Sampling RTE Product

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SAMPLING RTE PRODUCT

Objectives

After completion of this module, the participant will be able to:

1. Identify the pathogens of concern associated with sampling of ready-to-eat 

(RTE) product.

2. Describe the conditions for RTE product to be considered adulterated.

3. Define the following terms:

a. Food contact surface

b. Intact package

c. Sampled lot

4. Describe the steps for performing a RTE sampling task.

5. Explain the difference between the RTEPROD_RAND and the

RTEPROD_RISK sampling project codes.

6. Explain what IPP should consider when scheduling RTE samples.

7. Describe why it is important to notify establishment management prior taking

a sample.

8. Explain how FSIS samples are documented.

9. Describe the process for ensuring sample integrity, from sample collection

until sample is shipped. 

10.List the items that are packed into the sample container.

11.Identify how IPP obtain sample results.

12.Describe what actions IPP take when a positive FSIS RTE sample result is 

identified.

13.Describe the actions IPP take when establishment testing obtains a positive

sample result.

14.Explain the procedures in verifying corrective actions for a positive RTE

sample.

15.Identify the two sampling programs that EIAOs may perform in RTE 

establishments.

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Introduction

FSIS’s microbiological testing program is designed to verify that the

establishment’s food safety system is effective and that FSIS performance

standards and regulations are met. FSIS tests RTE products for pathogens 

because of the potential public health impact of a breakdown in the

establishment’s food safety system. The pathogens of public health concern in

RTE products are Listeria monocytogenes (Lm) and Salmonella. Therefore, RTE 

product samples are tested for both of these organisms by FSIS laboratories. 

Salmonella is generally associated with under-processing or cross-contamination

post-processing while Lm is more often associated with cross-contamination

post-processing. RTE product is adulterated if it contains Lm, Salmonella, or any

pathogen known to cause illness including E. coli O157:H7, or if it comes into

direct contact with a food contact surface contaminated with Lm. 

Note that FSIS is continuously updating its sampling programs in order to keep

pace with changes in policy. FSIS directives and notices for current sampling

programs contain specific instructions to follow. It is important to read recent

issuances, so that when you are requested to collect a sample you have

the latest information. See Attachment 1 for a list of relevant FSIS Directives.

Definitions 

Aseptic means, “free from pathogenic organisms.” Aseptic technique implies that 

IPP do not add any organisms (pathogenic or not) to the sample when it is 

collected. It does not imply that the sample is aseptic. The purpose of aseptically

collecting a sample is to prevent contaminating the sample or the surrounding

product/product contact area. That is why it is important to aseptically collect a

sample even when the sample is intact. IPP should wash and sanitize their

hands before collecting an intact sample, but it is not necessary to sanitize the

area and put on gloves. Good personal hygiene is essential anytime a sample is 

collected, whether intact or not.

Environmental samples are samples from surfaces that have:

 Indirect or potential contact with exposed RTE product in the RTE 

production area (mop handles, outer garments, etc., that may be

handled by a person who may touch RTE product), or

 Non-contact surfaces in a RTE production area (e.g., floors, drains, 

walls, overhead structures).

Food contact surface is specific to the RTE verification testing program. A food

contact surface is the equipment or utensil surface with which exposed RTE

product has direct contact (for example, conveyor belt, tabletop, knife blade). A

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food contact surface does not include items that may have indirect or potential 

contact with exposed RTE product.

Food contact surface samples are a collection of samples (e.g., swabs) from 

food contact surfaces that represent the conditions under which the sampled lot 

was processed. The samples are usually collected during the production shift, 

not pre-operational, but without disrupting production, such as during breaks and

at the end of a shift.

Intact means product in the final packaged form (immediate container) in which it 

will be shipped. The lab receives the sample in the same immediate container as 

intended for the consumer.

Recall is an establishment’s voluntary removal of distributed meat or poultry

products from commerce when there is reason to believe that such products are 

adulterated or misbranded under the provisions of the Federal Meat Inspection

Act (FMIA) or the Poultry Products Inspection Act (PPIA). Product that is 

adulterated and has left the establishment’s control may be subject to a recall. 

The recall would involve at least the sampled lot, but it could be expanded

depending upon a review by the Recall Management Division (RMD) of all

factors in the situation. FSIS Directive 8080.1 gives additional details on recalls.

RTE production area is one where exposed RTE products are stored, further 

processed, or packaged. This is the area from which food contact surface

samples and environmental samples are taken and analyzed for Lm or indicator 

organisms.

Sample is a collection of product that represents a larger group of product (i.e.,

the sampled lot). 

Sampled lot is the amount of product represented by the sample. For microbial 

issues, the actual (affected) product represented by the sample is usually

interpreted as the product produced from clean-up to clean-up. Often, factors like 

the establishment’s coding system, the pathogen of concern, the processing and 

packaging, the equipment, the establishment’s sampling programs, the HACCP

plan monitoring and verification activities, the SSOP records, etc., are considered

when determining how much product is actually represented by the sample. 

Short-weight or slack-filled containers meet the definition of an intact sample, 

but with less product (e.g., a liner from a bulk package which contains 

approximately 2-lb of product, folded down and sealed in the same manner that

the bulk product is normally packed to prevent product contamination). A shortweight or slack-filled sample is one that has progressed through all the

production steps that the product normally goes through (not changed in any way

that would affect the processing parameters). A short-weight or slack-filled

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sample may appear to the lab as a non-intact sample and may be discarded if 

PHIS information does not indicate it is short-weight or slack-filled.

Subsequent production is all product produced after the sampled lot. It is not 

usually part of the sampled lot, but it may or may not be affected product.

Sample Initiation

PHIS will display any RTE sampling tasks on the Task List based on the

sampling programs for which the establishment is eligible. These PHIS

generated requests are called “directed” sampling tasks. There are no “collector 

generated” sample requests for RTE product sampling. However, if IPP have

concerns about the product or process they may follow their supervisory chain of

command to request additional “directed” samples. IPP are to provide information

on the type of sample to be collected and a justification for the sample collection

request. If additional sampling is justified, the district office will contact DAIG to

request that the tasks be generated through PHIS as a directed sample task. 

Once the additional directed sampling tasks appear on the establishment’s task 

list, IPP may then schedule them.

Steps in Sampling

There are 6 general steps in sampling RTE product.

1. Determine which product to sample and schedule the sample

2. Notify establishment management

3. Collect the sample

4. Document the Sample

5. Pack and ship the sample and form

6. Respond to the results

Step 1: Determine which product to sample and schedule the sample

IPP collect RTE product samples under the following project codes:

RTEPROD_RAND: For this sample program, IPP will randomly select any RTE

product produced at the time of collection, regardless of whether the product has 

been exposed post-lethality; and make every effort to randomly sample all the

RTE products produced at the establishment by rotating through the products 

over time (i.e., through subsequent sample requests).

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HACCP Processing Finished Prod uct Production Volume Categories Risk 

Cateqories Cateqories (by Product Groups) Level 

Other Fully Cooked Sliced 1 Product 

Hot Ooq Products 2 

RTE fu lly-cooked meat Salad/Spread/Pate 3 

Fully Cooked-Not Shelf (PLE}1/ RTE fully-cooked Diced/Shredded 4 

Stable poultry (PLE) Meat+ Nonmeat Components 5 

Sausage Products 6 

Patties/Nuggets 7 

Other Fully Cooked Not Sliced 8 Product 

RTE acidified/fermented RTE fermented meat (sliced or 

meat (without cooking}-- not sliced)/ RTE fermented 

PLE/ RTE poultry (sliced or not sliced) 9 

Not Heat Treated-Shelf 

acidified/fermented poulltry (Acidifi ed/Fermented 

(without cooking)-PLE Products)2 

Stable/Heat Treated-Shelf RTE dried meat (sliced or not 

Stable RTE dried meat (PUE}/ sliced)/RTE dried poultry 

RTE dried poultry (PLE} (sliced or not sliced} 10 

(Dried Products) 2 

RTE salt-cured meat RTE salt-cured meat (sliced or 

(PLE)/ RTE satt cured not sliced)/ RTE salt-cured 11 

poultry (sliced or not sliced) poultry (PLE) (Salt-cured Products) 2 

Product with Secondary RTE salt-cured meat RTE salt-cured meat (sliced or 

Inhibitors - Not Shelf (PLE)/ RTE salt cured not sliced)/ RTE salt-cured 11 Stable poultry (sliced or not sliced} poultry (PLE) (Salt-cured Products) 2 

,, Post-lethality exposed product. 2 Product type to be used on Form 10,210-3. 

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RTEPROD_RISK: For this sample program, IPP are to select a post-lethalityexposed product from the highest risk level, according to the table below.

Exceptions: Do not collect samples of oils, shortening, lard, margarine, 

oleomargarine, or mixtures of rendered animal fats that are Ready-to-Eat (RTE)

because there is no validated test method for detecting Lm in these products.

FSIS will sample popped pork skins, pork rinds, dried soup bases, concentrated

(high salt content) soup mixes, and pickled pig’s feet under both programs. FSIS

will collect samples of RTE products that are shipped hot from the establishment.

When IPP receive an RTEPROD_RAND or RTEPROD_RISK request in PHIS, 

they are to schedule an RTE product sample within the sampling window

timeframes given. IPP are to randomly select a day, shift, and time within the

sample window timeframe. There should be an equal chance that sampling will 

occur during any shift where eligible product is produced. IPP should not wait 

until the end of the sampling window to schedule the sample. Scheduling the

sample at the beginning of the sampling window will allow more time to ensure 

that a sample is available during that timeframe.

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Step 2: Notify Establishment Management

Before collecting a sample, IPP are to officially notify the establishment 

management that they will be collecting a sample and to explain the reason that 

they are collecting the sample.

When notifying the establishment that FSIS will collect a sample, IPP are to

confirm that the establishment will be producing post-lethality exposed RTE

product (RTEPROD_RISK) or RTE product (RTEPROD_RAND) on the day

sampling is scheduled. In addition, IPP are to confirm that the establishment is 

planning to implement its documented routine production, Sanitation SOP, and

food-safety practices on the day the sample is scheduled.

IPP are to generally provide a one day advance notice if that is sufficient for the

establishment to hold the sampled lot but not to change practices. IPP may

provide more advance notice if the establishment can support that more time is 

necessary because of the innate characteristics of the process. IPP should

inform the establishment that, if it changes routine practices without justification

for doing so, FSIS may provide it with less than a one day notice if that is 

sufficient to hold the sampled lot. If IPP have questions about an establishment’s 

basis for requesting more notice, they are to submit them through askFSIS.

IPP should inform the establishment that, if it intends to modify its documented

routine production, sanitation, or food-safety practices before the sampling, it 

should inform IPP as soon as possible so that sampling can be rescheduled. If

the establishment continues to change routine practices and cannot support the

changes, less than one day advance notice may be provided, or an FSA may be

scheduled at the establishment.

NOTE: Justifiable reasons for changing practices may include limiting the lot size

to facilitate holding the product, changes in customer orders, or documented

changes to Sanitation SOPs or HACCP plans.

IPP should inform the establishment that it is responsible for supporting its basis 

for defining the product represented by the sample (i.e., the sampled lot); and

inform the establishment that it is required to hold or control the sampled lot until 

negative results are received. IPP will verify that the establishment is holding or 

controlling the product represented by the sampled lot (the product produced

from clean-up to clean-up) and record the information in PHIS. Immediately

contact the DO if the establishment does not hold or maintain control the

sampled lot.

Step 3: Collect the Sample

IPP will collect the sample from the current day’s production after the

establishment has applied all interventions except any microbiological testing

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intervention. If the establishment intends to test the product for Lm or Salmonella, 

IPP are not to wait for the establishment to receive the test results.

For both RTEPROD_RAND and RTEPROD_RISK samples, IPP are to collect a

two-pound sample of product in an intact package. Collecting products in the

intact package will help to ensure that the product does not become

contaminated with Lm from the environment during the sample collection

process. If packages weigh less than two pounds, IPP are to collect enough

packages to bring the total to a minimum of two pounds.

IPP are to collect the product at least three hours after the start of production (if

possible), to allow Lm to work its way out of the equipment. If the establishment’s 

production lot is typically less than three hours, IPP may collect the samples 

during the production shift. IPP are to vary the shifts in which they collect 

samples, if possible. 

If the establishment produces reworked product, IPP are to sample the product 

as part of the production lot, as long as IPP provide the establishment with

adequate notice to hold the sample. Rework is the process of re-cooking, 

reprocessing, or repackaging the product. FSIS considers any process that

removes the product from the package and exposes it to the environment as 

rework.

If the finished product contains meat or poultry and non-meat or non-poultry

ingredients, IPP are to follow the instructions below.

 If the meat or poultry and non-meat or poultry ingredients are commingled

(in contact) in the final package (e.g., a salad with meat or poultry mixed

in), IPP are to collect a two-pound sample of the complete product 

(including the meat or poultry and nonmeat or poultry component).

 If the meat and nonmeat ingredients are not commingled (not in contact) 

in the final package (e.g., an entree with separate compartments for meat 

or poultry and vegetables), then IPP are to collect a two-pound sample of

the meat or poultry component in the final package.

IPP are to submit the samples to the laboratory for microbiological analysis in 

intact packages. The laboratory does not supply sterile bags or gloves for 

sampling because IPP are not to have direct contact with the exposed, 

unpackaged RTE product. This is because Listeria may be present in the

environment and could be transferred to the product if exposed RTE product is 

collected.

If an intact product or product container is too large, heavy, or costly to ship to

the laboratory, IPP can ask the establishment to slack-fill or short-weight a

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product for a 2-pound sample and send it in the usual establishment packaging

such as the container liner.

If the slack-filled or intact package is an unsealed bag, IPP are to tie it off (e.g.,

twist tie or rubber band) so smaller particles (e.g., shredded meat pieces) do not 

spill into the shipping container. IPP are to place the slack-filled package in a

secondary bag. The laboratory will discard the sample if it contains spilled or 

leaking products. When IPP document the sampling task in PHIS, under the

“Additional Info” tab, they are to click “yes” to the question “Is this sample shortweighted/slack-filled?” to ensure that the sample is not discarded as a non-intact

sample by the laboratory.

IPP are not to use any laboratory-supplied bag as the primary wrap for the

sample. Laboratory supplied bags provided by the laboratory are for secondary

containment only because they are not sterile. The laboratory-supplied bag

protects the box in case the primary container leaks.

If IPP cannot collect an intact short-weighted or slack-filled sample, and the

establishment is not producing any other type of RTE product that the IPP could

collect, IPP are to contact the designated laboratory to discuss other options for 

collecting the sample.

NOTE: Examples of inappropriate samples for short-weight or slack-filled

samples include a sample that would have to be cut to fit inside the shipping

container, and samples that are packed in a waxed box without a liner bag that is 

too large to fit inside a laboratory shipping box.

When a sample cannot be collected on the date originally scheduled, inspectors

should follow instructions specific to rescheduling lab sampling tasks in PHIS.

When sample collection cannot be rescheduled for any date within the requested

time frame, IPP should cancel the sample request within PHIS and provide a

justification as to why the sampling could not be performed.

Intervention Considerations

If the establishment treats the product with an intervention (e.g., HPP), either at 

the establishment or at another establishment, IPP are to review documentation

the establishment keeps as part of its HACCP program to determine the purpose

of the treatment.

If the HPP is applied as a Listeria intervention, and the establishment has 

supporting documentation demonstrating that the treatment achieves at least a 1-

log reduction of Lm, IPP are to collect the sample after the treatment is applied. If

the product is not returned to the producing establishment after the HPP

treatment, IPP are to sample another product, if possible. The product, in this

case, would be subject to sampling at the HPP facility if records show that the

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treatment was applied as a Listeria intervention. If the establishment is not

producing any other RTE product at the time the sampling is scheduled, IPP are

to cancel the task and enter into PHIS “all interventions have not been applied at 

this establishment.” 

NOTE: If the establishment’s validation supports that the HPP treatment 

achieves at least a 5-log reduction of Lm, the product is not considered postlethality exposed and would only be sampled under the RTEPROD_RAND

project code.

If the treatment is applied to extend the shelf life of the product, and the

establishment does not have supporting documentation describing the treatment 

as a Listeria intervention, then IPP are to collect the product before the

treatment. The product would not be subject to sampling at the HPP facility, as 

long as it has records on file supporting that the treatment was applied to extend

the shelf life.

Altered Practices

On the day of sample collection, if IPP find that the establishment has altered its 

documented routine production, sanitation, or food-safety practices, and the

establishment cannot provide a supportable rationale, IPP are not to perform

sampling and are to reschedule if possible.

IPP are to issue an NR under the following circumstances:

 If IPP find that the establishment has made changes in its food safety

systems (e.g., temporarily changing its supplier of RTE product on the day

the sample is collected) and does not have documents supporting the

appropriateness of the change, IPP are to issue an NR. The NR would be

issued because the establishment did not consider the changes in its

hazard analysis in accordance with 9 CFR 417.2(a) (1), or did not support 

the changes to its hazard analysis as in 9 CFR 417.5(a) (1).

 Likewise, if IPP find that the establishment has made changes in its

sanitation practices (e.g., temporarily increasing the use of sanitizer only

on the day the sampling is scheduled) and did not revise its Sanitation

SOP to reflect these changes, IPP are to issue an NR under 9 CFR

416.14.

NOTE: If an establishment decides to limit its product lot size solely to facilitate

holding the product during sampling, it would not be considered to have

significantly altered its production practices, as long as IPP can collect samples 

that accurately represent routine production. If IPP have questions about whether 

an establishment is altering routine production, sanitation, or food-safety

practices, they can submit them through askFSIS.

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At the next weekly meeting, IPP are to discuss the altered food safety practices 

with the establishment. Inform the establishment that if it continues to change its 

practices, FSIS may collect more samples and may give less than 1 day notice (if

less time is enough to hold the sampled lot) or schedule a “for-cause” FSA. 

Step 4: Document the Sample in PHIS

On the day of sample collection, IPP will enter sample collection data and

additional product info in PHIS as directed in PHIS Directive 13,000.2. IPP are to

complete a questionnaire in PHIS for each RTEPROD sample request and are to

ensure that all requested information is entered completely and accurately.

IPP must answer the questionnaire in PHIS before submitting the sample. The

questionnaire includes:

1. Selection of the appropriate RTE product type. 

2. Amount of pounds represented in the sample. This is based on what the

establishment declared the sample lot to be.

3. Is the product post lethality exposed? If yes then the IPP must answer 3a, 

which asks for the Alternative the product was processed under. If no then

PHIS will forward to question 4.

4. Identify the production line the sample was taken from. If the

establishment has only one line mark N/A.

5. Enter the time the collection was made in military format.

6. Enter the contact person for the establishment.

7. Enter the contact phone number for the contact.

8. Answer yes or no, whether establishment management was notified of this 

sample collection.

9. Indicate if the sample was short weighted or slack filled. This will prevent 

the laboratory from discarding the sample because it is not in the final 

retail package.

10.Answer where the sampled lot is being held or controlled.

When IPP are certain that the correct information has been entered in PHIS, they

must submit both the questionnaire and the Sample Analysis Request 

Form electronically to the laboratory. Then IPP will print and sign the form and

include it with the sample in the sample shipment container. If the lab receives a

sample with missing or incomplete paperwork the sample will be discarded.

Step 5: Pack and Ship the Sample and Form

Identify the sample and paperwork, and place them into the bag provided 

by the lab. Double check and compare the address on the FedEx expanded

billable stamp to make sure it is going to the lab indicated in PHIS and on the

Sample Analysis Request Form. The lab will discard the sample if shipped to the

wrong lab. Also be sure to check the expiration date on the expanded billable

stamp. Do not use an expired expanded billable stamp.

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IPP are to safeguard the integrity of samples during submission according to

FSIS Directive 7355.1, Use of Sample Seals for Laboratory Samples and Other 

Applications. Place one of the small bar code stickers from the 7 part sample 

seal set (7355-2A/B) on the sample package, and another on the Sample 

Analysis Request Form. Put the Sample Analysis Request Form in a plastic bag

or sleeve to protect it. Put the sample and the form into a zip-lock bag, and attach

the Identification Label, 7355-2B, to the zip-lock bag so that the bar code is 

readable.

Pack the sample. Samples should be shipped in FSIS-furnished containers, 

unless special arrangements are made with the lab. Pack one sample per prechilled shipping container to avoid confusion. Multiple samples can be sent in

one container, as long as each sample is accompanied by its sample form and

there are no concerns over maintaining product temperature. In cases where 

multiple product packages are necessary for a single sample, all of them must be

shipped in the same shipment container. Pack the sample in this order.

1. Absorbent pad

2. Gel pack

3. Cardboard separator

4. Zip-lock bag containing the identified sample and paperwork

5. Extra small bar code sticker that was not used

6. Foam plug

7. Close shipper with Container Seal (7355-2A)

NOTE: The shipping containers should have the top and bottom sealed by the

lab with tamper-evident tape. IPP will not receive any tamper-evident tape to

use. If the tape is cut or missing, do not open the container. Follow the

instructions in FSIS Directive 7355.1 (seal it with the Container Seal, 7355-2A, 

and ship it back to the lab of origin for processing; complete the seal by writing

“seal broken” in the “Form No.” blank). 

The absorbent pad is placed in the bottom of the shipping container. Its purpose

is to absorb any fluid that may leak into the box in order to maintain the integrity

of the shipping container for future use. A frozen freeze pack must be added for 

product that was stored refrigerated or frozen. The cardboard separator goes on

top of the freeze pack to separate the freeze pack from the sample. The bagged

sample is then put into the shipper. Do not use filler material in the shipping

container. Any unused bar code sticker needs to go into the shipper with the

sample. This insures that it won’t accidentally get used on another sample, and

allows the lab to account for all 7 parts of the seal/label. Alternatively, the unused

bar code may be retained with the file record of sample collection. The foam plug

must be pushed down as far as possible to keep the sample from being tumbled

inside the shipper.

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An FSIS Laboratory Sample Container Seal (FSIS Form 7355-2A) must be put

on the shipping container in such a way that it cannot be opened without

disturbing the seal. 

Ship the sample. IPP are to ship samples Monday through Friday so that they

arrive at the laboratory overnight. IPP are not to ship samples on Saturdays or on

the day before a Federal holiday, or as directed by a user notice via e-mail.

Step 6: Respond to Results

IPP will access LIMS-Direct to track sample receipt and for detailed information

on FSIS sample results or discards. LIMS stands for Laboratory Information

Management System. LIMS-Direct is a program that reports FSIS lab sample

results directly from LIMS. It will provide close to real-time sample data

electronically to FSIS program personnel, Federal, and State establishments (via 

email), and State officials, if FSIS laboratories conduct testing for States. LIMSDirect will be updated every 15 minutes and display sample data history longer 

than the last 90 days of data. If, in limited cases, LIMS does not receive an

electronic record from the Public Health Information System (PHIS) because of 

technical reasons, sample results will still be available in LIMS-Direct.

When IPP go to the LIMS-Direct address, several options are available.

1. Single Sample Results – search using the form number.

2. Single Establishment Results – search using the establishment number to

obtain all the results in the database for that establishment.

3. Results for All Establishments in a Circuit – search by entering the circuit 

number.

4. Results for State Inspection Sample – search using the state code.

5. Samples Not Analyzed for All Establishments in a Circuit – search using

the circuit number.

6. More Reports – search for more types of reports that are available. 

Option 3 is particularly useful if it is a patrol assignment, since one can see the

status of the samples of all the establishments at one time. 

Once the analyses are complete, the results are posted in the results column.

IPP should provide sample result information to establishment management even

if the establishment receives e-mail notifications automatically. 

Sampling Project Positive Results 

If any RTE product sample collected by IPP under the RTEPROD_RAND or 

RTEPROD_RISK sampling projects tests positive for Lm or Salmonella, product 

in the sampled lot is adulterated. 

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IPP are to follow the instructions in FSIS PHIS Directive 5000.1 when taking

enforcement actions in response to positive sampling results. In addition, IPP are 

to consider the following:

 If FSIS finds the product positive, and the establishment tested the

product under its documented sampling programs, IPP are to check the

establishment’s Salmonella or Lm testing results to determine whether the

establishment also found the sampled product to be positive for 

Salmonella or Lm.

 IPP are to determine whether the establishment held the product or 

maintained control of the product pending its own test results.

 If IPP find that the establishment did not hold or maintain control of the

product, they are to issue an NR. The NR would be warranted because

the establishment shipped product before FSIS found that the product was 

not adulterated, and because the establishment did not complete preshipment review following availability of all relevant test results, as set out 

in 9 CFR417.5(c).

Generally, if FSIS finds the product positive for Salmonella or Lm, IPP are to

issue an NR (cite 9 CFR 417.4(a)). However, if the establishment also found the

product to be positive for Salmonella or Lm and held the product, IPP are not to

issue an NR. They are to verify that the establishment performs the appropriate

corrective actions, using a directed HACCP Verification Task. 

Establishment Sampling Program Positive Results

Establishments under Alternative 2 Choice 2 and Alternative 3 are required to

conduct sampling of food contact surfaces. Establishments may also choose to

conduct sampling of product. If an establishment’s product or food contact 

surface test result is positive for Lm, IPP should not issue an NR unless the

establishment failed to hold the affected product and did not implement corrective

actions, which includes properly disposing of the sampled product lot. 

An establishment may or may not conduct environmental sampling, other than on 

food contact surfaces, under its HACCP plan or Sanitation SOPs or other 

prerequisite program. If the establishment is conducting such sampling, and

positive results are received, IPP are to verify that the establishment takes the

appropriate action as outlined in the program under which the establishment did 

the sampling. If the establishment is conducting such sampling but is not 

addressing the sampling under HACCP or Sanitation SOPs or other prerequisite

programs, and IPP find that such sampling is resulting in repetitive positive

results, IPP are to notify the district office through supervisory channels. 

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Verifying Corrective Actions

If FSIS finds a product or food contact surface positive for Lm or Salmonella, IPP

are to verify that the establishment takes the appropriate corrective actions by

performing a directed HACCP Verification Task.

When performing a directed HACCP Verification Task in response to a Lm

positive result, IPP are to review the same information they review during a

routine HACCP Verification Task. IPP are also to verify that the establishment 

implemented corrective actions according to 9 CFR 417.3 (a) and (b) if the

measures for addressing Lm are included in the HACCP plan or prerequisite

program, or 9 CFR 416.15 if the measures are incorporated in the Sanitation

SOP. FSIS will also perform an IVT/FSA for Lm, as described in FSIS Directive

10,300.1.

When performing a directed HACCP Verification Task in response to a

Salmonella positive result, IPP are to verify that the establishment took the

appropriate corrective actions according to 9 CFR 417.3(a) or (b), or 9 CFR

416.15. Although the regulations do not require establishments to specifically

control for Salmonella in post-lethality exposed RTE products, as stated

previously, FSIS considers RTE products to be adulterated if products or food

contact surfaces test positive for Salmonella or other pathogens. Therefore,

establishments are required to take corrective actions in response to positive

results and to reassess their HACCP plan. FSIS will perform an IVT/FSA for 

Salmonella, as described in FSIS Directive 10,300.1.

In addition, if FSIS develops a verification plan in response to an establishment’s 

proffered corrective actions and preventive measures when enforcement is 

deferred following the issuance of a Notice of Intended Enforcement (NOIE), or a

suspension is held in abeyance, IPP are to verify that the establishment 

implements its corrective actions, and that the corrective actions are effective.

IPP are to verify that the establishment reassessed its HACCP plan as follows:

 If Lm control is addressed as a CCP in the HACCP plan (e.g., PLT), the

establishment must meet the requirements of 9 CFR 417.3(a), which 

requires that corrective action be taken but does not require reassessment 

of the HACCP plan.

 If Lm is addressed in the Sanitation SOP, then the establishment must 

implement corrective actions in accordance with 9 CFR 417.3(b), which 

includes reassessment of the HACCP plan. In addition, it must implement 

the corrective action requirements for the Sanitation SOP in 9 CFR

416.15, which includes appropriate re-evaluation or modification of the

Sanitation SOP.

Inspection Methods 39-14
 

 

 

 

 

 

for Verifying an Establishment's Corrective Actions 

... 

If there is a 

Listeria postive 

result IPP, are 

to perform a: 

Directed HACCP I 

Verification Task i\ ~ 

'-

If the Listeria 

Control 

Program is 

located in the: 

HACCP Program 

Sanitation SOP 

Prerequisite 

program 

'-

Verify 

corrective 

actions 

according to: 

417.3{a) 

416.15 and 

417.3{b) 

417.3{b) 

--;,-

-

-

'-

Verify HACCP 

Reassessment 

according to: 

Not Required 

9 CFR 417.3{b) 

9 CFR 417.3{b) and 

comply with 

417.4{a){3) 

Sampling RTE Product

11/8/2019

 If Lm is addressed in a prerequisite program (e.g., Listeria Control 

Program) that is used to support the decision that Lm is not a hazard

reasonably likely to occur in the product, then the establishment must 

implement the corrective actions in 9 CFR 417.3(b) and comply with

417.4(a)(3). These regulations state that when there is a change in the

process (e.g., a positive result) that could impact the hazard analysis, a

reassessment must be performed.

The establishment is required under 9 CFR 417.4 (a)(3)(ii) to make a record of

the reassessment and document the reasons for any changes that it made to its 

HACCP plan based on the reassessment, or, if it did not make any changes, to

document the reasons that it did not. 

Verifying Product Disposition

The establishment may reprocess or dispose of adulterated product. If the

establishment reprocesses the product, IPP are to verify that it used a process 

that achieves adequate lethality of pathogens. FSIS considers a process that has 

been validated to achieve a 5-log reduction of Lm sufficient for reworking

contaminated product.

In addition, establishments may use Appendix A and Appendix B of the final rule,

“Performance Standards for the Production of Certain Meat and Poultry

Inspection Methods 39-15
 

 

 

 

 

Sampling RTE Product

11/8/2019

Products,” FSIS Guidance on Safe Cooking of Non-Intact Meat Chops, Roasts,

and Steaks, and the Time-Temperature Tables for Cooking Ready-to-Eat Poultry

Products, or other supportable processes to reprocess Lm-positive product.

NOTE: Appendix A and B, the FSIS Guidance on Safe Cooking of Non-intact 

Meat Chops, Roasts, and Steaks, and the Time-Temperature Tables for Cooking

Ready-to-Eat Poultry Products, are designed to achieve reductions in

Salmonella. Establishments are not expected to validate that these processes

also achieve reductions in Lm because Salmonella is considered an indicator of

lethality for Lm.

If the establishment chooses to dispose of the product, it may do so either on-site

or off-site. If the product is disposed of on-site, IPP are to verify that the

establishment maintained records showing that the positive product received the

proper disposition.

If the establishment transports positive product to another site for appropriate

disposition, IPP are to verify that the establishment has met all corrective action

requirements by verifying that the establishment:

 Maintained records identifying the official establishment, renderer, or

landfill operation that received positive product;

 Maintained control of product that was destined for a landfill operation or 

renderer while the product was in transit (e.g., through company seals);

 Maintained control of product that was destined for an official 

establishment while the product was in transit (e.g., through company

seals) or ensured that such product moved under FSIS control (e.g., under 

USDA seal or accompanied by FSIS Form 7350-1);

 Maintained records showing that positive product received the proper 

disposition, including documentation showing proper disposal of the

product from the official establishment, renderer, or landfill operation

where disposition occurred; and

 Completed pre-shipment review for the positive product only after it has 

received the records described above for that particular product.

If an establishment ships adulterated product to a renderer or landfill operation,

IPP are to verify the establishment denatures the product before the product

leaves the establishment (9 CFR 314). In situations where the establishment has 

not properly moved or disposed of the product, IPP are to notify their DO through

supervisory channels.

Inspection Methods 39-16
 

 

 

 

 

Sampling RTE Product

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If IPP find that there is noncompliance with the corrective action requirements for 

product disposal, they are to document the noncompliance in accordance with

FSIS PHIS Directive 5000.1.

IVT Sampling Program

EIAOs trained in the IVT methodology will collect samples under the Intensified

Verification Testing (IVT) program which involves collecting product, food

contact, and environmental (non-food contact) samples. This sampling is typically

done “for cause” (e.g., positive sample results) under the following sampling

project codes.

1. IVTCONT - the testing of surfaces that have direct contact with RTE product 

in the RTE production area, e.g., conveyor belts, cooler storage racks, luggers, 

slicers, peelers, loaders, table tops. This would also include brine that comes in

contact with product (e.g., product is chilled in a permeable container).

2. IVTPROD – the testing of intact product samples collected concurrently with

food and environmental contact surface swabs throughout the selected

production shift.

3. IVTENV - testing of environmental (non-food contact) surfaces in the RTE

production areas, e.g., floors, drains, walls, air-vents, overhead structures. This 

would include brine that does not contact product directly (e.g., product is chilled

in an impermeable container). 

IVTs are scheduled by the district office within 30 days and completed within 90

days of receiving notification of a positive sample result. IVTs may also be

scheduled due to repetitive occurrences of noncompliance in the establishment’s 

Lm control program, including sanitation issues. IVTs are performed in response

to Salmonella positives as well.

RLm Sampling Program

EIAOs trained in the IVT methodology also collect samples under the Routine

Risk-based Lm (RLm) sampling program when conducting routine FSAs in

establishments that produce RTE products. The RLm testing program consists of

the following sampling project codes:

1. RLMCONT – the routine risk-based testing of surfaces that have direct contact

with RTE product in the RTE production area, e.g., conveyor belts, cooler 

storage racks, luggers, slicers, peelers, loaders, table tops. This would also

include brine that comes in contact with product (e.g., product is chilled in

permeable container).

Inspection Methods 39-17
 

 

 

Sampling RTE Product

11/8/2019

2. RLMENVC – the routine risk-based testing of environmental (non-food

contact) surfaces in the RTE production areas, e.g., floors, drains, walls, airvents, overhead structures. Samples are composited in the lab testing protocol.

3. RLMPRODC – the routine risk-based testing of intact product samples 

collected concurrently with food and environmental contact surface swabs 

throughout the selected production shift. Samples are composited in the lab

testing protocol.

4. RLMENVR – the routine risk-based testing of brine used for chilling RTE

product and the product does not come in contact with the brine (e.g., product is 

chilled in an impermeable container).

RLm sample collection does not take precedence over the other sampling

programs.

RLm Sampling Program Results

IPP may be instructed to document noncompliance at the completion of an FSA

conducted by an EIAO. IPP issues the NR on the determinations of the EIAO’s 

FSA which may include positive sample results from the RTE RLm or IVT 

sampling program. IPP are to issue an NR under the appropriate HACCP

Verification task citing 9 CFR 417.4(a) and 301.2 or 381.1 for positive product or 

food contact surface results. If the determination of the EIAO’s FSA is to

document a noncompliance related to the design or execution of environmental 

sampling, the CSI is to issue an NR under the SPS Verification task and cite 9

CFR 416.4(b).

Inspection Methods 39-18
 

 

 

 

Sampling RTE Product

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Workshop - Sampling RTE Product

1. __________ is a verification activity for RTE products.

a. Enforcement 

b. Sampling

c. Recall

d. Documentation

2. You are assigned to an establishment that produces a variety of ready-to-eat 

(RTE) products including those that are shelf-stable. You receive a directed

sample request for a RTE product (project code RTEPROD_RISK). Which of

the following would you choose based on the risk level?

a. RTE deli-meats that are cooked in an impervious bag and shipped

from the establishment without being removed from the impervious bag

b. RTE deli-meats that are sliced in the federal establishment 

c. Any RTE product as long as it is randomly selected

d. RTE fermented products 

3. Fill in the blank. When you get a directed sample request for RTE product, you

should __________ collect a sample. 

4. FSIS sampling is done to

a. Verify that FSIS performance standards and regulations are met.

b. Validate HACCP plans and compare results to establishment analyses.

c. Generate public support.

d. Monitor in-plant activities.

5. RTE sliced ham is analyzed for: (Circle all that apply)

a. E. coli O157:H7.

b. Salmonella. 

c. L. monocytogenes.

d. Staphylococcus enterotoxin. 

Inspection Methods 39-19
 

 

 

 

 

 

Sampling RTE Product

11/8/2019

6. When an establishment has a sanitation program that includes sampling RTE

product as part of the HACCP plan, you do not have to collect RTE samples.

a. True

b. False

7. When an establishment has a sanitation program that includes sampling RTE

product as part of the HACCP plan, and they receive a positive for L. 

monocytogenes, what actions would we expect them to do? (Circle all that

apply)

a. Hold the affected product

b. Implement corrective actions per §417.3(a)

c. Make appropriate disposition of the sampled product

d. Notify the IIC

8. When an establishment has a sanitation program that includes sampling RTE

product contact surfaces as part of the SSOP program, and they receive a

positive for L. monocytogenes, what actions would we expect them to do?

(Circle all that apply)

a. Hold the affected product

b. Implement corrective actions per §417.3 & 416.15

c. Make appropriate disposition of the affected product

d. Notify the IIC

9. Under what circumstance might the DO schedule Intensified Verification

Testing (IVT)? What would be the purpose?

10. When should a RTE product sample be sent to the lab for a L.

monocytogenes directed sample?

a. The day before the “use by” date

b. Just prior to packaging

c. The first day pickup for shipment is available after sample collection

d. As soon as the lot is assembled

Inspection Methods 39-20
 

 

 

Sampling RTE Product

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11. Establishment management must be notified of pending sample collection

a. When you receive the analysis result.

b. After pre-shipment review has been completed.

c. Enough in advance to allow the establishment to hold the product, but 

not soon enough to allow it to alter the process.

d. Because of the Freedom of Information Act (FOIA).

12. If a sample is too large for the shipping container, you

a. Have the establishment use a different package to enclose the product.

b. Contact the FSIS lab for a larger shipping container.

c. Select a different product produced under the same HACCP plan.

d. Contact the DO.

13. An establishment produces fully cooked, not shelf stable ham. This product

is produced using Alternative 2, Choice 1. The establishment performs a

post-lethality treatment on the hams immediately following packaging. As a

verification activity for the post-lethality treatment, it samples the hams for 

Lm, and holds product pending results. This morning, the establishment 

received a positive result for Lm from one of its samples. Based on the

information presented so far, answer the following questions.

a. Which corrective action regulation would apply in this situation?

b. What would you verify in this case? List all that apply. 

c. Would you issue an NR?

d. Would FSIS request a recall?

Inspection Methods 39-21
 

 

Sampling RTE Product

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Continuing with the above situation, while you are reviewing the

establishment’s corrective action documentation, you observe “The product

represented by the sample will be relabeled as not fully cooked. The future 

production of these products will be as heat-treated, not fully cooked. The

HACCP plan will be reassessed and modified to change the cooking

temperature. The label will be changed to include cooking instructions.”

e. What would you do next?

Inspection Methods 39-22
 

 

 

 

 

 

Sampling RTE Product

11/8/2019

ATTACHMENT 1

Resources

Currently, there are several directives and notices associated with microbial 

sampling of RTE products. IPP should review the pertinent directives prior to

obtaining a sample. The review should consist of checking to see if the directive

is the current version. The FSIS website lists those directives that have been

published most recently. 

Number Title

5000.1 Verifying an Establishment’s Food Safety System

7355.1 Use of Sample Seals for Laboratory Samples and Other Applications

8080.1 Recall of Meat and Poultry Products

10,200.1 Accessing Laboratory Sample Information via LEARN (to be revised for 

LIMS-Direct)

10,210.1 Unified Sampling Form

10,230.2 Procedures for Collecting and Submitting Domestic Samples for 

Microbiological Analyses

10,240.4 Verification Procedures for Consumer Safety Inspectors for the Listeria 

monocytogenes (Lm) Regulation and Lm Sampling Programs

10,240.5 Enforcement, Investigations, and Analysis Officer (EIAO) Assessment of

Compliance with the Listeria monocytogenes (LM) Regulation and

Introduction of Phase 2 of the LM Risk-based Verification Testing Program

10,300.1 Intensified Verification Testing (IVT) Protocol for Sampling of Product,

Food Contact Surfaces and Environmental Surfaces for Listeria 

Monocytogenes

13,000.1 Scheduling In-Plant Inspection Tasks in the Public Health Information

System

13,000.2 Performing Sampling Tasks in Official Establishments Using PHIS

Inspection Methods 39-23
 

 

 

 

 

Sampling RTE Product

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ATTACHMENT 2 RTEPROD_RISK and RTEPROD_RAND Sampling Instructions

Project Codes RTEPROD_RISK – Risk Based 

Verification Testing of Only Post-lethality

Exposed RTE Meat and Poultry Products

RTEPROD_RAND– Random 

Verification Sampling of

RTE Meat and Poultry

Products

SAMPLE IPP in establishments that produce post- IPP in establishments that 

COLLECTOR lethality exposed RTE product. produce all RTE products, 

regardless of whether the

product is post-lethality

exposed or not. 

PRODUCT TO IPP are to select the highest-risk post- IPP are to randomly select a 

SAMPLE lethality exposed RTE product produced at 

the time of collection using the Product 

Sampling Priority List (Page 4). When 

assigning product categories, IPP are to 

use the RTE Product Group Flowchart 

Resource 2.

product produced at the time 

of collection. IPP are to make 

every effort to sample all the 

RTE products produced at 

the establishment by rotating 

through the products.

ANALYZED FOR Listeria monocytogenes and Salmonella

SPECIAL IPP are to submit a two-pound sample of product in an intact package. FSIS

COLLECTION is not collecting samples of oils, shortening, lard, margarine, oleomargarine, 

INSTRUCTIONS or mixtures of rendered animal fats because there is no validated method for 

testing these products for Lm. FSIS will continue to sample popped pork

skins, pork rinds, dried soup bases, concentrated (high salt content) soup

mixes, and pickled pig’s feet under both RTE project codes. FSIS will collect 

samples of RTE products that are shipped hot from the establishment. In 

addition, IPP are not to collect product labeled “For Further Processing,” in 

which the product is expected to receive a lethality treatment at another

federally inspected establishment.

SCHEDULING IPP are to randomly select a day, shift, and time within the sample window

INSTRUCTIONS timeframe. IPP are to collect samples from all shifts the establishment 

operates. There should be an equal chance that sampling will occur during

any particular shift.

ESTABLISHMENT

NOTIFICATION

IPP are to notify the establishment before collecting samples. IPP are to

provide enough time for the establishment to hold the sampled lot but not 

enough time to alter its process. 

SPECIAL IPP are to safeguard the integrity of samples during submission according to

SHIPPING FSIS Directive 7355.1, Use of Sample Seals for Laboratory Samples and

INSTRUCTIONS Other Applications. IPP are to ship samples to the designated laboratory as

soon as collected and during the next available FedEx pickup. IPP are to 

ship samples refrigerated or frozen, depending on establishment practices. 

IPP are to use sufficient frozen coolant to keep samples cold during transit. 

IPP are to ship samples Monday through Friday so that they arrive at the

laboratory overnight. IPP are not to ship samples on Saturdays or on the 

day before a Federal Holiday

REFERENCES Directive 10,240.4, Rev. 3

Inspection Methods 39-24