Food Safety and Inspection Service

U.S. DEPARTMENT OF AGRICULTURE

Inspection Methods

Student Study Guide

2 of 2
Only this provided printed Student Study Guide may be used during the test.
Handwritten notes and highlights are allowed on the provided pages.

No additional pages, sticky notes, tabs, paper clips, or anything else added
to the study guide is allowed.

Revised October 2022

 Table of Contents
01 Course Introduction ....................................................................................................5
02 Statutes (Acts) ............................................................................................................7
03 Rules of Practice..........................................................................................................9
04 Regulatory Process Overview...................................................................................13
05 Food Safety Systems Fundamentals........................................................................15
06 Food Microbiology & Specified Risk Materials (SRM).............................................18
07 Sanitation Performance Standards (SPS) ................................................................28
08 Sanitation Standard Operating Procedures (SSOP) ................................................36
09 Sanitation Scenarios .................................................................................................45
10 Noncompliance..........................................................................................................46
11 HACCP Processing Categories and Fish Inspection...............................................50
12 HACCP 7 Principles...................................................................................................57
13 HACCP Regulatory Process......................................................................................60
14 Hazard Analysis Verification (HAV) Task .................................................................64
15 HACCP Verification Task...........................................................................................69
16 Slaughter Food Safety Standard...............................................................................88
17 Salmonella and Campylobacter Testing ..................................................................92
18 Raw Beef Sampling .................................................................................................101
19 Hazard Analysis Verification (HAV) and Raw Beef Sampling Scenario................108
20 Sampling Requirements to Demonstrate Slaughter Process Control..................114
21 Humane Handling (Livestock) and Good Commercial Practices (Poultry) ..........119
22 Sanitary Dressing ....................................................................................................128
23 Review Establishment Data Task ...........................................................................132
24 Ready-to-Eat and Shelf Stable Products Process Familiarization........................138
25 Lethality and Stabilization (Part 2 of Study Guide)................................................140
26 Food Ingredients of Public Health Concern...........................................................144
27 RTE-SS Hazards and Controls Workshop..............................................................155
28 Ready-to-Eat Sanitation ..........................................................................................158
29 Listeria monocytogenes Regulations.....................................................................162
30 RTE Sampling ..........................................................................................................176
31 HACCP System and Recall Verification .................................................................180
32 Export Certification .................................................................................................196
33 Food Defense...........................................................................................................200
34 Non-Food Safety Consumer Protection .................................................................204
PHIS Introduction to the Public Health Information System (PHIS) ..........................208
PHIS 1 – Establishment Profile ....................................................................................212
PHIS 2 – Task List / Task Calendar..............................................................................216
PHIS 3 – Inspection Documentation, NRs, MOI, Notes, Meeting Agenda .................220
PHIS 4 – Sample Management .....................................................................................228
PHIS 5 – Animal Disposition Reporting.......................................................................231
PHIS 6 – Perform Hazard Analysis Verification Task with 2 Noncompliances .........232
Workshops....................................................................................................................233
PHIS Simulations…………………………………………………………………………….…244
Case Scenarios………………………………………………………………………………....258
Food Safety Regulations Job Aid ................................................................................271
Acronyms......................................................................................................................272
Note-taking Pages ........................................................................................................276
 25 Lethality and Stabilization

Objectives:

1. Define: Lethality, Stabilization, Performance Standard, Target, Critical Operating Parameter, and
Scientific Gap.

2. State regulatory lethality and stabilization performance standards.

3. Identify compliance guidelines frequently used to support lethality, stabilization, and multiple
hurdles processes.

4. Identify critical operational parameters in the FSIS guideline for lethality.

5. Describe the relationship between humidity and cooking.

6. Identify which microorganisms are controlled in the lethality and stabilization steps.

7. Explain the food safety significance of drying in the jerky process.

8. Explain how multiple hurdles are used in a food safety system.

9. Describe how inspectors verify that establishments have support for their lethality, stabilization
and multiple hurdle processes.

Ready-to-Eat (RTE) products are meat or poultry products that are edible without additional
preparation to achieve food safety. Two main processes which are critical for achieving safety in
RTE products are known as lethality and stabilization. They are used to control the biologicalhazards
in RTE products.

Lethality (cooking) is defined as the process or steps used to destroy pathogenic

microorganisms in a product to make the product safe for human consumption.

After the product is cooked, spores of Clostridium botulinum and C. perfringens that survive the
cooking process can germinate, becoming vegetative cells that can multiply tohazardous levels if
cooling is inadequate. Rapid cooling from 130°F to 80°F is necessary to prevent the growth of
Clostridium bacteria. The processes that establishments employ to limit the growth of spore-forming
bacteria are called stabilization (cooling).

The most common stabilization is cooling. However, other treatments, such as lowering the product
pH through fermentation or marination, prevents the growth of Staphylococcus aureus. Drying or
salt-curing to reduce the water activity or adding antimicrobials may also be used in combination with
heating or each other to destroy pathogens. The use of multiple treatments to achieve lethality or
stabilization is called the multiple hurdle concept.

For certain RTE products, FSIS has established regulatory performance standards becausethey
have a higher public health risk. These products have historically been associated withfoodborne
illnesses caused by specific pathogenic bacteria or their toxins (Salmonella, L. monocytogenes, E.
coli O157:H7, C. perfringens, and C. botulinum).

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RTE products are adulterated if they contain pathogens of public health concern, or their toxins:
o Any Salmonella, Lm, or STEC is injurious to health.
o Any C. botulinum growth is a public health concern.
o C. perfringens at levels that could lead to toxin formation indicates product was prepared,
packed or held under insanitary conditions.

Performance standards are quantifiable pathogen reduction levels or growth limit requirements set
by FSIS for lethality and stabilization of certain products.

Lethality performance standards require establishments to ensure the lethality process for certain
RTE products meets a specific log-10 reduction of Salmonella microorganisms. The lethality
performance standard requires a minimum 6.5-log reduction of Salmonella for roast beef, cooked
beef, and corned beef, at least a 7.0-log reduction of Salmonella in cooked poultry products, and
cooked uncured meat patties to achieve a 5-log reduction of Salmonella (and other pathogens
including STEC).

The stabilization performance standards are quantifiable pathogen growth limit requirements set
by FSIS for the stabilization of certain meat and poultry products. The stabilization performance
standard requires: No multiplication of C. botulinum and no more than 1-log increase of C.
perfringens throughout the product shelf life.

Establishments may use alternative lethality or stabilization support for certain products. The
establishment must be able to demonstrate that the alternative support achieves a different (usually
lower) log reduction than what is prescribed in the regulations.

Targets are quantifiable pathogen reduction levels or growth limits set by the establishment to
produce safe products in the absence of regulatory performance standards. Salmonella is used as a
target organism because death of Salmonella indicates destruction of other vegetative pathogens.

Critical operating parameters are the time-temperature intervention combinations establishments

apply to cooked products that affect pathogen log-10 reductions and achieve lethality. Critical
operating parameters may include but are not limited to time, temperature, water activity,
concentration, relative humidity, and even type of equipment necessary to achieve the critical
operating parameter.

FSIS Compliance Guidelines provide guidance to industry and may be used to support CCPs and
critical limits in a HACCP plan. It is not mandatory for the establishment to use these guidelines. For
example, Appendix A provides support for lethality (time, temperature, and humidity for cooking
processes) and Appendix B for stabilization (cooling options). These Compliance Guidelines do not
cover catfish, pork rinds, lard and tallow, dried products, partially heat treated not ready-to-eat
products, or the production of products that rely on multiple hurdles to achieve lethality and shelf-
stability. The Jerky Guideline describes requirements for lethality (heat and humidity) prior to drying.

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 FSIS time-temperature tables identify relative humidity as a critical operating parameter to ensure
moist cooking and adequate surface lethality of pathogens, especially Salmonella. Unless the
establishment can provide additional support for why humidity would not be needed in its process to
ensure lethality on the product surface, there is a concern in not maintaining humidity because:

o Product surfaces will take longer to heat.

o Product surfaces can dry out.
o Bacteria can become more heat resistant.

Appendix A and Appendix B have identified Scientific Gaps in several common cooking processes
where adequate support for achieving critical operating parameters is lacking. Until scientific research
becomes readily available, establishments may address scientific gaps by referring to
recommendations from older FSIS cooking guidance for:

- Products cooked for short times at high temperatures.

- Products cooked using cooking methods, such as microwaves, that are not designed to control
relative humidity.

- Other processes that may inherently maintain relative humidity around the meat and poultry filling
but cannot follow one of the relative humidity options.

- Processes where the drying step comes before cooking under moist conditions.

- Products with long heating come-up-times (CUT).

- Partially heat-treated, smoked, not fully cooked products containing nitrite and either erythorbate or
ascorbate that cannot follow the new cooling options due to long heating come-up and cooling times.

- Large mass, non-intact, fully cooked products, including scalded offal that cannot cool quickly
enough to follow the new cooling options.

- Fully cooked, smoked bacon containing nitrite and erythorbate/ascorbate that achieve the lethal time
and temperature combinations but cannot use the new cooking options because relative humidity is
not addressed.

- Immersion or dry-cured products containing nitrite that use equilibration time instead of erythorbate
or ascorbate but cannot meet cooling options without nitrite.

- Products that contain nitrite and use equilibration time instead of erythorbate or ascorbate, but do not
have a brine concentration of ≥ 6%.

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 Lethality, Stabilization, and Multiple Hurdles Workshop

1. State the regulatory lethality performance standard for cooked beef, including the log
reduction and the target organism. Include the regulation that covers this.

2. Why must high relative humidity be applied during the first part of the heating process
(lethality treatment) for jerky products, and certain fully cooked RTE meat and poultry
products?

3. Could an establishment use the FSIS Appendix A lethality compliance guideline to

support its critical limits for meeting the lethality performance standard, if the establishment
cooks cured beef briskets in a sealed, moisture impermeable bag to an internal temperature
of 145°F for 4 minutes?

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 26 Food Ingredients of Public Health Concern

Objectives:

1. List the “Big 8” food allergens.

2. Distinguish between a food allergy and a food intolerance.
3. List examples of food ingredients to which some individuals are intolerant.
4. Describe establishment responsibilities for controlling ingredients of public health
concern.
5. Identify situations that may lead to cross-contact with a food allergen.
6. Identify situations that may result in mislabeling of a product containing an ingredient of
public health concern.
7. Distinguish between labeling requirements for ingredients of public health concern and
voluntary labeling declarations.
8. Describe when an establishment can include factual statements about the processing
environment on a finished product label.
9. Perform and document the “Big 8” Formulation Verification task.
10. Identify additional labeling concerns that require a directed General Labeling task and
documentation of general labeling noncompliance.

Introduction
FSIS is responsible for verifying that establishments have adequate in-plant ingredient controls and
appropriate product labeling that lists ingredients in descending order of predominance by common or
usual name.

Food Allergies

Exposure to specific proteins in certain food ingredients, not a direct harmful effect from the
ingredient itself, can trigger a severe immune system reaction in individuals with food allergies.
An allergic reaction is a hypersensitive, aggressive immune system response with symptoms
that include tingling in the mouth, tongue and throat swelling, breathing difficulty, hives,
vomiting, abdominal cramps, diarrhea, drop in blood pressure, and unconsciousness. In severe
cases, life-threatening allergic responses called “anaphylactic reactions” may result in death. No
conclusive scientific evidence exists that defines a necessary minimum threshold level for a food
allergen to cause an adverse reaction. In most cases, the presence of an undeclared substance
that is a known allergen, even in trace amounts, poses a significant public health risk and a
potentially catastrophic allergic reaction in an allergic individual.
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The FDA has identified eight foods (“Big 8”) and any ingredients that contain protein derived
from these eight foods as major food allergens. The foods that account for approximately 90% of
food allergies are:

• Milk
• Eggs
• Fish (e.g., bass, cod, or flounder)
• Crustacean shellfish (e.g., crab, lobster, or shrimp)
• Tree nuts (e.g., almonds, pecans, or walnuts)
• Peanuts
• Wheat
• Soybeans

NOTE: Attachment 1 in FSIS Directive 7230.1 provides a comprehensive list of ingredients and
products that may be derived from the “Big 8” food allergens.

According to FDA estimates, food allergies result in 30,000 emergency room visits, 2,000
hospitalizations, and 150 deaths each year. While these reactions can be treated, there is no
cure for food allergies. To avoid consequences, consumers with a food allergy rely on accurate
labeling of food products to strictly avoid foods containing the allergen.

Food Intolerances

Some individuals may be intolerant of certain food and color additives. The adverse effects of
food intolerances, which are often confused with allergic reactions, are generally not life-
threatening and do not involve the same immunological mechanisms. Nevertheless, they can
have significant public health consequences.

Lactose is a sugar molecule in milk and milk product derivatives. Some people are deficient in
lactase, an enzyme in the intestinal tract that breaks down lactose. People with lactose
intolerance experience gas, bloating, cramping, and sometimes diarrhea.

Sulfites are added ingredients used as to preserve food and prevent browning of processed
fruits, vegetables, and shellfish. People with sulfite intolerance can experience chest tightness,
hives, stomach cramps, diarrhea, breathing problems, and an increased risk of having asthma
symptoms for sensitive people with asthma.
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FD&C Yellow No. 5, a color additive also known as tartrazine, is used in a variety of food
products. Tartrazine can cause symptoms similar to an allergic reaction (i.e., hives and swelling)
in intolerant consumers.

Monosodium Glutamate (MSG) is added to a number of meat and poultry products as a flavor
enhancer. Some individuals report headache, chest tightness, nausea, diarrhea, and sweating
following consumption of MSG-containing products.

Gluten is the protein found in cereal grains (e.g., barley, rye, oats) that helps give dough its
elasticity. Individuals who are intolerant to gluten have a condition known as celiac disease.
Symptoms may include fatigue, bloating, cramping, chronic diarrhea, nutrient malabsorption,
and, although not an allergic reaction, inflammation and damage to the lining of the small
intestine.

Nitrate and nitrites are different nitrogenous compounds used as curing agents in many meat
and poultry products (e.g., hotdogs, bologna, salami, other processed meats) to inhibit the
growth of Clostridium spp. and contribute to the characteristic flavor and color of cured
products. Consuming nitrate or nitrite compounds may cause headache and hives in some
people. The amount of nitrite or nitrate added to a product is restricted by regulation because
excessive concentrations can be toxic.

Some product formulations include only naturally occurring sources of nitrite or nitrate (e.g.,
celery juice powder, parsley, cherry powder, beet powder, spinach, sea salt) and must be
labeled appropriately (e.g., “uncured” bacon product that includes a declaration on the product
label stating, “Uncured Bacon, No Nitrates or Nitrites added except those naturally occurring
in ") because naturally occurring sources of nitrite or nitrate do not inhibit the
outgrowth of Clostridium spp. as well as the highly purified chemical forms. In addition, cured
products generally bear a statement such as "Not Preserved, Keep Refrigerated Below 40°F at
All Times." Exceptions to the refrigeration handling statement include finished products that have
been sufficiently dried according to other requirements or contain an amount of salt sufficient to
achieve an internal brine concentration of ≥10%.

NOTE: FD&C coloring agents (e.g., Red No. 3 and Red No. 40 added to cures as a tint to
distinguish nitrite-containing compounds from salt) do not need to be declared on the product
label since their use is considered incidental and does not function as a color additive in the
meat or poultry product. Similarly, release agents used on grills, loaf pans, cutters, or other hard
production surfaces are generally considered to be a processing aid and their incidental use is
not required to be declared on the product label.

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Establishment Responsibilities

The establishment is responsible for researching all ingredients used in its product formulations
and determining if an ingredient may trigger a food allergy. FSIS expects establishments to
employ appropriate food safety procedures (i.e., HACCP plans, SSOPs, or other prerequisite
programs) that ensure added ingredients match the product formula and all ingredients are
properly and accurately disclosed on the product label.

Ongoing sanitary measures must prevent cross-contact between allergenic and non-allergenic
products, equipment, and utensils, and ensure accurate label declarations on products that
contain allergens. Cross-contact can be avoided through effective controls and appropriate use
of ingredients, such as checking ingredient containers at receiving for damage, ensuring proper
identification and control of allergenic ingredients and products throughout production, effective
sanitation measures, training employees to work with allergens, and adhering to product
formulations.

In addition to inadequate sanitary controls, accidental application of inaccurate labels to properly

formulated products poses a threat to sensitive consumers. The establishment can ensure
accurate product labeling by changing labels when changing product formulations, reviewing
incoming non-meat/non-poultry ingredient labels for changes, discarding obsolete labels after a
change in product formulation, reviewing newly printed labels for accuracy, controlling labels to
ensure application of the correct label, maintaining adequate identification controls of product
containing an allergenic ingredient that is intended for rework, and declaring an allergen
indirectly added to the product.

NOTE: When reviewing an establishment’s hazard analysis and supporting documentation

regarding the use of highly refined edible oils, be aware that highly refined edible oils (e.g.,
soybean oil, peanut oil) are plant-based oils that have been processed and rendered virtually
free of allergenic proteins and are safe for the food-allergic population to consume. However,
allergen-containing products cooked or par-fried in highly refined edible oils may leave traces of
allergenic proteins behind in the oil. Establishments that reuse the same oil to cook or par-fry
products should consider the potential hazard oil reuse might pose to food-allergic consumers.

Avoiding cross-contact between products containing a food allergen and those that do not is
critically important. Cross-contact could result from inadequate control or inappropriate use of
ingredients of public health concern.

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Situations that might allow for cross-contact to occur include the establishment failing
to:

• Check ingredient containers for damage at receiving to prevent allergen contamination

within the establishment.
• Implement a program to ensure proper identification and control of allergenic
ingredients, allergen containing products, and allergen containers through receiving,
weighing, formulation, and packaging.
• Ensure effective sanitation measures are in place to address the potential for cross-
contact when producing multiple products with different formulations.
• Implement adequate sanitation procedures for cleaning of utensils and equipment used
in formulating and processing both products containing an allergen and products without
allergens.
• Train employees on the appropriate use of ingredients and the need to be especially
careful when working with allergens.
• Appropriately identify/store products to be reworked that contain an allergen.
• Manufacture a product in accordance with the intended product formulation.

In addition to inadequate controls to prevent cross-contact, accidental application of inaccurate

labels to properly formulated products could pose a threat to consumers sensitive to any
ingredients in the formulation. Examples of how inaccurate labeling of a product can occur
include the establishment failing to:

• Declare ingredients listed in the product formula on the product label by common or usual
name.
• Change labels when changing over from one product formulation to another.
• Review the labels on incoming non-meat/non-poultry ingredient mixes at receiving for
changes.
• Discard obsolete labels after a change in product formulation.
• Review newly printed labels to ensure accuracy.
• Control labels for products with similar appearance but different ingredients to ensure
application of the correct label (e.g., storing mixed bundles of labels for similar products with
different ingredient formulas which could lead to a mix-up of labels).
• Maintain adequate production controls over a product that contains an allergenic ingredient
and is intended for rework, allowing it to be reworked into a product not labeled to contain
that ingredient.

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• Declare an allergen that was indirectly added to the product. An example would be an
establishment that is producing product on a food contact surface sprayed with a non-stick
coating (a release agent intended to prevent product from adhering to the food contact
surface) containing soy lecithin and is not properly declaring the soy lecithin on its finished
product label. Note that substances used as release agents on surfaces, including grills, loaf
pans, cutters, or other hard surfaces, are generally considered to be processing aids and
are not required to be declared in the ingredients statement on the meat or poultry product
label. However, if a particular release agent contains a known allergen, such as soy lecithin,
official establishments must list the allergenic ingredient in the ingredients statement on the
product label. Many cooking sprays (e.g., PAM®) used as release agents will contain soy
lecithin as an emulsifier. Some may contain other allergenic ingredients as well.

Label Declarations

Under FMIA and PPIA, all ingredients used to formulate meat or poultry products generally
must be declared by its common or usual name in the ingredients statement on the
product label.
With few exceptions, a meat or poultry product is considered to be misbranded if it
contains permitted ingredients that are not declared on product labels.

The need for accurate, informative product labeling is especially important for individuals with
allergies or food intolerances. FSIS supports the use of voluntary statements on labels to further
alert people with sensitivities or intolerances to the presence of specific ingredients (e.g., a label
statement such as, “Contains: milk, wheat gluten” or a product label specifying, “Contains
sodium caseinate (from milk)” to alert milk allergic consumers that an ingredient contains or is
derived from milk).

On a limited case-by-case basis, the FSIS Labeling and Program Delivery Staff (LPDS) may
permit the use of factual labeling statements about a product’s manufacturing environment.
However, the Agency does not consider the casual use of an elective statement about a
product’s manufacturing environment as helpful to consumers and does not promote good
manufacturing practices under a HACCP system.

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Factual Labeling Statements

With the exception of ingredients consistent with the FDA’s definition of a processing aid or
incidental additive, all ingredients listed on labels of incoming food and food ingredients must be
declared on finished product containers. Official establishments must list an allergenic
ingredient in the product label ingredients statement if a formulation component used contains a
known allergen (e.g., soy lecithin in a release agent). All ingredients listed in a “may contain” or
“produced in a facility” statement must be listed on the final label unless the establishment has
(1) contacted the supplier and confirmed, preferably in writing, that the statement is a
cautionary statement, and no such ingredient is in the product; and (2) included a written
statement in its hazard analysis supporting why the “may contain” or “produced in a facility”
statement is not documented on the finished meat or poultry product label.

FSIS will consider any non-misleading symbols, statements, or logos to inform consumers of the
presence of ingredients of public health concern in meat or poultry products. An establishment
may submit such a request to the Agency as a policy inquiry but not as label-approval
submission.

NOTE: Some chemicals mentioned in this handout may be classified as “generally recognized
as safe” (GRAS) for human consumption. Although this module focuses on the addition of
ingredients reported to cause adverse health effects in some individuals, establishments must
consider all potential chemical food safety hazards, including ingredients that are GRAS, in their
hazard analyses.

Factual Labeling Statement Example:

An official establishment uses chopped peanuts in making a dry, Thai-style meat sauce mix.
The processing environment must remain dry during operations. Since the production
equipment cannot be washed, peanut dust may become airborne and unavoidably contaminate
other meat or poultry products manufactured in the same production area. In such situations, a
statement about the manufacturing environment as described above or the use of a “may
contain (name of allergenic ingredient)” statement has been approved by LPDS. However, it is
not acceptable to use this type of statement to address poor SSOPs, such as potential cross-
contamination between different products due to inadequate equipment wash between
production.

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Inspection Program Personnel Responsibilities

Establishments are expected to have effective controls and preventive measures to address all
potential chemical hazards, including food allergens and other ingredients of public health
concern. IPP will verify that the establishment addressed allergens as a potential chemical food
hazard in its hazard analysis, has support for decisions made in its hazard analysis, and
implemented effective controls based on those decisions.

IPP must be up to date and aware of the establishment’s controls and preventive measures for
allergens and ingredients of public health concern. Multiple inspection activities (e.g., HAV task,
HACCP Verification task, Review of Establishment Testing Data task, Pre-operational and
Operational SSOP tasks, General Labeling Task, and “Big 8” Formulation Verification task) may
be necessary to verify that an establishment’s food safety system meets regulatory
requirements for allergens and ingredients of public health concern. IPP will issue an NR under
the appropriate inspection task if the establishment:

• Fails to address a potential chemical food safety hazard in its process.

• Does not have adequate documentation on file to support decisions made in its hazard
analysis for hazards that are not reasonably likely to occur.
• Fails to adequately implement its SSOPs or other prerequisite programs to support a
decision that a chemical food safety hazard is not reasonably likely to occur.
• Fails to appropriately declare any allergen or other ingredient of public health concern on the
product label.

“Big 8” Formulation Verification Task

The “Big 8” Formulation Verification task provides IPP with a method for verifying that
establishments are accurately controlling and labeling the eight most common food allergens.
Performing the task as described in FSIS Directive 7230.1 includes reviewing records,
observing production processes, and responding to specific task-related questions in PHIS.

IPP assigned to establishments that produce products in any of the HACCP processing
categories other than slaughter must determine whether the establishment produces any
products that may contain any of the “Big 8” food allergens. Review the preventive and control
measures developed by the establishment to verify that such measures are being effectively
implemented and product label ingredients are consistent with product formulation records.

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Depending on its processes and decisions made in its hazard analysis, an establishment’s
preventive and control measures to control allergens may be in its HACCP plan, Sanitation
SOPs, or a prerequisite program.

For establishments in which the “Big 8” Formulation Verification task is relevant, the task will
appear monthly as a routine Priority 3 task on the Establishment Task List in PHIS. IPP will
perform the routine verification task on each shift in establishments with multiple shifts. In
establishments that produce more than one product, IPP are to use the chart from Directive
7230.1 (page 5) to prioritize product selection. Whether or not the establishment produces
products containing a “Big 8” allergen, IPP are to apply the priority list to all products in an
eligible establishment.

NOTE: Examples of multi-ingredient components include sauces, condiments (e.g., ketchup,

mustard), seasoning packets, flavorings, spice mixes, soup bases, or other combinations of two
or more ingredients mixed together. Additional considerations regarding multi- ingredient
seasonings or spices, processing aids, incidental additives, release agents, and “may contain”
or “produced in a facility” statements on incoming food and food ingredients are outlined in FSIS
Directive 7230.1.

To perform a routine “Big 8” Formulation Verification task, IPP must first schedule the task in
advance and determine which products will be produced on that date. Next, they must select a
product for the task, which may require coordinating with IPP on other shifts to avoid selecting
the same product for consecutive tasks. Always attempt to select products that have not been
selected previously unless there has been a change in supplier, ingredients, formulation, or the
establishment produces a very limited number of products.

NOTE: If FSIS Directive 7230.1 task criteria does not apply to the operation, IPP are to find the
“Big 8” Formulation Verification task on the Establishment Profile/Inspection Tasks page for the
establishment and disable the task in accordance with FSIS Directive 13,000.1.

After selecting a product, IPP are to obtain that product’s specific product formulation from the
establishment for verification in accordance with 9 CFR 318.6 and 9 CFR 381.180. The “Big 8”
Formulation Verification task may be performed using a combination of the recordkeeping and
review and observation inspection components.

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Performing the task involves:
1. Reviewing product formulation records and observing product formulation process steps
to verify that all ingredients used in the production of the product are consistent with the
intended product formulation.
2. Reviewing the product label to verify that all ingredients used in formulating the product
are declared in the ingredients statement by common or usual name and in descending
order of predominance.
3. Observing that the appropriate label is applied to the product.
4. Observing that the applied label is consistent with the establishment’s label approval on
file.

As part of documenting the task in PHIS, IPP will respond to specific questions related to this
task located on the “additional info” tab of the task documentation page. Attachment 2 of FSIS
Directive 7230.1 provides more information regarding these questions.

If there are any indications of increased risk of undeclared allergens in the establishment, the
“Big 8” Formulation Verification task may be performed more frequently as a “for cause” directed
task. Before scheduling additional “Big 8” Formulation Verification tasks, IPP should discuss
with their supervisor the circumstances and any concerns of increased risk of undeclared
allergens.

Documenting Noncompliance with the “Big 8” Formulation Verification Task

IPP are to document noncompliance on an NR in PHIS under the “Big 8” Formulation

Verification task whenever they determine that a meat or poultry product contains a “Big 8”
allergen not declared in the ingredients statement on the product label. IPP will cite the relevant
safety regulation(s) in 9 CFR 317.2(f) for products bearing the meat inspection legend or 9 CFR
381.118 for products bearing the poultry inspection legend. In addition, IPP must always notify
their supervisor when they identify such noncompliance so that a recall request determination
can be made.

The establishment’s food safety system has failed anytime it ships product containing an
undeclared allergen in commerce.

NOTE: If IPP identify concerns when performing the “Big 8” Formulation Verification task and
believe a directed HAV task should be performed, they are to discuss those concerns with their
supervisor.

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Documenting Noncompliance for Other Undeclared Ingredients

If IPP determine that a product contains an ingredient not declared in the ingredients statement
but it is not a “Big 8” allergen, a directed General Labeling task should be scheduled to
document General Labeling noncompliance with 9 CFR 317.2(f) for products bearing the meat
inspection legend or 9 CFR 381.118 for products bearing the poultry inspection legend.

Other Actions

IPP may need to take regulatory control of product at the official establishment as necessary
to prevent the product from entering commerce. IPP should always contact the FLS for
guidance any time they have reason to believe any product bearing labels that fail to declare
one of the “Big 8” food allergens or any other ingredient of public health concern has entered
commerce. An immediate withholding action on the process may be necessary and a product
recall may be requested by the Recall Management and Technical Analysis Division
(RMTAD). Refer to FSIS Directive 8080.1 for more information on recalls.

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 27 RTE-SS Hazards and Controls Workshop
Hotdog Flow Diagram

Receiving Receiving Receiving

Packaging Non-meat Raw Meat
Materials Ingredients

Storage Storage Storage

Packaging Non-meat Raw Meat
Materials Ingredients and Rework

Weighing Weighing &

Non-meat Pre-grinding
Ingredients Raw Meat and
Rework

t
Chopping & Mixing Rework

...____________·- ~
Stuffing

Cooking / Smoking / Cooling

Peeling

Packaging / Labeling

Metal Detector

Finished Product Storage

Shipping

No returned product accepted.

(Training Example Only)

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 Hotdog - Hazard Analysis – …EXCERPT… (Training Example Only)

Process Potential Food Safety Hazard RLTO Basis If RLTO, What Control Measures? Is this Step a CCP?
Step
Receiving - B-Pathogen growth No Temperature Control Vegetative pathogens and Trichinae eliminated at No
raw meat Program the Cooking CCP
Salmonella, STECs, Yes
Campylobacter, Trichinella Clostridia growth and toxin formation prevented
spiralis with Chilling CCP and Temperature Control
Program
Clostridium botulinum and Yes
Clostridium perfringens
(Clostridia)

C-None

P-Metal, rubber, plastic, wood in No Receiving Inspection

incoming raw product Program
… … … … … …
Cooking & B-Pathogens and parasites Yes Cooking at temperatures sufficient to eliminate Yes-1B
Smoking pathogens and parasites
C-None
P-None
Cooling B-Clostridium growth Yes Rapid cooling to ensure no growth of C. Yes-2B
botulinum &
less than one log growth of C. perfringens

B-Contamination with Lm and No Brine SOP for salt

potential subsequent growth concentration, temperature,
and microbial testing for
C-None Listeria spp.
P-None
… … … … … …

156
 Hotdog HACCP Plan (Training Example Only)

CCP Critical Limits Monitoring Verification Procedures Records Corrective Actions

Procedures

1B Internal Every 2 hours, internal Accuracy of all thermometers Cooking log QC will take Corrective
Cooking temp at temperature checked by checked prior to each shift Actionsper 417.3
Thermometer log
least 160°F floor supervisor using
handheld digital Once per shift QC will Corrective Actions
thermometer, two temps observe one internal
log
taken from each (upper temp monitoring
and lower) chain of procedure
continuous
cooker/smoker/cooler unit Daily, QC supervisor will
checked at specified review monitoring records and
access point “B” other records required by
417.5(a)(3)

2B Cooler brine Every 2 hours cooler Accuracy of all thermometers Cooling log QC will take
Cooling medium kept brine medium checked checked prior to each shift Corrective Actions
at or at specified Thermometer log per 417.3
below 28°F. access point “A”
Once per shift QC will
Chain speed observe one internal temp Corrective Actions log
not to exceed Every 2 hours chain monitoring, one brine temp
100 racks per speed checked check, and one chain speed
minute. check procedure
Internal temp Every 2 hours internal Daily, QC supervisor will
reduced from product temperature at review monitoring records and
130°Fto less exit checked using other records required by
than 40°F in90 handheld digital 417.5(a)(3)
minutes or less thermometer, two temps
taken from each (upper
and lower) chain of
continuous
cooker/smoker/cooler
All three monitoring checks
done by floor supervisor

157
 28 Ready-to-Eat (RTE) Sanitation

Objectives

1. Identify why establishments producing RTE products have a special responsibility for
adequate sanitation in the RTE processing environment.

2. Describe effective methods of sanitation in RTE processing environments.

3. Identify potential sanitation issues in RTE processing environments.

Ready-to-eat product - As per 9 CFR 430.1 definitions, a meat or poultry product that is
edible without additional preparation to achieve food safety and may receive additional
preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes. RTE
product is not required to bear safe-handling instructions (as required for non-RTE products by
9 CFR 317.2(i) and 381.125(b) or other labeling that directs that the product must be cooked or
otherwise treated for safety and can include frozen meat and poultry products.

Post-lethality Treatment - A process that eliminates or reduces levels of Listeria

monocytogenes on or in an RTE product to make it safe for human consumption. Examples of
post-lethality treatments are cooking and high pressure processing (HP). The application of an
antimicrobial agent (e.g., potassium lactate; sodium diacetate) or an antimicrobial process
(e.g., freezing; low water activity or pH) that limits or suppresses L. monocytogenes growth
may also be used as a post-lethality treatment if it eliminates or reduces L. monocytogenes
growth over the shelf life of the RTE product. .

Post-lethality exposure - Exposure of product that has been subjected to an initial lethality
treatment to the environment in the processing area as a result of slicing, peeling, re-bagging,
cooling semi-permeable encased product with a brine solution, or other procedures.

Cross-contamination - The transfer of bacteria, possibly including pathogenic bacteria, to the

exposed RTE product after the lethality treatment. These bacteria can come from the
environment, from the employees, or from the equipment. They can be transferred directly,
such as when an exposed RTE product is placed on a tabletop that has bacteria on it. Often
they are transferred indirectly, such as when a pallet placed on the floor in a raw area is
subsequently used in the RTE area, or when an employee handles a pallet and then touches
exposed product.

Consumed as packaged - Product eaten or consumed as it comes from the package (no
heating/cooking/mixing/etc).
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Many RTE processes involve handling the product after it has been subjected to an initial
lethality treatment (post-lethality exposure). When the product is directly exposed to the
environment, it can become cross-contaminated. Cross-contamination is the transfer of
bacteria, possibly including pathogenic bacteria, to the exposed RTE product after the
lethality treatment.

Some RTE products may be reheated by the consumer to enhance palatability, but a reheating
process will not necessarily eliminate any pathogens that exist on or in the product. Because
many RTE products are consumed right from the package or minimal reheating, any
pathogens that are present will be consumed along with the product. Thus, there is an
increased risk of these products causing foodborne illness, and establishments producing
these products have an increased responsibility for sanitation of the RTE processing
environment. Sanitation is critical for ensuring that RTE products do not become cross-
contaminated. Sanitation SOPs should be established to provide effective and consistent
results.

Establishments are responsible for producing product that is free from any pathogen.
The pathogen Listeria monocytogenes (Lm) is the species of Listeria bacteria of particular
concern because it has potentially fatal consequences. Lm is a biological food safety hazard
that an establishment producing post-lethality exposed RTE products must control through its
HACCP plan or prevent in the processing environment through Sanitation SOPs or some other
prerequisite program. RTE product is considered adulterated if it contains Lm or if it comes into
direct contact with a food contact surface that is contaminated with Lm.

Lm is spread very easily by direct contact with a contaminated surface. Lm can survive and
grow in cool, damp environments, such as those found in processing areas, coolers, or
floors. Incomplete removal of product debris can provide nutrients and a place of attachment
which allows bacterial growth. Maintaining dry processing equipment will help reduce the
growth of Lm.

Lm can form biofilms on solid surfaces, such as stainless steel and rubber, and can survive
adverse conditions on apparently smooth surfaces. Biofilm is a thin, slimy film of bacteria that
adheres to a surface effectively protecting it from the environment. Biofilms protect the bacteria
embedded in the biofilm from sanitizers. Rotating detergents and sanitizers help maintain
effectiveness and keeps bacteria from building resistance. Sanitizing is done after cleaning,
because a sanitizer cannot work effectively unless the equipment is cleaned first.
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Lm contamination has been linked to disruptive construction. Lm is in the environment and the
dust/debris generated during construction can carry it to many different places if not controlled.
Dust generated by construction and other disruptive activities can establish contamination on
food contact and other environmental surfaces.

Sanitation is critical for ensuring that RTE products do not become cross-contaminated.
Sanitation SOPs should be established to provide effective and consistent results. Effective
sanitation is a complex process. A successful establishment must understand and apply the
cleaning and sanitizing process and select the proper methodology and chemical agents for
the particular environment and equipment being cleaned. Typically, effective preoperational
sanitation can be distilled down to the following recommended steps:

a) Perform dry cleaning of the equipment, floors, conveyor belts, and tables to remove
meat particles and other solid debris. Some equipment, such as slicers and dicers, may
require disassembly so that parts can be adequately cleaned.
b) Wash and rinse floor.
c) Pre-rinse equipment (rinse in same direction as product flow). Pre-rinse with warm or
cold water – less than 140°F (hot water may coagulate proteins or “set soils”).
d) Clean, foam, and scrub equipment. Always use at least the minimum contact time for
the detergent/foam. Instructions should be provided on identifying possible niches and
use of appropriate cleaning methods. Live steam for cleaning is not acceptable at this
step since it may bake organic matter on the equipment.
e) Rinse equipment (rinse in same direction as product flow).
f) Visually inspect equipment to identify minute pieces of meat and biological residues.
g) Sanitize floor and then equipment to avoid contaminating equipment with aerosols from
floor cleaning. Care should be taken in using high pressure hoses in cleaning the floor
so that water won’t splash on the already cleaned equipment. Use hot water, at least
180°F, for about 10 seconds to sanitize equipment. Sanitizers (e.g., acidic quaternary
ammonia) may be more effective than steam for Lm control.
h) Rotate sanitizers periodically. Alternating between alkaline-based and acid-based
detergents helps to avoid “soapstone” and biofilms. This also helps change the pH to
prevent adaptation of bacteria to a particular environment.
i) Dry. Removing excess moisture can be done most safely and efficiently by air drying.
Reduced relative humidity can speed the process. Avoid any possible cross-
contamination from aerosol or splash if a method other than air drying (e.g., using a
squeegee or towel) is used.
160
Cleaning and sanitizing are very important. Pathogens can be transferred to RTE products
from equipment and employee hands that have not been adequately cleaned and sanitized.
Lm can hide in poorly accessible areas of equipment, and it may take several hours of
production before it has seeded onto direct product contact surfaces of equipment sufficiently
to become detectable on the product contact surface or the product itself.

161
 29 Listeria monocytogenes (Lm) Regulations

Objectives

1. Identify reasons Listeria monocytogenes (Lm) is a public health threat for ready-to eat
(RTE) meat and poultry products.
2. Verify compliance with the regulations in 9 CFR 430 by following instructions in FSIS
Directive 10,240.4 “Listeria Rule Verification Activities.”

Introduction

Listeria monocytogenes (Lm) is a widespread pathogen capable of surviving under various

environmental conditions. It has been isolated from the soil, plant materials, animal feedstuffs,
the intestinal tract of various mammals and birds, and has also been found in some species of
fish and shellfish. Lm is very tolerant of freezing, drying, salt, and heat, and can grow at
temperatures from 31.3°F up to 113°F. It can adapt to significant changes in pH values and
reproduce at a pH range between 4.39 and 9.4. Lm can also reproduce with a water activity
(aw) as low as 0.92.

Listeriosis, a disease caused by consuming food products contaminated with Lm, can occur
from a few days up to six weeks after ingestion. The infective dose of Lm is believed to be
fewer than 1,000 organisms. Lm is especially pathogenic to high risk populations, including
pregnant women and their fetuses, young children, the elderly, and immunocompromised
individuals. An individual with a mild Lm infection may have general flu-like symptoms,
including nausea, vomiting, and diarrhea. However, severe infections can lead to septicemia,
meningitis, encephalitis, and death. Infections during pregnancy may result in a miscarriage or
stillbirth.

A common link in Lm outbreaks is contamination of RTE products in the post-lethality

environment prior to packaging. Lm can contaminate a food processing environment from
animals, ingredients, equipment, personnel, environmental reservoirs, or other means. Once
Lm contaminates the processing environment, it can establish in drains, on processing
equipment, and in refrigeration units. The organism can also form a durable biofilm.

Lm may cross-contaminate RTE product exposed to the post-lethality environment due to

inadequate sanitary practices. Dust, movement of personnel, and equipment associated with
construction projects (e.g., air handling system repairs, removal of walls, repairs to plumbing
systems) create opportunities for Lm to cross-contaminate post-lethality exposed product. An
establishment may need to implement additional sanitation practices and containment
procedures for any construction projects in or around processing areas where post-lethality
exposed products are handled and packaged.

FSIS considers Lm to be a significant foodborne pathogen of great potential public health

concern that must be controlled by establishments producing post-lethality exposed RTE

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products. FSIS has developed regulatory requirements specifically for controlling Lm in post-
lethality exposed RTE products. In addition, the agency has developed Lm sampling programs
as part of its public health strategy for protecting consumers against Lm.

Listeria Rule

On June 6, 2003, FSIS published an interim final i.e., 9 CFR Part 430 “Listeria Rule” that
requires establishments producing post-lethality exposed RTE products to prevent adulteration
by Lm. 9CFR 430.4(a) identifies Lm as a hazard that establishments producing RTE products
exposed to the post-lethality environment must control through a HACCP plan or prevent in the
processing environment through an SSOP or other prerequisite program. It states that RTE
product is adulterated if it contains Lm or comes into direct contact with a food contact surface
contaminated with Lm. 9 CFR 430.4(b) identifies three alternatives that establishments are to
choose from in order to control Listeria in post-lethality exposed RTE product. IPP are
responsible for using appropriate HACCP or SSOP verification tasks to verify establishment
compliance with §430.4(b).

Definitions

9 CFR 430.1 provides several definitions that are specific to ready-to-eat (RTE) products.
Two RTE product definitions are deli products and hotdog products. A deli product is an
RTE meat or poultry product that is typically sliced, either in an official establishment or after
distribution, and assembled in a sandwich for consumption. A hotdog product is an RTE meat
or poultry frank, frankfurter, or wiener product with a standard of identity defined in 9 CFR
319.180 and 319.181. A risk assessment performed jointly by FSIS and the FDA indicated that
on a per serving basis, deli meats and hotdogs (not reheated) posed the greatest risk of illness
and death from Lm.

A lethality treatment is the initial process RTE meat and poultry product undergoes to
eliminate or reduce the number of pathogenic microorganisms on or in a product. Examples of
lethality treatments that will make an RTE product safe for human consumption include cooking
or the application of an antimicrobial agent or process that eliminates or reduces pathogenic
microorganisms.

The post-lethality processing environment is the area in an establishment into which product
subjected to an initial lethality treatment has been routed. The product may be exposed to the
environment through slicing, peeling, re-bagging, cooling semi-permeable encased product in a
brine solution, or other procedures.

Post-lethality exposed product is RTE product that comes into direct contact with a food
contact surface in the post-lethality processing environment after an initial lethality treatment.
Only post-lethality exposed RTE products are subject to 9 CFR 430.

163
The following three terms are associated with the three Listeria control alternatives used to
control or prevent Lm in an RTE product in the post-lethality environment:

• Post-lethality treatment (PLT) - an additional lethality treatment, following the initial lethality
treatment, applied to the final product or sealed package of product to reduce or eliminate the
risk of Lm contamination during post-lethality exposure. Examples of post-lethality treatments
include steam pasteurization, hot water pasteurization, radiant heating, and high pressure
processing (HPP). Some antimicrobial agents may also function as post-lethality treatments.

• Antimicrobial agent - a substance in or added to an RTE product that suppresses or limits

growth of Lm in the product throughout the shelf life of the product. Examples of antimicrobial
agents used in RTE products are sodium lactate, potassium lactate, and sodium diacetate.
FSIS Directive 7120.1 identifies additional antimicrobial agents approved for use in the
production of RTE meat and poultry products.

• Antimicrobial process - an operation (e.g., freezing) applied to an RTE product that

suppresses or limits the growth of Lm in the product throughout the shelf life of the product.
Drying and fermenting are operations that may be applied to a product to make it RTE and
subsequently suppress or limit the growth of Lm.

Note: The post lethality treatment should demonstrate at least 1-log decrease of Lm before the
product is released into commerce and the antimicrobial agent or process should demonstrate
no more than 2-logs growth of Lm over the shelf life of the product.

While not defined in §430.1, indicator organism is defined in 9 CFR 430 as a species of
bacterium used to determine if the sanitary conditions of food processing equipment,
production areas, or storage rooms will allow for the presence of pathogenic microorganisms.

Establishment Responsibilities

An establishment that produces post-lethality exposed RTE meat and poultry products must
maintains its facility in a sanitary manner. The sanitation program must be designed and
implemented to prevent contamination of food contact surfaces (FCS) and adulteration of RTE
product with Lm and other pathogens in the post-lethality environment. The establishment must
conduct a hazard analysis designed to control FCS contamination and adulteration of RTE
products. Any hazards considered reasonably likely to occur must be included in a HACCP
plan and the effectiveness of the RTE processes validated. The establishment should
incorporate procedures for accurately labeling RTE products, including identifying product for
rework. The hazard analysis, HACCP plan, supporting documentation, and prerequisite
programs should be maintained and made available to FSIS upon request.

Sampling Program

Under §430.4(b)(2)(iii)(A) and (3)(i)(A), establishments that produce post-lethality exposed

RTE products are required to provide for FCS testing in the post-lethality processing
environment to ensure that the surfaces are sanitary and free of Lm or indicator organism.
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While sampling is not required under Alternative 1 or Alternative 2, Choice 1, FSIS recommends
the establishment collect from each post-lethality exposed production line a minimum of 2 Lm
FCS samples per year (every 6 months) under Alternative 1 and a minimum of 4 Lm FCS
samples per year (quarterly) under Alternative 2, Choice 1. FCS sampling is required for
Alternative 2, Choice 2 and Alternative 3. The minimum required sampling frequency from each
post-lethality exposed production line under Alternative 2, Choice 2 is 4 Lm FCS samples per
year (quarterly) and once per month (monthly) under Alternative 3. For establishments that
produce RTE deli products and hotdogs under Alternative 3, the minimum FCS sampling
frequency from each post-lethality exposed production line is monthly in very small
establishments, every 2 weeks for small establishments, and weekly in large establishments. 9
CFR 430.4 requires establishments to identify the size, location, and frequency of the FCS sites
to be sampled and provide an explanation of why the testing frequency is sufficient to ensure
that Lm will be effectively controlled.

IPP Responsibilities for Verifying Compliance with 9 CFR Part 430.4

In order to verify compliance with 9 CFR 430.4, IPP must be familiar with the establishment’s
RTE products and processes. If necessary, establishment management should be asked if they
produce any RTE product that is exposed to the environment following the initial lethality step.

IPP should ask the establishment which of the three Listeria control alternatives was chosen for
each post-lethality exposed RTE product produced. If necessary, plant management should be
advised that initial validation results supporting the effectiveness of the selected alternative must
be made available to FSIS upon request.

IPP should verify that the establishment is meeting the requirements of the alternative it
selected by performing the appropriate SSOP or HACCP tasks. If the establishment decides to
produce different products using different alternatives, the inspector should verify that each
post-lethality exposed RTE product meets the requirements for the alternative selected.

In addition to verifying the effectiveness of the Listeria control alternatives selected, IPP will
verify that the establishment is maintaining sanitary conditions sufficient to prevent product
contamination, including Lm. Sanitation is the foundation for controlling Lm and without it, no
alternative will successfully control Lm.

Note: See Attachment 1 for L. monocytogenes control requirements and Attachment 2 for
summaries of the Listeria control alternatives and their requirements.

Alternative 1 - 9 CFR 430.4(b)(1)

Alternative 1 uses a post-lethality treatment (which may also be the antimicrobial agent or
process) that reduces or eliminates microorganisms on the product ---
AND an antimicrobial agent
or process that suppresses or limits the growth of Lm.

165
Alternative 1 Compliance Example

While verifying that an establishment is meeting the requirements of 9 CFR 430 and Alternative
1, you review the establishment’s hazard analysis for sliced semi-dry sausage products (e.g.,
Genoa salami, sandwich pepperoni, etc.). You determine that the fermentation, heating, drying,
and packaging steps have been identified as CCPs in the hazard analysis and were
incorporated into a HACCP plan. The hazard analysis and HACCP plan identify lowered acidity
(pH) through the use of bacterial starter cultures and lowered water activity from drying as
measures to limit the growth of Lm in the finished product throughout the product’s shelf life. A
steam pasteurization process after the product has been vacuum packaged was identified as a
post-lethality treatment to reduce or eliminate Lm contamination. There are critical limits at the
respective steps for pH, water activity, and time and temperature exposure for the steam
pasteurization process. You request the supporting documentation for the critical limits and the
establishment provides scientific literature and the results of challenge studies conducted by a
processing authority. Supporting documents show that pH and water activity in the product
allows no more than a 2-log increase of Lm during refrigerated product shelf life and the steam
pasteurization process is effective in achieving at least a 1-log decrease of Lm. Based upon
your review, you determine that the establishment is in compliance with 9 CFR 430.4(b)(1).

Alternative 2 - 9 CFR 430.4(b)(2)

Alternative 2 uses either a post-lethality treatment (which may be an antimicrobial agent or

process) that reduces or eliminates microorganisms on the product or an antimicrobial agent
or process that suppresses or limits the growth of Lm.

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

 Alternative 2, Choice 1 - The establishment uses a post-lethality treatment (which may

be an antimicrobial agent) that reduces or eliminates Lm on the product.

 Alternative 2, Choice 2 - The establishment uses an antimicrobial agent or process

that suppresses or limits the growth of Lm.

Alternative 2 Compliance

Example 1: An establishment's product line includes chicken salad and ham salad in
hermetically seals containers under Alternative 2, Choice 1. . The cooked, sealed containers
are batch loaded into cylinders and the cylinders are loaded into a chamber, to undergo High
Pressure Processing (HPP) as a post-lethality treatment. You are reviewing the establishment's
hazard analysis and HACCP plan for these products to verify compliance with the requirements
for Alternative 2, Choice 1 as specified in 9 CFR 430. In its hazard analysis, the establishment
concluded that Lm was a hazard reasonably likely to occur (RLTO) in the post-lethality
processing environment. The establishment identified the HPP as a post-lethality treatment and
included it in its HACCP plan as a CCP. The critical limit for HPP is time at a specific pressure
level. In reviewing supporting documents for the CCP, you determine there are other critical
parameters associated with this type of treatment, including product temperature before high
pressure processing and water fill level of the pressure chamber. You request additional
166
documentation supporting that the establishment achieves these additional critical parameters.
The establishment provides documents that show the product temperature is consistently 40°F
or less at the packaging step and that the pressure chamber water level is monitored to ensure
that the required level of pressure can consistently be achieved in the high pressure process.
You conclude that the establishment is in compliance with 9 CFR 430.4(b)(2).

Example 2: You are verifying that an establishment is meeting the requirements of §430 and
Alternative 2, Choice 2. You review the establishment’s hazard analysis for fully cooked frozen
breaded chicken products and verify that the cooking and chilling steps have been identified as
CCPs in the hazard analysis and were incorporated into a HACCP plan. In addition to these
CCPs, Lm was considered a potential hazard not reasonably likely to occur (NRLTO) at the
packaging step because of the Listeria control measures in the establishment’s SSOP designed
to prevent Lm in the post-lethality processing environment. You request the supporting
documentation for decisions made in the hazard analysis and the establishment provides a
scientific document that identifies freezing as an antimicrobial process that would inhibit Lm
growth in the finished product throughout the shelf life of the product. The establishment also
provides the verification procedures and associated records it uses to demonstrate that
products are frozen below the level that the scientific validation document establishes as
effective in preventing the growth of Lm. The records for the past several months show that the
product is achieving the frozen temperature needed to suppress the growth of Lm and is labeled
with the instructions “Keep Frozen.” You review the establishment’s SSOP and records and
verify that the establishment is testing food contact surfaces in the post-lethality processing
environment to ensure that the surfaces are sanitary and free of Listeria spp. The establishment
has identified the conditions under which the establishment will implement hold-and-test
procedures following a positive test of a food contact surface for Listeria spp., the size and
location of the sample sites, and the testing frequency. It also provided a thought process as to
why the testing frequency it selected is sufficient to ensure that effective control of Lm is
maintained. Based upon your review, you determine that the establishment is in compliance
with 9 CFR 430.4(b)(2).

Alternative 3 - 9 CFR 430.4(b)(3)

Alternative 3 involves the use of sanitation measures alone to prevent Lm in the

processing environment and on the RTE product. There are separate FCS sampling
requirements for deli meat and hotdogs produced under this alternative.

Alternative 3 Compliance

Example 1: You are verifying that the establishment is meeting 9 CFR 430 and Alternative 3
requirements. You review the establishment’s hazard analysis for fully cooked, not shelf stable
breakfast type products (e.g., bacon, sausage patties, sausage links, etc.). You verify that the
cooking and chilling steps have been identified as CCPs in the hazard analysis and were
incorporated into a HACCP plan. Lm was considered a potential hazard NRLTO at the
packaging step because the establishment has implemented sanitary measures to control Lm
in the post-lethality processing environment. You request the supporting documentation for the
decision that Lm is NRLTO in the post-lethality environment. You review the establishment’s

167
SSOP program and records. You verify that the establishment is testing food contact surfaces
in the post-lethality processing environment to ensure that the surfaces are sanitary and free of
Listeria spp. the establishment has also identified the conditions under which it will implement
hold-and-test procedures following a positive test of a food contact surface for Listeria spp., the
size and location of the sample sites, and frequency of testing. The establishment provided a
thought process documenting why the testing frequency selected is sufficient to ensure that
effective control of Lm is maintained. Based upon your review, you determine that the
establishment is in compliance with 9 CFR 430.4(b)(3).

Example 2: You are verifying that the establishment is meeting the requirements of 9 CFR
430 and Alternative 3. You review the establishment’s hazard analysis for fully cooked, not
shelf stable deli and hotdog type products (e.g., franks, sliced ham, sliced bologna, sliced roast
beef, sliced turkey breast, etc.). You verify that the cooking and chilling steps were identified
as CCPs in the hazard analysis and incorporated into a HACCP plan. The establishment
considered Lm a food safety hazard NRLTO at the packaging step because of Listeria control
measures in its SSOP intended to prevent Lm from occurring in the post-lethality processing
environment. You request the supporting documentation for the decision that Lm is NRLTO in
the post-lethality environment. You review the establishment’s SSOP and records and verify
that the establishment is testing food contact surfaces in the post-lethality processing
environment to ensure that the surfaces are sanitary and free of Listeria spp. The
establishment has identified the conditions under which it will implement hold-and-test
procedures following a positive test of a food-contact surface for Listeria spp., the size and
location of the sample sites, and the testing frequency. It also provided a thought process
documenting why the testing frequency selected is sufficient to ensure that effective control of
Lm is maintained.

You determine that the establishment verifies the effectiveness of the corrective actions taken
with respect to sanitation after an initial positive test result. The corrective actions require
follow-up testing, including a targeted test of the specific site that is the most likely source of
contamination by the organism, and other additional tests in the surrounding food contact
surface area. You verify that if the establishment obtains a second positive test during follow-
up testing, it will hold the lots of product that may be contaminated from contact with the food
contact surface until a subsequent test result indicates that the sanitation problem is
corrected. After a second positive Lm sample result, the establishment will also test each lot
of product that may have become contaminated with Lm. The establishment will release the
implicated product into commerce only after it has been tested and found free of Lm. If the
sampled product tests positive for Lm, the establishment considers the product adulterated
and withholds it from distribution. The establishment will then either destroy the held product
or rework it using a process that is destructive to Lm. The establishment will also document
the test results and product disposition. Based upon your review, you determine that the
establishment is in compliance with 9 CFR 430.4(b)(3).

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VERIFYING COMPLIANCE

Gather Information

IPP should use the GAD thought process to verify compliance with Alternatives 1, 2, or 3.
Alternative 2 is based on the same requirements as Alternative 1 except that the establishment
can choose to use only a post-lethality treatment (Choice 1) or an antimicrobial agent or
-
process (Choice 2). When verifying compliance with Alternative 1 and Alternative 2
requirements, IPP should seek answers to the following questions:

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

HACCP plan?

2. Does the establishment have scientific documentation supporting the effectiveness of its
post-lethality treatment in accordance with §417.5(a)(2)?

3. Does the establishment have validation data for the post-lethality treatment in accordance
with §417.4?

4. Is the establishment implementing the post-lethality treatment as described in the HACCP

plan?

5. Has the establishment incorporated the use of the antimicrobial agent or process to
suppress or limit the growth of Lm in its HACCP plan, its Sanitation SOPs, or a
prerequisite program?

6. Is the establishment using the antimicrobial agent or process as described in its HACCP
plan, its Sanitation SOPs, or a prerequisite program, and can it scientifically support how
the antimicrobial agent or process is being used?

7. Has the establishment incorporated the use of the antimicrobial agent or process to
suppress or limit the growth of Lm in its HACCP plan, its Sanitation SOPs, or a
prerequisite program?

8. Is the establishment using the antimicrobial agent or process as described in its HACCP
plan, its Sanitation SOPs, or a prerequisite program?

When verifying compliance with Alternative 2, Choice 2, or Alternative 3 requirements, IPP

should seek answers to these questions regarding the establishment’s sanitation procedures.

1. Has the establishment incorporated sanitation measures in a HACCP plan, SSOP, or

other prerequisite program?

2. Is the establishment’s food contact surface testing used to verify the on-going
effectiveness of its sanitation procedures?

3. Does testing of food contact surfaces in the post-lethality processing environment ensure
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 that the surfaces are sanitary and free of Lm or of an indicator organism?

4. Did the establishment identify the conditions under which it will implement hold-and-test
procedures following a positive test of a food contact surface for an indicator organism?

5. Did the establishment state the frequency with which testing will be done?

6. Did the establishment identify the size and location of the sites that will be sampled?
NOTE: establishments should identify all possible FCS sites (AskFSIS QA dated 2-17-12)

7. Did the establishment include an explanation of why the testing frequency is sufficient to
ensure that effective control of Lm, or an indicator organism, is maintained?

If an establishment produces a RTE deli product or hotdog product under Alternative 3, IPP
should verify that the establishment:

1. Effectively implemented corrective actions (with respect to sanitation after an initial positive
result on a food contact surface in the post-lethality processing environment) by follow-up
testing that includes targeted testing of the specific site on the food contact surface area and
other sites as necessary to ensure effectiveness of the corrective actions.

2. Holds product lots that may have become contaminated by contact with the food contact
surface when the establishment obtains a second positive test for Lm or an indicator
organism during follow-up testing until the problem is corrected as indicated by negative
follow-up test results.

3. Sample and test product lots for Lm or an indicator organism using a sampling method and
frequency that will provide a level of statistical confidence that ensures that each lot is not
adulterated with Lm.

4. Documents testing results.

5. Reworks held product using a process that is destructive to Lm.

Assess Information

To answer these questions, IPP should:

 Review the HACCP plan.

 Review validation data (supporting documentation) for the post-lethality treatment.
 Review HACCP records.
 Review the Sanitation SOP and/or prerequisite programs associated with the use of the
antimicrobial agent or process (as necessary).
 Review Sanitation SOP and/or prerequisite program records (as necessary).

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Determine Compliance

IPP must determine regulatory compliance after all available information pertaining to the
Listeria Control Alternative selected has been gathered and assessed. There is no
noncompliance if the establishment has met all regulatory requirements. If the establishment
has not met all regulatory requirements, the noncompliance should be documented on an NR
under the appropriate PHIS task as described in FSIS Directive 5000.1, citing the appropriate
sections of §430.4(b), §417 for HACCP and prerequisite programs, and/or §416 for sanitation.
IPP should verify that the establishment has taken effective corrective and preventive actions
to bring itself into compliance with 9 CFR 430. Such actions may include a reassessment of the
HACCP plan and the establishment’s choice of another alternative.

Alternative 1 Noncompliance Examples:

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

the HACCP plan but does not have the use of the antimicrobial agent or process to
suppress or limit the growth of Lm incorporated into its HACCP plan, its Sanitation SOP, or a
prerequisite program. (Cite §430.4(b)(1), 417.5(a)(1) & (2))

2. The establishment has the use of the antimicrobial agent or process to suppress or limit the
growth of Lm incorporated into its HACCP plan, its Sanitation SOP, or a prerequisite
program, but does not have a post-lethality treatment to reduce or eliminate Lm incorporated
into the HACCP plan. (Cite §430.4(b)(1), 417.5(a)(1) & (2))

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

environment to ensure that the surfaces are sanitary and free of Lm or of an indicator
organism but does not have a post-lethality treatment to reduce or eliminate Lm
incorporated into the HACCP plan OR the use of the antimicrobial agent or process to
suppress or limit the growth of Lm incorporated into its HACCP plan, its Sanitation SOP, or a
prerequisite program. (Cite §430.4(b)(1), 417.5(a)(1) & (2))

Alternative 2 Noncompliance Examples

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

environment to ensure that the surfaces are sanitary and free of Lm or of an indicator
organism but does not have a post-lethality treatment to reduce or eliminate Lm included in
a HACCP plan OR an antimicrobial agent or process to suppress or limit the growth of Lm
incorporated into a HACCP plan, SSOP, or a prerequisite program. Cite §430.4(b)(2),
417.2,417.5(a)(1) & (2)

2. The written sanitation procedures the establishment is using to meet the requirements of
Choice 2 only addresses the testing of non-food contact surfaces in the post-lethality
processing environment to ensure that the surfaces are sanitary and free of Lm or of an
indicator organism. Cite §430.4(b)(2), 416, 417.5(a)(1) & (2)

3. The written sanitation procedures the establishment is using to meet the requirements of
Choice 2 do not identify the conditions under which or at what point hold-and-test
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 procedures following a positive test of a food-contact surface for Lm or an indicator
organism will be initiated. Cite §430.4(b)(2), 417.5(a)(1) & (2)

4. The written sanitation procedures the establishment is using to meet the requirements of
Choice 2 do not identify the size of the sites to be sampled or explain why the testing
frequency selected is sufficient to ensure that effective control of Lm or an indicator
organism is maintained. Cite §430.4(b)(2), 417.5(a)(1) & (2)

Alternative 3 Noncompliance Examples

1. The establishment does not have sanitation measures incorporated in its HACCP,
Sanitation SOP, or other prerequisite program. Cite §430.4(b)(3), 417.5(a)(1) & (2)

2. An establishment that produces deli and hotdog products does not conduct follow-up
testing of target sites on the FCS area that is the most likely source of contamination after
an initial positive test for Lm, or its indicator organisms, to verify the effectiveness of its
sanitation corrective actions. Cite §430.4(b)(3), 417.5(a)(1) & (2)

3. An establishment that produces deli and hotdog products does not hold-and-test lots of
product for Lm, or an indicator organism, that may have become contaminated by contact
with the food contact surface when it obtains a second positive test for Lm, or an indicator
organism, during its follow-up testing. Cite §430.4(b)(3), 417.5(a)(1) & (2)

Documentation and Enforcement

If noncompliance with the Lm regulations is found, IPP are to issue an NR under the appropriate
HACCP or SSOP task as described in FSIS Directive 5000.1, citing 9 CFR 430.4(b)(1), (2), or
(3) and the appropriate sections of 9 CFR 417 or 416 if applicable. IPP are to verify that the
establishment has taken effective corrective actions to bring itself into compliance with 9 CFR
430. Such actions may include, but are not limited to, a reassessment of the HACCP plan and
the establishment’s choosing of another alternative or determining that the decisions it made
in the hazard analysis regarding the use of a prerequisite program remain valid.

If an establishment is producing post-lethality exposed products and has failed to meet any of
the requirements of 9 CFR 430, IPP should contact the District Office through supervisory
channels. A NOIE may be issued if the establishment HACCP system and/or SSOP is
inadequate due to failure to meet the 9 CFR 430.

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 ATTACHMENT 1: CONTROL REQUIREMENTS for Listeria MONOCYTOGENES
 Increasing Risk Levels and Frequency of FSIS Verification Testing 
ALTERNATIVE 1 ALTERNATIVE 2 ALTERNATIVE 3
Post-lethality Post-lethality Treatment OR Sanitation and Testing

I
Treatment AND Antimicrobial agent or Process Program

I
Antimicrobial Choice 1: Choice 2: Non-deli, Deli or hot-
agent or Process Post-lethality Antimicrobial Non-hotdog dog product
Requirements Treatment Agent or Process
Validate effectiveness of post-lethality treatment (PLT). Must be
included as a CCP in the establishment’s HACCP Plan and should show at
X X
least a 1-log reduction in Lm prior to distribution of the product into
commerce
Document effectiveness of antimicrobial agent or process: Must be
included as part of the establishment’s HACCP, Sanitation SOP, or Pre-
X X
requisite Program and should demonstrate no more than 2-logs growth of
Lm over the estimated shelf life.
Sanitation Program Requirements X X X
Testing food contact surfaces (FCS) in the post-lethality processing
X X X
environment for Lm or an indicator organism.
State testing frequency. X X X
Identify size and location of sites to be sampled. X X X
Explain why testing frequency is sufficient to control Lm or an indicator
X X X
organism.
Identify conditions for Hold-and-Test, when FCS (+) for Lm or an indicator
X X X
organism.
Additional Sanitation Program Requirements
Effective after 1st FCS (+) for Lm or an indicator organism. Includes testing
of targeted FCS as most likely source and additional testing of the X
surrounding area.
If follow-up testing yields 2nd FCS (+), hold products that may be
contaminated until problem is corrected as shown by FCS (-) in follow-up X
testing.
Hold and test product lots using a sampling plan that provides statistical
confidence that the lots are not contaminated with Lm or an indicator
X
organism. Release, rework or condemn products based on results.
Document results and product disposition.
Establishments in all three alternatives must maintain sanitation in
-

X X X X X
-
-

accordance with 9 CFR 416.

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 Listeria monocytogenes Regulations: Workshop

1. Establishments are required to comply with section 9 CFR 430.4 (Control of Listeria
monocytogenes) if they produce:

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

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

□ c. Ready-to eat products.

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

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

a) Alternative 1
b) Alternative 2, Choice 1
c) Alternative 2, Choice 2
d) Alternative 3

Use of only a post-lethality treatment (which may be the antimicrobial agent or

process) that reduces or eliminates microorganisms on the product.

Use of a post-lethality treatment (which may also be the antimicrobial agent or

process) that reduces or eliminates microorganisms on the product AND an
antimicrobial agent or process that suppresses or limits the growth of L.
monocytogenes.

Sanitation measures only, in the HACCP plan, SSOP, or prerequisite program,

including testing of food contact surfaces to verify the effectiveness of the
sanitation procedures.

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

monocytogenes, along with a sanitation program addressing the testing of food
contact surfaces to verify the effectiveness of the sanitation procedures.

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3. An establishment MUST implement hold-and-test procedures when a positive result for
an indicator organism is found on a food-contact surface during follow-up testing (second
consecutive food contact surface positive for L. monocytogenes) if the establishment is
producing:

□ a. RTE products exposed to the environment after the lethality treatment using
Alternative 1, 2, or 3.

□
b. Non-deli and hotdog type RTE products exposed to the environment after the
lethality treatment using Alternative 3.

c. Deli and hotdog type RTE products exposed to the environment after the lethality
□ treatment using Alternative 3.

d. Deli and hotdog type RTE products exposed to the environment after the lethality
□ treatment using Alternative 2, Choice 2

4. An establishment MUST identify the conditions under which it will implement hold-and-
test procedures after a positive result for an indicator organism is found on a food-contact
surface if the establishment is producing:

□ a. Non-deli and hotdog type or deli or hotdog type RTE products exposed to the
environment after the lethality treatment using either Alternative 2 (Choice 2) or
Alternative 3.

□ b. Deli and hotdog type RTE products exposed to the environment after the lethality
treatment using either Alternatives 1, 2, or 3.

c. Deli and hotdog type RTE products exposed to the environment after the lethality
□ treatment using Alternative 1 or Alternative 2, Choice 1.

d. Non-deli and hotdog type RTE products exposed to the environment after the
□ lethality treatment using Alternative 2, Choice 1

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 30 Sampling Ready-to-Eat (RTE) Product

Objectives:

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

product.
2. Describe the conditions for RTE product to be considered adulterated.
3. Define the following terms:
a. Food contact surface
b. Intact package
c. Sampled lot
4. Describe the steps for performing a RTE sampling task.
5. Explain the difference between the RTEPROD_RAND and the RTEPROD_RISK
sampling project codes.
6. Explain what IPP should consider when scheduling RTE samples.
7. Describe why it is important to notify establishment management prior taking a
sample.
8. Explain how FSIS samples are documented.
9. Describe the process for ensuring sample integrity, from sample collection until
sample is shipped.
10. List the items that are packed into the sample container.
11. Identify how IPP obtain sample results.
12. Describe what actions IPP take when a positive FSIS RTE sample result is
identified.
13. Describe the actions IPP take when establishment testing obtains a positive sample
result.
14. Explain the procedures in verifying corrective actions for a positive RTE sample.
15. Identify the two sampling programs that EIAOs may perform in RTE establishments.

FSIS’s microbiological testing program is designed to verify that the establishment’s food
safety system is effective, and that FSIS performance standards and regulations are met.
FSIS tests RTE products for pathogens because of the potential public health impact of a
breakdown in the establishment’s food safety system.

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 The pathogens of public health concern are Listeria monocytogenes and Salmonella
• Salmonella usually indicates a breakdown in lethality step
• Lm usually indicates post-lethality contamination

RTE product is adulterated if it:

• Contains Lm, Salmonella, or any pathogen known to cause illness including E. coli
O157:H7
• Comes into contact with a food contact surface positive for Lm

A food contact surface is the equipment or utensil surface with which exposed RTE product has
direct contact (for example, conveyor belt, tabletop, knife blade).

Intact package. This is product in the final packaged form (immediate container) in which it will be
shipped.

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

There are 6 general steps in sampling RTE product:

1. Determine which product to sample and schedule the sample
2. Notify establishment management
3. Collect the sample
4. Document the sample
5. Pack and ship the sample and form
6. Respond to the results

RTEPROD_RAND: For this sample program, IPP will randomly select any RTE product
produced at the time of collection, regardless of whether the product has been exposed post-
lethality; and make every effort to randomly sample all the RTE products produced at the
establishment by rotating through the products over time (i.e., through subsequent sample
requests).

RTEPROD_RISK: For this sample program, IPP are to select a post-lethality-exposed product
based on the highest risk level.

Before collecting a sample, IPP are to officially notify the establishment management that they will
be collecting a sample and explain the reason they are collecting the sample.

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IPP will collect the sample from the current day’s production after the establishment has
applied all interventions except any microbiological testing intervention. If the establishment
intends to test the product for Lm or Salmonella, IPP are not to wait for the establishment to
receive the test results.

For both RTEPROD_RAND and RTEPROD_RISK samples, IPP are to collect a one-
pound sample of product in an intact package.

On the day of sample collection, IPP will enter sample collection data and additional
product info in PHIS as directed in PHIS Directive 13,000.2. IPP are to complete a
questionnaire in PHIS for each RTEPROD sample request and are to ensure that all
requested information is entered completely and accurately.

IPP are to safeguard the integrity of samples during submission according to FSIS
Directive 7355.1, Use of Sample Seals for Laboratory Samples and Other Applications.

Pack the sample in this order:

1. Absorbent pad
2. Gel pack
3. Cardboard separator
4. Zip-lock bag containing the identified sample and paperwork
5. Extra small bar code sticker that was not used
6. Foam plug
7. Close shipper with Container Seal (7355-2A)

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

RTEPROD_RISK sampling projects tests positive for Lm or Salmonella, product in the
sampled lot is adulterated. IPP are to follow the instructions in FSIS PHIS Directive 5000.1
when taking enforcement actions in response to positive sampling results.

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

sampling of food contact surfaces. Establishments may also choose to conduct sampling
of product. If an establishment’s product or food contact surface test result is positive for
Lm, IPP should not issue an NR unless the establishment failed to hold the affected
product and did not implement corrective actions, which includes proper disposition of the
sampled product lot.

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If FSIS finds a product or food contact surface positive for Lm or Salmonella, IPP are to
verify that the establishment takes the appropriate corrective actions by performing a
directed HACCP Verification Task.

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

result, IPP are to review the same information they review during a routine HACCP
Verification Task. IPP are also to verify that the establishment implemented
corrective actions according to 9 CFR 417.3 (a) and (b) if the measures for
addressing Lm are included in the HACCP plan or prerequisite program, or 9 CFR
416.15 if the measures are incorporated in the Sanitation SOP. FSIS will also
perform an IVT/FSA for Lm, as described in FSIS Directive 10,300.1.
 When performing a directed HACCP Verification Task in response to a Salmonella positive
result, IPP are to verify that the establishment took the appropriate corrective actions
according to 9 CFR 417.3(a) or (b), or 9 CFR 416.15.

EIAOs trained in the IVT methodology collect samples under the Intensified Verification
Testing (IVT) program which involves collecting product, food contact, and environmental
(non-food contact) samples. This sampling is typically done “for cause” (e.g., positive
sample results).

EIAOs trained in the IVT methodology also collect samples under the Routine Risk-based
Lm (RLm) sampling program when conducting routine FSAs in establishments that
produce RTE products.

[Link]

[Link]

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 31 HACCP System and Recall Verification

Objectives

1. Explain the regulatory thought process, define its four components, and identify key
aspects of each component.

2. Understand four essential questions to consider in determining when to document a failure

to meet HACCP regulatory requirements.

3. Use the regulatory thought process to determine if a food safety system is inadequate.

4. Identify three types of enforcement actions taken when a noncompliance determination is

made.

5. Identify two scenarios when a HACCP verification plan is necessary.

6. Verify that establishments maintain written recall procedures per 9 CFR 418.3
requirements.

Introduction

The HACCP system, referenced in 9 CFR 417.4, is defined in 9 CFR 417.1 as “the HACCP
plan in operation, including the HACCP plan itself.” The HACCP plan in operation includes ALL
of the following:

• Hazard analysis.
• HACCP plan.
• Supporting documentation including prerequisite programs used to make decisions in
the hazard analysis.
• HACCP records generated on an ongoing basis.

In using the regulatory thought process to determine if wholesome, unadulterated products are
being produced, IPP are actually verifying the overall effectiveness of the establishment’s
HACCP system. Verifying whether individual product units are wholesome is less important
than determining the overall effectiveness of the establishment’s comprehensive HACCP
system.

HACCP Regulatory Process

The diagram in module 13 (HACCP Regulatory Process) shows the HACCP regulatory
process, which includes the following four components:

• Inspection Methodology

 Performing HACCP inspection tasks

 Verifying specific HACCP regulatory requirements by performing the HACCP
inspection task

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• Decision-making (GAD)

 Gathering information, making observations, reviewing documentation, assessing the

gathered information, arriving at a supportable compliance determination

• Documentation

 Entering HACCP inspection task results (observations and determinations) in PHIS

 Documenting noncompliance on a Noncompliance Record (NR)
 Associating noncompliance from the same cause

• Enforcement

 Following the Rules of Practice (ROP)

 Providing the establishment with due process

FSIS Responsibilities

FSIS responsibilities for verifying an establishment’s food safety system are outlined in FSIS
Directives 5000.1 and 5000.6. IPP are responsible for understanding and properly performing
in PHIS the HACCP inspection tasks described in these Directives.

Inspection Methodology

To verify that establishments are complying with 9 CFR Part 417, IPP perform two HACCP
inspection tasks: The Hazard Analysis Verification (HAV) task and the HACCP Verification
Task. The HAV Task directs IPP to review the establishment’s hazard analysis, prerequisite
programs, and other supporting documentation for one HACCP plan. The HACCP Verification
Task focuses on verifying the implementation of the establishment’s HACCP plans, prerequisite
programs, and other supporting programs. Both of the HACCP verification tasks, which can be
performed as a routine or directed task, has two verification components:

• Recordkeeping (RK)
• Review and Observation (RO)

IPP may use either component or a combination of the components to verify regulatory
compliance.

Decision-Making (GAD)

IPP should use the regulatory GAD (Gather, Assess, and Determine) thought process to
perform the HACCP inspection tasks. IPP are to gather all available information to help them
determine regulatory compliance. This may include:

• Reviewing hazard analyses, HACCP plans, prerequisite programs, supporting

documentation, and ongoing monitoring records, HACCP plans, SSOPs,
prerequisite programs, and other supporting programs or procedures.

• Observing establishment employees performing or implementing HACCP, SSOP, or

prerequisite program or other supporting program procedures, and occasionally taking
measurements as specified in HACCP system documents.

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After reviewing the gathered information, IPP are to assess the significance and meaning of
information gathered by:

• Comparing the information gathered to HACCP regulatory requirements.

• Considering how each piece of information, either taken separately or with other findings,
supports that the HACCP system is functioning as intended.

• Considering the information in the context of past findings to identify any patterns or trends
(e.g., Is this an isolated or recurring problem? Are conditions getting worse? Is the
establishment responding effectively and in a timely manner to problems?)

HACCP system noncompliance is a failure to meet any of the regulatory requirements outlined
in 9 CFR Part 417. If a HACCP system noncompliance is identified, the establishment is
expected to take immediate and further planned actions to come back into compliance. Before
IPP determine whether or not they should document the failure to meet the HACCP regulatory
requirements as a noncompliance, they should consider the following four questions:

1. Did the establishment identify the failure to meet regulatory requirements or deviations from
a critical limit?

2. If product is involved, has the establishment ensured product safety?

3. Has the establishment taken immediate and further planned actions to correct the failure to
meet regulatory requirements, or has it taken corrective actions to address the deviation in
accordance with 9 CFR 417.3?

4. Is a trend developing (i.e., has the establishment failed to carry out the actions in 1 through
3 above for similar situations)?

Note: When answering these questions, it may be necessary for the IPP to gather additional
information (e.g., ongoing verification records).

There is no noncompliance if the answer to questions 1, 2, and 3 is “yes” and “no” for question
4 because the establishment identified and addressed the situation. IPP would verify and
document compliance with the applicable regulations in PHIS because the establishment’s
response included the further planned actions and preventive measures for the noncompliance
or deviation. The ability to track developing trends would not be adversely affected by not
issuing an NR.

However, if the answer to questions 1, 2, or 3 is “no” or question 4 is “yes,” a noncompliance

exists. IPP would document the noncompliance in PHIS and generate an NR. IPP should
discuss with their supervisor any concerns whether the information supports a particular
compliance determination.

HACCP System Compliance

The purpose of the HACCP verification task is more than to just identify isolated instances of
noncompliance. IPP must also consider what their positive, negative, or inconclusive findings
indicate about the overall effectiveness of the establishment’s HACCP system. It is important
that each piece of information be considered in the context of the HACCP system and the
potential for product adulteration. The following questions will help IPP to consider the
significance of each finding for the HACCP system:

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• Is this information part of a pattern or trend? For example, is the establishment missing
a measurement for a prerequisite program an isolated incident or has the establishment
regularly failed to implement its prerequisite programs?

• Is there other information to indicate that the HACCP system is working or is not
working? For example, if an establishment’s prerequisite program specifies product will be
received with supplier certificates of analysis (COA) and periodically tested but the
establishment failed to receive a COA for a particular product, how did they respond on
whether or not to use the product?
• Does the information seem to agree with the other available information about the
food safety system? For example, an establishment uses a prerequisite program to
prevent a hazard in incoming products, and the records appear to show that a particular
hazard is being prevented. However, the establishment’s testing of finished product for the
particular hazard finds positive results.

• Do these results support each other or is there an apparent contradiction? For

example, an establishment that uses a prerequisite program to prevent E. coli O157:H7 in
incoming beef has COAs and verification test results on incoming trim that indicate the
hazard is not reasonably likely to occur, but the establishment gets a positive test result on a
finished product lot. The finished product test result calls into question the effectiveness of
the prerequisite program as means of supporting the decision that E. coli O157:H7 is not
reasonably likely to occur.

Inadequate HACCP System Determination

By considering the preceding questions, IPP can determine whether the information supports a
finding of HACCP system regulatory compliance:

• Has adulterated product been produced or shipped?

• Is the HACCP system effectively controlling the relevant food safety hazards?
• Has the establishment failed to meet one or more HACCP regulatory requirements?

If noncompliance is found, IPP need to determine if it indicates an inadequate HACCP system.

Depending on the problems identified, the establishment may need to reassess the hazard
analysis and HACCP plan. For example, if an establishment has not identified E. coli O157:H7
as a food safety hazard reasonably likely to occur, tests outside the HACCP plan or SSOP, and
gets a positive result, a reassessment of its HACCP plan and hazard analysis would then be
required by 9 CFR 417.4(a)(3). The establishment must support the decisions made during the
reassessment as specified in 9 CFR 417.5(a)(1) & (2).

If the establishment did not reassess its HACCP plan and hazard analysis as required by 9
CFR 417.3(b)(4) and §417.4(a)(3)(i) or does not have supporting documentation required by
§417.5(a)(1) & (2), IPP cannot determine that the HACCP system meets the requirements of 9
CFR 417.6. Consider the following questions to determine if there is an inadequate HACCP
system:

1. Does the HACCP plan meet the regulatory requirements of 9 CFR Part 417?

If an establishment did not implement all or some of its HACCP plan or did not meet regulatory
requirements, IPP would be unable to determine whether or not the establishment was
producing unadulterated product in compliance with 9 CFR Part 417. For example, the HACCP
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system is inadequate if an establishment does not maintain any records associated with its
HACCP plan, does not monitor critical limits at any CCP, or did not reassess or modify its
HACCP plan when necessary.

2. Was adulterated product produced or shipped?

The HACCP system is inadequate if it did not prevent the production and distribution of
adulterated product. For example, if an establishment failed to meet a critical limit for a CCP
and did not take corrective actions per 9 CFR 417.3 but performed a pre-shipment review, the
HACCP system is inadequate.

3. Is there a trend in establishment noncompliance?

Trends in the regulations cited on NRs are a key factor in determining if an establishment’s
HACCP system is inadequate. Two or more NRs citing the same regulations and recurring
noncompliance descriptions addressing similar causes may be a trend that indicates the
HACCP system is inadequate.

No specific number of incidents constitutes a trend because of the variabilities in processing

environments and HACCP plans. IPP should closely review the noncompliance descriptions
contained in Block 10 of the NR form and not rely solely on the number of linked NRs to indicate
a possible trend in noncompliance. Careful analysis of the regulations cited and written
descriptions of noncompliance are necessary when determining if a trend indicates that the
HACCP system may be inadequate.

Action to Take If an Inadequate System Exists

After determining that an inadequate HACCP system exists, IPP would take action and notify
the District Office via supervisory channels. If adulterated product was produced and shipped in
commerce, IPP would take an immediate withholding action according to the Rules of Practice.

DOCUMENTATION

Completing a Noncompliance Record

When documenting noncompliance on an NR, identify each noncompliance. Be specific,

thorough, and include the time and location. Explain that establishment management received
notification and state any regulatory control actions taken. Consult FSIS Directive 5000.1 and
the PHIS User Guide for further information about completing the NR.

Throughout this course, you have learned that noncompliance is documented when it is
observed, and the same causes of noncompliance are associated when they are identified.
Documenting and associating noncompliance is not only useful in identifying trends, it also
enables the Agency to provide establishments with due process and to take enforcement action
when necessary.

If IPP document multiple or recurring noncompliance, they could request (through their chain of
command) that the DO issue a Notice of Intended Enforcement Action (NOIE) to the
establishment per §500.4. A request for an NOIE should come as no surprise. In reaching this
conclusion, IPP should have been discussing the noncompliance trend with the establishment
during weekly meetings and keeping the FLS or IIC apprised of what was happening.

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Enforcement Rules of Practice

The Rules of Practice (ROP) in 9 CFR 500 provide establishments with due process. They also
describe how and under what circumstances the Agency progresses with further enforcement
actions. Enforcement action may be necessary to prevent adulterated product from being
produced and shipped. In accordance with the Rules of Practice, enforcement action could be
one of three types.

1. Regulatory Control Action - The retention of product, rejection of equipment or facilities,

slowing or stopping of lines, or refusal to allow the processing of specifically identified
product.

2. Withholding Action - The refusal to allow the marks of inspection to be applied to

products. A withholding action may affect all product in the establishment or product
produced by a particular process.

3. Suspension - An interruption in the assignment of program employees to all or part of an

establishment.

Withholding actions affect whether the mark of inspection may be applied, while suspensions
affect whether inspection verification activities will be performed.

Regulatory Control Actions

FSIS may take a regulatory control action (RCA) for insanitary conditions or practices, product
adulteration or misbranding, conditions that preclude FSIS from determining that product is not
adulterated or not misbranded, or inhumane handling or slaughtering of livestock.

An RCA allows IPP to prevent the movement of the affected product or use of the equipment or
facility involved until the noncompliance has been corrected. IPP are not required to give the
establishment prior notification that they are about to execute a RCA. IPP will take the RCA
(e.g., retaining product, rejecting the equipment or room with a tag) and then complete an NR.
RCAs should remain in effect until the establishment has brought itself back into regulatory
compliance.

If there is SPS or SSOP noncompliance with direct product contamination or adulteration, IPP
will verify that the establishment addressed the noncompliance by meeting the requirements of
either 9 CFR 416 or 9 CFR 417, including corrective actions. An NR will be written, citing the
appropriate SSOP or HACCP regulations. The establishment may need to re-evaluate the
effectiveness of its procedures in its HACCP plan or SSOP and modify them if they are no
longer effective in preventing contamination or adulteration of product.

If the direct product contamination poses a food safety hazard, IPP will verify that the
establishment effectively implemented corrective actions that meet the requirements of
§417.3(b). These corrective actions should include a reassessment to determine whether the
unforeseen hazard should be incorporated into a HACCP plan. Regulatory control actions are
not frequently used for HACCP regulatory noncompliance unless control is necessary to prevent
shipment of contaminated or adulterated product.
Examples of common regulatory control actions related to slaughter include stopping a line or
retaining a carcass as a result of a slaughter food safety standard finding.

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Withholding Actions Without Prior Notice

It may be necessary for IPP to take immediate enforcement actions without giving the
establishment prior notice to prevent an imminent threat to public health. For example, IPP
would need to take an immediate withholding action if an establishment produced and shipped
adulterated product. In this situation, the immediate withholding action would be taken and then
the District Office and supervisor would be notified as soon as possible. Refer to the ROP
module for additional information.

Withholding and Suspension Actions With Prior Notification

Some withholding and suspension actions require prior notification according to the ROP. The
most common withholding or suspension actions related to HACCP noncompliance are those in
which the HACCP system is inadequate due to multiple or recurring noncompliance.
Withholding or suspending inspection for this cause requires prior notification to the
establishment. The prior notice is in the form of a written Notice of Intended Enforcement Action
(NOIE). Remember that a suspension may only be issued by a District Manager or higher FSIS
official.

District Office Notification

After determining that an inadequate HACCP system may exist, IPP should notify the District
Office and request that a Notice of Intended Enforcement (NOIE) be issued to the
establishment. The DO will provide direction about any further actions that may need to be
taken. The DO may assign an EIAO to evaluate the establishment’s HACCP system.

District Office Determines Enforcement Action

After evaluating all of the facts of the case, the District Office will determine the appropriate
enforcement action based upon the ROP.

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 Notice of Intended Enforcement Action
Establishment has 3 business days to respond

Establishment responds Establishment does not

including proposed corrective respond to the NOIE
actions

FSIS defers enforcement Establishment’s FSIS suspends the assignment of

to allow the response does not program employees to all or part
establishment to adequately address of the establishment
implement proposed the issues
corrective actions addressed in the
NOIE

Establishment responds Establishment’s

including proposed corrective response does
FSIS prepares a verification plan based actions not adequately
on the establishment’s proposed address the
corrective actions issues in the NOS.
The suspension
remains in effect
FSIS holds the suspension in until the issues in
abeyance to allow the the NOS are
Corrective actions are establishment time to implement
adequately
implemented by the proposed corrective actions
addressed
establishment and are
effective. FSIS closes out the
NOIE with a Letter of
Warning (LOW)
FSIS prepares a verification plan Corrective
based on the establishment’s actions are
proposed corrective actions implemented by
Corrective actions were either the
not fully implemented or were establishment
ineffective. FSIS closes out the and are
NOIE by suspending the Corrective actions were either not effective. FSIS
assignment of program fully implemented or were closes out the
employees to all or part of the ineffective. FSIS reinstates the suspension with
establishment suspension a Letter of
Warning (LOW)

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Verification Plan

When FSIS defers an enforcement action or holds a suspension in abeyance, the establishment
is allowed time to implement proposed corrective actions. A verification plan (VP) is developed
by the EIAO with input from the in-plant inspection team, FLS, and DO. A VP captures all of the
corrective actions the establishment stated they would do and provides a systematic means for
FSIS to verify that an establishment is effectively implementing the proffered corrective
measures.

A Verification Plan:

 Describes the verification activities to be performed by inspection personnel based on

the establishment’s corrective measures.
 Lists the procedures and frequency for each verification activity.
 Identifies the regulatory citation for each verification activity.

IPP schedule and perform the directed verification activities identified in the VP, which typically
lasts for 90 days and is updated every 30 days. On a weekly basis, the in-plant team reports the
results of the activities conducted under the VP, via e-mail to the District Office. The in-plant
inspection team has the flexibility to increase the frequency of the verification activities based on
its findings. Any failure to meet the conditions of the proposed corrective measures would
support FSIS imposing further enforcement actions.

RECALLS

Recalls are initiated when there is evidence of adulterated or misbranded product in commerce
(e.g., a positive pathogen sample result is obtained for product the establishment already has
shipped). FSIS Directive 8080.1, Rev. 7, “Recall of Meat and Poultry Products,” details all
verification requirements for recalls.

NOTE: Product is “in commerce” if it is out of the producing establishment’s direct control and
is in distribution (e.g., in a warehouse, distribution center, retail facility, restaurant, or other
institution).

Establishment Recall Requirements

On May 8, 2012, FSIS published the final rule “Requirements for Official Establishments to
Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall
Procedures, and Document Certain Hazard Analysis and Critical Control Points System Plan
Reassessments” (77 FR 26929). The rule requires official establishments to:

1. Notify the local FSIS DO within 24 hours of learning or determining that an adulterated or
misbranded meat or poultry product received by or originating from the official establishment
has entered commerce (9 CFR 418.2). The 24-hour period begins once an establishment
believes that a product in commerce is adulterated or misbranded under the FMIA or PPIA
(e.g., final results of a laboratory analysis show that raw ground beef contains E. coli
O157:H7 or product contains an allergen that is not declared on the product label).

2. Prepare and maintain written procedures for the recall of all meat and poultry products
produced and shipped by the establishment (9 CFR 418.3).

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3. Prepare written recall procedures as required by 9 CFR 418.3 before being granted Federal
inspection (9 CFR 304.3(a) and 381.22(a)).
NOTE: There may be situations in which laboratory results are not available, but
epidemiological evidence indicates there may be a probability of harm from consuming the
product. Under these circumstances, official establishments should consider the strength of
the epidemiological evidence to determine whether there is reason to believe that the
product is adulterated or misbranded.

When notifying the DO that an adulterated or misbranded meat or poultry product was received
by or originated from the official establishment, establishment officials should provide the type,
amount, origin, and destination of the adulterated or misbranded product.

The DO is to notify the Recall Management and Technical Analysis Division (RMTAD) as soon
as possible after notification. If establishments contact other FSIS personnel, those employees
are to contact RMTAD promptly through supervisory channels.

The DO and possibly the RMTAD evaluate each situation on a case-by-case basis (see FSIS
Directive 8080.1, Rev. 7, “Recall of Meat and Poultry Products”). The RMTAD coordinate any
recall activities and are to be notified immediately if product has left the establishment’s control.
The RMTAD is also notified so that a press release can be issued and recall effectiveness
checks can be performed.

More or less product may be determined to be “affected product” when all factors are
considered (e.g., whether some or all products produced under the same or a substantially
similar HACCP plan have been affected, what pathogens are involved, whether there have been
any other incidents of contamination in the establishment associated with the pathogen, and
whether there have been persistent and recurring noncompliance in the establishment).

The establishment is expected to perform a voluntary recall of any unsafe product in

commerce. If the establishment does not voluntarily recall product, the DO will coordinate
actions to detain or seize affected product.

Meat and poultry establishments must have written procedures for the recall of any meat or
poultry product produced and shipped by the official establishment. FSIS Directive 5000.8,
Verifying Compliance with Requirements for Written Recall Procedures, dated 12/18/2013,
outlines the details of how to verify the requirements of 9 CFR 418.3.

FSIS Verification

At least once a year, IPP are to perform a directed Other Inspection Requirements task to verify
that establishments have written recall procedures. If IPP determine that the establishment has
written recall procedures, they are to document in PHIS that they performed the task, and that
the establishment complies with 9 CFR 418.3. If IPP determine that the establishment does not
have written recall procedures, they are to document the noncompliance in PHIS on a
noncompliance record, citing 9 CFR 418.3.

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 HACCP Regulatory Process

Inspection Regulatory Decision-

Methodology making Documentation Enforcement

10. District
Office will
t

determine
9. Notify appropriate
1. Perform
Yes Yes [Link]
3. Noncompliance 5. District enforcement
HAV 6. Complete NR ROP
Found? Inadequate Office action based on
Task through the ROP
t __

supervisory
No channels

No

4. Stop
7. Complete NR

2. Perform HACCP
verification Task

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 HACCP Systems and Recall Verification: Workshop

Refer to the module and to FSIS Directive 5000.1 to complete the following questions.

1. You are the IIC at a small establishment that produces frozen spaghetti and tomato sauce with
meat entrees and frozen non-amenable spaghetti entrees made with a lobster cheese sauce.
You are performing Pre-Operational Sanitation Review and Observation Task.

a. What are the regulation sections you are to use when verifying regulatory compliance?

You observe various product contact surfaces in the formulation area. You see that some of the
blending equipment appears to have product residue from the previous day’s production. You
inspect the interior surfaces of the blenders and find residue. You see what appears to be cheese
sauce residue in several areas, and you see what appears to be tomato sauce residue in several
other areas. You check the production records from the previous day and determine that the
establishment produced lobster cheese spaghetti in the morning and tomato sauce with meat
spaghetti in the afternoon. The label of the spaghetti containing meat does not list any lobster or
milk ingredients.

b. Are the conditions you observed creating an insanitary condition?

c. Could the conditions you observed lead to contaminated product?

d. Is there a food safety hazard associated with the contamination you observed? Why or why
not?

e. You take official control of the blenders by placing a U.S. Rejected tag on them.
What regulations give you the authority to take this action?

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 f. What statutes give you the authority to take this action? Explain in your own words the
reasoning behind this authority.

g. What actions would you take next?

You review the HACCP plan and hazard analysis. The establishment found that food allergens
were potential food safety hazards but determined that they were not likely to occur in this
process because the establishment has a food allergen control program which prevents the
hazard.

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

As part of a Directed Fully Cooked but Not Shelf Stable HACCP Verification Task, you review the
establishment’s food allergen control program. You find that the establishment lists several daily
in-plant checks and verification activities and the associated documentation that will be kept. You
request recent records, and your review reveals that the food allergen control program
verification activities are not being done at the frequency listed in the program. Records are also
not available for some of the days.

i. Could this indicate an inadequate system? Why or why not?

j. How would you document what you have found? What regulations would you use?

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 k. What actions would you take next?

2. While performing a Fully Cooked Not Shelf Stable HACCP verification task in a ready-to-eat
product operation to verify the HACCP regulatory requirements, you review the establishment’s
HACCP plan. During this review, you determine that the establishment has not identified a
CCP to control Lm in the post-processing environment. You also observe that the
establishment has documented a recent reassessment of its HACCP plan. You do not see
the establishment’s Lm testing program referenced in the HACCP plan.
You request from plant management the establishment’s hazard analysis and verify that the
establishment identified Lm as a food safety hazard NRLTO. After reviewing the HACCP plan
and hazards analysis, you ask management what event triggered the reassessment. The
operations manager states that the reassessment was performed in response to a positive Lm
result from finished RTE ham lunchmeat. When questioned about the Lm sampling program,
the operations manager states that Lm testing is performed as a verification requirement at
the request of a customer. You ask management to provide the results of their
microbiological testing of the finished ham lunchmeat, which the establishment provides to
you. You determine that the most recent sample analyzed was found to be positive for Lm.
You request information about corrective actions taken and are shown an unforeseen hazard
log that documents that the establishment segregated and held affected ham product. The
establishment also has records to show that it performed a review to determine the
acceptability of affected product and took corrective actions to ensure that no product
injurious to health entered commerce by denaturing and disposing of the adulterated product.
Documentation that the product was denatured and disposed of in a landfill is provided. The
unforeseen hazard log further shows that a reassessment was performed, and the
establishment determined that Lm was a hazard not reasonably likely to occur in the ham
lunchmeat process. The basis for this decision is documented as: “It is the only positive ever
received. We apply a full lethality treatment and apply our Sanitation Standard Operating
Procedures daily. The application of our Sanitation Standard Operating Procedures daily
should continue to be sufficient in the future. This result is a fluke. No changes to the HACCP
plan are necessary at this point.”
When you ask for support for the decision that the hazard is still not reasonably likely to occur,
the establishment manager says, “The result was a fluke and we documented that on the
corrective action log.” Based on this information, you determine that no alterations were
made to the hazard analysis or the HACCP plan as a result of the Lm positive sample. You
are also able to verify that all other HACCP requirements, including pre-shipment review,
were met as part of the Fully Cooked Not Shelf Stable HACCP Verification Task for this
specific product.

193
a. Has the establishment supported its decision about the results of the reassessment? Why
or why not?

b. What are the 4 questions you would seek answers to as you gather information to determine
whether or not to document this as a noncompliance, and what conclusion would you make?
NOTE: Remember the 4 questions from the HACCP Regulatory Process presentation. If
the system is working, you may not document some noncompliance.

c. What regulations need to be considered?

d. Is there a noncompliance? Why or why not?

e. If you determine that noncompliance should be documented, what regulations would you
cite?

f. What are the questions you would seek answers to as you gather information to determine
whether or not there is an adequate HACCP system?

g. Based on your determinations, is the establishment’s HACCP system inadequate? Why or why not?

---
h. If you determine that you would document an NR, please complete only blocks 6, 8, 9, and 10
on the next page.

194
The request for this information is voluntary. It is needed to monitor defects found in this inspection system. It is used by FSIS to
determine whether establishments are in compliance. 9 CFR 301 and 9 CFR 381. FORM APPROVED OMB No. 0583-0089. OMB
DISCLOSURE STATEMENT: Public reporting burden for this collection of information is estimated to average 7 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to Department of Agriculture, Clearance Officer, OIRM, Room 404-W,
Washington, DC 20250: and to the Office of Information and Regulatory Affairs, Office of Management and Budget.
U.S. Department of Agriculture TYPE OF NONCOMPLIANCE
FOOD SAFETY AND INSPECTION SERVICE
NONCOMPLIANCE RECORD  Food Safety  Other Consumer Protection
1. DATE 2. RECORD NO. 3. ESTABLISHMENT NO.

4. TO (Name and Title) 5. PERSONNEL NOTIFIED

6. RELEVANT REGULATIONS 6a. ASSOCIATED NR(s)

7a. NAME OF CCP(S) or PREREQUISITE PROGRAM

7. TITLES OF HACCP OR SSOP PLAN or OTHER SUPPORTING
DOCUMENTATION

8. INSPECTION TASK 9. VERIFICATION ACTVITY

 Review & Observation  Recordkeeping  Both
9a. AFFECTED PRODUCT INFORMATION

9b. RETAIN/REJECT TAGS

10. DESCRIPTION OF NONCOMPLIANCE

11. SIGNATURE OF INSPECTION PROGRAM EMPLOYEE

You are hereby advised of your right to appeal this decision as delineated by 306.5 and/or 381.35 of 9 CFR

12. PLANT MANAGEMENT RESPONSE:

This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or
administrative action.
13. SIGNATURE OF PLANT MANAGEMENT 14. DATE

15. VERIFICATION SIGNATURE OF INSPECTION PROGRAM EMPLOYEE 16. DATE

FSIS FORM 5400-4 DISTRIBUTION: Original & 1 Copy to Establishment, 1 Copy to Inspector

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 32 Export Certification

Objectives:
1. Describe how to perform the Inspection Verification
2. Describe where to locate current export requirements
3. List the reasons why a Certifying Official would not sign an export certificate
4. List the reasons when a replacement export certificate can be issued
5. Describe when to write a Memorandum of Interview related to export certification
6. Who administers the Export Verification, Quality System Assessment Program (EV/QSA)
7. How to navigate through PHIS Electronic Export module

Resources:
FSIS Export Library - [Link]
Directive 9000.1 – Export Certification - Revision 2
Directive 12,600.1 – Voluntary and Other Reimbursable Inspection Services - Revision 2
Directive 13,000.5 – Public Health Information System Export Certification
Notice 26-22 – Seven-Digit Export Stamp, Enhanced Digital Signature, Plain Paper Printing,
and Statements Module for Use With the Export Module of the Public Health Information
System - Phase Six
Notice 49-22 – Seven-Digit Export Stamp, Enhanced Digital Signature, Plain Paper Printing,
and Statements Module for Use With the Export Module of the Public Health Information
System - Phase Seven

For both phase six and seven IPP are to print the approved export certificates on standard white
copy paper (8.5” x 11”) from the View Export Records (9060) grid, but only for establishments
that do not have functional printers or PHIS access, as indicated in Section VI below. All other
establishments will print the approved export certificates on standard white copy paper (8.5” x
11”) from the Create/View 9060-6 Export Applications (9060) grid in PHIS, as indicated in
Section III below. IPP are not to print from PHIS on FSIS security paper (item number ECP-11)
except for countries that require it as documented in the Export Library.

The certifying official (CO), any FSIS official who signs the completed export certificate (9060-
5), verifies the information on the export certificate comparing to the information on the signed
export application (9060-6) and the country requirements in the FSIS Export Library. The CO
may not be directly associated with the production or inspection of exported product. IPP
perform a physical check of containers, labels, and product. If after checking the Export Library

196
and the product you believe that products listed on the application are not eligible for export to
the country listed on the application, first discuss your concerns with the exporter. Then, write a
memorandum of interview (MOI) detailing your discussions and whether your concerns were
addressed adequately. Give a copy of the completed MOI to the exporter and file a copy in the
inspection file.

Means of stamping

The USDA export stamp is an accountable item that must be held under control. The stamp is
applied to the container. Establishments may also use computer-generated stickers. Stickers
must be the exact size and impression as the export stamp, must be printed with authorization,
must be based on assigned export number, and the establishment must identify number of
stickers produced prior to applying. They must give all unused stickers to the inspector upon
completion. Establishments may also perform direct inkjet printing of the export mark to the
carton or container. You are to verify that the inkjet mark is equal in size and an exact
impression of the FSIS rubber export stamp. They should also not be printed on the cartons or
containers until authorized by you, should only be applied in the quantity needed for application
to the consignment, and the establishment should notify you in advance of the quantity of
cartons or containers to be printed. Applying the export mark to the cartons or to the containers
should be done under the supervision of a designated plant employee.

A unique identifier (UI) is an alternate export mark that may be used for export consignments
instead of using the standard USDA export mark that contains the export certificate number.
The UI may be any combination of numbers or letters. IPP are not to certify export
consignments marked with a UI unless the importing country allows containers to be marked
with a UI. The applicant should link the UI to the corresponding export certificate by including
the following statement in the remarks section of the export certificate or on FSIS Form
9060-5B (remarks continuation page); “The products covered by this certificate are marked
with the Unique Identifier X#X#X#X#X#XX#X#.”

Pre-stamping

Under some conditions, establishments can pre-stamp the product. Pre-stamping occurs when
the establishment stamps the boxes and completes the export certificate when you are not
present.

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FSIS Form 9060-5 (Export Certificate of Wholesomeness) are accountable items and should be
maintained secured. Keep a record of the issued and voided certificate numbers at the
establishment. When completed, the CO reviews the certificate. The country requirements show
if the importing country needs additional certificates, which are usually hyperlinked in the Export
Library.

Before signing the certificate, the CO should check the certificate for corrections, check for
attachments and ensure that the exporting firm has lined-out any unused space. If you have
questions about the information on the application, the export certificate, or other supplemental
documents, do not to sign the certificate until you seek clarification. If you still have concerns
about signing the export certificate after reviewing the completed export documents and
performing product re-inspection or export verification activities, discuss the concerns with
establishment management. Document the discussion with establishment management in an
MOI and identify any of their concerns that cannot be resolved. Provide a copy of the MOI to
establishment management and retain a copy for the government file. Document any regulatory
noncompliances by issuing an NR, notify the supervisor of your concerns, and describe the
establishment’s plan to address the concerns. Do not sign the export certificate.

A replacement certificate is to be issued for one of the following reasons:

• Original certificate did not contain required information;

• Original certificate contained incorrect information, importer, exporter, consignee,
or consignor has changed, but is within the same country that appears on the
certificate.

If the certificate is lost, IPP are not to issue a replacement certificate unless the exporter
provides a letter of assurance to the CO stating the certificate will be returned if found. The
replacement certificate only restates the information contained on the original certificate or if
the country of destination has changed. The exporter may split or consolidate a shipment with
stamped pallet or conveyance. The Remarks section for a replacement certificate must contain
the statement as follows: “This certificate replaces certificate number (insert original
certificate number(s) dated (insert date(s) of the original certificate(s)). The export mark
covered by the certificate shows certificate number (insert original certificate number).”

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Export Verification/Quality System Acceptance (EV/QSA)

Establishments which want to participate in this program must first contact the Agricultural
Marketing Service (AMS), who approves by auditing and notifies FSIS Office Program and
Policy Development (OPPD) and Import/Export Policy Development Staff (IEPDS), then
notifies the appropriate DO. You will need to check the country requirements in the Export
Library to verify the receiving country participates in EV/QSA. IPP check that the product codes
are approved for export and if the country requires a Statement of Verification (SOV) for the
exported product. IPP also check that the applicant supplied a copy of the SOV with the
completed export application, completed additional certificates, and completed export
certification when presenting for IPP signature. In addition, IPP check if supporting documents
such as lab sampling results are available, although not all countries will require all these
steps. The exporting facility must obtain the SOV confirming that the EV/QSA program met the
country requirements and that the products are eligible for export before the FSIS certifying
official signs the completed export certificate. Establishments that need to obtain an SOV for
export must contact AMS directly. If there is improper execution of the EV/QSA, notify AMS
with the following information: establishment name, address, product type, product code,
quantity of product, date of production, lot number, shift produced, date and nature of
observation, name of country for which product is intended, export certificate number, any
other information to verify claim, and name of IPP documenting concerns. If any of the
problems with the EV/QSA requirements are also regulatory non-compliances, take the
appropriate enforcement actions and issue an NR.

Reimbursable export activities include: familiarizing with requirements in the Export Library,
conducting and documenting inspection or certification activities required by an EV/QSA
program, conducting and documenting any other additional inspection or certification activities,
reviewing foreign country label requirements and certifications requiring a PHV signature, and
approval and issuance of all replacement export certificates.

Export activities are recorded in PHIS. Each day IPP issue an export certificate at an official
establishment, they are to schedule and document one domestic Export Certification task in
PHIS. Regardless of the number of export certificates issued or the number of IPP that issue
certificates on a given day, IPP are only to record the task as performed once each day, per
shift and not for each inspector or export certificate they issue. If performing export
certification activities in PHIS, each export application will appear as a separate task.

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 33 Food Defense

OBJECTIVES

1. Explain the risk that intentional contamination presents to FSIS-regulated products.

2. Define the following terms:
a. Food safety
b. Food defense
c. Food defense practices
d. Supply chain
e. Food defense vulnerability
3. List the characteristics of a functional food defense plan.
4. Recognize examples of vulnerabilities and associated food defense practices.
5. Describe the purpose of the food defense task.
6. Identify measures an establishment can take to protect their product from intentional contamination.
7. Explain how inspectors are to perform the Food Defense task and document food defense
vulnerabilities in the Public Health Information System (PHIS).

FOOD DEFENSE TERMINOLOGY

Food Defense – The protection of food products from intentional contamination or

adulteration intended to cause public health harm or economic disruption. Food Defense is
an integral part of FSIS’s mission in protecting public health. The mission of the FSIS Food
Defense Program is to protect the U.S. food supply from dynamic and evolving threats.

Food Security – Ensuring all people at all times have both physical and economic access
to enough food for an active, healthy life. Food security includes both physical and
economic access to food that meets people's dietary needs and food preferences.
Therefore, the concept of food security certainly includes but encompasses much more
than the idea of food defense.

Food Safety – Guarding against unintentional contamination of food. HACCP plans and
Sanitation SOPs, which are developed based on what can be predicted to happen if we do
not put safety measures at critical points, are used to guard against unintentional
contamination.

Food Defense Practices – Policies, procedures, or countermeasures to mitigate

vulnerability to intentional contamination.
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 Critical Infrastructure – Defined in the Patriot Act of 2001 as systems and assets, whether
physical or virtual, so vital to the United States that the incapacity or destruction of such
systems and assets would have a debilitating impact on security, national economic
security, national public health or safety, or any combination of those matters. The Food and
Agriculture Sector is one of 16 critical infrastructures identified by the Patriot Act.

Supply Chain – Continuous process, including every step involved in food production and
food reaching the consumer; often referred to as “farm-to-table” or “farm-to-fork.”

FOOD DEFENSE VULNERABILITIES AND FOOD DEFENSE PRACTICES

A vulnerability can be any part of the food production or storage system where a protective
measure should be implemented to protect a product from intentional adulteration, but such a
measure is found to be missing or not in place.

Food defense vulnerabilities are weaknesses within the food production process that make it
easy to intentionally contaminate product.

An establishment can put food defense practices (also called mitigation strategies) into place
to reduce the likelihood that intentional contamination will occur. Food defense is not a one-
size-fits-all approach! Food defense practices that are implemented to protect products within
a large establishment may not be effective or may not be necessary in a small or very small
establishment. This should be considered when inspection program personnel (IPP) conduct
their food defense activities.

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FOOD DEFENSE IN FSIS-REGULATED ESTABLISHMENTS

Food defense is voluntary for FSIS-regulated establishments.

A functional food defense plan is an approach to identify and mitigate vulnerabilities; it can
help an establishment prevent, protect against, respond to, and recover from an intentional
contamination incident. A food defense plan is functional when it meets all four of the following
criteria:

1. Developed – The plan is documented and signed.

2. Implemented – Food defense practices identified in the plan are actually implemented.
3. Tested – Food defense measures are monitored and validated to ensure they are
working.
4. Reviewed and maintained – The plan is reviewed at least annually and revised as
needed.

Note: An establishment must be implementing the elements of its food defense plan in order
for FSIS to consider it “functional.”

IPP are responsible for maintaining the functional food defense plan status for an establishment
in the Establishment Profile in PHIS. This status should be updated per the frequency identified
in Directive 5300.1, Managing the Establishment Profile in the Public Health Information
System, or when IPP become aware of a change in the establishment’s functional food defense
plan status.

NATIONAL TERRORISM ADVISORY SYSTEM

The National Terrorism Advisory System (NTAS) is a system managed by the Department of
Homeland Security (DHS) to communicate information about terrorist threats by providing
information to the American public.

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PERFORMING FOOD DEFENSE TASKS IN PHIS

IPP in meat and poultry establishments are to perform the Food Defense task as assigned in
PHIS. PHIS will automatically generate one routine Food Defense task per quarter to the
establishment Task List. This task has a priority 3 in the establishment Task List, including a
start/end date window of three months. Only one questionnaire is to be completed per
establishment. The task is to only be performed on one shift in multi-shift establishments. The
supervisor should determine which shift performs the task. The shift that does not complete the
task should mark the task as not performed with a justification of ‘Task assigned to another
inspector.’

IPP perform the Food Defense task to identify vulnerabilities within establishments that may
lead to intentional contamination of FSIS-regulated products.

In the case of a NTAS alert identifying an elevated or imminent threat to food or agriculture, the
inspector-in-charge (IIC) will receive specific instructions through supervisory channels on other
measures to take.

SUMMARY

Defending the food supply against intentional contamination is a critical function. IPP, both in
and outside of establishments, serve as the Agency’s eyes and ears to help identify
vulnerabilities that may lead to intentional contamination. IPP are responsible for three
activities related to food defense:

1. Updating the functional food defense plan status in the PHIS establishment profile
and ensuring it is accurate;
2. Performing food defense tasks;
3. Submitting a food defense MOI when food defense vulnerability is observed and
discuss with establishment management.

Implementation of Food Defense tasks serves to protect the public, which is essential to our
mission, and ensures the security of our food, a vital component of homeland security.

Report any suspicious activities in establishments to your District Manager through supervisory
channels or call the FSIS 24-hour emergency hotline at 1-866-395-9761.
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 34 Non-Food Safety Consumer Protection (NFSCP)

Objectives:

1. Identify the statutes, regulations and primary directives that relate to non-food safety
consumer protection responsibilities.
2. Explain what to do when noncompliance is observed with the Non-Food Safety
Consumer Protection Tasks.
3. Explain the regulatory requirements for products that are subject to standards of
identity.
4. Explain the purpose of the Non-Food Safety Consumer Protection Tasks.

The Non-Food Safety Consumer Protection (NFSCP) requirements are verified by Other
Consumer Protection tasks to determine that establishments are complying with regulatory
requirements designed to protect the consumer in ways other than ensuring food safety,
such as economic adulteration and misbranding.

Statutes

Let’s start by reviewing the statutes in the Federal Meat Inspection Act (FMIA) related to
NFSCP requirements. The term “misbranded” is defined in 21 U.S.C. 601(n) of the FMIA. There
are twelve parts to this definition. Misbranded is defined in the FMIA as a meat product that:
• Part (1), has labeling which is false or misleading.
• Part (2), is offered for sale under the name of another food.
• Part (3), is an imitation of another food.
• Part (4), has a container that is misleading.
• Part (5), has a label that fails to show the name and place of business that produced the
product, or fails to contain an accurate statement of the quantity of the contents of the meat
product.
• Part (6), contains a label that is missing required information.
• Part (7), has a label that purports that it was produced in a manner that follows a standard
of identity, but the product does not conform to those standards.
• Part (8), does the amount of product in the container fall below the fill standard.
• Part (9), contains ingredients that are not represented on the label by common names of
the food.
• Part (10), makes special dietary claims but does not list the corresponding dietary
properties and information required on the label.
• Part (11), contains artificial flavoring, coloring, or chemical preservatives that are not listed
on the label.
• Part (12), requires some type of handling for a wholesome condition to be maintained but
the label fails to contain that information.

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The terms “label” and “labeling” are also defined in the FMIA as follows.

• FMIA 601(o) – The term “label” means a display of written, printed, or graphic matter upon
the immediate container of any article.
• FMIA 601(p) – The term “labeling” means all labels and other written, printed, or graphic
matter upon any article or any of its containers or wrappers or accompanying such article.

Section 607 of the FMIA covers labeling, marking, and container requirements. Section 607(e)
states that when there is reason to believe the marking or labeling or container is false or
misleading, FSIS has the authority to withhold its use until it is modified so that it is no longer
false or misleading.

There are similar provisions in the poultry statutes. The Poultry Products Inspection Act (PPIA)
453 (h) contains similar definitions of “misbranded” and 457 contains labeling and container
standards.

Labeling & Standards of Identity

There are certain general labeling requirements that apply to all product that bear a label. Some of these
basic requirements include:
• The label must list the name of the product and ingredients.
• The ingredients statement should be accurate (i.e., that all ingredients are listed in descending
order of predominance and any proteinaceous substances used in the formulation are declared in
the ingredients statement).
• The name and place of business of the manufacturer must be shown.
• It must contain an accurate statement of the net weight or quantity.
• The label must not be false or misleading.
• It must list any handling (refrigeration) of the product that is required in order to maintain the
product in a wholesome condition.
• There are also very specific requirements for safe handling instructions for raw or not ready-to-eat
meat and meat products.
• Restricted ingredients (if any) are used as per regulatory requirements.
• The label is used on appropriate product.
• There is a label approval on file.

The term Standard of Identity, however, refers to certain regulatory requirements that must be met in
order to label specific types of product. These regulations dictate that products for which standards of
identity exist must have a label showing the product name and ingredients statement and any other
information as listed in the standard of identity regulations.

The 9 CFR 319.15-319.881 (Subparts B through U) cover the specific requirements for various meat
products – from raw products that have only a few ingredients, to products such as cooked sausage that
may have a number of ingredients and may go through numerous processing steps.

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Here’s an outline of all the regulations covering the definitions and standards of identity or composition
(Part 319) for meat products:

Subpart A – General
Subpart B – Raw meat products
Subpart C – Cooked meats
Subpart D – Cured meat, unsmoked and smoked
Subpart E – Sausage generally: fresh sausage
Subpart F – Uncooked, smoked sausage
Subpart G – Cooked sausage
Subpart K – Luncheon meat, loaves, jellied products
Subpart L – Meat specialties, puddings, nonspecific loaves
Subpart M – Canned, frozen, dehydrated meat food products
Subpart N – Meat food entrée products, pies, and turnovers
Subpart O – Meat snacks, hors d’oeuvres, pizza, and specialty items
Subpart P – Fats, oils, shortenings
Subpart Q – Meat soups, soup mixes, broths, stocks, extracts
Subpart R – Meat salads and meat spreads
Subpart U – Miscellaneous (breaded and liver meat products)

9 CFR 381 Subpart P covers the labeling requirements for poultry products that have standards of identity.
9 CFR 381.156 covers the requirements for using terms such as light or dark meat on a label containing
poultry products. Similar to the regulations related to meat products, these regulations covering poultry
products specify percent of poultry light/dark meat required for the product to meet the standard, and in
some cases the type of ingredients required/allowed, such as binders or extenders.

Here are the 9 CFR §381 Subpart P regulations covering the standards of identity for poultry products:

381.155 – General
381.156 – Poultry meat content standards for certain poultry products
381.157 – Canned boned poultry and baby or geriatric food
381.158 – Poultry dinners (frozen) and pies
381.159 – Poultry rolls
381.160 – (Kind) burgers; (Kind) patties
381.161 – “(Kind) A La Kiev”
381.162 – “(Kind) steak or fillet”
381.163 – “(Kind) baked” or “(Kind) roasted”
381.164 – “(Kind) barbecued”
381.165 – “(Kind) barbecued prepared with moist heat
381.166 – Breaded products
381.167 – Other poultry dishes and specialty items
381.168 – Maximum percent of skin in certain poultry products
381.169 – Ready-to-cook poultry products to which solutions are added
381.170 – Standards for kind and classes, and for cuts of raw poultry
381.171 – Definitions and standards for “Turkey Ham”
381.173 – Mechanically Separated (Kind of Poultry)
381.174 – Limitations with respect to use of Mechanically Separated (Kind of Poultry)
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Verification Methodology for Non-Food Safety Tasks

FSIS Directive 7000.1 provides general instructions for how IPP are to perform specific
verification tasks related to non-food safety requirements. The PHIS system will assign other
consumer protection tasks to establishment task lists based on the product information recorded
in the establishment profile. As with other tasks, IPP are to schedule the tasks on the dates
most appropriate for performing the particular verification task.

The NFSCP Tasks include the Economic/Labeling Tasks, Labeling Tasks, Livestock Finished Product
Standards Task, Poultry Finished Product Standards Task, Economic Sampling Task, and Species
Specific Sampling Tasks. IPP will perform the appropriate verification procedures by:

• Observing establishment product formulation;

• Verifying the accuracy of labeling;
• Observing processing procedures;
• Reviewing establishment records;
• Examining product;
• Checking product identification, condition and temperature;
• Performing a variety of other in-plant measurements, testing and calculations; or
• Observing slaughter practices.

Product compliance determinations are made based on non-food safety regulatory requirements,
including product standards, net weight standards, regulatory minimum or maximum limits of ingredients
or components, or product defects. If product is found to exceed any of the maximum limits, falls below
the minimum requirements, or fails to meet any of the other regulatory requirements, there is
noncompliance. As mentioned before, determinations of noncompliance should be based on production
lots or process controls rather than on individual units of product.

When noncompliance is found, take the appropriate regulatory control actions, such as retention of
product, rejection of equipment or facilities, stopping lines, or refusing to allow the processing of
specifically identified product (9 CFR 500.1(a)), if it is determined that misbranded or economically
adulterated product would otherwise enter commerce or be shipped from the establishment. Additionally,
FSIS may rescind or refuse approval of false or misleading marks, labels, or sizes, or forms of any
container for use with any meat or poultry product per 9 CFR 500.8. If it is determined that economically
adulterated or misbranded product has entered commerce, FSIS will expect establishments to implement
recall procedures.
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 PHIS - Introduction to the Public Health Information System

Objective: Understand how PHIS enhances inspection and protects public health The Food

Safety and Inspection Service (FSIS) is the public health regulatory agency responsible for

ensuring that domestic and imported meat, poultry, and processed egg products are safe,

wholesome, and properly labeled. FSIS has made significant advances in the inspection process

and is constantly evolving to enhance our ability to protect public health. Looking back, certain

milestones may come to mind. In 1906, Congress passed the Federal Meat Inspection Act. In

1996, FSIS finalized the “Pathogen Reduction: Hazard Analysis Critical Control Point (HACCP)

Systems” rule. In 2011, FSIS implemented the Public Health Information System (PHIS) to

support a data-driven approach to FSIS inspection, auditing, and scheduling.

PHIS Introduction

PHIS is a user-friendly, web-based application that replaces several legacy systems and

automates many processes. It allows FSIS to obtain and quickly analyze more data about

domestic and international food safety systems producing FSIS regulated products. It also

enables the Agency to better identify food safety risks before they result in outbreaks or recalls.

The Predictive Analytics component supports a data driven approach to inspection and

sampling by automatically searching data to identify trends and notifying FSIS personnel about

potential public health threats.

PHIS generates specific tasks and adjusts task frequencies based on public health risk factors.

IPP, supervisors, and analysts access real time data for early recognition of food safety system

deficiencies and trends. Data is used to quickly and effectively respond to prevent product

adulteration, recalls, and outbreaks. The quality of the analysis and the response however

depends on the quality of the data in the system. It is critical that IPP enter data that is complete

and accurate.

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PHIS was developed in response to an Office of the Inspector General (OIG) recommendation

that FSIS develop an integrated data infrastructure to support a comprehensive, timely and

reliable data driven inspection system. PHIS enables FSIS to utilize real time data to inform all

aspects of its business process (e.g., domestic inspection, import inspection, and export

activities).

PHIS replaced several legacy systems, facilitating maintenance and analysis of the composited

data. Work efficiency and effectiveness continues to improve since FSIS personnel with

different roles (e.g., inspectors, managers, analysts, policy developers) can readily access and

utilize inspection and sampling data. Agency resources are better utilized since tasks are

prioritized.

There are four functional areas within PHIS:

• Domestic Inspection

• Exports Certification

• Imports

• Predictive Analytics

This course covers Domestic Inspection and Export Certification. Imports are covered in a

separate training course.

PHIS is role-based. There are many different roles and permissions based on duties, job

description and job series. Each user role sees a unique navigation menu. For example, CSIs

can access the establishment profile, task calendar, inspection verification data, animal

disposition, and export certification menus for their assignments.

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Establishment profile data drives many important PHIS functions. Therefore, IPP must routinely

update and ensure the accuracy of the profile data. The profile includes critical information

about the establishments’ operations, product types, product volumes, and HACCP system.

This information allows FSIS to tailor inspection, sampling, or other activities based on

establishment factors. Sample requests are electronically routed to inspectors based on

establishment profile information. If profile data is inaccurate or missing, IPP could receive

sample requests for products that the establishment no longer produces.

A “task list” is generated for each establishment based on profile data. The Task List identifies

task priorities and frequencies. IPP consider the task priorities, time constraints, and their

knowledge of establishment operations to schedule tasks on their task calendar.

In addition to routine tasks, “directed” tasks may be added to the task list. PHIS generates

some directed tasks in response to sample results. Sampling tasks specify a time frame during

which IPP are to schedule and collect the requested sample. IPP can add directed tasks to

document a noncompliance found when not performing a routine task. PHIS also allows

directed tasks to be initiated at various Agency levels and targeted to subsets of establishments

in response to public health findings or other information. The system tracks completion of tasks

and can alert supervisors when tasks are performed.

PHIS contains links to applicable guidance material (e.g., Directives, Notices). The guidance is

based on the establishment profile and the specific inspection task. Linking to only the

applicable guidance reduces time spent searching for and reviewing information that may not be

helpful or pertinent.

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In PHIS, IPP document the specific regulations verified and the findings of compliance or noncompliance for

each regulation. If a noncompliance is found, it is documented on an NR along with other applicable

information such as product type, lot number, retain or reject tags used, and/or the applicable CCP verified

for some tasks. The system also facilitates documenting meeting minutes in a memorandum of interview

(MOI). Inspectors can create notes in PHIS that can be used to communicate with other inspectors or

included as agenda topics for meetings.

Predictive Analytics

Predictive analytics integrates data from various sources such as Centers for Disease Control

and Prevention (CDC), PulseNet, the Agricultural Research Service VetNet, and the National

Antimicrobial Resistance Monitoring System (NARMS) and stores the collected data in the FSIS

Data Warehouse. Algorithms perform real time data analysis. When anomalies are identified,

PHIS sends alerts to the appropriate user homepages or email addresses. Users may subscribe

to alerts that are of interest.

Predictive analytics also uses algorithms to automate scheduling in response to certain events.

The system generates appropriate follow-up tasks in response to sampling results. For

performing and scheduling directed tasks, IPP should follow guidance in FSIS Directive

13,000.1.

Predictive analytics incorporates decision criteria to schedule Food Safety Assessments and

identifies when an establishment should reassess their hazard analysis. Analysts can also

conduct spontaneous data analyses from multiple data sources to identify trends and

anomalies.

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 PHIS 1 – Establishment Profile
Objectives
1. Describe the Establishment Profile in PHIS and why it is important to maintain the accuracy of
information
2. Describe when and how to perform the Update Profile task in PHIS
3. Describe what to discuss and do at the weekly meeting related to the profile

References

1. FSIS Directive 5300.1, Rev. 1, Managing the Establishment Profile in the Public Health
Information System (PHIS)
2. PHIS Quick Reference Guide
3. FSIS Directive 5030.2, Managing the Establishment Profile in the Public Health Information System
(PHIS) for Egg Products Inspection
4. FSIS Notice 47-21, Profile Updates in Domestic Egg Products Plants Implementing Sanitation
Standard Operating Procedures or That Opt-In Early to Implement the Hazard Analysis and Critical
Control Point System Requirements

Background

The Establishment Profile (EP) is a series of web pages in PHIS that Inspection Program
Personnel (IPP) use to enter data about official establishments and other facilities where FSIS
provides inspection services. The profile includes information on the products produced, the
processes performed, the equipment employed, the HACCP systems that the establishment has
put in place, and other general information.

PHIS uses the establishment profile information to assign routine inspection tasks, to create
tailored inspection tasks, to generate FSIS sample requests, and to manage inspection
assignments. Therefore, it is critical to make sure that the profile is accurate and reflects what
the establishment is actually producing and the food safety system it is using to ensure that its
products are safe.

For new establishments, the District Office enters information in PHIS to populate parts of the
profile and IPP complete the remainder and verify the accuracy of information on an ongoing
basis. For existing establishments, IPP maintain and verify accuracy of information on an
ongoing basis. During the process of granting inspection, the Grant Curator (GC) is to assign an
establishment number and enter information regarding the application for grant of inspection or
inspection services. A Frontline Supervisor (FLS), EIAO, or other designated personnel will visit
the applicant’s establishment and report the information gathered at the establishment which will
be used to complete parts of the establishment profile. After the grant process is complete, the
assigned inspector-in-charge (IIC) is responsible for keeping the information in the
establishment profile up-to-date and accurate as part of their in-plant duties.

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The EP information is essential to the Agency’s goal of protecting public health because FSIS
uses the establishment profile information for generating inspection tasks, determining eligibility
for sampling programs, for automated reporting and for ad hoc data analysis. When an
establishment begins production of a new product, there is a significant change in product
volume, an establishment address changes or there is a jurisdiction change, IPP are to update
the establishment profile as soon as the change occurs to ensure the appropriate inspection
tasks are being generated. Other changes, not directly related to task scheduling and sampling
eligibility, can be completed during the next routine monthly Update Establishment Profile task.

The following profile features aid in the determination of task scheduling and sampling
eligibility and are critical to keep updated and accurate:

1. HACCP Processing Category

2. Product Volume Information
3. Jurisdiction
4. Sampling Supplies Address

Other Establishment Profile information of critical importance includes:

Grants and Approvals

Operating Status
Inspection Activities
Shifts
Slaughter
Products produced

Grants include all information related to the Application for Federal Inspection (AFI) and
Application for Voluntary Reimbursable Services (AVRS). Operating Status is the overall
status of the establishment (not just of a particular grant) and is “active” or “inactive”. When
Operating Status is “inactive”, no inspection tasks are allocated to the establishment, so it is
critical to recognize and correct an “inactive” status as soon as possible. An Inspection Activity
is one of the following: meat slaughter, meat processing, poultry slaughter, poultry processing,
egg product, or imported product. Inaccurate inspection activities indicate that EP information
needs changing and as a result the proper tasks may not show up in the establishment task list.
Shift information is critical to ensure that all shifts receive the appropriate inspection tasks and
coverage. Operating Status, Inspection Activities, Grants and Shifts cannot be modified by IPP
as it is “Read Only.” However, it is very important that this information is corrected as soon as
possible, so IPP should examine it right away. Contact the DO through supervisory channels if it
is incorrect.

Slaughter includes the slaughter system, inspection system, number of slaughter lines, number
of slaughter lines operating simultaneously, maximum line speed, and staffing. HACCP
Processing Categories are critical because the tasks for each category will only be assigned if
reflected in the profile. It is important that Inspection Tasks assigned to the establishment’s
inspection task list are applicable and no tasks are missing. The Products and Production
Volume Information has an impact on sampling projects and sampling frequencies. The

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Jurisdiction information identifies the government organization that performs inspection of food
products at the establishment. The Sampling Supplies Address is critical since lab sampling
supplies cannot be delivered to the establishment if this information is missing or not accurate.
This information can be entered or edited by IPP.

Performing the Update Profile Task

PHIS will display the routine update profile task on the establishment task list monthly.

• IPP are to perform the routine Update Establishment Profile inspection task monthly by
updating the information in the establishment profile with any new information and
reviewing the establishment task list. IPP are also to focus on verifying the accuracy of a
specific area of the establishment profile each month according to the following
schedule:

Table: Establishment Profile Update Schedule

Month Profile Information Focus Area
January Establishment Contacts
February HACCP Systems Information for Raw-Intact product categories
March HACCP Systems Information for Raw-Non-Intact product categories
April HACCP Systems Information for Thermally Processed-Commercially
Sterile, Not Heat Treated-Shelf Stable, and Heat Treated Shelf Stable
product categories
May HACCP Systems Information for Fully Cooked–Not Shelf Stable, Product
with Secondary Inhibitors–Not Shelf Stable, and Heat Treated but Not Fully
Cooked–Not Shelf Stable product categories
June General Profile Information
July Product Information for Raw-Intact product categories
August Product Information for Raw-Non-Intact product categories
September Product Information for Thermally Processed-Commercially Sterile, Not
Heat Treated-Shelf Stable, and Heat Treated Shelf Stable product categories
October Product Information for Fully Cooked–Not Shelf Stable, Product with
Secondary Inhibitors–Not Shelf Stable, and Heat Treated but Not Fully
Cooked–Not Shelf Stable product categories
November Slaughter Information
December General Profile Information

• IPP are to also perform the Update Establishment Profile task if they become aware
while performing other inspection tasks, or through communication with a management
official, that the establishment is producing a new product. A directed task may be used
for this purpose if the routine task has already been performed for that month. IPP
perform the update profile task by reviewing and updating the information in the
establishment profile. The EP link on the left navigation menu contains the sub-links
needed to access the various establishment profile pages. IPP can only edit profile
information for establishments in their inspection assignments.

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 • IPP provide a copy of the EP report to establishment management during the next
weekly meeting upon entering a new assignment, or following a change to an existing
assignment. Management will have an opportunity to affirm or correct any of the profile
information in PHIS. When management responds with a correction, IPP are to change
their response only after seeing establishment records or other data that is needed to
support the basis for the correction. IPP are to resolve any issues or discrepancies
regarding profile information before they document the task as completed in PHIS.

• To generate the Establishment Profile Report, IPP are to:

o Select the establishment under the Establishment Profile tab on the left navigation
menu;
o Scroll down to the bottom of the page and find the Reports tab; and
o Click on Reports, then select Establishment Profile Report. This will generate the
report that can then be saved or printed.

Note: Refer to the PHIS user guide or the PHIS Help Button for step-by-step information.
When performing the Update Establishment Profile task, IPP are to gather information from a
management official at the establishment or facility and complete or update information as
needed. The following parts of the EP will be accessed in making updates:

• Establishment Contacts
• General
• Establishment Task List
• HACCP Systems Information (meat and poultry establishments only)
• Slaughter Information (meat and poultry establishments only)
• Product Information (meat and poultry establishments only)
• Production Volume Information (meat and poultry establishments only)
• Profile Questionnaires

Note: Information concerning Grants and Approvals (Read only), Profile Summary,
Operating Schedule, Facilities, Equipment (Thermal Processing), and Training can also be
accessed.

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 PHIS 2 – Task List / Task Calendar
Objectives
1. Identify the FSIS directive that provides instructions to IPP for scheduling inspection task
in PHIS
2. Define the following terms: Task Library, Establishment Task List, Task Calendar,
Routine Task, Directed Task
3. Describe how the task list is created for an establishment and how to navigate the
features of the task list
4. Identify situations that require IPP to schedule and perform directed tasks and how to
schedule a directed task
5. Identify the two sections of the PHIS tasks calendar page and how to navigate the
features of the page and filter for the inspector and the establishment.
6. Describe the principles that IPP follow when scheduling and performing inspection tasks
7. Describe the steps that IPP need to perform the first time they log in to PHIS each day

PHIS, which stands for Public Health Information System, is a web-based application used by
FSIS to generate specific tasks for inspection personnel to schedule tasks to perform based on
public health risk factors.

The PHIS Task Library is a component of PHIS that lists all the different kinds of routine
inspection tasks that may be performed by IPP. It also provides a description of each task. The
Office of Policy and Program Development staff members maintain the tasks in the task library.
Each task is given a priority level and an expected frequency to be performed in a one-month
period. The Task Library will also display inspector guidance, mandatory regulations cited, other
regulatory concerns, and the specific data to be recorded each time IPP perform the task.

The Task Calendar page is divided into two sections, the Establishment Task List and the
Establishment task calendar. The Establishment Task List displays all the tasks which are
assigned to the establishment based on the information in the establishment profile. In other
words, the establishment task list is the source of routine inspection tasks added on the Task
Calendar and performed by IPP assigned to that establishment. The Establishment Task
Calendar displays all the scheduled, in-process, completed, and not performed task for the
establishment. It provides IPP with the flexibility to schedule tasks on days that work best for
their assignments.

There are two types of tasks: Routine tasks and Directed tasks. Routine tasks are inspection
verification activities conducted on a routine, on-going or planned basis under normal
conditions. Routine tasks are allocated based on the information in the establishment’s profile,
e.g., HACCP processing category and products.

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Directed inspection tasks are those that do not occur on a routine basis under normal
circumstances. These tasks are performed on an as needed basis. Sampling tasks and export
certification tasks are considered to be directed tasks because they do not occur on a routine
basis. Directed tasks may be initiated in several ways: Positive pathogen result, FSIS
headquarters personnel, supervision, and conditions observed in the establishment.

When scheduling tasks, inspection personnel should us the frequency and priority level of each
task. They should also utilize their knowledge of the establishment, travel times between
inspection assignments, allocate the tasks over the entire month, avoid predictable patterns,
and do not schedule too many tasks. If IPP determine that they will not be able to complete all
high priority tasks or all directed tasks by the applicable end dates, they are to discuss the
situation with their immediate supervisor as soon as possible. The supervisor will be able to
advise IPP on how to best arrange the necessary tasks or may be able to spread the necessary
work to other IPP.
At the beginning of each work week, IPP should ask establishment management what
operations will be conducted and what products will be produced during the week. Based on
the information provided by the establishment, IPP may need move, or remove and reschedule
inspection tasks. If all of the work cannot be performed on a given day due to the addition of
directed tasks, sampling tasks or export certification requests, IPP should adjust the Task
Calendar by moving tasks to another day. IPP assigned to the same establishment are
expected to coordinate work efforts. This may require reassigning and completing tasks on the
Task Calendar that have not been started and tasks that have been started (in-progress) but
not completed from each another. Note: An inspector cannot assign a task (work) to another
inspector, but an inspector can claim a task (work) assigned to or originally scheduled by
another inspector. The ideal situation or overall goal is that IPP complete all routine tasks for
the month. In this case, the number of completed tasks would equal the number of planned
tasks by the end of the month.

The ideal situation or overall goal is that IPP complete all the routine tasks for the month (i.e.,
the number of completed tasks matches the number of expected or planned tasks at the
end of the month). Even though IPP have scheduled all of the expected tasks, there are going
to be times when they cannot perform all them by the end of the month. Those tasks that are
still on the Task Calendar that have not been started by the end of the month are marked as
“not performed”. IPP must select the appropriate “justification” for not performing the task from a
dropdown list in PHIS. Thus, at the end of the month, IPP account for all of the expected
instances of a task that were on the establishment’s Task List in one way or another.

PHIS maintain information about IPP in-plant assignments. The information available to the IPP
is limited to his/her work assignments. However, IPP often cover assignments other than their
permanent assignment. The most obvious example is relief inspectors, but other IPP will
temporarily cover an assignment that is not their assignment. To access and interact with PHIS
while temporarily covering another employee’s inspection duties, IPP must be designated as
covering that assignment in PHIS. The temporary coverage does not disrupt the permanent
assignment structure but allows IPP to enter information into the system for the coverage
assignment. A coverage assignment can be set up within PHIS on a long-term basis and only
used when needed, or it can be set up only when the coverage occurs.

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PHIS Daily Activities to Ensure Tasks are Scheduled and Performed When Logging into
PHIS for the First Time during the Work Day, IPP should (in this order):

1. Review any new alerts on the dashboard of the homepage. The alerts:

• Are generated automatically based on data entered into the system and events
that occur in the establishment
• Provide IPP with urgent or critical information
• May direct IPP to perform additional inspection tasks or take other action

2. Review each establishment’s Task List to find any new directed tasks. Directed
inspection tasks:

• Are generated automatically based on data entered into the system

• May be generated by supervision, the District Office, or Headquarters

3. Review each establishment’s task list to find any new sampling tasks.

4. If the establishment exports product, determine if there are any new export requests.

5. Review the task calendar to see what inspection tasks are already scheduled for the
week or month.

6. Add any new directed inspection tasks/sampling tasks/export requests to the Task
Calendar.

IPP are to consider the priorities of the new tasks relative to the tasks already scheduled
on the calendar to ensure that they still complete the most important tasks by the end of
the month. For sampling tasks, they need to plan to ensure they can collect the sample
during the designated time period.

7. Adjust the Task Calendar, if the work cannot all be performed on a given day due the
addition of directed inspection tasks/sampling tasks/export requests.

8. Review any open NRs to determine if they can verify that the establishment has brought
itself back into compliance while performing inspection tasks.

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 Status in Definition
PHIS

Inspection Not Open • Task has been added to inspector’s task calendar
Task
Task Color • Verification component option has NOT been selected in
Blue on the PHIS
calendar
Open • Verification component option has been selected in PHIS
(in-progress) • IPP have begun to enter results
Task Color
Yellow on the
calendar

Status in Definition
PHIS

Inspection Completed • All verification has been performed and all results have
Task been entered for the task
Task Color
Green on the • If an NR was issued, the NR’s status has been updated to
calendar “completed”
• “Inspection completed” box has been marked on “the
inspection results” page for the task

Not • IPP has NOT started the task before its end date (usually
Performed the last workday of the month)
Task Color
Red on the
calendar “if
scheduled”

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 PHIS 3 - Inspection Documentation, NRs, MOIs, Inspector Notes,
Meeting Agenda

Objective: Understand how to:

1. Navigate the Inspection Results page
2. Record the result of an inspection task
3. Document the regulations verified
4. Create an inspection note
5. Document an NR
6. Document an MOI
7. Create a meeting agenda

Documenting Inspection Task Results in PHIS

FSIS uses the results of inspection tasks and information about establishment operations to
guide policy development and target Agency resources to those activities that will best protect
public health. To assist with these types of decisions, the Public Health Information System
(PHIS) is designed to capture information about inspection tasks such as:

1. Which regulatory requirements IPP verified, and whether they observed compliance or
noncompliance;
2. How IPP verified the regulatory requirements (i.e. recordkeeping, review and observation, or
both).

IPP use PHIS to document the results of their inspection tasks. After IPP perform an inspection
task, they are to open the “Inspection Results” page for the specific inspection task, select
applicable “tabs”, and record their results in PHIS. They are to make the appropriate entries
regarding the task and their findings of regulatory compliance or noncompliance by checking
appropriate boxes, making appropriate selections from lists, or typing in text. PHIS will allow
inspection tasks to extend over more than one day. Thus, IPP may enter partial results on one
day and then continue/finish performing the task by entering the remaining results on another
day.

The primary method of accessing the Inspection Results page is through the Task Calendar.
Other pathways are also available in PHIS for accessing the Inspection Results page. For
example, IPP can also access the Inspection Results page using the Inspection Verification left
navigation menu. The results of all inspection tasks are documented on the Inspection Results
page.

Completing the Noncompliance Record (NR, FSIS Form 5400-4) in PHIS

When IPP determine that the establishment has not met one or more regulatory requirements,
they check the “Regulatory Noncompliance” box at the bottom of the “Regulations” tab of the
Inspection Results page, and then click “Save” in PHIS. Checking the “Regulatory
Noncompliance” box enables the “Create/Edit NR button” on the bottom of the Inspection
Results page. Much of the information that appears in the sections/blocks on the printed NR is
automatically added by PHIS. Some blocks on the printed NR are completed with information
entered by the IPP. For instance, the IPP must provide a complete, clear, and concise
description of each noncompliance.
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The Role of Inspection Notes

The “Notes” tool enables IPP to document observations, trends, and other issues that relate to
establishment operations that should be brought to the attention the establishment. Notes can
also be used as memory joggers for IPP to follow-up on a particular observation or issue. For
example, IPP should document and discuss less-than-perfect sanitary conditions or execution of
establishment procedures and programs with establishment management that at the time do not
represent noncompliance but could lead to noncompliance. Inspection notes are maintained
within the system in 10 categories: facilities, equipment, sanitation, processing, safety, FSA,
food defense, export, support and records.
There are several advantages to entering specific observations into PHIS using the Inspection
Notes feature. For instance, entering notes into PHIS can facilitate communication between:

1. IPP in the same assignment;

2. Relief IPP and the assigned IPP;
3. IPP and their supervisors, and
4. IPP and other parts of the FSIS chain of command.

The Inspection Notes tool allows IPP in the same assignment and relief IPP to review findings,
issues, or concerns previously observed. By having access to such information, they are better
equipped to identify developing problems. They can act to prevent issues that could affect
public health. For example, while performing inspection verification tasks, assigned IPP can
continue to focus attention on a particular finding, trend, or issue and if necessary, continue to
document the establishment’s inability or unwillingness to address or correct the issue before it
leads to noncompliance.

****************************************************************************************************
Note: The use of inspection notes is not intended to replace documentation of noncompliance
on NRs. All regulatory noncompliance should be documented on an NR.
****************************************************************************************************

PHIS Features IPP Use to Document Meetings between IPP and Establishment
Management

PHIS has several time-saving features that IPP use to document the mandatory meetings that
they have with establishment management. These features enable IPP to work efficiently. First,
there is a Meeting Agenda tool for recording the topics to be discussed at the meeting.
Secondly, there is an inspection notes tool to record IPP concerns that do not rise to the level of
noncompliance but still need to be discussed with establishment management. The Inspection
Notes can be easily transferred to the Meeting Agenda. Lastly, the Memorandum of Interview
(MOI) tool creates the official record of the discussion between IPP and establishment
management at each meeting.

Entrance Meetings

Upon rotation into an assignment, or when IPP are newly assigned to an establishment, they
are to review the establishment’s history, which is reflected in the establishment’s homepage
in PHIS. They are to consult with their immediate supervisor if they have questions or concerns
about the establishment’s history.

After IPP familiarize themselves with establishment’s history, HACCP plans, and programs, they
are to conduct an entrance meeting (e.g., the first weekly meeting) with the establishment
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management. At this meeting, IPP should inquire about the specific operations of the
establishment and seek to answer any questions that came up during their review of the
establishment’s history or programs. IPP are to ask establishment management about the
location of the applicable records and the protocol for FSIS personnel to access and review the
records. Establishments are required to provide access to records needed by IPP to perform
their duties. However, IPP must review the necessary records in the location specified by
establishment management. IPP are not to maintain any copies of the establishment’s written
programs or data from such programs in the inspection office. Likewise, IPP are to ask about
any previously agreed upon notification (e.g., when IPP need to inform the establishment they
will be collecting a sample) when Agency sampling is performed at the establishment. IPP need
to know this information so that an establishment can properly control sampled product pending
FSIS test results.

IPP take notes at the entrance meeting and document the notes in a MOI in PHIS and
provide a copy of the MOI to the establishment.

Awareness Meetings

When new regulations, policies, performance standards, compliance guidelines, or product

sampling protocols are published in a Federal Register Notice, FSIS provides information,
guidance and instructions to IPP for verifying the new policy or implementing the new
performance standards or implementing the new sampling protocol through either a FSIS
Directive or FSIS Notice. The Directive or Notice often directs IPP to conduct an awareness
meeting with establishment management upon receipt of notice or directive. The Notice or
Directive identifies specific information that IPP are to share with establishment management at
the meeting. IPP take notes at the awareness meeting and document the notes in a MOI in
PHIS and provide a copy of the MOI to the establishment.

Weekly Meetings and Agenda Items

As set out in FSIS Directive 5000.1, IPP are to have weekly meetings with establishment
management. IPP are to use the tools in PHIS to record inspection notes, create meeting
agendas, document MOIs, and record the performance of weekly meeting tasks. The
performance of the weekly meeting AND other meetings is documented in PHIS under the
“Meeting with Establishment Management” task.

The purpose of the weekly meeting is to provide an opportunity for IPP to address matters that
affect the establishment’s on-going compliance with FSIS requirements. The discussion of
issues during the weekly meeting is not intended to replace documentation of noncompliance on
an NR. Moreover, the fact that an issue is not discussed at the weekly meeting does not mean
that the issue could not become the subject of an NR.

Meetings should benefit both IPP and the establishment. For instance, it is important that IPP
discuss topics pertinent to the establishment’s food safety system that could affect public health.
IPP are not precluded from asking establishments about any subject of regulatory concern, e.g.,
recalls, allergen control, etc. Establishment management may wish to share information
regarding their operations, such as facility improvements and changes to their food safety
systems, or express concerns at the meetings.

A wide variety of topics can be discussed at the meetings, including individual noncompliances,
developing trends of noncompliance, and findings by IPP that do not represent regulatory
noncompliance but that need to be brought to the attention of the establishment. For example,
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discussion of information from external sources, such as customer or consumer complaints, can
provide information to alert establishment management about a safety risk or about other
information that is relevant to the establishment’s food safety system.
********************************************************************************************
Note: FSIS Directive 5000.1 requires IPP to discuss developing trends in noncompliance at the
weekly meetings and document the discussion of noncompliance trends and the associated
NRs in an MOI. IPP are to discuss any identified associations between current and past
noncompliances, and describe to establishment management why the associated NRs indicate
a trend of noncompliance. It is recommended that IPP explain that continued noncompliance
may result in further enforcement actions, to help the establishment understand the
consequences of continued noncompliance.
********************************************************************************************

FSIS Directive 5010.1 provides a general list of food safety related topics that IPP may
consider discussing with the establishment during weekly meetings. Given the range of the
issues confronting FSIS-regulated establishments, it may be difficult to discuss all of the topics
that either FSIS or the establishment wishes to address during any one weekly meeting.
Similarly, IPP should not use the list of topics in FSIS Directive 5010.1 like check list nor should
they attempt to discuss all topics listed during a given period of time. The topics in the directive
should be discussed as they arise. The list below is not all-inclusive. Possible topics for
discussion listed in FSIS Directive 5010.1 include:

1. In-plant observations, e.g., individual NRs, less than perfect conditions that may, if not
addressed, become noncompliances, and humane handling/poultry good commercial
practices issues;
2. Issues and information that the establishment wishes to share;
3. Agency issuances, e.g., FSIS Notices and Directives and askFSIS questions;
4. Information regarding FSIS sampling;
5. Information related to the establishment’s food safety system, e.g., changes to prerequisite
programs used to support food safety decisions;
6. Information from external sources, e.g., consumer complaints and recalls; and
7. Any inspection related activities occurring outside of approved hours of operation.

On a periodic basis, about once a month as scheduled using the PHIS “Update Establishment
Profile” task, IPP are to ask establishment management at the weekly meeting whether it has
made any changes in the production process or other changes that could affect the safety of the
product. If IPP learn that establishment management has made a change in its process, based
on the nature of the change, IPP are to perform the appropriate verification activities outlined in
FSIS Directives 5000.1 and 5000.6. If IPP are unsure how to proceed, they are to contact their
supervisor for guidance.

Before the weekly meeting with the establishment, IPP may use the Meeting Agenda tool in
PHIS to create an outline of the topics to be discussed. The topics discussed at the weekly
meeting are dependent upon the events or conditions that occur in the establishment each
week. The meeting agenda may be printed and distributed to IPP who will attend the meeting.
IPP are to share a copy of the meeting agenda with establishment management when
requested. PHIS will enable IPP to link the meeting agenda to an MOI to create an
establishment meeting MOI.

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When an establishment has multiple inspection shifts and/or multiple assigned IPP, it is the
Inspector-in-Charge’s (IIC) duty and responsibility to conduct and document weekly meetings.
The IIC:

• Ensures that regulatory concerns that arise on all shifts are discussed at the weekly
meetings;
• May delegate conducting the meeting to IPP;
• May include IPP (CSIs or FIs) in the meeting with establishment management;
• Signs all documentation, and
• Ensures that all IPP on all establishment shifts are made aware of regulatory concerns
that are discussed at weekly meetings.

When the IIC designates an FSIS employee to conduct the weekly meeting, it does not mean
that IIC never conducts the weekly meeting or attends the weekly meeting. Depending upon the
events occurring (e.g., a product recall, positive pathogen result, humane handing issues or an
inadequate HACCP system) or conditions observed (e.g., trends in noncompliance) in the
establishment, it may be appropriate for the IIC, or even the FLS, to conduct the weekly meeting
or at least be in attendance to assist and support IPP.

As set out in FSIS Directive 5000.1, IPP are to take notes at the weekly meetings and are
to document the notes in a MOI in PHIS. IPP are to provide establishment management
with a copy of the MOI.

********************************************************************************************
Note: If IPP do not conduct a weekly meeting, they are to document this fact and the reason
why in an MOI. For example, if establishment management chooses not to attend the weekly
meeting, IPP are to document this in an MOI. If IPP cannot conduct the meeting due to the
performance of higher priority tasks, such as sampling, IPP are to document this in an MOI.

For Cause Meetings

As needed, IPP can schedule a meeting with establishment management to discuss urgent
issues such as a positive pathogen result, recall, outbreak, or inhumane handling incident.
IPP take notes at the meeting, document in a MOI in PHIS, and provide a copy of the MOI
to the establishment.

********************************************************************************************

Memorandum of Interview (MOIs)

FSIS Directives 5000.1 and 5010.1 and several notices instruct IPP to meet with establishment
management and document the outcome of the meeting in an MOI. An MOI is used to record
and convey discussions with establishment or facility management. The MOI is the written
summary of an interview. It should not be a verbatim recitation of the interview, nor does it
necessarily have to be written in the same order as the interview was conducted. Instead, it
includes the date of the meeting, who was at the meeting, and captures and summarizes
critical, relevant information including the specific topics discussed and answers to any
questions asked during the meeting.

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********************************************************************************************
Note: IPP are not to use the MOI as a means to document daily conversations with
establishment employees.
********************************************************************************************

IPP can create and document the following MOIs in PHIS:

• Establishment Meeting
• Standard
• Domestic Food Defense
• Import Food Defense

An MOI is a very important inspection tool for IPP because it documents the fact that IPP
maintain open lines of communication with official establishments. For instance, after the
weekly meeting, IPP are to prepare either an establishment meeting MOI or a standard MOI in
PHIS to document the agenda items covered in the meeting and document any establishment
responses. IPP are to document any discussion of noncompliance trends and NR associations
at the weekly meeting in the MOI. Open NRs and NRs under appeal may be linked to an
establishment meeting MOI or a standard MOI in PHIS.

An MOI can also document a variety of other issues including, but not limited to the:
• Discussion of a new inspection policy transmitted through a FSIS notice (e.g., a directed
awareness meeting);
• Performance of records review in accordance with FSIS Directive 5000.2, and
• Performance of specific verification activities (e.g., supplier tracking information and
humane handling) as deemed necessary by FSIS.

If establishment management provides no response to issues/concerns, this fact should be

recorded in the MOI.

IPP are to maintain a copy of the MOI in the official government file and must provide a copy of
the MOI to the establishment. When the MOI is provided to the establishment or facility, it is
designated as “finalized” in PHIS.

MOIs can be used to track the establishment’s history of responding to issues/conditions in the
establishment that are not noncompliance but can lead to noncompliance if conditions worsen
or if the establishment doesn’t act upon the information the IPP has given the establishment,
e.g., less than perfect execution of prerequisite program. If the situation has been documented
in a MOI on numerous occasions, it would be hard for the establishment to say it didn’t know the
issue/condition could lead to noncompliance when it finally results in noncompliance
documented on an NR.

If an establishment objects to any part of the MOI, IPP are to document the objection at the end
of, or as an attachment to, the MOI. If the establishment's objection is in writing, IPP are to
attach the written objection to the MOI. When the establishment’s written objection is
transmitted electronically, e.g., e-mail or other file format, IPP can upload the file in PHIS and
save the document as an attachment to the MOI record. IPP provide a copy of the amended
MOI to the establishment. MOIs can be reviewed by the Frontline Supervisor.

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Tips for Writing MOIs

• Write the MOI as soon as possible after conducting the meeting. “Cold notes” are difficult to
understand.
• Document who attended the meeting, the topics that were discussed, and what was said at
the meeting. Document only the facts and not any opinions.
• Use quotations only when directly quoting a person.
Example: Mr. Adams said, “I told Ms. Popadoupolis, the Food Safety Manager, that the
SSOP and HACCP records need to be available to the second shift inspector. “ Ms.
Popadoupolis said she would take care of it.”
• Paraphrasing is generally a safer way of relating what someone said since it is difficult to
capture the verbatim account when a person is speaking quickly.
• When paraphrasing, use words like “said” and “stated” to maintain a neutral tone.
Example: “Mr. Adams stated that Mr. Wallace, the Maintenance Manager, is waiting for a
quote to repair a large section of epoxy flooring outside the smokehouses and rack wash
area.”
• Do not use “claimed” as a synonym for “said” because this verb has an undertone of blame
and mistrust.
Example: “Mr. Wilson claimed he was not present during pre-operational sanitation
inspection.” (This sounds as though we do not believe him.)
• When discussing several people of the same gender, restate the name to prevent confusion.
Example: “Mr. Irvine said that he told his Quality Assurance Manager that not making the
SSOP and HACCP records available to the second shift inspector was a violation of the
USDA regulations and that he will develop a method of making them available.” (Who will
develop a method of making the records available? Mr. Irvine or the Quality Assurance
Manager?)
• Use the first person for your observations.
Example: “I asked Mr. Irvine to tell me which office he contacted within the FSIS.”
• Use the third person to relate information about the interviewee.
Example: “Ms. Jones said she was the acting HACCP Coordinator of the establishment
during the Food Safety Assessment.”

Creating Inspection Notes

The PHIS inspection notes feature is designed to be helpful to IPP in several ways: First,
inspection notes help foster communication between IPP assigned to the establishment across
days and shifts. Secondly, they provide a way to capture inspection findings that do not rise to
the level of noncompliance but still need to be discussed with establishment management.
Lastly, PHIS provides a mechanism for easily transferring these notes into a meeting agenda for
the weekly meeting and MOIs.

Creating a Meeting Agenda

FSIS Directive 5000.1 requires IPP to conduct entrance meeting and weekly meetings with
establishment management. Some FSIS Notices require IPP to conduct an awareness meeting
with establishment. Conditions in the establishment and some inspection findings may require
IPP to have non-routine meeting with establishment management, e.g., a positive pathogen or
positive residue sample result, humane handling issues, or a recall. These are often referred to
as for cause meetings. A wide variety of topics can be discussed at the meetings, including
individual noncompliances, developing trends of noncompliance, and findings by IPP that do not
represent regulatory noncompliance but need to be brought to the attention of the
establishment. IPP can use the meeting agenda tool in PHIS to create an agenda for the
meeting.
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The PHIS agenda feature lets IPP select inspector notes and import those notes into a meeting
agenda. This allows IPP to include appropriate entries from the PHIS inspector notes feature
into a draft agenda in preparation for the weekly meeting. Some inspector notes may be
memory joggers for the IPP or just to convey information to IPP assigned to the same
establishment that may not need to be a discussion item at the weekly meeting with the
establishment. When there are no inspection notes that need to be discussed at the weekly
meeting, IPP will use the Agenda tab to add discussion topics to the meeting agenda.

Inspection notes are placed in the agenda “as is” and may need some editing and additions
such as introduction and conclusion text before completing the meeting agenda.

IPP may add additional topics to the agenda that they did not enter in as inspector notes that
they feel need to be discussed at the weekly meeting. If the IPP feels that a particular
noncompliance on an open NR needs to be discussed with establishment management at the
weekly meeting, IPP should associate the open NR with the Meeting Agenda.

Conduct the Meeting

Now that the IPP has created the establishment meeting Agenda, he or she would log off PHIS
and conduct the meeting. IPP use the Agenda to assist in the organization and focus of the
meeting. IPP are required to take notes and document the outcome of the meetings they have
with establishment management. An MOI is used to record and convey IPP discussions with
establishment or facility management.

Creating an Establishment Meeting MOI from the Agenda

After the meeting, IPP document the outcome of the meeting on the MOI. IPP should include
the establishment’s response to regulatory and non-regulatory concerns discussed at the
meeting.

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 PHIS 4 - Sample Management

Objectives
1. Describe the difference between directed samples and collector generated samples
2. Schedule a directed sampling task
3. State the purpose of the laboratory capacity reservation system
4. Document a directed sampling task
5. Cancel a scheduled sampling task from the Task Calendar
6. Check laboratory results
7. Print laboratory forms
8. Describe the method of collecting a sample for establishments with no internet access

General Instructions:

• IPP review relevant FSIS Directives and Notices applicable to the sampling program
before collecting the sample.
• IPP utilize the PHIS Quick Reference and Users Guides for detailed instructions on the
sample management feature of PHIS.
• IPP answer the sample questionnaire, submit it, then print the lab sample form, sign it and
place it in sample box.
• IPP follow the instructions in FSIS Directive 7355.1 for packaging, sealing sample boxes,
and maintaining the integrity of samples submitted to the lab.

References:

FSIS Directive 13,000.2, Rev. 1, Performing Sampling Tasks in Official Establishments using
the Public Health Information System

FSIS Directive 10,800.1 Rev. 3, Procedures for Residue Sampling, Testing and Other
Responsibilities for the National Residue Program

PHIS Users Guide on Inside FSIS Intranet PHIS page

The Sample Management feature of PHIS streamlines scheduling, assigning, documentation,

and tracking of FSIS’s sampling tasks. IPP have the flexibility to schedule sample collection
within the constraints of their particular assignment and the availability laboratory resources.

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Sampling Verification Programs and Sampling Tasks

FSIS administers three sampling verification programs:

• Microbiological sampling for food borne pathogens such as for E. coli O157:H7 on raw beef
products, Salmonella sampling for raw products, and Listeria monocytogenes and Salmonella
on ready-to-eat (RTE) products.

• Carcass/tissue (kidney, liver, heart, or spleen) sampling for drug and chemical residues
(antibiotics, pesticides, and heavy metals) to ensure that residue tolerance or action level
established by FDA and EPA are not violated.

• Carcass/tissue sampling for pathology determinations (e.g., disease conditions,

wholesomeness, etc.) to determine if there is a risk to humans handling or consuming the meat
or poultry products.

Lab sampling tasks fall into two collection types:

1. Directed Sampling task

2. Collector Generated sample

Directed Sampling Tasks displayed on the Establishment Task List are based on the
sampling verification programs for which the establishment is eligible. Eligibility for a specific
sampling program is determined by information entered in the establishment’s profile in PHIS
such as the slaughter class, type of product produced or processed, and production volumes.
One or more directed lab sampling tasks may be created by an authorized user (typically at the
Headquarters or District level) and directed to specified establishments. IPP must use the
Establishment Task List and Task Calendar when scheduling or collecting a directed sample.
For each lab sampling project, IPP will add the sampling tasks on their Task Calendar.
Scheduling the task, reserving lab capacity, and documenting the collection of all directed
sample requests is done through the Task Calendar and not the sample management left
navigation menu in PHIS.

Collector Generated Samples are not displayed on the Establishment Task List.
For all collector generated samples, the IPP will need to create a sampling task in PHIS by
determining laboratory capacity, scheduling the collection date, and documenting the collection
of the sample. The mechanism for scheduling a sampling task and documenting collector
generated samples varies in PHIS.

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PHIS Laboratory Capacity Reservation System

PHIS allows IPP to schedule sample collection tasks using the PHIS Laboratory Capacity
Reservation System. The laboratory reservation system alerts the laboratory to expect the
sample and ensures that FSIS laboratory resources will be available on the day the sample
arrives. The requested collection date will be checked against the laboratory capacity and
reservation module of PHIS. Confirmation will be provided indicating that there is available
laboratory capacity on the requested collection date for the type of sample being collected. If
capacity is not available, IPP are to select an alternate date. Once sample scheduling is
completed, PHIS will display the address of the FSIS Laboratory that is scheduled to receive
and analyze the sample.

Remember:
o Sampling tasks should be scheduled to the task calendar using a realistic collection date
based on the plant’s production schedule. This should be done as early as possible to
ensure a capacity slot is available for the desired collection date. Once the sampling task
has been moved from the task list to the calendar, a capacity slot is reserved to
accommodate the scheduled sample (see FSIS Directive 13,000.2 Rev. 1).
o Scheduled sampling tasks should be canceled or rescheduled as soon as IPP are aware
they will not collect on a scheduled date so capacity slots can be released for others to
use.
o Waiting to schedule sampling tasks in the last few days of the collection window may
result in no capacity being available.
o Sampling for low and infrequent producers should be scheduled as far in advance
as possible.

General Instructions for Performing Sampling Tasks in PHIS

The FSIS laboratory is completely dependent on IPP to properly collect, prepare, and ship the
sample. The FSIS Sampling Form that accompanies each sample must be completely and
accurately filled out. The IPP role in the sampling process is vital. The information entered on
the form becomes part of a legal document. If mistakes are made during the collection of the
sample or on the form, the lab will discard the sample.

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 PHIS 5 - Animal Disposition Reporting (ADR)

Objective: Perform the following functions in PHIS:

• Specify weight reporting frequencies
• Record No Kill periods
• Enter livestock inspection results
• Record custom slaughter data
• Enter poultry inspection results
• Print condemnation certificates

References

PHIS Users Guide - FSIS Intranet PHIS Resources

FSIS PHIS Directive 6100.1, Ante-Mortem Livestock Inspection
FSIS PHIS Directive 6100.2, Post-Mortem Livestock Inspection
FSIS PHIS Directive 6100.3, Ante-Mortem and Post-Mortem Poultry Inspection
FSIS PHIS Directive 6170.1, Ratite Ante-Mortem and Post-Mortem Inspection
FSIS Directive 10,800.1 rev. 3, Residue Sampling, Testing and Other Verification Procedures
under the National Residue Program for Meat and Poultry Products

Animal Disposition Reporting

Inspection findings by Inspection Program Personnel (IPP) during ante-mortem and post-
mortem inspection that identify diseased animals or carcasses, must be reported in PHIS in
Animal Disposition Reporting. The IPP is responsible for collecting, storing, and reporting
information on the disposition of livestock and poultry presented for slaughter at all official
Federal and Talmadge-Aiken establishments. Within PHIS, IPP are authorized to create and
edit several types of animal disposition data within the system.

Daily dispositions for livestock slaughter establishments are entered on a per shift basis. If there
are two slaughter shifts, then data will be entered for both shifts. Daily dispositions for poultry
slaughter establishments are entered on a per lot basis. The establishment is responsible for
designating the lots.

Disposition data is associated with the actual day of slaughter, not the date that the information
is entered into PHIS. Whenever possible, ADR data should be entered at the end of shift.
In PHIS, only the post-mortem carcass dispositions made by the PHV (carcasses railed out to
the PHV) are entered into PHIS. The individual entries will have the retain tag number, and
there is a free text narrative box to record additional information.

Condemnation certificates can be automatically generated by PHIS for both AM and PM

condemnations. These certificates can be printed out and signed.

Animal Disposition will be the portal for collecting data on in-plant residue screening test results
(KIS™) and for requesting laboratory confirmation of presumptive positive test results. Each
residue screening test result will be individually associated with the AM or PM disposition
decision for that carcass. Additionally, ADR will be the portal for collecting the number of
Brucellosis and Tuberculosis samples taken, along with BSE sample information.

231
 PHIS 6 - Perform Hazard Analysis Verification (HAV) Task with 2 Noncompliances

Objective: Show how IPP document a HAV Task noncompliance

Scenario #1

An IPP is conducting a HAV task in a portion control establishment that produces ground beef for HRI

use. While reviewing the flow chart he notes the establishment has no returned product step in its flow

chart, but recalls observing several cases of ground beef being offloaded from a food service truck the

day before. At that time, a shipping supervisor had stated a restaurant was returning these cases of

ground beef. The IPP determines that the establishment’s flow chart is not in compliance with

417.2(a)(2).

Scenario # 2

An IPP is reviewing the HACCP plan for a large beef slaughter establishment and finds that it has a

CCP for E. coli O157:H7 at the steam pasteurization step prior to chilling. The verification procedures

specify that maintenance will calibrate the temperature recording device once a week prior to

operations. She asks the establishment for documentation supporting this frequency of calibrating the

temperature recording device, and they produce some technical documents from the manufacturer

that states the temperature recording device should be calibrated daily. The establishment has no

documentation supporting the verification procedure and frequency; therefore, it is not in compliance

with 417.5(a)(2).

232
Workshop #1 – Poultry Slaughter/Processing Establishment, SPS, SSOP,
and HACCP

Please read the following scenario and answer the questions at the end within the
table boxes.

Please review the HACCP plan and the records that are associated with this scenario.

Background: K. Nugget, a Consumer Safety Inspector (CSI), is assigned to a poultry

establishment that slaughters and further processes young chickens during a single operating
shift, Monday through Friday, from 0700 to 1530 hours. The establishment has 2 evisceration
lines, produces raw intact and raw non-intact products, and occasionally exports poultry
products.

Scenario: At 1000 hours, on March 1, 2022, CSI Nugget was leaving the shipping dock after
completing export certifications and noticed a foul odor in the hallway outside the processing
department. The CSI determined the odor originated from empty, damaged, inedible
containers that were being stored in the hallway to be discarded due to their unacceptable
condition. CSI Nugget performed an Operational SSOP Review and Observation verification
task as she walked through the further processing department on her way to the slaughter
department. In the processing department, she observed the establishment monitoring
operational sanitation activities. Quality Assurance (QA) personnel were applying yellow
caution tape around an area below a leak in the processing room ceiling. The leak was
located between two processing lines in a potential product zone.

CSI Nugget proceeded to the slaughter floor to continue to observe operational sanitation
throughout the establishment.

At 1230 hours, CSI Nugget decided to review the establishment’s SSOP program and
records for the leak that was observed earlier in the further processing department. (Note that
these SSOP records are not required to be available until the start of the same shift on the
following day). The establishment’s SSOP records had two entries related to the leaking

233
ceiling. An entry at 0900 hours which stated that an employee observed a leak and notified
QA and maintenance personnel. The area was roped off by QA. There was another entry on
the SSOP record at 1030 hours that the area was released because maintenance fixed the
leak, and the ceiling was no longer leaking.

Before CSI Nugget headed back to the processing room, she asked the establishment QA
Supervisor for the CCP 1 records for the current day since she had not noticed any
establishment personnel performing the Zero Tolerance CCP monitoring. CSI Nugget was
told that due to short staffing, the designated monitor had been working on the ceiling leak in
the further processing department, but the record is usually kept on the clipboard on the wall.
CSI Nugget found the clipboard with the CCP monitoring record, but it was blank. CSI Nugget
asked the QA Supervisor about the monitoring checks, she stated that the checks were
performed by the QA Tech, but the checks were not documented. The establishment’s
HACCP program specified that the slaughter Zero Tolerance CCP will be monitored each
production hour on each line.

CSI Nugget decided to follow-up on the conditions in the processing room. When she arrived,
she noticed that the caution tape had been removed from the area that was previously
segregated. Now, there were five metal combo bins with poultry thighs and wings in that area.
The CSI observed that there was a large blue plastic tarp partially covering three of the five
bins. The other two combo bins were completely uncovered. There was an accumulation of
clear liquid on the plastic tarp that was slowly running into one of the three combo bins that
were partially covered. The CSI investigated further and noticed that the ceiling above the
metal combo bins was slowly leaking liquid into the uncovered combo bins.

234
HACCP Plan (excerpt) CCP 1

Poultry Slaughter HACCP Plan

Process CCP CCP Critical Limits Monitoring Procedures Verification
Step Number Description Procedures
Zero 1– No visible No visible fecal Designee will examine Once per week a
tolerance Biological contamination material 10 randomly selected supervisor
(Pathogens
Examination in fecal carcasses each observes the
(carcass) material) If a deviation from the production hour per designee
critical limit occurs, shift, per line. performing the
corrective actions monitoring.
shall meet all Document findings on
requirements of 9 Zero Tolerance A supervisor will
CFR 417.3 and be Monitoring Form. conduct records
documented on the review daily.
Zero Tolerance
Monitoring form.

Establishment’s Zero Tolerance Monitoring Record for March 1, 2022

Zero Tolerance Monitoring Form (CCP1)

Date No fecal Performe Time Corrective Verification
material d by Actions and/or Procedures
identifie Comments
d on 10
carcass
sample
=0
3/1/2022

235
 Establishment’s SSOP Monitoring Record for March 1, 2022

SSOP Monitoring Record – Further Processing (Monitor Implementation 4 times daily)

Date Time Performed by Processing Room Corrective Actions and Preventive

Measures
3/1/22 0800 MJ Acceptable

3/1/22 0900 MJ Unacceptable - employee No product was involved.

observed leak and notified QA Maintenance is working on the leak
and maintenance personnel. and area is sectioned off.
3/1/22 1030 MJ Acceptable Maintenance fixed the leak.
The ceiling is no longer leaking.
Area released.

Blue plastic tarps will be placed

over the product combo bins until
the corrective actions are complete.
A QA Tech will monitor the area
twice per shift, per day for the next
three days.

236
Questions:

Q1 - Please explain why the establishment is not in Q2 - If you were the CSI in this
compliance with FSIS regulations. Please include the establishment, what are the actions you
regulatory citation. would take? (i.e., List the actions you
should take as a CSI in relation to each
noncompliance you identify in this
scenario).

Noncompliance Description Regulation(s) Your Actions for This Noncompliance

not met

HACCP Noncompliance HACCP

Regulation

SSOP Noncompliance SSOP

Regulation

SPS Noncompliance SPS

Regulation

237
Workshop #2 – Livestock Establishment NR

After completing the workshop, the participants will be able to:

1. Determine the required data that needs to be included in an NR.

2. Determine the situations that require associating NRs.

Please read the scenario, review the NR, and answer the questions at the end.

Livestock Establishment Scenario

Background: CSI Naomi Thompson is assigned to Veal on Wheels, a small veal slaughter and

processing facility. The establishment slaughters approximately fifty veal calves a day on one

shift, five days a week. They use a bed dress system (cradle) during slaughter operations.

Incorporated into the HACCP system to address E. coli O157:H7 and non-O157:H7 STEC are

two critical control points including zero tolerance and a lactic acid intervention.

Scenario: On June 1, 2022, at approximately 0910 hours, CSI Thompson performed a

scheduled Slaughter HACCP verification task on the slaughter floor and noticed that the

establishment is hanging both hindquarters of each carcass on one rail trolley hook prior to the

final wash and antimicrobial intervention steps. Since the establishment does not split the veal

carcasses, they usually use a gambrel to separate the hindquarters for adequate washing and

antimicrobial coverage. By using the one trolley hook this caused both hindquarters of each

carcass to be touching. Upon observing the inside of the hindquarters of three carcasses she

identified that they were not receiving any lactic acid coverage. The plant employee pushed

these three carcasses into the cooler. She notified the slaughter foreman, Mr. James Drayer, of

the noncompliance.

238
The critical limit for the antimicrobial intervention CCP includes a 2% lactic acid concentration

applied to the entire carcass so that complete coverage is achieved. CSI Thompson observed

the establishment perform a titration to verify the appropriate concentration prior to starting

operations. Note: Titration is a standard method of chemical analysis which can be used to

determine the concentration of a known reactant. CSI Thompson also noted that the

establishment used a small garden type sprayer to apply the lactic acid. She determined that

solution was mixed to the correct concentration and the garden sprayer was an acceptable

means of applying the solution.

Since the ten veal carcasses already hanging in the cooler were observed to be hanging from

one hook in the same manner and the inside of the hindquarters appeared completely dry, CSI

Thompson told Mr. Drayer she is taking a regulatory control action by applying U.S. Retained

tag B19042869 to the carcass cooler door. She notified Mr. Drayer that the one tag

encompassed all thirteen carcasses. It included the carcasses she observed on the slaughter

floor and the ones slaughtered earlier that morning because of the deviation from a critical limit.

CSI Thompson reviewed PHIS and determined NR KIH4527923981N was documented May

10, 2022, for failing to detect a deviation from the critical limit at the zero tolerance CCP. She

associates the two NRs because they indicate a problem with establishment employees

assigned to monitor CCPs.

Resources:

FSIS Directive 5000.1, Revision 6 Verifying an Establishments Food Safety System

9 CFR Part 417

239
CSI Thompson’s Noncompliance Record

U.S. Department of Agriculture TYPE OF NONCOMPLIANCE

FOOD SAFETY AND INSPECTION SERVICE X Food Safety  Other Consumer
NONCOMPLIANCE RECORD Protection
1. DATE 2. RECORD NO. 3. ESTABLISHMENT NO.
06/01/2022 KNL1612111329N M8383
4. TO (Name and Title) 5. PERSONNEL NOTIFIED
Mr. Scott Snook, Plant Manager Mr. James Drayer, Slaughter Foreman
6. RELEVANT REGULATIONS 6a. ASSOCIATED NR(s)
9 CFR 417.2(c)(4) KIH4527923981N
7. TITLES OF HACCP OR SSOP PLAN or OTHER 7a. NAME OF CCP(S) or
SUPPORTING DOCUMENTATION PREREQUISITE PROGRAM
Veal Slaughter Lactic Acid
8. INSPECTION TASK 9. VERIFICATION ACTVITY
Slaughter HACCP  Review & Observation  Recordkeeping X Both
9a. AFFECTED PRODUCT INFORMATION: 13 Whole Veal Carcasses
9b. RETAIN/REJECT TAGS: B19042869
10. DESCRIPTION OF NONCOMPLIANCE

On June 1, 2022, at approximately 0910 hours, while performing the Slaughter HACCP verification

task, I noticed that the establishment was hanging both hindquarters of each veal carcass on one

hook prior to the final wash and antimicrobial intervention steps. The critical limit for the antimicrobial

intervention CCP includes a 2% lactic acid concentration applied to the entire carcass so that

complete coverage is achieved. I observed the establishment perform a titration to verify the

concentration prior to starting operations. Upon observing the inside of the hindquarters of each

carcass were not receiving any lactic acid coverage, I notified the slaughter foreman, Mr. James

Drayer, of the noncompliance. A review of PHIS showed a similar NR documented on May 10, 2022,

in NR KIH4527923981N, for a different CCP. The preventative measures and further planned

actions of retraining employees on correct HACCP monitoring procedures have been ineffective in

preventing noncompliance recurrence.

11. SIGNATURE OF INSPECTION PROGRAM EMPLOYEE

You are hereby advised of your right to appeal this decision as delineated by 306.5 and/or 381.35 of 9 CFR
12. PLANT MANAGEMENT RESPONSE:

This document serves as written notification that your failure to comply with regulatory requirement(s)
could result in additional regulatory or administrative action.
13. SIGNATURE OF PLANT MANAGEMENT
14. DATE

15. VERIFICATION SIGNATURE OF INSPECTION PROGRAM EMPLOYEE

16. DATE

240
Questions:

1. What errors can you detect in the written NR?

2. Rewrite the NR Block 10 the way you would write it if you were the CSI.

241
Workshop #3 – Poultry Establishment: Sampling and Process Control

Please read the following scenario and answer the questions at the end.

Background: Establishment Ink, LLC is a large poultry slaughter and processing establishment
(P-0000) located in Salt, Alabama. Their slaughter and processing operations are conducted by
way of a first shift (0530 to 1400 hours) and second shift (1400 to 2030 hours), with a cleanup
operation after both shifts have been completed. Establishment Ink has two Meyn Maestro
slaughter lines that run at a maximum speed of 140 birds per minute. Establishment Ink
slaughters and processes approximately 268,000 young chickens a day. The further processing
operations consist of a Cut-up Department, Debone Department, and Mechanically Deboned
Meat (MDM) Department. The MDM Department produces NRTE ground chicken that is shipped
to their sister plant where it is used to produce raw chicken patties. This product is eligible for
Salmonella/Campylobacter testing. Both shifts have a staffing level of 8 Food Inspectors (4
inspectors per line), 2 Consumer Safety Inspectors, 1 Supervisory Consumer Safety Inspector,
and a Public Health Veterinarian.

Scenario: It’s Tuesday, April 5, 2022. CSI Red opens PHIS and observes in the establishment
task list that he needs to verify the establishment’s generic E. coli testing procedures and results
to see if they are maintaining process control for microbial contamination. He knows that
Establishment P-IK has chosen generic E. coli as their indicator organism to demonstrate
whether or not they are maintaining process control and that this program is addressed in their
SSOP plan, so he schedules a routine Operational SSOP Review and Observation task in PHIS.

He goes to the QA office and reviews the SSOP program which contains the procedures for
collecting and testing for generic E. coli. The program states that the establishment will perform
testing via a carcass rinse using an approved AOAC method. The procedures state that the
establishment will aseptically collect 1 carcass rinse sample per 22,000 carcasses, but a
minimum of one sample during each week of operation. The sample will then be maintained
under refrigerated conditions and analyzed the same day in the establishment’s onsite
laboratory.

242
He next inquires about the next time a sample would be taken for E. coli sampling. The QA
supervisor informs him that one of his technicians was about to take a sample in the next few
minutes. He goes along with the QA technician to the post chill location where the sample will be
taken. He observes her prepping the sampling table and using aseptic technique by washing her
hands, etc. The technician decides to do a swab sample using a carcass from the chiller belt.
CSI Red was confused, because the program read that the sampling was supposed to entail a
whole bird rinse. He saw nothing about a swab sampling nor support for it.

He observes the technician follow through on procedures of a swab sampling but not a bird rinse
as per the establishment’s written program. Once completed, he follows the QA technician to the
lab and watches her place the sample in the freezer. She states that it is the end of the day and
she needs to make an appointment and will analyze it in the morning. In the meantime, CSI Red
asks to review the Statistical Process Control chart for data that has been plotted for the last 10
days. When he reviews the chart, he notices that 4 of those 10 days had results that were
markedly below the normal (average) control line in the chart. This was very odd to CSI Red,
because he knows that 2 sanitation NRs and 3 fecal zero tolerance NRs were written during this
ten day period.

Resources:

9 CFR 381.65 (g) & (h)

9 CFR 416.15 (b)

9 CFR 417.3 (b)

FSIS Directive 5000.1 Rev. 6 10/14/21 Verifying an Establishment’s Food Safety System

FSIS Directive 6420.5 Verifying Poultry Slaughter Establishments Maintain Adequate Procedures for
Preventing Contamination with feces and Enteric Pathogens

243
Question:

Please list the issues that you noticed in the above scenario that you have concerns about
(critique the actions, results, or the procedure that was performed by the establishment
employee).

244
 PHIS Simulations

There are 13 PHIS training simulations that will familiarize you with navigating and using the
Public Health Information System (PHIS) to document various inspection tasks. The instructor
will introduce each simulation and then provide time for you to review the simulation on your
own in the FSIS Training Site. Please follow the instructions in the simulation and click on the
various buttons and targets to complete each simulation. Depending on the strength of your
internet connection, the simulation may load slowly. Each simulation will have a separate link
for you to click on to access the training.
[Link]

References:
Directive 13,000.1 - Scheduling In-Plant Inspection Tasks in the Public Health Information
System (PHIS) - Revision 1

Directive 13,000.2 - Performing Sampling Tasks in Official Establishments Using the Public
Health Information System - Revision 1

1 - PHIS Navigation

This lesson introduces the PHIS navigation process.

Objective: Upon completing this lesson, you will be able to describe how to navigate through
PHIS features and pages

• Log into PHIS

• Homepage

• My Dashboard tab – Alerts, My Tasks, Inspection Results, Smart Links

• My Establishments tab – My Establishments, Non-Compliance Record, FSA

• My Inspections and Samples tab – Inspection Agenda, Inspection Note, Lab Sample

Collection

• Left Navigation Menu

245
2 – SPS Verification Task

This lesson introduces the SPS Verification Task – compliance scenario.

Objective: Upon completing this lesson, you will be able to describe how to complete the SPS

verification task in PHIS.

• Schedule the SPS Verification Task from the Task List to the Task Calendar

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• Regulations Tab – Check mandatory regulations and any other regulations verified

• Create an Inspection Note

246
3 – Pre-Operational SSOP Review and Observation Task

This lesson introduces the Pre-Operational Sanitation Standard Operating Procedures (SSOP)

Review and Observation Task – Noncompliance scenario.

Objectives: Upon completing this lesson, you will be able to: 1) Describe how to document

noncompliances in PHIS, and 2) Describe how to complete the Pre-Operational SSOP review &

observation task in PHIS.

• Schedule Pre-Op SSOP Review and Observation Task from the Task List to the Task

Calendar

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• Regulations Tab – Check mandatory regulations and any other regulations verified, check

Regulatory Non-Compliance box

• Create/Edit NR

• Add Noncompliance, check noncompliant regulation(s), type Noncompliance Description

• Print NR, view NR, edit NR, Finalize NR

• Verify Corrective Actions, Complete NR

• Complete the task

247
4 – Operational SSOP Review and Observation Task

This lesson introduces the Operational Sanitation Standard Operating Procedures (SSOP)

Review and Observation Task – Compliance scenario.

Objectives: Upon completing this lesson, you will be able to describe how to complete the

operational SSOP review & observation task in PHIS.

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• Regulations Tab – Check mandatory regulations and any other regulations verified

• Complete the task

248
5 – HACCP Verification Task

This lesson introduces the HACCP Verification Task scenario.

Objective: Upon completing this lesson, you will be able to describe how to complete the HACCP

Verification task in PHIS.

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• Regulations Tab – Check mandatory regulations and any other regulations verified

• Complete task

249
6 – Poultry Zero Tolerance Verification Task

This lesson introduces the Poultry Zero Tolerance Task – Compliance scenario.

Objective: Upon completing this lesson, you will be able to describe how to complete the Poultry

Zero Tolerance Verification task in PHIS.

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• Regulations Tab – Check mandatory regulations and any other regulations verified

• Complete task

250
7 – Livestock Zero Tolerance Task

This lesson introduces the Livestock Zero Tolerance Task – Noncompliance scenario.

Objectives: Upon completing this lesson, you will be able to: 1) Describe how to complete the

Livestock Zero Tolerance Verification task in PHIS and 2) Describe how to document

Noncompliances in PHIS.

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• Regulations Tab – Check mandatory regulations and any other regulations verified

• Create/Edit NR

• Add Noncompliance, check noncompliant regulation(s), type Noncompliance Description

• Print NR, view NR, edit NR, Finalize NR

• Verify Corrective Actions, Complete NR

• Complete task

251
8 – Scheduling and Submitting a Salmonella/Campylobacter Poultry Parts Sample

This lesson introduces the scheduling and submitting of a Salmonella/Campylobacter poultry

parts sample in PHIS.

Objectives: Upon completing this lesson, you will be able to: 1) Describe how to create a lab

sampling task in PHIS and 2) Describe how to submit a lab sample in PHIS.

• Filter Task List by Establishment

• Filter Task by Lab Sampling

• Add the Sampling for Chicken Parts – Legs, Breasts, and Wings Task.

• Select the Collection Date and View Laboratory Capacity

• Document the task

• Select Sample

• Complete Sample Collection Data

• Take Questionnaire and Submit

• Print Form

• Submit to Lab

252
9 – Creating Inspection Notes, Meeting Agendas, and MOIs

This lesson introduces how to create inspection notes, agendas, and Memorandum of Interviews

(MOIs) in PHIS.

Objectives: Upon completing this lesson, you will be able to describe how to create inspection

notes, agendas, and MOIs in PHIS.

• Select Establishment

• Inspection Notes

o Create Note

o Select Category

o Enter Text

• Meeting Agendas

o Create Agenda

o Select Meeting Date, Time, Subject, and Attendees

o Comment List

o NR

• MOI

o Meeting Agendas

o MOI - Meeting

o Agenda Text Box

o NR

o Review

o Finalize

o Print
253
10 – Livestock Humane Handling Task

This lesson introduces the livestock humane handling task.

Objective: Upon completing this lesson, you will be able to describe how to complete a livestock

humane handling task in PHIS.

• Document the task

• Inspection Results

• Activity Tab – Select verification activity (review and observation, record keeping, both)

• HATS Tab (Humane Activities Tracking System)

o Select HATS categories verified

o Enter Duration (minutes/hours) in 15-minute intervals

• Regulations Tab – Check mandatory regulations and any other regulations verified

• Complete task

254
11 – Establishment Profile – Add a HACCP Plan

This lesson introduces the PHIS Establishment Profile navigation process.

Objectives: Upon completing this lesson, you will be able to add a new HACCP plan to an

establishment’s profile

Step 1: Click Establishment Profile

Step 2: Click Open on the establishment row

Step 3: Click on the HACCP Tab for the establishment

Step 4: Click on the HACCP Plans Tab

Step 5: Click on Add a HACCP Plan above the grid

Step 6: Click the Signature date and select the date on the calendar

Step 7: Click on Plan Name and enter the name of the plan

Step 8: Click on the Processing Categories box for the product type

Step 9: Click on Add

Step 10: The HACCP Plan has been added to grid, click Exit Profile

255
12 – Establishment Profile – Updating Production Volume

This lesson introduces the PHIS Establishment Profile navigation process.

Objective: Upon completing this lesion, you will be able to explain the steps CSIs take to update

an establishment’s production volume.

Step 1: Click Establishment Profile

Step 2: Click Open on the establishment row

Step 3: Click on the Products Tab for the establishment

Step 4: Click Open for the Raw-Intact/Raw-Intact Chicken/Chicken/Poultry (Leg, Breast, Wings ONLY)

Step 5: Click Edit

Step 6: Click the Drop down arrow for the Average Daily Volume. Select 50,001-250,000.

Click Update

Step 7: Click Save HACCP Volumes. The HACCP Volumes have been updated in the grid.

256
13 – Establishment Profile – Updating and Adding an Establishment Contact

This lesson will introduce you to the procedure to update and add an Establishment Contact.
Objective: Upon completing this lesion, you will be able to explain the steps CSIs use to update
and add an establishment contact.

Step 1: Click Establishment Profile

Step 2: Click Open on the establishment row

Step 3: Click on the Facility Tab for the establishment

Step 4: Click on the Contacts Tab

Step 5: Click on Open on the contact’s row to be updated

Step 6: Click inside the First Name box, enter the replacement first name

Step 7: Click inside the Last Name box, enter the replacement last name

Step 8: Click inside the Email Address box, enter the replacement email address

Step 9: Click Save

Step 10: The establishment contact has been edited, to Add a new establishment contact, Click

Add a new Contact

Step 11: Click inside the box for Responsibilities and select from the drop-down menu

Step 12: Click inside the First Name box, enter the first name

Step 13: Click inside the Last Name box, enter the last name

Step 14: Click inside the Phone Number box, enter the phone number

Step 15: Click inside the Email Address box, enter the email address

Step 16: Click Yes or No if the person is a Primary Contact

Step 17: Click Yes or No if the person is an After-Hours Contact

Step 18: Click Yes or No if the person should receive NR Notification

Step 19: Click Yes or No if the person is a Billing Contact

Step 20: Click Add button

Step 21: The new contact has been added to grid

257
 Case Studies: Scenario-Based Learning

Use the information below to navigate through case-study scenarios and apply what you’ve
learned during the Inspection Methods training. If you get stuck or identify a topic you need to
revisit further, make a note and continue on with the scenario. You can note the slide number
■
(upper right corner, e.g. L-1) for reference.

Don’t worry if you make a mistake – you will have multiple opportunities to try if you don’t get it
right the first time. You can select “Back” to try again. After you complete the scenario, the
trainers will review key points and answer any questions you noted.

Note: In each scenario, you can choose any task first. Prior to completing the
scenario, you will complete all the tasks.

1) Livestock Slaughter/Processing Scenario

a. Part I – Familiarize yourself with the establishment

b. Part II – Complete Livestock Zero Tolerance, Operational SSOP Review and Observation, and

SPS Verification tasks

2) Poultry Slaughter/Processing Scenario

a. Part I – Familiarize yourself with the establishment & complete Pre-Op SSOP task

b. Part II – Complete Poultry Zero Tolerance and Slaughter HACCP tasks

3) Ready-to-eat (RTE) Heat Treated Shelf Stable Scenario

a. Part I – Familiarize yourself with the establishment & update establishment profile

b. Part II – Complete SPS Verification, Heat Treated Shelf Stable HACCP, and Operational

SSOP Record Review tasks

258
#1 - Livestock Slaughter/Processing Scenario

■
L-3 Background: Congratulations! You are a new CSI assigned to a very small livestock slaughter and
processing establishment, M8765. It's your first day on the job, and you want to familiarize yourself
with the establishment.

A. Livestock Scenario Part I – Familiarize

■
L-4 Review the establishment profile. Notes:

1111
L-7/9 Review establishment programs (HACCP, Sanitation SOPs, Prerequisite programs). Notes:

Questions to consider:
Which SSOP regulations correspond to which parts of the Sanitation SOPs?

What are some examples of this establishment’s Prerequisite Programs?

What are the CCPs at this establishment?

■
L-8 Match the Sanitation SOP regulations to the corresponding Sanitation SOP. Notes:

-
L-12 Review Directive 5000.1 for information on conducting an Entrance Meeting.

Questions to consider:
What types of content would you include in an entrance meeting?

After conducting an entrance meeting, how will you document the meeting?

After documenting the meeting, what will you share with the establishment?

-
L-13 Type the topics you plan to discuss at the entrance meeting. Notes:

-
L-16 Review the example MOI. Notes:

-
L-17/18 Review your PHIS Task list. Review Directive 13,000.1.

259
 Question to consider:
How would you prioritize scheduling tasks in PHIS?

-
B. Livestock Scenario Part II – Complete 3 inspection tasks

L-20 Choose which task to complete first: Livestock Zero Tolerance, Operational SSOP Review and
Observation, or SPS Verification.

Note: you can choose any task first. Prior to completing the scenario, you will complete all
three tasks.

Livestock Zero Tolerance task

-
L-21 Review Directive 6420.2 for information on how to conduct a Livestock Zero Tolerance task.

Questions to consider:
What substance(s) must livestock carcasses be free of on the Zero Tolerance task?

What are examples of supportable descriptions of fecal and ingesta in each species?

How will you determine what number of carcasses to examine on Zero Tolerance?

What will you do if you identify fecal or ingesta on Zero Tolerance?

What do you expect the establishment to do if they fail Zero Tolerance?

What regulations will you use to document Zero Tolerance noncompliance?

What should your Zero Tolerance NR include to be supportable?

What task should you schedule in response to a Zero Tolerance noncompliance, and why?

-
L-23 Match the feces descriptions by species. Notes:

-
L-25 Conduct the Zero Tolerance task. What are your observations? Notes:

260
-
L-30 Identify the W’s in the Livestock Zero Tolerance NR. Notes:

-
L-33 Match corrective actions from Zero Tolerance failure to regulations. Notes:

Operational SSOP Review and Observation task

-
L-39 Review Directive 5000.1 for information on how to conduct an Operational Sanitation SOP
Review and Observation task.

Questions to consider:
What is the difference between SPS Verification and SSOP tasks?

What are you observing when you conduct an Operational SSOP Review and Observation
task?

What action would you take if you observe product or food contact surface contamination?

What do you expect the establishment to do if product or food contact surfaces become
contaminated?

What should your SSOP NRs include to be supportable?

When must an establishment have their SSOP records completed?

-
L-42 Conduct the Operational SSOP Review and Observation task. What actions do you take? Notes:

-
L-47/48 Document an SSOP NR. Review the example SSOP NR. Notes:

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SPS Verification task

-
L-35 Review Directive 5000.1 for information on how to conduct a SPS Verification task.

Questions to consider:
What is the difference between SPS Verification and SSOP tasks?

What types of facilities are you observing to verify which SPS regulations?

-
L-37 Match the regulations to the SPS picture. Notes:

Once you have completed the Livestock ZT, Operational SSOP Review and Observation, and SPS
Verification tasks, you have completed this scenario. Add any additional notes or questions below.
Notes:

262
#2 - Poultry Slaughter/Processing Scenario

•
P-3 Background: You are a CSI assigned to a large chicken slaughter establishment, P1357. The
establishment slaughters Monday through Saturday. Finished products include whole birds and
poultry parts. You're at the establishment bright and early this morning, because you are going to
conduct a Pre-Operational SSOP Review and Observation task.

A. Poultry Scenario Part I – Familiarize

•
P-4 Review Directive 5000.4 for information on how to conduct the Pre-Op task.

Questions to consider:
What type of verification activities will you use when conducting a Pre-Op SSOP Review and
Observation task?

How much equipment should you inspect?

What equipment should you inspect?

What will you take with you when you conduct Pre-Op?

•
P-5 Review the establishment’s Sanitation SOP program. Notes:

1111
P-11 Review recent NRs. Do you notice any trends? How will you apply this information to Pre-Op?
Notes:

1111
P-12 Choose which equipment you will bring to conduct Pre-Op. Notes:

-
P-14/15 Make Pre-Op observations. What do you see? What will you do? Notes:

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1111
P-16 Review the establishment’s Pre-Op records. Compare their findings to yours. Notes:

1111
P-21 After your Pre-Op observations, consider how your observations will be documented. Review
Directive 5000.1 on how to associate noncompliance.

Questions to consider:
Why is it important to associate NRs?

What should you include in the narrative of an NR when documenting an association?

1111
P-24 Review an example NR documenting your Pre-Op observations. Notes:

1111
P-26 Review Directive 10250.2 for information on actions you should take when an establishment is
assigned to Category 3 for Salmonella positive results.

Questions to consider:
Where can you go to learn more about conducting poultry follow-up sampling?

When should you schedule and conduct poultry follow-up sampling?

1111
P-32 Which topics will you discuss at the weekly meeting? Notes:

1111
P-33 Review the MOI documented from your weekly meeting. Notes:

1111
P-34 Review Directive 5010.1 for information on other topics you may consider discussing at weekly
meetings.

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B. Poultry Scenario Part II – Complete 2 inspection tasks

1111
P-35 Choose which task to complete first: Poultry Zero Tolerance or Slaughter HACCP.

Note: you can choose any task first. Prior to completing the scenario, you will complete all
three tasks.

Poultry Zero Tolerance task

1111
P-36 Review Directive 6420.5 for information on how to conduct the Poultry Zero Tolerance task.

Questions to consider:
How do you determine how often to conduct a Poultry Zero Tolerance task?

Where do you conduct the Poultry Zero Tolerance task?

How many carcasses will you inspect during the Poultry Zero Tolerance task?

What procedures will you follow to conduct the Poultry Zero Tolerance task?

What contaminants are you looking for during your Poultry Zero Tolerance task? Which
finding will result in noncompliance? What regulations would you cite?

1111
P-42 You perform your Zero Tolerance inspection and identify ingesta on a carcass. What should you
do? Notes:

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Slaughter HACCP Verification task

1111
P-45 Review the Slaughter HACCP plan. Review Directive 5000.1 for information on how to conduct a
HACCP task.

Questions to consider:
What CCPs will you verify regulatory requirements for?

What Prerequisite programs will you verify regulatory requirements for?

What regulations are you verifying when conducting HACCP tasks?

What are examples of compliance with the HACCP regulatory requirements? With CCP
monitoring? Verification? Recordkeeping? Corrective Actions?

1111
P-59 Match the recordkeeping regulation to the HACCP regulatory requirements. Notes:

1111
P-61 Review the establishment’s prerequisite programs. Notes:

1111
P-62 Review the establishment’s prerequisite program records. Notes:

1111
P-66 Review the establishment’s corrective actions record. Notes:

Once you have completed the Poultry Zero Tolerance and Slaughter HACCP tasks, you have
completed the scenario. Add any additional notes or questions below.
Notes:

266
#3 - Ready-to-eat (RTE) Heat-Treated Shelf-Stable Scenario

•
R-3 Background: You are a CSI at Establishment M/P 1234, Riverton Foods. You've just come back
from two weeks of annual leave and you are excited to be back at work! Previously, you and the
establishment agreed upon having your weekly meeting every Monday at 10am. You decide to get
prepared for the weekly meeting. To catch up on what has happened since you are gone, you decide
to see if the Coverage CSI placed any information in the Inspection Notes in PHIS.

A. RTE Scenario Part I – Familiarize

•
R-4 Review the inspector notes. Notes:

•
R-7 Review Directive 5300.1 for information on updating the establishment profile.

Questions to consider:
How do you know what to review for accuracy in the PHIS profile each month?

After you conduct the update establishment profile task, what do you need to provide the
establishment?

1111
R-10 Review the labels for the new jerky products. What do you note about the ingredients? Notes:

1111
R-12 Review the establishment’s HACCP system. Notes:

1111
R-13 Match the HACCP regulations to the corresponding part of the HACCP plan. Notes:

B. RTE Scenario Part II – Complete 3 inspection tasks

1111
R-15 Choose which task to complete first: Heat Treated Shelf Stable HACCP, Operational SSOP
Record Review, or SPS Verification.

Note: you can choose any task first. Prior to completing the scenario, you will complete all
three tasks.

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SPS Verification task

1111
R-51 Review Directive 5000.1 for information on verifying SPS regulatory requirements.

Questions to consider:
What are some examples of SPS noncompliance?

What should you do if you observe SPS noncompliance?

What regulations would you site in SPS noncompliance reports?

What actions should you take after documenting a noncompliance in PHIS?

1111
R-52 Match the SPS regulation with the SPS findings. Notes:

1111
R-53 Conduct SPS observations. What do you observe? What will you do next? Notes:

-
R-18/19 Document a SPS noncompliance report. Compare your NR to the example. Notes:

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Heat Treated Shelf Stable HACCP task

1111
R-23 Review your Inspection Methods student notebook for information on the steps to conduct a
HACCP verification task.

1111
R-24 Match the steps used to conduct a HACCP verification task. Notes:

1111
R-25 Review Directive 5000.1 for information on what activities you could conduct to verify
compliance with HACCP regulatory requirements.

Questions to consider:
What activities could you perform to verify HACCP regulatory requirements (monitoring,
verification, recordkeeping, corrective actions)?

What regulations will you be verifying when conducting the HACCP verification task?

What are examples of noncompliance with HACCP regulatory requirements?

-
R-29/33 Review the establishment’s HACCP records for compliance. Notes:

1111
R-35 Review Directive 5000.1 for information on how to verify regulatory requirements associated with
prerequisite programs.

Questions to consider:
What activities will you use to verify regulatory requirements with Prerequisite programs?

What regulations will you verify?

How can you verify that pre-shipment review is being conducted per regulation? What
regulatory requirement is associated with this activity?

1111
R-36 Review the establishment’s Prerequisite programs. Notes:

1111
R-37 Review the establishment’s Prerequisite program records. What do you determine? Notes:
269
Operational SSOP Record Review task

1111
R-43 Review Directive 5000.1 for information on how to conduct an Operational SSOP Record
Review task.

Questions to consider:
What actions should you take to conduct an Operational SSOP Record Review task?

What are examples of noncompliance with SSOP recordkeeping regulatory requirements?

What regulations are you verifying when conducting an Operational SSOP Record Review
task?

What are establishments required to take when product or food contact surfaces become
adulterated?

1111
R-44 Review the establishment’s Sanitation SOPs. Notes:

1111
R-45 Review the establishment’s Sanitation SOP records. Notes:

Once you have completed the Heat Treated Shelf Stable HACCP, Operational SSOP Record Review
and SPS Verification tasks, you have completed the scenario. Add any additional notes or questions
below.
Notes:

270
RULES OF PRACTICE HAZARD ANALYSIS CRITICAL CONTROL POINT
ROP HACCP
500.1 Definitions 417.1 Definitions
500.2 Regulatory control action 417.2 Hazard Analysis and HACCP Plan
500.3 Withholding/Suspension WITHOUT prior notification (a) Hazard analysis
500.5(a) Notification (1) Determine RLTO hazards, identify preventive
500.4 Withholding/Suspension WITH prior notification measures
500.5(b) Notification (2) Flow chart
500.6 Withdrawal (3) Expected food safety hazards
500.7 Refusal to grant inspection (b) HACCP plan
500.8 Rescinding labels, marks (1) develop and implement for each
process/product, if hazard RLTO
(2) requirements for single HACCP Plan
SANITATION PERFORMANCE STANDARDS (3) requirements for thermally processed
(c) Contents of HACCP Plan
SPS (1) List of food safety hazards
416.1 General rules (2) List of CCP’s
416.2 Establishment grounds and facilities (3) List of critical limits
(a) Grounds and pest control (4) List of procedures & frequency
(b) Construction (5) Corrective actions
(c) Light (6) Record keeping system
(d) Ventilation (7) List of verification procedures/frequency
(e) Plumbing (d) Signing and dating HACCP plan
(f) Sewage disposal (1) Signed and dated by responsible person
(g) Water supply and water, ice, and solution reuse (2) Sign and date frequency
(h) Dressing rooms, lavatories & toilets (e) Failure to Develop and Implement HACCP Plan
416.3 Equipment and utensils 417.3 Corrective Actions
(a) constructed to facilitate cleaning (a) Describe action after deviation
(b) accessibility for inspection (1) Cause is identified & eliminated
(c) receptacles for storing inedible material (2) CCP is under control
416.4 Sanitary operations (3) Prevent recurrence
(a) food contact surface, cleaning & sanitizing (4) No adulterated product shipped
(b) non-food contact surface, cleaning & sanitizing (b) Unforeseen hazard
(c) cleaning compounds and sanitizers (1) Segregate, hold product
(d) product protected (2) Perform review
416.5 Employee Hygiene (3) Actions to ensure product not shipped
(a) Cleanliness (4) Reassessment of HACCP plan
(b) Clothing (c) Document corrective actions
(c) Disease control 417.4 Validation, Verification, Reassessment
416.6 Tagging equipment, rooms or compartments (a) Every establishment shall validate HACCP plan/s
(1) Initial validation
(2) Ongoing verification to include, (i) calibration
SANITATION STANDARD OPERATING PROCEDURES (ii) direct observation (iii) review of records
(3) Reassessment, (i) at least annually or when
SSOP change is made, (ii) record reassessment
416.11 General Information (b) Reassessment of hazard analysis
416.12 Development of SSOP’s 417.5 Records
(a) describe all procedures (a) Establishment shall maintain
(b) signed and dated (1) Written hazard analysis
(c) procedures for pre-op (2) Written HACCP plan
(d) frequency of procedures & responsible (3) Records of CCP’s, temps., corrective actions
individual (b) Made at time event occurs
416.13 Implementation of SSOP’s (c) Pre-shipment review
(a) conduct pre-op (d) Records on computer
(b) conduct all other procedures (e) Record retention
(c) monitors implementation of SSOP procedures (f) Official review
416.14 Maintenance of SSOP’s routinely evaluate 417.6 Inadequate HACCP System
416.15 Corrective Actions (a) Plan doesn’t meet requirements
(a) conduct corrective actions, including (b) HACCP tasks not accomplished
(b) disposition of contaminated product (c) Fails to take corrective actions
restore sanitary conditions (d) No records
prevent recurrence (e) Adulterated product shipped
416.16 Record Requirements 417.7 Training
(a) daily records required, responsible individual, (a) Trained individual develops/reassesses
initialed and dated (b) Course of instruction
(b) records on computers 417.8 Agency Verification
(c) location and retention of records maintained (a) Review HACCP plan/s
416.17 Agency Verification (b) Review CCP records
review SSOP’s, daily records, direct observation of SSOP (c) Review adequacy of corrective actions
procedures & direct observation of testing (d) Review critical limits
(e) Review other records pertaining to HACCP plan/s
(f) Direct observation of CCP
RECALL (g) Sample collection
(h) On-site observation & records review
418.2 Notification
418.3 Preparation and maintenance of written procedures
418.4 Records

10-8-15
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Additional Resources

askFSIS ([Link] – askFSIS answers questions about meat, poultry,

and egg products inspection, FSIS policies and related topics from inspection personnel, industry and other
stakeholders. Inspection program personnel and other users can find detailed instructions on how to use
askFSIS in FSIS Directive 5620.1 Rev. 2 Using askFSIS.

askUSDA ([Link] – Find askFSIS public Q&As by including “askFSIS” in your search terms.
You can also find answers to questions about safe food handling at home or food safety in general and a
range of other topics for all USDA regulated products.

IPP Help ([Link] – Find lots of useful information on a variety of topics

including PHIS Help, sampling, training, and a media library.

Acronym Listing

AA Assistant Administrator
ACS Acidified Calcium Sulfate
ADR Animal Disposition Reporting
AER Administrative Enforcement Report
AM Antemortem Inspection
AMA Antimicrobial Agent
AMAP Antimicrobial Agents and Processes
AMP Antimicrobial Process
AMS Agricultural Marketing Service
AOAC Association of Official Analytical Chemists (now called AOAC International)
APC Aerobic Plant Count
APHIS Animal and Plant Health Inspection Service
AMR Advanced Meat Recovery
ASC Acidified Sodium Chlorite
ATP Adenosine Triphosphate
aw Water Activity
BITES Biological Information Transfer Email System
BSE Bovine Spongiform Encephalopathy
CA Corrective Actions
CCMS Consumer Complaint Monitoring System
CCP Critical Control Point
CDC Centers for Disease Control and Prevention
CFL Center for Learning
CFR Code of Federal Regulations
CFU Colony Forming Units
CIP Clean in Place
CL Critical Limit
COA Certificate of Analysis
CPS Coagulase Positive Staph
CSI Consumer Safety Inspector
CSO Consumer Safety Officer

272
DM District Manager
DDM Deputy District Manager
DCS District Case Specialist
DJE Dual Jurisdiction Establishment
DO District Office
DRO District Recall Officer
DVMS District Veterinary Medical Specialist
EARO Executive Associate for Regulatory Operations
EIAO Enforcement Investigations and Analysis Officer
EMC Emergency Management Committee
EPA Environmental Protection Agency
EPIA Egg Products Inspection Act
FCS Food Contact Surface
FDA Food and Drug Administration
FDIB Foodborne Disease Investigation Branch
FFDCA Federal Food, Drug, and Cosmetic Act
FI Food Inspector
FIFRA Federal Insecticide Fungicide and Rodenticide Act
FLS Frontline Supervisor
FMIA Federal Meat Inspection Act
FNS Food and Nutrition Service
FO Field Operations
FOIA Freedom of Information Act
FPS Finished Product Standard
FR Federal Register
FSA Food Safety Assessment
FSIS Food Safety and Inspection Service
GAD Gather Assess Determine
GMP Good Manufacturing Practice
GRAS Generally Recognized as Safe
HA Hazard Analysis
HACCP Hazard Analysis and Critical Control Point
HATS Humane Activities Tracking System
HAV Hazard Analysis Verification
HCG Hazards Control Guide
HEP High Event Period (with regard to STECs)
HH Humane Handling
HIMP HACCP-based Inspection Models Project
HMSA Humane Methods of Slaughter Act
HPP High Pressure Processing
HRI Hotels, Restaurants, and Institutions
HUS Hemolytic Uremic Syndrome
ICMSF International Commission on the Microbiological Specification for Foods
IIC Inspector in Charge
IKE Interactive Knowledge Exchange
IPP Inspection Program Personnel
IVT Intensified Verification Testing
KIS Kidney Inhibition Swab
LIMS Laboratory InformationManagement System Direct

273
Lm Listeria monocytogenes
LOG Letter of Guarantee
LOI Letter of Information
LOW Letter of Warning
LPDS Labeling and Program Delivery Staff
LTD Less Than Daily
MOI Memorandum of Interview
MOU Memorandum of Understanding
MPCM Microbial Pathogen Computer Modeling
MPN Most Probable Number
MPR Moisture Protein Ratio
NACMCF National Advisory Committee on the Microbiological Criteria for Foods
NACMPI National Advisory Committee on Meat and Poultry Inspection
NFCS Non Food Contact Surface
NFSCP Non-Food Safety Consumer Protection
NIST National Institute of Standards and Technology
NOIE Notice of Intended Enforcement
NOL No Objection Letter
NOS Notice of Suspension
NPDW National Primary Drinking Water
NR Noncompliance Record
NRLTO Not Reasonably Likely to Occur
NRTE Not Ready to Eat
OCP Other Consumer Protection
OFO Office of Field Operations
OIG Office of Inspector General
OM Office of Management
OEED Office of Employee Experience and Development
OPACE Office of Public Affairs and Consumer Education
OPARM Office of Planning, Analysis, and Risk Management
OIEA Office of Investigation, Enforcement, and Audit
OPHS Office of Public Health Science
OPPD Office of Policy and Program Development
OSHA Occupational Safety and Health Administration/Act
PDS Policy Development Staff
PFGE Pulsed Field Gel Electrophoresis
PHV Public Health Veterinarian
PHIS Public Health Information System
PLE Post Lethality Exposed
PLT Post Lethality Treatment
PM Postmortem Inspection
PMP Pathogen Modeling Program
PMP Pest Management Program
PPIA Poultry Products Inspection Act
PPM Parts Per Million
PR Pathogen Reduction
PRP Pre-Requisite Program
QA Quality Assurance
QC Quality Control
QRG Quick Reference Guide

274
RCA Regulatory Control Action
RD Regional Director (OIEA)
REC Recall Effectiveness Check
RMIS Risk Management and Innovation Staff
RLm Risk Based Listeria monocytogenes Testing
RLTO Reasonably Likely to Occur
RMA Resource Management Analyst
RMS Resource Management Specialist
RMTAD Recall Management and Technical Analysis Division
ROP Rules of Practice
RTE Ready to Eat
RTE/SS Ready to Eat/Shelf Stable
SCSI Supervisory Consumer Safety Inspector
SEIAO Supervisory Enforcement Investigations and Analysis Officer
SIP Salmonella Initiative Program
SOP Standard Operating Procedures
SPC Statistical Process Control or Standard Plate Count
SPHV Supervisory Public Health Veterinarian
SPS Sanitation Performance Standards
SRM Specified Risk Materials
SSOP Sanitation Standard Operating Procedures
STEC Shiga toxin-producing E. coli
STEPS System Tracking E. coli Positive Suppliers
SVMO Supervisory Veterinary Medical Officer
TA Talmadge-Aiken Act
TCOE Training as a Condition of Employment
TDT Thermal Death Time
TPC Total Plate Count
TSP Trisodium Phosphate
TT Time Temperature
USC United States Code
USDA United States Department of Agriculture
vCJD Variant Creutzfeldt-Jakob disease
VMO Veterinary Medical Officer
VP Verification Plan

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