Raw Beef Product Sampling

6/9/2014

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 subject to 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 E. coli (STEC) annually
(Scallan et al, 2011). E. coli O157:H7 is the most well known STEC and,
according to the CDC, 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 more than 50 non-O157 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. In the U.S, at least one outbreak and several sporadic illnesses from
non-O157 STEC serogroups have been associated with ground beef products. In
2012, FSIS began testing beef manufacturing trimming from cattle slaughtered
on-site after June 4th for six non-O157 STECs.

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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
adequate for non-O157 STEC, therefore, establishments do not have to consider
non-O157 STECs in their hazard analysis unless sampling history or other
information indicates they are a hazard reasonably likely to occur.

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. Establishment records and HACCP documents such as the hazard
analysis should identify the intended use of intact raw beef products. 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.

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 science-
based 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.

FSIS Policy - FSIS directives contain policy details specific to sampling projects
and programs (see Attachment 1). 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

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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. New policy often requires that IPP meet with
establishment management to discuss the information, and those awareness
meetings must be documented in a Memorandum of Interview (MOI).

FSIS Directive 10,010.1, Verification Activities for Escherichia coli O157:H7

in Raw Beef Products contains key concepts and instructions regarding the
testing of raw beef products for E. coli O157:H7. These include:
 Collecting and submitting samples of raw ground beef, and other non-
intact raw beef products and intact beef products intended for use in raw
ground beef products,
 FSIS actions after an E. coli O157:H7 positive sample result,
 Verifying E. coli O157:H7 positive product disposition when product is
shipped to a renderer, landfill operation or another federal establishment,
 Procedures for follow-up sampling after an E. coli O157:H7 positive
sample result,
 Responsibilities related to establishment generated E. coli O157:H7
samples, and
 Verifying instructional and disclaimer statements on labels.

FSIS Notice 47-13, Verification Testing for Non-O157 Shiga toxin-producing

Escherichia coli (Non-O157 STEC) under MT60, MT52, and MT53 sampling
programs, contains instructions on testing for non-O157 STEC under the MT60,
MT52 and MT53 programs. Again, it is important that you review new issuances
when they are issued because the policy related to sampling and testing will
continue to change.

Terminology

Alternative Lot
When an establishment meets specific criteria regarding its own robust sampling
program, FSIS may agree to sample from a lot of reduced size, such as single
combo bin, as long as the alternative lot represents normal production. Collect
samples from the alternative lot following applicable instructions outlined in FSIS
Directive 10,010.1.

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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). “Recall” does not
include a market withdrawal or a stock recovery.

Product that is adulterated and has left the establishment’s control may be
subject to a recall. The Recall Management Staff (RMS) is notified immediately if
product has left the establishment’s control. The DO notifies the RMS (see FSIS
Directive 8080.1, “Recall of Meat and Poultry Products”). RMS coordinates all
recall activities including issuing a press release and having effectiveness checks
performed. The press release has the product name, lot number and the
supplier. The recall would involve at least the sampled lot, but the scope of the
recall could be expanded depending upon a review by the RMS of all production
factors and establishment’s control measures in place within the operation to limit
potential contamination exposure. All recalls of meat and poultry products are
voluntary. Raw beef products produced on the shift represented by the positive
sample could be subject to voluntary recall. 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. If the positive product was used as an
ingredient in cooked products or other further processed products, the FSIS
Recall Committee evaluates the situation and proceeds on a case-by-case basis.

Sample
A sample for raw products is a collection of product, such as ground beef, beef
trimmings, bench trim, and AMR product that represents a larger amount of
product (e.g., 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-to-
cleanup” 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-to-
cleanup” 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 cross-
contamination 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 All E. coli O157:H7 Sampling Projects

Establishment Interventions and CCPs
All samples are collected after the establishment has applied all antimicrobial
interventions to the production lot, except for any microbiological testing
intervention.

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.

If the HACCP plan has a CCP for freezing product, such that the establishment
can support that a microbiological reduction occurs, freezing may occur in the
process after the establishment’s microbiological testing. Under these

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circumstances, you are to wait until the product passes the freezing CCP before
collecting a sample.

Random Selection
All samples are selected randomly from the current day’s production of the raw
beef product requested. 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. You’re not required to randomly select the lot, but you
do have to randomly select the sample from that lot. 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.

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 final package (intact), such as ground
beef, you are to clean and sanitize your hands before collecting the sample. For
non-intact samples, 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.
Before collecting a sample, review the FSIS Notices and Directives covering that

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sample type or program. The sample request may have additional instructions in
PHIS in the sample management- sample collection screens.

Sampling Project Codes

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

 MT60 – Routine Testing of Domestic Raw Beef Manufacturing Trimmings

 MT55 – Routine Testing of Bench Trim, Derived from Cattle Not

Slaughtered at the Establishment

 MT54 – Routine Testing of Domestic Components Other than Trim at

Federal Establishments

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

MT 60 - Beef Manufacturing Trimmings that are Sampled from Cattle

Slaughtered at the Establishment

MT60 is the sampling program for beef manufacturing trimmings. 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
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.

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Randomly select only one type of trim to collect for each sample. Refer to FSIS
Notices for further guidance on how to randomly collect beef manufacturing
trimmings.

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.

Note: FSIS replaced the project code MT50 with project code MT60 in May
2012, to reflect changes to the statistical elements of the sampling design and to
facilitate data analysis. FSIS will eventually update previous policy issuances to
reflect the new project code. In the interim, follow instructions related to MT50
sampling when conducting MT60 sampling. Refer to FSIS Notices 69-13, 47-13,
and 22-12 for a more detailed description and sampling frequency for the testing
program.

MT55 - Bench Trim or Beef Manufacturing Trimmings that are Sampled

from Cattle NOT Slaughtered on-site at the Establishment

Generally, the same type of beef trimmings are sampled under the MT55
sampling program as under the MT60 sampling program. However, MT55
samples are from beef trimmings the establishment intends for use in raw ground
beef or other raw ground beef products collected from cattle not slaughtered at
the establishment. The purpose of the MT55 project is to verify the further
processor’s food safety procedures for STEC, for example, purchase
specifications, or antimicrobial interventions. 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 MT55 sampling program.

To determine the intended use of the products, review establishment records and
HACCP documents. In cases where the establishment records and HACCP
documents are unclear about the product’s intended use, the bench trim (beef

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trimmings) will be considered for use in raw ground beef products and other non-
intact raw beef products.

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 official establishment.

MT54 - Raw Ground Beef Components and Beef Patty Components OTHER
than Beef Manufacturing Trimmings that are Sampled

Raw ground beef and patty components other than beef manufacturing trimmings
subject to FSIS sampling for E. coli O157:H7 under the MT54 program are intact
or non-intact beef products intended for manufacturing into ground beef products
identified in §319.15(a), (b), or (c). Such products include raw beef esophagus
(weasand) meat, head meat, cheek meat, beef from AMR systems, and lean
finely textured beef (LFTB), partially defatted chopped beef (PDCB) and partially
defatted beef fatty tissue (PDBFT).

Note: A beef AMR system is a mechanical process separating skeletal muscle

tissue from bones of cattle other than skulls or vertebral column bones of cattle >
30 months of age that meets the requirements in 9 CFR 318.24. Establishments
may label the resulting product from beef AMR systems as “beef”.

Note: LFTB, PDCB and PDBFT are low temperature rendered products. The
lean is removed from fat or very fat trimmings using heat or in the case of beef
fatty tissue a centrifugation, drum drying process.

You only collect samples of raw ground beef components or raw beef patty
components other than beef manufacturing trimmings that are intended for use
in raw ground beef and other raw non-intact beef products 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 MT54 sampling
project code, you choose among the products produced at the slaughter
establishment by following the priority list below. For example, if the
establishment produces product from AMR systems (#1 on the list) on the day of

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collection, you are to take a sample of it; if not, you are to collect low temperature
rendered beef (#2 on the list) if it is available, and move down the list until there
is an available product.

1. Product from AMR (Advanced Meat Recovery) Systems

2. Low Temperature Rendered (LTR) Beef (lean finely textured beef--LFTB
and ammoniated LFTB)
3. Partially Defatted Beef Fatty Tissue (PDBFT)
4. Partially Defatted Chopped Beef (PDCB)
5. Weasand Meat
6. Head Meat
7. Cheek Meat
8. Heart Meat

When you receive subsequent directed sample request tasks for the project code
MT54, start at the top of the list and continue down the list choosing the NEXT
item on the list that is produced by the establishment on day the sample is
collected. Select a different component than previously collected, i.e., rotate
between products when possible.

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. The low temperature rendered products, (for example
LFTB, PDBFT and PDCB) are often added to the formulation of ready-to-eat
products. 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.

Do not collect 2 piece chucks when sampling components other than beef
manufacturing trimmings under the MT54 project code. Two piece chucks are
sampled under the MT60 sampling program because the definition for beef
manufacturing trimmings includes “trimmings from sub-primal cuts such as 2
piece chucks, boneless chuck, or other primal/sub-primal/boxed beef parts of
boneless beef.”

Ammoniated Beef Products that are Sampled

Some establishments inject gaseous ammonia into low temperature rendered

(LTR) beef products such as partially defatted chopped beef (PDCB), lean finely

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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 CO 2.
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.
Production of ammoniated lean finely textured beef from beef trimmings can be
done in less than 20 minutes. 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 directed sampling request task for the MT54 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. If a slaughter establishment produces other beef
products in addition to the ammoniated beef products that can be sampled under
the MT54 sampling program, sample the ammoniated beef products as LTR beef
products in the priority list on the previous page. When you receive a sample
request task for the MT54 sampling project code at a processing (non-slaughter)
establishment that produces ammoniated beef products, sample that product.

MT43 - Raw Ground Beef Products that are Sampled

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

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 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
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. Prior notification enables management to hold the product
represented by the sample pending test results. 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.

The purpose of FSIS sampling is to verify the establishment is producing

unadulterated product, not to interfere with the establishment’s operations. You
need to be knowledgeable concerning the establishment’s production
practices. Give establishment management 1 day’s notice before you collect a

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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
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 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.

Each time you collect samples tested for adulterants such as STECs, verify that
establishments are holding or controlling product per the instructions in FSIS
Notice 07-13. When you collect the sample, record in PHIS whether the product
is held on-site, off-site under company control, or not held. If an establishment
does not hold or maintain control of product, immediately contact the District
Office.

Step 3: Collect the Sample

Collecting Beef Manufacturing Trimmings, 2-Piece Chucks, and Primals
and Sub-primals

Follow the general sampling instructions outlined in this handout, e.g., randomly
collect a sample (day, shift and time for routine sampling) using aseptic
technique from one production lot after all of the establishment’s interventions
except for a microbiological testing intervention within the 30-day sampling
window. The exception is now the MT60 samples will have a 60 day window.
The N60 method is used for sampling various raw beef cuts intended for use in
raw ground beef products.

The N60 method is used for sampling:

 Beef manufacturing trimmings,

 2-piece chucks,

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 Primal/sub-primal cuts (e.g., rounds, briskets, etc.) when the

establishment (or another establishment) intends to grind the entire cut
into ground beef, and
 Raw beef products when the intended use is unclear (includes primals
or sub-primals in which the establishment is unable to identify whether the
final end product will be intact (steaks and roasts) or non-intact product
(ground beef products).

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
laboratories, are disposable sampling surfaces (for locations where samples are
not collected and cut in the combo bin or where an easily sanitized surface in the
production area is not available), 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.

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.

You may order small bottles of sanitizing solution from the FSIS Laboratory, if
needed to sanitize the caddy, knife, hook or clip. 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.

Collect samples by using the N60 method of sample collection (as described
below).
 If a specific production lot is composed of greater than 5 containers of
beef manufacturing trimmings, 2-piece chucks, primal or sub-primal cuts
or bench trim, randomly select 5 containers for sampling; and
 If the specific production is composed of 5 or less containers, use the
table below for sampling.
Number of Sample Pieces to Collect Per Container

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# of containers in each # of sample pieces to select from each container

specific production
5 12 pieces
4 15 pieces
3 20 pieces
2 30 pieces
1 60 pieces

Note: If the establishment has its own E. coli O157:H7 testing program and
meets the alternative lot definition criteria on page 12, the sample pieces may
come from one container, e.g., combo bin or box.

Aseptically collect the appropriate number of pieces of beef trim, 2-piece chucks,
primal or sub-primal cuts, or bench trim based on the number of containers that
represent one specific production period. 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. 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 ¾ 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 beef manufacturing

trimmings or bench trim 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

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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.

Collecting Bench Trim

Bench trim (sampled under the MT55 project code) may include beef trimmings
from boning carcasses, boning primal parts, and the secondary trimming of
primals and subprimals resulting in small or large pieces, or any other beef cuts
designated for use in ground beef product derived from cattle NOT slaughtered
on site at the establishment.

Follow the general sampling instructions outlined in this handout, e.g., randomly
collect a sample (day, shift, and time for routine sampling) using aseptic
technique from one production lot after all of the establishment’s interventions,
except for a microbiological testing intervention within the 30-day window.

If the establishment produces large pieces of bench trim derived from

carcasses or primals and sub-primals, you are to sample product using the N60
sampling procedure described above when taking samples under project code
MT55. If the establishment produces bench trim derived from primals and sub-
primals such as steaks, roasts or other cuts designated for non-intact use 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.

Note: If an establishment produces both large pieces of bench trim derived from
primals and sub-primals and small pieces of bench trim derived from trimming
steaks, roasts and other cuts, you are to sample only the product that can be
sampled using the N60 sampling procedure. If the establishment commingles
both types of trim, you are to collect samples from the product that lends itself to
N60 sampling procedure described above.

Collecting Raw Ground Beef and Beef Patty Components OTHER than Beef
Manufacturing Trimmings

Follow the general sampling instructions outlined in this handout, that is,
randomly collect a sample using aseptic technique from one production lot after
all of the establishment’s interventions except for a microbiological testing
intervention within the 30-day sampling window.

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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. 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.

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.

Training for the N60 Sampling Procedure

The N60 sampling collection procedure outlined in your handout is the same as
the method shown in the training posted on the FSIS intranet at the following
website.

https://inside.fsis.usda.gov/fsis/emp/static/employee/training/eLearning/eLearning
.jsp

If you perform the N60 sampling procedure, you must complete the training. You
are to complete the training as soon as practical before collecting samples. The
training video has been captioned and streamed so that it will run on the FSIS
intranet; InsideFSIS (see attachment 2 in FSIS Directive 10,010.1 for instructions
on accessing the training). After reviewing the training, participants must pass a
10 question exam with a score of 70% or better to receive credit for the course.

NOTE: The Agency will allocate up to one hour of official time (code 01 time) for
you to complete the requisite training.

The Center for Learning in the Office of Outreach, Employee Education and
Training will track the individuals who take the training and provide a list to the
Office of Field Operations. If you have problems accessing the course, or need to
request a CD with the training, contact the Center for Learning through this
Outlook e-mail address: FSISAgLearn@fsis.usda.gov.

Collecting Raw Ground Beef Products

Follow the general sampling instructions outlined in this handout, that is randomly
collect a sample using aseptic technique from one production lot after all of the
establishment’s interventions, except for a microbiological testing intervention
within the requested sample task start and end dates.

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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 3 Whirl-Pak® bags to the fill-line.
By filling all 3 bags to the fill-line, this will equal 2 pounds. 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.

You may receive a request to collect a raw ground beef product sample for E.
coli O157:H7 testing under the MT43 sampling program at the following monthly
rates:

 Up to 4 times within a calendar month for establishments that produce

greater than 250,000 lbs of ground beef product per day from the
estimated production volumes calculated in PHIS up to 3 times within a
calendar month for establishments that produce between 50,000 to
250,000 lbs of ground beef product per day from the estimated production
volumes calculated in PHIS

 Up to 2 times within a calendar month for establishments that produce

between 1,000 to 50,000 lbs of ground beef product per day from the
estimated production volumes calculated in PHIS

 Generally, no more than once within a calendar month for establishments

that produce less than 1,000 lbs of ground beef product per day from the
estimated production volumes calculated in PHIS. FSIS will ensure that
these establishments are sampled at least once per quarter.

When more than 1 sample is scheduled to be collected during a month, you are
to randomly select a day, shift, and time to collect each sample. You can collect a
maximum of two samples per day as long as each sample corresponds to a
microbiologically independent and individually identifiable lot of product.
However, when the establishment cannot continue to operate under the 2 sample
per day frequency (e.g., because the establishment cannot fill orders and hold all
sampled product) or because your workload cannot accommodate this sampling
frequency, you should only collect a single sample. You must collect at least
one sample whenever a sample request task is received and product is
available during the collection window start and end dates.

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Note: If an establishment requests that IPP collect more than 2 samples per
day, IPP are to instruct the establishment:

 to make a request to the Risk and Innovations Management Staff (RIMS),

Office of Policy and Program Development via http://askfsis.custhelp.com
for review.
 to type “sampling” in the subject line in askFSIS.
 that the question in askFSIS should include a description of the control
program that the establishment has in place that ensures microbiological
independence between lots.

RIMS will review the request and consider the establishment’s FSIS testing
history, System Tracking E. coli O157:H7 – Positive Suppliers (STEPS) history,
and FSIS’s resources. RIMS will provide a response to the establishment as to
whether the establishment qualifies to have up to 4 samples taken per day by the
IPP. If you have questions about RIMS’s response you may contact RIMS
through askFSIS or at 1-800-233-3935 by pressing 1 and then 4.

An establishment with a sound basis for defining lots and sub-lots of raw ground
beef product and has production schedules that define the specific raw ground
beef components used at specific times, may request that you collect the sample
at the start of operations rather than at the randomly chosen time during the day.
When the establishment requests the use of this alternative sampling method,
you are to determine if the establishment:

 has treated the source materials for the ground beef product that you
intend to sample differently from other source materials used for grinding,
e.g., has applied antimicrobial interventions it does not normally use on
the source materials of the ground beef product you intend to sample.

 has ground the source materials distinctly different (e.g., different

suppliers, different types of source materials) from those source materials
it typically grinds on the day you intend to collect the sample.

If the establishment has not made any changes to how the source materials are
treated and how it ground them and the establishment has documentation
showing that a specific lot of product is scheduled to be ground at the random
time you selected, you are to allow the establishment to grind that lot of product
at the beginning of operations on the day that you randomly selected for
sampling. At the weekly meeting, you are to discuss the alternative parameters
that allow a sample to be taken at the beginning of production.

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You must understand the establishment’s lotting and sub-lotting practices and
the establishment’s standard practices for scheduling, or “staging,” product the
establishment grinds on production days because you must verify that the
establishment has a sound method of lotting and sub-lotting source materials.
Use the questions in Chapter 2, III. C.—Verifying Establishment Lotting and Sub-
lotting— in FSIS Directive 10,010.1, to assist you in determining the
establishment lotting and sub-lotting practices. The responses to these questions
will determine if an establishment meets the alternative parameters that allow a
sample to be taken at the beginning of production.

Collecting Samples in Establishments that Slaughter, Produce

Manufacturing Trimmings and/or Other Raw Ground Beef Components and
Grind Beef

Some establishments may produce raw beef products that are subject to different
routine verification sampling programs, for example, MT43, MT60, MT54 and
MT55. Therefore, you may receive multiple routine sample request tasks (MT60
or MT55 and MT43 or MT54) during the same 30-day sampling window. You are
to complete all sample requests by selecting samples from independent
production lots, unless you are only able to collect one sample (because the
establishment produces 1,000 pounds or less of product on a daily basis, or only
on an intermittent basis). In this situation, you prioritize by sampling the beef
manufacturing trimmings under the MT60 and MT55 sampling programs using
the N60 collection method.

Some slaughter establishments may grind all the beef trimmings and other raw
ground beef or beef patty components they produce and not ship any beef trim or
other components. In this situation, IPP are to sample the trim under the MT60
sampling program or the other components under the MT54 sampling program
when they receive sampling requests with these codes.

Additional Analysis for Salmonella Under the Sampling Programs for Shiga
Toxin-Producing Escherichia Coli (STEC)
Certain raw beef samples that are analyzed for STEC will now be analyzed for
Salmonella, including MT43 (raw ground beef product), MT60 (beef
manufacturing trimmings), MT55 (bench trim), MT54 (other raw ground beef
components), and follow-up sampling. IPP are to inform the establishment that
all samples analyzed for STEC will now also be analyzed for Salmonella.
However, 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

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In accordance with FSIS Notice 06-13, IPP are to record source material and
supplier information when they collect a sample of ground beef product (MT43)
or bench trim (MT55) 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. IPP are not to wait for a confirmed positive test result before
they gather the supplier information as stated in FSIS Directive 10,010.1. These
new instructions will better serve FSIS’s goal to respond to FSIS presumptive
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).

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).

Note: You can keep the actual label from empty packages.

If the source materials are imported from a foreign establishment, you will
need to gather additional information (country of origin, foreign establishment

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

identifying the product as outlined in FSIS Notice 06-13).

You document source material and supplier information in a memorandum of

interview (MOI) and maintain the MOI in the official file. 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.

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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, Establishment Number M38581

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, 2-9-2012"
 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:

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a) Use today’s default Meeting Date as the date you plan to meet with
establishment management

b) Select the planned meeting time

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

a) Enter the example Sample Form Number 100006478

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: 2/9/2012 (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:

a) Close the window showing the MOI

b) Sign out of PHIS

Meeting Info
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

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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.

Log in to PHIS as Barclay

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) Click the "Save" button to save it 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

d) Sign out of PHIS

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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. When the form has been submitted electronically, print it out and sign
it, and include the printed copy in the sample container.

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.

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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 pre-
shipment review for the product sampled.

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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.

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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. More information is contained in
FSIS Notice 46-13.

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

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

The following table compares the different testing stages for E. coli O157:H7 and
non-O157:

Comparison between non-O157 STEC and E. coli O157:H7 Testing

Stage non-O157 E. coli O157:H7

Potential Sample that causes a positive Sample that causes a positive

reaction with both screen tests: reaction with the screen test
• stage 1 - for the stx and
the eae genes and
• stage 2 (concurrent with
stage 1) for one or more
of the target serogroup
genes

Presumptive Sample that has typical Sample that has typical

colonies, observed on colonies, observed on Rainbow
Rainbow Agar, and reacts Agar, and reacts specifically with
specifically with one or more of O157 antiserum
the target serogroup antiserum

Confirmed An isolate has stx, eae, and Biochemically-identified E. coli

one or more of the target isolate that is serologically or
serogroup genes and has genetically determined to be
been biochemically confirmed ‘O157’ that meets at least one of
to be E. coli. the following criteria:
1) positive for Shiga toxin
production,
2) positive for Shiga toxin gene,
3) “H7”genetically determined

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.

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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.

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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.

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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?

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FSIS Actions after a Positive FSIS or another Federal or State

Entity 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 Service-

AMS) or State entity confirms a sample is positive for E. coli O157:H7 or a non-
O157 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
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,

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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 (for example, the establishment moved the product off site but did not
complete pre-shipment review or transfer ownership of the product to another
entity) 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. Review previous NRs and associate this NR to the last positive, if
appropriate. If the establishment has a documented procedure for diverting all
product lots that are sampled by FSIS, you would not issue an NR. However, it
is important to note that you must perform all other FSIS follow-up verifications,
including verifying that the establishment performs the appropriate
corrective actions following the positive result.

Issue an NR when FSIS finds product positive for E. coli O157:H7, but the
establishment does not, under the appropriate HACCP Verification task, and cite
§417.4(a) and §301.2 as the relevant regulations. Continuing with that HACCP
Verification task, determine whether or not the establishment implements
corrective actions that meet the requirements described in §417.3. Verify that the
establishment has held on-site or maintained control of the affected product. 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 5000.4. 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 proper and
timely disposal of the 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.

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

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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. (Documentation and enforcement
will be covered in more detail in a later module.)

Establishment management must account for all affected products by identifying

them and their location. The establishment must take corrective actions that
meet one of the following requirements.

 417.3(a) if E. coli O157:H7 or non-O157 (depending on the test and the

result) is addressed in the HACCP plan, or
 417.3(b) if E. coli O157:H7 or non-O157 (depending on the test and the
result) 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 non-O157 (depending on the test
and the result) 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 perform a directed Hazard Analysis Verification task to review
the establishment’s HACCP system. (Upon future implementation, you will also
perform a PHIS Supplier Tracking task to identify suppliers.)

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
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,

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“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

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

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destroyed. For example, this record may be a record of receipt and control
pending the product receiving a lethality treatment. The record should
include information necessary to identify the product, the number of pounds
of raw beef product received (landfill check weights), and the number of
pounds of such product 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:

 9 CFR 417.3(a) if E. coli O157:H7 or non-O157 (depending on the test

and the result) is addressed in the HACCP plan,

 9 CFR 416.15 and 417.3(b) if E. coli O157:H7 or non-O157 (depending on

the test and the result) is addressed in the Sanitation SOPs, or

 9 CFR 417.3(b) if E. coli O157:H7 or non-O157 (depending on the test

and the result) is addressed in a prerequisite program.

You should contact the DO, through supervisory channels, if the determination is
made, or if questions arise about whether the establishment committed the
prohibited act of selling or transporting adulterated articles in commerce (no
controls) that have not been inspected and passed.

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

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

establishment adequately addresses the pathogen in the product.

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

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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
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.

For instance:

 Sample raw ground beef product under the MT44 project code after a
MT43 project code (ground beef product) positive result;

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 Sample source materials (beef manufactured trimmings, primals or sub-

primals bench trim, or ground beef/beef patty components) under the
MT52 project code when the originating supplying slaughter establishment
is the sole supplier identified as a supplier of source materials for product
found to be positive 120 days prior to the date of the current raw beef
product positive result, i.e., a repeat supplier of source material that has
been implicated in a positive result.

 Sample beef manufacturing trimmings, bench trim, OR other raw ground

beef or raw beef patty components under the MT53 project code after a

 MT60 project code positive result (beef trim derived from cattle
slaughtered at the establishment); or

 MT54 project code positive result (raw ground beef/beef patty

component); or

 MT55 project code positive result (beef trim derived from cattle NOT
slaughtered at the establishment); or

 Sample ground beef products under the MT53 project code after a follow-
up MT44 project code positive result (ground beef product); or

 Sample beef manufacturing trimmings or ground beef/beef patty

components under the MT53 project code after a follow-up MT52 project
code positive result (source material from the originating supplying
slaughter establishments).

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. As soon as the
establishment resumes production of the product(s) to be sampled, start your
sample collection of either 8 or 16 samples at the following daily and weekly
frequencies.

 Sample a maximum of 2 follow-up samples per shift per day from different
lots (up to 4 samples per day for a 2-shift establishment). Follow this
procedure unless the establishment cannot continue to operate under that
sampling frequency (for example, cannot fill orders or hold all sampled
product) or your workload will not accommodate that sampling frequency.
If either of these concerns arises, discuss it with FSIS supervision
immediately.

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 At a minimum collect 3 samples per week unless the establishment cannot

continue to operate under that sampling frequency or your workload will
not accommodate that sampling frequency. If either of these concerns
arises, discuss it with FSIS supervision immediately.

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 or
beef patty component (for example, head meat, heart meat, or product from
advanced meat recovery (AMR) systems) that the establishment intends to use
in the production of raw ground beef products.

You only collect follow-up samples of beef manufacturing trimmings, bench trim,
or raw ground beef components or beef patty components that the establishment
intends for use in raw ground beef or other raw ground beef products. Randomly
select the time to collect the sample of raw ground beef product, beef
manufacturing trimmings, or raw ground beef or beef patty component from the
establishment’s current production. Follow the sample collection instructions (for
example, 2 lb of raw ground beef product, the N60 sampling procedure for beef
manufacturing trimmings, bench trim, and 2-piece chucks, 2 lbs (3 Whirl-Pak®
bags) for AMR product, low temperature rendered products, and other raw beef
components). Follow the instructions for notifying establishment management
before taking the sample in FSIS Directive 10,010.1 and as previously covered in
this handout. Schedule each sample in PHIS, document sample data on the day
that sample is collected, submit the sample information electronically through
PHIS and print the form to include with the sample as previously discussed.

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

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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 3 rd 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

Analysis of E. coli O157:H7 sample data collected by FSIS indicates that an

establishment that has had a positive sample is likely to receive a second
positive within 120 days of receiving the first positive result. In response to this
finding, 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.

The Data Analysis and Integration Staff (DAIS) generates, in PHIS, follow-up
sampling tasks at supplier establishments. IPP are to collect a single follow-up
sample or multiple follow-up samples. 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.

Note: If an originating slaughter establishment was the only supplier for the raw
beef product found positive for E. coli O157:H7, and that the same originating

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slaughter establishment was also a supplier that had been identified within
approximately 120 days of this raw beef product positive result, PHIS generates
16 MT52 project code follow-up sample tasks for the originating slaughter
establishment identified for each component 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, project code MT52, for each type of source material.

When AMS notifies FSIS of a positive E. coli O157:H7 result for raw ground beef
product sample collected under the AMS commodity purchase program, DAIG
determines the originating supplying slaughter establishments. The DO is
informed that AMS found a positive sample. PHIS generates 8 follow-up sample
tasks for the type of ground beef product AMS found positive, regardless of
establishment production volume, in response to the AMS positive result. In
addition, if a sole supplier or repeat supplier supplied source materials for the
ground beef product that AMS found positive, PHIS requests 8 follow-up sample
tasks for the supplier of the raw beef source material regardless of the supplier’s
production volume.

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 MT52 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 LTR product was used as a component in raw ground beef

products that tested positive for E. coli O157:H7 when sampled by FSIS or
another Federal or State entity, PHIS generates either 1, 8 or 16 sample request
tasks. IPP are to collect a sample of ammoniated beef trim at the establishment
that produced the ammoniated low-temperature-rendered product, even if that
establishment is not an originating supplying slaughter establishment.

If a sample collected under the MT52 sampling program tests positive, PHIS
generates multiple follow-up sample requests under the MT53 sampling program.

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Upon receipt of the MT52 follow-up sample request tasks, you randomly collect
the sample of source materials (beef manufacturing trimmings, or other raw
ground beef components, or raw beef patty components) indicated from the
establishment’s current production. Follow the sample collection instructions and
the instructions for notifying establishment management before taking the sample
previously covered in this handout. All samples and follow-up samples will be
scheduled and documented in PHIS.

Follow-up Sampling of Ammoniated Low Temperature Rendered Products

after an E. coli O157:H7 Positive Sample Result

Ammoniated LTR product is subject to the MT52 follow-up verification sampling

program when it is used as a component in raw ground beef products that are
sampled by FSIS under MT43 or MT44 sampling programs or by another Federal
or State entity and are positive for E. coli O157:H7. You are to randomly collect
a sample consisting of 1 lb but not more than 2 pounds of the ammoniated low-
temperature-rendered product from a specific production lot.

If the establishment that produced the ammoniated LTR product is not an

originating supplying slaughter establishment, e.g., a combination slaughter
processing establishment, sample request forms with project code MT52 in Block
14 are not generated for the slaughter establishments that produced the source
materials used in the ammoniated LTR, unless the sample of ammoniated LTR
product that you submit to the FSIS laboratory lab is positive. When the
ammoniated LTR product is submitted to the lab under the MT52 project code,
you collect supplier information from the establishment that produced the
ammoniated low-temperature rendered product and document the information in
a MOI. If the sample is positive, the DO will enter the supplying establishments
into STEPS. Sample requests with project code MT52 are generated for the
slaughter establishments that produced the source materials used in the positive
ammoniated LTR product.

Document the follow-up sampling in PHIS by recording a Directed Sampling

Task. Pack the sample and complete sample request form as outlined in this
handout. Send the sample to the laboratory on the first available day the
contract carrier picks up after collecting the sample.

Follow-Up Sampling at the Originating Supplying Slaughter Establishments

for Intact Raw Beef Products not Intended For Use in Raw Ground Beef
Products

When an establishment used intact product, (for example, primals or sub-

primals) as source materials in a raw ground beef product that FSIS finds

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positive for E. coli O157:H7, you are to select a carcass at the originating
supplying slaughter establishment for follow-up sampling under project code
MT52 rather than the raw ground beef component, e.g., beef trimmings, AMR
product, head meat, etc., from the carcass if the originating slaughter
establishment can demonstrate:

 Through HACCP production records and purchase specifications that the

intact beef product used as a raw ground beef component was not
intended for grinding or non- intact product, and the establishment had
informed purchasers of this intent, and

 That the intact product was derived from beef carcasses in a manner to
minimize commingling with other raw beef cuts and product was packaged
separately and not commingled with other beef cuts prior to packaging
(e.g., bone-in loins or boneless rounds were placed on a conveyor belt
and were then off-loaded for packaging without being commingled with
other beef cuts). You must be able to verify that the product was handled
as stated above through records review or direct observation.

The two conditions are meant to show that the supplying establishment intended
the product for use in intact product, e.g., steaks and roasts. If both conditions
are not met, you are to continue to sample the beef trimmings or primals or sub-
primals that were used to produce the positive raw ground beef products using
the N60 sampling procedures. If both of these conditions are met, you
aseptically collect enough tissue slices from the external surface off the carcass
to equal 2 pounds. The slices are to be very thin (approximately 1/8 inch thick).
Follow the instructions for sampling large components, sanitize the caddy, knife,
and hook before collecting the samples and use sterile gloves and sterile Whirl-
Pak® bags.

Cut the slices from:

 the surface of the same part of the carcass (e.g., chuck, loin, round, etc.)
that the establishment used in producing the positive raw ground beef
product sample, when possible.

 the carcass while the carcass is hanging in the cooler before fabrication,
when possible.

Note: If it is not possible to do either of these things, contact the Risk and
Innovations Management Staff (RIMS) through askFSIS at
http://askfsis.custhelp.com/. RIMD personnel are to cc the appropriate
district personnel on their reply.

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Document the follow-up sampling PHIS. Pack the sample and complete the
sample request form as outlined in this handout. Send the sample to the
laboratory on the first available day the contract carrier picks up after collecting
the sample.

If the follow-up sample result for the carcass is positive for E. coli O157:H7, then
only the sampled carcass is implicated because E. coli O157:H7 contamination is
generally point-source contamination that occurs sporadically as a consequence
of handling during hide removal and dressing of the carcass. The establishment
will need to take corrective actions for that carcass. The establishment may
decide to destroy the implicated carcass or to use it to produce products that will
be processed to destroy the pathogen (for example by cooking or irradiation).
Head and cheek meat from that carcass which was removed from the skull
during the slaughter process is not implicated by the positive result. You should
verify the establishment’s control of its sanitary dressing procedures per FSIS
Directive 6410.1.

FSIS Actions after a Positive E. coli O157:H7 or non-O157 Follow-Up

Sample Result

Access LIMS-Direct to track your follow-up sample receipt and results. Respond
to discarded samples, negative results, presumptive positive results, and
confirmed positive results as previously described in your handout. The actions
FSIS takes in response to E. coli O157:H7 positive FSIS follow-up samples are
the same actions FSIS takes for an E. coli O157:H7 or non-O157 positive FSIS
routine verification sample.

When an FSIS generated follow-up sample is found positive for E. coli O157:H7
or one or more of the six non-O157 serogroups and the establishment’s sample
for the same lot is also positive, you should not issue an NR provided that the
establishment held the product represented by sample (or maintained control of
the product) pending its own test results. You need to verify that the
establishment takes corrective actions that meet the requirements in §417.3.

When an FSIS generated follow-up sample is found positive and the

establishment either did not test the product lot or did not find the pathogen, you
will issue an NR under the appropriate HACCP Verification Task citing §417.4
and §301.2 as the relevant regulations. Review previous NRs and associate this
NR to the last positive, if appropriate. As soon as possible after the establishment
has implemented its corrective actions, perform the HACCP Verification Task for
the specific production that tested positive. Determine whether or not the
establishment implements corrective actions that meet the requirements
described in §417.3.

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If disposition of the positive product is to occur off-site, verify that the

establishment has met all corrective action requirements, e.g., maintained control
of product during transportation, has records identifying who received the product
and showing proper disposition or disposal, and has conducted a pre-shipment
review after receiving the disposition or disposal records as described in the Off-
Site Product Disposition section earlier in this handout. If you find
noncompliance, document it in accordance with Directive 5000.1. Notify the DO
through supervisory channels when the establishment has not properly moved
the positive product off-site.

DO and EIAO Responses to Positive Results

The District Office (DO) will schedule a Food Safety Assessment (FSA) at an
establishment within 30 days after being notified that FSIS or another Federal
Agency or State entity has found a raw beef product positive for E. coli O157:H7.
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 is
to schedule an EIAO to conduct an FSA at establishments identified in STEPS as
sole suppliers of positive E. coli O157:H7 ground beef product and
establishments in the STEPS database more than once in the past 120 days
identified as a multiple supplier except if the establishment applied a full lethality
treatment to the implicated source material.

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. Below are factors the DO and
EIAOs consider when making a determination about whether to stop collecting
follow-up samples and to take a suspension or withholding action:

 the establishment is failing to implement proposed corrective actions;

 the establishment’s corrective actions that the establishment is
implementing are ineffective;
 the establishment has recurring sanitary dressing noncompliances that
render its corrective actions ineffective (see FSIS Directive 6410.1); or
 the establishment does not have support for decisions made in its HACCP
plan or hazard analysis (see FSIS Directive 5000.1).

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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
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 E. coli O157:H7 while they are moving the product, but the product is
still under the establishment’s control. FSIS is providing establishments the
flexibility to move their product before pre-shipment review when the
establishment is conducting testing for E. coli O157:H7 and maintains control of
the product (e.g., through company seals or FSIS 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

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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
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

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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.

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.

Some establishments may opt to divert the product to another official

establishment for cooking when they receive a presumptive positive in their
testing program, or to a landfill or renderer for disposal. However, the
establishment is still obligated to meet all parts of §417.3. It is still required to
have proper control of the product while it is in transit for disposition. It also must
maintain documentation of appropriate disposition.

When product that is presumptive positive or confirmed positive for E. coli

O157:H7 is transported to another official establishment, renderer, or landfill
operation for appropriate disposition, the establishment sending the product
must:

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 maintain records identifying the official establishment, renderer, or landfill

operation that receives the presumptive positive or positive product,

NOTE: If the product is analyzed while in transit, the establishment must

maintain records identifying the official establishment to which the product is
being sent.

 maintain control of product (company controls or FSIS controls),

 maintain records that indicate product received proper disposition, and

 complete pre-shipment review only after it has all disposition records for that
particular product.

If you are aware that presumptive positive or positive product is in transit, verify
the controls. If you find noncompliance with the establishment’s handling of
presumptive or confirmed positive product, contact the District Office.

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
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).

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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.

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.

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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.

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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?

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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?

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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 Action

Task Name
General Labeling Remove from schedule
Food Defense - Water Systems Remove from schedule
Net Weight Re-schedule for any date next week
Pre-Operational Record Review Add a directed task today
Operational SSOP Record Review Add a directed task today
MT44 Sample Request Add two tasks for today

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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 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-Operational 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.

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Robert Allen at Open Beef Action

Task Name
MT52 Sample Request Schedule 2 sample tasks today
Pre-Operational Record Review Schedule a directed task today
Operational SSOP Record Review Schedule the routine task as
directed for next working day
Storage Areas Remove
General Labeling Remove
MSS, PDBFT, PDPFT, PDCB, Remove
PDCP, AMRS
MT60 – Routine Testing of Reschedule for 2/24
Domestic Raw Beef Manufacturing
Trimmings
Pre-operational SSOP Review and No change
Observation

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-Operational 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.
9. Remove the following tasks:

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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 Action

Task Name
Directed Slaughter HACCP Schedule the directed task for today
Verification
Beef Sanitary Dressing Schedule the routine task as
directed for today
Livestock Humane Handling Schedule routine task for today
Verification
Generic E. coli Re-assign from Robert Allen to
himself
Livestock Zero Tolerance 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 task Slaughter HACCP Verification in February. Click
the Add link in the column. Add 1 task for today and use Response to
Alert Notification for the reason.

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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.
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 Generic E. coli and select Edit.
Notice that the task is now assigned to Jeb. Click Save.
10. Right-click on Robert’s scheduled task Livestock Zero Tolerance and
select Edit. Notice that the task is now assigned to Jeb. Click Save.
11. 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.
12. 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

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ATTACHMENT 1
Resources

There are several directives and notices associated with microbial sampling of
raw beef products. The FSIS website provides the current versions.

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations

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 Verification Activities for Escherichia coli O157:H7 in Raw Beef
Products
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
Additional Analysis For Salmonella Under the Routine and Follow-
Up Sampling Programs for Shiga Toxin-Producing Escherichia Coli
(STEC)
13-14 Collecting Supplier Information at the Time of Sample Collection for
Escherichia coli (E. coli) O157H:7 in Raw Ground Beef Products
and Bench Trim
03-14 Documenting Sample Source When Collecting Samples for Shiga
Toxin-Producing Escherichia Coli (STEC) Verification Testing
01-14 Verification Activities for Non-O157 Shiga Toxin-Producing
Escherichia Coli (Non-O157:H7 STEC) under MT60, MT52, and
MT53 Sampling Programs
81-13 Clarification and Expansion of Sampling Eligibility Criteria for the
Routine Beef Manufacturing Trimmings (MT60) and Bench Trim
(MT55) Sampling Programs
69-13 Containers for use when Collecting Raw Beef Samples for Shiga
Toxin-Producing Escherichia coli (STEC) and Salmonella Testing

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47-13 Verification Testing for Non-O157 Shiga toxin-producing

Escherichia coli (Non-O157 STEC) under MT60, MT52, and MT53
sampling programs
46-13 LIMS-Direct to Replace LEARN for Sampling Data Reporting
See also: LIMS-Direct User Guide
19-13 Sampling of Low Production Volume Raw Ground Beef
Establishments for Salmonella
07-13 Control of Agency Tested Product for Adulterants

58-12 Scheduling and Submitting Lab Samples in PHIS

27-12 Changes In Sampling Frequency For E. coli O157:H7 Testing of
Beef Manufacturing Trimmings (MT60)
22-12 Sampling Of Raw Beef Product Intended For The
National School Lunch Program
21-12 Randomly Selecting Beef Trim to be Collected Under the Beef
Manufacturing Trimmings (MT50) Sampling Program

Industry Compliance Guides

http://www.fsis.usda.gov/Regulations_&_Policies/Compliance_Guides_Index/ind
ex.asp

 Compliance Guideline Controlling Met and Poultry Products Pending

Products Pending FSIS Test Results
http://www.fsis.usda.gov/PDF/Compliance_Guide_Test_Hold_020113.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
(http://www.fsis.usda.gov/PDF/Compliance_Guide_Est_Sampling_STEC_
0512.pdf)

FSIS Microbiology Laboratory Guidebook

http://www.fsis.usda.gov/Science/Microbiological_Lab_Guidebook/index.asp

Background information on the STEC sampling methods

http://www.fsis.usda.gov/PDF/Mlg_5B_02.pdf

Articles

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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.

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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

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ATTACHMENT 3 Sample Analysis Form

100006478

100006478

100006478 M38
Groveton Meats, LLC

Robert Barclay

(555) 555-5555

9225B

Training Example Only

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100006478

9999

Jeff Irvine
(555) 555-5555

Training Example Only

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Inspection Methods 28-69