, rebagging, cooling semi-permeable encased product with a brine solution, or other

procedures. 

Post-lethality treatment. A lethality treatment that is applied or is effective after postlethality exposure. It is applied to the final product or sealed package of product in order 

to reduce or eliminate the level of pathogens resulting from contamination from postlethality exposure. 

Prerequisite program. A procedure or set of procedures that is designed to provide 

basic environmental or operating conditions necessary for the production of safe, 

wholesome food. It is called “prerequisite'' because it is considered by scientific experts 

to be prerequisite to a HACCP plan. 

Ready-to-eat (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. 

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RTE product is not required to bear a safe-handling instruction (as required for non-RTE 

products by 9 CFR 317.2(l) and 381.125(b)) or other labeling that directs that the product

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

products. 

9 CFR 430.4, Control of Listeria monocytogenes in post-lethality exposed readyto-eat products. 

(a) Listeria monocytogenes can contaminate RTE products that are exposed to the 

environment after they have undergone a lethality treatment. L. monocytogenes is a 

hazard that an establishment producing post-lethality exposed RTE products must 

control through its HACCP plan or prevent in the processing environment through a

Sanitation SOP or other prerequisite program. RTE product is adulterated if it contains L. 

monocytogenes or if it comes into direct contact with a food contact surface which is 

contaminated with L. monocytogenes. 

(b) In order to maintain the sanitary conditions necessary to meet this requirement, an 

establishment producing post-lethality exposed RTE product must comply with the

requirements included in one of the three following alternatives: 

(1) Alternative 1. Use of a post-lethality treatment (which may be an antimicrobial 

agent) that reduces or eliminates microorganisms on the product and an antimicrobial 

agent or process that suppresses or limits the growth of L. monocytogenes. If an 

establishment chooses this alternative: 

(i) The post-lethality treatment must be included in the establishment's HACCP 

plan. The antimicrobial agent or process used to suppress or limit the growth of the 

pathogen must be included in either the establishment's HACCP plan or its Sanitation

SOP or other prerequisite program. 

(ii) The establishment must validate the effectiveness of the post-lethality 

treatment incorporated in its HACCP plan in accordance with Sec. 417.4. The 

establishment must document, either in its HACCP plan or in its Sanitation SOP or other

prerequisite program, that the antimicrobial agent or process, as used, is effective in 

suppressing or limiting growth of L. monocytogenes. 

(2) Alternative 2. Use of either a post-lethality treatment (which may be an 

antimicrobial agent) that reduces or eliminates microorganisms on the product or an 

antimicrobial agent or process that suppresses or limits growth of L. monocytogenes. If 

an establishment chooses this alternative: 

(i) The post-lethality treatment must be included in the establishment's 

HACCP plan. The antimicrobial agent or process used to suppress or limit growth of the 

pathogen must be included in either the establishment's HACCP plan or its Sanitation

SOP or other prerequisite program. 

(ii) The establishment must validate the effectiveness of a post-lethality 

treatment incorporated in its HACCP plan in accordance with Sec. 417.4. The 

establishment must document in its HACCP plan or in its Sanitation SOP or other

prerequisite program that the antimicrobial agent or process, as used, is effective in 

suppressing or limiting growth of L. monocytogenes. 

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(iii) If an establishment chooses this alternative and chooses to use only an

antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes, 

its sanitation program must: 

(A) Provide for testing of food contact surfaces in the post-lethality 

processing environment to ensure that the surfaces are sanitary and free of L. 

monocytogenes or of an indicator organism; 

(B) Identify the conditions under which the establishment will implement 

hold-and-test procedures following a positive test of a food-contact surface for L. 

monocytogenes or an indicator organism; 

(C) State the frequency with which testing will be done; 

(D) Identify the size and location of the sites that will be sampled; and 

(E) Include an explanation of why the testing frequency is sufficient to 

ensure that effective control of L. monocytogenes or of indicator organisms is 

maintained. 

(iv) An establishment that chooses this alternative and uses a post-lethality 

treatment of product will likely be subject to more frequent verification testing by FSIS

than if it had chosen Alternative 1. An establishment that chooses this alternative and 

uses an antimicrobial agent or process that suppresses or limits the growth of L. 

monocytogenes will likely be subject to more frequent FSIS verification testing than if it 

uses a post-lethality treatment. 

(3) Alternative 3. Use of sanitation measures only. 

(i) If an establishment chooses this alternative, its sanitation program must: 

(A) Provide for testing of food contact surfaces in the post-lethality processing

environment to ensure that the surfaces are sanitary and free of L. monocytogenes or of 

an indicator organism; 

(B) Identify the conditions under which the establishment will implement holdand-test procedures following a positive test of a food-contact surface for L. 

monocytogenes or an indicator organism; 

(C) State the frequency with which testing will be done; 

(D) Identify the size and location of the sites that will be sampled; and 

(E) Include an explanation of why the testing frequency is sufficient to ensure 

that effective control of L. monocytogenes or of indicator organisms is maintained. 

(ii) An establishment producing a deli product or a hotdog product, in addition to 

meeting the requirements of paragraph (b)(3)(i) of this section, must meet the following

requirements: 

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(A) The establishment must verify that the corrective actions that it takes with 

respect to sanitation after an initial positive test for L. monocytogenes or an indicator 

organism on a food contact surface in the post-lethality processing environment are 

effective by conducting follow-up testing that includes a targeted test of the specific site 

on the food contact surface area that is the most likely source of contamination by the 

organism and such additional tests in the surrounding food contact surface area as are 

necessary to ensure the effectiveness of the corrective actions. 

(B) During this follow-up testing, if the establishment obtains a second positive 

test for L. monocytogenes or an indicator organism, the establishment must hold lots of 

product that may have become contaminated by contact with the food contact surface 

until the establishment corrects the problem indicated by the test result. 

(C) Further, in order to be able to release into commerce the lots of product that 

may have become contaminated with L. monocytogenes, the establishment must 

sample and test the lots for L. monocytogenes or an indicator organism using a sampling 

method and frequency that will provide a level of statistical confidence that ensures that

each lot is not adulterated with L. monocytogenes. The establishment must document 

the results of this testing. Alternatively, the establishment may rework the held product 

using a process that is destructive of L. monocytogenes or the indicator organism. 

(iii) An establishment that chooses Alternative 3 is likely to be subject to more 

frequent verification testing by FSIS than an establishment that has chosen Alternative 1

or 2. An establishment that chooses Alternative 3 and that produces deli meat or hotdog 

products is likely to be subject to more frequent verification testing than one that does 

not produce such products. 

(c) For all three alternatives in paragraph (b): 

(1) Establishments may use verification testing that includes tests for L. 

monocytogenes or an indicator organism, such as Listeria species, to verify the 

effectiveness of their sanitation procedures in the post-lethality processing environment. 

(2) Sanitation measures for controlling L. monocytogenes and procedures for 

antimicrobial agents or processes that suppress or limit the growth of the pathogen may 

be incorporated either in the establishment's HACCP plan or in its Sanitation SOP or 

other prerequisite program. When these control procedures are incorporated into the 

Sanitation SOP or prerequisite program, and not as a CCP in the HACCP plan, the

establishment must have documentation that supports the decision in its hazard analysis 

that L. monocytogenes is not a hazard that is reasonably likely to occur. 

(3) The establishment must maintain sanitation in the post-lethality processing 

environment in accordance with §416. 

(4) If L. monocytogenes control measures are included in the HACCP plan, the 

establishment must validate and verify the effectiveness of measures for controlling L. 

monocytogenes included in its HACCP plan in accordance with §417.4. 

(5) If L. monocytogenes control measures are included in the Sanitation SOP, the 

effectiveness of the measures must be evaluated in accordance with §416.14. 

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(6) If the measures for addressing L. monocytogenes are addressed in a 

prerequisite program other than the Sanitation SOP, the establishment must include the

program and the results produced by the program in the documentation that the 

establishment is required to maintain under 9 CFR 417.5. 

(7) The establishment must make the verification results that demonstrate the 

effectiveness of the measures it employs, whether under its HACCP plan or its

Sanitation SOP or other prerequisite program, available upon request to FSIS inspection 

personnel. 

(d) An establishment that produces post-lethality exposed RTE product shall provide 

FSIS, at least annually, or more often, as determined by the Administrator, with 

estimates of annual production volume and related information for the types of meat and 

poultry products processed under each of the alternatives in paragraph (b) of this

section. 

(e) An establishment that controls L. monocytogenes by using a post-lethality 

treatment or an antimicrobial agent or process that eliminates or reduces, or suppresses 

or limits the growth of the organism may declare this fact on the product label provided

that the establishment has validated the claim. 

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