Raw Beef Product Sampling 

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RAW BEEF PRODUCT SAMPLING 

Objectives 

To demonstrate mastery of this module, you will 

1. Identify the pathogen of concern for raw beef products. 

2. Select from a list those raw beef products eligible for sampling. 

3. State where to find FSIS raw beef product sampling instructions. 

4. Explain the steps of raw beef product sampling. 

5. Describe how to determine which raw beef product to sample. 

6. State how sample results are received. 

7. State when to mail samples to the FSIS laboratory. 

8. List the actions associated with positive pathogen results. 

9. List the requirements for transportation of raw beef product which has 

tested positive or presumptive positive for a pathogen. 

10. Explain the IPP responsibilities for review of establishment sampling data. 

Introduction 

Throughout the history of meat and poultry production, various pathogenic 

bacteria have caused food borne illness. FSIS works with other governmental 

agencies, industry, and consumer groups to set policy and establish performance 

standards to reduce or eliminate pathogens from meat and poultry products. 

CDC Estimates - The Centers for Disease Control and Prevention (CDC) 

estimates that there are approximately 175,905 domestically acquired foodborne 

illnesses associated with all Shiga toxin-producing Escherichia coli (STEC) 

annually. E. coli O157:H7 is the most well-known STEC and annually is 

responsible for approximately 63,153 (36%) of the domestically acquired 

foodborne STEC illnesses. The remainder of the illnesses associated with STEC 

(112,752 or 64%) are caused by non-O157 STEC. While many STEC 

serogroups have been associated with human illness, 70 to 80 percent of 

confirmed non-O157 STEC illnesses are caused by six STEC serogroups – O26, 

O45, O103, O111, O121, and O145. These illnesses can be equivalent in 

severity to those caused by E. coli O157:H7. Illnesses from non-O157 STEC 

serogroups have been associated with ground beef products. FSIS tests beef 

manufacturing trimming from cattle slaughtered on-site for six non-O157 STECs. 

Hazard Analysis - E. coli O157:H7 is a food safety hazard that establishments 

need to consider in their hazard analysis if slaughtering, receiving, grinding, or 

otherwise processing raw beef products. Controls for E. coli O157:H7 should be 

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Raw Beef Product Sampling 

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adequate for non-O157 STEC. See Directive 10,010.2 Verification Activities for 

Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef Products for more 

information on verifying measures that an establishment may use to address 

STEC. 

Positive Product is Adulterated - Non-intact raw beef products such as ground 

beef or mechanically tenderized beef, which are contaminated with E. coli 

O157:H7 or one of six non-O157 STECs (O26, O45, O145, O103, O111, and 

O121) are adulterated. Intact raw beef products contaminated with E. coli 

O157:H7 that are intended to be processed into non-intact products are also 

adulterated. Beef manufacturing trimmings are an example of an intact raw beef 

product that is intended to be used for non-intact product such as ground beef. 

Establishment records and HACCP documents such as the hazard analysis 

should identify the intended use of intact raw beef products. By sampling for 

STEC, we're verifying that establishment's adequately address STEC in raw nonintact products and product components (adequate in this context means STEC 

is below detectable levels). Salmonella sampling, on the other hand, is a 

measure of process control, and Salmonella is not considered an adulterant in 

raw product. 

Purpose of Sampling - An objective of FSIS’s verification sampling program is 

to test for E. coli O157:H7 (and for some products, six non-O157 STECs) and as 

a result, stimulate industry actions to reduce the presence of that pathogen in 

raw beef products. 

FSIS microbiological sampling programs are part of FSIS verification activities 

to ensure the protection of public health. HACCP systems integrate sciencebased controls into food production processes. These controls must be 

combined with some means of verifying that meat and poultry establishments are 

achieving acceptable levels of food safety performance. Sampling programs are 

designed to verify that HACCP systems are effective in controlling harmful 

microorganisms in meat and/or poultry products. Establishments may also 

include a microbiological sampling program in their HACCP system in order to 

verify that the system is performing as intended, that is, controlling, reducing or 

eliminating the identified food safety hazards. 

FSIS also protects public health by keeping pace with changes, such as 

emerging pathogens, new products and processes, and new laboratory analyses 

methods. FSIS is continuously improving its sampling protocol and techniques, 

updating sampling and testing programs, and developing more rapid means of 

reporting results. 

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FSIS Policy - FSIS directives contain policy details specific to sampling projects 

and programs. Policy changes rapidly; amendments and new issuances are 

developed to keep you informed. You are responsible for properly selecting 

products and using appropriate sample collection techniques to ensure the 

integrity of samples received by the laboratories. You must review the updated 

resources each time you take a sample. You should review new issuances when 

they are issued. 

The key policy related to raw beef sampling, FSIS Directive 10,010.1 Rev. 4, 

Sampling Verification Activities for Shiga Toxin-Producing Escherichia coli 

in Raw Beef Products, has been revised with instructions for collecting and 

submitting samples of raw beef products. 

FSIS Directives 

5000.1 Verifying an Establishment’s Food Safety System 

5000.2 Review of Establishment Data by Inspection Program Personnel 

7355.1 Use of Sample Seals for Laboratory Samples and Other 

Applications 

7700.1 Irradiation of Meat and Poultry Products 

8080.1 Recall of Meat and Poultry Products 

10,010.1 Sampling Verification Activities for Shiga Toxin-Producing 

Escherichia coli (STEC) in Raw Beef Products 

10,010.2 Verification Activities for Shiga Toxin-Producing Escherichia coli 

(STEC) in Raw Beef Products 

10,010.3 Traceback Methodology for Escherichia Coli (E. Coli) O157:H7 in 

Raw Ground Beef Products and Bench Trim 

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

revised) 

10,210.1 Unified Sampling Form 

10,230.2 Procedures for Collecting and Submitting Domestic Samples for 

Microbiological Analyses 

13,000.2 Performing Sampling Tasks in Official Establishments Using the 

Public Health Information System 

FSIS Notices 

39-14 Clarification and Expansion of Sampling Eligibility Criteria for the 

Routine Beef Manufacturing Trimmings (MT60) and Bench Trim 

(MT55) Sampling Programs 

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Terminology 

Alternative Sampling and Lotting 

When an establishment meets very specific criteria, FSIS may agree to 

alternative sampling or alternative lotting. Follow applicable instructions outlined 

in FSIS Directive 10,010.1. 

Recall 

A 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. Contact the DO immediately if adulterated product has left the 

establishment’s control. (see FSIS Directive 8080.1, “Recall of Meat and Poultry 

Products”). The recall would involve at least the sampled lot, but the scope of 

the recall could be expanded depending upon a establishment’s control 

measures to limit potential contamination exposure. If the raw beef product, e.g., 

rework, was used as an ingredient in other raw product formulations, those 

secondary products could also be subject to recall. 

Sample

A sample for raw products is a collection of product, such as ground beef or beef 

trimmings, that represents a larger amount of product (the sampled lot). A 

sample unit is an individual package or portion of product. It may take several 

sample units to make up one sample, depending upon the amount needed for 

the analysis. 

Sampled lot

The sampled lot is the amount of product represented by the sample tested for E. 

coli O157:H7. The establishment defines the sampled lot. “Cleanup-to-cleanup” 

may be a part of the procedures that the establishment has in place to distinguish 

one portion of production from another portion of production. “Cleanup-tocleanup” may be an effective means of preventing E. coli O157:H7 cross 

contamination between raw beef products during production. However, 

“cleanup-to-cleanup” without other supporting documentation may not be 

adequate to distinguish one portion of production from another (i.e., “cleanup-tocleanup” is not a stand-alone reason for distinguishing between segments of 

production because E. coli O157:H7 is source material contaminant). 

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Factors or conditions that may determine the sample lot include an 

establishment’s: 

• Use of a scientific, statistically based sampling program for E. coli 

O157:H7 to distinguish between segments of product; 

• Sanitation Standard Operating Procedures (Sanitation SOPs) or any other 

prerequisite programs used to control the spread of E. coli O157:H7 crosscontamination between raw beef components during production; 

• Use of processing interventions that limit or control E. coli O157:H7 

contamination; 

• Use of beef manufacturing trimmings and raw beef components or rework 

carried over from one production period to another production period; and 

• Production of bench trim, i.e., small pieces of beef trimmings from raw 

intact steaks and roasts. 

If multiple lots of raw ground beef product were produced from source materials 

from the same production lot of a single supplier, and some of this product was 

found positive for E. coli O157:H7, a scientific basis is necessary to justify why 

any other raw ground product produced at the grinder from the same source 

materials should not be considered adulterated. The use of source materials 

from multiple suppliers and establishment concerns related to potential recalls 

following a positive sample result are not a reason to not collect a sample. 

General Instructions for STEC Sampling Projects 

Establishment Interventions and CCPs 

Collect the sample after the establishment has completed production of a lot and 

applied all antimicrobial treatments to the production lot. 

If the establishment intends to test the product for E. coli O157:H7, non-O157 

STEC or virulence markers before completing the pre-shipment review, you do 

not wait for the establishment to receive the test results before collecting and 

sending a sample to the FSIS laboratory. 

Collect fresh and not frozen product for STEC sampling. The only exception is if 

the establishment has a CCP for freezing in its HACCP plan, and freezing is a 

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process that achieves a reduction in STEC. In this case collect the sample after 

the freezing step. 

Random Selection 

All samples are selected randomly from the current day’s production of the raw 

beef product requested. Use a method for randomly selecting the production lot. 

You must randomly select a day, shift, and time within the collection window start 

and end dates indicated in the PHIS establishment task list. In order for the 

sample to be representative of a lot, every attempt must be made to avoid taking 

a sample that is biased, or non-random. There should be an equal chance that 

sampling will occur during all shifts that the establishment operates. One of the 

best ways to ensure an unbiased sample is to randomly select a time to collect 

the sample. You can use a random number table or generator to determine the 

day and time. Record the time you collected the sample in PHIS in the additional 

information questionnaire. All shifts and days are to be included in the 

random selection, including Fridays and night shift. 

Aseptic Sampling

Samples must be collected using aseptic sampling technique. An aseptic 

technique implies that you do not add any organisms to the sample when it is 

collected. You want to assure that the sample is not contaminated with 

extraneous microorganisms from the environment, hands, clothing, sample 

containers and sampling devices. 

For raw beef products collected in their intact final package, such as ground beef 

in 1 lb. retail chubs, you are to clean and sanitize your hands before collecting 

the sample. For samples not in final packaging, such as beef manufacturing 

trimmings and bulk packaged ground beef products, you are to clean and 

sanitize your hands to the mid-forearm and put on sterile gloves before collecting 

the sample. The only items that should contact the external surface of the sterile 

glove on the sampling hand are the sample being collected and the sterile 

sampling equipment. You must put the samples collected from product 

packaged in institutional or bulk containers in the sterile Whirl-Pak® bags. 

Answer the questions on the additional information questionnaire in PHIS. Raw 

beef samples collected for E. coli O157:H7 sampling must be submitted to the 

laboratory in either the supplied sterile Whirl-Pak® bag or the establishment’s 

final packaging, or else they will be discarded. 

Sample Security and Shipping 

You must safeguard the security of the samples when preparing, storing, 

packaging, and mailing the sample to the FSIS laboratory. Samples are to be 

sent to the laboratory the same day they are collected, or as soon as the 

overnight courier service is available. 

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Use the following guidelines: 

• Samples collected before Federal Express pickup Monday through Friday 

should be held refrigerated until shipped that same day. 

• Samples collected after Federal Express pickup Monday through 

Thursday should be held refrigerated overnight and shipped the next day. 

• Samples collected during the weekend (after Federal Express pickup 

Friday through Sunday night) should be frozen and shipped on Monday. 

Note: If Monday is a holiday that Federal Express does not pick up 

samples, they may be held frozen until shipping on Tuesday. 

• The only time a frozen sample is collected is when the establishment has 

a CCP for freezing. If the establishment has a CCP for freezing, the 

sample you collect is frozen and must be kept frozen. 

Samples not meeting the above shipping criteria will be discarded upon receipt at 

the laboratory. 

Steps in Sampling 

There are 5 steps in product sampling. 

1. Determine which product to sample 

2. Notify establishment management 

3. Collect the sample 

4. Pack and mail the sample and form 

5. React to the results 

Step 1: Determine which Product to Sample 

When directed sample request tasks are sent to the establishment task list they 

will be specific to the type of product to be collected. The project code and the 

raw beef product or category is specified in the task name, for example “MT43 – 

Risk-based E. coli O157:H7 Sampling of Raw Ground Beef or Veal Products” or 

“MT60 – E. coli O157:H7 Sampling of Beef Manufacturing Trimmings”. More 

information about the sampling project code can be found in FSIS Directive 

10,210.1, including special collection information. 

To assist you in determining which product to sample, you need to be familiar 

with the establishment’s processes and know how the finished product is labeled. 

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Before collecting a sample, review the FSIS Notices and Directives covering that 

sample type or program. 

Ensure that the PHIS Establishment Profile is accurate. Update the profile as 

necessary to ensure the establishment is subject to the correct sampling tasks. 

An accurate Establishment Profile is critical – FSIS uses the information in 

the PHIS profile to generate specific sampling tasks. Refer to specific instructions 

in the Directives for updating the establishment profile based on the types of 

products produced and intended use. 

Sampling Project Codes

The routine sampling project codes for E. coli O157:H7 testing at domestic 

federal establishments are: 

• MT60 –Raw Beef Manufacturing Trimmings from cattle slaughtered onsite 

(Analyzed for E. coli O157:H7, non-O157:H7 STEC, and Salmonella) 

• MT64 –Components other than Trim 

(Analyzed for E. coli O157:H7 and Salmonella) 

• MT65 –Bench Trim, derived from cattle not slaughtered at the 

establishment 

(Analyzed for E. coli O157:H7 and Salmonella) 

• MT43 – Routine Testing of Raw Ground Beef in Federal Establishments 

(Analyzed for E. coli O157:H7 and Salmonella) 

MT 60 - Beef Manufacturing Trimmings that are Sampled from Cattle 

Slaughtered at the Establishment 

MT60 is the sampling program for beef manufacturing trimmings sampled for 

E. coli both O157:H7 and the other non-O157 STEC, and Salmonella. Beef 

manufacturing trimmings are trimmings produced from cattle (including veal) that 

are slaughtered onsite, that is, at the establishment where the MT60 sampling is 

occurring. Beef manufacturing trimmings includes trim of any size; or 

primal/subprimal cuts, like chucks, rounds, or shanks; or boneless beef of any 

size, in any packaging. The MT60 sampling project covers any trim that is used 

at the slaughter establishment for non-intact use, or is intended for raw non-intact 

use by other establishments. 

The purpose of the MT60 beef manufacturing trimmings program is to assess the 

food safety controls the slaughter establishment has in place to address Shiga 

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toxin-producing Escherichia coli (STEC) in the cattle it slaughters. MT60 test 

results reflect the effectiveness of the establishment’s slaughter and dressing 

operations because the trim is from cattle slaughtered onsite. 

In limited cases, beef manufacturing trimmings will be sampled at sister 

processing establishments that fabricate trim for their supplying sister slaughter 

establishments (FSIS Directive 10,010.1). 

If the establishment commingles the beef trimmings with beef product processed 

at other establishments, collect the sample before the establishment commingles 

the product. 

Randomly select only one type of trim to collect for each sample. 

Do not collect samples of beef manufacturing trimmings from production lots that 

are going to be further processed into ready-to-eat products or from lots of 

commingled beef manufacturing trimmings produced at different establishments. 

To determine the intended use of the products, review establishment records and 

HACCP documents such as flow charts, and hazard analyses. In cases where 

the establishment documents are unclear about the intended use, FSIS will 

sample the trimmings. 

MT64 - Raw Ground Beef Components OTHER than Beef Manufacturing 

Trimmings that are Sampled 

Raw ground beef components other than beef manufacturing trimmings eligible 

for FSIS sampling for E. coli O157:H7 and Salmonella under the MT64 program 

are intact or non-intact beef products intended for manufacturing into raw ground 

beef products. Components include raw beef esophagus (weasand) meat, head 

meat, cheek meat, hearts, beef from advanced meat recovery (AMR) systems, 

and low temperature rendered products such as lean finely textured beef (LFTB), 

partially defatted chopped beef (PDCB) and partially defatted beef fatty tissue 

(PDBFT) that were produced from cattle slaughtered at the establishment. 

To determine the intended use of the products, review establishment records and 

HACCP documents. In cases where such documents are unclear about the 

intended use or consumer, or the establishment lacks control measures to 

ensure that the product is used as intended, handle the product as if it were for 

use in a ground beef product or other raw non-intact raw beef product. 

When you receive a directed sampling request task for the MT4 sampling project 

code, you choose randomly among the products produced at the slaughter 

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establishment. Over time, all eligible products the establishment produces will be 

selected. 

If the establishment commingles components with beef product processed at 

other establishments, you need to collect the sample before the establishment 

commingles the product. 

Do not collect samples of components from production lots that are going to be 

further processed into ready-to-eat products at that establishment or another 

official establishment. If any of the components listed above such as heart meat, 

cheek meat or head meat are send to a retail store, these products should be 

sampled because the official establishment no longer has control over the 

intended use. 

Ammoniated Beef Products - Some establishments inject gaseous ammonia 

into low temperature rendered (LTR) beef products such as partially defatted 

chopped beef (PDCB), lean finely textured beef (LFTB), and product known as 

boneless lean beef tissue (BLBT)) to raise the pH of the product rapidly. 

Ammoniated beef products are typically intended as a component of raw ground 

beef and beef patty products. These products are produced from beef trimmings. 

The beef trim is warmed to partially melt and loosen the fat portion from the lean 

portion. The warming allows the connective tissue to be removed and also the 

edible fat portion can be separated from the lean beef using centrifugation. The 

edible fat portion can be further processed. The partially rendered beef 

trimmings are ground into a slurry. The sinew (tendon) and connective tissue are 

removed from the lean tissue in a subsequent step by forcing the slurry through a 

“desinewer.” The lean beef slurry is then ammoniated with gaseous ammonia to 

rapidly raise the pH to produce the antimicrobial effect. The ammoniated lean 

beef portion is rapidly frozen on a drum freezer, broken into chips, and sprinkled 

with pelleted CO2. Some processes then grind these chips and compress them 

into 60 lb. blocks using high hydrostatic pressure. The freezing and compressing 

steps typically provide an additional antimicrobial effect when combined with 

ammoniation. Scientific studies have demonstrated that raising the pH of the 

product can reduce E. coli O157:H7 to an undetectable level in beef 

manufacturing trimmings. 

When you receive a sampling request task for the MT64 sampling project code in 

establishments that produce ammoniated (pH enhanced) beef products, you are 

to sample the ammoniated product after it passes the final antimicrobial 

treatment. Ammoniated beef products that are produced at non-slaughter 

establishments are also eligible for MT64 sampling. 

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MT65 - Bench Trim or Beef Manufacturing Trimmings that are Sampled 

from Cattle NOT Slaughtered on-site at the Establishment 

The purpose of the MT65 project is to verify the further processor’s food safety 

procedures for STEC, for example, purchase specifications, or antimicrobial 

interventions. Generally, the same types of beef products are sampled under the 

MT65 sampling program as under the MT60 sampling program. However, MT65 

samples are from products derived from cattle not slaughtered at the 

establishment. 

The intended use is key - to determine it, review establishment records and 

HACCP documents. In cases where the establishment documents are unclear 

about the product’s intended use, the bench trim will be considered for use in raw 

ground beef products and other non-intact raw beef products. 

In addition, unlike the MT60 sampling program, if the establishment commingles 

beef trimmings from cattle it slaughtered with bench trim derived from cattle 

slaughtered at another establishment, those commingled beef trimmings are 

subject to sampling under the MT65 sampling program. 

Do not collect samples of bench trim from production lots that are going to be 

given a full lethality treatment, e.g., further processed into ready-to-eat (cooked) 

products at the establishment or at another federal establishment. 

MT43 - Raw Ground Beef Products that are Sampled 

Raw ground beef products are subject to FSIS sampling for E. coli O157:H7 and 

Salmonella under the MT43 program. Raw ground beef products are described in 

the standards of identity for ground and chopped beef (9 CFR 319.15(a)), 

hamburger (9 CFR 319.15(b)), or beef patties (9 CFR 319.15(c)). They include: 

• ground or chopped beef or veal; 

• hamburger; 

• beef or veal patties; 

• beef or veal patty mix; and 

• similar ground beef or veal products made with added seasonings or 

ingredients. 

Sampled products may contain components such as beef derived from AMR 

systems, LFTB, or PDCB. 

When an establishment produces multiple ground beef products and you receive 

subsequent sample request tasks for project code MT43 in PHIS, unless a 

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specific product is requested, collect a sample from a different product than you 

submitted with the previous sampling task. 

You are to collect samples from products that contain a mixture of ground beef 

and non-beef species (for example, beef and pork patty mix), unless the product 

is labeled in a manner to show that beef is not the predominant meat or poultry 

component. For example, “Beef Patty Mix, ground pork added” (ingredients: 

beef, water, pork, corn syrup and seasonings) would be subject to sampling 

because beef is the predominant species in the product. You are also to collect 

samples from products that contain seasonings. 

Do not sample the ground beef product if the establishment only repacks intact 

packages and does not expose the product to the environment; for example, if 

the establishment removes product from bulk containers and breaks the bulk 

product it into consumer ready packages. Ground beef products intended to be 

further processed into ready-to-eat products, or products made with ground 

beef but subject to a different standard of identity than in §319.15(a)-(c), such as 

meatballs, meatloaf, beef sausage (§319.140), and fabricated steaks (§319.15(d) 

are not subject to E. coli O157H:7 sampling. 

Step 2: Notify Establishment Management 

Establishment management must be notified before a sample of its raw beef 

product is taken. Inform the establishment that it is required to hold or maintain 

control of the sampled lot until negative results become available. Since the 

establishment must hold the lot, it needs sufficient time to make the necessary 

arrangements to do so. You need to give the establishment enough advance 

notice so the sampled lot may be held but not enough time for the establishment 

to alter the production process. Always identify the reason why you are taking 

the sample when you notify the establishment. Inform establishment 

management that it is responsible for supporting its basis for defining what 

product is represented by the sample. 

You should discuss the notification and time frames with establishment 

management prior to any sample requests being received in order to have a 

notification protocol in place when a sample must be collected. 

You need to be knowledgeable concerning the establishment’s production 

practices. Give establishment management 1 day’s notice before you collect a 

sample if that’s enough time for the establishment to hold the sampled lot, or less 

than 1 day’s notice if it does not cause a hardship to the establishment. 

However, after becoming familiar with the establishment’s process, you may 

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realize that 1 day’s notice before collecting a sample is not adequate time for the 

establishment to hold all of the product represented by the sample. You may 

provide 2 day’s notice, if necessary. 

If the establishment requests more than 2 days’ notice prior to collection of the 

sample, consider the establishment product and process flow. The District Office 

or the Policy Development Staff (PDS) should be contacted for guidance before 

allowing more than 2 days’ notice. 

Each time you collect samples tested for adulterants such as STECs, verify that 

the establishment is holding or controlling product. If an establishment does not 

hold or maintain control of product, Write an NR because the establishment 

shipped product before FSIS found that the product was not adulterated, and 

because the establishment did not complete pre-shipment review following 

availability of all relevant test results, as required in 9 CFR 417.5(c). Also notify 

the District Office. 

Step 3: Collect the Sample 

Follow the general sampling instructions outlined in this handout. Randomly 

select a lot, day, shift and time for routine sampling. Collect a sample using 

aseptic technique from one completed production lot after all of the 

establishment’s antimicrobial interventions. Collect the sample from one type of 

trim or component. Select the sample within the PHIS sampling window. 

The N60 Sampling Method 

The N60 method is used for sampling both beef manufacturing trimmings 

(MT60) and bench trim (MT65). 

Before sampling, be sure you have the proper supplies. A plastic caddy, sharp 

boning knife, hook, sterile gloves and sterile sampling bag are needed for the 

N60 sampling procedure. It is critical that the knife used for sampling be kept 

sharp and properly steeled for collecting samples. Also available from the FSIS 

Western laboratory are disposable sampling surfaces, sanitizing solution, cut 

resistant mesh gloves, sampling templates and sanitizable clips which can be 

used to clip the wire at the top of the sampling bag to either the top of the combo 

bin or the edge of the sampling caddy during collection. The Whirl-Pak® 

sampling bags have a gusseted bottom (flat bottom) which allows the bags to 

stand without a rack or stand to hold them up. This allows you some assurance 

that the bag will be anchored in place while samples are cut and that the 

sampling bag will remain standing while sample pieces are placed in the bag. 

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You are to sanitize the caddy, knife, and hook before collecting the samples by 

using the establishment’s sanitizing solution according to label instructions. If the 

establishment uses hot water only, then use hot water to sanitize sampling 

equipment. 

Use sterile gloves and handle all sanitized surfaces so that they do not become 

contaminated. To use the mesh glove in an aseptic manner when collecting 

samples, you place the sterile glove over the mesh glove. 

If a specific production lot is composed of greater than 5 containers, randomly 

select 5 containers for sampling. If the specific production is composed of fewer 

than 5 containers, use the table below. 

Number of Sample Pieces to Collect Per Container 

# of containers in each 

specific production 

# of sample pieces to select from each container 

5 12 pieces 

4 15 pieces 

3 20 pieces 

2 30 pieces 

1 60 pieces 

Aseptically collect the appropriate number of pieces of beef trim. Use the 

sanitized hook to reposition and anchor a piece of meat at the top of the 

container. For larger pieces of meat, a curved boning knife and short boning 

hook may work better than the standard meat inspection hook and straight 

boning knife. 

Cut off a slice of the surface that is approximately 3 inches long by 1 inch wide 

and 1/8 inch thick from each of the 60 pieces of meat. The priority is to collect 

samples from pieces of product taken from the original external surface of the 

beef carcass (this is the outside surface of the carcass when it is first dehided). 

You must make every effort to ensure that at least 60 thinly (approximately

1/8 inch thick) excised external surface tissue samples are included in the 

sample. Using the sampling template to lightly score the surface in 2 parallel 

cuts approximately 1 inch apart and 3-4 inches long may facilitate obtaining the 

appropriately sized sample piece. The priority is to get the external surface of 

the carcass. Make sure that each sample slice contains some meat, that it isn’t 

completely fat. Also, collect only one slice from each piece of trim. 

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For raw ground beef components, IPP are to use the Whirl-Pak® bag, but the fill 

line will not apply. When sample collection is completed, each bag will hold the 

equivalent of 325g of product. For beef manufacturing trimmings, each bag will 

hold 30 pieces. The laboratory will analyze the contents of one or two bags and 

hold a third bag as a reserve in case of a need to conduct additional analysis on 

positive samples. IPP are to use only the laboratory supplied Whirl-Pak® bags 

for submitting these samples. Do not use any other bag, for example a zip-top 

bag. 

The 60 pieces that are 3 inches long by 1 inch wide and 1/8 inch thick should 

weigh approximately 3⁄4 lb. (325g ± 10%). Place a total of 30 pieces in each of the 

first 2 bags for a total of 60 pieces. 

In addition, you are to collect available smaller pieces of meat from the same 

specific production lot and place this product in the third Whirl-Pak® sample bag. 

You do not need to cut or trim the pieces to any particular dimension or count the 

pieces. You can just grab smaller pieces. However, you need to collect pieces 

with as much external surface area as possible. Cut larger trim pieces so they fit 

in the bag. Leave at least 2 inches of space at the top of the bag to prevent 

leakage. The total weight of the 3 bags of samples should be approximately 2 

pounds. Do not under- or over fill the bag. 

Note: If an establishment produces both large pieces of trim and small pieces of 

trim, you are to sample only the product that can be sampled using the N60 

sampling procedure. 

Aseptic Grab Sampling 

If the establishment only produces trim pieces that are too small to be sampled 

using the N60 sampling procedure, just collect three grab samples aseptically up 

to the fill line for each of the 3 Whirl-Pak® bags. If you are sampling larger 

components, such as hearts, you can collect one or more pieces to fill each of 

the 3 bags. Leave at least 2 inches of space at the top of each Whirl-Pak® bag to 

avoid overfill and leakage incidents. For component types that you can collect 

using a grab sample, such as AMR product or low temperature rendered 

products, you would collect 3 grab samples and fill up the fill lines of each of the 

3 Whirl-Pak® bags. 

Always place samples taken aseptically from bulk packaged raw ground beef 

components in sterile Whirl-Pak® bags provided by the laboratory, not ordinary 

zip-top bags. 

Inspection Methods 18-15 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Collecting Raw Ground Beef Products 

You are to collect a 2 lb. sample of ground beef product from the current day’s 

production in final packaged form (whenever possible). You are to put the 

product in its final packaging in the larger, non-sterile bag provided with the 

sampling supplies. Collect the appropriate number of packaged products so that 

the sample equals two pounds. For example, 2 1-pound packages may be 

included in the larger, non-sterile bag. If product in final packaging is not 

available, aseptically collect a 2 lb. sample using the grab sampling method, fill 3 

Whirl-Pak® bags to the fill-line. When an establishment produces multiple raw 

ground beef products, the IIC should oversee sampling procedures to ensure that 

a different product within the requested product type is sampled each time a 

sample request form is received. 

Video Training for STEC Sampling of Domestic Raw Beef Products 

If you perform sampling of raw beef products, you may complete two additional 

optional training courses. 

Voluntary Training Courses Concerning Raw Beef Sampling Procedures 

FSIS has posted two voluntary training courses that show how to collect 

domestic and imported raw beef products for FSIS’ shiga toxin-producing 

Escherichia coli (STEC) testing. The course on collecting domestic raw beef 

products targets inspection program personnel, and is available at 

https://www.youtube.com/watch?v=BlV_GpoTpUU&feature=youtu.be. The 

course takes approximately thirty minutes to complete. To request a copy of the 

training materials on DVD, please contact the Continuing Education and Distance 

Learning mailbox at CEDL@fsis.usda.gov. If you have problems accessing the 

course material, contact the Center for Learning at FSISAgLearn@fsis.usda.gov. 

Additional information concerning how to access and get credit for the voluntary 

training courses can be found in Attachment 6 of FSIS Directive 10,010.1, 

Sampling Verification Activities for Shiga toxin-producing Escherichia coli (STEC) 

in Raw Beef Products. 

FSIS Directive 10,010.1: Raw Beef Sampling Eligibilities Training 

A voluntary online course geared at inspectors is now available on InsideFSIS. 

The course describes what products are eligible for FSIS’ STEC sampling 

programs in a fun and engaging way. The training takes approximately thirty 

minutes to complete. To take the course, log in to InsideFSIS at 

http://inside.fsis.usda.gov. Under “Employee Services,” select “Training” and then 

select “Featured CFL Courses and Programs.” The course title is “FSIS Directive 

10,010.1 Raw Beef Sampling Eligibilities Training.” For questions about the 

sampling eligibilities, contact the Risk, Innovations, and Management Staff 

Inspection Methods 18-16 
 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

through askFSIS or by calling (800) 233-3935. For AgLearn issues, call the Help 

Desk at (800) 336-3747. 

Sampling Frequencies 

Maximum monthly sampling task frequencies for routine sampling programs vary 

by plant size and production volume, per Figure 1 in Directive 10,010.1. You 

must collect a sample whenever a sample request task is received and product is 

available during the collection window start and end dates. 

Analysis for Salmonella of all Beef Products Sampled for Shiga ToxinProducing Escherichia Coli (STEC) 

Raw beef samples that are analyzed for STEC will also be analyzed for 

Salmonella. This analysis is used to gather baseline data to determine the 

prevalence of Salmonella in ground beef and trim for future sampling program 

policy use. IPP are to inform the establishment that all samples analyzed for 

STEC will also be analyzed for Salmonella. The establishment only has to hold 

and control lots until the results for STEC are received. 

Collecting Supplier Information at the Time of Sample Collection 

IPP are to record source material and supplier information when they collect a 

sample of ground beef product (MT43) or bench trim (MT65) or any follow-up 

sampling for these sampling programs (MT44, MT52, or MT53) to be submitted 

to the FSIS laboratory for E. coli O157:H7 testing. This will serve FSIS’s goal to 

respond to FSIS positive results by identifying all affected product and all 

potential suppliers as quickly as possible to protect public health. 

When the establishment produced the source materials in-house that were 

used in the production of the sampled lot, you are to obtain and record the 

following information. 

• Establishment name and number, 

• Lot numbers or slaughter dates, 

• Production dates including slaughter production days if available, 

• Name of the beef components used in the production of the sampled product 

(e.g., beef trimmings, subprimal cuts, beef hearts, veal trimming, weasand, 

head or cheek meat) or any information that identifies the material, such as 

product labeling if used, and 

• Approximate amount of the beef component produced in each lot (in lbs). 

Inspection Methods 18-17 
 

 

 

Raw Beef Product Sampling 

11-03-2021 

When the establishment uses source materials from another domestic 

establishment (outside source) to prepare the sampled lot, you are to obtain 

and record the following information. 

• Establishment name and number that produced the source materials, 

• Establishment phone number, 

• Establishment point of contact (name, title, e-mail address, and fax number), 

• Supplier lot numbers, 

• Production dates, 

• Name of the beef components used in the production of the sampled product, 

or any information from the label of the product that identifies the source 

material used, and 

• Approximate amount of the beef component produced in each lot (in lbs.). 

If the source materials are imported from a foreign establishment, you will 

need to gather additional information (country of origin, foreign establishment 

number, shipping mark, I-house, and bar-coding or other information to aid in 

identifying the product). 

You document source material and supplier information in a memorandum of 

interview (MOI) in PHIS. Provide a copy of the MOI to establishment 

management. You also make a note of any information that the establishment is 

unable to provide in the MOI. If the sample is reported as presumptive positive, 

notify management of the presumptive positive as soon as possible. 

Also, when collecting for STEC record the sample source as: 

• Veal; 

• Beef; or 

• Mixed (beef and veal, or beef or veal and other species). 

This information will be recorded in PHIS when completing the sampling task. 

Inspection Methods 18-18 
 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

PHIS Hands-on Activities 

Collection of Supplier Information 

The situation: Robert Barclay, an IPP at Groveton, has collected a MT43 sample 

- "Routine Sampling for E. coli O157:H7 in Raw Ground Beef Patties" and must 

document the supplier information in an MOI. 

Overview 

In this hands-on learning, Barclay: 

• Acquires the supplier data for the product that was sampled from the 

establishment 

• Records his findings in an MOI 

• Schedules a meeting with establishment management to confirm his 

findings 

• Confirms his findings at the meeting and finalizes the MOI 

Information needed for Hands-on 

• Barclay has determined that Groveton does not have their own sampling 

program. 

• Today’s Lot 9225B was produced entirely from beef trimmings purchased 

from Open Beef 

Barclay observed that beef trimmings for the raw ground beef patties were from 2 

combo bins of a 5 combo bin shipment: 

• Received from Open Beef 

• Labeled "Beef Trimmings, 90/10, 2-9-2016" 

• Net weight 2122 lb. 

• A production lot number was stamped on the combo bins, “020912B”. 

1. Log in to PHIS as Robert Barclay 

2. From the left Navigation Menu, click on Inspection Verification, then Select 

Establishment, and select Groveton Meats 

3. Click on Memorandum of Interview in the Navigation Menu 

4. On the MOI List, click the Add MOI link 

5. On the Memorandum of Interview (MOI) page - the Status tab: 

Inspection Methods 18-19 
 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

a) Use today’s date as the default date and the Meeting Date that you 

plan to meet with establishment management, 

b) Select any planned meeting time, 

c) Enter Supplier Information for the subject of the MOI, and 

d) Select Jeff Irvine as the attendee. 

6. On the Memorandum of Interview (MOI) page, go to the Issues tab. 

a) Enter the example Sample Form Number 111222333 

b) Leave the reason for the MOI blank 

c) Enter the following supplier information in the Comments field 

Supplier Information 

• Establishment: Open Beef, M38581 

• Supplier phone number: 707-845-2145 

• Supplier point of contact: Frank Lutz 

• Supplier production lot: 020912B 

• Production date: 2/9/2016 (assumed) 

• Beef components used: beef trimmings 

• Amount of the beef component produced/lot: 2,122 lbs. 

• 2 combo bins of a 5 combo bin shipment 

• Bill of lading # 15677 

7. On the Issues tab 

a) Click the Save button, then click Cancel 

The MOI List page is presented 

b) Click the Print icon for the MOI 

The MOI will open in another window for review or printing 

8. On the window showing the MOI, close the window showing the MOI by 

clicking the small X at the top 

Meeting Information

Barclay meets with Groveton’s management to share the MOI. He will return to 

PHIS to add the information provided by management during the meeting, in 

Inspection Methods 18-20 
 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

order to have an official record. He shows a copy of the MOI to the establishment 

management in order to confirm accuracy, and then he finalizes the MOI. 

9. From the left Navigation Menu, click on Inspection Verification, then Select 

Establishment, and select Groveton Meats 

10.Click on Memorandum of Interview on the Navigation Menu 

11.Find the MOI you created to capture the supplier information 

12.Click the edit icon 

13.On the Memorandum of Interview (MOI) page, go to the Issues tab: 

14.Enter pertinent information provided by plant management during your 

meeting in the Comments field: 

Plant management (Jeff Irvine) provided the following information: 

• Confirmed supplier information, including that Open Beef was the sole 

supplier of the lot that was sampled for E. coli O157:H7 

• Groveton is holding the production lot on-site 

• Lot 9225B is the only lot of raw ground beef product that Groveton 

produced on (today) 

• There was no rework used in this lot nor any rework saved from it and 

a complete cleanup was done before and after the sample was taken 

Finalize MOI 

15.Check the Finalize box 

16.Click the Save button 

17.On the MOI List page 

a) Select the Print icon in order to create a record 

b) Save the MOI as a PDF to your laptop's Desktop 

Include the Sample ID number in the file name for future reference 

c) Close the window showing the MOI using the small X at the top 

d) Sign out of PHIS 

Inspection Methods 18-21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Step 4: Packing and Mailing the Sample 

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

additional product info in PHIS, click “submit to lab” to submit the Sample 

Analysis Request Form electronically to the laboratory, and then you 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, or 

if the sample is the wrong type of raw beef product, the lab will discard the 

sample. Also, if the lab receives an insufficient amount of product to perform the 

specified analyses, the sample is discarded (see Attachment 2 for discard 

reasons). Be sure the identification on the sample and the paperwork match, 

otherwise the lab will discard sample. 

All samples received by the lab without a collection date are discarded. 

The Sample Collection Data and Additional Information screens in PHIS for 

microbiological pathogen samples will have specific questions depending on the 

product requested. All requested data must be accurately recorded; otherwise 

the lab will discard the sample. For example, PHIS may ask for the date 

collected, the date sent to the lab, the product temperature, whether product was 

held by the establishment management, and whether the sample was collected 

in the final packaged form. There will be a question regarding with product is veal 

or beef. Other data requested may include the raw beef component sampled, the 

production volume, the shift, or other information needed for the type of sample 

submitted. 

One or more individually identified samples may be submitted in a shipping 

container. Follow the instructions in FSIS Directive 7355.1, “Use of Sample 

Seals for Program Samples and Other Applications.” You may need to include 

additional cooling packages in the shipping container to keep the sample or 

samples cool during transportation. To submit multiple samples, you may 

request larger boxes from the laboratory identified by sending an e-mail message 

to their e-mail addresses on page 9 of this handout. If you include more than one 

sample in the shipping container, include one of the identifiers (bar code) for the 

other sample on the Container Seal, 7355-2A. This lets the lab know that there 

are multiple samples in the box. The labs will discard them if it is not clear which 

sample goes with which sample form. 

Double-check and compare the address on the expanded billable stamp to make 

sure it is going to the lab indicated in PHIS and on the sample form. The lab will 

discard the sample if you mail it to the wrong lab. 

Inspection Methods 18-22 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

The shipping containers you receive should have the top and bottom sealed by 

the lab with tamper-evident tape. You 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). 

Pack the sample in this order. 

1. Absorbent pad 

2. Gel pack 

3. Cardboard separator 

4. Sample with paperwork (all in a zip-top bag) 

4. Foam plug 

5. Close the shipper with seal (7355-2A – Container Seal) 

To ensure the product is maintained at refrigeration temperature, place the 

sample in a pre-chilled shipping container with an absorbent pad and frozen gel 

pack, even if the sample was previously refrigerated or frozen. A piece of 

cardboard goes on top of the gel pack to separate it from the sample. Put a 

small bar code sticker from Form 7355-2 at the top center of the sample form and 

put the form in a plastic bag. Put another small bar code sticker on each of the 

bagged sample units. Put the sample and form into the larger zip-top bag and 

affix the Identification Label (7355-2B) to the larger bag. Note that the 7355-2B 

is a label rather than a seal and is simply stuck on the bag. There is no need to 

fold over and seal the bag with the label. The zip-top bag, containing the bagged 

sample and the paperwork, is put into the shipper. Filler material is not allowed 

in the shipping container. This means that no newspaper or paper towels should 

be put inside the shipping container to take up empty space. The foam plug 

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

inside the shipper. Put any extra unused bar codes into the box so that the lab 

can account for them, or put them on the Container Seal where they won’t cover 

any written or printed information. Alternatively, if you keep a record of the 

sample, you can affix the extra bar code to your record. Close up the box and 

seal it. 

For sample integrity, a 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. 

Raw beef product samples are mailed to the laboratory on the first available day 

the contract carrier picks up after collecting the sample. Samples should be 

shipped when collected, do not wait for the establishment to complete their preshipment review for the product sampled. 

Inspection Methods 18-23 
 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Double-check that the lab address in PHIS is the same as on the expanded 

billable stamp. If these are different, your sample will be discarded. If the lab 

listed is different from the one on the expanded billable stamp, e-mail the lab 

listed and request an expanded billable stamp from that lab. You should 

determine if you have a billable stamp for the correct lab when you first schedule 

the sample task, not when you are about to mail the sample. 

Check the expiration date on the expanded billable stamp. Do not use it if it is 

expired. 

On the expanded billable stamp, enter the establishment number, shipping date 

(day sample box picked up by carrier) and the establishment’s phone number. 

Example 1: You receive a sample request task for project code MT43. You 

read the information in the related directives. You note the sample collection 

window time frame in the establishment task list. You schedule the sample in 

PHIS and make sure you have the proper sampling supplies and billable stamp 

for the lab. On the appropriate date, you notify establishment management that 

you will be collecting a sample today and provide the reason for taking the 

sample. 

You ask what products are being produced. The production manager tells you 

that today they are producing bulk raw ground beef in 20-lb bag; raw hamburger 

in 2-lb tray packs, and raw beef patty mix in 40-lb boxes. In the recent past, you 

had sent in samples of the beef patty mix and the bulk ground beef, which were 

negative for E. coli O157:H7. To ensure you are sampling the various products, 

this time you select the hamburger. You inform the production manager that 

you’ll sample the hamburger. 

At the time you go to collect the sample from the packaging line, you notify 

establishment management. A QC person accompanies you out to the line. 

You wash and sanitize your hands and then pick up a package. The QC person 

asks why you selected that package. You tell her it was random based on time. 

You realize that you won’t be able to mail the sample until tomorrow morning, so 

you refrigerate the sample. You put it in the retain cage in the cooler and secure 

it with a government lock. You collect the supplier information and document the 

information in a MOI. The following morning, you pack and send the sample to 

the FSIS lab listed on the sample request form. 

Inspection Methods 18-24 
 

 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Step 5: Results 

Access Laboratory Information Management System (LIMS)-Direct to track your 

sample receipt and results. LIMS-Direct is a computer application that provides 

sample data electronically to FSIS program personnel. LIMS-Direct reports 

sample status and the results of the analyses.. 

Check LIMS-Direct each day after you submitted the sample to the FSIS 

laboratory. If the sample was discarded, notify the establishment immediately so 

it can release the product. 

The first lab analysis is accomplished within two days of sample receipt. It is a 

screening test that identifies the possible presence of E. coli O157:H7 or one of 

the six non-O157 STEC. If the screening test is negative, E. coli O157:H7 is not 

present (or below detectable levels) in the sample tested. The negative results 

are posted in LIMS-Direct as “Acceptable”. FSIS resumes normal sampling at 

that establishment. 

Every FSIS verification sample that the laboratory confirms positive for E. coli 

O157:H7 goes through three stages of analysis. If the screening test is positive, 

the sample is potentially positive for E. coli O157:H7 and additional testing is 

necessary to confirm the result. The laboratory reports the sample result in 

LIMS-Direct as a “Potential Positive”. In the next stage, based on further 

analyses that reveal more evidence to suggest that E. coli O157:H7 may be 

present in the product, LIMS-Direct reports the sample result as “Presumptive 

Positive”. Upon further analysis and conclusive evidence that E. coli O157:H7 is 

present in the sample, the result is reported as “Confirmed Positive”. The 

confirmatory testing is usually accomplished within 3 to 4 days of the sample 

receipt at the FSIS laboratory, but can sometimes take longer. 

Every FSIS verification sample that the laboratory confirms positive for one or 

more non-O157 STEC serogroups also goes through three stages of analysis. 

If the screening test is positive, the sample is potentially positive for one or more 

non-O157 STEC serogroups and additional testing is necessary to confirm the 

result. The laboratory reports the sample result in LIMS-Direct as a “Potential 

Positive”. In the next stage, based on further analyses that reveal more evidence 

to suggest that one or more non-O157 STEC serogroups may be present in the 

product, LIMS-Direct reports the sample result as “Presumptive Positive”. Upon 

further analysis and conclusive evidence that one or more non-O157 STEC 

serogroups is present in the sample, the result is reported in LIMS-Direct as 

“Confirmed Positive”. The O group that was found to be positive will also be 

reported, for example O26 or O111. The confirmatory testing usually takes 3 to 4 

Inspection Methods 18-25 
 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

days after the sample receipt at the FSIS laboratory, but can sometimes take 

longer. 

Presumptive positive and positive sample results are e-mailed to establishments 

that have an e-mail address in the PHIS establishment profile. Negative results 

are not e-mailed to the establishment. Even if the establishment receives 

sample result notifications by e-mail, it is still your responsibility to notify

the establishment when sample results are posted on LIMS-Direct. 

Note: Positive Salmonella results from raw ground beef samples submitted to 

the laboratory under project code MT43S will not have any immediate regulatory 

consequences. Therefore upon receiving negative E. coli O157:H7 results from 

the same sample (MT43) you are to notify the establishment that it may release 

any affected product on hold. If you receive the Salmonella results before the E. 

coli O157:H7 results, you should wait to notify the establishment until you receive 

the E. coli O157:H7 results. 

Inspection Methods 18-26 
 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Workshop I 

1. When would a ground beef sample be sent to the lab for an E. coli O157:H7 

directed sample? 

a. the day before the “use by” date 

b. just prior to packaging 

c. as soon as the contract carrier is available after the sample is collected 

d. as soon as the lot is assembled 

2. Establishment management is notified that you are taking a sample 

a. when you receive the analysis result (either from LIMS-Direct or the DO). 

b. if the establishment has a good working relationship with FSIS. 

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). 

Scenario 

1. You received a directed sample request on your task list for a raw ground 

beef or veal sample under the MT43 project code. This is the first time you 

have received this type of sample request. 

As a critical thinker, what do you do next? 

The instructions tell you to randomly select and aseptically collect an unfrozen 

two pound sample prior to freezing. The establishment receives beef 

trimmings and chubs of ground beef. The chubs may be added to the beef 

trimmings and ground, or they may be shipped without any further 

processing. The ground beef and beef trimmings are ground into ground 

beef, ground beef patties with seasoning ingredients, raw beef and pork 

sausage, and cooked meatloaf. The establishment has one grinder and does 

a complete cleaning and sanitizing of the equipment prior to the start of 

operations each day. 

Inspection Methods 18-27 
 

 

Raw Beef Product Sampling 

11-03-2021 

What product could you sample for the E. coli O157:H7 under this 

project? 

When would you notify establishment management that you will take a 

sample? 

What should you do after you collect and submit the sample? 

Inspection Methods 18-28 
 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

FSIS Actions after a Positive FSIS or another Federal or State 

Entity Sample Result 

FSIS Directive 10,010.2, Verification Activities for Shiga Toxin-Producing E. coli 

(STEC) in Raw Beef Products, provides instructions on the actions to take 

following a positive sample result. 

FSIS Presumptive Positive Sample Result 

The lab notifies the DO using BITES (Biological Information Transfer E-mail 

System) prior to posting the information in LIMS-Direct if the sample is 

presumptive positive for E. coli O157:H7 or one or more non-O157 serogroups, if 

applicable. Because the laboratory confirms most “presumptive positives”, the 

contact person in the DO where the establishment is located alerts the 

establishment if the sample is “presumptive positive.” This ensures that the 

establishment receives that important message when you are not available. The 

DO contact will also inform the establishment if the results are confirmed positive. 

Even though the establishment may already know about the presumptive positive 

or confirmed positive result, you are still required to notify the establishment of 

the presumptive positive and confirmed positive result. 

Confirmed Positive Sample Result 

When an FSIS laboratory or another Federal (Agricultural Marketing ServiceAMS) or State entity confirms a sample is positive for E. coli O157:H7 or a nonO157 serogroup the DO accesses the System Tracking E. coli O157:H7 – 

Positive Suppliers (STEPS), and opens a case file for the incident. The DO 

enters all the supplier information you gathered into STEPS. The DO is also 

responsible for determining whether any of the supplying establishments were 

also originating supplying slaughter establishments that produced the source 

materials that were used in the raw beef product that tested positive for E. coli 

O157:H7. Follow-up samples are collected from originating supplying slaughter 

establishments. 

With respect to supplying establishments that are not originating supplying 

slaughter establishments, the DO is to inform the IIC to collect supplier 

information on the source materials that went into the lot represented by the 

positive sample and forward the information to the DO. 

Enforcement Actions Based on FSIS and Establishment Test Results 

Before you can determine whether to document the positive result as a 

noncompliance, you need to gather information. You need to determine if the 

Inspection Methods 18-29 
 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

establishment has its own E. coli O157:H7 sampling program for its raw beef 

products or whether it tests for non-O157 STEC or virulence markers. If the raw 

beef product sample you submitted is positive for E. coli O157:H7 or one or more 

non-O157 STEC serogroups and the establishment tested the same product, 

check the establishment’s test results to determine whether it also found the 

sampled product positive for E. coli O157:H7 or one or more non-O157 STEC 

serogroups. 

If the establishment held the product or maintained control of the product pending 

its own test results, and FSIS AND the establishment found the product positive 

for E. coli O157:H7 or one or more non-O157 STEC serogroups, you do not 

issue a noncompliance record (NR). For example, if a sample of beef 

manufacturing trimmings tested positive for E. coli O26 and the establishment 

tested a sample from the same lot and found it positive for E. coli O157:H7 you 

would not issue a noncompliance record because they found the product positive 

for a Shiga-toxin producing Escherichia coli (STEC) organism. Even if the type 

of STEC positive did not match, you would still not an issue an NR. 

If the establishment has a documented procedure for diverting all product lots 

that are sampled by FSIS, you would issue an NR, unless the establishment also 

tested the product and found a positive. Verify that the product is diverted per 

the written program. The establishment must take corrective action per 9 CFR 

417.3. If the establishment doesn’t take CA, then issue an NR. 

Issue an NR when FSIS finds product positive for E. coli O157:H7, but the 

establishment does not. Use a directed HACCP Verification task for the 

appropriate processing category, and cite §417.4(a) and §301.2 as the relevant 

regulations. Verify that the establishment has held on-site or maintained control 

of the affected product. When issuing the NR, review documentation to 

determine whether there have been previous NRs for positive product sampling, 

and if so consider whether it is appropriate to associate the NRs. 

In addition, if the establishment has its own testing program, review its records to 

determine if the establishment has found multiple E. coli O157:H7 positive results 

which would be evidence of a systemic problem. Verify the implementation of 

the Sanitation SOP by following the instructions in FSIS Directive 5000.1and 

5000.4. Verify sanitary dressing procedures, if the positive result is from beef 

manufacturing trimming or other components produced at a slaughter 

establishment. If the establishment delays disposition of the positive product, you 

are to work with your FLS to determine how to work with the establishment to 

ensure timely disposal of the product. 

Inspection Methods 18-30 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Establishment management must account for all affected products by identifying 

them and their location. Establishments are expected to ship only wholesome 

unadulterated product. The establishment is responsible for determining what 

product it holds and what it determines to be affected product. (FSIS Directive 

8080.1 contains more information related to affected product.) If the 

establishment does not control its product, then take a regulatory control action 

(retain product if it is available or take a withholding action per §500.3(a) (1) if the 

establishment shipped the adulterated product into commerce). If any affected 

product has left the establishment and it is no longer under the establishment’s 

control, notify the DO immediately. A recall may be recommended. 

Continuing with that HACCP Verification task, determine whether or not the 

establishment implements corrective actions that meet the requirements 

described in §417.3. The establishment must take corrective actions that meet 

one of the following requirements. 

• 417.3(a) if E. coli O157:H7 or STEC is addressed in the HACCP plan, or 

• 417.3(b) if E. coli O157:H7 or STEC is not addressed in the HACCP plan, or 

if it is addressed in prerequisite programs, or 

• 417.3(b) and 416.15 if E. coli O157:H7 or STEC is addressed in the 

Sanitation SOP. 

The establishment may need to conduct a reassessment of its HACCP plan or 

reevaluate its Sanitation SOP or prerequisite programs to meet these 

requirements. In addition, the establishment should reassess (§417.4(a) (3)) 

because something in the process has changed. Issue an NR if the 

establishment fails to take the appropriate corrective actions. 

In addition, you will conduct follow-up sampling, per instructions later in this 

module. You will verify that products that test positive for STEC receive 

appropriate disposition. Positive product may be treated with a lethality 

treatment to destroy the pathogen (cooking), rendered, or disposed of in a 

landfill. 

If product disposition is to occur off-site, verify that the establishment maintains 

appropriate control of the product as explained in the next section. 

Off-Site Disposition of E. coli O157:H7 or non-O157 Positive Product 

Raw beef products confirmed positive for E. coli O157:H7 or a non-O157 

serogroup may be moved off-site for proper disposition, under appropriate 

controls. Product may be transferred to another official establishment for further 

processing to destroy the pathogen. Establishments may opt to dispose of the 

Inspection Methods 18-31 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

product through rendering or disposal in a landfill. Establishments may also 

divert product that is presumptive positive, rather than wait for a confirmation. 

Presumptive positive product must be controlled just like confirmed positive 

product. Establishments may use their own controls (company seals) or move 

the product under FSIS control (using USDA seals or FSIS Form 7350-1, 

“Request and Notice of Shipment of MPI Sealed Meat/Poultry”). When the 

product is destined for a landfill or rendering operation, it moves under company 

controls, because FSIS representatives are not at those locations to remove 

USDA seals or follow up with FSIS Form 7350-1. 

When the establishment moves presumptive positive or positive product off-site 

for disposition, verify the establishment that produced the positive product 

maintains appropriate control of the product at all times, including while it is in 

transit to the off-site location where the product will either be processed to 

destroy pathogens before entering commerce or be disposed of so it will not be 

used for human consumption. 

When you perform a directed follow up HACCP Verification task verify 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 (through company seals); 

Note: If an establishment ships adulterated product to a renderer or landfill 

operation, you are to verify the establishment denatures the product before 

the product leaves the establishment (9 CFR 314.3). 

• Maintained control of product that was destined for an official establishment 

while the product was in transit (through company seals) or ensured that 

such product moved under FSIS control (under USDA seal or accompanied 

by FSIS Form 7350-1); 

Note: An instructional “For Cooking Only” statement on the container label 

is not a sufficient control. 

• Maintained records showing that every lot of product implicated by the 

positive test result received appropriate disposition, including documentation 

showing proper disposal of the product from the official establishment, 

renderer, or landfill operation where disposition occurred; and 

Inspection Methods 18-32 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

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Note: Records of receipt at an official establishment, landfill operation, or 

renderer are not adequate to show that the product received appropriate 

disposition. Documentation (a record) from the official establishment, 

landfill operation, or renderer must show that the positive product was 

further processed to destroy E. coli O157:H7 or the specific product was 

destroyed. For example, a record of receipt and control until the product 

receives a lethality treatment. The record should include information 

necessary to identify the product, the number of pounds of raw beef product 

received and the number of pounds rendered or destroyed. 

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

received the records described above for that particular product. 

You cannot complete the HACCP Verification Task for the specific production 

until the establishment completes the corrective action and documentation 

requirements (417.3(a) or 417.3(b) and 416.15), which includes receiving 

documentation from the official establishment or landfill operation or renderer that 

demonstrates proper disposition/disposal of every lot implicated by the positive 

result and conducts pre-shipment review of the corrective actions. 

Note: If the product is shipped to another official establishment for disposition 

(for example, cooking), IPP at that establishment are to verify that the receiving 

establishment adequately addresses the pathogen in the product as part of their 

ongoing verification duties. 

Issue an NR if you find noncompliance while verifying the establishment’s off-site 

product disposition corrective actions. Document the noncompliance under the 

appropriate task, depending on where STECs are addressed in the 

establishment’s food safety system. 

Verification Activities at an Establishment Receiving E. coli O157:H7 or 

non-O157 Positive Product 

If you are the inspection program employee at the establishment that receives 

raw ground beef products, beef manufacturing trimmings, or other raw ground 

beef components, or raw beef patty components that tested positive for E. coli 

O157:H7, you have certain verification functions to perform to ensure the 

establishment adequately addresses the pathogen in the product. 

Inspection Methods 18-33 
 

 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

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When you perform a HACCP Verification task for such products, verify that the 

establishment: 

• documents receipt of presumptive or confirmed positive product (as per 

§417.5), 

• maintains control of the product, and 

• addresses the receipt E. coli O157:H7 in its hazard analysis, flow chart, 

and HACCP plan (which includes an adequate lethality treatment to 

destroy the pathogen). 

You are not required to be present at the establishment to verify the disposition 

of the raw beef product that is positive or presumptive positive for E. coli 

O157:H7 or one of the six non-O157 serogroups. You can verify that the product 

received proper disposition through records review. 

Note: You are to verify that the establishment has supporting documentation 

validating the effectiveness of the lethality treatment during the Hazard Analysis 

Verification task. 

Note: FSIS does not require establishments to re-test product for E. coli 

O157:H7 after the establishment subjects the product to a lethality treatment 

adequate to destroy the pathogen. 

Document all noncompliance as per PHIS FSIS Directive 5000.1. 

FSIS Verification Activities at Supplying Establishments when a Raw Beef 

Product at an Official Establishment or Retail Facility Tests Positive for E. 

coli O157:H7 or a non-O157 serogroup 

When raw beef products are confirmed positive, FSIS will conduct verification 

activities at supplier establishments, including the originating supplying slaughter 

establishment that produced the source materials that were used to produce the 

positive product. The DO will contact the IIC at each of the supplying 

establishments, including the originating supplying slaughter establishments. If 

you are at the supplying establishment, remind the establishment that the 

notification is to ensure that the supplier knows that it could be the source of 

positive product. The IIC at the supplying establishment will ensure that a 

HACCP Verification Task is performed to verify that the supplier met all the 

HACCP regulatory requirements (monitoring, verification, recordkeeping, and 

corrective actions) at all CCPs in the HACCP plan for source material production 

lots sent to the establishment or retail facility where the positive was found. If the 

Inspection Methods 18-34 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

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establishment has its own E. coli O157:H7 sampling program for its raw beef 

products, IPP are to review establishment records to determine if it has found 

multiple positive results which would indicate there is a systemic problem. IPP 

are to verify the establishment’s control of its sanitary dressing procedures during 

the beef slaughter Sanitary Dressing task per FSIS Directive 6410.1. In addition, 

perform a Hazard Analysis Verification (HAV) task to review the HACCP system. 

Multiple Follow-Up Sampling After an E. coli O157:H7 or non-O157 Positive 

Sample Result 

Each time that an FSIS routine sample or another Federal or State entity’s 

sample of raw ground beef product, ammoniated beef product, beef 

manufacturing trimmings, bench trim, or ground beef or raw beef patty 

components tests positive for E. coli O157:H7 or one or more non-O157 STEC 

serogroups, IPP will receive a directed sample task for 16 follow-up samples to 

sample product from the establishment that produced the positive raw beef 

product. IPP will also receive a directed sample task for 16 follow-up samples 

when FSIS follow-up samples of beef trimmings or other raw beef patty 

components or ground beef test positive for E. coli O157:H7 OR when an 

originating slaughter establishment is the sole supplier or a repeat supplier of 

the source materials implicated in positive sample result. IPP will automatically 

receive sample requests through PHIS to sample product from the establishment 

that produced the positive raw beef product. In addition, IPP will automatically 

receive sample requests as a result of a positive follow-up test of raw ground 

products. All follow-up sampling at originating slaughter establishments is 

generated by PHIS and the Policy Analysis Staff (PAS) as outlined in the next 

section. 

For low volume establishments, (establishments that produce less than 1000 

pounds per day of the product to be sampled), 8 samples need to be collected 

instead of 16 samples. 

The type of sample requested will be based on the type of raw beef product 

implicated in the positive test result. The sampling project code will identify the 

type of raw beef product to sample. 

• MT44 Follow-up sampling of raw ground beef product in response to a 

MT43 or Agricultural Marketing Service (AMS) positive result in raw 

• MT52 Follow-up sampling at suppliers of beef manufacturing trimmings or 

other components from originating slaughter suppliers, in response to a 

MT43, MT65, or AMS ground beef positive result 

Inspection Methods 18-35 
 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

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• MT53 Follow-up sampling of trim or other components at the 

establishment that produced product in response to a MT60, MT65, MT64, 

or AMS trim testing positive 

• MT44T Follow-up sampling of raw ground beef, trim, or other component 

outside of projects MT44, MT53, and MT52 collected by IPP at Federally 

inspected establishment 

Sampling from production lots produced after the positive result starts as soon as 

possible following receipt of the follow-up sample requests. You DO NOT wait for 

the establishment to complete the corrective actions taken in response to the 

positive result before conducting follow-up sampling. 

If the establishment is not currently producing the type of raw ground beef 

component requested, you are to collect a sample of another component that is 

available. You are to sample beef manufacturing trimmings if the establishment 

is producing them. If the establishment is also not producing beef manufacturing 

trimmings, then you are to collect a sample of another type of raw ground beef 

component. 

As soon as the establishment resumes production of the product(s) to be 

sampled, start your sample collection at the following daily and weekly 

frequencies. Collecting follow-up samples in a timely manner is of vital 

importance. 

• Sample a maximum of 2 follow-up samples per shift per day, from different 

lots. 

• At a minimum collect 3 samples per week. 

You may submit more than one sample per shipping container if each sample is 

individually identified and the shipping container is large enough to hold more 

than one sample. Send the sample to the laboratory on the first available day the 

contract carrier picks up after collecting the sample. 

While you are collecting follow-up samples for STEC testing, you may receive a 

routine verification sample request form for a raw beef product to be tested 

for E. coli O157:H7 and potentially non-O157 (for beef manufacturing trimmings). 

In this situation, continue to collect follow-up samples and make follow-up 

sampling the priority, rather than routine sampling. If your workload and the 

establishment’s production practices allow it, collect the sample for routine 

testing within the allotted collection window. Do not collect a follow-up sample 

and a routine verification sample from the same product lot. If it is not possible 

for you to collect the routine sample, you should cancel the sample task and in 

Inspection Methods 18-36 
 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

the justification, state that you did not collect the routine sample because of 

follow-up sampling. 

While you are collecting follow-up samples for E. coli O157:H7 and potentially 

non-O157 testing under one sampling project code, you may receive follow-up 

sample request forms for another project code or the same (repetitive) follow-up 

sampling project code. For example, you may be in the process of collecting the 

16 follow-up samples under project code MT52 when the 3rd sample of this set 

tests positive. As a result of this positive sample result, you will receive 16 

follow-up samples for project code MT53. You are to collect the rest of the 16 

follow-up samples from the MT52 project code as well as the 16 follow-up 

samples for the MT53 project code. 

FSIS will continue to collect follow-up samples after a positive follow-up sample 

result until the FSIS laboratory finds no positive sample results in 16 or 8 

consecutive follow-up samples. For example, if you receive forms to collect 16 

follow-up samples under the MT53 project code, and the 3rd sample of this set 

tests positive, you will then receive 3 more follow-up sampling forms for MT53 

sampling program. As a result of the positive sample result, you would collect 

the remaining 13 follow-up samples and the 3 new follow-up sampling forms for a 

total of 16 follow-up samples. 

Follow-up Sampling at Supplying Establishments 

FSIS has implemented a follow-up sample testing protocol for establishments 

that supply raw beef products to establishments that have had product test 

positive for E. coli O157:H7. 

PHIS generates follow-up sampling tasks at supplier establishments. PHIS will 

send 16 follow-up sample request tasks if the originating slaughter establishment 

was the only supplier, or if an originating slaughter establishment is a repeat 

supplier for each source material used in the positive raw beef product. 

However, when a supplier is not the sole supplier or a repeat supplier, PHIS 

requests a single follow-up sample from the supplier for each source material 

used in the positive raw beef product. 

The DO informs IPP of which type source materials the establishment supplied to 

the beef boning, cut-up, or grinder facility, so that IPP can sample that raw beef 

source material from the establishment’s current production. If the originating 

supplying slaughter establishments produced more than one source material 

used by the boning, cut-up or grinding establishment, PHIS will generate sample 

request tasks, for each type of source material. 

Inspection Methods 18-37 
 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

In combination slaughter/processing establishments, if FSIS or another Federal 

or State entity finds a raw ground beef product positive, and the establishment 

produced the source materials used to produce raw ground beef product that 

tested positive, PHIS generates MT53 sampling program request tasks. IPP are 

to collect either 8 or 16 samples, based on establishment production volume, of 

the type of source materials used in the positive raw ground beef product. IPP 

are not to collect follow-up samples of the ground beef product. 

If ammoniated low-temperature-rendered (LTR) product was used as a 

component in raw ground beef products that tested positive for E. coli O157:H7, 

PHIS generates follow-up sample request tasks. IPP are to collect a sample of 

ammoniated beef trim at the establishment that produced the LTR product, even 

if that establishment is not an originating supplying slaughter establishment. 

If a sample collected under follow-up sampling program tests positive, PHIS 

generates multiple follow-up sample requests. 

Follow the sample collection instructions previously covered in this handout. 

DO and EIAO Responses to Positive Results 

Positive pathogen results will trigger a Public Health Risk Evaluation, PHRE, and 

as a result, the District Office (DO) may schedule a Food Safety Assessment 

(FSA). The follow-up sampling results will provide objective data that an EIAO 

will use in formulating an Agency position when conducting the FSA. In addition, 

the DO may schedule an EIAO to conduct an FSA at establishments identified as 

sole suppliers of positive E. coli O157:H7 product. 

The DO and EIAOs will consider the results of follow-up sampling and take the 

appropriate enforcement actions (e.g., issue an NOIE, withhold or suspend 

inspection, reinstate a suspension), if warranted. 

Establishment-Generated Sampling 

Some establishments have their own sampling and testing programs for E. coli 

O157:H7, non-O157 STEC or virulence markers. Establishments are not 

required to sample and test their raw beef products or raw materials for E. coli 

O157:H7 or non-O157 STEC or virulence markers. What establishments are 

required to do is to conduct a hazard analysis and support the decisions they 

Inspection Methods 18-38 
 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

make in their hazard analysis. Sampling and testing is one way to support 

decision-making. 

Establishments may address their sampling programs in the HACCP system, in 

either the HACCP plan, Sanitation SOP, or in a prerequisite or other supporting 

program. Even if these programs are not addressed in the HACCP system, 

establishments are still required to share records and analyses results with FSIS. 

No establishment that produces raw ground beef products or beef manufacturing 

trimmings and raw ground beef and beef patty components intended to be used 

in non-intact product is exempt from FSIS verification testing for E. coli 

O157:H7, even when the establishment has its own robust testing program for E. 

coli O157:H7, non-O157 STEC or virulence markers. 

Pre-shipment Review - FSIS has taken the consistent position that 

establishments can conduct pre-shipment review when the product is at locations 

other than at the producing establishment provided that the product does not 

leave the control of the producing establishment. Some establishments analyze 

samples for STEC while they are moving the product, but the product is still 

under the establishment’s control 

Review of Establishment Data - Based on the regulatory requirements of 9 

CFR 417.2(a)(1)(2) and 9 CFR 417.5(a)(1), FSIS believes that the results of any 

testing that the establishment performs that may have an impact on the 

establishment’s hazard analysis are subject to FSIS review and must be 

available to IPP upon request, including records from prerequisite programs. 

FSIS Directive 5000.2 states that, on at least a weekly basis, you must review 

the results of any testing and of any monitoring activities the establishment 

performed that may have an impact on the hazard analysis. There is a task in 

PHIS, “Review of Establishment Data” to document the performance of this 

review. Based on review of establishment records, if you have concerns about 

the design of testing, monitoring, or verification activities outside of a HACCP 

plan, or concerns about results from such activities, procedures, or prerequisite 

programs, contact the Policy Development Staff (PDS) or raise the concern 

through supervisory channels. When records show that the establishment tests 

beef trim and raw ground beef components for E. coli O157:H7, but never finds 

any positives, you are to contact the DO. In addition, when establishment testing 

records show multiple positive results for E. coli O157:H7, non-O157 or 

virulence markers that may be evidence of a systemic problem, you are to 

contact the DO. It may be determined that an EIAO needs to conduct a food 

safety assessment to assess such factors as what the test results reveal about 

food safety and whether the design of testing, procedures, or prerequisite 

Inspection Methods 18-39 
 

 

 

 

 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

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programs are adequately supported by the decisions made in the hazard 

analysis. 

If the Establishment Rejects Product From Suppliers - An establishment may 

sample raw beef products for E. coli O157:H7, non-O157 STEC or virulence 

markers when they are received and hold the production lot pending the sample 

result. If the product is presumptive positive or positive for E. coli O157:H7 or 

non-O157, the establishment considers the product to be adulterated, does not 

accept the production lot, and returns the lot to the supplying establishment using 

FSIS Form 8140-1, “Notice of Receipt of Adulterated or Misbranded Product” 

under appropriate controls (e.g., company seals or FSIS seals). After the 

establishment notifies you that it has rejected the production lot, collect the 

supplier information. You need to notify the DO (9 CFR 320.7) and include the 

supplier information in your e-mail. The DO is to notify the IIC at the supplying 

establishment that rejected product is being returned and have IPP at the 

establishment conduct a HACCP Verification task on the affected lot of product. 

Note: The Agency recognizes that it is probable that, despite the ongoing 

processing interventions for controlling E. coli O157:H7 and non-O157 STEC, 

some establishment samples of beef manufacturing trimmings and raw ground 

beef and beef patty components may test positive for E. coli O157:H7 or one or 

more of the six non-O157 STEC serogroups tested for by FSIS. These positives 

may be random events caused by normal process variation, or may have an 

identifiable, assignable cause that can be acted upon as part of corrective 

actions. Establishment verification testing should occur at a frequency to help 

determine the difference between acceptable process variation and assignable 

cause variation in the testing results associated with beef manufacturing 

trimmings and raw ground beef and beef patty components. Through this 

statistical analysis, the establishment will be able to justify whether corrective 

actions to address an assignable cause are appropriate and sensible. 

If the Establishment Performs Only Screening Tests - If review of the 

establishment’s E. coli O157:H7 and/or non-O157 sampling program reveals it is 

only performing screening tests and not further analyzing “potential positive” test 

results to determine whether E. coli O157:H7 or non-O157 is isolated from the 

product, e.g., presumptive positive or confirmed positive, you are to verify that 

the establishment appropriately addresses the product as if the product is 

positive for E. coli O157:H7 or non-O157. The establishment cannot perform a 

second screening test for E. coli O157:H7 or non-O157 on the product and find it 

negative. Performing additional screening tests does not negate the original 

positive screening test. A screening test is not a conclusive (specific) test for the 

pathogen. 

Inspection Methods 18-40 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

If the establishment has a positive result from its own sampling program -

The establishment is not obligated to notify FSIS when it receives a presumptive 

positive or a positive sample result, but it must take corrective actions that 

meet the requirements of §417.3 each time a presumptive positive or a positive 

result is obtained. The establishment must also maintain appropriate control for 

any product that is presumptive positive or confirmed positive for E. coli O157:H7 

or one of the six non-O157 STEC serogroups that is shipped to another 

establishment, or to a landfill or renderer for appropriate disposition. 

FSIS Actions - When you are aware that there was a presumptive positive or 

positive result in establishment testing, you must: 

• Conduct a HACCP Verification Task to verify the establishment’s corrective 

actions (§417.3(a) or (b)), and 

• Issue an NR only if the establishment fails to implement the corrective 

actions that meet the requirements of §417.3(a) or (b). 

Note: The HACCP Verification Task cannot be completed until pre-shipment 

review is completed, which includes the establishment’s review of disposition 

documentation. 

Example 2

An establishment has its own testing program for E. coli O157:H7 for its raw 

hamburger patties. The establishment has not included it as a verification activity 

in its HACCP plan. In the last test, the result was positive. The establishment 

always holds product pending results. The establishment does not need to 

inform you of its positive result, but the establishment must implement corrective 

actions that meet the requirements of 9 CFR 417.3(b). You must verify that the 

establishment took the necessary corrective actions to meet these requirements, 

by performing a HACCP verification task. You should become aware of the 

positive from your weekly review of the establishment’s sampling results, or from 

reviewing corrective action records, or observing corrective actions the 

establishment takes. 

Example 3

An establishment has its own testing program for E. coli O157:H7 in its beef trim. 

The testing is part of the verification of the overall HACCP plan. The 

establishment analyzes the samples while the product is in transit, but still under 

the establishment’s control (not in commerce). When a negative result is 

Inspection Methods 18-41 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

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received, the establishment completes the pre-shipment review, and product is 

released into commerce. 

The last test result was positive. The establishment must implement corrective 

actions that meet all four requirements of 9 CFR 417.3(a). 

Whether the establishment brings the product back to the establishment for 

disposition, diverts it for further processing at another official establishment, or 

sends it to a landfill or renderer, the establishment must demonstrate control of 

the adulterated product until that product receives proper disposition. The 

establishment must receive documents proving proper disposition. Only after 

proper disposition of the product is documented should the establishment 

complete the pre-shipment review for that specific production. 

Example 4

The establishment has a finished product sampling program as part of its 

verification of the HACCP plan for raw ground beef product. Its last sample was 

presumptive positive. 

The establishment diverted the product to cooking at its own in-plant cooking 

operation. It identified all affected product and cooked it separately from its other 

products. The company used a HACCP plan that had been designed specifically 

for product known to contain E. coli O157:H7 and which contains a CCP for 

lethality that was validated to eliminate E. coli O157:H7. Records demonstrating 

the positive product received proper disposition are available. 

The establishment identified the source of the presumptive positive E. coli 

O157:H7 contamination as coming from a new supplier. Establishment 

management required the supplier to demonstrate that validated antimicrobial 

interventions are implemented in its process, sample and test its product for E. 

coli O157:H7 and provide a Certificate of Analysis (COA) with each shipment 

before purchasing any other products from that supplier. The establishment 

includes this certification as a HACCP verification. 

Inspection Methods 18-42 
 

 

 

 

 

Raw Beef Product Sampling 

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Summary 

Currently, several STEC serogroups – E. coli O157:H7 and six non-O157 STEC 

(O26, O111, O121, O45, O145, O103) are a public health concern associated 

with raw beef products. Therefore, FSIS is analyzing beef manufacturing 

trimmings, bench trim, other raw ground beef components and ground beef for E. 

coli O157:H7. FSIS is also currently analyzing beef manufacturing trimmings for 

six non-O157 STEC in addition to E. coli O157:H7. 

If you are assigned to a beef establishment you may perform sampling for food 

safety concerns. 

When an FSIS sample for a raw beef product is confirmed positive for E. coli 

O157:H7 or one or more of the six non-O157 STEC, and the establishment has 

not found the same product to be positive, issue an NR for HACCP 

noncompliance, verify the establishment’s corrective actions, check appropriate 

decision-making documents, assist as needed in any recall, and conduct a 

HACCP Verification task on the specific production that tested positive. You 

cannot complete the task until the establishment has taken corrective actions and 

the product has received proper disposition (including completing a pre-shipment 

review). If the establishment maintained control of the product and sampled it, 

and both the establishment and FSIS samples were found positive for E. coli 

O157:H7 or a non-O157 STEC serogroups, you are NOT to issue a 

Noncompliance Record. You must verify that the establishment’s corrective 

actions meet the requirements in §417.3. 

If you find regulatory noncompliance, e.g., the establishment fails to take 

corrective action in accordance with §417.3, while performing the HACCP 

Verification Task, document it on an NR (as per FSIS Directive 5000.1). If you 

find that the establishment moved positive product without the necessary 

controls, or if you find that the establishment does not have records documenting 

proper disposition of the positive product moved off-site, contact your DO through 

supervisory channels. 

As new technologies and methods of producing products are developed, and as 

new pathogens emerge that affect meat and poultry food safety, FSIS will adjust 

its efforts to continue being a public health agency. New or different 

microorganisms may be added to the list of those for which the Agency currently 

tests. It will continue to be the responsibility of the in-plant inspection force to 

verify that establishments meet their food safety obligations. 

Inspection Methods 18-43 
 

 

Raw Beef Product Sampling 

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Workshop II 

1 Which products, when confirmed positive for E. coli O157:H7 are considered 

adulterated? 

a. Mechanically tenderized beef steak 

b. PDBFT for use in raw beef patties 

c. Beef trimmings for use in grinding 

d. Beef sub-primals boned for use in raw ground beef 

e. Raw ground veal patties 

2. If the establishment sends presumptive positive product for E. coli O157:H7 to 

a landfill, what are the requirements to do so? 

3. If the establishment sends presumptive positive product for a non-O157 

STEC such as E. coli O26 to a landfill, what does the CSI do? 

Inspection Methods 18-44 
 

 

 

 

 

 

Raw Beef Product Sampling 

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Scenarios 

1. The establishment where you are assigned slaughters and fabricates beef. It 

samples its own beef trimmings as a prerequisite program. On Thursday 

afternoon, as part of the Review Establishment Data task, you decide to 

review these records. You go to the office where the records for the 

prerequisite program are kept and review the sampling results. You notice 

that on Monday morning, the beef trim tested from the previous Wednesday 

was confirmed positive for E. coli O157:H7. What are your responsibilities in 

this scenario? 

2. Last week, you submitted a sample of the establishment’s raw ground beef 

patties to the FSIS lab. Three days ago you notified the establishment that 

the sample was presumptive positive. Today, when you arrived at the 

establishment, the establishment manager told you that he’d been informed 

by the District Office that the sample was confirmed positive. What are your 

responsibilities in this scenario? 

Inspection Methods 18-45 
 

 

 

 

Raw Beef Product Sampling 

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PHIS Hands-on Activities 

Managing Workload 

Objective: 

• Use task calendar functions to manage your workload. 

• Review tasks by priority on the task calendar. 

• Reschedule, remove or cancel tasks based on priorities. 

• Use calendar functions to view another inspector’s work, reschedule tasks 

when covering for another inspector. 

Scenario: 

• As a result of a positive E. coli O157:H7 finding at Groveton Meats, Robert 

Barclay will schedule follow-up sampling tasks. 

• Due to the time needed to do these tasks, Robert Barclay will review his 

schedule and reschedule lower priority tasks. 

• Since Open Beef was identified as the sole supplier to Groveton Meats, 

IIC Phyllis Isaacs directs Robert Allen and Jeb Morwork to re-arrange 

tasks at Open Beef based on priority. 

• Jeb and Robert will schedule sampling tasks and other directed tasks 

associated with the positive finding. 

Exercise #1 Groveton 

Because of their low priority and the time needed for the E. coli O157:H7 positive 

result, Robert Barclay reschedules tasks as follows. In addition, he will schedule 

directed tasks. 

Robert Barclay at Groveton 

Task Name 

Action 

General Labeling Remove from schedule 

Food Defense - Water Systems Remove from schedule 

Labeling-Net Weight Re-schedule for any date next week 

Pre-Op SSOP Record Review Add a directed task today 

Operational SSOP Record Review Add a directed task today 

MT44 Sample Request Add two tasks for today 

Inspection Methods 18-46 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

1. Log in to PHIS and Select User Robert Barclay. 

2. Select Task Calendar from the navigation menu. 

3. From the Task Calendar, scroll to the calendar section. Filter the calendar 

by Inspector Robert Barclay and the establishment Groveton Meats. 

4. View Robert Barclay’s planned tasks. 

5. Right-click on Barclay’s General Labeling task and click Remove. 

6. Right-click on Barclay’s Food Defense - Water Systems task and click 

Remove. 

7. Right-click on Barclay’s Labeling-Net Weight task and click Edit. Change 

the scheduled date to any date next week. 

8. Scroll up to the Task List section. 

9. Find the task Pre-Op SSOP Record Review in the task list for February. 

Click the Add link in the Directed column. Add 1 task for today and use 

Response to Alert Notification for the reason. 

10.Find the task Operational SSOP Record Review in the task list for 

February. Click the Add link in the Directed column. Add 1 task for today 

and use Response to Alert Notification for the reason. 

11.Find the task MT44 Sample Request in the task list for February, and 

then click the “Add” button in the assign column. Next use the calendar 

icons to set the “Collection Date” and Parcel Pick Up Date” for today and 

click “Save”. Add two sample requests today. 

12.Scroll down to the calendar view and ensure that the tasks have been 

added to the calendar. 

13.Sign Out of PHIS. 

Exercise #2a Robert Allen at Open Beef 

Robert Allen is asked to shuffle tasks based on priority. Because Open Beef was 

the sole supplier and originating slaughter establishment for Groveton’s lot which 

had the positive result, Allen has a list of follow-up tasks to perform, including 

sampling. 

Inspection Methods 18-47 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

Robert Allen at Open Beef

Task Name 

Action 

MT52 Sample Request Schedule 2 sample tasks today 

Pre-Op SSOP Record Review Schedule a directed task today 

Operational SSOP Record Review Schedule the routine task as 

directed for the next working day 

Storage Areas Remove 

General Labeling Remove 

MSS, PDBFT, PDPFT, PDCB, 

PDCP, AMRS 

Remove 

MT60 – Routine Testing of 

Domestic Raw Beef Manufacturing 

Trimmings 

Reschedule for 2/24 

Pre-Op SSOP Review and 

Observation 

No change 

1. Log in to PHIS and Select User Robert Allen. 

2. Select Task Calendar from the navigation menu. 

3. Scroll to the task list. Filter by Establishment = Open Beef 

4. Filter the type of task by Lab Sampling and find the task MT52 Sample 

Request in the task list for February, then click the “Add” button in the 

Assign column. Next use the calendar icons to set the “Collection Date” 

and “Parcel Pick Up Date” for today and click “Save”. Schedule two 

samples for today. 

5. Find the task Pre-Op SSOP Record Review in the Domestic task list for 

February. Click the Add link in the Directed column. Add 1 task for today 

and use Response to Alert Notification for the reason. 

6. Find the task Operational SSOP Record Review in the task list for 

February. Click the Add link in the Directed column. Add 1 task for the 

next working (active) day on the schedule and use Response to Alert 

Notification for the reason. 

7. Scroll to the calendar view. Filter the calendar by Inspector Robert Allen 

and the establishment Open Beef. Ensure that the two sampling tasks and 

the two sanitation record review tasks have been added to the calendar on 

the correct dates. 

8. View Robert’s planned tasks. 

Inspection Methods 18-48 
 

 

 

 

 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

9. Remove the following tasks: 

a) Food Defense - Storage Areas 

b) General Labeling 

c) MSS, PDBFT, PDPFT, PDCB, PDCP, AMRS 

10.To reschedule the routine sampling task, right click on MT60 and 

select Cancel/Reschedule. From the Lab Sample Cancel or Reschedule 

screen, select Reschedule this task. Select 2/24 for the Collection and 

Pickup Dates and click Save. 

11.Sign out of PHIS. 

Exercise #2b Jeb Morwork at Open Beef 

Jeb Morwork is another CSI assigned to Open Beef. He helps Robert Allen by 

making more room on Robert’s schedule, taking some of the necessary tasks, 

and reassigning some of Robert Allen’s tasks to himself as follows: 

Jeb Morwork at Open Beef 

Task Name 

Action 

Directed Slaughter HACCP Schedule the directed task for today 

Beef Sanitary Dressing Schedule the routine task as 

directed for today 

Livestock Humane Handling Schedule routine task for today 

Livestock Zero Tolerance Verification Re-assign from Robert Allen to 

himself 

1. Sign into PHIS and Select User Jeb Morwork. 

2. Select Task Calendar from the navigation menu. 

3. Scroll to the Task List. 

4. Find the Directed Slaughter HACCP task with a February date. Click the 

Add link in the column. Add 1 task for today and use Response to Alert 

Notification for the reason. 

5. Find the task Beef Sanitary Dressing in the task list for February. Click 

the Add link in the Directed column. Add 1 task for today and use 

Response to Alert Notification for the reason. 

Inspection Methods 18-49 
 

 

 

 

Raw Beef Product Sampling 

11-03-2021 

6. Find the Livestock Humane Handling task for February. Schedule this 

as a routine task for today. 

7. Scroll down to calendar view and ensure that the three tasks you just 

scheduled have been added to the calendar on the correct date. 

8. Filter the calendar by Inspector Robert Allen and the establishment Open 

Beef. Now Jeb is looking at Robert’s tasks. 

9. Right-click on Robert’s scheduled task Livestock Zero Tolerance 

Verification and select Edit. Notice that the task is now assigned to Jeb. 

Click Save. 

10.Ensure that Robert’s tasks have been reassigned to Jeb. Filter the 

calendar by Inspector Jeb Morwork, then Robert Allen, then All, to see the 

tasks. 

11.Sign out of PHIS. 

Review - PHIS Fundamentals 

When logging in to PHIS for the first time during the work day, IPP should 

: 

1. Review Alerts 

2. Review Task List for New Directed Tasks 

3. Review Current Task Schedule 

4. Add any New Directed Tasks to Calendar 

5. Adjust Scheduled Tasks as necessary 

Inspection Methods 18-50 
 

 

 

Raw Beef Product Sampling 

11-03-2021 

ATTACHMENT 1 

Resources 

Industry Compliance Guides 

FSIS Guidelines | Food Safety and Inspection Service (usda.gov) 

• Compliance Guideline Controlling Meat and Poultry Products Pending 

Products Pending FSIS Test Results 

https://www.fsis.usda.gov/sites/default/files/media_file/2021-09/FSIS-GD2013-0003.pdf 

• Compliance Guidelines for Establishments on the FSIS Microbiological 

Testing Program and Other Verification Activities for Escherichia coli 

O157:H7 

• Compliance Guideline for Establishments Sampling Beef Trimmings for 

Shiga Toxin-Producing Escherichia coli (STEC) Organisms or Virulence 

Markers https://www.fsis.usda.gov/sites/default/files/import/ComplianceGuide-Est-Sampling-STEC.pdf 

•

FSIS Microbiology Laboratory Guidebook

https://www.fsis.usda.gov/news-events/publications/microbiologylaboratory-guidebook 

Articles 

Law, D. A Review: Virulence factors of Escherichia coli O157 and other Shiga 

toxin-producing E. coli. Journal of Applied Microbiology 2000, 88, 729-745 

Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones 

JL, and Griffin PM. 2011. Foodborne illness acquired in the United States – major 

pathogens. Emerg Infect Dis. 17(1):7-15. 

Inspection Methods 18-51 
 

 

Raw Beef Product Sampling 

11-03-2021 

ATTACHMENT 2 

Discard Reasons 

Several discard reasons that may apply to raw samples are listed here. Your 

frontline supervisor has access to this information and monitors the number of 

discarded samples. You should review the sample and paperwork before 

submitting them to the lab to ensure these mistakes are not made. 

Delayed Shipment (FedEx doesn’t get sample to the lab in 24 hour time frame) 

Missing Date 

Sample Container Leaking 

Sent to Wrong Lab 

Temperature Too High 

Container Damaged 

Insufficient Sample 

Collected Outside Scheduled Time Frame 

Shipped on Friday w/o Saturday Delivery label 

No Form Received with Sample 

Laboratory Problem 

No Gel Packs/Coolants in Sample Box 

Sample Container Leaking 

Collection Date Not Day Prior to Sample Receipt 

Sample ID # on Bag does not match ID # on Form 

Security Seal Missing or Not Intact 

No Accredited Lab Tests Performed 

Headquarters/ PDS/DO Discard 

Sampling Instructions Not Followed 

Inspection Methods 18-52 
 

 

IJ.S. DE!PARTMENT ·OF AGfflCU1LJlli:lE 

FOOD s:Af1ETY AiNtil IHS'.?EGTIONSERVICE 

SAMPLE ANALYSIIS REQUEST FO.RIII 

-----------------------~ ' - RNl.aUSIIOll'Y- ' PJ'illcti ' ' ' ' Silmjlill S8i1I -------------------------- tabill ffMI 

COl..LECTION INFORIIATIOII 

11. SAMPLE FORM ll!l: 7 . ESTA6USH:MENT ID: 

2. PROJECTC-OOE. MT4!il II-. ESTA5USl1:MENT Wi.ll,IE' 

J,. SAMPI..E SOURCE: Prollucl-Raw-8ol.llld. COJm\lllJB!d, 9. COUECTI.ON DATE: 

orotl'H!nM)Ee 1'111111~ 

4.Atu.L'l'SIS: E. co 0157:ti7 10. SHIPMENT 0-.TE: 

11--COU!.ECTOR ttl'IME: 

t2. COU!.l:CTOR PlitONE: 

5. ASSIGNED LAB: t,lkrfti&Jem LiillOralory jS'I. LDIAS.,MO) 

ii. Dl!SlfflCTJ'CIRClllT: J5-SJl{lngl:l2,AR 

Pl«JOO'CT INFORMATION 

13. PlilOOUCT NAME: Gmulill.Eiil!!!t 

1\11.. PlilODUCTJON DATE Di7iDl/21l13 

t5.. LOT NlJMBE!R: 

Hi. IS P,A!OOUCT HEI.D: 'l'e6 

17. COIJ..ECillDN RaAARK!: 

18,. (11A,Pflllll:allil8J 

QUESTl!ltlliAIHE 

D7.-J!Z121l\3 

D7.-J2J21J1,3 

$ IGliATl!IRE: _____________ _ DlilE: _____ _ 1]1111,TE; ___ _ 

FOR. I.ABORATORY USE ONLY 

farm ID: 

Ill 111111111111111111 

lti-l'lnlltJ=II COdo ~Eq,blit 

PA:GE I OF 2. ~---------------, 

FSIS FORNI BOClll•- 18 (121i11Ji12] I I 

I I 

·- ---------------· 

I 

I 

I 

Raw Beef Product Sampling 

11-03-2021 

ATTACHMENT 3 Sample Analysis Form 

100006478 

100006478 

100006478 M38 

Groveton Meats, LLC 

Robert Barclay 

(555) 555-5555 

9225B 

Training Example Only 

Inspection Methods 18-53 
 

 

l.l.S. DEPARTMElfl" OF AGR.K:Ul!.JURE 

FOOD s:AflEnl' ANlil INS!PECTIOH SERVICE 

SAMPLE ANALYSIS REQUEST FORII 

Time al 5all1lf!! ClClfectloll ,f_Hl1MM~ 

\'la!; plarll mamagemerrl: noimedl Df illll; 1&ll! eoliedaln? 

Clled: one: 

16,UE &Ullmllied! ianp~ beel II Ye-al? 

Hb-w mn,- pouldSor procllcl a~~ lb)' 1111&~? Ei1h!t" mmbers or&y. 

l'IIIW1d!; d!J11(111d lbeeliffi ~pro:IOOll6-Cl1 a~ da)',[a ll lillll!!;) ­

i;ell!CI ~ : 

E&tul!lmer:llcoobdperaom;. name: 

Ei&bbllmmer:llcoobd.pllOO!! nLmllbe!r: 

~ I& procllcl l:lekl? 

.JIGNATl.att:: ______________ _ ilil ill.E: _____ _ 

11!110 

Yes 

Form ID:· 

A&ep1!callyeolleded r(Wlqill II.lg,} 

Beel 

111 MOie ll1ill1 z:;u.lJW' 106.. 

U ll1irH!~ 

DATE: ___ _ 

FOR. I.ABORATORY USE OIL\' 

~~ 

PA:GE 2 OF 2 

FSIS FCffl.11 BOCE1- IB (121'11112] r- - - - - - - - - - - - - - - -. I I 

I I l---------------~ 

Raw Beef Product Sampling 

11-03-2021 

100006478 

9999 

Jeff Irvine 

(555) 555-5555 

Training Example Only 

Inspection Methods 18-54