001

PHV Intern

Final Week

Participant Notebook

September 2022

Office of Employee Experience and Development

Center for Learning
002

USDA

:.ii

United States Department of Agriculture

Food Safety and

Inspection Service

1400 Independence

Avenue, SW.

Washington, D.C.

20250

TO: Field Operations Attending Training

FROM: Soumaya Tohamy, Ph.D c:-::::e,· --:Z:

Assistant Administrator.................................................................................. ..··

Office of Employee Experience and Development

SUBJECT: Food Safety and Inspection Service (FSIS) Training Classes

Congratulations on being selected to attend FSIS training. This is an opportunity

to gain significant knowledge about the skills and abilities needed to perform

your job duties.

Please use these opportunities to learn as much as you can from the training and

to actively participate by asking questions and engaging in class activities.

You represent FSIS and your conduct must reflect a high degree of

professionalism. Improper conduct and unprofessional behavior will not be

tolerated. Individuals exhibiting unprofessional behavior may be removed from

class and returned to their duty station.

Although FSIS does not have a formal dress code, the goal is to project a positive

professional image at all times. Shorts, flip flops, short skirts, crop tops, tank

tops, clothing with a message that may be offensive to others, are not neat, clean,

and free from holes or tears, are examples of inappropriate clothing in an FSIS

worksite.

Finally, your feedback is very important. Please take the time to complete the

evaluation forms and let us know what worked well and what could be improved.

Thank you for maintaining a positive and professional learning environment.

An Equal Opportunity Provider and Employer
003

PHV FInal Week Notebook

Topic

- Table of Contents

Pages

FSIS Statutes Your Role 4-34

Recalls (Office) 35-58

Recalls - Old Notes 59-72

AER 73-111

Food Micro Part 1 (Slaughter) 112-118

Food Micro Part 2 (Processing) 119-176

Overview of Food Micro - Old Notes 177-213

SBREFA (Office) 214-220

Wellness (Office) 221-238

Wellness - Old Notes 239-252

IPPS STAR Part 1 (Office) 253-261

IPPS/STAR Part 2 (Office) 262-269

IPPS/STAR Part 3 (Office) 270-277

IPPS/STAR Part 4 (Office) 278-288

IPPS/STAR - Old Notes 289-349

NFSCP Part 1 (Slaughter) 350-368

NFSCP Part 2 (Processing) 369-393

NFSCP - Old Notes 394-442

HACCP (Slaughter) 443-469

5000.1 Walk-Through - Old Notes 470-531

Export Certification (Office) 532-548

Export Certification - Old Notes 549-564

Day in the Life: Poultry 565-601

Day in the Life: Beef 602-617

Food Defense - Old Notes 618-659

Food Safety Eduction - Old Notes 660-665
004

FSIS STATUTES AND YOUR ROLE

OBJECTIVES

Once you complete this module, you should be able to:

Understand the purpose of the Acts.

Identify key definitions from the Acts.

Understand the statutory authority for FSIS activities.

Understand how those activities plus authorities in the statutes support enforcement

actions.

REFERENCES

Federal Meat Inspection Act

Poultry Products Inspection Act

INTRODUCTION

The “Regulatory Framework” module provided an overview of the regulatory framework

under which we operate in FSIS. This module will provide more detail about that

regulatory framework and the statutory authority for day to day inspection, and

verification activities.

As we go through this module, keep in mind the inspection and verification activities you

performed or supervised while in the establishment working along side your mentor.

Feel free to ask questions as we go. It’s important for us to discuss some practical

examples of how the statutory authorities apply to your work.

Overview of the Statutes

The statutes related to FSIS activities include the:

Federal Meat Inspection Act (FMIA),

Poultry Products Inspection Act (PPIA), and

Egg Products Inspection Act (EPIA).

The FMIA was enacted first, in 1906 after the public outrage stirred up by the writings of

Upton Sinclair’s book, “The Jungle.” How many of you are familiar with this book? It

contained graphic and detailed descriptions of the insanitary and abhorrent conditions

that existed in meat establishments at the turn of the century in the city of Chicago,

which was the heart of the meat processing industry at the time. Excerpts from the book

were published in newspapers. With this information as a background, Congress

enacted the FMIA. The PPIA was modeled after the FMIA. When you read it, you will

see a number of similarities between the two statutes. The PPIA, enacted in 1957, was

based on the growing poultry industry. Initially, there were two separate Agencies – one

responsible for enforcing the provisions of the FMIA and one responsible for enforcing
005

the provisions of the PPIA. This explains why, in some cases, establishments that

process both meat and poultry products have two establishment numbers. We will not

be covering the EPIA in our review.

BASIS FOR FSIS AS A PUBLIC HEALTH REGULATORY AGENCY

These Acts provide for the basis for FSIS’s ability to perform as a public health agency.

In Section 602 of the FMIA, Congressional statement of findings, states the following:

FMIA Sec. 602. “Meat and meat food products are an important source of the Nation’s

total supply of food. It is essential in the public interest that the health and welfare of

consumers be protected by assuring that meat and meat food products distributed are

wholesome, not adulterated and properly marked, labeled, and packaged. It is hereby in

found that all articles and animals which are regulated under this chapter are either in

interstate or foreign commerce or substantially affect such commerce, and that

regulation by the Secretary and cooperation by the States and other jurisdictions as

contemplated by this chapter are appropriate to prevent and eliminate burdens upon

such commerce, to effectively regulate such commerce, and to protect the health and

welfare of consumers.”

These three things - verifying that meat or poultry products are:

• wholesome,

• not adulterated,

• properly marked/labeled, and packaged

are the essentials of the job you have in protecting public health. All of your inspection

and verification activities focus around one or more of the things covered in the Acts.

The Congressional statement of findings in the Poultry Products Act (Section 451) is

almost identical to that of the FMIA. Again, it emphasizes public health, and it

emphasizes the four essentials – wholesome, not adulterated, properly marked/labeled,

and packaged. We’ll be going into each of these in more detail as we continue.

PPIA Sec. 451. “It is essential in the public interest that the health and welfare of

consumers be protected by assuring that poultry products distributed to them are

wholesome, not adulterated and properly marked, labeled, and packaged.”

Another foundation principle is outlined in Section 452 of the PPIA, which indicates that

inspection is authorized to prevent products from entering commerce that

are adulterated or misbranded.

PPIA Sec. 452. It is hereby declared to be the policy of Congress to provide for the

inspection of poultry products and otherwise regulate their processing and

distribution...to prevent the movement or sale in interstate or foreign commerce of, or

the burden upon commerce by, poultry products which are adulterated or misbranded.

Remember, all the things you do or you supervise as part of your job can be traced back

to the statutes to make sure that any meat, poultry, or egg product that is adulterated or
006

misbranded does not enter commerce to protect the public health. You will do that

through the enforcement authorities that we will discuss later.

DEFINITION OF “ADULTERATED”

One of the key provisions in the statutes is the provision related to the term “adulterated”

product. What does the term “adulterated” mean, and how does it apply to the work that

you do? The term “adulterated” is defined in the FMIA under Section 601, which

contains all of the definitions for the statute. The definition is found in Section 601(m).

This definition actually has 9 parts. We’re going to focus on the first few parts of the

definition because they have the greatest bearing on your daily work.

First, the term “adulteration” applies to any of the following:

carcass,

part thereof,

meat or meat food product

under one or more of the circumstances described in Section 601(m) of the FMIA.

Now, let’s look at some key parts of that definition.

FMIA Sec. 601(m)(1): “If it bears or contains any poisonous or deleterious substance

which may render it injurious to health; but in case the substance is not an added

substance, such article shall not be considered adulterated under this clause if the

quantity of such substance does not ordinarily render it injurious to health;”

The definition of adulterated product in 601 m(1) focuses on added substances. Two

examples of added substances that have been declared to be adulterants in meat

products include Listeria monocytogenes (Lm) and E. coli O157:H7. Lm is an example

of an adulterant in ready-to-eat (RTE) products. It represents an added substance that

renders the product injurious to health. Scientific studies have shown that this pathogen

is present in the product due to the way in which product is handled or produced. For

example, Lm is typically present in RTE products because of recontamination that

occurs during the processing of product, such as through contact with the environment

or with establishment employees, after an initial lethality treatment has been delivered.

This pathogen is considered injurious to health because RTE products are not reheated

by consumers before they are eaten. Therefore, if this substance is present, products

are very likely to cause injury to human health and can even cause death. The only

adulterant in non-intact raw meat or meat products is E. coli O157:H7.

Based on what we know from scientific studies, E. coli O157:H7 is considered to be an

added substance because it is introduced into the product during processing. For

example, it’s spread from the hide or digestive tract of the animals during slaughter or

processing. It’s injurious to health because one of the normal ways of cooking this

product includes “rare” which is not sufficient to destroy the pathogen. Again, the

presence of this pathogen in the product under these conditions is likely to cause injury –

and can even result in death.
007

FMIA Sec. 601(m)(2)(A): “If it bears or contains (by reason of administration of any

substance to the live animal or otherwise) any added poisonous or added deleterious

substance other than one which is (i) a pesticide chemical in or on a raw agricultural

commodity (ii) a food additive, or (iii) color additive which may, in the judgment of the

Secretary, make such article unfit for human food;”

The second definition of the term “adulterated” in Section 601(m)(2)(A) of the FMIA

relates to the residues of drugs in live animals that have been declared to be harmful to

human health. It’s a little bit tricky when you read this, because the things listed in (i),

(ii), and (iii) are NOT covered in this definition. Remember that the residue testing done

by FSIS is based on the statutory authorities of the Food and Drug Administration (FDA).

In its pre-market approval programs, FDA considers what, if any, residues of animal

drugs should be viewed as safe. FSIS is responsible for enforcing the levels that are

established by FDA. In your duties, you will conduct tests for animal drug residues; such

as antibiotics, hormones, or sulfonamides. Because animal drug residues are not

pesticides, food additives, or color additives, the Agency is left to prove that the animal

drug residue makes the meat product unfit for food. The regulations that cover animal

drug residues are found in 21 CFR 556, which are the FDA regulations.

FMIA Sec. 601(m)(2)(B): “If it is, in whole or in part, a raw agricultural commodity and

such commodity bears or contains a pesticide chemical which is unsafe within the

meaning of section 346a of this title;”

The definition of the term “adulteration” found in Section 601(m)(2)(B) of the FMIA

covers pesticide chemicals. The Environmental Protection Agency (EPA) has the

statutory authority to, in its pre-market approval programs, consider what, if any, levels

of pesticide residues, if found on food, can be viewed as safe. FSIS is responsible for

enforcing the tolerances that are established by EPA. The regulations related to

pesticide chemicals are found in 40 CFR 180. An example of a pesticide chemical for

which a tolerance has been established is Diazinon; which is used in fields to eliminate

fire ants, or the herbicide 2,4-D used in fields to eliminate undesirable grasses or weeds.

These pesticides are not normally found in food animals. However, food animals may

become exposed to them inadvertently; for example, through incidental contact such as

drift in wind at the time when the pesticides are administered in a field, or through

accidental ingestion. In your duties, you will sample products for pesticide residues and

send the samples to the appropriate laboratory. In this case, if the residue level for the

pesticide chemical is found to have exceeded the tolerance level set by EPA, the

product (which may be a carcass or part) is considered to be adulterated based on this

statutory definition.

FMIA Sec. 601(m)(2)(C): “If it bears or contains any food additive which is unsafe within

the meaning of section 348 of this title;”

Section 601(m)(2)(C) defines meat or meat products bearing any unsafe food additives

to be adulterated. The FDA reviews all food additives for safety before use in food

production. FDA establishes their conditions for use. An example of such a food

additive approved under specified conditions is carcass washes used on the slaughter

line. There are two types of food additives. One is direct and the other is indirect.

Direct food additives are directly applied to the food, such as preservatives for meat

products. Indirect food additives are those that are not used for food purposes, but

come into contact with food; such as, sanitizers that are used on equipment or on food
008

contact surfaces. All food additives used in federal establishments must be approved by

FDA. FSIS Directive 7140 lists all food additives that have been approved for use. So,

again, FSIS enforces the policy that is set by FDA. The following definition in section

601(m)(2)(D), color additives, is not important in relation to your duties.

FMIA Sec. 601(m)(3): “If it consists in whole or in part of any filthy, putrid, or

decomposed substances or is for any other reason unsound, unhealthful, unwholesome,

or otherwise unfit for human food.”

This next section, 601(m)(3), of the definition of adulteration emphasizes health. This is

the definition that FSIS has used as the statutory basis for taking all actions against

BSE. The reason this definition was used is that scientific studies have shown that

infectivity of the disease exists within the animals before they show clinical signs of the

disease. Legally, the burden is on FSIS to prove that these conditions – filthy, putrid,

and decomposed – exist. This is why being graphic and accurate in descriptions of

conditions is very important on the NRs. Some examples of filthy conditions include rail

dust, rust, or rodent droppings on product.

Be aware that the adulteration provisions of the statutes are not mutually exclusive. For

example, a product may be adulterated under 601(m)(3) AND 601(m)(1) because it is

positive for E. coli O157:H7.

FMIA Sec. 601(m)(4): “If it has been prepared, packed, or held under insanitary

conditions whereby it may have become contaminated with filth, or whereby it may have

been rendered injurious to health;”

Section 601(m)(4) covers the definition of “adulterated” related to insanitary conditions.

The SPS and Sanitation SOP regulations (9CFR 416) as well as the HACCP rule

(regulation 417) are about ensuring that products are not adulterated through insanitary

conditions. It’s about ensuring that sanitary conditions are maintained throughout the

production process. If we apply this to the slaughter process, establishments must

ensure that their processes (such as de-hiding, and opening the digestive tract of

livestock) do not create insanitary conditions that may contaminate the carcasses with

filth. You will also be responsible for verifying that there are no insanitary conditions in

the establishment.

The inspection duties that you and other inspection program personnel perform after

slaughter, that can be trace back to this part of the FMIA are those covered by HACCP,

Sanitation SOPs and the Sanitation Performance Standards. This is obviously the focal

point of what you do. We’ll come back to the HACCP regulation when we cover section

608 of the FMIA. Your inspection duties related to ensuring that the establishments

maintain sanitary conditions are outlined thoroughly in FSIS Directive 5000.1, “Verifying

an Establishment’s Food Safety Systems.” The remainder of Section 601 of the FMIA

covers additional definitions of the term “adulterated.” You can review these, including

the ones dealing with the term “misbranded” on your own time.

There are parallel definitions of the term “adulterated” in the PPIA.

PPIA Sec. 453(g)(1): “If it bears or contains any poisonous or deleterious substance

which may render it injurious to health;”
009

Like the FMIA, Section 453(g)(1) covers added substances that are poisonous or

deleterious which may render a product injurious to health.

Section 453(g) (2)(A)(B) covers adulteration caused by a pesticide chemical or article,

which make the poultry products unfit for human food. Just like the corresponding

section of the FMIA, this represents the statutory authority for the residue testing tasks

that you perform. Although the substances and tolerance levels vary from those in meat

products; again, you must be aware that EPA is responsible for setting the tolerances for

these substances and FSIS is responsible for enforcing that policy through the residue

testing program.

PPIA Sec. 453(g)(2)(C): “If it bears or contains any food additive which is unsafe within

the meaning of section 348 of this title;”

Section 453(g)(2)(C) of the PPIA covers adulteration caused by a food additive. Again,

remember that you will be responsible for ensuring that any food additives used by the

establishment in the processing of poultry products have been approved by FDA.

PPIA Sec. 453(g)(3): “If it consists in whole or in part of any filthy, putrid, or decomposed

substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise

unfit for human food;”

Parallel to section 601(m)(3) of the FMIA, there is a section in the PPIA that emphasizes

the importance of ensuring that poultry products do not injure human health in any way

because they, “consist in whole or in part of any filthy, putrid, or decomposed substance

or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for

human food. “

PPIA Sec. 453(g)(4): “If it has been prepared, packed, or held under insanitary

conditions whereby it may have become contaminated with filth, or whereby it may have

been rendered injurious to health;”

And finally, there is a parallel definition of “adulterated” in the PPIA that covers insanitary

conditions.

We’ve highlighted the parts of the definition of adulteration in the Acts that are most

relevant to your work. Now, let’s briefly review the other parts of the definition. They

include the following.

FMIA Sec. 601(m):

- (5) product of an animal which has died otherwise than by slaughter;

- (6) product in a container that is composed of poisonous or deleterious substance;

- (7) product that has been intentionally subjected to radiation that does not conform to

regulatory requirements;

- (8) product from which a valuable constituent has been omitted or abstracted, or a

substance has been substituted;

- (9) margarine containing animal fat that is filthy, putrid, or decomposed.

This overview provides a very thorough basis for understanding what the statutory

definition of “adulterated” is, and what it means in relation to FSIS inspection and

verification activities. It is significant in relation to ensuring public health and food safety.
010

STATUTORY PROVISIONS FOR INSPECTION ACTIVITIES

Let’s turn our attention to some our inspection activities.

Ante-mortem Inspection

Sections 603(a) of the FMIA, and 455(a) of the PPIA are the statutory authorities for the

inspection activities you and other inspection personnel conduct during ante mortem

inspection.

FMIA Sec. 603(A): “That hereafter, for the purpose of preventing the use in commerce,

as hereinafter provide, of meat and meat food products which are adulterated, the

Secretary shall cause to be made, by inspectors appointed for that purpose, an

examination and inspection of all cattle, sheep, swine, goats, horses, mules, and other

equines before they shall be allowed to enter into any slaughtering, packing, meat

canning, ..............”

These are the provisions upon which the regulations for ante mortem inspection were

promulgated. For example, the regulation that corresponds with the statute 603(a)

regarding ante mortem inspection in livestock is 9 CFR 309. This regulation contains

more specific information that you should use in judging whether an official

establishment that slaughters livestock is meeting the standard established by 603(a).

For example, the inspection tasks include inspecting the livestock at rest; and then, in

motion to detect abnormal conditions or symptoms of diseases that are identified in the

regulations. If any of these animals are suspected of having abnormal conditions or

diseases, they must be identified for further examination, and if necessary, identified for

final disposition in post mortem inspection. Any animals found with symptoms of

diseases must be disposed of properly. Remember, the authority for these actions as a

result of ante mortem inspection comes from the section 603(a). Also remember that the

purpose for conducting ante mortem inspection activities is to prevent animals that if

slaughtered would result in adulterated product or would introduce insanitary conditions

in the establishment from entering the establishment, and to ensure that if they do enter

the establishment, they do not adulterate products.

Post-mortem Inspection

FMIA Sec. 604: “...the Secretary shall cause to be made by inspectors appointed for

that purpose a post mortem examination and inspection of the carcasses and parts

thereof of all (livestock)....to be prepared at any slaughtering...or similar

establishment...which are capable of use as human food; and the carcasses and parts

thereof all such animals found to be not adulterated shall be marked, stamped, tagged,

or labeled as “Inspected and passed;” and...label, mark, stamp, or tag as “Inspected and

condemned” all carcasses and parts...found to be adulterated;”

The statutory authorities for post mortem inspection are found in section 604 of the

FMIA, and in section 455 (b) and (c) of the PPIA. These provisions cover two important

concepts. One is the jurisdiction for inspection. The other is the requirement for

inspection. For jurisdiction, post mortem inspection must be performed on all of the

carcasses and parts prepared at an official establishment. The wording used in the

poultry statutes is slightly different. Instead of “prepared” it uses the word “processed.”
011

Regarding inspection tasks, this provision establishes the basis for the inspection tasks

performed. As you recall from your training, post mortem inspection involves performing

specific tasks that include observation and palpation or incision of lymph nodes in the

head and viscera, and observation of the carcass. The purpose of inspection is to detect

any carcasses or parts that exhibit signs of disease or conditions that otherwise make

the carcass or parts unwholesome or unfit for human food. These tasks must be

performed using methods that are safe and sanitary. The legal authority for these tasks

can be traced directly back to this statutory provision.

This statute has been held in the court system to require that FSIS make a determination

about each carcass during inspection. You may hear this called a “carcass by carcass”

inspection legal requirement.

Post mortem inspection must be performed on all of the carcasses and parts prepared at

an official establishment. The definition for the term “prepared” is found in Section 601(l)

of the FMIA. It includes, “slaughtered, canned, salted, rendered, boned, cut up, or

otherwise manufactured or processes.” You should be aware that the only products

FSIS inspects are those that are defined as “prepared” in the FMIA or “processed” in the

PPIA. In other words, FSIS does not have jurisdiction to inspect warehouses or

distribution centers, although FSIS has the authority to visit these facilities. The

inspection of other types of products is covered by other federal agencies, such as FDA.

You should also be aware that FSIS has statutory authorities to conduct activities other

than inspection. For example, if we look at Section 624 of the FMIA, which is the same

as section 453 of the PPIA, you’ll see the authority to prescribe by regulations the

conditions under which carcasses, parts, and meat products are stored or handled

during buying, selling, freezing, storing, or transportation. While FSIS can conduct

examinations at the out of establishment locations where these processes are

performed, these examinations are not “inspection.”

The statutes continue by indicating that for those carcasses and parts that are found not

to be adulterated, inspectors are to mark them as “inspected and passed.” Inspectors

are to mark those carcasses and parts that are found to be adulterated as “inspected

and condemned.” This is the statutory basis for your inspection duties. So, you apply

the standards established by the definitions of adulteration; which, we have already

discussed in making this judgment.

Exemptions from Inspection Requirements

The statutes also outline some exemptions to the inspection requirements. These are

found in the FMIA in Section 623 and 624, and in Section 454 and 464 of the PPIA. For

example, personal slaughtering and custom slaughter for personal, household, guest, or

employee uses are exempt from inspection. However, the exempt products are still

subject to the adulteration and misbranding provisions of the statutes (FMIA 623(d)).

In these exempt facilities, the establishment performs activities that constitute

preparation of meat products, or processing of poultry products, but they have been

exempted from inspection by Congress.
012

Marks of Inspection

FMIA Sec. 606: “...said inspectors shall mark, stamp, tag, or label as “Inspected and

passed” all such product found to be NOT adulterated; and said inspectors shall label,

mark, stamp, or tag as “Inspected and condemned” all such products found

adulterated....”

Several times we have referred to labeling, marking, stamping, or tagging product as

“Inspected and passed.” We call these labels, marks, stamps, and tags the marks of

inspection. The purpose of post mortem inspection is to determine whether the products

are wholesome, not adulterated, and properly marked, labeled, and packaged, as

required by the statutes. This ensures that the public health is protected. Remember in

section 604 of the FMIA and in section 455 (b) and (c) of the PPIA, the statutes state

that the carcasses and parts that are found NOT to be adulterated are to be marked as

“inspected and passed.” This same concept is covered again in more detail in Section

606 of the FMIA. These marks of inspection, stating “Inspected and passed”, show that

all meat products are cleared to enter commerce after they are found to be fit for human

consumption. This is very important. Remember that product cannot move out of the

establishment into commerce until it has been inspected and marked as passed. This

means that you must be able to find that product is NOT adulterated. The burden of

proof is on the establishment. If you have questions about whether or not to pass the

product, don’t pass it and don’t stamp it as “Inspected and passed” unless; and until, you

get satisfactory answers to your questions by the establishment. If you cannot find that

the product is not adulterated, you must follow the Rules of Practice. So, Section 606

defines our product control authority.

To summarize, those carcasses and parts that are found to be adulterated are to be

marked “inspected and condemned.” They must be either reprocessed or destroyed,

and cannot leave the establishment to enter commerce to be used for human food.

They must be destroyed in the presence of a USDA inspector. The statute also

specifies that if the establishment fails to destroy a condemned carcass or part, the

Secretary may remove the inspectors from the establishment. We call this removal of

inspection “suspension” of inspection. We’ll discuss this further in a few minutes when

we talk about enforcement authorities.

Reinspection

Reinspection is covered in 605 of the FMIA and 455(b) in the PPIA. Reinspection

covers the situation when products are shipped from one establishment to another. For

example, this could be carcasses coming from one establishment to be fabricated into

special cuts at another establishment. It could be ground beef and trimmings coming

from one establishment to another to be ground more finely, or to be used as a meat

ingredient in a fully cooked product. When you work in an establishment that receives

meat or poultry products from another establishment, part of your responsibility will be to

ensure that those products entering the establishment are reinspected using the same

standards that you use in the initial inspection – that products are wholesome, not

adulterated, and properly marked, labeled, and packaged. Another condition requiring

reinspection is when products are returned to the establishment for any reason. Again,

your role is to ensure that these products are reinspected using the standards in the

statutes, regulations, and Directives.
013

Under both of these conditions you should ask a lot of questions to ensure that the

product is wholesome, not adulterated, and properly marked, labeled, and packaged.

For example, if the product has been transported to the establishment, was it held under

conditions in a manner that would ensure that it did not become filthy, putrid, or

decomposed, or for any other reason unsound, unhealthful, unwholesome, or otherwise

unfit for human food? Here are some examples of questions you might ask to make this

determination. Was the temperature of the product controlled throughout transportation?

Are there measures to prevent cross contamination of the product with the environment?

These questions should be part of the decision making process you use in determining if

product is wholesome and not adulterated.

Sanitation

Another statutory provision that is very important to your daily activities is the one

dealing with the requirement for the establishment to maintain sanitary conditions –

Section 608 of the FMIA and 456(a) of the PPIA. To paraphrase the FMIA, the statute

indicates that if the sanitary conditions are found by inspectors to be such that the meat

or meat food products are rendered adulterated, inspectors shall refuse to allow the

meat or meat food products to be labeled, marked, stamped, or tagged as “Inspected

and passed.” These statutes give FSIS the ability to ensure that product is handled and

held in a sanitary manner. This is one of the provisions upon which the HACCP

regulations (417), the Sanitation Performance Standard Regulation and the Sanitation

Standard Operating Procedures Regulation (both covered in 416) are based.

FMIA Sec. 608: “The Secretary shall prescribe the rules and regulations of sanitation

under which establishments shall be maintained. The Secretary shall cause to be made

by experts in sanitation or by other competent inspectors the inspection of all

establishments where meat or meat products are prepared as may be necessary to

inform concerning the sanitary conditions of these establishments.”

Let’s look at the provision that sets forth the requirements for sanitation in meat

establishments a little closer. First, it authorizes the Secretary of Agriculture to

promulgate regulations that describe what establishments must do to maintain sanitary

conditions. It also authorizes inspections to ensure that establishments are in

compliance.

First, let’s look at the meaning of three key words. They are:

1. Sanitation

2. Sanitary

3. Adulteration

We’ve talked about the definition of the term “adulterated.” Remember that it has

several definitions in the statute. But, the word “sanitation” is not defined in either the

FMIA or the PPIA. Because the term is not defined in the statute, we have to look to its

common meaning. A common definition of the term “sanitation” is, “keeping things

clean.” This definition is supported by FSIS regulations, which distinguish between

sanitation and HACCP. When a term, such as “sanitation” is not defined in the statutes,

the courts are required to turn to the common meaning for evidence. This is typically

done by consulting the dictionary.
014

The dictionary definition of the term “sanitation” shows that it means something broader

than just keeping things clean. According to Webster’s Collegiate Dictionary, the word

“sanitation” means, “the development and application of sanitary measures for the sake

of cleanliness, protecting health, etc.” So, the dictionary drives us back to one of the two

key terms that are common to the PPIA and the FMIA, which is the term “sanitary.” The

statutes talk about “sanitary practices”, and “sanitary measures?” What doesn’t this term

“sanitary” mean? According to the dictionary, the term “sanitary” means, “of or

pertaining to health or the conditions affecting health, especially with reference to

cleanliness, precautions against disease, etc.”

So, are the HACCP regulations and the sanitation regulations sanitary measures?

Clearly they are, and we can demonstrate that fact to a court. To ensure that products

are handled and held in a sanitary manner, establishments must follow the HACCP

regulations. For example, the establishment must develop and implement a HACCP

plan covering each product produced when the establishment’s hazard analysis reveals

one or more food safety hazards are reasonably likely to occur in the production

process. This includes biological, chemical, and physical hazards.

The regulation outlines that establishments must follow the seven HACCP principles

(417.2); which include conducting a hazard analysis, determining critical control points,

establishing critical limits, establishing monitoring procedures, developing corrective

action procedures, establishing recordkeeping and documentation procedures, and

developing verification procedures. The regulation also specifies the conditions under

which the establishment must reassess its HACCP plan. FSIS verification duties related

to these regulations are described specifically in FSIS Directive 5000.1, “Verifying an

Establishment’s Food Safety System.” It describes the inspection methods, regulatory

decision making process, documentation, and enforcement tasks to use in relation to

ensuring that the establishment complies with the regulations and statutes regarding

sanitation. For example, the Hazard Analysis Verification (HAV) and HACCP

Verification tasks are performed to verify that the establishment is meeting the

requirements of 9 CFR 417.

The HACCP regulations require establishments to identify the hazards to health that

may arise as a result of their operation and to address those that are reasonably likely to

occur. If those hazards are not properly addressed and prevented, the result is

adulterated product. As you will remember, the term “adulterated” is defined in the

statutes. In enforcing the HACCP rules, what the Agency needs to show is why, in not

complying with the regulations, the establishment is not complying with the statutory

provisions that underlie the regulation. Section 608 gives the Agency authority for

enforcing HACCP. So, if the Agency is to enforce the HACCP and sanitation rules (SPS

and Sanitation SOP), we will need to show how an establishment’s failure to follow the

sanitary measures required by HACCP or sanitation rules creates insanitary conditions

in its operation that resulted in the production of product that may be injurious to health.

It is important to note that under case law, the deleterious change in the product, that is,

the change that may have the effect of making consumption of the product injurious to

health, must occur while the product is being prepared, packed, or held; and, have

occurred because of the insanitary conditions. How can we show that this is the case?

We can show that having a sanitation standard operation procedure that is effective in

preventing direct contamination of product with environment contaminants is a

necessary precaution against producing product that may be injurious to health.
015

Moreover, a failure to implement an effective Sanitation SOP or to ensure the on going

effectiveness of the Sanitation SOP would create conditions under which such

contamination may occur; and thus, product is rendered injurious to health. Similarly, a

failure by an establishment to perform an adequate hazard analysis would create

insanitary conditions because, without such an analysis, the establishments cannot be

sure that it has identified and addressed conditions that could cause the product to be

injurious to health.

A parallel section is found in Section 456 of the PPIA.

PPIA Sec. 456: “Operation of premises, facilities, and equipment (a) Sanitary practices:

Each official establishment slaughtering poultry...shall have such premises, facilities,

and equipment, and be operated in accordance with such sanitary practices, as are

required by regulations promulgated by the Secretary for the purpose of preventing the

entry into or flow or movement in commerce or burdensome effect upon commerce, of

poultry products which are adulterated.”

This section clearly gives FSIS the authority to adopt regulations to ensure that there are

sanitary conditions in establishments where poultry products are prepared and packed

so that the resulting product is not injurious to health.

Progression of Statutes

The statutes follow the processes that take place in the establishment. For example,

Section 603 of the FMIA covers ante-mortem inspection. Section 604 covers post

mortem inspection, and the carcasses. Section 606 covers the inspection of all meat

products – the carcasses, the parts, processed products, and cut up products. Each

product must be inspected. Section 608 covers the requirement for the establishment to

maintain a sanitary environment for the slaughter and processing of animals to take

place. The provisions in the PPIA follow this same progression.

Recordkeeping

The statutes outline requirements for recordkeeping related to the production of meat

and poultry products. If you recall from your civics classes, the U.S. Constitution has a

provision that protects citizens from unreasonable searches and seizure. The

establishment has this same right, and just like other rights, it must be protected.

However, it’s important for inspection personnel to have access to establishment records

(production, shipment, and other business records), particularly records related to the

implementation of HACCP and Sanitation SOP. A review of those records can tell us

important information about how product was handled, prepared, shipped, received, and

stored to help us in making the determination about whether product that is being

produced is wholesome, not adulterated, and properly labeled. Section 642 of the FMIA

and Section 460(b) of the PPIA outline record keeping requirements and classes of

businesses that are required to keep records; also, it gives FSIS the right to be in the

establishment and to have access to the establishment facilities and records.

Establishments must maintain production records, and to provide the records within a

reasonable amount of time when given notice. FSIS has issued regulations (9CFR

320.4 and 381.178) which further addresses entry into places of business and

examination of records, including record keeping requirements. Tracing these
016

authorities in regulations, Directives, and Notices, remember that the HACCP and

sanitation regulations (417, 416), which are promulgated under the Act, both outline

more specific recordkeeping requirements. For example, the right of FSIS to access

establishment records is reflected in the HACCP regulations in 417.5, which outlines the

recordkeeping requirements related to HACCP plans. FSIS Directive 5000.1 outlines

inspection methods covering these recordkeeping requirements. An example of a key

directive dealing with establishment records is FSIS Directive 5000.2, ”Review of

Establishment Data by Inspection Personnel”. It reminds inspection personnel that they

have access to any type of record that the establishment maintains that relates to

maintaining its food safety system, whether the records are referenced in the HACCP

plan or not (e.g., records of microbiological sampling).

ENFORCEMENT AUTHORITIES AND ACTIONS

Now, let’s review the statutory authority for taking enforcement action when federal

inspected establishments fail to comply with provisions outlined in the Acts and

regulations. There are three basic enforcement authorities covered in the Acts:

administrative,

civil, and

criminal

Among these, most of the enforcement actions in establishment personnel are involved

with are the ones that come from the administrative authority. For example, you or other

inspection personnel may withhold the marks of inspection or retain product. Let’s

review each of these authorities in more detail.

Administrative Authorities

Section 671 of the FMIA provides the authority to refuse or withdraw grants of inspection

from federally inspected meat slaughter and processing establishments. Section 467 of

the PPIA provides similar authority for the refusal and withdrawal of inspection services.

Actions to refuse or withdraw grants of inspection can be initiated for such things as:

-violation of agency’s sanitation, adulteration, and related requirements;

- conviction of an establishment or of a responsibly connected individual for certain

crimes; and

- inhumane slaughter

In addition, under Section 607 of the FMIA and Section 457 of the PPIA, FSIS can

rescind or refuse the approval of marks, labels, and containers.

The administrative enforcement authorities covered in the statutes include retaining

product, withholding the marks of inspection, suspending inspection, and withdrawing

inspection. Remember that the Rules of Practice, found in section 500 of the FSIS

regulations, outline the due process that we must ensure takes place to protect the rights

of establishments. Let’s review these regulations briefly.

Section 500.2 of the regulations covers the regulatory control actions that take place in

the establishment, such as tagging product, equipment, or facilities. Remember, under
017

the provisions contained in Section 608 of the FMIA, these actions are taken to prevent

product that has been determined through inspection, to be unwholesome or adulterated

from leaving the establishment and entering commerce. We are authorized to take

regulatory control actions when we find insanitary conditions or practices, product

adulteration, conditions that prevent us from determining that product is not adulterated

or misbranded, and when there is inhumane handling or slaughter of livestock. When a

regulatory control action is taken, you must notify the establishment immediately orally or

in writing of the action and the reason for the action. Remember that for any type of

enforcement action, the establishment has the right to appeal that action.

Section 500.3 of the Rules of Practice covers situations that warrant a withholding action

or suspension without prior notification to the establishment. These actions are

authorized when: the establishment has produced and shipped adulterated or

misbranded product and there is an imminent hazard to health, the establishment does

not have a HACCP plan, the establishment does not have a Sanitation SOP, sanitary

conditions are such that products in the establishment are or would be rendered

adulterated, the establishment violated the terms of a regulatory control action, someone

associated with the establishment assaults or threatens to assault or intimidate or

interfere with an FSIS employee or FSIS inspection, the establishment fails to destroy

condemned product according to regulatory requirements, or the establishment handles

or slaughters animals inhumanely. Section 500.5(a) covers the notification that must be

provided to the establishment as promptly as circumstances permit.

Section 500.4 of the Rules of Practice covers the conditions under which withholding

actions are taken or when suspensions occur with prior notification to the establishment.

The prior notification is called a “Notice of Intended Enforcement Action,” or NOIE.

Specifics about what is contained in the NOIE are covered in 500.5(b). The conditions

that require prior notification include an inadequate HACCP plan, a Sanitation SOP has

not been properly implemented or maintained, failure to maintain sanitary conditions due

to multiple or recurring noncompliance, failure to collect generic E. coli samples, and

failure to meet the Salmonella performance standards. Here’s a simple, practical

example. According to the Rules of Practice, if there is a condition that requires prior

notice before the marks of inspection are withheld, you will provide the establishment a

written notice of the enforcement action. The written notice (NOIE) gives the

establishment three days to respond. During this time, the establishment can provide a

corrective action plan, which if judged to be adequate will result in putting the

suspension in deferral. Or, the establishment can challenge the validity of FSIS actions

through the appeals process.

Withdrawal of inspection, covered in 500.6, is a formal legal process that involves filing a

complaint in an administrative proceeding at the Department level. This will be handled

by a Program Investigator (OIEA). However, the documentation you provide in the NRs

that you write are the evidentiary basis upon which this action is taken.

Civil Authorities

The civil authorities covered in the acts are found in Section 674 of the FMIA and 467(c)

of the PPIA. Under these authorities, FSIS can enforce, prevent, and restrain violations

of the acts. The actions involve U.S. District courts. The primary actions will be

detention, and seizure of product. On rare occasions, FSIS can obtain an injunction in a

federal court to prevent or restrain an establishment engaging in violations of the acts.
018

Detention authorities, found in Section 672 of the FMIA, and Section 467(a) of the PPIA,

cover unwholesome, adulterated, or misbranded product that has left the establishment

and has entered commerce. Detention actions are taken by Program Investigators

(OIEA), Import Surveillance Liaison Officers (ISLO, OIEA – IID), or EIAOs (OFO). The

role you might play in a detention action is that you might make a call about adulterated

product that has left the establishment, which would lead to the detention action. For

example, you may learn of test results that show product is adulterated with E. coli

O157:H7. The detention action places the product on hold for 20 days. During this time,

a decision is made on the ultimate disposition of the detained product.

The statutory authorities for seizure of product are found in FMIA section 673 and PPIA

section 467(b). Seizure is also an action that is taken against product that is no longer in

an establishment and has entered commerce. Typically, the first step in a civil action is

detention, which is then followed by seizure and condemnation. It involves a court

judgment that affirms that the product is in violation of the acts and must be condemned

and destroyed. When the court determines that the product is to be condemned, it is

released under bond to be destroyed. Court costs and fees, storage and other

expenses are charged to the violator.

When there are violations of the Acts that are civil in nature, FSIS has the authority to

obtain an injunction from a court to keep the establishment from doing something (e.g.,

continuing its operations) – although this rarely occurs.

Although you will not be involved in taking any civil enforcement action, some of the

documentation created in the establishment, such as NRs or memoranda, may be

included in a case file that is submitted to the court. Therefore, it’s very important that

you, and the inspection personnel you supervise, follow the instructions in the Directives;

such as those in FSIS Directive 5000.1, on completing NRs accurately, completely, and

in a timely manner. They are important pieces that may make a difference in court

decisions.

Criminal Authorities

In addition to the administrative and civil authorities, there are criminal authorities

granted under the acts. Again, you will probably not have a direct involvement in these

kinds of actions. However, the documentation that you and inspection personnel you

supervise generate , may be used in actions. The acts cover among other things, intent

to defraud the public by distributing adulterated articles, prohibited acts, criminal acts of

assault and intimidation of a person engaged in official duties, and bribing or offering a

bribe to an inspection official. Let’s look at each of these closer.

The prohibited acts are listed in Section 610 of the FMIA and Section 458 of the PPIA

and covers specific prohibited actions that are subject to criminal sanctions, including:

• Slaughter or preparation of product except in compliance with the Act.

• Inhumane slaughter or handling.

• Sale, transport, offering, or receipt, in commerce, of articles capable for use as

human food that are either adulterated, misbranded, or not inspected.

• Causing products to become adulterated or misbranded.
019

• Misuse or unauthorized use of official marks, certificates, labels or devices of

inspection.

• The knowing misrepresentation of any article as inspected and passed or exempt

under the Act.

These prohibitions apply to persons, firms and corporations. Perpetrators of any

violation of these prohibited acts are subject to fines and other penalties.

FMIA Sec. 675; PPIA Sec. 461(c) covers criminal acts related to assault, and

intimidation of inspection personnel. Under these statutes, no person shall forcibly

assault, resist, oppose, impede, intimidate, or interfere with any USDA employee

engaged in or on account of official duties. Therefore, it is prohibited for establishment

employees to impede you, or interfere in any way with your work. Assault and

intimidation are conditions that result in immediate withdrawal of inspection with no

requirement to notify the establishment (Rules of Practice, 9 CFR 500). If you or any

other inspection personnel in the establishment are threatened in any way by a person

at the establishment, consider safety first. Report it immediately to your supervisor as

you have been instructed. The acts outline that these conditions can result in fines and

prison time for violators. These types of violations may result in a $5,000 fine, 3 years

prison or both. There are more severe penalties for use of a deadly or dangerous

weapon. These statutes also cover the murder of FSIS employees on duty.

Section 676(a) of the FMIA and Section 461(a) of the PPIA define that persons who

intend to defraud or distribute, or attempt to distribute a meat or poultry article that is

adulterated is subject to fines, imprisonment, or both.

Section 622 of the FMIA covers the criminal act of bribery. It prohibits any person, firm

or corporation from paying or offering to pay any money or other thing of value to an

agency employee with the intent to influence his/her discharge of duties. Bribery is

defined as a felony act, and violators are subject to a fine ranging from $5,000 to

$10,000, and imprisonment for 1 to 3 years. In addition to these penalties, FSIS will

withdraw inspection. This section also prohibits FSIS employees from accepting or

receiving money or something of value from representatives of the establishment, or

industry. As you may recall from the unit on ethics, you are not to accept any item of

value from a establishment employee. Other felonies include failing to destroy

condemned product, having an owner/operator who has been convicted on a felony, or

two or more misdemeanors. Be aware that the USDA’s Office of the Inspector General

(OIG) conduct investigations into allegations of bribery. The investigations are usually

initiated as a result of an anonymous call to the OIG’s hotline.

The Secretary may refer criminal violations to the Department of Justice for prosecution.

The Secretary has discretion to forego criminal referral for minor violations where it is

determined that the public interest will be served by a suitable written notice of warning.

Discretion also applies to libel and injunction authorities. Violators of any provisions for

which no other criminal penalty is provided shall be guilty of a misdemeanor, and subject

to fine and up to one year imprisonment.
020

OTHER STATUTORY AUTHORITIES

In the previous sections, we covered the statutory authorities that were most significant

in relation to ensuring the protection of public health. In this section, we will review some

additional statutory authorities that relate to your work.

Humane Handling of Livestock

Section 603(b) of the FMIA covers the authorities related to the humane handling and

slaughtering of livestock. The Section outlines inspection authority over the

methodology of humane handling, and slaughtering of animals. It states that FSIS can

establish rules and regulations to oversee that the requirements of the Humane Methods

of Slaughter Act are being met at official establishments. It also gives FSIS authority to

suspend or refuse inspection for violations of the Humane Methods of Slaughter Act.

FSIS may refuse to grant inspection, or temporarily suspend inspection for slaughter or

handling done other than in accord with Humane Methods of Livestock Slaughter Act.

Labeling

Labeling is also covered in the Acts. Remember that these authorities are secondary to

your public health focus. The Agency is ensuring that inspection program personnel

focus on food safety first (including Sanitation SOP, HACCP, Sanitation Performance

Standards, and food safety sampling) followed by food security (when specific

heightened security threat condition is declared), and into other activities we call “Nonfood Safety Consumer Protection” (NFSCP). Labeling is one of those NFSCP activities.

The Directive that covers your inspection responsibilities for labeling is FSIS 7000.1

Verification of Non-Food Safety Consumer Protection Regulatory Requirements.

Section 607 of the FMIA and Section 457 of the PPIA outline the following:

All meat and meat food products must be properly labeled, marked and packaged.

Labels must not be false or misleading.

FSIS can withhold the use of any false or misleading labels or marks.

As is true of any other provision, these statutes provide for hearing and appeal rights on

FSIS decisions.

Exported Product

Section 615 of the FMIA covers exported product. The Act requires FSIS to inspect

meat, and meat food products prior to export. Section 616 through 618 of the FMIA

gives the Secretary broad authority to appoint inspectors and hold clearance of vessels

until certificates of product wholesomeness are obtain from inspectors. It also covers

the certification of products by FSIS prior to shipping.

The Directive that relates to your inspection responsibilities for exported product is

9000.1. This directive describes what you should do to access the Export Library on the

FSIS web site to check the current export requirements. You should do this frequently,

as the requirements change regularly. It also covers your role in export certification.

The forms that you are to use when performing your inspection duties related to

exported products are also found in this Directive.
021

SUMMARY

Now that we have completed our review of the statutes, you should be able to:

Understand the purpose of the Acts.

Identify key definitions from the Acts.

Understand the statutory authority for FSIS activities.

Understand how those activities plus authorities in the statutes support enforcement

actions.

These Acts provide for the basis for FSIS’ ability to perform as a public health agency.

Although you find direction for your day-to-day activities in the Code of Federal

Regulations, FSIS Directives, and Notices, the statutes we have reviewed underlie all of

these activities and provide the legal basis for them. As you perform your inspection and

verification duties, you should always be conscious of the Acts, as they are the

foundation for all that we do.

WORKSHOP

Instructions: For each scenario, describe the statutory authority, regulation, and

Directive that is associated with it.

Scenario 1:

While performing ante mortem inspection, the PHV observes establishment personnel

using a sharp object to drive hogs to slaughter. When questioned, the establishment

employee says he did not know that he was not permitted to use the sharp object – in

other words, he was not properly trained to perform his duties. The PHV verifies that the

establishment takes immediate action to address this situation and necessary steps to

prevent recurrence. The PHV also documents an NR in PHIS. The use of the sharp

object is discontinued.

What is the Directive that guides your activities for this scenario? _

What is the regulation that relates to this scenario? _

What is the statutory authority that provides FSIS with the authority to address this

scenario? 

Scenario 2:

The PHV is performing a review of establishment records. As directed, the PHV reviews 

the records associated with the establishment’s testing program for E. coli O157:H7 in 

its raw ground product. The establishment records indicate that no positive results have 

been found this week. 

What is the Directive that guides your activities for this scenario? _ _

What is the regulation that relates to this scenario? 
022

What is the statutory authority that provides FSIS with the authority to address this

scenario?

Scenario 3:

The PHV observes the off-line inspectors to determine if they are using the appropriate

inspection methods and decision making to verify that the meat from heads, cheeks, and

weasands of beef are free of fecal material, ingesta, and milk.

What is the Directive that guides your activities for this scenario? _ _

What regulations relate to this scenario? 

What is the statutory authority that provides FSIS with the authority to address this

scenario? 

Scenario 4:

The PHV observes a cow during ante mortem inspection in very poor condition. The

animal is identified as a U. S. Suspect. At post mortem inspection, the PHV observes a 

lesion in the carcass suggestive of an injection site. The PHV retains the carcass, 

collects kidney tissue samples and conducts the KISTM test. After a presumptive 

positive KISTM test, the PHV proceeds to follow the FSIS Directive to process all the 

tissues collected. After freezing, all samples with the form are packaged for shipping to 

the Midwest Lab in St. Louis MO. 

What is the Directive that guides your activities for this scenario? _ _

What regulations relate to this scenario? 

What is the statutory authority that provides FSIS with the authority to address this 

scenario? 

Scenario 5:

The Consumer Safety Inspector (CSI) comes into the government office and tells the

PHV the following: After the establishment had completed its preoperational sanitation

procedures, the CSI observed residue of the previous day’s operation on the conveyor

belt that comes into direct contact with product. The CSI took a regulatory control action

and issued an NR.

What is the Directive that guides your activities for this scenario? 

What regulation relates to this scenario? 

What is the statutory authority that provides FSIS with the authority to address this

scenario? 
023

Scenario 6

You are performing the Poultry Slaughter HACCP Verification Task in a poultry slaughter

operation, and verifying the establishment’s verification requirements for the chilling

CCP. You review the establishment’s HACCP plan, and find that it specifies verification

personnel will review the temperature records and observe the monitoring procedures at

this CCP once per shift. It also specifies that maintenance personnel will verify the

accuracy of the temperature recording charts once per shift by taking an independent

temperature check. Based upon your review of the HACCP plan, you determine that the

establishment is in compliance with regulatory requirements.

What is the Directive that guides your activities for this scenario? _ _

What regulations relate to this scenario? 

What is the statutory authority that provides FSIS with the authority to address this

scenario? 
024

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

FSIS DIRECTIVE 6900.2

Revision 3

9/24/20

HUMANE HANDLING AND SLAUGHTER OF LIVESTOCK

CHAPTER I - GENERAL

I. PURPOSE

This directive informs inspection program personnel (IPP) of the requirements, verification activities, and

enforcement actions for ensuring that the handling and slaughter of livestock, including disabled livestock

and livestock slaughtered by religious ritual methods, is humane. This directive provides instructions to

IPP (e.g., public health veterinarian (PHV), consumer safety inspector (CSI)) for conducting humane

handling activities randomly throughout their tour of duty and provides instructions to IPP, in

establishments that assert that they have put in place a systematic approach, on how to assess whether

that approach is robust. PHVs are to no longer perform a monthly verification task (Verification of a

Robust Systematic Approach) to determine whether an establishment maintains a robust systematic

approach for humane handling as they are expected to make this assessment on an ongoing basis and

inform the establishment of any status change in this regard. FSIS has modified the definition of

egregious inhumane treatment and instructs IPP to document egregious inhumane treatment on a

noncompliance record (NR) instead of a memorandum of interview (MOI). This revision also updates

instructions for entering humane handling verification data into the Public Health Information System

(PHIS).

II. CANCELLATION

FSIS Directive 6900.2, Revision 2, Humane Handling and Slaughter of Livestock, 8/15/11

III. BACKGROUND

A. The Humane Methods of Slaughter Act (7 U.S.C. 1901, 1902, and 1906, see Attachment 1) requires

that the slaughtering and handling of livestock be carried out only by humane methods. In this statute,

Congress determined that the use of humane methods of handling and slaughtering livestock prevents

needless suffering of animals and results in safer and better working conditions for employees in

slaughter establishments. This includes:

1. Slaughtering in accordance with the ritual requirements of the Jewish faith or of any other

religious faith that prescribes a method of slaughter whereby the animal suffers loss of

consciousness by anemia of the brain caused by the simultaneous and instantaneous

severance of the carotid arteries with a sharp instrument and handling in connection with such

slaughtering.

2. Using humane handling and slaughter practices for all livestock including non- ambulatory

disabled livestock in accordance with the Humane Methods of Slaughter Act (HMSA). See

Attachment 2 for FSIS humane handling regulations.

DISTRIBUTION: Electronic OPI: OPPD
025

B. PHVs are to notify establishments that they may choose to develop and implement a systematic

approach for the humane handling and slaughtering of livestock. In 2004, FSIS published a notice in the

Federal Register Notice (69 Fed. Reg. 54625) Humane Handling and Slaughter Requirements and the

Merits of a Systematic Approach to Meet Such Requirements. This notice details the background on the

humane handling and slaughter statutes issued by Congress and regulation of humane handling by

FSIS. It also details steps industry should take to assure effective compliance with the Acts and

regulations.

IV. IPP PERSONAL SAFETY

When IPP conduct humane handling verification activities of livestock, personal safety is paramount. IPP

are to conduct this verification from a safe and suitable vantage point, taking into consideration the size

and temperament of livestock and the type of stunning method employed by the establishment.

V. HUMANE HANDLING TERMINOLOGY

A. Ambulatory Disabled Livestock: Livestock capable of walking, but with physical impairment

such as central nervous system signs, lameness, or similar conditions.

B. Egregious inhumane treatment: An egregious situation is an act or condition that results in severe

harm to animals, for example:

1. Making cuts on or skinning conscious animals;

2. Excessive beating or prodding of ambulatory or nonambulatory disabled animals or dragging of

conscious animals;

3. Driving animals off semi-trailers over a drop off without providing adequate unloading

facilities (animals are falling to the ground);

4. Running equipment over conscious animals;

5. Stunning of animals and then allowing them to regain consciousness;

6. Failing to immediately (or promptly) render an animal unconscious after a failed initial stunning

attempt (e.g., no planned corrective actions);

7. Multiple ineffective stun attempts (2 or more) that are due to one or more of the following

establishment failures to properly handle or stun the animal:

a. Failure to immediately (or promptly) apply the corrective actions that demonstrates a blatant

disregard for animal discomfort and excitement;

b. Failure to adequately restrain an animal;

c. Failure to use adequate stunning methods (e.g., inadequate air pressure, inadequate

caliber, insufficient electric current) for the animal being stunned (e.g., species of animal,

size of animal, etc.);

d. Poorly trained/untrained operator or inexperienced operator; or

2
026

e. Prolonged discomfort and excitement of the animal due to the inability to render it

insensible/unconscious after the application of the immediate (or prompt) corrective actions.

8. Dismembering conscious animals, for example, cutting off ears or removing feet;

9. Leaving disabled livestock exposed to adverse climate conditions while awaiting disposition, or

10. Otherwise causing unnecessary pain and suffering to animals, including situations on

trucks.

C. Falls: When an animal loses an upright position suddenly, in which a part of the body other than

the limbs touches the ground or floor.

D. Humane Handling: Handling and slaughter practices that cause a minimum of excitement,

pain, injury, or discomfort to livestock.

E. Hoisting: The process whereby an animal after it is shackled, is raised, usually from a lying position,

and suspended by a leg or legs.

F. Non-Ambulatory Disabled Livestock: Livestock that cannot rise from a recumbent position or that

cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments,

nerve paralysis, fractured vertebral column, or metabolic conditions.

G. Shackling: Livestock are shackled when a device (e.g., rope, chain) used to hoist the animal has

been placed around the animal's leg, even if the device has not been drawn tight.

H. Slips: When a portion of the leg other than the foot touches the ground or floor, or a foot loses

contact with the ground or floor in a non-walking manner.

I. Suitable Equipment: Establishment equipment that can enable establishment personnel to move nonambulatory disabled livestock with a minimum of excitement, pain, or injury. This type of equipment

includes skid loaders and self-propelled tractors capable of pulling stone boats (sleds) or similar

conveyances, those conveyances themselves, holding chutes, and a voltmeter or other suitable

equipment that can verify voltage of electric prods attached to AC current.

J. Suitable Restraints: Establishment-provided restraints capable of effectively restraining livestock

(including disabled livestock when necessary) and preventing injuries to Agency personnel when

performing ante-mortem inspection. This includes inspections when conducted on a transport vehicle.

VI. SYSTEMATIC APPROACH TO HUMANE HANDLING AND SLAUGHTER (SYSTEMATIC

APPROACH) IN A WRITTEN ANIMAL HANDLING PROGRAM

A. There is no regulatory requirement for a written systematic approach to humane handling. However,

an establishment may choose to develop and implement a robust written animal handling program that

effectively addresses the four aspects of a systematic approach that FSIS outlined in the Federal

Register Notice [Docket No. 04-013N] Humane Handling and Slaughter Requirements and the Merits of a

Systematic Approach to Meet Such Requirements.

B. These four steps are:

3
027

1. Conduct an initial assessment to determine where, and under what circumstances, livestock may

experience excitement, discomfort, or accidental injury while being handled in connection with

slaughter, and where, and under what circumstances, stunning problems may occur;

2. Design facilities and implement practices that will minimize excitement, discomfort, and

accidental injury to livestock;

3. Evaluate periodically the handling methods the establishment employs to ensure that those

methods minimize excitement, discomfort, or accidental injury and evaluate the stunning methods

periodically to ensure that all livestock are rendered insensible to pain by a single blow; and

4. Respond to these evaluations, as appropriate, by addressing problems immediately and by

improving those practices and modifying facilities when necessary to minimize excitement,

discomfort, and accidental injury to livestock.

C. When establishment management believes they have an animal handling program that equates to a

robust systematic approach and would like it reviewed by FSIS, IPP are to review the program and any

records generated during its implementation.

1. The PHV, District Veterinary Medical Specialist (DVMS) and District Office (DO) management are

to determine whether the information presented by establishment management meets the criteria

for a robust systematic approach. If the criteria are met, the inspector-in-charge (IIC) is to inform

the establishment that it has a robust systematic approach; and

2. The PHV is to document the determination in a MOI under the Livestock Humane Handling

Verification task in PHIS. A copy of the MOI is to be emailed to the DVMS, Frontline Supervisor

(FLS), and Deputy District Manager (DDM) and provided to establishment management.

3. IPP are to take into consideration whether the establishment has implemented and maintained a

robust systematic approach in determining how to proceed in the circumstances set out in

Chapter V, III, A (e.g., how to proceed when an incident occurs that involves egregious inhumane

treatment of an animal).

D. The establishment is not required to provide IPP access to a written humane handling program.

However, IPP will not be able to verify effective implementation of a program that the establishment

believes reflects a robust systematic approach without access to the written program. Because a

documented systematic approach is not a regulatory requirement, failure to implement provisions of such

a program is not a noncompliance unless such failure to implement results in an identifiable failure to

meet specific regulatory requirements.

E. If the establishment develops and implements what it considers to be a robust systematic approach

and IPP have informed the establishment that the Agency agrees, IPP are to verify implementation of

the establishment’s robust systematic approach, as described in Chapter IV. II. F.

NOTE: If an establishment is suspended (Notice of Suspension (NOS)) or receives a Notice of Intended

Enforcement Action (NOIE) due to an egregious inhumane handling and slaughter event, they will no

longer be considered by FSIS to have a robust systematic approach. The establishment will need to

proffer corrective actions and preventive measures to the DO in order to develop a verification plan

(Refer to: FSIS Directive 5100.3 “Administrative Enforcement Action Decision-Making and

4
028

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

FSIS DIRECTIVE 5000.2

Revision 2

12/4/08

REVIEW OF ESTABLISHMENT TESTING D ATA BY

INSPECTION PROGRAM PERSONNEL

I. PURPOSE

The purpose of this directive is to clarify that inspection program personnel have

access to a wide range of records under the Hazard Analysis and Critical Control

(HACCP) regulations (9 CFR part 417), and that they are to use that access to review

certain types of records on a regular basis.

II. CANCELLATION

FSIS Directive 5000.2, Revision 1, Review of Establishment Data by Inspection Program

Personnel, dated 6/19/08

III. REASON FOR REISSUANCE

FSIS is reissuing this directive to clarify what records inspection program personnel

are to review and how they are to document the review. Specifically, FSIS has attached

a question and answer that explains what data are available to the Agency.

IV. REFERENCES

9 CFR part 417

FSIS Directive 5000.1

V. BACKGROUND

Under the HACCP regulations, an establishment is required to keep records related

to the HACCP plan, including all decisionmaking documentation associated with its

development and all records associated with its operation (i.e., monitoring, verification,

and corrective action). To develop a HACCP plan, under 9 CFR 417.2(a)(1), an

establishment is to have a written hazard analysis that reflects its determination of the

food safety hazards that are reasonably likely to occur in the production process and to

identify the preventive measures that the establishment will employ to control those

hazards. The establishment develops a flow chart that lists the steps of each process

and product flow in the establishment and that identifies the intended use or consumers

DISTRIBUTION: Electronic OPI: OPPD
029

of the finished product (9 CFR 417.2(a)(2)). In addition, under 9 CFR 417.5(a)(1),

establishments are to maintain “...the written hazard analysis prescribed in 9 CFR

417.2(a) ..., including all supporting documentation.”

Given these regulatory requirements, the results of any testing that is performed by

the establishment that may have an impact on the establishment’s hazard analysis,

whether or not such testing is incorporated into an actual HACCP plan, referenced in a

HACCP plan, or considered in assessing a prerequisite program, are subject to FSIS

review and are to be available to FSIS personnel.

The activities in this directive are directly related to those found in FSIS Directive

5000.1, Chapter II - HACCP. Inspection program personnel are to verify the proper

execution of an establishment’s HACCP plans and any prerequisite programs as set out

in FSIS Directive 5000.1. Examples of such test results include, but are not limited to,

testing records, data, and supporting documentation associated with testing associated

with prerequisite programs and good manufacturing procedures; and testing conducted

for the establishment’s business customers that could bear on the hazard analysis.

VI. INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES

A. Inspection program personnel are to be aware of any testing that is performed by

the establishment that may have an impact on the establishment’s hazard analysis and

are to ask establishment management to make available for review the data that is

generated by such testing so that it is available when inspection program personnel are

verifying HACCP records.

B. At least once a week during the performance of an HACCP 01 procedure,

inspection program personnel are to review the results of any testing that the

establishment has performed that may have an impact on the establishment’s hazard

analysis.

C. When reviewing these test results, inspection program personnel are to seek

answers to questions such as:

NOTE: Inspection program personnel are not to request that the establishment provide a

written response to these questions.

1. Is there documentation that supports the frequency of the testing that the

establishment employs?

2. If the testing is used by the establishment to reflect the effects of a prerequisite

program do the results support the decision-making for the design of the program?

(also see FSIS Directive 5000.1, Chapter II).

This Directive deliberately truncated for training purposes
030

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

FSIS DIRECTIVE 6420.2

Revison 2 12/19/19

VERIFICATION OF PROCEDURES FOR CONTROLLING FECAL MATERIAL, INGESTA,

AND MILK IN LIVESTOCK SLAUGHTER OPERATIONS

CHAPTER I -- GENERAL

I. PURPOSE

This directive provides inspection program personnel (IPP) with the current method for

protecting public health by verifying, documenting, and enforcing the requirement that there be

no visible fecal material, milk, or ingesta on livestock carcasses at or immediately after the final

rail, and for verifying that feces, ingesta, and milk are not present on head, cheek, and weasand

meat at packing. In this revision, FSIS increased the livestock carcass sample size in

Attachment 1. This change will help the Agency better analyze data from establishments that

operate under traditional inspection and the New Swine Slaughter Inspection System (NSIS).

II. CANCELLATION

FSIS Directive 6420.2, Rev. 1, Verification of Procedures for Controlling Fecal Material, Ingesta,

and Milk in Livestock Slaughter Operations, 4/27/17

III. BACKGROUND

A. In slaughter establishments, contamination of carcasses and parts from feces, ingesta, and

milk are primary avenues for the spread of pathogens. Pathogens may reside in fecal material,

both in the gastrointestinal tract and on the exterior surfaces of the animal going to slaughter.

Without care being taken in handling and dressing procedures during slaughter and processing,

the edible portions of the carcass can become contaminated with bacteria capable of causing

illness in humans. Once introduced into the establishment environment, the organisms may be

spread from carcass to carcass or by other means. FSIS enforces a “zero tolerance” standard

for visible fecal material, ingesta, or milk on carcasses and parts at the time of inspection.

B. One approach that FSIS takes to minimize the occurrence of pathogens on meat is to verify

that feces, ingesta, and milk do not contaminate livestock carcasses and parts, or if they do, that

they are properly removed. FSIS provides instructions to IPP on how to verify that meat from

heads, cheeks, and weasands - livestock carcass parts used in the manufacture of ground meat

(e.g., ground beef) - that may become contaminated with feces, ingesta, or milk - are not

contaminated with these substances. If the meat from these parts is contaminated, it represents

a way of introducing pathogens into ground meat products. FSIS is reissuing this directive as

one of a number of steps that it is taking to ensure that the possibility of contamination with

pathogens is reduced to the extent possible.

DISTRIBUTION: Electronic OPI: OPPD
031

C. Some ground meat components (e.g., head, cheek, and weasand meat) may not be

attached to the carcass at the time that the carcass passes the final rail. IPP are to verify that

these parts are not contaminated by fecal material, ingesta, or milk at the end of the harvesting

process e.g., at the packaging step or when the product is placed into a container for storage.

D. FSIS has instructed IPP that they have access to the results of any testing and of any

monitoring activities that are performed that may have an impact on the establishment’s hazard

analysis (See FSIS Directive 5000.2). IPP must review results on at least a weekly basis.

E. In addition to zero tolerance verification, IPP verify compliance with HACCP requirements

and verify that establishment controls incorporated into the establishment’s HACCP system

ensure all meat and meat by-products (e.g. offal) are safe, wholesome, clean, and free of

contamination using the Slaughter HACCP Verification task. See instructions in FSIS Directive

5000.1, Verifying an Establishment's Food Safety System.

F. For additional instructions on how IPP are to verify Livestock Zero Tolerance requirements in

official establishments operating under the New Swine Inspection System (NSIS), see FSIS

Directive 6,600.1, Ante-mortem and Post-mortem Inspection and Verification of Ready-To-Cook

Requirements.

CHAPTER II -- LIVESTOCK FECAL MATERIAL, INGESTA, AND MILK INSPECTION

I. GENERAL

9 CFR 310.18(a) states: Carcasses, organs, and other parts shall be handled in a sanitary

manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter;

however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the

inspector.

A. Under 9 CFR 417, a HACCP plan must include, as appropriate, critical control points (CCPs)

that are designed to control identified food safety hazards (9 CFR 417.2(c)(2)). Because fecal

material is a vehicle for pathogens, and because virtually all slaughter establishments recognize

that contamination of meat by pathogenic microorganisms from fecal material, ingesta, or milk is

a food safety hazard that is reasonably likely to occur in the slaughter production process, IPP

are to verify that slaughter establishments have adopted controls that they can demonstrate are

effective in reducing the occurrence of pathogens, including controls that prevent contamination

of carcasses with fecal contamination, milk and ingesta.

B. In each establishment slaughtering livestock, IPP inspection activities include verification

checks to determine whether the establishment is producing carcasses and head, cheek, and

weasand meat that are not contaminated with fecal material, ingesta, or milk. (See 9 CFR

307.2(g), 310.3, 310.17(a), 310.18(a), and 318.2(b) and (d).)

II. ON-LINE INSPECTION RESPONSIBILITIES

A. When on-line IPP find feces, ingesta, or milk on the carcass and its parts during the postmortem inspection of each carcass and its parts, they are to verify the satisfactory removal of

contamination before passing each carcass or part.

B. When the on-line inspectors find feces, ingesta, or milk on the carcass, they are to stop the

slaughter line to allow for trimming of the carcass by establishment personnel and reinspection

of the carcass by the inspector unless the establishment has provided a rail-out loop:

2
032

1. For the purpose of moving contaminated carcasses off-line for trimming, reexamination,

and positioning back on the line for final inspection; and

2. Determined by the Inspector-in-Charge (IIC) to be adequate to prevent accumulation of

contaminated carcasses or cross-contamination of other carcasses.

C. On-line IPP who retain a carcass for veterinary disposition for pathology are not to authorize

establishment trimming of such carcass until after disposition by a public health veterinarian

(PHV).

D. On-line IPP are to notify the IIC or the off-line inspector as directed by the IIC when they

believe that the:

1. Establishment’s rail-out procedure is inadequate to prevent carcass accumulation or

cross-contamination of other carcasses; or

2. Establishment’s slaughter or dressing processes are not under control based on

repeated presentation of contaminated carcasses for post-mortem inspection.

E. If the on-line head or viscera inspector finds contamination, the establishment must remove

the contamination before the head or affected viscera or part can be passed. If the on-line head

or viscera inspector repeatedly finds contamination at the point of inspection, he or she is to

notify the IIC or the off-line inspector as directed by the IIC.

III. LIVESTOCK VERIFICATION PROCEDURES

A. Off-line IPP are to select carcasses for examination at the post-mortem rail inspection station

to verify the adequacy of the establishment’s procedures in preventing carcass contamination

with fecal material, ingesta, or milk, and that head, cheek, and weasand meat are not

contaminated with fecal material, ingesta, or milk at the completion of the harvesting process

using the Livestock Zero Tolerance Verification task. Livestock Zero Tolerance Verification

tasks are to be scheduled once per day per shift, at a minimum, in the Public Health Information

System (PHIS). Additional directed tasks may be performed by the off-line inspector if the IIC

determined that the establishment has lost process control.

B. When performing a Livestock Zero Tolerance Verification inspection task, off-line IPP are to

select carcass units at the post-mortem rail inspection station for examination on-line, or after

the post-mortem rail inspection station (see Attachment 1 for selection of carcass units) and

before the final wash.

NOTE: To address any issues related to a less than ideal slaughter floor design, inspectors’

safety, or presentation of carcasses or parts, the IIC and Front Line Supervisor (FLS) can

develop appropriate temporary or alternate procedures or arrangements with establishment

management in order for IPP to properly conduct this inspection task per 9 CFR 307.2.

C. Verifying that the establishment’s HACCP process is controlling fecal material, ingesta, or

milk contamination during the carcass production process, off-line IPP are to:

1. Determine the expected slaughter volume for that day;

2. Determine the number of carcass units based on daily slaughter volume (see

Attachment 1);

3
033

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

FSIS DIRECTIVE 10,800.1

Rev. 1

3/3/14

RESIDUE SAMPLING, TESTING AND OTHER VERIFICATION PROCEDURES UNDER THE

NATIONAL RESIDUE PROGRAM FOR MEAT AND POULTRY PRODUCTS

CHAPTER ONE – GENERAL

I. PURPOSE

A. This directive provides instructions to inspection program personnel (IPP), including Public Health

Veterinarians (PHVs) and Consumer Safety Inspectors (CSIs), on selecting animals and performing

chemical residue sample collection and testing procedures in accordance with the National Residue

Program (NRP) for meat, and poultry products. This directive addresses the role of IPP in the

collection of animal identification (ID) and producer information, in conducting in-plant residue

screening tests, and in completing residue sampling tasks using the Public Health Information System

(PHIS).

B. This directive advises IPP about their responsibilities, as part of the NRP, to verify that the

establishment is controlling residues in its food safety system. It also advises them on actions to take

when a residue violation is suspected or identified through sampling, when a residue repeat violator is

identified, and when an establishment fails to collect animal ID information or to maintain animal ID

identifiable with the carcass pending FSIS residue test results.

KEY POINTS:

• IPP select carcasses for NRP scheduled (directed) sampling from all animals that pass

antemortem inspection, regardless of post-mortem disposition.

• Establishments that do not have an effective residue control program in place in their Hazard

Analysis and Critical Control Point (HACCP) system when slaughtering cull dairy cows and

bob veal calves are targeted for in-plant testing for chemical residues at an increased rate.

• FSIS condemns an entire carcass and its parts when there is no Food and Drug

Administration (FDA) or Environmental Protection Agency (EPA) established tolerance or

action level for the identified chemical residue in muscle, whether the chemical residue is

found in muscle, organ, or other tissue.

• IPP will take action in an establishment that receives animals from a producer who has been

determined to have more than one (1) FSIS laboratory-confirmed residue violation within a

twelve (12) month period.

• The Kidney Inhibition Swab (KISTM) test has replaced the Fast Antimicrobial Screen Test

(FAST) in all slaughter establishments

DISTRIBUTION: Electronic OPI: OPPD
034

• FSIS laboratories now use multi-residue screening methods on tissue samples submitted from

positive KISTM tests.

• The sample size for muscle tissue collected for directed livestock and poultry residue samples

submitted to FSIS Laboratories has increased from one (1) pound to two (2) pounds.

• FSIS requires livestock slaughter establishments to hold or control livestock carcasses and

parts selected for FSIS directed residue testing and not to allow them to enter commerce until

the FSIS laboratory reports negative or non-violative test results.

II. SIGNIFICANT CHANGES

FSIS is reissuing this directive to incorporate instructions from FSIS notices and other FSIS directives

related to residue verification and to provide instructions for completing residue verification tasks

using PHIS. It also provides clarification on actions that IPP are to take when an establishment fails

to provide information on the violator upon reporting of a violative residue.

III. CANCELLATIONS

FSIS Directive 10,800.1, Procedures For Residue Sampling, Testing, And Other Responsibilities For

The National Residue Program, dated 7/12/07

FSIS Directive 10,220.2, Use of CAST and FAST Screening Tests for Bob Veal Calves, dated 4/9/96

FSIS Directive 10,220.3, Using the FAST Antimicrobial Screen Test (FAST) to Detect Antimicrobial

Drug Residues in Swine and Cattle, dated 8/23/06

FSIS Notice 54-13, Inspection Responsibilities When a Chemical Residue Does not Have an

Established Tolerance, dated 8/14/13

FSIS Notice 52-13, Level of In-Plant Targeted Testing For Chemical Residues in Cull Dairy Cows and

Bob Veal, dated 8/12/13

FSIS Notice 73-13, Instructions for Carcass Selection for the National Residue Program Scheduled

Samples, dated 11/4/13

IV. BACKGROUND

A. The United States has a complex residue control system, with rigorous processes for approval,

sampling, testing, and enforcement activities. Three principal agencies are involved in the control of

residues in meat and poultry products: FSIS, FDA, and EPA. FSIS works with EPA and FDA to

implement the NRP. The primary responsibility of FSIS in the NRP is to verify that establishments

control animal drug residues, pesticides, environmental contaminants, and any other chemical

hazards in and on meat and poultry products through sampling programs within the NRP. The NRP

also provides national data on chemical residue testing results to support risk assessment,

enforcement, and educational activities. In accordance with FDA and EPA regulations, the NRP is

designed to prevent the occurrence of violative levels of chemical residues in meat and poultry

products.

B. Under 9 CFR 417.2, establishments are to conduct a hazard analysis and consider the food safety

hazards that are reasonably likely to occur in their production processes and establish steps to

prevent, eliminate, or reduce those hazards to an acceptable level. A food safety hazard is any

biological, chemical, or physical hazard that may cause a food to be unsafe for human consumption.

The possible sources from which chemical food safety hazards may arise include chemical

contamination, drug residues, and pesticides. Establishments are also required to maintain

documentation that supports the decisions made in their hazard analysis as a part of their records

under 9 CFR 417.5(a)(1).

2
035

Meat, Poultry, and Egg Products

Recalls
Office: Meat, Poultry, and Egg Products Recalls

23-2

044

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................4

Scientific..............................................................................................................................4

Regulatory/Administrative ...................................................................................................4

RECALLS DEFINED...............................................................................................................5

References..........................................................................................................................5

Definition .............................................................................................................................6

Question: Adulterated or Misbranded..................................................................................6

Examples: Adulterated in Statutes ......................................................................................7

Examples: Misbranded in Statutes......................................................................................7

Recall Classes (Decided by Recall Committee) ..................................................................8

Potential Sources for Recalls ..............................................................................................8

Recalls Classifications.........................................................................................................9

Types of Recalls..................................................................................................................9

Recall Process: Overview ................................................................................................. 10

Recall Process: PHV Responsibilities ............................................................................... 12

Recall Regulations ............................................................................................................ 13

In-plant Verification of Recall Plan..................................................................................... 14

RECALL SCENARIOS.......................................................................................................... 14

Scenario 1 ......................................................................................................................... 14

Scenario 1 Discussion....................................................................................................... 15

Scenario 2 ......................................................................................................................... 16

Scenario 2 Discussion....................................................................................................... 16

Scenario 3 ......................................................................................................................... 17

Scenario 3 Discussion....................................................................................................... 17

RECALL CASE STUDY........................................................................................................ 18

Case Study........................................................................................................................ 18

Question 1......................................................................................................................... 18

Question 2......................................................................................................................... 19

Question 3......................................................................................................................... 19

Question 4......................................................................................................................... 19

Question 5......................................................................................................................... 19

Question 6......................................................................................................................... 20

Question 7......................................................................................................................... 20

Question 8......................................................................................................................... 20

Question 9......................................................................................................................... 21

Question 10....................................................................................................................... 21

Question 11....................................................................................................................... 21

Question 12....................................................................................................................... 22
Office: Meat, Poultry, and Egg Products Recalls

23-3

044

Question 13....................................................................................................................... 22

Question 14....................................................................................................................... 22

Question 15....................................................................................................................... 23

Question 16....................................................................................................................... 23

Question 17....................................................................................................................... 23

Question 18....................................................................................................................... 23

SUMMARY ........................................................................................................................... 24
Office: Meat, Poultry, and Egg Products Recalls

23-4

044

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Explain the key steps in the product recall process, i.e., identification, outbreak

notification, investigation, evidence collection, decision document, recall

committee, recall, and follow-up.

2. Identify the points in the product recall process at which a PHV would become

involved and the PHV's role at those points in the process.

3. Explain how the PHV interacts with other entities involved in a recall.
Office: Meat, Poultry, and Egg Products Recalls

23-5

044

Slides RECALLS DEFINED

3 References

Relevant Directives:

• 5000.8 - Verifying Requirements for Written Recall Procedures

• 8080.1 - Recall of Meat & Poultry Products

• 8080.3 - Foodborne Illness Investigations

• 8091.1 - Procedures for Health Hazard Evaluation Board

• 8410.1 - Detection and Seizure

• 10,010.3 - Traceback Methods for E. coli O157:H7

Small Plant Recall Plan Guidebook
Office: Meat, Poultry, and Egg Products Recalls

23-6

044

4 Definition

• Voluntary removal of FSIS regulated products from commerce

• Adulterated or misbranded product

• Initiated by manufacturer or distributer

o May be requested by FSIS

• If company does not recall:

o Office of Investigation Enforcement and Audit (OIEA) and EIAO’s may

detain and seize product in commerce

5 Question: Adulterated or Misbranded

Where do you find the legal definition of adulterated or misbranded product?
Office: Meat, Poultry, and Egg Products Recalls

23-7

044

6 Examples: Adulterated in Statutes

• Poultry Products Inspection Act – 21 U.S.C. 453 (g)

• Federal Meat Inspection Act – 21 U.S.C. 601 (m)

What are some examples of “adulterated” in the real world?

7 Examples: Misbranded in Statutes

• Poultry Products Inspection Act – 21 U.S.C. 453 (h)

• Federal Meat Inspection Act – 21 U.S.C. 601 (n)

What are some examples of “misbranded” in the real world?
Office: Meat, Poultry, and Egg Products Recalls

23-8

044

8 Recall Classes (Decided by Recall Committee)

9 Potential Sources for Recalls

• Establishment records and data

• FSIS inspections

• FSIS laboratory sampling data

• Epidemiological data

• CDC, FDA, and State Agences or sources
Office: Meat, Poultry, and Egg Products Recalls

23-9

044

10 Recalls Classifications

Recalls are also classified by:

• Scope: the amount and type of product in question

• Depth: the level of product distribution

11 Types of Recalls

To find information about recalls on the USDA website:
Office: Meat, Poultry, and Egg Products Recalls

23-10

044

Typical recall types:

12 Recall Process: Overview

You are one of the first lines of defense!

What role does the in-plant PHV have?
Office: Meat, Poultry, and Egg Products Recalls

23-11

044

What type of information will you gather?
Office: Meat, Poultry, and Egg Products Recalls

23-12

044

13 Recall Process: PHV Responsibilities
Office: Meat, Poultry, and Egg Products Recalls

23-13

044

14 Recall Regulations

§ 418.2 Notification.

“Each official establishment must promptly notify the local FSIS District Office within 24

hours of learning or determining that an adulterated or misbranded meat, meat food,

poultry, or poultry product received by or originating from the official establishment has

entered commerce, if the official establishment believes or has reason to believe that

this has happened. The official establishment must inform the District Office of the

type, amount, origin, and destination of the adulterated or misbranded product.”

• Establishments must notify the District within 24 hours when adulterated or

misbranded product has entered commerce

• Information must include the type, amount, origin, and destination of the product

§ 418.3 Preparation and maintenance of written recall procedures.

Each official establishment must prepare and maintain written procedures for the recall

of any meat, meat food, poultry, or poultry product produced and shipped by the official

establishment. These written procedures must specify how the official establishment

will decide whether to conduct a product recall, and how the establishment will effect

the recall, should it decide that one is necessary.

• Establishments must prepare and maintain written recall procedures
Office: Meat, Poultry, and Egg Products Recalls

23-14

044

15 In-plant Verification of Recall Plan

• At least once a year, use a directed Other Inspection Requirements task to

verify establishments have written recall procedures.

o If there are written recall procedures, mark 418.3 as verified and

complete the task in PHIS.

o If there are no written recall procedures, document noncompliance in

PHIS on an NR citing 418.3

• Refer to FSIS Directive 5000.8

Slides RECALL SCENARIOS

17 Scenario 1

The District Office has provided the PHV with a heads up electronic mail message

regarding a potential recall situation. A federally inspected establishment received

three complaints from customers regarding the presence of plastic pieces in their fully

cooked, not shelf stable, ready-to-eat Bologna. The complaints did not indicate the

plastic in the Bologna injured the consumers. A search in the FSIS Consumer

Complaint Monitoring System (CCMS) did not reveal any additional complaints against

the establishment or associated with their Bologna products. The establishment

provided photographs of two of the plastic pieces measured against a ruler, and the

plastic pieces varied in length.
Office: Meat, Poultry, and Egg Products Recalls

23-15

044

18 Scenario 1 Discussion

• By asking a series of questions, referring back to the statutes and regulations,

the recall committee generates a decision tree.

• Use the decision tree to determine if a recall needs to be made in this scenario.

• Remember, FSIS always includes the regulatory and statutory basis for the

decision made. The decision must be legally defensive, scientifically based, and

procedurally correct.
Office: Meat, Poultry, and Egg Products Recalls

23-16

044

19 Scenario 2

The District Office has provided the PHV with a heads up electronic mail message

regarding a potential recall situation associated with an allergen and sensitive

ingredient. During a food safety assessment (FSA), an Enforcement, Investigations,

and Analysis Officer (EIAO) discovered the Chorizo used as an ingredient in the

establishment’s finished product contained lactose and isolated soy protein as

ingredients; however, these ingredients were not declared on the finished product

label.

20 Scenario 2 Discussion

Use the thought process to determine if a recall should be done or not.
Office: Meat, Poultry, and Egg Products Recalls

23-17

044

Why did you choose that?

21 Scenario 3

An inspector notifies the PHV that during a labeling review task, the inspector observed

that the establishment mislabeled a cheddar hot dog product with a plain hot dog

product label.

22 Scenario 3 Discussion

1. What information would you want to know?

2. What actions do you expect the inspector to take?
Office: Meat, Poultry, and Egg Products Recalls

23-18

044

3. As a supervisor, how could you acknowledge this employee’s finding?

Slides RECALL CASE STUDY

24 Case Study

You are a PHV trained in the EIAO methodology assigned at a large combination

poultry slaughter/processing plant, P-42. The establishment produces fully cooked,

breaded RTE chicken parts. It sells the product to distributors and to national

supermarket chains.

On July 12, 2018, one of the establishment’s customers, a national supermarket,

notified P-42 that a consumer that is allergic to soy, notified the store that she had an

allergic reaction to the breaded chicken. A preliminary investigation by P-42 indicated

that a label not listing soy in the ingredients’ statement may have been used on

breaded cooked chicken, the breading of which contained soy protein.

The establishment notifies you of the finding immediately after they learn about it.

25 Question 1

What action would you take next?

❑ Wait and observe how the establishment reacts to the situation, determine if it

follows its HACCP plan

❑ Notify the DO

❑ Tell P-42 to notify the District Office (DO)

❑ Notify the DO and instruct P-42 to notify the DO as well
Office: Meat, Poultry, and Egg Products Recalls

23-19

044

26 Question 2

From whom would you take direction regarding this situation?

❑ The DO-Recall Officer (RO)

❑ The establishment’s Quality Assurance (QA) Manager

❑ The IIC at establishment P-42

❑ Recall Management and Technical Analysis Staff (RMTAS)

27 Question 3

Briefly list the type of information you may be asked to collect.

28 Question 4

To whom do you submit the information collected?

❑ RMTAS

❑ DO-Recall Officer (RO)

❑ Establishment IIC

❑ Plant management to submit to DO-Recall Officer (RO)

29 Question 5

It is acceptable to share/verify the information with the establishment prior to

submitting.

❑ True

❑ False
Office: Meat, Poultry, and Egg Products Recalls

23-20

044

30 Question 6

Under FSIS, a recall is an establishment's voluntary action to remove product from

commerce to protect the public from consuming adulterated or misbranded product.

❑ True

❑ False

31 Question 7

Which entity of FSIS is responsible for evaluating potential recall situations and when

warranted, recommending that an establishment recalls product?

❑ Office of Public Health Science

❑ District Office

❑ Recall Committee

❑ Office of Field Operations, Recall Management and Technical Analysis Staff

32 Question 8

If an establishment decides to recall product, what information (documents) does FSIS

prepare and post on its website to inform the public?

❑ Only a Retail Consignee List

❑ A Recall Notification Report (RNR) or Recall (press) Release and Retail

Consignee List depending on the class and depth of the recall

❑ None, it is the establishment’s responsibility to notify the public

❑ Only a Recall (press) Release
Office: Meat, Poultry, and Egg Products Recalls

23-21

044

33 Question 9

Based on the scenario, if P-42 decided to recall product, briefly list the actions the

establishment would be expected to take?

34 Question 10

Who is the primary contact in FSIS for the establishment when conducting a recall?

❑ Recall Management and Technical Analysis Staff

❑ Office of Field Operations, Assistant Administrator

❑ Inspector-in-Charge

❑ DO-Recall Officer (RO)

35 Question 11

As an EIAO/PHV, which follow-up actions might you be expected to take? (Select all

that apply.)

❑ Detaining product in commerce (when needed)

❑ Effectiveness checks

❑ Notify consignees that received product about the recall

❑ Verification of product disposition
Office: Meat, Poultry, and Egg Products Recalls

23-22

044

36 Question 12

Which entity is responsible for contacting businesses on the consignee list when

conducting recall effectiveness checks?

❑ Recall Management and Technical Analysis Staff

❑ Recalling establishment

❑ Office of Field Operations, EIAOs and Compliance Investigation Division (CID)

Investigators

❑ Compliance Investigation Division (CID) Investigators

37 Question 13

If directed to do effectiveness checks list some of the actions you would take.

38 Question 14

To whom would you submit your report?

❑ DO Recall Officer

❑ Your Front Line Supervisor

❑ Recall Management and Technical Analysis Staff

❑ Your Inspector-in-Charge
Office: Meat, Poultry, and Egg Products Recalls

23-23

044

39 Question 15

FSIS has reason to believe that adulterated or misbranded product is in commerce and

requests that an establishment do a recall, but the establishment chooses not to do so.

Which action would FSIS take?

❑ Immediately withdraw inspection from the establishment

❑ Withhold inspection

❑ Detain product in commerce

❑ Retain the product in commerce

40 Question 16

Establishments are required to have written recall procedures.

❑ True

❑ False

41 Question 17

How often do IPP verify if establishments have written recall procedures?

❑ When directed

❑ Each occurrence of a recall

❑ Once every 30 days

❑ Once per year

42 Question 18

Which PHIS task should be used when verifying if establishments have written recall

procedures?

❑ SSOP

❑ SPS

❑ HACCP

❑ Other inspection requirements
Office: Meat, Poultry, and Egg Products Recalls

23-24

044

Slides SUMMARY

43 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
059

OBJECTIVES

Recalls

At the end of this module, you will be able to:

1. Identify the regulations and statutes which are relevant to recalls.

2. Discuss recall class types and common examples.

3. Understand the PHV’s role in the recall process

4. Walk through the critical thinking process and generate a decision tree used to determine if a recall is

recommended.

RESOURCES

FSIS Directive 5000.8 “Verifying Compliance with Requirements for Written Recall Procedures”

FSIS Directive 8080.1 “Recall of Meat and Poultry Products”

FSIS Directive 8091.1 “Procedures for the FSIS Health Hazard Evaluation Board”

FSIS Directive 8410.1 “Detention and Seizure”

How to Develop a Meat and Poultry Product Recall Plan guidebook

PRE-CLASS ACTIVITY (optional)

Visit FSIS Recalls and Public Health Alerts Website

Review Federal Register 77 FR 26929

Review FSIS Food Recalls Fact Sheet

Review 9 CFR 418.2 – 418.4

Review FSIS Directive 8080.1 “Recall of Meat and Poultry Products”

INTRODUCTION

A recall is a firm’s voluntary removal of product from trade or consumer channels (e.g., by manufacturers,

distributors, or importers) to protect the public from consuming adulterated (injurious to health or unfit for

human consumption) or misbranded (false or misleading labeling and/or packaging) products. (21 U.S.C.

601(m),(n); 21 U.S.C. 453(g),(h); 21 U.S.C. 1033 (a),(l))

If a company refuses to recall its product, then FSIS has the legal authority to detain and/or seize meat and

poultry product(s) in commerce when there is a reason to believe they are hazardous to public health or if other

consumer protection requirements are not met. Although recalls are voluntary, FSIS oversees all recall

activities by official meat & poultry establishments, and coordinates any FSIS actions with the recall taken by

the firm. For recalls conducted by state-inspected firms or retail establishments, the appropriate state agency

oversees the recall in most cases. FSIS will provide the state agencies any needed assistance and

information.

FSIS Directive 8080.1 “Recall of Meat and Poultry Products” provides the FSIS program personnel with the

terminology, responsibilities, and public notification procedures regarding the voluntary recall of FSISinspected meat and poultry products.

Federally inspected meat and poultry establishments are required to prepare and maintain written recall

procedures. The written procedures must specify how the establishment will decide if they need to conduct a

product recall and how they will implement a recall. The written procedures and all records associated with

recalls must be available for FSIS review. (9 CFR 418)
060

TERMINOLOGY

The following are some of the common terms (pertinent to the discussion of this module) that Directive 8080.1

uses related to recalls:

Recall Classifications

FSIS assesses the public health concern or hazard presented by a product being recalled, or considered for

recall, whether firm-initiated or requested by FSIS, and classifies the recall based on the relative health risk as

follows:

• Class I: Reasonable probability of serious, adverse health problem or death

• Class II: Remote probability of adverse health problem

• Class III: No adverse health consequences

Each product recall’s classification is unique. Let’s look at each of these in more detail, with some common

examples.

Class I. This is a health hazard situation where there is a reasonable probability that the use of the product will

cause serious, adverse health consequences or death. For example, the presence of pathogens in ready-toeat product or the presence of E. coli O157:H7 in ground beef.

Class II. This is a health hazard situation where there is a remote probability of adverse health consequences

from the use of the product. For example, the presence of undeclared allergens such as very small amounts of

potential allergenic substances (milk or soy) or small sized non-sharp edged foreign materials (plastic).

Class III. This is a health hazard situation where the use of the product will not cause adverse health

consequences. For example, the presence of undeclared generally recognized as safe non-allergenic

substances, such as excess water.

Depth & Scope

Recalls are also classified by the level of product distribution to which the recall is to extend (Wholesale, Retail,

HRI, Consumer). This is defined as the depth of the recall.

The scope of a recall is defined by the amount and type of product in question. Multiple factors are used in

determining the scope, such as establishment sanitation procedures and process flow.

OPHS

This group addresses microbiological, epidemiological, and other scientific issues associated with the recall.

Health Hazard Evaluation Board (HHEB)

This group is convened on an ad hoc basis to address situations involving potential human health hazards

when the Agency is uncertain about the nature or severity of the human health risk. If the hazard presented by

a given product appears to be unique or in some way unusual, the Recall Committee may consult with the

HHEB.
061

Recall Committee

A committee of representatives from various FSIS offices and staffs assembled to respond to potential or real

health hazard incidents reported to the Recall Management and Technical Analysis Division. The primary

members of the committee are representatives of the following program areas:

1. Recall Management and Technical Analysis Staff (RMTAD) OFO

RMTAD calls a committee meeting, distributes information about the recall to committee members, has the

primary responsibilities for recall activities and is responsible for the following:

• Leads the Recall Committee meeting.

• Reviews and evaluates incoming data (Recall worksheets, charts, labels, etc).

• Formally recommends and closes out recalls.

• Acts as a liaison with other programs and Agencies.

They invite other program areas to assist as necessary. This includes:

• Office of Investigation, Enforcement and Audit (OIEA), Compliance and Investigations Division (CID)

(conducts investigations of alleged criminal violations),

• Office of Public Health Science (OPHS),

• Office of Policy and Program Development (OPPD),

• Office of Public Affairs and Consumer Education (OPACE), Congressional and Public Affairs Staff

(CPA),

• Office of Data Integration and Food Protection (ODIFP), and

• Other Federal or State agencies (such as FDA, Food and Nutrition Service, CDC, Office of General

Counsel, State Departments of public health).

2. FSIS Recall Officer (RO), District Office, OFO

Each District designates an individual who acts as the FSIS Recall Officer, or RO. This is a designated FSIS

person with jurisdiction in the district of the firm conducting the recall. This may be a Deputy District Manager

(DDM), the District Case Specialist (DCS), or Enforcement, Investigations, and Analysis Officer (EIAO) in the

district where the recalling firm is located. The RO is responsible for the following activities:

• Coordinates field recall activities if a recall should be recommended.

• Assigns designee (often an EIAO).

• Interacts with recalling firm, other districts, and RMTAD.

• Clarifies and explains to the Recall Committee the information collected during the preliminary inquiry.

• Develops effectiveness check strategy.

• Interprets results of the effectiveness checks and disposition of affected product.

• Submits a final recall effectiveness report to RMTAD.

3. Office of Policy and Program Development (OPPD)

Personnel in this Office provide the statutory basis for each recall; address other statutory issues, the

regulations, and any regulatory policies that are relevant to the recall.
062

4. Office of Public Health Science (OPHS)

Personnel in this Office address microbiological, epidemiological, and other scientific issues associated with

the recall

5. Congressional and Public Affairs Office (CPAO; Media Relations), Office of Public Affairs and Consumer

Education (OPACE)

Personnel in this office father information and generate a Recall Release or a Recall Notification Report if there

is a recall. When appropriate, they generate public notification, such as a Public Health Alert or Press Release,

in situations where a recall action is not warranted.

ROLE OF THE PUBLIC HEALTH VETERINARIAN

The role of the PHV in a recall is to assist the RO and designee when requested in gathering information about

the affected product. For example, you may be asked to provide information about whether the product

represented by an FSIS or establishment sample that tested positive for E. coli O157:H7 has been held under

the establishment’s control, or whether it has left the establishment’s control and has entered commerce. You

might be asked to help the RO designee gather information about a consumer complaint concerning a product

that was produced in the establishment that you cover in your assignment.

Establishment personnel may notify you that they learned or determined that adulterated or misbranded

product entered commerce. If this happens, you need to contact the District Office, through supervisory

channels, as soon as possible. You also need to notify establishment managers that they need to contact the

District Office directly within 24 hours. (9 CFR 418.2)

If you are an EIAO-trained PHV, you may be asked to investigate a consumer complaint at your duty station or

other nearby establishments. You may be asked to complete recall effectiveness checks if product subject to

recall was produced or distributed in your local area.

Finally, as you go about your daily in-plant activities, if you suspect that there is a problem with product such

that it may need to be recalled, discuss your concerns with your supervisor first. You may then be asked to

report your concerns to the district RO.

Verifying Written Recall Plans

Part of your responsibilities is to verify that establishments have written recall procedures as required by 9 CFR

418.3. To do this, at least once a year, you or your designee will perform a directed Other Inspection

Requirements task. Document your findings in PHIS.

RECALL PROCESS

Problem Identification

The process of recalling a product begins with problem identification. A problem with a product is identified

through various sources such as the firm, the Agency, or sources outside of the Agency. The most common

sources are:

• Information from in-plant inspectors and program investigators in the course of their routine duties.

• A positive result from FSIS sampling programs (microbiological, physical, chemical, misbranding).

• The company that manufactured or distributed the food product informs FSIS of the potential hazard (e.g.,

positive microbiological test results, consumer complaint, formulation records).
063

• Information from outbreak investigations, epidemiological or laboratory data submitted by State or local

public health department, or other Federal Agencies.

• Consumer complaints reported to FSIS (reported in the FSIS Consumer Complaint Monitoring System –

see text box below).

• Information from other agencies such as the Department of Homeland Security, Customs and Border

Protection, the Animal and Plant Health Inspection Service, or foreign inspection officials.

Preliminary Inquiry

When FSIS learns there is reason to

believe that adulterated or misbranded

product is in commerce, FSIS will

conduct a preliminary inquiry. A recall

officer (RO) contacts in-plant IPP and

the establishment’s Recall Coordinator

(RC) to gather product information,

contact information, and any additional

relevant information. Information is

collected on FSIS Recall Worksheets

and provided to RMTAD. The

establishment is responsible for

providing this information, however as

in-plant PHVs with working knowledge of

establishment protocols and records,

you may be asked to assist with

information gathering. It is important that

this information is gathered accurately

and in a timely manner.

Recall Committee Meeting

Recall Committee members discuss the

reason that a particular product may

need to be removed from commerce and

whether there is a statutory basis to

recommend a recall. If the committee

decides to recommend a recall, it is also

to determine the appropriate recall classification.

When determining whether to recommend a product recall, the Recall Committee is to seek the answers to the

following questions:

• Does FSIS have reason to believe that the product in question is adulterated or misbranded under

the FMIA or PPIA? For example, if the results of a laboratory analysis show that raw ground beef or

beef manufacturing trimmings contains E. coli O157:H7, the product is clearly adulterated because

it is likely to be injurious to health.

• What is the extent of the hazard to public health? This will assist in determining the recall

classification.

• Does any of the product in question remain in commerce or remain available to consumers? If the

committee finds that the establishment has recovered all products from commerce that would have

been subject to recall, a recall is not recommended as no product is available to consumers.

To determine if product remains available to consumers, the committee seeks answers to questions such as:

• When was the product produced?

The CCMS, or Consumer Complaint Monitoring System, is an electronic

database used to record, triage, coordinate, and track all consumer complaints

reported to the agency. Some examples of complaints associated with

consumption of a meat, poultry or egg product are as follows:

• Product caused an illness or injury

• Product contained a foreign object/material

• Product caused an allergic reaction

• RTE product has been under processed

• Product is misbranded/economic adulteration

• Product is of inferior quality

A consumer may report a complaint either locally to a public health official, to

FSIS OPHS, or to the Meat & Poultry Hotline. An EIAO can enter consumer

information into the CCMS and OPHS triages the information. They may

recommend case investigation.

When cases are investigated, the DDM of the complainant district is notified

through the CCMS. An EIAO is assigned to the matter for further investigation

and should immediately contact the consumer to verify information alleged in

the complaint. The EIAO visits the consumer who made the complaint to

verify that the information provided by the consumer and entered into the

CCMS is accurate. The EIAO will collect the relevant information and

evidence needed to identify and document the problem. Based on the findings

of the investigation, FSIS may initiate recall proceedings, or take a regulatory

or enforcement action.

The Office of Investigation, Enforcement, and Audit (OIEA) should be

contacted if there are concerns regarding criminal activity. In addition,

complaints concerning product tampering or potential food security threats

should be referred to the USDA, Office of the Inspector General (OIG).
064

• To whom has the product been distributed?

• What type of product is involved?

• How much product is involved and how was this determined?

• What is the typical, useable shelf life of the product?

Recall Recommended

If a recall is recommended, RMTAD generates a memo which includes the reason for the recall and the recall

classification (Class I, II, or III).

Notification and Action of Firm

FSIS outlines in “Product Recall Guidelines for Firms” the actions a firm can take to ensure that it recovers the

maximum amount of product in the shortest amount of time. If the firm decides not to accept the Agency’s

recommendation and chooses not to conduct a recall, FSIS personnel may detain any product found in

commerce that would have been subject to recall as set out in FSIS Directive 8410.1.

Public Notification

For every recall, FSIS notifies the public through a press release, entitled Recall Release (for Class I or Class

II), and/or a Recall Notification Report (RNR; for Class III only). The press release will inform the consumer,

industry, and other stakeholders of information related to the product in question. It is issued to media outlets in

the areas where the product was distributed and to an e-mail listserv. All FSIS press releases concerning

recalls can be found on the FSIS web site at the Recalls and Public Health Alerts page.

These press releases clearly describe the product recalled along with any identifying marks or codes, explain

the reason for the recall, and describe the risk involved in consuming the product. They also provide

instructions to the public on what to do with the product if people identify it and have it in their possession and

the name and telephone number of a company contact for consumers to call with any questions. In addition,

they provide general information about the product’s destination, for example, “The beef burritos were

distributed to an airline caterer and restaurants in the states of.....” or “Frankfurters were sold to grocery stores,

delis, and convenience stores in the states of ....” Press releases issued by FSIS will not identify the name

and address of the recipients of product (e.g., specific grocery stores, restaurants, airlines, etc.). However, for

Class I recalls, FSIS posts a retail distribution list, which identifies the retail establishments that may have

received the recalled products.

There may be situations in which the Recall Committee determines that a specific product may present a risk

to human health, but the committee cannot recommend a recall. In these circumstances, a Public Health Alert

may be issued. Public Health Alerts include information on the product involved, identify whether the product

presents any health risk, and instructs consumers on how to properly handle the product if they have it in their

possession.

Effectiveness Checks

The RO or designee will follow up on the recalling firm’s actions by verifying that the distribution information is

collected and provide feedback to the RO. The RO directs FSIS personnel in the District Office (DO) where

the recall originated to conduct recall effectiveness checks.

Effectiveness checks are a process by which FSIS program personnel verify that the recalling firm has been

diligent and successful in notifying and advising the consignees of the need to retrieve and control recalled

product, and that the consignees have responded accordingly. Subsequent consignees are then expected to

notify their customers of the recall. FSIS will conduct these effectiveness checks throughout the distribution

chain.
065

The RO or designee will perform effectiveness checks using the process outlined in Directive 8080.1. The

effectiveness checks are conducted based on risk to public health. Risk is measured by combining the hazard,

as defined by the class of recall and any available epidemiological data, and potential exposure to the product

measured by the number of the consignees or exposure. Recall effectiveness checks allow FSIS program

personnel to ensure that the firm makes all reasonable efforts to retrieve the recalled meat, poultry, or egg

product. A sufficient number of effectiveness checks are made to verify that the recall is conducted in an

effective manner, and that the firm locating, retrieving, controlling, and disposition of the product is acting

according to regulatory requirements.

If the affected product has been distributed in other Districts, the RO notifies other DDMs that assistance in

conducting recall effectiveness checks is needed. Other Districts conduct effectiveness checks and report

results back to RO. If there is a Memorandum of Understanding (MOU) with a state (9 CFR 390.9), the RO or

DDM notifies state authorities about the recall. When it is appropriate, the RO recommends closure of the

recall to the RMTAD and RMTAD recommends closure of the recall to the Assistant Administrator of OFO.

Recall Closure

After FSIS has determined that the recalling firm has made all reasonable effort to retrieve and appropriately

dispose of the recalled food product, the firm is officially notified by letter that the recall is completed and no

further action is expected.
066

Decision Tree

RMTAD organizes and supports its thought process for determining if a recall is warranted by using a decision

tree. As the committee asks questions, the answers form the tree.

The committee decision process is not standardized. It is unique to each recall and can vary greatly. In other

words, there is no one “correct” version of a decision tree/process. The tree develops as more information

about a recall and involved products is discovered.

WORKSHOP

Instructions: Work in small groups and as a class to generate decision trees to assess if a recall may be

recommended.

Scenario 1: The District Office has provided you with an electronic mail message regarding a potential recall

situation. A Federally inspected establishment received three complaints from customers regarding the

presence of plastic pieces in their fully cooked, not shelf stable, ready-to-eat Bologna. The complaints did not

indicate the plastic in the bologna injured the consumers. A search in the FSIS Consumer Complaint

Monitoring System (CCMS) did not reveal any additional complaints against the establishment or associated

with their bologna products. The establishment provided photographs of two of the plastic pieces measured

against a ruler, and the plastic pieces varied in length.

Scenario 2: The District Office has provided you with an electronic mail message regarding a potential recall

situation associated with an allergen and sensitive ingredient. During a food safety assessment (FSA), an

Enforcement, Investigations, and Analysis Officer (EIAO) discovered the Chorizo used as an ingredient in the

establishment’s finished product contained lactose and isolated soy protein as ingredients; however, these

ingredients were not declared on the finished product label.
067

Scenario 1 –

Example decision tree

Products contaminated

with foreign matter

Are products in

commerce?

No (No recall) Yes

Has the company received any consumer

complains with injuries and/or have there

been any documented complaints regarding

injuries on CCMS?

21 U.S.C. 601(m)(1)

Yes

Is there enough evidence to

demonstrate the injury was an

isolated incident?

No

What are the reported physical

characteristics of the plastic?

Yes (no recall) No (proceed to

Recall

Committee)

Soft- Will the material pose a hazard for

chocking and/or laceration based upon physical

characteristics and on the FDA-ORA and FSIS

HHEB guidelines for physical hazards?

21 U.S.C. 601(m)(1)

Hard -Will the material pose a hazard for

chocking and/or laceration based upon physical

characteristics and on the FDA-ORA and FSIS

HHEB guidelines for physical hazards?

21 U.S.C. 601(m)(1)

Yes

(proceed to Recall

Committee)

No

Will the soft plastic pose as a

chemical hazard upon

exposure to heat?

21 U.S.C. 601 (m)(1)

Yes (proceed to

Recall

Committee)

No

Will the hard plastic pose

as a chemical hazard

upon exposure to heat?

21 U.S.C. 601 (m)(1)

No – will not be

cooked or will not

melt (proceed to

Recall Committee)

Yes (proceed to

Recall

Committee)

No – will not be

cooked or will not

melt (proceed to

Recall Committee)

Yes (proceed to

Recall

Committee)
068

RECALL WORKSHEET- FOR INTERNAL FSIS USE ONLY

(Include attachments, additional pages, label copies and flowcharts as necessary)

TODAY DATE:

ESTABLISHMENT NUMBERS:

ESTABLISHMENT NAME:

ADDRESS:

COMPANY RECALL COORDINATOR (name, title, telephone)

COMPANY MEDIA CONTACT (name, title, telephone)

COMPANY CONSUMER CONTACT (name, title, telephone)

REASON FOR RECALL:

IDENTIFY RECALLED PRODUCTS SEPARATELY BY:

BRAND NAME

PRODUCT NAME

PACKAGE

(Type & Size)

PACKAGE CODE

(Use By/Sell By)

PACKAGING DATE

CASE CODE

(Identifying)

COUNT/CASE

PRODUCTION DATE

AMOUNT (lbs./cases)

PRODUCED

AMOUNT HELD AT

ESTABLISHMENT

AMOUNT (lbs./cases)

DISTRIBUTED

DISTRIBUTION LEVEL

(institutional/retail/etc)

DISTRIBUTION

AREA

EXPORTED TO

(country)

SCHOOL LUNCH

(CN, AMS Contract) (YES) (NO) (YES) (NO) (YES) (NO)

DEPT. OF DEFENSE

(DSCP, Commissary, etc.) (YES) (NO) (YES) (NO) (YES) (NO)

INTERNET OR

CATALOG SALES (YES) (NO) (YES) (NO) (YES) (NO)

THE FOLLOWING TO BE COMPLETED BY FSIS HEADQUARTERS STAFF:

CASE DATE

NUMBER: INITIATED: CLASS: DEPTH: DO Rep.:
069

RECALL WORKSHEET -FOR INTERNAL FSIS USE ONLY

(Listeria monocytogenes ATTACHMENT)

(READY-TO-EAT PRODUCT)

DESCRIBE THE PRODUCTION/PROCESSING OPERATION AND/OR ATTACH A PROCESS FLOW DIAGRAM:

_

_

WHAT WERE THE “CLEAN-UP TO CLEAN-UP” TIMES?

WAS CARRYOVER PRODUCT FROM PREVIOUS PRODUCTION PACKED WITH THIS PACKAGING CODE? (YES) (NO)

WAS THERE A COMPLETE LINE CLEANUP AFTER THE CARRYOVER WAS RUN? (YES) (NO)

WHAT DATE WAS THE CARRYOVER PRODUCT CARRIED OVER FROM?

WERE THERE ANY PROCESS DEVIATIONS DURING THE PRODUCTION OF THE CARRYOVER PRODUCT? (YES) (NO)

EXPLAIN:

WHAT WAS/WERE THE CORRECTIVE ACTION(S)?

WERE OTHER PRODUCTS PRODUCED ON THE SAME LINE OR USING SOME OF THE SAME EQUIPMENT DURING THE “CLEAN-UP

TO CLEAN-UP” PERIOD? (YES) (NO) EXPLAIN:

WHAT INTERNAL COOK TEMPERATURE WAS REACHED?

DID THE PRODUCT REACH ANY SPECIFIED Aw OR pH REQUIREMENT? (YES) (NO) SPECIFY:

DOES THE FIRM HAVE AN IN-PLANT ENVIRONMENTAL MONITORING PROGRAM FOR Listeria monocytogenes? (YES) (NO)

WAS THE SOURCE OF THE CONTAMINATION IDENTIFIED? (YES) (NO)

EXPLAIN:

IS THERE DATA THAT COULD LIMIT THE AMOUNT OF PRODUCT AFFECTED? (YES) (NO) EXPLAIN:
070

RECALL WORKSHEET- FOR INTERNAL FSIS USE ONLY

(E. coli O157:H7 ATTACHMENT)

DESCRIBE THE PRODUCTION/PROCESSING OPERATION AND/OR ATTACH A PROCESS FLOW DIAGRAM:

_

DOES THE ESTABLISHMENT CONDUCT DAILY E. coli O157:H7 TESTING? (YES) (NO) WHAT FREQUENCY?

WHAT WERE THE “CLEAN-UP TO CLEAN-UP” TIMES?

WHAT WAS/WERE THE SOURCE(S) OF THE MATERIALS YOU PROCESSED? 

POUNDS OF PRODUCT PRODUCED “CLEAN-UP TO CLEAN-UP”:

WAS REWORK OR CARRYOVER FROM THIS PRODUCT USED IN FUTURE PRODUCTION? (YES) (NO)

ON WHAT DATES WERE THE REWORK OR CARRYOVER USED AND WAS THERE ANY REWORK OR CARRYOVER FROM THAT

DAYS PRODUCTION USED IN FUTURE PRODUCTION?

_

WERE THERE ANY PROCESS DEVIATIONS DURING THE PRODUCTION OF THE REWORK/CARRYOVER? (YES) (NO)

WHAT WAS/WERE THE CORRECTIVE ACTION(S)?

WERE OTHER PRODUCTS PRODUCED ON THE SAME LINE OR USING SOME OF THE SAME EQUIPMENT DURING THE “CLEAN-UP

TO CLEAN-UP” PERIOD? (YES) (NO) EXPLAIN:

WERE OTHER PRODUCTS PRODUCED FROM THE SAME MATERIALS? (YES) (NO) EXPLAIN: _

WAS ANY MICROBIOLOGICAL TESTING PREFORMED BY THE COMPANY? (YES) (NO) EXPLAIN, INCLUDE RESULTS:

IS THERE DATA THAT COULD LIMIT THE AMOUNT OF PRODUCT AFFECTED? (YES) (NO) EXPLAIN:
071

RECALL WORKSHEET -FOR INTERNAL FSIS USE ONLY

(Salmonella sp. ATTACHMENT)

(READY-TO-EAT PRODUCT)

DESCRIBE THE PRODUCTION/PROCESSING OPERATION AND/OR ATTACH A PROCESS FLOW DIAGRAM:

_

_

WHAT WERE THE “CLEAN-UP TO CLEAN-UP” TIMES?

WAS CARRYOVER PRODUCT FROM PREVIOUS PRODUCTION PACKED WITH THIS CODE? (YES) (NO)

WAS THERE A LINE CLEANUP AFTER THE CARRYOVER WAS RUN? (YES) (NO)

WHAT DATE WAS THE CARRYOVER PRODUCT CARRIED OVER FROM?_

WERE THERE ANY PROCESS DEVIATIONS DURING THE PRODUCTION OF THE CARRYOVER PRODUCT? (YES) (NO)

EXPLAIN:

_

WHAT WAS/WERE THE CORRECTIVE ACTION(S)?

_

WERE OTHER PRODUCTS PRODUCED ON THE SAME LINE OR USING SOME OF THE SAME EQUIPMENT DURING THE “CLEAN-UP

TO CLEAN-UP” PERIOD? (YES) (NO) EXPLAIN:

WHAT INTERNAL COOK TEMPERATURE WAS REACHED?

DID THE PRODUCT REACH ANY SPECIFIED Aw OR pH REQUIREMENT? (YES) (NO) SPECIFY:

DOES THE ESTABLISHMENT HAVE POST-PROCESSING CONTROLS? (YES) (NO) SPECIFY (include records):

WAS ANY MICROBIOLOGICAL TESTING PERFORMED BY THE COMPANY? (YES) (NO) EXPLAIN, INCLUDE RESULTS:

IS THERE DATA THAT COULD LIMIT THE AMOUNT OF PRODUCT AFFECTED? (YES) (NO) EXPLAIN:
072

RECALL WORKSHEET- FOR INTERNAL FSIS USE ONLY

(Foreign Material or Non-Microbial Contamination Attachment)

DESCRIBE THE PRODUCTION/PROCESSING OPERATION AND/OR ATTACH A PROCESS FLOW DIAGRAM:

_

_

WHAT WERE THE “CLEAN-UP TO CLEAN-UP” TIMES (where applicable)?

HAVE YOU IDENTIFIED THE SOURCE OF THE CONTAMINATION? EXPLAIN:

_

IS THERE DATA THAT COULD LIMIT THE AMOUNT OF PRODUCT AFFECTED? (YES) (NO)

EXPLAIN:

WERE THERE ANY DEVIATIONS REPORTED IN THE MEASURING AND/OR MIXING OF INGREDIENTS? (YES) (NO)

EXPLAIN:

DOES THE ESTABLISHMENT ROUTINELY USE METAL DETECTORS OR OTHER VISUAL IMAGING DEVICES? (YES) (NO)

EXPLAIN:

_

WERE OTHER PRODUCTS PRODUCED ON THE SAME LINE OR USING SOME OF THE SAME EQUIPMENT DURING THE “CLEAN-UP

TO CLEAN-UP” PERIOD? (YES) (NO) EXPLAIN:
073

The Administrative Enforcement Report (AER) Process

OBJECTIVES

After successful completion of this module the trainee will be able to:

1. Explain and/or list the following concepts of critical thinking

a. What is critical thinking?

b. The importance of critical thinking to the AER process

2. Explain the role of the PHV in the AER process

a. In-plant team leader

b. Ensuring accurate supporting documentation

c. Ensuring proper lines of communication

d. Performing verification activities (verification plans)

3. Explain the role of the AER within the FSIS regulatory framework

a. Statutes and Rules of Practice as a framework of the AER case file

b. Ensuring that the establishments receive due process

4. List and describe the main supporting components of the AER

a. Noncompliance Records (NRs)

b. Memoranda

c. Memoranda of Interview (MOI)

d. Signed Statements

e. Other Agency Letters

5. Accurately document a Memorandum of Interview (MOI)

6. List two “other” sources of information pertinent to the AER process

a. Consumer Complaint Monitoring System (CCMS)

b. Recall System

INTRODUCTION

This module covers the agency’s “Administrative Enforcement Report” (AER) format

and thought processes.

This module will also cover:

• The use of critical thinking in developing an enforcement action.

• Different types of official documentation.

• The work methods and general process of building a case.

• The process behind recommending or taking an enforcement action.
074

• The basics of building a case and assembling an AER case file.

• How an establishment’s response is verified by the agency.

• How to assess an establishment’s corrective actions.

Overview of the AER Process

Background

Program Investigators prepare enforcement reports for serious violations of the Federal

Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products

Inspection Act (EPIA). These reports typically include a Predication Statement,

Synopsis of Facts, Narrative Summary, Chronology of Events, List of Witnesses, and

Evidence Obtained but not Submitted. This format has proven to be useful and

necessary for significant criminal and civil cases. However, this format can also be time

consuming to complete. Under 9 CFR Part 500 - Rules of Practice, FSIS is faced with

the challenge of providing a report immediately which supports the basis of the action

taken.

Administrative proceedings, including the documentation produced as a result of

administrative actions, provide FSIS the authority to suspend inspection, with or without

notice. They also provide FSIS the authority to stop a establishment’s right to do

business when serious inhumane practice or food safety concerns are raised.

Administrative proceedings can immediately affect the establishment’s right to conduct

business and profit financially. FSIS needs this documentation immediately if an appeal

by the establishment is received, if the establishment requests an expedited hearing, if

FSIS requests a complaint to withdraw the grant of inspection, or if legal actions are

taken such as hearings, injunctions, requests for seizure, etc.

Administrative enforcement actions can be appealed immediately and can result in an

expedited hearing before an Administrative Law Judge, or other legal officials such as a

District Court Judge. The AER and accompanying exhibits support that the agency has

a basis for the action taken. This section describes the role of the PHV in the AER

process to ensure that there is accurate supporting documentation when the agency

proposes or imposes an enforcement action (e.g., Notice Of Intended Enforcement
075

(NOIE), withholding the marks of inspection, suspension). The documentation (e.g.,

NRs, memoranda, other Agency letters, etc.) must demonstrate the link between the

enforcement action and the regulations. The regulations will be linked with specific

provisions of the FMIA, PPIA, or EPIA later in the AER process. The AER process is

used by FSIS to ensure that Agency personnel have analyzed all available information,

applied critical thinking when making decisions, and have documented those decisions

in a manner that will support the actions taken by the agency. The AER method of

documentation demonstrates that FSIS has an effective and efficient means to

document and maintain administrative actions taken under the Rules of Practice. The

methodology helps to ensure uniformity and consistency.

The AER Report (FSIS Form 5400-9)

The Administrative Enforcement Report (AER), FSIS Form 5400-9, provides an effective

and efficient means for FSIS to document and maintain enforcement actions taken under

the Rules of Practice (9 CFR Part 500). Some AER documentation is written with

statutory and regulatory citations. It is important that both the regulatory and statutory

support is properly cited for the instances that the AER case file is needed as an exhibit

in court proceedings.

The Rules of Practice include:

• Regulatory control action

• Withholding action or suspension without prior notification

• Withholding action or suspension with prior notification

• Notification, appeals, and actions held in abeyance

• Withdrawal of the grant of inspection

• Refusal to grant inspection

• Procedures for rescinding or refusing approval of marks, labels, and containers

Statutory support includes the Acts:

• Federal Meat Inspection Act (FMIA)

• Poultry Products Inspection Act (PPIA)

• Egg Products Inspection Act (EPIA)
076

The AER process entails using a critical systems thinking approach to analyzing

available information and facts. Once all pertinent and available information has been

properly documented and analyzed and the decision leads to a recommended

enforcement action, the case file is assembled and maintained by specially trained

personnel. After the establishment has responded to the intended or effective

enforcement action, the adequacy of the response must be verified by agency

personnel. You as the PHV-IIC will play a critical role gathering and documenting facts,

as well as in these verification procedures.

The AER process is not necessarily linear. Many of the elements are performed

concurrently, in a “back and forth,” or circular/spiral manner. For example, if it is decided

that more information is needed to make a solid recommendation, and then steps must

be taken back to gather this necessary information and then the information must be

reanalyzed. It may take several “rounds” of information gathering/documenting and

analyses before a recommendation for an enforcement action can or should be made.

Under many circumstances, the issue may be resolved by the establishment without the

need for such a recommendation.

Critical Thinking

An Overview of Critical Thinking

This section is a brief introduction into “critical thinking.” This is an integral part of the

AER process and your job as a PHV-IIC and also later in your role as an EIAO. Every

field PHV will receive training as an EIAO and will ultimately perform the same duties as

“full time” EIAOs, albeit at a lower frequency.

Applying critical thinking and analysis will help ensure that any action taken or

recommendation made by you as the PHV, whether it be to recommend or not to

recommend enforcement, is well thought out and based on a thorough review of all

pertinent information. It is important to realize that this process is meant to result in a

legally defensible case file that will, if necessary, stand up in a court of law. If your

analysis is correctly performed and your thought process is well documented, then

chances are very good that any resulting enforcement decision will never be taken to

court.
077

Applying critical thinking will help associate any actions taken with the applicable statute

or regulation, and also ensure that a solid basis exists for taking further action when

warranted. The best laid out thought process is worthless if actions taken are not

supported by the statutes or regulations.

Critical Thinking and How It Fit into the AER Process

Richard Paul1 defines critical thinking as: “The ability to think about one’s thinking in

such a way as to recognize its strengths and weaknesses and, as a result, to recast the

thinking in an improved form.”

Studies have also been performed that have looked at people identified as “critical

thinkers” and the following common characteristics were identified2. Not everyone that is

a critical thinker will possess all of these characteristics, but this gives you an idea of

some of the qualities that are beneficial to the process:

• People who hone critical thinking as a skill

• Inquisitive people

• People with a keenness of mind

• People with a hunger for reliable information

• People who actively use reason

• Open minded people

• People who are systematic

• Analytically minded people

Some examples of people who use critical thinking in their profession or life include

scientists, doctors, trial lawyers, engineers, and good thinkers in general. Critical

1 Dr. Richard Paul. (1993) Critical Thinking – What Every Person Needs to Survive in a

Rapidly Changing World, edited by Jane Willsen and A.J.A. Binker, Foundation for

Critical Thinking, Santa Rosa, CA

2 Steven D. Schaefersman, 1997, Miami University and Peter A. Facione, 1998, Santa

Clara University
078

thinking is a natural part of these professions, and by default your education in veterinary

medicine has set you up for a career in “critical thinking.”

Critical Thinking Frameworks

As scientists and veterinarians, you are already familiar with several types of critical

thinking frameworks:

• The scientific method

• A medical diagnosis

• A systems analysis

You have used the “scientific method” in veterinary school and in practice. A medical

diagnosis is basically a mixture of the scientific method and a systems analysis. When

you make a veterinary diagnosis, you use the basic framework of the scientific method,

but also include a “systems analysis” approach when you assess the symptoms by

organ system(s). You must have an understanding of the organ systems to rule out

certain differential diagnoses. When performing an analysis of the effectiveness of an

establishment’s food safety system, you will use these same basic principles.

You may not be as familiar with the legal or regulatory analysis method as with the other

methods mentioned. This method is used when assessing an establishment’s

compliance with regulatory requirements, as they relate to their food safety system and

public health.

In reality, you will be using a mixture of the above methods to achieve your goal. You

will be analyzing a variety of both scientific and regulatory information that is intertwined

in an establishment’s food safety system. It will be your job as a PHV-IIC to determine

whether the mixture that the establishment has put together is effective and meets basic

regulatory requirements. Later, after receiving specialized EIAO training, you will be

assessing whether the mixture meets the intent of all of the statutory and regulatory

requirements.
079

Critical Thinking and Public Health

So far, we have been focusing on critical thinking as a component of the AER thought

process. Let’s look at it from a public health point of view, since ensuring the public’s

health is the ultimate goal of FSIS. FSIS has long been a public health regulatory

agency. The recent emergence of certain foodborne diseases, such as E. coli O157:H7

has forced FSIS to take a new look at this mission and make changes to the long

established system of meat, poultry, and egg inspection.

It is part of any regulatory public health agency’s mission to seamlessly integrate

scientific principles with a legal framework and public health values3. Critical thinking is

important in achieving this seamless integration. It was used while making significant

organizational and necessary changes at the agency level—it will be as important when

you are making public health and related enforcement decisions at the local level.

The Scientific Method as an Example of Critical Thinking

Now that we have covered some of the basics of critical thinking, we will spend some

time reviewing the “scientific method” as an example of a critical thinking method. This

will help to better understand the connection of scientific critical thinking to the AER

process. Later, we will look at the legal analysis methodology as an example of how to

assess information from a regulatory aspect.

According to Steven Schafersman4, the scientific method requires three major

prerequisites:

1. Use of empirical evidence

2. Use of logical reasoning

3. Possessing a skeptical attitude

The first prerequisite of the scientific method is the use of empirical evidence, which is

using evidence that can be seen, heard, touched, tasted, etc. It is tangible evidence that

can be experienced and is repeatable. In other words, it is using evidence that can be

objectively verified.

3 Steven D. Schafersman, 1997, Miami University

4 Steven D. Schafersman, 1997, Miami University
080

The use of logical reasoning, the second prerequisite of the scientific method, is an

acquired skill—it must be learned. Logical reasoning forces us to face the true facts and

not give in to personal emotions or beliefs. Remember, emotions are not empirical

evidence they are personal reactions to the facts. Likewise, feelings and subjective

beliefs are not empirical facts. Beliefs are personal perceptions of the truth—they have a

personal or subjective spin on them that is influenced by many things, such as culture,

environment, etc. The use of logical reasoning forces us to face reality and be as

objective as possible.

The third major prerequisite of the scientific method is the possession of a skeptical

attitude. This does not mean that you should be skeptical beyond accepting the truth—

but it does mean that you should not accept something as the truth without question.

Change and progress would not happen if we did not constantly question our beliefs,

examine new evidence, reexamine old evidence, and combat self deception. Just

because someone says it is so—does not make it true. A healthy questioning of the

perceived “truth” can lead to new insights and change for the better.

One way of questioning the “truth” is by testing beliefs against objective reality.

Remember beliefs are personal, subjective perceptions of reality. If the consequences

and/or outcomes of an action can be consistently and objectively predicted, regardless

of who is performing the action, we are much closer to the real truth.

The Steps of the Scientific Method:

Now that we have covered the prerequisites of performing the scientific method, we will

review the individual steps to be performed in this methodology. Remember, this is not

a new concept for you as a scientist and veterinarian, but it will be used in an unfamiliar

way in your new position as a PHV.

In the purely scientific world, the steps to perform are as follows:

1. The first step is to identify the problem to study. This is done through an analysis

of existing information and facts, as well as through gathering new information

and facts. This is often performed through observation or qualitative studies.
081

2. The second step is to gather information and facts relevant to the identified

problem. This will help further define the problem and assist in formulating a

hypothesis to be scientifically tested.

3. The third step, once sufficient information has been gathered, is to formulate the

hypothesis.

4. The fourth step is to scientifically test the hypothesis. This is generally performed

through quantitative studies. The result of this test will be to either prove that

your hypothesis is correct—or not.

5. The fifth step, if your hypothesis was not correct is to modify the hypothesis after

further study and then test the revised hypothesis. This is repeated until the

correct solution is found.

6. The final step is then to construct a theory from the evidence gathered and the

proven hypothesis.

In your role as PHV-IIC, you will not be conducting pure scientific studies. You will,

however, use the basic concepts of this logical thought process when analyzing the

effectiveness of an establishment’s food safety system. You will be tasked with

identifying problems, such as regulatory noncompliance, gathering and documenting

information pertinent to the identified problem, and proposing a regulatory solution if the

establishment does not adequately remedy the problem on their own.

By using this type of thought process, you stand less of a chance of letting your

emotions or feelings dictate your actions. Your actions will be supportable by the

agency, both to the regulated industry and if necessary in a court of law.

Regulatory Analysis as an Example of Critical Thinking

As was mentioned before, you will also be performing a legal or regulatory analysis in

your role as PHV-IIC. This section of the module will be an introduction into this thought

process. You will receive more in-depth and detailed training on this type of

methodology when you receive EIAO training in the near future.

When performing a regulatory (legal) analysis, you will follow a framework that is very

similar to the scientific methodology you are acquainted with. There is, however, an

important distinction between the two methods: The goal of the scientific method is to
082

scientifically prove a point, while the goal of the legal analysis is to legally prove a point.

Another way of looking at it is that the scientific method follows the laws of science, while

the legal analysis follows man-made laws, statutes, regulations, etc.

The steps to perform are as follows:

1. Gather the facts

2. Evaluate the evidence

3. Identify the regulatory (legal) elements

4. Develop the rationale

5. Draw the conclusion

The first step is basically the same as in the scientific methods—gather the facts or

information needed to determine what the problem is. You will ask yourself such

questions as:

• Who are the persons involved?

• What event has happened?

• What is the location that is involved?

• Why did the event happen?

It is important that the information gathered is pertinent and based on objective facts—

not subjective opinions. All of the gathered evidence should be properly documented.

After the facts have been gathered, then the evidence must be evaluated. In doing this,

the significance of the gathered information is weighed and assessed to determine if

there is an indication of a problem. In other words, does the evidence point to a

potential statutory or regulatory noncompliance? If not, do we need more evidence? Or,

does the evidence indicate that there is no problem at all?

If it is determined that there is evidence of a potential noncompliance, then the next step

is to identify the statutory and regulatory elements involved. This, of course, requires a

basic understanding and good working knowledge of the most commonly used statutes,

regulations, and current policies (i.e. directives, notices).
083

To identify the applicable elements, you can ask yourself:

• What are the applicable provisions of the statute?

• What are the applicable regulations?

• What are the applicable policies?

It is not expected of you that you will be an expert in all of the statutory and regulatory

language. You may also need an interpretation of the most current policies, since these

are frequently updated to meet changing conditions. If you need technical assistance

with unfamiliar statutes, regulations, or current policies, then you can contact your

supervisor, mentor, or the Technical Service Center.

After you have identified the regulatory elements, the next step is to develop the

rationale. This is putting the pieces of the puzzle together to see the big picture.

• In doing so, you evaluate and explain the relationship of all of the pertinent

events and actions. For example, you could create a “timeline” of the events by

time, place, person, etc.

• Once you have identified the relationships of the events and actions, you will

need to explain the cause and effect of the relationships. In other words, you

need to be able to explain why the events took place in the manner that they did.

• Finally, you will explain the consequences, or outcomes, of the action or actions,

given the relationships identified.

The final step of the regulatory analysis is using a process of deduction to draw a

conclusion. When drawing your conclusion, it is once again vital that you limit yourself to

the known facts. In legal language, the facts are stated in a “premise,” which includes

the reasons for the action, the pertinent facts, and the gathered evidence. Relying on

certainty that is based on the logical connection of premises will result in an accurate

and defensible conclusion that has been proven as true.

As you can see, the general principles are very similar to the scientific methods; the

difference is that this method is more focused on whether a law, statute, or regulation

has been violated rather than whether a scientific principle has been met.
084

In recommending actions, you will need an explanation of your conclusion. In doing so,

you will state the results of your thought process—of your reasoning. You will then

justify your reasoning and base this justification on the facts and credible evidence.

Finally, you will present your explanation in the form of a compelling argument. Being

able to accurately state results, justify procedures, and effectively present arguments,

both orally and in writing, are essential skills in accomplishing this goal.

Examples of how a justification can be presented include:

• Constructing a chart that organizes the findings

• Citing the standards and contextual factors used to judge the quality or

interpretation of a text

• Appealing an established criteria as a way of showing the reasonableness of a

given judgment

As a PHV-IIC you will mainly be documenting your thought process on NRs and in

memoranda. There are also other occasions that will require you to justify your

reasoning, such as in responses to an establishment’s appeals to actions, when

answering inspector’s grievances, and many others.

Self regulation is not as much an individual step in critical thinking as it is a common

thread throughout the process. When performing any of the five steps mentioned above,

you should constantly be evaluating and correcting your interpretation as more or better

information becomes available. You should consequently examine and correct any

inferences that have been drawn and that are affected by the change in interpretation.

You should then review and reformulate any explanations you have completed that are

based on the corrected inferences. This requires skills in self examination and self

correction.

As an example, you may possibly need to change your conclusion in view of the

realization that you have misjudged the importance of certain information. This

realization could come about after you have received additional credible and pertinent

evidence that was not immediately available during your first analysis of the information.
085

As a PHV-IIC, you will find this to often be the case, such as when an establishment

appeals a decision made by yourself or a CSI. If the establishment can provide you with

new, credible, and pertinent information, you may need to revise your conclusion and

possibly sustain the appeal. It is important to be open to new information and not let

your emotions or beliefs be your guide.

One of the inherent problems with any assessment of information is that there might be

holes in the information. Another problem is that the information may be presented in

such a way that the person assessing the information is missing something—even

though all of the information is there. In other words, they are not seeing the forest for

the trees.

Information Sources Used in the AER Process

The critical thinking process is all about looking at information - and there are many

sources of information available. The following section is a brief overview of some the

more common sources of information used in the AER process.

Sources of documented information from “within” the establishment include:

• Noncompliance Records (NRs)

• Memoranda of interview, discussions, meetings, agreements, and similar

documents

• Other agency letters

These methods of documentation will be discussed in more detail later in the module.

There are other sources of information that are located outside of the establishment.

These include:

• The Consumer Complaint Monitoring System (CCMS)

• The Recall System

The following is only a very brief introduction to these systems. You will receive more indepth training in your EIAO training.
086

Other Administrative Activities

OFO personnel also carry out other administrative activities for which an FSIS Form

5000-9 is started, and all supporting documentation will be attached exhibits. Such

administrative activities include:

1. Reviews of the sanitary conditions at custom exempt operations, and, when

necessary, the preparation of written recommendations along with evidence to

the Office of Program Evaluation, Enforcement, and Review (OPEER).

2. Detention of product as set out in FSIS Directive 8410.1

3. Recall Effectiveness Checks as set out in FSIS Directive 8080.1, Recall of Meat

and Poultry Products, and FSIS Directive 5100.2, Enforcement, Investigations,

and Analysis Officers (EIAO) Responsibilities Related to Recalls and Consumer

Complaints,

4. Investigations of prohibited activities as set out in the FMIA, section 10, the PPIA,

section 9 and 10, and the EPIA section 8, such as adulterated product

deliberately distributed into commerce,

5. Investigating illness outbreaks such as illness outbreak related to recall

NOTE: Illness outbreak investigations related to the Consumer Complaint

Monitoring System are documented under the CCMS system, not the AER

system.

6. Non-routine incident investigations addressed in FSIS Directive 5500.2,

Significant Incidence Response, and FSIS Directive 5500.3, Incident

Investigation Team Reviews.

The Consumer Complaint Monitoring System, or CCMS, can be described as follows:

• FSIS receives, tracks, and uses consumer complaints to help identify unsafe

meat, poultry, and egg products that are available to consumers in commerce

• It is important to remember that complaints are alleged by the consumer until

they have been verified by the agency

• It is however not possible to verify all complaints

FSIS receives consumer complaints through a wide variety of sources:

• USDA Meat and Poultry Hotline
087

• Office of Field Operations (OFO) District Offices/Headquarters, FSIS

• Office of Program Enforcement Evaluation and Review (OPEER), FSIS

• Office of Public Health Science (OPHS), FSIS

• Labeling and Consumer Protection, FSIS

• State or Local Health Departments

• Other Federal Agencies

Once the complaint is received, it is entered into an electronic database that is used to

record, triage, coordinate, and track all consumer complaints that are reported to the

agency. Personnel in the District Office review the database daily for open and new

cases and dispatch an EIAO when necessary to investigate.

Similarly, if FSIS becomes aware of a presumptive positive laboratory sample result for a

foodborne public health hazard and the establishment has shipped the affected product,

a recall of that product will be issued. In this instance, the District Office will once again

dispatch an EIAO to investigate.

In both cases, you as the PHV-IIC at the affected establishment will be working closely

with the EIAO in the investigation and, if necessary, in building the case for the AER.

Supporting Documentation in the AER Process

Proper and well thought out documentation is the key to supporting any conclusions or

decisions made. Documentation is the rock foundation of the AER process. Like any

foundation, if it is built of solid rock it can support a lot of weight. If, on the other hand, it

is built of sand, it will not adequately support any structure.

In your role as a PHV-IIC, it will be your duty to ensure that all documentation generated

by you and your inspection team is complete, accurate, well thought out, and well

supported

The following section is a brief overview of some of the documentation that is used in the

AER process. These documents are then attached to an AER as support.
088

The most common types of documentation encountered in the AER process include:

• Noncompliance Records (NRs)

• Memoranda

• Memoranda of Interview (MOIs)

• Signed Statements

• Decision Memos

• Other Agency Letters

Now let’s take a closer look at some of these types of documents.

The Noncompliance Record (NR)

The Noncompliance Record, or NR, will be the format that you will use most frequently in

the establishment environment. This is an electronic form used to document regulatory

noncompliance and build a history through linking non-compliances with common

causes. The NR is created in the Public Health Information System (PHIS) when a

noncompliance is found during an inspection task.

As was discussed in the Inspection Methods portion of your PHV training, it is important

to ensure that the proper regulatory citation is included on the form when documenting

any noncompliance. If an improper regulation is cited, then the document will not stand

up to the appeals process or in a court of law. If you are not sure about the regulatory

citation, then ask your supervisor or contact the Policy Development Division for

assistance.

The documentation on an NR should be complete and accurately depict the

circumstances and relevant facts. The description should focus on the big picture—on

the systems-level problem. If you concentrate on minor non-compliances then chances

are you will miss larger systems problems. Again, you should focus on the forest, not

the trees—the trees should help describe the forest.
089

Memoranda

Memoranda are important documents in establishing a history. These documents are

created in PHIS in a standard format. Regardless of style, the memorandum should be

signed and dated.

The content of a memorandum can include matters that are not regulatory

noncompliance, but are pieces of information that “round out” or complete the picture.

This includes information provided to the establishment, documentation of group

discussions, or minutes of meetings. It is important to keep a copy of any memorandum

provided to the establishment in the agency files.

Memoranda of Interview (MOI)

Memoranda of Interview (MOI) are a special form of memorandum that documents a

formal or informal interview with agency personnel. An interview is conducted if the

pertinent facts are unclear or if there is additional relevant information that is otherwise

not documented. These are important pieces of documentation in establishing a history

Such memoranda are to: 1) identify all participants present at the meeting; 2) explain all

facts that provide the basis for the meeting; 3) fully describe the meeting and 3) be

written in a concise and clear manner.

MOIs are used to document information pertaining to a specific set of facts and

summarize key points of this information as it is gathered in an interview with a person

with direct, not second-hand, knowledge of relevant information.

When documenting the information, it is important to accurately depict the relevant facts

as they have been revealed in the interview. Do not document opinions or speculation.

Like any other memorandum, the interviewer documents the information and is the one

who signs and dates the document.

Signed Statement

A signed statement is very similar to an MOI, but is a more formal record of an interview

taken by specially trained personnel. In this case, the person interviewed is asked to

sign and date the document after they have reviewed for accuracy. You will not be

taking signed statements until you receive further training.
090

Decision Memo

Decision memos are an integral part of the AER documentation process. In the

discussion of critical thinking and cognitive skills, we illustrated the importance of

explaining, or justifying, one’s reasoning based on credible evidence.

A decision memo does just that; it explains the reasoning behind a decision or

recommendation for an enforcement action.

Decision memos are vital pieces of documentation in the AER case file. They

synthesize the available information and supporting documents into a single document.

They relay to the reader the critical thought process used in analyzing the information

and how a conclusion was reached. The decision memo relates the information not only

back to regulatory requirements, but also back to the statutory authority of the agency.

This is an important aspect of the AER documentation process, since the AER case file

is a legal document.

As a PHV-IIC, you may be documenting decision memos pertaining to the

recommendation of enforcement action related to repeated noncompliances or

inhumane handling.

Official Agency Letters

There are a number of official agency letters that are issued to establishments by the

District Office. These letters officially inform an establishment, in writing, of an intended

enforcement action or one in effect. These are enforcement letters and are not issued

by PHV-IICs. They are listed here for informational purposes only.

• Notice of Intended Enforcement (NOIE)

• Notice of Deferral

• Notice of Suspension

• Notice of Suspension Held in Abeyance

• Letter of Information (LOI)

• Letter of Warning (LOW)
091

BUILDING A CASE

Up to now, we have focused on the building blocks of the AER process. These are:

• How to critically process information and reach a defensible and logical

conclusion

• How to properly document the information and justify your conclusion

We are now going to look at how to put these building blocks together and build the case

for enforcement.

The first step in building a case for enforcement is determining the “enforcement stage”

that the establishment is currently in. The enforcement stages are based on the Rules of

Practice (ROP), which are found in 9 CFR Part 500. The ROP were covered in the

Inspection Methods portion of your training.

The enforcement stages include:

• Pre-Enforcement Stage

• Enforcement Stage

• Deferral or Abeyance Stage

• Legal Stage

These stages require different actions in your role as PHV-IIC, which will be covered

later in this module. For now, let’s take a brief look at each of the stages.

Pre-Enforcement Stage

In the Pre-Enforcement Stage, the establishment is not currently under any type of

active enforcement action—either NOIE, suspension, or withdrawal.

Possible regulatory actions taken under the ROP in this stage are:

• Regulatory Control Action (RCA)

• Withholding the Marks of Inspection

This is the stage that most establishments operate under and is the stage where the

professional judgment and critical thinking abilities of the in-plant inspection team are
092

extremely important and most frequently used. In this stage, you as the PHV-IIC will

ensure proper documentation of regulatory non-compliances on NRs and appropriate

association of recurring problems. You discussed how to do this in the Inspection

Methods portion of your training. You will also ensure proper documentation of other

issues and concerns on memoranda, as was discussed earlier in this module in the

“Documentation” section. This is a vital part of the AER process for two reasons. First,

you are building a history of any recurring problems while taking the establishment’s

entire food safety system into account. Second, you are ensuring that the

establishment’s due process rights are not violated by providing them with the feedback

they need to comply with the regulatory and statutory requirements of the agency.

Under normal circumstances the establishment will not leave this stage. If, however,

you determine through your critical thinking process that the establishment’s food safety

system is not effective and that there is a public health food safety concern, you are

required to act. In doing so, you will follow the ROP:

• If there is an immediate concern, you will take immediate action and ensure that

there is no threat to the public’s health. You will then contact your supervisor for

further guidance.

• If there is no immediate concern, you will recommend an enforcement action to

your supervisor. At this point, an EIAO may or may not be dispatched to the

establishment to perform a comprehensive food safety assessment. This will

depend on the specifics of the case and whether the specific type of detailed

information gathered through this type of methodology is necessary for the

analysis or not.

• In both instances, your documentation of the information and the justification you

provide regarding your conclusion is an integral part of the continuation of the

process.

Enforcement Stage

The establishment is in the Enforcement Stage if it has been issued an NOIE or placed

immediately under a suspension. According to the ROP, these constitute two types of

suspensions:
093

Suspension of inspection personnel with prior notification: In this case, the establishment

will receive an NOIE prior to the suspension going into effect. This gives the

establishment an opportunity to respond to the agency’s concerns before the suspension

goes into effect and provides them due process.

Suspension of inspection personnel without prior notification: Here, the establishment is

placed immediately under a suspension; the suspension is in effect, because of an

immediate threat to the public’s health.

At the point the establishment receives an NOIE, or when the suspension goes into

effect without prior notification, is when the establishment is in the enforcement stage.

As a PHV-IIC, you and your in-plant inspection team will be actively engaged in the

evaluation process of the establishment’s response to the suspension while the

establishment is in this stage.

Deferral or Abeyance Stage

The Deferral or Abeyance Stages are technically a sub-set of the enforcement stage.

An establishment is in this stage when:

• An NOIE has been issued and the establishment has adequately responded to

FSIS. The suspension then temporarily does not go into effect, allowing the

establishment to operate and demonstrate to FSIS the effectiveness of their

response. You as the PHV-IIC, together with your in-plant inspection team, will

verify this effectiveness through a verification plan. If your verification results

lead to the conclusion that the response is not effective, the suspension then

goes into effect. So the decision to place the suspension in effect is deferred

while the effectiveness of the establishment’s response is verified.

• An establishment has been placed under a suspension in effect and has

adequately responded to FSIS’ concerns. The suspension is then temporarily

lifted, or held in abeyance, while the establishment demonstrates the

effectiveness of their response. As above, you as the PHV-IIC and your in-plant

inspection team will verify this effectiveness through a verification plan. If your

verification results lead to the conclusion that the response is not effective the

suspension is reinstated.
094

Legal Stage

The Legal Stage is a special type of enforcement stage. In this stage, the agency has

filed a legal complaint for withdrawal of inspection. This means that the establishment’s

Grant of Inspection, which allows them to operate under federal inspection, is

permanently revoked. The agency will petition the court for withdrawing inspection from

an establishment if there are acts of criminal intent or if multiple enforcement actions

against the establishment have been necessary.

If the establishment has been placed in the legal stage, then many layers of the agency

will be involved in the case, including legal council. You, as the PHV-IIC may be

requested to provide information or to testify under these circumstances. This only once

again illustrates the importance of properly thinking through and documenting your

decisions and conclusions.

Recommending or Taking an Enforcement Action

As you have seen, the decision to place an establishment under an enforcement action

is a multi-layered process and should not be taken lightly. It must be well thought out

and supported. The following is a synopsis of the elements involved in making a

recommendation for an enforcement action or for taking one.

First, remember that recommending or taking enforcement actions is based on a

conclusion reached through a critical analysis of the pertinent and credible information.

Ultimately, portions of the analysis will be performed by various members of the District

inspection team, such as EIAOs, FLSs, and DMs. But, under normal circumstances, the

in-plant inspection team will be the driving force that initiates the process. This

recommendation will or will not be supportable based on the strength of their

documented case history and the objectivity and logic of the justification. It is your

responsibility as a PHV-IIC to ensure that all “in-plant” pieces of the process are well

thought out, properly documented, and supportable.

The action that you recommend will depend on several factors that you must take into

account during your critical thinking process:
095

• The enforcement stage the establishment is in—as a PHV-IIC, you will most

commonly be recommending an action revolving around a suspension.

• The egregiousness of the issue(s)—depending on the severity of the issue you

will recommend a suspension either with or without prior notification, or under

extreme situations, a complaint for withdrawal of inspection may be

recommended. The Rules of Practice (9 CFR 500) are the regulations used for

making these decisions.

• Prior actions taken—the regulatory and enforcement history of the establishment

will play an important role in your recommendation. As such, an establishment

that repeatedly cannot, or will not, comply with the regulatory and statutory

requirements will be considered for regulatory enforcement based on the

repetitive noncompliance. FSIS documentation of the establishment’s failures is

critical in this case.

It cannot be stressed enough that the recommended or implemented action must be

adequately supported and justified. The documented history found in the relevant NRs,

memoranda, and other agency letters, build the foundation for the critical thought

process leading to the recommendation. The synopsis of the entire thought process and

the justification for the recommendation is then documented in the decision memo and

attached to the AER file. Once again, it is your responsibility as a PHV-IIC to ensure

that all in-plant pieces of the AER process are well thought out, properly documented,

and supportable.

Assembling an AER Case File

At the point that a recommendation is made to take an enforcement action against an

establishment, an AER case file is initiated. This section is a short introduction into how

such a case file is assembled. In your EIAO training, you will receive a more thorough

introduction into the management of these AER case files.

The AER case file is commonly compared to a book that is comprised of multiple

chapters. The entire case file is the “book” which is assembled in multiple sections that

are the “chapters,” called Administrative Enforcement Reports (AER). Each AER
096

corresponds to an enforcement action or stage—from beginning to end. The AER is a

special FSIS form that is filled out by specially trained personnel, such as EIAO.

For example, a chapter would begin with the issuance of an NOIE and would end, either:

• When the case is closed after a deferral and the establishment’s response was

verified as effective, or

• When the suspension goes into effect due to an inadequate response.

All supporting documentation, including the decision memo, is then attached to the AER

form for future reference. Each “chapter” (AER) is assembled in the same manner and

receives a special AER number that is assigned to it by the DO. While each AER is an

independent piece of the file, or “story,” they build on one another to complete the “story”

that is told by the “book.”

There are special rules for assembling and maintaining the AER case files and you will

receive specialized training for this purpose in your EIAO training. Until you have

received this specialized training, you will not be expected to complete an AER form

and/or assemble or maintain an AER case file. You will, however, still be a vital part of

the AER process.

See chart at the end of this module on pages 34 & 35

Verifying an Establishment’s Response to an Enforcement Action

Earlier in this module, we discussed verifying the adequacy or effectiveness of an

establishment’s response to an enforcement action. FSIS verifies this response through

the development and implementation of a verification plan. You have already covered

verification plans in the Inspection Methods portion of your training, so this section will

serve as a short review. This is an extremely important part of the AER process.

The verification plan provides a systematic means for FSIS to ensure that an

establishment is effectively carrying out its corrective actions regarding an NOIE or

suspension. Its main purpose is to ensure that all aspects of the establishment’s

response are appropriately verified.
097

The verification plan is designed to:

• Verify that an establishment has fully implemented revisions to its Sanitation

SOP and HACCP system

• Verify that an establishment has fully implemented all corrective actions

• Verify that the revisions and corrective actions are effective in assuring regulatory

compliance

The verification plan also assists the establishment in understanding the nature and

importance of FSIS’ verification activities. This is an important factor in the

establishment’s due process rights.

A verification plan should be developed whenever:

• A decision is made to defer enforcement (suspension) following the issuance of

a NOIE

• A decision is made to hold a suspension in abeyance following the suspension

of the assignment of inspectors

• In both instances, the establishment will provide FSIS with a response to agency

concerns. This response must then be verified.

Under normal circumstances, the assigned EIAO has the primary responsibility for

preparing the written verification plan. If an EIAO was not involved in the development

of the case, then this responsibility will be with the FLS and the in-plant inspection team.

In any case, development of the plan should be based on input from the FLS, the

assigned EIAO, and the in-plant inspection team, since these are the individuals with the

best knowledge of the establishment and the conditions under which it operates.

As the plan is being developed, the FLS should correlate with the PHV-IIC and the EIAO

to assure the verification plan:

• Covers pertinent issues

• Is comprehensive

• Accurately reflects verification activities to be carried out by the inspection team
098

It is important that the plan be correctly developed containing all critical details. This

requires objective input from all agency parties involved. The establishment is not a part

of this process.

The Role of the PHV in the AER Process

Now that you are familiar with all of the components of the AER process, we will recap

your role as a PHV-IIC in the process. Your primary role as a PHV-IIC is to be the inplant team leader in the development of enforcement actions. Once you receive EIAO

training, you will also be called upon to perform AER functions specific to that

methodology. This will include more detailed assessments of the design of an

establishment’s food safety system, writing decision memos, and more.

Pre-Enforcement Stage

Depending on the enforcement stage that the establishment is in, you as a PHV-IIC will

perform varying functions related to the AER process. In the Pre-Enforcement Stage

you will ensure that NRs are properly documented for regulatory non-compliances by the

in-plant inspection team. Remember, NRs are not only a vital document for the AER

case file, they also are an important vehicle in ensuring that the establishment’s due

process rights are not violated.

In the pre-enforcement stage, you will ensure that timely information on the conditions in

the establishment is provided to your FLS, and when necessary, you will consult with

your FLS for guidance on how to proceed, as well as your approach to an enforcement

action or recommendation. You will also ensure constant communication with

establishment management to provide and obtain relevant information related to

pertinent issues. As the PHV-IIC, you will ensure that these discussions are

documented in memoranda and placed in the agency’s files for future reference.

Enforcement Stage

In the Enforcement Stage, you will ensure important information regarding any action to

be taken is communicated to establishment management. You will further work with

your FLS, any assigned EIAO, and your in-plant inspection team to provide accurate and
099

pertinent information and/or content to the DO for inclusion in the NOIE or suspension

letter.

In the enforcement stage, you will remain in communication with your FLS to provide him

or her with timely information and updates on the current and continuing conditions in

the establishment. You will also continue your role as the in-plant team leader and

provide your in-plant inspection team with leadership and support, and you will ensure

that the team remains on track and is focused on the task at hand. Tempers can rise

during an enforcement action. You will ensure that your in-plant team remains objective

and professional, as well as ensure that they are not subjected to intimidation or

harassment from the establishment’s employees.

Deferral or Abeyance Stage

In the Deferral or Abeyance Stage, you will provide information to your FLS as it applies

to the review of the establishment’s proposed corrective actions. When necessary, you

will communicate with establishment management to obtain additional clarifying

information to facilitate the review. You will also work with your FLS and any assigned

EIAO to ensure that the verification plan is complete and comprehensive. In doing so,

you will discuss the verification plan with the FLS and the in-plant inspection personnel,

prior to the establishment implementing its corrective actions. As the in-plant team

leader, you will provide guidance to and coach your in-plant inspection team on the

appropriate execution of the verification work methods necessary for the proper

implementation of the verification plan.

In the Deferral or Abeyance Stage, you will continue to conduct weekly meetings with

the establishment with an emphasis on discussing issues that emerge during the

deferral or abeyance period. You will conduct special work unit meetings with your inplant inspection team to correlate on verification activities and discuss any problems,

questions, or concerns. When necessary, request clarification from your FLS, who is the

overall team leader in this effort. You will provide information to and collaborate with any

EIAO assigned to the case to summarize the verification activities.
100

Finally, you will provide timely information to your FLS to recommend a decision on

whether to close out, continue, or reinstate a suspension of inspection at the

establishment.

Legal Stage

While it is a relatively rare occurrence, the District Office may recommend that the

agency file a complaint for withdrawal of inspection from the establishment. As the PHVIIC, you will also have a role in this Legal Stage of the AER process.

In the Legal Stage, you may be asked to:

• Collaborate with the FLS, assigned EIAO, and/or DDM to prepare the

recommendation for withdrawal.

• Prepare or assist in the preparation of a declaration to be submitted to the court.

• Testify at a hearing regarding the conditions in the establishment.

• Provide timely information to the FLS, DO, and/or Office of General Council

regarding current conditions in the establishment.

A Systematic Review of Enforcement Actions

Now that you have a basic understanding of the components of, and your role in, the

AER process, let’s look at the flow of the enforcement process from beginning to end.

The following pages are flowcharts that depict the options of enforcement actions

possible, as they are determined by the critical thought process.

The Pre-enforcement Stage

Pre-Enforcement Stage

1a Pre-Enforcement Documents & Issues:

•Linked NRs

•Documented Histories

•Other

1b

No Action Crystallize Issues: NRs 30-Day Letter

Comprehensive FSA

2a Other Reviews 2b

Interviews Need More

Etc. Information

2c

3a 3b

Decision Memo

3c

Go To: Enforcement Stage 93
101

The pre-enforcement stage begins with a documented history of noncompliances and

issues. Based on the in-plant inspection team’s assessment of the information, which is

led by the PHV-IIC, there are two courses of action:

1a) The available information does not support any action at this time.

1b) The available information supports further review.

If the consensus is that a further review is warranted (1b), depending on the types of

noncompliance an EIAO may or may not become involved in the process at this point.

There are three options at this point, depending on the conclusion of the review:

2a) The available information does not support any action at this time.

2b) There is insufficient information to draw a proper conclusion, or the available

information is inadequately documented to support an action.

2c) There is sufficient information to start a formalized process. This is the most

common option at this point if an EIAO is involved; this is in order to have

complete records of their review.

If the option of a formalized review (2c) is chosen, then a decision memo is documented

with a formal recommendation. There are three possible recommendations:

3a) No action is warranted.

3b) There is insufficient or inadequate information at this time to make a

recommendation.

3c) There is sufficient evidence to recommend a suspension, either with or

without prior notification.

It should be pointed out that there is no specific, minimum, or maximum timeframe

attached to this process—the process should be timely and the ultimate timeframe will

depend on the specific circumstances.
102

The Enforcement (NOIE) and Deferral Stage

Enforcement Stage: NOIE

Establishment Response to NOIE

Letter of 4a 4b

Information Decision Memo Deferral Notice

4c

Close AER Suspension 5bVerification

#1 In Effect Plan

Go To: Establishment Response 5a

To Suspension

Letter of

Warning 94

The Enforcement Stage begins when an NOIE has been issued to the establishment.

Based on the District inspection team’s assessment of the response, which is led by the

FLS, there are three courses of action:

4a) The establishment’s response reveals that the agency’s conclusion is wrong

and a suspension is not warranted. The case is closed out with a Letter

of Information—this should be an extremely rare occurrence if the

assessment is properly performed and supported.

4b) The establishment’s response is adequate and the suspension is placed in

deferral. (Note: At this point, the establishment is in the deferral stage,

which is also depicted on this slide.)

4c) The establishment’s response is inadequate and the suspension is placed in

effect.

If the decision to suspend is deferred (4b), then a verification plan is developed and

implemented. Based on the results of the agency’s verification, there are two options:

5a) The establishment has adequately and effectively demonstrated compliance

and the case are closed with a Letter of Warning. This also closes out

the AER and the case file.
103

5b) The establishment cannot adequately and effectively demonstrate

compliance and the case the suspension is placed in effect.

If the suspension is placed in effect (4c or 5b), then the AER for this stage is closed and

a new AER for the suspension stage is opened. The case file remains open.

It should be pointed out that, as above, there is also no specific timeframe attached to

this process.

The Enforcement (Suspension) and Abeyance Stage

Enforcement Stage: Suspension

Establishment Response to

Suspension

Legal Stage:

Request Withdrawal 6c 6b

Suspension

Of Inspection Decision Memo Remains in Effect

6a

Close AER Suspension

#2 Held in Abeyance

7a 7b

Close with Verification Reinstate

Letter of Warning Plan Suspension

95

The enforcement stage for a suspension begins when a suspension goes into effect.

Based on the District inspection team’s assessment of the response, which is led by the

FLS, there are three courses of action:

6a) The establishment’s response is adequate and the suspension is held in

abeyance. (Note: At this point in time the establishment is in the

abeyance stage, which is also depicted on this slide.)

6b) The establishment’s response is inadequate and the suspension remains in

effect.

6c) Circumstances warrant that the agency file a complaint for withdrawal of

inspection. This closes out this AER and opens a new AER for the legal

stage. The case file remains open.
104

If the suspension is held in abeyance (6a), then a verification plan is developed and

implemented. Based on the results of the agency’s verification, there are two options:

7a) The establishment has adequately and effectively demonstrated compliance

and the case are closed with a Letter of Warning. This also closes out the

AER and the case file.

7b) The establishment cannot adequately and effectively demonstrate

compliance and the suspension is reinstated. As above, there is no

specific timeframe attached to this process.

SUMMARY

Using the AER process is an important part of your job as a PHV. The process entails

using your critical thinking skills to assess information and take or recommend actions

based on those assessments. The assessment will only be as good as the quality and

completeness of the information that is analyzed. Likewise, the accuracy of the

conclusion will be heavily dependent on the objectivity of your assessment.

As an in-plant PHV-IIC, another of your main functions in the AER process will be to

ensure accurate, relevant, and complete documentation of all information related to a

problem or concern. Your in-plant inspection team plays a vital role in identifying

problems and collecting information. If this is not properly documented, then the

information will not be available as support for a potential future case. Proper

documentation also means that the appropriate regulation and/or statute is cited.

Remember, your team’s documentation and assessments are the foundations of the

AER case files. It is your responsibility as the in-plant team leader to ensure that that

foundation is rock solid.
105

A numbering system has been devised to facilitate using the AER for multiple types of

cases.

To number the AER:

• The first number is the DO number.

• The second number is the fiscal year.

• The lettering identifies the report type.

• The last numbers enable FSIS to determine how many reports of this

nature have been completed in a given District.

For example, AER 15-05-N003, the:

• 15 is for the Denver DO.

• 05 is for the fiscal year 2005.

• N indicates an NOIE.

• 003 means the NOIE is the 3rd NOIE issued in Denver in the fiscal year.

The table on the following page contains all of the types of reports that may be

completed under the AER system and the abbreviations for each type.
106

AER Report Type Report Number

Example

NOIE (N) 65-05-N003

Suspension (S) 65-05-S001

Reinstatement (R) 65-05-R001

Appeal to DM (A) 65-05-A010

Withholding of Labels (WL) 65-05-WL001

Custom (C)(Request to withdraw the custom exemption) 65-05-C001

Recall Effectiveness Check (REC)

NOTE: When completed for recall effectiveness checks, insert in block 11 of the FSIS 5400-9, the

FSIS Recall Number, (e.g., FSIS-REC-XXX-200X).

65-05-REC001

Detention (D) 65-05-D002

Prohibited Act (PA) 65-05-PA001

Outbreak of Illnesses Investigation (OI) 65-05-OI001

Non-routine incident report (NRI) 65-05-NRI001

Withdrawal of Inspection (W)

NOTE: This would be specified under OTHER in block 11.

65-05-W001

Complaint for Suspension (CS)

NOTE: This would be specified under OTHER in block 11.

65-05-CS001

Other (O) 65-05-O001
107

WORKSHOPS

Workshop I

1. The role of the PHV in the AER process is to:

a. Act as the in-plant team leader

b. Ensure accurate supporting documentation

c. Ensure proper lines of communication

d. Perform verification activities

e. All of the above

2. Which of the following are supporting components of the AER:

a. NRs

b. Memoranda

c. MOIs

d. NOIEs

e. All of the above

3. A Memorandum of Interview is signed by the person performing the interview.

TRUE FALSE

4. Which of the following are sources of information pertinent to the AER process?

a. Documented establishment history (NRs, memoranda, etc.)

b. Consumer Complaint Monitoring System (CCMS)

c. Recall System

d. All of the above

5. A recommendation for an enforcement action should be based on subjective

opinions.

TRUE FALSE

6. A Memorandum of Interview can be the only documentation issued to an

establishment by a PHV for a SPS regulatory noncompliance.

TRUE FALSE

7. When completing an NR, it is important that it be (choose the best answer):

a. Short and concise

b. Long and very descriptive

c. Accurate and complete

d. Written in technical terms

8. All noncompliance records should be accurate, well thought out, and properly

supported by an appropriate regulatory citation.

TRUE FALSE
108

Workshop II

Assignment:

You are the PHV assigned to a large establishment that slaughters swine and

processes miscellaneous pork cuts and cooked sausages. Over the last three

months, you and inspection personnel have issued NRs for multiple and

recurring noncompliances identified for failure of the Sanitation SOP to prevent

direct product contamination and failure to maintain sanitary conditions as

required in the SPS and linked them appropriately. You issue two more NRs

this week for heavily beaded condensation found in multiple non-production

areas. You review the following NRs:

# 1 The original NR was written on rodent activity.

#2 A NR issued for condensation leading to direct product contamination.

#3 A NR issued for condensation leading to direct product contamination.

#4 A NR issued for holes in walls around pipes behind the smokehouse.

#5 A NR issued for a door with gaps leading to the outside and a hole in the

processing room wall leading to the outside.

#6 A NR issued for rodent droppings in the boiler room.

#7 A NR issued for insanitary conditions due to rodents and contamination

of product by insanitary conditions.

#8 A NR issued for condensation in a production area without direct product

contamination.

#9 A NR issued for condensation in a non-production area without direct

product contamination.

#10 A NR issued for condensation in a non-production area without direct

product contamination.

#11 A NR issued for condensation in a non-production area without direct

product contamination

A) Is this a SPS or Sanitation SOP issue? What is the root cause(s) of the

noncompliances?
109

The establishment responses indicate that corrective actions and preventive

measures have been identified and implemented for each noncompliance. FSIS

verification and documentation shows that these actions were either not

implemented or not effective.

You have kept your Frontline Supervisor informed of the recurring nature of the

situation. You have discussed this with establishment management during the

weekly meetings, and documented these discussions in a memorandum of

interview.

B) What is your recommendation, if any?

You first contact your Frontline Supervisor and make him aware of your

recommendation. You then contact the District Office and provide data to

support your recommendation.

C) From the NRs listed above which ones support your recommendation?
110

D) What would be your role during this deferral stage?

The District Manager will make a decision on the adequacy of the preventive

action as soon as sufficient information becomes available. The DM will use

the information to determine the adequacy of the establishment’s proposed

corrective action, and will notify the establishment in writing of the final

decision.
111

Workshop III

Assignment:

• Pair up with your neighbor

• Interview you partner.

• You are interested in the specifics of his/her veterinary education and career

• Write a short Memorandum of Interview (MOI) documenting the facts you have

learned

Be prepared to present your MOI to the class.
112

Food Microbiology: Part 1
Slaughter: Food Microbiology: Part 1

13-2

113

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

PATHOGENS OF CONCERN ................................................................................................4

SAMPLING .............................................................................................................................5

Common Sampling Errors ...................................................................................................5

Establishment Sampling Programs .....................................................................................6

FOOD MICRO KNOWLEDGE CHECK...................................................................................7

Knowledge Check 1 ............................................................................................................7

Knowledge Check 2 ............................................................................................................7

Knowledge Check 3 ............................................................................................................7

SUMMARY .............................................................................................................................7
Slaughter: Food Microbiology: Part 1

13-3

114

Slides LEARNING OBJECTIVES

N/A Scientific:

1. List pathogens of concern in the Slaughter/Kill Floor context.

2. Identify and give an example of observable pitfalls that could skew sampling

results in the Slaughter/Kill Floor context.

3. Explain how establishment sampling programs in the Slaughter/Kill Floor

context are used to validate and support the establishment’s food safety system.

Regulatory/Administrative:

[None for this topic in this context.]
Slaughter: Food Microbiology: Part 1

13-4

114

Slides PATHOGENS OF CONCERN

2 In groups, review the references related to your assigned pathogen and present

relevant findings about your pathogen. Consider: What do the directives say about

your pathogen? What are the regulatory requirements? What types of products are

high risk? What are appropriate controls? Take notes in the space provided below.
Slaughter: Food Microbiology: Part 1

13-5

114

Slides SAMPLING

3 Common Sampling Errors

What are some common FSIS sampling errors that may lead to skewed sampling

results? What are some examples of how these errors can happen?
Slaughter: Food Microbiology: Part 1

13-6

114

4 Establishment Sampling Programs

How are establishment sampling programs used to validate and support the

establishment’s food safety system?
Slaughter: Food Microbiology: Part 1

13-7

114

Slides FOOD MICRO KNOWLEDGE CHECK

5-8 Knowledge Check 1

Which of the following (on screen) are sources of Salmonella? (Choose all that apply.)

Knowledge Check 2

In the poultry slaughter process, which of the following (on screen) are common

antimicrobial treatments to control for Campylobacter? (Choose all that apply.)

Knowledge Check 3

Which of the following (on screen) are characteristics of Escherichia coli O157:H7?

(Choose all that apply.)

Slides SUMMARY

9 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
119

Food Microbiology: Part 2
120

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................4

Scientific..............................................................................................................................4

Regulatory/Administrative: ..................................................................................................4

PROCESS CONTROL OVERVIEW........................................................................................5

Microbial Contamination......................................................................................................5

Process Control Regulations...............................................................................................6

PROCESS CONTROL VERIFICATION..................................................................................7

Verification Overview...........................................................................................................7

Potential Problems ............................................................................................................ 10

Verification Question ......................................................................................................... 12

Next Step for Verification................................................................................................... 12

Written Procedures............................................................................................................ 13

Process Control Questions................................................................................................ 14

Next Step for Verification................................................................................................... 15

Antimicrobial Interventions ................................................................................................ 16

Next Step for Verification................................................................................................... 17

Sampling Regulations for Process Control........................................................................ 18

PROCESS CONTROL CHARTS.......................................................................................... 19

Chart Overview.................................................................................................................. 19

Maintaining Process Control.............................................................................................. 20

Process Control Charts: Your Role ................................................................................... 20

PROCESS CONTROL CHARTS EXERCISE....................................................................... 22

Step 1................................................................................................................................ 22

Question 1......................................................................................................................... 24

Step 2................................................................................................................................ 24

Step 3................................................................................................................................ 25

Check Your Answers......................................................................................................... 25

Interpretation ..................................................................................................................... 25

PROCESS CONTROL CHART INTERPRETATION EXERCISE ......................................... 26

Interpreting the Data.......................................................................................................... 26

Scenario 1: Part 1.............................................................................................................. 28

Scenario 1: Part 2.............................................................................................................. 29

Scenario 1: Part 3.............................................................................................................. 29

Scenario 1: Questions ....................................................................................................... 31

Scneario 1: Part 4.............................................................................................................. 31

Scenario 1: Questions (Continued) ................................................................................... 32

PROCESS CONTROL CHARTS CONTINUED.................................................................... 34

Skewed Samples............................................................................................................... 34
121

Next Step for Verification...................................................................................................36

Process Control Problem...................................................................................................37

CASE STUDIES....................................................................................................................38

Case Study 1: Part 1 .........................................................................................................38

Case Study 1: Part 2 .........................................................................................................38

Next Step for Verification...................................................................................................38

Salmonella Sample ...........................................................................................................39

Case Study 2.....................................................................................................................40

LIVESTOCK OPERATIONS .................................................................................................40

Livestock Operations Regulations .....................................................................................40

Livestock Operations Resources.......................................................................................41

OPEN BEEF PROCESS CONTROL CHART EXERCISE....................................................49

Scenario 2: Part 1..............................................................................................................49

Discussion Questions........................................................................................................49

Scenario 2: Part 2..............................................................................................................51

Discussion Questions........................................................................................................51

Scenario 2: Part 3..............................................................................................................53

Discussion Questions........................................................................................................54

Scenario 2: Summary........................................................................................................57

KNOWLEDGE CHECK.........................................................................................................58

Knowledge Check 1 ..........................................................................................................58

Knowledge Check 2 ..........................................................................................................58

Knowledge Check 3 ..........................................................................................................58

Knowledge Check 4 ..........................................................................................................58

SUMMARY............................................................................................................................58
122

Slides LEARNING OBJECTIVES

N/A Scientific:

1. Given a scenario, analyze given microbiological data in the Processing context

and interpret the data.

2. List pathogens and allergens of concern in the Processing context.

3. In the Processing context, demonstrate correct techniques for collecting raw,

intact N=60 sampling, RTE sampling, and Salmonella sampling of poultry.

4. Explain and demonstrate how sampling programs are used to validate and

support an establishment’s food safety systems in the Processing context.

5. Given a scenario about an establishment’s sampling practices in the Processing

context, identify and explain observable pitfalls that could skew sampling

results.

Regulatory/Administrative:

1. Identify FSIS sampling programs related to the Processing context.

2. Identify the pathogen of focus for each of those programs and products eligible

for sampling.

3. Identify and locate the directives and notices related to those sampling

programs.
123

Slides PROCESS CONTROL OVERVIEW

3 Microbial Contamination

In the Roadmap Connection below, identify the points in the process where you think

the level of microbial contamination will increase and where you think the level of

microbial contamination will decrease.
124

4 Process Control Regulations

9 CFR 381.65(g) Notes:

So, how do we know if a process is in control or not?

5 Process Control Regulations (Continued)

What directive pertains to verifying that poultry slaughter establishments have

procedures to control visible fecal and enteric pathogen contamination throughout the

slaughter and dressing operations?
125

Slides PROCESS CONTROL VERIFICATION

7 Verification Overview

Evaluation of Poultry:
126

Factors Used to Verify:
127

According to the schematic, what’s the first thing we verify to determine process

control?
128

8 Process Control Verification

How will you verify whether the establishment is effectively implementing these

procedures to control contamination throughout the poultry slaughter process? What

questions would you ask? (Select all that apply.)

❑ If there have been issues, has the establishment taken corrective actions and

were they effective?

❑ What do establishment records indicate about their implementation of these

procedures? [Keep in mind that in poultry this would include their monitoring

records, records of corrective actions taken, sampling records, and the process

control charts themselves.]

❑ Is there any previous noncompliance documented in NRs?

❑ Is there a trend of noncompliance that has been discussed in meetings and

documented in MOIs?

❑ Did the establishment pass the last two weeks of finished product standard

tests?

❑ What is temperature of the scald vat water?

❑ What do FSIS IPP observations of implementation of these procedures indicate

today? [Keep in mind that in poultry, establishment procedures to prevent

contamination throughout slaughter and dressing include sampling and analysis

for microbial organisms, so we should observe establishment sampling

procedures.]

❑ Are there any associated NRs?

9 Potential Problems

Potential problems in poultry slaughter operations that may increase contamination:
129

• Transport crate that is not washed with sufficient frequency. There is a buildup

of fecal material and feathers that can contaminate subsequent flocks during

transport.

• Excessive fecal material is present in the scalder.

• Birds not held off feed may have full crops resulting in increased contamination

at the cropping step.

• Viscera are stuck in machine and there is product build up on breast plates and

bars around wings and legs (yellow arrows).

• Organic material is present on an establishment employee’s arm (yellow arrow).

Water is available for washing, but the employee is not washing with sufficient

frequency to prevent cross-contamination during manual evisceration. Plastic

sleeves are more sanitary and easier to wash than bare arms.

• Bird washes are out of adjustment providing incomplete coverage in rinsing the

bird. Only part of the carcass is receiving the spray.

• Rinses are not positioned to wash contamination off tail area. On the left, a

contaminated carcass moves on the line toward two washes. On the right, the

carcass has moved past the washes, and the contamination remains. In this

situation, should the nozzles be moved up, it is likely that due to the high

pressure and angle of the spray, contamination may not be washed off but

instead may spread to surrounding areas of the carcass.

• Overspray spreads contamination to adjacent areas of the carcass. In the closeup on the right, the middle spray bar results in splashing of water from the thigh

up over the back of the thigh and onto the abdomen area (under yellow arrow),

where it will run down the breast area. The contaminated vent area visible on

the left (inside the red box) will not be washed off when it goes through the

middle spray bar. Instead it will spread contamination to adjacent areas. This is

also true of the faint yellow contamination on the outside of the thigh and bird’s

side (black bar of the right image).

• Cut-up stations do not have water for cleaning knives. Knife sharpeners are

available at each cut-up station and are used as needed. This set up and

practice increases cross-contamination.

• Plastic tubs used to hold raw poultry parts are stacked on wooden pallets, which

are moved to another area in the establishment for further processing.

Establishment employees picked up the tubs and frequently touched the

bottoms of the tubs when emptying them into the hopper. Then, without first

sanitizing their gloves, employees pushed the parts into the hopper. This is an

example of both cross contamination and not maintaining operational sanitation.

• Sanitary operation is not being maintained. There is significant buildup of fat and

other organic material on the belts. This presents an increased risk of cross

contamination.

• Sanitary operation is not being maintained. There is a significant buildup of fat

and other organic material on the conveyors, blades, and associated product

contact surfaces. This presents an increased risk of cross contamination.
130

What would you expect the pre-chill microbiological process control charts to show if

the establishment is effectively implementing their procedures?

10 Verification Question

What would you suspect if you saw evidence of the establishment regularly or

systematically allowing frequent or recurring contamination of carcasses with feces or

ingesta to occur, but the pre-chill microbial process control charts showed almost

perfect process control?

11 Next Step for Verification

According to our schematic, what’s the next thing we would use to verify process

control in official poultry slaughter establishments?
131

12 Written Procedures

9 CFR 381.65(f) Notes:
132

True or False: An official poultry slaughter establishment must have a CCP to prevent

carcasses with visible fecal contamination from entering the chiller.

13-15 Process Control Questions

Question 1: A trend of noncompliance with 9 CFR 381.65(f) would be likely to correlate

with which of the following?

Question 2: If a poultry slaughter establishment has an increase in carcasses

contaminated with fecal material at pre-chill, it is likely due to a failure of what?

Question 3: If an establishment has placed its procedures for controlling visible fecal

contamination in its HACCP plan as a CCP and FSIS finds fecal contamination while

performing a Poultry Zero Tolerance task, what regulation(s) should IPP cite?

Question 4: If an establishment has placed its procedures for controlling visible fecal

contamination in its Sanitation SOPs and FSIS finds fecal contamination while

performing a Poultry Zero Tolerance task, what regulation(s) should IPP cite?

Question 5: If an establishment has placed its procedures for controlling visible fecal

contamination in a prerequisite program and FSIS finds fecal contamination while

performing a Poultry Zero Tolerance task shat regulation(s) should IPP cite?
133

16 Next Step for Verification

According to our schematic, what’s the next thing we would use to verify process

control in official poultry slaughter establishments?
134

17 Antimicrobial Interventions

Which of the following would indicate a problem with the establishment’s antimicrobial

interventions? (Select all that apply.)

❑ Intervention is unvalidated

❑ Critical operating parameters were not met

❑ Multiple zero tolerance failures occurred

❑ Interventions located in unsupportable position

❑ Antimicrobial not being applied as stated in written procedure

❑ Antimicrobial level is less than specified in written procedure

❑ Establishment monitoring of intervention conducted more frequently than

specified in procedure

❑ Are there any associated NRs?

18 Poultry Slaughter Interventions

What could possibly go wrong?
135

• Incomplete coverage is because of inadequate reach of antimicrobial spray in

both images. On the left, only part of the carcass is receiving the spray. On the

right, no spray is applied to the underside of products. In addition, not all pieces

on the conveyor belt are being treated because the arc of the spray (just inside

the yellow lines) is too narrow to cover all product that could pass on the

conveyor. Spray is also not being applied to all pieces due to product piling up

and overlapping on the conveyor belt.

• Note: Dipping (Immersion) is generally a better application method than

spraying as it ensures full coverage of an intervention for a longer period

of time.

• Best practice: Boneless, skinless poultry parts receive an antimicrobial dip prior

to being ground.

What if the critical operating parameters of dwell time, temperature, and concentration

of antimicrobial were not met?

19 Next Step for Verification

According to our schematic, what’s the next thing we would use to verify process

control in official poultry slaughter establishments?
136

20 Sampling Regulations for Process Control

381.65(g)(1) Notes:

381.65(g)(1) states, “Establishments, except for very small establishments operating

under Traditional Inspection or very low volume establishments operating under

Traditional Inspection must collect and analyze samples for microbial organisms at the

pre-chill and post-chill points in the process. Very small establishments operating

under Traditional Inspection and very low volume establishments operating under

Traditional Inspection must collect and analyze samples for microbial organisms at the

post-chill point in the process.”

381.65(g)(2)(i) Notes:

381.65(g)(2)(i) states, “Establishments, except for very low volume establishments as

defined in paragraph (g)(1)(ii) of this section, must, at a minimum, collect and analyze

samples at a frequency proportional to the establishment’s volume of production at the

following rates:

o (A) Chickens. per carcasses, but a

minimum of once during each week of operation.

o (B) Turkeys, ducks, geese, guineas, and squabs. per

carcasses, but at a minimum once each week of

operation.”
137

Slides PROCESS CONTROL CHARTS

22 Chart Overview

What are the key considerations regarding process control charts?
138

23 Maintaining Process Control

Who is required to document the test results monitoring the establishment’s ability to

maintain process control?

• The establishment is required to implement their procedure for sampling and

analysis for microbial organisms and monitor their ability to maintain process

control by 9 CFR 381.65(g) and are required to document the implementation

and monitoring of the procedure by 9 CFR 381.65(h).

24 Process Control Charts: Your Role
139

If the establishment is required to have the data and monitor their ability to maintain

process control, why would FSIS personnel (including you) want to know how to enter

data and make process control charts?
140

Slides PROCESS CONTROL CHARTS EXERCISE

26-31 Step 1
141
142

Question 1

Is the mean for the last two weeks above or below the historical mean for Novosibar

Poultry’s Ebac?

Step 2

What is the standard deviation (SD) of the last two week’s worth of data rounded to two

decimal points? Answer: 152.40

Is it above or below Novisbar’s historical SD of 231.31 which was used to calculate the

Upper Control Limit? Answer: Below (152.40 vs. 231.31)
143

Step 3

Check Your Answers

How did you do?

Interpretation

Now that you know how to enter and chart process control data, how do you interpret

it?
144

Slides PROCESS CONTROL CHART INTERPRETATION EXERCISE

33 Interpreting the Data
145
146

34 Scenario 1: Part 1

Notes:
147

Conditions Notes:

35 Scenario 1: Part 2

Notes:

36 Scenario 1: Part 3

Notes:
148
149

37 Scenario 1: Questions

1. Given what you've observed and what has been documented in the last two

weeks at Novosibar Poultry, do the charts show what you'd expect?

2. If not, what are some possible explanations?

3. What would be your next steps?

38 Scenario 1: Part 4
150

39 Scenario 1: Questions (Continued)

1. Could this information be relevant to your analysis of the charts?

2. In verifying compliance with 9 CFR 381.65(f and g), what other information

would you seek? (Hint: Verification of Procedures for Controlling Contamination

Throughout Poultry Slaughter and Dressing Operations Observation and Record

Review)
151
152

Slides PROCESS CONTROL CHARTS CONTINUED

41 Skewed Samples

How might samples be skewed?
153

Example 1: Potential Sample Skewing from Improper Sampling Technique

Any number of things can affect or skew sample results for pathogens and indicator

organisms. Below is a list of items that could potentially skew sample results. It is not

an all-inclusive list.

1. Lack of aseptic sampling. This can potentially elevate counts.

2. Using outdated or turbid sterile sampling solutions such as Butterfield's

phosphate diluent (BPD) or buffered peptone water (BPW).

3. Not storing sterile sampling solutions according to the manufacturer’s

recommendations.

4. Freezing samples will tend to decrease bacterial counts.

5. Applying additional interventions to products to be sampled or increasing

concentrations of antimicrobial interventions beyond what is used in the normal

process does not “randomly” sample product, as it is not indicative of the actual

process.

6. Improper storage of samples. Samples should be held under refrigeration until

shipped to the lab. Samples should be shipped to the lab cold with frozen gel

packs in insulated containers.

7. Delayed time to ship samples to the lab. Samples should be held under

refrigeration and shipped so as to arrive at the laboratory and be analyzed no

later than the day after it is collected. If this is not possible, the carcass or

product should be refrigerated until the process can be accomplished in the

appropriate span of time.

8. Not allowing adequate drip time after microbial interventions are applied.

Immediate sample collection will include a significant amount of residual

antimicrobial, which can and will make it harder for the laboratory to detect live

bacteria. FSIS generally recommends establishments wait at least 60 seconds

after application of antimicrobial interventions before collecting a sample to

reduce the amount of antimicrobial carryover. Allowing more than 60 seconds of

drip time will further reduce antimicrobial carryover. Tipping over the carcass to

allow drainage of chiller water that has accumulated in the body cavity should

also result in greater accuracy of the test result.

9. The sample collection method can significantly affect the ability to detect

bacteria on carcasses. For example, non-destructive collection methods (such

as rinses and sponge samples) are less likely than destructive methods (such

as collecting product) to collect bacteria that are in feather follicles, crevices, or

skin folds as well as bacteria present in biofilms on the poultry skin.
154

10.Samples should be carefully controlled to prevent temperature abuse, sample

leakage, and other events that could affect sample integrity and lead to

unreliable test results.

11.Compositing pre-chill samples without adequate support that minimal variation

exists within its pre-chill process.

12.Compositing pre-chill and post-chill samples.

13.If equipment is sampled, it should not be sanitized prior to sampling.

Example 2: Potential Sample Skewing from Lab Analysis

Any number of things can affect or skew sample results for pathogens and indicator

organisms. Below is a list of items that could potentially skew sample results. It is not

an all-inclusive list.

1. Labs not using FSIS equivalent methods.

2. Sample size used is below what methodology specifies.

3. Sample remains chilled for a longer period than normal during incubation.

4. In-house lab is not segregated from manufacturing areas and access to the

laboratory is not limited to qualified personnel.

5. In-house lab personnel not under the supervision of a qualified microbiologist or

equivalent.

6. In-house lab technicians not properly trained or not following written protocols.

7. Lab did not properly document any of the following:

• Date received;

• Condition of the sample upon receipt, including sample temperature, if

applicable;

• Date the analysis was started and completed; and the

• Analytical result.

42 Next Step for Verification

According to our schematic, what’s the next thing we would use to verify process

control in official poultry slaughter establishments?
155

43 Process Control Problem

Which would be considered a more severe process control problem?
156

Slides CASE STUDIES

45-46 Case Study 1: Part 1

What would this indicate?

Case Study 1: Part 2

What do you conclude from your observations?

47 Next Step for Verification

According to our schematic, what’s the next thing we would use to verify process

control in official poultry slaughter establishments?
157

48 Salmonella Sample

Four of the last thirteen FSIS samples for Salmonella have had positive results. What

do you conclude?
158

49 Case Study 2

What do you conclude?

Reminder: Poultry and livestock slaughter processes are similar, but there are some

physical and regulatory differences.

Slides LIVESTOCK OPERATIONS

51 Livestock Operations Regulations

Which FSIS Directive gives guidance on beef sanitary dressing procedures and

process control in cattle slaughter operations?

FSIS Directive Notes:
159

52 Livestock Operations Resources
160
161
162
163
164
165
166
167

Slides OPEN BEEF PROCESS CONTROL CHART EXERCISE

54-56 Scenario 2: Part 1

Scenario Notes:

Below is the chart from February 14-25.

Discussion Questions

1. Are livestock slaughter establishments required to conduct carcass mapping

and chart results by regulation?
168

2. What does the above chart indicate about sanitary dressing and process control

in the de-hiding area?

3. Were there any days when there may have been problems with Open Beef's

sanitary dressing procedures and process control? If so, what days were they?

4. What other things would you verify in evaluating sanitary dressing and process

control?
169

57-59 Scenario 2: Part 2

Scenario Notes:

Below is the chart from February 15-26.

Discussion Questions

1. Why did you request a chart showing the last 10 days of data?

2. Why did you request results from February 15-26 when the Process Control

Carcass Mapping Chart shows data for February 14-25?
170

3. Do you see any correlations in data between the Generic E. coli chart and the

Process Control Carcass Mapping Chart? If so, what correlation do you see?

4. What does the E. coli chart indicate about sanitary dressing and process

control?

5. Does the Generic E. coli chart indicate that there are any days when there may

have been problems with Open Beef's sanitary dressing procedures and

process control? If so, what days were they?
171

6. What other things would you verify in evaluating sanitary dressing and process

control?

60-63 Scenario 2: Part 3

Scenario Notes:
172

Discussion Questions

1. Were there any High Event Periods during the timeframe charted? If so, how

many?

2. Why did you request results from February 15-26 when the Process Control

Carcass Mapping Chart shows data for February 14-25?
173

3. Name three ways these samples could be skewed through improper sampling

techniques.

4. Would sampling combos for STEC on days other than the day after slaughter

influence the way the chart looks?
174

5. What does the chart indicate about sanitary dressing and process control?

6. Were there any days when there may have been problems with Open Beef's

sanitary dressing procedures and process control? If so, what days were they?

7. Do you see any correlations in data between the Generic E. coli chart and the

Process Control Carcass Mapping Chart? If so, what correlation do you see?
175

8. What other things would you verify in evaluating sanitary dressing and process

control?

64 Scenario 2: Summary

Match the terms on the left with the definitions on the right.

1. N=60 Sampling A. Post-lethality exposed product is

aseptically collected in its final

package and analyzed for Listeria

monocytogenes and Salmonella.

2. RTE Sampling B. Whole bird rinses or sponge

samples are aseptically collected

at the post-chill location.

3. Salmonella Sampling of Poultry C. Thin slices of exterior surfaces of

raw beef components are

aseptically taken and analyzed for

Shiga toxin producing E. coli

(STEC).
176

Slides KNOWLEDGE CHECK

66-69 Knowledge Check 1

Which of the following is not used by FSIS personnel to verify process control?

Knowledge Check 2

Process control procedures such as Sanitary Dressing Procedures and Process

Control Chart data are not related.

Knowledge Check 3

What is the indicator of variation in Process Control Charts?

Knowledge Check 4

There are no regulatory requirement differences concerning process control between

poultry and livestock slaughter operations.

Slides SUMMARY

70 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 1

177

Overview of Food Microbiology

OBJECTIVES

At the end of this module, you will be able to:

1. Explain the structural similarities and/or differences among Gram-positive and

Gram-negative bacteria as well as their isolation and identification using

serological, biochemical, and molecular techniques.

2. Identify the functions of the bacterial cell wall.

3. Identify the extrinsic and intrinsic parameters that affect bacterial growth.

4. List the primary sources of microorganisms in meat and poultry products as well

as the establishment’s environment.

5. Explain the rationale of how food become contaminated and how does it leads

to food borne illnesses.

6. Identify the food borne pathogens of concern from the public health regulatory

and food industry perspectives. Explain their physiology and pathogenicity.

7. Describe how a food borne outbreak occurs, the methods of detection, and the

outcome in food legislation.

8. Define the terms epidemiology, epidemic, and endemic.

9. Identify the surveillance systems for tracking food borne disease.

10. List the types of food preservation that are currently practiced to control,

reduce, or eliminate food borne pathogens.

11. List the microbiological testing programs conducted by FSIS and the meat and

poultry establishments.

INTRODUCTION

Food microbiology encompasses the study of microorganisms, which have both

beneficial and deleterious effects on the quality, and safety of raw and processed meat,

poultry, and egg products. Food microbiology focuses on the general biology of the

microorganisms that are found in foods including: their growth characteristics,

identification, and pathogenesis. Specifically, areas of interest which concern food

microbiology are food poisoning, food spoilage, food preservation, and food legislation.

Pathogens in product, or harmful microorganisms, result in major public health problems

in the United States as well as worldwide and are the leading causes of illnesses and

death.

It is important for you as a Public Health Veterinarian (PHV) to understand some of

these basics because they have an effect on the meat, poultry, and egg products that

FSIS regulates. In this module, we will cover a brief overview of some of the basic

principles of food microbiology and explain how they apply to meat, poultry, and egg

products. In addition, we will review the FSIS microbiological sampling programs.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 2

2

OVERVIEW OF BASIC MICROBIOLOGY

Let us review, in general, the microbiology basics that you learned in Veterinary School.

As an FSIS PHV, it is important for you to understand the dynamics (identification,

physiology, pathogenesis, survival, etc) of those pathogens of concern to the food

industry and consumers.

As you know microbiology is defined as the science that deals with the study of

microorganisms, including algae, bacteria, fungi, protozoa, and viruses. Specifically,

bacteria are the most abundant of all organisms, they are unicellular, are relatively small

ranging in size from 0.5- to 5.0 μm, and for the most part they reproduce asexually.

Although there are bacterial species capable of causing human illness (pathogens) and

food spoilage, there are also beneficial species that are essential to good health and the

environment (examples: synthesize vitamins, digest plant cellulose, fixing nitrogen in

plant roots, etc.).

Every bacterial species have specific nutritional requirements, temperature, humidity, etc

for energy generation and cellular biosynthesis. The bacterial cells divide at a constant

rate depending upon the composition of the growth medium and the conditions of

incubation and under favorable conditions, a growing bacterial population doubles at

regular intervals ranging from about 15 minutes to 1 hour. This means that if we start

with 1,000 cells with a generation time of 30 min. then after an hour we end with 4,000

cells. In the next section of this module, the parameters affecting bacterial growth will be

discussed.

Bacteria are also known as prokaryotes because they do not possess nuclei; i.e., their

chromosome is composed of a single closed double-stranded DNA circle. Structurally, a

prokaryotic cell has three architectural regions: appendages (attachments to the cell

surface) in the form of flagella and pili (or fimbriae); a cell envelope consisting of a

capsule, cell wall and plasma or inner membrane; and a cytoplasmic region that contains

the cell genome (DNA), ribosomes and various sorts of inclusions. Following is a brief

discussion of some of these structural components.

Cell envelope- is made of three layers: cytoplasmic membrane (inner layer), the cell

wall (relatively rigid outer layer called peptidoglycan), and – in some bacterial

species- an outer capsule. The role of the bacterial capsule is to keep the

bacterium from drying, can serve as a virulence factor and as an antigen for

identification, mediate adherence of cells to surface (crucial in biofilm formation),

and confer protection against engulfment and attack by antimicrobial agents of

plants, animals, and the environment. Bacteria can be placed into two basic groups,

Gram-positive or Gram-negative, based on the profiles of the bacterial cell wall (see

below).

Chromosome- where the bacterium’s genetic information is contained. It is a crucial

tool for genetic fingerprinting (will be discussed further in this module).

Cytoplasm- is where the function for cell growth, metabolism, and replication are

carried out. It is composed of water, enzymes, nutrients, metabolic wastes, and

gases; it also contains the ribosomes, chromosomes, and plasmids. As mentioned

before, the cell envelope encases the cytoplasm and all its components.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 3

3

Flagella- are hair-like structures that serve as propellers to help bacterium move

toward nutrients and away from toxic chemicals. This structure can be found at

either or both ends or all over the bacterium surface and serve as antigen (Hantigen) for serotyping. In addition, this organelle is a contributor for biofilm

formation.

Pili and fimbriae- many species of bacteria have these small hair-like projections

emerging from the outside cell surface. Its function is to assist in attaching to other

cells and surfaces. Specialized pili are used for passing nuclear material between

bacterial cells (conjugation).

Plasmid- short length of extra-chromosomal genetic structure (circles or loops)

which are carried by many strains of bacteria. They are not involved in reproduction

but replicate independently of the chromosome and are instrumental in the

transmission of special properties, such as antibiotic drug resistance, resistance to

heavy metals, and virulence factors necessary for infection of animal and human

hosts. Plasmids are extremely useful tools in the area of genetic engineering.

Ribosomes- these are organelles that translate the genetic code DNA to amino

acids which are the building blocks of proteins. They are also an important tool in

the fields of molecular biology and genetics.

Spores- produced by some species and they are resistant to hostile conditions such

as heat and drying. They serve as survival mechanisms when environmental

conditions are not suitable for growth and replication.

The cell wall of bacteria is dynamic and extremely important for several reasons:

1.They are an essential structure for viability; protects the cell protoplast from

mechanical damage and from osmotic rupture or lysis.

2.They are composed of unique components found nowhere else in nature.

3.They are one of the most important sites for attack by antibiotics.

4.They provide ligands for adherence and receptor sites for drugs or viruses.

5.They cause symptoms of disease in humans and animals.

6.They provide for immunological distinction and immunological variation among

strains of bacteria.

7.They can be modified to protect the cell against harsh environmental conditions

like heat, pH, antimicrobials, etc.

Cell wall composition varies widely amongst bacteria and is an important factor in

bacterial species analyses and differentiation. The main functions are to give the cell its

shape (rod, sphere, helix, or comma) and surround the cytoplasmic membrane,

protecting it from the environment. As mentioned above, the profiles of the cell walls of

bacteria, as seen with the electron microscope, make it possible to distinguish two basic

types of bacteria as follows:
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 4

4

Gram-positive bacteria (those that retain the purple crystal violet dye when

subjected to the Gram-staining procedure) - the cell wall adjoining the inner or

cytoplasmic membrane is thick (15-80 nanometers), consisting of several layers of

peptidoglycan, also known as murein. Intertwine within the cell wall are polymers

composed of glycerol, phosphates, and ribitol, which are known as teichoic acids.

In general, Gram-positive bacteria produce extra cellular substances that typically

account for most of the virulence factors and this is illustrated by Staphylococcus

aureus.

Gram-negative bacteria (which do not retain the crystal violet) - the cell wall

adjoining the inner membrane is relatively thin (10 nanometers) and is composed of

a single layer of peptidoglycan surrounded by a membranous structure called the

outer membrane. The outer membrane of Gram-negative bacteria invariably

contains a unique component, lipopolysaccharide (LPS or endotoxin), which is toxic

to animals. This outer membrane is usually thought of as part of the cell wall. The

pathogenesis and virulence properties of Gram-negative bacteria are far more

complex including outer membrane components as well as the production of extra

cellular substances, which can be illustrated by E. coli O157:H7.

It may be advantageous for epidemiological purposes to identify a particular bacterial

strain by serotyping, which is a useful tool to accomplish this goal. Previously we

mentioned that there are components in the cell envelope that serves as antigens for

serotyping, therefore, serotyping is based on the ability of the bacteria to agglutinate

antibodies specific for those antigens. Following is a brief description regarding to the

serotyping of those pathogens of public health concern.

Serotyping of Gram-negative bacteria (examples: E. coli and Salmonella spp.) consist of

the immunoreactivity of three classes of antigens: the O-antigen (somatic), H-antigen

(flagellar), and the K-antigen (capsular) surface profiles. The O-antigen is a

polysaccharide which is a polymer of O-subunits, composed of 4-6 sugar residues,

attached to the lipid A-core polysaccharide portion of the LPS molecule. Differences in

the immunoreactivity of antibodies (O antiserum) with the O-antigen result from the

variation in the sugar components and/or covalent linkages between the O-subunit. On

the other hand, the H-antigen is the filamentous portion of the flagella, which is

composed of protein subunits called flagellin. The antigenically variable portion of

flagellin determines the H serotype as determined by H antiserum. Finally, the Kantigens are the somatic or surface antigens that occur as envelopes, sheaths, or

capsules. They act as masking antigens for the O-antigen, inhibiting agglutination of

living cell suspensions in O antiserum (for the purpose of the scope of this module this

antigen will not be further discussed). A specific combination of O- and H-antigens

defines what is known as the serotype and/or serogroups of a bacterial isolate. The

serotype and serogroups in particular species provide identifiable chromosomal markers

that correlate with specific bacterial virulent clones.

In E. coli, a total of 170 different O-antigens and 55 H-antigens, defining the isolate

serotype, have been identified; a well-known example is E. coli O157:H7 serotype, which

is part of the enterohemorrhagic (EHEC) serogroup. More than 2,500 Salmonella

serotypes have been described and reported. Serotyping regarding to this species is

complex due to the multiple composition of the O-antigen and these are divided into

serogroups or O groups, designated by the primary O factor(s) that are associated with

the group. In addition, Salmonella is unique among enteric bacteria in that it can
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 5

5

express two different flagellin antigens, referred to as Phase 1 and Phase 2. Examples

are S. Enteritidis and S. Newport, which belong to Serogroup D and B, respectively.

Likewise, the serotyping of Gram-positive bacteria (an example is Listeria

monocytogenes) is based on the combination of somatic (O; teichoic acids) and flagellar

(H) antigens. Although serological confirmation is not necessary for regulatory

identification of L. monocytogenes, it is useful for determining the prevalence of specific

serotypes in epidemiological studies and for environmental recontamination tracking.

Strains of L. monocytogenes can be assigned to 13 different serotypes, based on their

combination of O- and H-antigens. While all of them are considered to be potentially

pathogenic, most (>95%) human clinical isolates belong to three serotypes 1/2a, 1/2b,

and 4b.

It is evident that bacteria are a complex system with the capability to adapt and survive

to adverse environmental conditions. This explains, in part, why some microorganisms

are very difficult to eliminate (biofilm formation), why other becomes pathogenic, and

why other develops resistance toward antibiotics or antimicrobial interventions. In

slaughter as well as in the processing establishments there are bacterial species

associated with particular meat and poultry products, including the environment.

PARAMETERS AFFECTING THE GROWTH OF MICROORGANISMS

There are two parameters affecting the growth of microorganisms in food products:

extrinsic and intrinsic. Extrinsic parameters are those properties of the environment

(processing and storage) that exist outside of the food product, which affect both the

foods and their microorganisms. In the other hand, intrinsic parameters, are properties

that exist as part of the food product itself, for example, tissues are an inherent part of

the animal that, under a set of conditions, may promote microbiological growth.

Following is a list of these parameters that may result in multiplication or inhibition of

microbial growth in meat, poultry, or egg product.

Examples of intrinsic parameters are:

pH: It has been well established that most microorganisms grow best at pH

values around 7.0 (6.6 – 7.5), whereas few grow below a pH of 4.0. Bacteria

tend to be more fastidious (complex nutritional or cultural requirements for

growth) in their relationships to pH than molds and yeasts, with the pathogenic

bacteria being the most fastidious. Most of the meats have a final pH of about

5.6 and above; this makes these products susceptible to bacteria as well as to

mold and yeast spoilage.

Moisture content (water activity [aw]): One of the oldest methods of preserving

foods is drying or desiccation. The preservation of foods by drying is a direct

consequence of removal or binding of moisture, without which microorganisms

do not grow. It is now generally accepted that the water requirements of

microorganisms should be described in terms of water activity (aw) in the

environment. Water molecules are loosely oriented in pure liquid water and can

easily rearrange. When a solute is added (like salt) to water, the water

molecules orient themselves on the surface of the solute, in this case the Na+
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 6

6

and Clions, and the properties of the solution change dramatically. Therefore,

the microbial cell must compete with solute molecules for free water molecules.

The water activity of pure water is 1.00; the addition of solute decreases aw to

less than 1.00. Most food borne pathogenic bacteria require aw greater than 0.9,

however, Staphylococcus aureus may grow in aw as low as 0.86.

Oxidation-reduction potential: Microorganisms display varying degrees of

sensitivity to the oxidation-reduction potential (O/R or EH) of their growth medium

or environment. Aerobic microorganisms require more oxidized environments

(more oxygen) versus anaerobic organisms which require more reduced

environments (lacking oxygen).

Nutrient content: In order to grow and function normally, the microorganisms of

concern in the food industry require the following: water, source of energy,

source of nitrogen, vitamins and related growth factors, and minerals.

Antimicrobial constituents: The stability of some foods against attack by

microorganisms is due to the presence of certain naturally occurring substances

that have been shown to have antimicrobial activity. Nisin and other bacteriocins

are good examples.

Biological structures: The natural covering of some food sources provides

excellent protection against the entry and subsequent damage by spoilage

organisms. Examples of such protective structure are the hide, skin and feathers

of animals.

Examples of extrinsic parameters are:

Storage temperature: Microorganisms, individually and as group, grow over a

wide range of temperatures. It is important to know the temperature growth

ranges for organisms of importance in foods as an aid in selecting the proper

temperature for product storage. A helpful reference is the FDA’s Food Code

(http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/default.ht

m); it contains some recommendations for storage temperatures of product that

are widely accepted in the scientific community.

Relative humidity: The relative humidity of the storage environment is important

from both the standpoint of water activity (aw) within foods and the growth of

microorganisms at the surfaces. Humidity can also be an important factor to

consider when producing some types of product.

Presence/concentration of gases: Carbon dioxide (CO2) is the single most

important atmospheric gas that is used to control microorganisms in foods. It has

been shown to be effective against a variety of microorganisms. Because of its

effectiveness, CO2 is used as one of the methods for modified-atmosphere

packaging (refer to FDA Food Code).

Presence/activities of other microorganisms: The inhibitory effect of some

members of the food microbiota on other microorganisms is well established.

Some food borne organisms produce substances that are either inhibitory or

lethal to others. These include antibiotics, bacteriocins, hydrogen peroxide, and
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 7

7

organic acids (such as lactic acid). General microbial interference is a

phenomenon that refers to general nonspecific inhibition or destruction of one

microorganism by other members of the same habitat or environment; the

mechanism for this interference is not very clear. Some of the possibilities are

competition for nutrients; competition for attachment/adhesion sites; unfavorable

alteration of the environment and/or combinations of these.

ISOLATION AND IDENTIFICATION OF PATHOGENS

You have learned during the FSRE Training that FSIS is responsible for aseptically

collecting samples to determine the presence of pathogens (E. coli O157:H7 and Listeria

monocytogenes) and Salmonella species according to the regulations.

Since January 2008 (Federal Register Docket No. FSIS-2008-0007; Sept 16, 2008)

FSIS has implemented a revised laboratory methodology for the detection, isolation, and

identification of Escherichia coli O157:H7 in the regulatory verification samples. The

FSIS revised methodology for this pathogen can be found in the Microbiology Laboratory

Guidebook (MLG), Chapter 5A and 5.04, which is available on the FSIS Web site

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

revised methodology has affected the sampling procedures and testing methods for E.

coli O156:H7 in raw beef products and environmental sponge samples. Furthermore,

state programs, foreign government programs, and non-FSIS laboratory testing methods

for this pathogen in raw beef products must be at least as sensitive as FSIS’ procedures

and testing methods or equivalent (concerning to foreign countries).

Once these samples are received by the Agency’s laboratory, how are they processed?

When sample is received by any of the three field service laboratories (Athens, GA, St.

Louis, MO, or Alameda, CA), it is first subject to a selective enrichment procedure to

favor growth of the desired organism, followed by an initial screening test for

presumptive positives. The BAX® system is used as one of the initial screening test for

the detection of Salmonella, Listeria monocytogenes and E. coli O157:H7, and is based

on the polymerase-chain reaction (PCR) technology which has proven to be rapid and

highly sensitive. Thereafter, those found to be a screening positive are further confirmed

using immunological, biochemical, and molecular methods.

Let us look at an example pertaining to the isolation and characterization of E. coli

O157:H7 and/or O157:H7/NM from raw and ready-to-eat beef products based on the

FSIS revised methodology. The first step is to enrich the samples using an enrichment

broth suitable for this pathogen followed by the screening test using the BAX® system or

lateral flow devices screening test. Those samples found to be positive (potential

positive) are further processed by performing an immuno-magnetic separation using

magnetic beads coated with O157-antibodies and plating an aliquot on a highly selective

media (Rainbow agar); plates are then incubated for 18-24 hours at 35 ̊C. One or more

typical colonies are tested with O157 antiserum and colonies that show agglutination

(presumptive positives) are processed for confirmation by performing serological,

biochemical, Shiga toxin assays, and genetic analyses. The time frame for reporting

potential positive or screen negative result is two days; presumptive positive is 3 days;

and confirm positives is 5-7 days. Please note that the example discussed above as
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 8

8

well as the other two microorganisms (see below) does not include follow-up testing

(e.g., NVSL serotyping, PFGE fingerprinting) and the days listed do not include delays

(e.g., re-streak for purity).

The isolation and characterization of L. monocytogenes and Salmonella spp follows the

same rationale as discussed in the previous example using the appropriate culture

media and assays. The time frame for reporting the test results of these microorganisms

is as follows:

- L. monocytogenes: for screen negative is 3 days; presumptive positive is 4-5

days (a sample from which one or more typical colonies produces betahemolysis on Horse Blood agar); and confirmed positive is 5-8 days (when a

beta-hemolytic isolate is CAMP test positive, shows tumbling motility, and is

characterized biochemically).

- Salmonella spp: for screen negative is 2 days; presumptive positive is 5 days

(when a sample yields one or more isolates which show typical appearance on

TSI and LIA slants, and agglutinate Salmonella somatic antisera); and

confirmed positive is 7 days (Salmonella O group positive isolates are

characterized biochemically as the genus).

These results are then posted on LEARN to be accessible for the FSIS inspection

personnel. Remember that, in the case of E. coli O157:H7 and L. monocytogenes in

ready-to-eat (RTE) products, presumptive positives reports are also posted so

immediate action can be taken by the establishment concerning to the adulterated

product.

PRIMARY SOURCES OF MICROORGANISMS IN FOOD

From the meat and poultry regulatory perspective, we will be addressing bacteria as a

main source of food contamination. Keep in mind that there are other microorganisms

like viruses, parasites, fungi, etc., that are able to contaminate food and cause food

borne illnesses in animals and humans.

Bacteria can be found virtually everywhere including humans and can enter food

products through different routes. The following list outlines some of the most common

ways in which microorganisms enter food products.

Soil, water, and establishment environment: Many bacteria are carried in soil and water,

which may contaminate food. In addition, the establishment environment is an important

source of contamination because of the daily activities and pest infestation. Listeria,

Clostridium, Salmonella, and Escherichia are good examples.

Animal feeds: This is a source of salmonellae to poultry and other farm animals. It is a

known source of Listeria monocytogenes to dairy and meat animals when fed silage.

The organisms in dry animal feed are spread throughout the animal environment and

may be expected to occur on animal hides, hair, feathers, etc.

Animal hides: The hide is a source of bacterial contamination of the general

environment, hands of establishment employees, and skinned carcasses. Studies have
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 9

9

shown that this may be a primary source for E. coli O157:H7, Salmonella, and Listeria in

cattle.

Gastrointestinal tract: The intestinal biota consists of many organisms; notable among

these are pathogens such as Salmonella, Campylobacter, E. coli O157:H7, and other

microorganisms. Any or all of the Enterobacteriaceae may be expected in feces of

livestock and poultry.

Food handlers: The microbiota on the hands and outer garments of handlers generally

reflect the environment and habits of individuals (hygiene), and the organisms in

question may be those from hides, gastrointestinal tracts, soil, water, dust, and other

environmental sources.

Food Utensils: Saws, cutting boards, knives, grinders, mixers, etc. may become

contaminated during slaughter and processing operations and ensure a constant level of

contamination of meat-borne organisms.

Air and dust: A variety of bacteria may be found in air and dust in food-processing

operations at any one time. Listeria is an example of a Gram-positive organism that

survives in the environment.

Vegetables (plant) and vegetable products: May be a significant concern in the

processing of meat, poultry and egg products. A good example is the processing of

frozen entrees, salads, etc. containing meat and poultry components. Many or most soil

and water organisms contaminate vegetables and fruits.

Globalization of food supply: This is a major factor of contamination resulting in transfer

of pathogenic agents between countries (import/export) such as Bovine Spongiform

Encephalopathy (BSE) infective agent and Salmonella Typhimurium DT104, among

others. Also, with the increase in international travel this imposes a risk of introducing

pathogens to this country like Foot and Mouth Disease.

Terrorist attacks: There are growing concern in the food industry that terrorist could use

pathogens to contaminate food and water supplies in attempt to disrupt the economy,

health, and lifestyle among others.

HOW DOES FOOD BECOME CONTAMINATED?

We live in a microbial world, and there are many opportunities for food to become

contaminated as it is produced and prepared. Many food borne microbes are present in

healthy animals (usually in their intestines, hides, feathers, etc) raised for food. Meat

and poultry carcasses can become contaminated during slaughter by contact with small

amounts of intestinal contents or poor dressing procedures. Also, it has been shown

scientifically that some Salmonella serotypes can infect a hen's ovary in such a manner

that the internal contents of a normal looking egg can be contaminated with Salmonella

even before the shell is formed.

In food processing, food borne microbes can be introduced from infected humans who

handle the food, or by cross contamination from some other raw agricultural product
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 10

10

and/or the establishment environment. For example, the unwashed hands of food

handlers who are themselves infected can introduce bacteria and viruses.

In the RTE processing environment exposed product that is fully cooked can become

cross contaminated if it touches raw meat or poultry that contain pathogens or from food

contact surfaces that are contaminated.

In the kitchen, microbes can be transferred from one food to another food by using the

same knife, cutting board or other utensil to prepare both without washing the surface or

utensil in between.

The way that food is handled after it is contaminated can also make a difference in

whether or not an outbreak occurs. Many microorganisms need to multiply to a larger

number before enough are present in food to cause disease. Given warm moist

conditions and an ample supply of nutrients, one bacterium that reproduces by dividing

itself every half hour can produce 17 million progeny in 12 hours. As a result, lightly

contaminated food left out overnight can be highly infectious by the next day. If the food

were refrigerated promptly, the bacteria would not multiply at all or at a very slow rate.

To inhibit bacterial growth in meat, poultry, or egg products or in food handled by the

consumer, it is important to store foods at a reduced temperature. Refrigeration or

freezing prevents virtually all bacteria from growing but freezing preserves them in a

state of suspended animation.

FOODBORNE ILLNESS

Microorganisms can cause a variety of effects in food products including spoilage, which

primarily affects product quality, and food poisoning, which is generally caused by

pathogens. As regulators, we are most concerned with the effects that microorganisms

have on food that leads to food borne illness, because this affects public health.

A food borne illness (or disease) is exactly what the term indicates - a disease or illness

caused by the consumption of contaminated foods or beverages. It would seem rather

obvious that a food borne microbial pathogen, or a preformed microbial toxic product, or

another poison such as a poisonous chemical that has somehow contaminated the food

and/or beverage, leads to one of the many different food borne illnesses.

There is no one “syndrome” that is representative of food borne illness/disease.

Different diseases have many different symptoms. However, the microbe or toxin enters

the body through the gastrointestinal tract, and often causes the first clinical signs such

as nausea, vomiting, abdominal cramps and diarrhea, which are common symptoms in

many food borne diseases.

More than 250 different food borne diseases have been described. Most of these

diseases are infections, caused by a variety of bacteria, viruses, and parasites. Other

diseases are poisonings, caused by harmful toxins or chemicals that have contaminated

the food, for example, poisonous mushrooms or heavy metal contamination.

To cause illness, the pathogen must overcome several hurdles. A simple summary of

these hurdles are as follows.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 11

11

-Survive the acidic environment of the stomach.

-Attach to/colonize intestinal walls.

-Compete against the natural microbiota of the gut.

-Survive the host defense mechanisms.

-Once attached in the large intestine: elaborate toxins and virulence factors, and

cross the epithelial barrier, which then results in the symptoms characteristic to the

disease or illness.

FOODBORNE PATHOGENS

Following is a list of pathogens and infectious agents of public health concern. This list

is not exhaustive; however, it contains most of the food borne pathogens that affect

meat, poultry, and egg products.

1. Bacteria

Gram Positive:

-Listeria monocytogenes

-Staphylococcus aureus

-Bacillus cereus

-B. anthracis

-Clostridium botulinum

-C. perfringens

Gram Negative:

-Salmonella spp

-Campylobacter spp

-Escherichia coli 0157:H7

-Yersinia enterocolitica

-Brucella spp

2. Viruses:

-Hepatitis

-Rotaviruses

3. Prions:

-new variant CJD

4. Tapeworms:

-Taenia spp

5. Roundworms:

-Trichinella spp

6. Protozoa:

-Toxoplasma spp

-Sarcocystis spp
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 12

12

The Centers for Disease Control (CDC) reports that the most commonly accounted food

borne infections are those caused by viruses (59%), bacteria (39%), and parasites (2%)

(2011, Emerging Infectious Diseases, Vol 17 (1), pages 7-20; www.cdc.gov/eid).

Furthermore, this report showed that the pathogens that caused the most illnesses were

noroviruses (58%), nontyphoidal Salmonella spp. (11%), C. perfringens (10%), and

Campylobacter spp. (9%). Looking at the hospitalization and death estimates caused by

contaminated food due to bacterial pathogens, the leading cause of hospitalization were

nontyphoidal Salmonella (35%) and Campylobacter ssp. (15%); nontyphoidal

Salmonella spp. (28%) and L. monocytogenes (19%) caused the most deaths.

We will be discussing these aforementioned microorganisms because they are of

concern to the food industry, to FSIS as a public health regulatory agency, and the

consumer.

Pathogens and Infectious Agents of Concern from the Public Health Regulatory

Perspective

Salmonella spp

Salmonella is a rod-shaped, motile bacterium (non-motile exceptions are S. Gallinarum

and S. Pullorum), non-spore forming and Gram negative. This microorganism grows at

6.5- 47 ̊C (43.7-116 ̊F), pH as low as 4.5, with or without air, and aw of >0.95 (may vary,

e.g., S. Newport = 0.941 and S. Typhimurium = 0.945). The optimum growth

temperature is at the human body temperature but it grows very poorly at refrigerated

temperatures. Even though freezing and frozen storage can have some deleterious

effect on Salmonella, it is known that this microorganism remains viable for long periods

of time in frozen foods. There are specific serotypes that are capable of producing food

borne illness (salmonellosis) including S. Enteritidis (eggs and egg products), S.

Newport (milk and dairy cows), and S. Typhimurium (cattle) among others.

Salmonella spp. have the ability to cross the mucosal barrier invading and replicating

within the host causing chronic infections, long term carriage, and systemic disease.

Pathogenic Salmonella possess a myriad of virulence factors including those that

promote adhesion to host cells in the intestine, endotoxins, siderophores, invasins, and

the production of cytotoxins and diarrheagenic enterotoxins, which act in concert in the

pathogenesis of infection. It is believed that the enterotoxins are responsible in causing

the acute symptoms of the disease.

As of 2007 there were 2,541 Salmonella serotypes identified and approximately 2,000

serotypes cause human disease. The CDC has estimated 1.4 million cases occur

annually in the United States but approximately 2.14% (culture-confirmed) of those

cases are reported to CDC. In addition, annual estimates of over 500 cases are fatal

and 2% of the salmonellosis cases are complicated by chronic arthritis. Furthermore,

salmonellosis is more common in the summer than winter. In 2006, a total of 40,666

isolates were reported from participating public health laboratories which represents

12.3% increase compared to 2005. The national rate of reported Salmonella isolates

(2006) was 13.6/10,000 people. From that total, the four most frequently reported

Salmonella serotypes from human sources (expressed in per cent) by CDC encompass

S. Typhimurium (includes var. 5-)(16.9%), S. Enteritidis (16.6%), S. Newport (8.3%), and

S. Heidelberg (3.7%). (PHLIS Surveillance Data, Salmonella at

http://www.cdc.gov/ncidod/dbmd/phlisdata/salmonella.htm). The four most common
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 13

13

aforementioned serotypes in 2006 (have been in this order since 1995) represent 45% of

all isolates.

The cumulative (year-to date; http://www.cdc.gov/mmwr/summary.html) of salmonellosis

cases reported by CDC for the years 2009 and 20010 were 49,192 and 18,734

(cumulative – not final), respectively. All age groups are susceptible to salmonellosis,

but symptoms are most severe in the elderly, infants (<5 yrs), and those individuals with

impaired immune systems. AIDS patients suffer salmonellosis frequently (estimated 20-

fold more than general population) and suffer from recurrent episodes. This

microorganism is usually transmitted to humans by ingestion of contaminated foods of

animal origin, such as beef, poultry, milk, or eggs. As mention before, the organism

penetrates and passes from the gut lumen into the epithelium of small intestine where

inflammation occurs. The enterotoxins produced by Salmonella, perhaps within the

enterocyte, cause acute symptoms such as nausea, vomiting, abdominal cramps,

diarrhea, fever, and headache. The symptoms may last from 1 to 7 days or may be

prolonged depending upon age, health of host, ingested dose, and the degree of

pathogenicity (virulence) among the members of the genus. Chronic consequences can

include arthritic symptoms, which may follow 3-4 weeks after onset of acute symptoms.

The onset time of the disease typically ranges from 8-72 hours and the minimal infective

dose (MID) to cause illness varies according to the individual and food material.

Generally, around 105 Salmonella per gram of food is enough (for different serovars) to

cause illness but it can be as few as 15-20 cells (depends upon age and health of host,

and strain differences among the members of the genus;

http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePath

ogensNaturalToxins/BadBugBook/ucm069966.htm).

Data on Salmonella isolates obtained from non-human sources (animals, feed, and

environment) can help identify possible sources of human illness. The three most

common serotypes of Salmonella isolated in livestock and poultry in 2006 are S.

Typhimurium (Serogroup C2), S. Newport (Serogroup B), and S. Heidelberg (Serogroup

C2) which accounted for approximately 28% of the isolates reported to CDC.

The epidemiology of Salmonella, based on serotype characterization, has been

changing; S. enterica serotype Typhimurium has decreased in incidence while the

incidence of serotypes Newport has remained relatively stable since 2004. Following we

are going to discuss in detail the five common serotypes that causes illness in humans

based on the list of the 20 most frequently serotypes from human sources for 2006.

Salmonella Typhimurium, the most common serotype in humans, is identified from

clinical samples (results from animal disease) mainly from bovine and porcine sources,

and from non-clinical samples (results from animal surveillance and food products) from

chicken sources. Some of the outbreaks of S. Typhimurium infections have been

associated with the consumption of ground beef. Rates of antibiotic resistance among

certain serotypes have been increasing; a substantial proportion of serotypes

Typhimurium and Newport isolates are resistant to multiple drugs. A large portion of the

isolates recovered from humans were resistant to multiple antimicrobial drugs including

those with a five-drug resistant pattern characteristic of the S. Typhimurium phage type

DT104 (26% in 2003). Davis et al (2007, Emerging Infectious Diseases, Vol. 13, 1583-

1586; www.cdc.gov/eid) compared the antimicrobial-drug resistance profiles and PFGE

profiles of human and bovine S. Typhimurium isolates (2002-2006; strains TYP035/TYP

187) originated from the Pacific Northwest. They concluded that these strains might
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 14

14

represent an emerging epidemic clonal strain in this region of the United States. The

recall (July 2009) of approximately 466,000 pounds in Colorado linked to an outbreak,

where an antibiotic resistant S. Typhimurium DT104 was confirmed by CDC, suggest

that this strain is spreading.

Salmonella Enteritidis (SE), the second most common serotype in humans, are identified

from clinical and non-clinical chicken sources. The present situation with SE is

complicated by the presence of the organism inside the egg yolk. This and other

information strongly suggest vertical transmission, i.e., deposition of the organism in the

yolk by an infected layer hen prior to shell deposition. Specific control programs (e.g.,

farm-based egg-quality assurance programs) have led to the reduction of SE infections,

which have been associated with the consumption of internally contaminated eggs.

Foods other than eggs have also caused outbreaks of SE.

While the number of human infections caused by the previous top two serotypes had

substantial decreases from 1994-2006, Salmonella Newport has emerged as a major

multidrug-resistant pathogen (resistant to at least nine of 17 antimicrobial agents tested),

becoming the third most common serotype in the United States. This serotype has been

identified from clinical bovine sources. Between 2002 and 2004, CDC reported four

outbreaks of antimicrobial resistant Salmonella infection that implicated FSIS regulated

products, including three attributed to ground beef. Two of the three ground beef

associated outbreaks were linked with S. Newport infection. In August 2009,

approximately 826,000 pounds of ground beef products was recalled that might have

been linked to an outbreak of salmonellosis in Colorado; an antibiotic resistant S.

Newport was identified as the culprit.

Lastly, S. Heidelberg was the fourth most common serotype in humans in 2003, 2005,

and 2006; it has been identified from clinical porcine sources as well as non-clinical

chicken and turkey sources.

The prevalence of the pathogen Salmonella in beef, lamb, pork, and poultry carcasses

varies greatly. The overall contamination of meat and poultry carcasses with these

pathogens depends not only on the numbers of the pathogens on the hair, hide,

feathers, skin, and in the intestinal tract of the animals, but is also significantly affected

by the degree of cross-contamination occurring from these sources during slaughter and

processing.

In addition, Salmonella has been isolated from milk and dairy products, fish, shrimp, frog

legs, yeast, coconut, sauces and salad dressing, cake mixes, cream-filled desserts and

toppings, dried gelatin, peanut butter, cocoa and chocolate, etc.

Environmental sources of the organism include water, soil, insects, factory surfaces,

kitchen surfaces, and animal feces, to name only a few.

The establishments that slaughter and/or process meat and poultry products must

adhere to pathogen reduction performance standards for Salmonella, as specified in 9

CFR 310.25 for livestock and in 9 CFR 381.94 for poultry. Between 2002 and 2005,

USDA reported an increase in the percentage of chicken carcasses that tested positive

for Salmonella (from 11.5 to 16.3 %.) including a significant increase in SE. On

February 27, 2006 (Federal Register, Docket No. 04-026N), FSIS posted a new

approach to Salmonella verification activities in meat and poultry establishments
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 15

15

including reporting each sampling test results (containing serotype data) to the

establishment as they become available, classifying establishments in three process

control categories according to their performance in completed sample sets relative to

the regulatory performance standard or baseline guidance level for Salmonella percent

positive in their product class, among others described activities.

FSIS has also developed guidelines and procedures for the comprehensive assessment

of food safety systems in poultry establishments with less than consistent Salmonella

process control. Furthermore, the Agency has accomplished a new risk-based approach

allocating Salmonella sampling resources. Since April 2006, FSIS has been providing

these results; this quarterly report can be access on FSIS Web site at

http://www.fsis.usda.gov/Science/Q2_2006_Salmonella_Testing/index.asp.

In response to comments received by the Agency on the aforementioned Federal

Register Notice of February 27, 2006, FSIS has announced new policies for the

Agency’s Salmonella Verification Sampling Program and related activities conducted in

meat and poultry establishments (Federal Register Docket No. FSIS-2006-0034,

January 28, 2008). These changes include:

 publication of completed FSIS verification sample set results for establishments

that show inconsistency in their ability to meet Salmonella performance

standards, beginning with those from young chicken slaughter establishments;

 a voluntary incentive-based program for meat and poultry establishments that

should yield significant data on attribution of human illness to FSIS-regulated

products; and

 increasing the Agency’s use of targeted sampling approaches and collaborative

serotype and subtype data.

In May 2010, FSIS published another Federal Register Notice (Docket No. FSIS – 2009-

0034) announcing the implementation of new Salmonella and Campylobacter

performance standards for young chicken (broiler) and turkey slaughter establishments.

The new performance standards are based on the Agency’s Nationwide Microbiological

Baseline Data Collection Programs of 2007 – 2008. This notice detailed the baseline

surveys and their use in developing the new performance standards.

In a follow-up Federal Register Notice (Docket No. FSIS-2010-0029, March 2011) FSIS

announced the implementation of the new standards for July 2011. The Notice stated

that the new Salmonella standards apply to sample sets from establishments included in

the Agency’s Salmonella Verification Program in the place of the performance standards

for young chickens (as broilers) codified in 9 CFR 381.94 and the standards for turkeys

announced in a Federal Register Notice of February 17, 2005. The Agency intends to

issue a proposed rule that would formally rescind the codified standards that are no

longer in effect.

FSIS recently published Notice 31-11 New Performance Standards for Salmonella and

Campylobacter in Chilled Carcasses at Young Chicken and Turkey Slaughter

Establishments. It instructs IPP to collect samples of young chickens and turkeys

according to the sampling methodology described in the Notice. Samples will be

analyzed for Salmonella and Campylobacter; serotyping and subtyping will be performed

for all positive samples.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 16

16

FSIS is taking these actions to advance its efforts to achieve the Agency’s public health

goal of significantly reducing human cases of salmonellosis.

Campylobacter species

Campylobacter species, including C. jejuni, C. coli, and C. lari, can be isolated from the

intestinal tract of poultry and poultry products. The two most frequently occurring

Campylobacter species of clinical significance for human consumption of food are C.

jejuni and C. coli, but C. jejuni causes most of the human infections (www.cdc.gov).

These species are the ones most often isolated in poultry products.

Campylobacter jejuni is a Gram-negative slender, curved, and motile rod. It is a

microaerophilic organism, which means it has a requirement for reduced levels of

oxygen and requires 3 to 5% oxygen and 2 to 10% carbon dioxide for optimal growth.

The isolation of this pathogen requires special antibiotic-containing media and a special

microaerophilic atmosphere (5% oxygen). Campylobacter jejuni is relatively fragile and

sensitive to environmental stresses such as 21% oxygen, drying, heating, disinfectants,

and acidic conditions. This microorganism can grow at temperatures between 25-42 ̊C

(77-107 ̊F), pH range of 5.5-8, and aw >0.95.

This bacterium is now recognized as an important pathogen. The pathogenic

mechanisms of C. jejuni are still not completely understood; however, research has

demonstrated that a series of virulence factors come into play for the pathogen to be

able to cause disease. These factors include motility, chemotaxis, invasins, and

adhesins, among others. Some investigators have shown that C. jejuni firstly colonizes

the jejunum and ileum, and then the colon producing a heat-labile toxin (Campylobacter

invasion antigens or CIA proteins) that may cause diarrhea.

Campylobacteriosis is the name of the illness caused by the pathogen C. jejuni and it is

often known as campylobacter enteritis or gastroenteritis. It is one of the most common

bacterial causes of diarrheal illness (even more than Shigella spp and Salmonella spp

combined) in the United States. Active surveillance through FoodNet indicates about 13

cases per 100,000 persons are diagnosed each year. Many more cases go

undiagnosed or unreported, and it is estimated that this illness affect over 2.4 million

persons every year and it is estimated that approximately 124 persons with

Campylobacter infections may die. Campylobacteriosis occurs more frequent in the

summer months than in the winter (www.cdc.gov).

Although anyone can become ill with campylobacteriosis, children under 5 years and

young adults (15-29) are more frequently afflicted than other age groups.

Campylobacter jejuni infection causes diarrhea, which may be watery or sticky and can

contain blood (usually occult) and fecal leukocytes. Other symptoms often present are

fever, nausea, cramping, abdominal pain, headache, and muscle pain within 2-5 days

after exposure to the organism. A very small number of the pathogen (fewer than 500)

can cause illness in humans. The illness generally lasts 7-10 days and in individuals

with compromised immune systems, the pathogen occasionally spreads to the

bloodstream and causes a serious life-threatening infection.

Since C. jejuni is an invasive organism long-term effects of this illness can lead to

Guillain-Barré syndrome, a rare disease that affects the nerves of the body beginning

several weeks after the diarrheal illness. This disease occurs when a person’s immune
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 17

17

system is triggered to attack the body’s own nerves, and can lead to paralysis that last

several weeks and usually require intensive care. It is estimated that approximately one

in every 1000 reported Campylobacteriosis cases leads to Guillain-Barré syndrome

(40% of the syndrome cases).

Many chicken flocks are asymptomatically infected with Campylobacter, i.e., the

chickens are infected with the organism but show no sign of infection and can be easily

spread from bird to bird through a common water source or contact with infected feces.

When infected chickens are slaughtered, the organism can be transferred from the

intestines to the meat. More than half of the raw chicken in the United States market

has Campylobacter on it. Campylobacter is also present in the giblets, especially the

liver.

Raw milk, raw beef and pork are also sources of infection. The bacteria are often

carried by healthy cattle, birds, and by flies on farms. Non-chlorinated water may also

be a source of infections.

In 1982, CDC began a national surveillance program and a more detailed active

surveillance was instituted in 1996; this will provide more information on how often the

disease occurs and what risk factors are for getting it. The U.S. Department of

Agriculture is conducting research on how to prevent the infection in chickens.

Moreover, since 2006 FSIS started nationwide young chicken and turkey microbiological

baseline data collection programs to acquire information concerning the prevalence and

quantitative levels of selected food borne pathogens including Campylobacter. The

outcome of this data has enabled the Agency to develop new performance standards for

Campylobacter in young chicken and turkey slaughter (Federal Register, Docket No.

FSIS-2009-0034, May 2010). One of the changes that is reflected in the Federal

Register publication is that the Agency responses to Campylobacter sample set resutls

will follow current Salmonella procedures for immediate follow-up testing for both

organisms and for Food Safety Assessments when necessary. In the future FSIS will

consider setting establishment categories 1/2/3 for Campylobacter under the new

performance standard. Furthermore, on May 2010, the Agency published a Compliance

Guideline for Controlling Salmonella and Campylobacter in Poultry, which include

recommendations for controlling both pathogens at pre-harvest and during slaughter and

processing.

Escherichia coli O157:H7

A minority of E. coli serotypes are capable of causing human illness (colibacillosis) by

different mechanisms. Escherichia coli are normal inhabitant of the intestine of all

animals, including humans; serves a useful function in the body by suppressing the

growth of harmful bacterial species and by synthesizing appreciable amounts of

vitamins.

Based on disease syndromes and other characteristics, there are six classes of

diarrheagenic E. coli recognized: enteroaggregative (EAggEC), enteroinvasive (EIEC),

enteropathogenic (EPEC), enterotoxigenic (ETEC), enterohemorrhagic (EHEC), and

diffusely adherent (DAEC). EHEC is the class that is of concern to industry, FSIS, and

public health; the more significant serotype is E. coli O157:H7.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 18

18

Escherichia coli serotype O157:H7 is one of the rare serotype of this genus and, as

mentioned above, belongs to the EHEC family that causes severe disease. This

pathogen is a rod-shaped, generally motile, non-spore forming and Gram-negative. It

generally grows at 2.5-45 ̊C (36.5-113 ̊F), pH between 4.6-9.5, with or without air, and aw

of >0.935. There are strains of E. coli O157:H7 that possess an unusual tolerance to

environmental stress such as temperature, pH, dryness, and can survive in water; recent

research have shown that some strains are capable of forming biofilms.

This pathogen produces several virulence factors that cause severe damage to the lining

of the intestine, acute renal failure (children and elderly), hemolysis, thrombocytopenia,

and neurological problems (the last three occur mainly in adults). All EHEC, including E.

coli O157:H7, produce Shiga toxins (Stx 1 and 2; also known as Vero toxins and Shigalike toxins) which are closely related to or identical to the toxin produced by Shigella

dysenteriae type 1; these toxins targets the human kidney, particularly the cortical region

which is rich in Gb3 receptors for the toxin. These toxins are encoded on a

bacteriophage that was transferred from Shigella to E. coli O55:H7 (parent strain of

serotype O157:H7). Other virulence factors are the pO157 plasmid (90-kb size) which

encodes the EHEC hemolysins and serine proteases; LEE pathogenic island which

enclose the genes accountable for the A/E histopathology including a type III secretion

system responsible for the epithelial cell signal transduction events leading to the

attaching/effacing (A/E) lesion, and a bacterial adhesion proteins called intimin and Tir

(Translocated intimin receptor); as well as other virulence factors.

Data collected by CDC through the National Notifiable Diseases Surveillance System

(NNDSS) in collaboration with the Council of State and Territorial Epidemiologists

(CSTE) have shown that during 1996-2004, the estimated cases of infections with E. coli

O157:H7 had a substantial decline (2005, MMWR 54(14):352-356). Escherichia coli

O157:H7 has been nationally notified since 1994. Surveillance categories for EHEC

infection include EHEC O157:H7, serogroup non-O157, and EHEC not serogroup.

During 2005, cases of EHEC infection were reported from 50 states, the District of

Columbia, and Puerto Rico. Of these, 74% were classified as EHEC O157:H7; 14% as

EHEC, serogroup non-O157; and 12% as EHEC, not serogroup. The majority of cases

were reported during July-October.

During the period of 2003-2005, the Shiga-toxin positive cases associated to non-O157

EHEC serogroup have been on the rise with a total of 252, 316, and 501, respectively.

Since 2006, Morbidity and Mortality Weekly Report (MMWR, CDC) has been reporting

the data as Shiga-toxin-producing E. coli (STEC) (4,432 reported cases), which includes

O157:H7, serogroup non-O157, and Shiga-toxin positive not serogroup making it difficult

to assess the predominance of each individual STEC. Since then (2007-2008),

incidence of human STEC infections has increased: 4,847 cases in 2007 and 5,309

cases in 2008. Worth mentioning, in 2009 the STEC reported cases decline to 4,643.

The 2007-2008 trend prompted FSIS, in conjunction with other Federal Agencies, to hold

a public meeting (Federal Register Docket FSIS-2007-0041, Oct 9, 2007) to consider the

public health significance of STEC non-O157. The scientific community believes that

STECs that are pathogenic not only contain the Shiga toxin but also additional virulence

determinants that, together with the toxin, causes illness similar to those caused by E.

coli O157:H7. It is widely accepted that the prevalence of STEC non-O157 is

underrepresented due to the limitations of the protocols for the isolation of non-O157

enteric pathogens in clinical laboratories. In a CDC publication, comprehensive and
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 19

19

detailed recommendations are provided for STEC testing by clinical laboratories,

including the simultaneous culture for E. coli O157:H7 with a simultaneous testing with

an assay that detects Shiga toxins to also identify non-O157 STEC (MMWR, Vol. 58, No.

RR-12; October 16, 2009). The O-antigen that has been identified in a large number of

the non-O157:H7 isolates include O26, O111, O103, O121, O45 and O145. In 2010,

FSIS became aware of an E. coli O26 cluster of illnesses in the states of Maine and New

York. The Agency determined that there was an association between the cluster of

illnesses and beef products from an establishment in Pennsylvania. FSIS recalled

approximately 8,500 pounds of ground beef products due to contamination with E. coli

O26. The source material used to produce product associated with the E. coli O26

illness was traced to a foreign establishment supplier.

This microorganism causes three distinctive clinical manifestation including hemorrhagic

colitis (HC), hemolytic uremic syndrome (HUS), and thrombotic thrombocytopenic

purpura (TTP). All people are believed to be susceptible to hemorrhagic colitis, but

young children and the elderly appear to progress to more serious symptoms more

frequently (HUS and TTP, respectively).

HC is characterized by severe cramping (abdominal pain) and diarrhea, which is initially

watery but becomes grossly bloody. Occasionally vomiting occurs and some individuals

can exhibit watery diarrhea only. Fever is either low-grade or absent. The infectious

dose is as few as 10 bacterial cells with an incubation period of approximately 4 days

(median) and clinical manifestations can develop within 24-48 hours with duration of 8

days (average).

A week after the onset of gastrointestinal symptoms with this pathogen some victims

(particularly the very young under the age of 10) have developed HUS, characterized by

the triad of hemolytic anemia, thrombocytopenia, and renal failure. Permanent loss of

kidney function may result and the mortality rate in children is 3-5%. Since 2005, the

majority of reported cases occurred among children aged <5 yrs. In addition, the total

HUS (post diarrheal) cases reported from the previous years has also shown an

increase: 288 cases in 2006, 292 cases in 2007, and 330 case in 2008. As of 2009 the

HUS reported cases declined to 242, which suggests that the trends reflected during the

period of 2006-2009 with the HUS cases follows a similar pattern as the aforementioned

STEC cases reported by CDC.

In the adults and elderly, a complication associated with this microorganism is TTP

characterized by central nervous system deterioration, seizures, and strokes. This

illness can have a mortality rate in the elderly as high as 50%.

Escherichia coli O157:H7 is a bacterial pathogen that has a reservoir mainly in cattle;

other reservoirs have been identified including pigs, sheep, flies, deer and other wild

animals. In published scientific studies, it has been shown that feedlot steers and

heifers appear to carry the organism at higher levels than once thought, even higher

than dairy cattle and calves. Also, it has been shown that E. coli O157:H7 is seasonal

(April through September) peaking during summer.

Undercooked or raw hamburger (ground beef) has been implicated in many of the

documented outbreaks. Because of its public health significance, the vast scientific

evidence showing the high incidence in cattle, the severity of the illness, and outbreaks

due to this pathogen, FSIS (1994) declared E. coli O157:H7 to be an adulterant in
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 20

20

ground beef products. By the year 2002, the Agency required all establishments

producing raw beef to reassess their HACCP plans to determine if E. coli O157:H7 was

a food safety hazard reasonably likely to occur in their production process (Fed Reg.

Vol.67, No.194:62325-62334, October 7, 2002/Rules and Regulations). In 2005 FSIS

published a notice (Fed Reg. Vol. 70, No. 101:30331-30334, May 26, 2005/Rules and

Regulations) informing the establishments that produce mechanically tenderized beef

products, including those that are injected with marinade, to reassess their HACCP plan

by the year 2006. This reassessment was triggered by the fact that there have been

three E. coli O157:H7 outbreaks associated with consumption of mechanically

tenderized beef.

In June 2007, FSIS noticed an increased number of positive Agency E. coli O157:H7

results that occurred within a short period. As a result, FSIS decided to increase the

number of scheduled raw ground beef product samples for testing during the month of

July 2007 (FSIS Notice 41-07). However, in September 2007, there was a recall of 21.7

million pounds of frozen hamburger, the second largest recalls in US history, linked to 40

reported illnesses from a multi-state outbreak with 21 known hospitalizations. DNA

fingerprint patterns were traced back from beef trim supplied by a foreign country firm.

Thereafter, another recall of approximately 1.9 million pounds took place during the

period of October-November 2007. In addition, on November 2007, 3.3 million pounds

of frozen meat pizza products were recalled; the problem was discovered following an

investigation carried out by the Tennessee Department of Health in coordination with

CDC into a multi-state cluster of 21 E. coli O157:H7 illnesses that may be linked to this

product. Therefore, in 2007 there were 18 recalls, in which 9 recalls were linked to

illnesses, totaling approximately 29 million pounds of ground beef. During the 2009,

there were 16 recalls (approximately 545,000 pounds), which two have been linked to

multi state outbreaks. There was a significant increase in the amount of recalled beef

products during 2010 (accounting for 11 recall cases) including approximately 6 million

pounds of ground beef and 135,500 pounds of beef trim. Up-to-date recall cases for

2011 have involved 10, 633 pounds of ground beef (involving 4 recalls) and 23,000

pounds of Lebanon bologna.

Additionally, E. coli O157:H7 outbreaks have also implicated alfalfa sprouts,

unpasteurized fruit juices, dry-cured salami, spinach, lettuce, game meat, cheese curds,

among others.

FSIS announced new, ongoing and upcoming actions to protect public health against the

risk of E. coli O157:H7. Among the measurements to target E. coli contamination and

adulteration of ground beef products, FSIS has issued a series of directives and notices

providing IPP the instructions necessary to fully implement risk-based verification

activities including:

Reissuance of FSIS Directive 10,010.1 to incorporate in one document the

instructions that the Agency has issued in multiple notices regarding E. coli

O157:H7.

In response to the recent finding of E. coli O26 contamination associated with

human illness from ground beef and the subsequent recall, FSIS has issued a

notice (FSIS Notice 70-10) to IPP and import inspection personnel to provide

instructions for collecting product samples from establishments that produced

product associated with the illness.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 21

21

Recently, there has been an outbreak in Germany where an unusual large proportion of

HUS cases (in adults and two thirds are women) has been reported as compared with

bloody diarrhea cases including 818 cases of HUS and 36 patients have died (Euro

Surveill. 2011; 16(24):19890). Extensive investigations implicated organic sprouts as

the likely vehicle of infection. Analysis of the clinical isolates revealed that the epidemic

agent was an STEC strain of a rare serotype O104:H4 which produces the Shiga toxin 2,

lacks the A/E pathogenicity island of virulent STEC strains, and presents a multi-drug

resistant pattern. Using genotyping methods, the results indicated the the STEC strain

causing the outbreak is a rare hybrid phenotype that harbours the phage-mediated

Shiga toxin determinant with an enteroaggregative E. coli (EAggEC; enteroaggregative

adherence phenotype) background in conjunction with other virulence factors, and it was

described as an enteroaggregative, Shiga toxin producing E. coli (EAggEC STEC). It is

widely accepted that EaggEC have a human reservoir. In the United States

(cdcinfo@cdc.gov) four confirmed cases (travel to Germany; 3 HUS cases matches the

outbreak strain) and one suspect case of STEC 104:H4 infections were identified. One

Shiga toxin-positive diarrheal illness did not travel to Germany but was in close contact

with one of the HUS case (person-to-person transmission). These emerging cases in

the United States are an example of transfer of pathogenic agents between countries by

humans.

Other vehicles of infection with E. coli O157:H7 include person-to person transmission

(child day care facilities), water (recreational, well, and municipal water systems), animal

contact (farms and petting zoos), and diagnostic laboratory related.

Listeria monocytogenes

Listeria species (spp) is a rod-shaped, non-spore forming Gram-positive bacterium.

Within the Listeria genus six species has been identified consisting of L.

monocytogenes, L. innocua, L. ivanovii, L. welshimeri, L. seeligeri, and L. grayi.

Specifically, L. monocytogenes is recognized as a human pathogen that causes

listeriosis. This pathogen is motile and can grow in cool (temperature range of 0-45 ̊C

[32-113 ̊F]) and damp environments, at a pH range of 4.4-9.4, and aw >0.92. Some

characteristics that make some strains of L. monocytogenes hearty include growth

and/or survival in acidic environment (pH < 5.0), ability to withstand heat treatments, and

growth and/or survival in concentrated salt solutions. The pathogenicity of this

microorganism is associated with the virulence factors such as internalin A (allow the

pathogen to induce its own uptake by specific host cells), Act A (a surface protein

required for intracellular movement and cell-to-cell spread through bacterially induced

acting polymerization), listeriolysin O (a toxin that acts as a hemolysin), among others.

Only three L. monocytogenes serotypes (4b, 1/2a, and 1/2b) are pathogenic and

account for the majority of human infections in the United States.

One outstanding characteristic of L. monocytogenes is its ability to form biofilm, which

serve as a protection shell. This pathogen, as well as other biofilm microorganisms,

elicits specific mechanisms for initial attachment (by the production of extra polymeric

substance and the bacterial cell surface structures such as flagella, fimbriae, and other

proteins) to a surface, development of a community structure and ecosystem (biofilm),

and detachment. Biofilm is a heterogeneous structure of microbial cells (can be a mix

culture) encased in an extracellular polymeric substance matrix (primarily polysaccharide

material) which can entrap non cellular material such as mineral crystals, corrosion

particles, blood components, food particles, etc. Active flow occurs in this niche allowing
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 22

22

diffusion of nutrients, water, oxygen, and even antimicrobial agents; there is also

exchange of waste metabolic material. Since this ecosystem is dynamic, the community

structure changes from a compact to a looser structure over time allowing the dispersion

of planktonic cells to other sites, which starts the cycle of biofilm formation at that new

site. Biofilm can form as little as a few hours to days depending of the number of

bacterial cells, nutrient availability, surface characteristics, temperature, etc. Once

formed, they can persist for a long time (years) and they are very difficult to remove, as

the biofilm confers protection from the chemicals used to clean and sanitize surfaces.

The occurrence of listeriosis in the United States from previous years is as follows: 884

cases in 2006, 808 cases in 2007 and 759 case in 2008. As of 2009, 851 cases was

reported by CDC. The numbers show that the incidence of listeriosis has been relatively

steady during the aforementioned period.

Generally, listeriosis occurs among the elderly, pregnant women (resulting in fetal

abortion, stillbirth, or neonatal sepsis), diabetics, those on kidney dialysis, and the

immunocompromised (bone marrow transplant patients, corticosteroids and graft

suppression, cancer patients- leukemic patients particularly, individuals with AIDS, etc.).

Some reports suggest that normal, healthy people are at risk, although antacids or

cimetidine may predispose.

Two forms of the illness, an invasive form and noninvasive form, characterize listeriosis

in adults. The noninvasive form is characterized by febrile gastroenteritis and it has

been documented in several outbreaks. The onset time may be greater than 12 hours.

In the invasive form, the manifestation of listeriosis include septicemia (mortality rate as

high as 50%), meningitis (mortality rate as high as 70%), encephalitis, and intrauterine or

cervical infections in pregnant women (mortality rate from perinatal

/neonatal infections greater than 80%). The onset of listeriosis is usually preceded by

influenza-like symptoms including persistent fever. The onset time is unknown but is

probably greater than 18-20 hours for noninvasive gastrointestinal symptoms and may

range from a few days to three weeks for invasive listeriosis.

The infective dose of L. monocytogenes is thought to vary with the strain and

susceptibility of the individual. From cases contracted through raw or pasteurized milk,

fewer than 1000 total organisms may cause disease in susceptible persons. As an

example, a listeriosis outbreak in Switzerland involving cheese suggested that healthy

uncompromised individuals could develop the disease, particularly if the foodstuff was

heavily contaminated with the organism. Summarizing, the risk of developing the

disease will depend on the susceptibility of the individual, the bacterial strain (infectivity),

ingested dose, and whether the food consumed is a high- or low-risk foods. Most

healthy persons probably show no symptoms by consuming contaminated foods and

some studies suggest that 1-10% of humans may be intestinal carriers of L.

monocytogenes.

There are particular meat and poultry high-risk foods that are associated with listeriosis

because of the potential for contamination, they support the growth (temperatures as low

as 3 ̊ C [37.4 ̊F]) of L. monocytogenes, and the common denominator is that they are

ready-to-eat (RTE). RTE products usually require refrigeration and are stored for an

extended period. Examples of high-risk foods are hot dogs, deli meats, pâté and meat

spreads.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 23

23

Other foods that are associated with contamination by L. monocytogenes include raw

milk, supposedly pasteurized fluid milk, cheeses (particularly soft-ripened varieties), ice

cream, raw vegetables, fermented raw meat sausages, raw poultry and meat (all types),

and raw and smoked fish. As mentioned previously, the ability of this pathogen to grow

at low temperatures permits the multiplication in refrigerated foods.

This pathogen has also been found in the gastrointestinal tract of 37 mammalian

species, both domestic and feral, as well as at least 17 species of birds and possibly

some species of fish and shellfish. Listeria is ubiquitous in nature; it can be isolated

from soil, silage, water, vegetation, and other environmental sources.

The pathogen L. monocytogenes is also ubiquitous in the establishment environment

(equipment, utensils, humans, water, airflow, etc). It’s presence in the RTE environment

can pose a serious problem, especially in RTE finished product and on food contact

surfaces. Product flow must be designed to segregate finished from raw products as

well as restrictions of personnel who handle RTE products to prevent crosscontamination. The main concern in the RTE environment is the ability of L.

monocytogenes to form biofilm, which allows the microorganism to survive under

adverse conditions such as freezing, drying, high salinity, antimicrobials, and heat.

Thus, good sanitation including microbial analysis must be part of the establishment’s

quality control practice to avoid cross-contamination of the product and food contact

surfaces.

Under the FMIA and PPIA, RTE product is adulterated if it contains L. monocytogenes or

if the product comes into direct contact with a food contact surface that is contaminated

with the microorganism. Government agencies (USDA, FDA) and the food industries

have taken steps to reduce contamination of food by the Listeria bacterium. In 2003,

USDA issued new regulations aimed at further reducing L. monocytogenes

contamination of RTE meat and poultry products (USDA/FSIS: “Control of Listeria

monocytogenes in ready-to-eat meat and poultry products”; Federal Register Docket No.

97-013F). FSIS requires the establishments producing RTE meat and poultry products

to address control measures in their HACCP plans or to prevent contamination through

their Sanitation SOP and/or pre-requisite programs. When a processed food is found to

be contaminated, food monitoring and establishment inspection are intensified, and if

necessary, the implicated food is recalled.

Bovine Spongiform Encephalopathy (BSE)

Bovine Spongiform Encephalopathy (BSE) or “mad cow disease” is a progressive

neurological disorder of cattle that results from infection by an agent known as a

proteinaceous infectious particle or prion protein. This agent exists in two forms,

namely, the normal (PrPc) and its pathological isoform (PrPres). The PrPres isoform is an

abnormal shaped protein (β-pleated sheet) which lacks nucleic acids, resists protease

digestion, and survives dry heat at 600 ̊C for 15 min. The normal isoform (α-helix) is

expressed most abundantly in the central nervous system (CNS) tissue and brain. The

nature of the transmissible agent is not well understood. BSE possibly originated

because of feeding of scrapie-containing sheep meat-and-bone meal to cattle.

In humans, the illness suspected of being food borne is variant Creutzfeldt-Jakob

disease (vCJD). The human vCJD and cattle BSE appear to be caused by the same
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 24

24

agent. The neurodegenerative phase (build-up of PrPres isoform) of vCJD typically

involves the formation of “daisy-shaped” areas of damage in the CNS, and there is

vacuolization (formation of holes) in the brain tissue that gives a spongy appearance

when examined under a microscope. Cases of vCJD present with psychiatric problems,

such as depression. As the disease progresses, neurological signs appears including

unpleasant sensations in the limbs/face, problems with walking and muscle coordination,

forgetfulness, among others. Late in the course of the disease, patients are hospitalized

until death.

The most reliable means for diagnosis of the human disease vCJD is the microscopic

examination (a post-mortem procedure). Preliminary diagnosis of vCJD is based on

patient history, clinical symptoms, electroencephalograms, and magnetic resonance

imaging of the brain. This disease is rapidly progressive and fatal. CDC has used

several mechanisms to conduct surveillance for vCJD and, during 1996-97, established

the National Prion Disease Pathology Surveillance Center (NPDPSC) at Case Western

Reserve University, Cleveland, Ohio. NPDPSC provides advanced neuropathologic and

biochemical diagnostic services free of charge to physicians and state and local health

departments.

The methods of diagnosis in cattle include immunohistochemistry (using

antibody/antigen staining of post-mortem biopsy tissue), SAF-Immunoblot of brain, and

Western Blots techniques, to name a few.

The major concern for consumer is the potential contamination of meat product by BSE

contaminated tissues or the inclusion of BSE contaminated tissues in foods, including

dietary supplements. High-risk tissues for BSE contamination include the cattle’s skull,

brain, spinal cord, dorsal root ganglia, and the distal ileum of the small intestine. The

direct or indirect intake of high-risk tissues may have been the source of human illness.

The U.S. experience of the BSE confirmed positive from a dairy cow in Washington

State (December 2003) triggered a series of actions by the Secretary of Agriculture. In

response to this event, in January 2004, FSIS issued three interim regulations and a

notice in the Federal Register. The purpose of these policy issuances is to minimize

human exposure to the BSE agent. For more information on FSIS policies and

issuances, and the APHIS surveillance program refer to the module titled “Bovine

Spongiform Encephalopathy (BSE): Key Points for the Public Health Veterinarian” in the

PHV Training materials.

Emerging Food borne Pathogens of Concern from the Food Industry Perspective

Staphylococcus aureus

Staphylococcus aureus is a Gram-positive bacterium (coccus) which on microscopic

examination appears in clusters resembling grapes. It is a non-motile, non-spore

forming facultative anaerobe that grows by aerobic respiration or by fermentation

yielding lactic acid. This microorganism can grow at a temperatures between 7-45 ̊C

(35.9-113 ̊F; optimum 37 ̊C [98.3 ̊F), pH range of 4.2-9.3 (depend on the type of acid

present), at NaCl concentrations as high as 25%, and it is resistant to drying capable of

producing enterotoxins in foods with aw as low as 0.85.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 25

25

Staphylococcus aureus should be considered a potential pathogen. Its pathogenesis is

multifactorial since it can expresses many potential virulence factors like surface proteins

(laminin, fibronectin, clumping factor, and an adhesion), that promote colonization in host

tissue; invasins (leukocidin, kinases, and hyaluronidase) that promote bacterial spread in

tissues; surface factors (capsule and Protein A) which inhibit phagocytic engulfment;

carotenoids and catalase production that enhance their survivor; and membrane

damaging toxins (α-hemolysin, leukotoxin, leukocidin) that lyses eukaryotic cell

membranes. There are other virulence factors including the exotoxins (enterotoxins of

antigenic type SE A-G, Toxic Shock Syndrome Toxin-1, and Exfoliating Toxin) that

damage host tissues or provoke symptoms of disease. The heat-stable enterotoxin A

(SE A) is the most toxic and is responsible for causing diarrhea and vomiting when

ingested and for staphylococcal food poisoning (staphyloenterotoxicosis or

staphyloenterotoxemia).

One of the biggest concerns of this pathogen is the increase incidence of Methicillin

resistant S. aureus (MRSA) and other strains that are resistant to a variety of different

antibiotics. Furthermore, S. aureus strains can exhibit resistance, as a survival

mechanism in the hospital environment, to antiseptic and disinfectants including

quaternary ammonium compounds.

All people are believed to be susceptible to this type of bacterial intoxication; however,

intensity of symptoms may vary. Death from staphylococcal food poisoning is very rare,

although such cases have occurred among the elderly, infants, and severely debilitated

persons. The onset of symptoms in staphylococcal food poisoning is usually rapid (30

min-8 hrs) and in many cases acute, depending on individual susceptibility to the toxin,

the amount of contaminated food eaten, the amount of toxin in the food ingested, and

the general health of the victim. The most common symptoms are nausea, vomiting,

retching, abdominal cramping, and prostration. Some individuals may not always

demonstrate all the symptoms associated with the illness. In more severe cases,

headache, muscle cramping, and transient changes in blood pressure and pulse rate

may occur. An enterotoxin A dose of less than 1.0 microgram in contaminated food will

produce symptoms of staphylococcal intoxication and this toxin level is reached when S.

aureus populations exceed 100,000 cells per gram. Recovery generally takes two days;

however, it is not unusual for complete recovery to take three days and sometimes

longer in severe cases.

The true incidence of staphylococcal food poisoning is unknown for a number of

reasons, including poor responses from victims during interviews with health officials;

misdiagnosis of the illness, which may be symptomatically similar to other types of food

poisoning (such as vomiting caused by Bacillus cereus toxin); inadequate collection of

samples for laboratory analyses; and improper laboratory examination. Thus, in the

diagnosis of staphylococcal food borne illness, proper interviews with the victims and

gathering and analyzing epidemiologic data are essential. Incriminated foods should

be collected and examined for staphylococci. The presence of relatively large numbers

of enterotoxigenic staphylococci is good circumstantial evidence that the food contains

toxin. The most conclusive test is the linking of an illness with a specific food or in

cases where multiple vehicles exist, the detection of the toxin in the food sample(s).

Foods that are frequently incriminated in staphylococcal food poisoning include meat

and meat products; poultry and egg products; salads such as egg, tuna, chicken,

potato, and macaroni; bakery products such as cream-filled pastries, cream pies, and
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 26

26

chocolate éclairs; sandwich fillings; and milk and dairy products. Foods that require

considerable handling during preparation and that are kept at slightly elevated

temperatures after preparation are frequently involved in staphylococcal food

poisoning. Human intoxication is caused by ingesting enterotoxins produced in food by

some strains of S. aureus, usually because the food has not been kept hot enough

(60°C [140°F] or above) or cold enough (7.2°C [45°F] or below).

Staphylococci exist in air, dust, sewage, water, milk, and food or on food equipment,

environmental surfaces, humans, and animals. Humans and animals are the primary

reservoirs. Animals and poultry carry S. aureus on parts of their body, which can lead

to infections. Cow’s udder and teats, tonsils and skin of pigs, and skin of chickens and

turkeys are known sources. Staphylococci are present in the nasal passages and

throats and on the hair and skin of 50 percent or more of healthy individuals. This

incidence is even higher for those who associate with or who are exposed to sick

individuals and hospital environments. Although food handlers are usually the main

source of food contamination in food poisoning outbreaks, equipment and

environmental surfaces can also be sources of contamination with S. aureus.

Staphylococcus aureus is highly vulnerable to destruction by heat treatment and nearly

all sanitizing agents when correctly applied. While heat processing (pasteurization) and

normal cooking temperatures are effective to kill the pathogen, food establishments have

to be alert that the enterotoxins are heat-stable (extremely resistant to heat) and are not

inactivated by heat. There are guidelines for the industry to ensure that the processing

steps they are using are adequate to meet their particular food safety objectives. Heat

resistance is increased in dry, high-fat and high-salt foods, and survives frozen storage.

Thus, the presence of this bacterium or its enterotoxins in processed foods or on food

processing equipment (in areas that are difficult to clean) is generally an indication of

poor sanitation and processing practices. Foods that present the greatest risk are those

in which a heat treatment has been applied (e.g. cooking) or application of an inhibitory

agent or treatment (e.g. cured, salted meats). Foods are examined for the presence of

S. aureus and/or its enterotoxins to confirm that S. aureus is the causative agent of food

borne illness, to determine whether a food is a potential source of staphylococcal food

poisoning, and to demonstrate post-processing contamination, which is generally due to

human contact or contaminated food-contact surfaces. The presence of a large number

of S. aureus organisms in a food may indicate poor handling or sanitation; however, it is

not sufficient evidence to incriminate a food as the cause of food poisoning. The

isolated S. aureus must be shown to produce enterotoxins.

As mentioned previously, this pathogen can cause severe food poisoning and it has

been identified as the causative agent in many outbreaks by eating foods in which

enterotoxin has been produced because of time and temperature abuse, poor sanitation

during processing, or other factors. Staphylococcus aureus is probably responsible for

even more cases in individuals and family groups than the records show. This pathogen

has been implicated in four Class I (high health risk) recalls. The first one took place in

Washington State (November 22, 2005) where the firm recalled various sized vacuumpacked packages of fully cooked honey cured ham and smoked beef strips

(approximately 340 pounds overall) that may had contained S. aureus enterotoxin. The

problem was discovered by FSIS and no illnesses were reported. The second recall

took place in New Jersey on June 13, 2006 where the importing firm voluntarily recalled

approximately 664 pounds of boneless Prosciutto ham that also may had contained S.

aureus enterotoxin. The problem was discovered through testing done by the Canadian

Food Inspection Agency. FSIS did not receive any reports of illness associated with the
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 27

27

consumption of this product. The third recall took place in 2007, when a firm in

Minnesota recalled approximately 330 pounds of ready-to-eat sausage products

associated with this pathogen. The problem was discovered by FSIS but there was no

report of illness. Lastly, a recent recall (March 2011) took place in New York where

approximately 2,997 pounds of bologna products were implied. After the establishment

discovering a malfunction with its smokehouse, the establishment recooked the bologna

products and shipped them to the distribution center. During routine inspection

activities, FSIS discovered that the time delay in recooking the product created an

environment allowing potential production of Staphylococcus aureus enterotoxin.

This pathogen can be found in the farm/slaughter environment affecting food safety. In

a study done in the Netherlands (2007), a new MRSA clone related to swine and cattle

farming were detected and this clone was also isolated in meat products. Contamination

of food products can be traced back to slaughter establishments and to poor sanitary

conditions. This is another example of a major factor of contamination resulting in

transfer of pathogenic agents between countries (import/export). Research done in

Canada has revealed that MRSA has been found in pork products (in less than 10% of

sampled pork chops and ground pork) bought in retail sores throughout that country.

Furthermore, in January 2008, the Department of Epidemiology of the University of Iowa

began testing swine for MRSA in the United States and found MRSA in 49% of the

swine tested (299 pigs from 10 farms in Iowa and Illinois). In addition, they found that

45% of the workers carried the same MRSA strains as the pigs (2009, Plos ONE

4(1):e4258.doi:10.1371/journal.poe.0004258).

Norwalk and Norwalk-like viruses

Viruses are inert particles that can pass from host to host. Since these particles are

completely inert, they cannot multiply in foods or outside the host, cannot carry out any

metabolic activity, nor respond to stresses encountered in the environment.

Nevertheless, viruses have emerged as causes of food borne disease.

Norwalk virus is the prototype strain of genetically and antigenically diverse single

stranded ribonucleic acid (RNA) viruses, which is classified in the genus Norwalk-like in

the family Caliciviridae. The family consist of several serological distinct groups of

viruses that have been named after the places where the outbreaks occurred (i.e., in the

U.S. the Norwalk virus was the first gastroenteritis virus in Norwalk County). Norwalklike viruses (NLVs) have the ability to survive in relatively high levels of chlorine and

varying temperatures (i.e., from freezing to 60 ̊C [140 ̊F]).

Common names of the illness caused by Norwalk and NLVs are viral gastroenteritis,

acute nonbacterial gastroenteritis, food poisoning, and food infection. The virus has an

incubation period of 12-48 hrs after consumption of contaminated food or water and lasts

for 1-21⁄2 days. The illness is self-limiting, mild, and characterized by acute onset of

nausea, vomiting, abdominal cramps, and diarrhea. Vomiting is more prevalent in

children whereas diarrhea is common to adults. The infectious dose is unknown but

presumed to be low (less than 100 viral particles).

Theoretically, any food item can potentially be infected with NVL through fecal

contamination; certain foods are implicated more than others in outbreaks of NLV

gastroenteritis, like shellfish. Also, food contamination by infectious food handlers is

another frequent cause of outbreaks (RTE foods like salads and deli sandwiches).
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 28

28

Other vehicles of transmission include water (from municipal supplies, wells, etc.) and

person-to-person spread (nursing homes and day care centers).

Because of the antigenic and genetic diversity of NLVs various diagnostic methods have

been developed to identify NLVs in clinical specimens. The most common ones include

electron microscopy, immune electron microscopy, enzyme Immunoassays (ELISA),

nucleic acid hybridization, and reverse transcription-polymerase chain reaction; the last

two methods are assays to detect NLV genome in clinical and environmental specimens.

FOODBORNE DISEASE OUTBREAKS

An outbreak of food borne illness occurs when a group of people consumes the same

contaminated food and two or more of the individuals develop the same symptoms or

illness. For example, it may be a group who ate a meal together, or it may be a group of

people who do not know each other at all, but who all happened to buy and eat the same

contaminated item from a grocery store or restaurant.

For an outbreak to occur, an event or combination of events must happen to

contaminate a batch of food eaten by a group of people. For example, contaminated

food may be left out at room temperature for many hours, allowing the bacteria to

multiply to high numbers, and then not properly cooked to kill the bacteria.

Many outbreaks are local in nature. For examples, a catered meal at a reception, a

potluck supper, or eating a meal at an understaffed restaurant on a particularly busy

day. These outbreaks are recognized when a group of people realizes that they all

became ill after a common meal, and someone calls the local health department.

However, outbreaks are increasingly being recognized that are more widespread, that

affect persons in many different places, and that are spread out over several weeks. As

an illustration, in 2002, a five-state salmonellosis outbreak was traced to persons who

consumed ground beef. Forty-seven cases were identified where 17 people were

hospitalized and one died. The outbreak was recognized because it was caused by a

multidrug-resistant Salmonella Newport and fingerprinting pattern of 94% of the isolates

were indistinguishable indicating that the outbreak was originated by the same bacterial

strain.

The vast majority of reported cases of food borne illnesses is not part of recognized

outbreaks, but occurs as individual or "sporadic" cases. It may be that many of these

cases are actually part of unrecognized widespread or diffuse outbreaks.

The initial clue that an outbreak is occurring can come in various ways:

It may be when a person realizes that several other people who were all together at

an event have become ill and he or she calls the local health department.

It may be when a physician realizes she has seen more than the usual number of

patients with the same illness.

It may be when a county health department gets an unusually large number of

reports of illness.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 29

29

Once an outbreak is detected, an investigation begins. The outbreak is systematically

described by time, place, and person by interviewing people, gathering epidemiological

information, testing implicated food vehicle, and other associated information. If the

causative microbe is not known, samples of stool or blood are collected from ill people

and sent to the public health laboratory to make the diagnosis.

Detecting and investigating such widespread outbreaks is a major challenge to our

public health system. This is the reason that new and more sophisticated laboratory

methods are being developed and used by CDC and in state public health department

laboratories.

EPIDEMIOLOGY

One of the public health strategies for dealing with food borne illness outbreaks is the

use of epidemiology. Epidemiology is the study of factors determining and influencing

the frequencies and distribution of a disease, injury, and other health-related events and

their causes in a defined human population. The purpose is to establish programs to

prevent and control their development and spread. Let us review a few very basic

principles.

The term “epidemic” is used when there is an occurrence of more cases of disease

than expected in a given area or among a specific group of people over a particular

period.

The term “endemic” refers to the usual prevalence of a given disease or agent in a

population or geographic area at all times.

FSIS employs a group of epidemiologists to assist in investigating food borne disease

outbreaks related to meat, poultry, and egg products.

Surveillance systems for tracking food borne diseases

The hardest outbreaks to detect are those that are spread over a large geographic area,

with only a few cases in each state. These outbreaks can be detected by combining

surveillance reports at the regional or national level and looking for increases in

infections of a specific type.

CDC is part of the U. S. Public Health Service, with a mission to use the best scientific

information to monitor, investigate, control and prevent public health problems. CDC

works closely with state health departments to monitor the frequency of specific

diseases and conducts national surveillance for them. CDC provides expert

epidemiologic and microbiologic consultation to health departments and other federal

agencies on a variety of public health issues, including food borne disease. CDC can

also send a team into the field to conduct emergency field investigations of large or

unusual outbreaks, in collaboration with state public health officials.

CDC researchers develop new methods for identifying, characterizing and fingerprinting

the microbes that cause disease. It translates laboratory research into practical field

methods that can be used by public health authorities in States and counties.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 30

30

CDC is not a regulatory agency. The Food and Drug Administration, the Food Safety

and Inspection Service (USDA), the National Marine Fisheries Service, and other

regulatory agencies carry out government regulation of food safety. CDC maintains

regular contact with the regulatory agencies. Although it does not regulate the safety of

food, the CDC assesses the effectiveness of current prevention efforts. It provides

independent scientific assessment of what the problems are, how they can be controlled,

and of where there are gaps in our knowledge.

FoodNet (Food borne Disease Active Surveillance Network)

FoodNet consists of active surveillance for food borne diseases and related

epidemiologic studies designed to help public health officials better understand the

epidemiology of food borne diseases in the United States. It is the principal food borne

disease component of CDC's Emerging Infections Program (EIP). It is a collaborative

project of the CDC, ten EIP sites (California, Colorado, Connecticut, Georgia, New York,

Maryland, Minnesota, Oregon, Tennessee and New Mexico), the USDA, and the Food

and Drug Administration.

FoodNet provides a network for responding to new and emerging food borne diseases of

national importance, monitoring the burden of food borne diseases, and identifying the

sources of specific food borne diseases.

The FoodNet methods by this surveillance network consist of establishing laboratoryconfirmed cases of infection from each site. A case report is completed which includes

information on demographics, clinical outcomes, and the pathogen.

PulseNet (The Molecular Subtyping Network for Food borne Bacterial Disease

Surveillance)

PulseNet is the national molecular subtyping network for food borne disease surveillance

and allows state laboratories and CDC to compare strains of pathogenic bacteria from all

across the United States to detect widespread outbreaks. This CDC network of public

health laboratories perform a DNA "fingerprinting" method called pulsed-field gel

electrophoresis (PFGE) on food borne bacteria. PulseNet is a national network of public

health laboratories that provides an early warning system for outbreaks of food borne

disease.

PFGE is a molecular method where bacterial chromosomal DNA is digested with specific

restriction enzymes (at least two); the digested fragments are then inserted into an

agarose gel and separated in an electrical field (electrophoresis). The electrophoretic

patterns are visualized following staining with a specific dye and the image is captured

using commercially available digital systems. The data analysis can be performed by

using software programs, and the PFGE typing criteria employed to determine the

genetic relatedness among strains of particular bacterial specie is correlated with the

similarities in the DNA banding pattern.

The network identifies and labels each "fingerprint" pattern and permits rapid

comparison of these patterns through an electronic database at the CDC to identify

related strains. At present, PulseNet tracks four food borne disease-causing bacteria: E.

coli O157:H7, nontyphoidal Salmonella, Shigella, and Listeria monocytogenes at the

DNA level.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 31

31

The spectrum of food borne diseases is constantly changing. A century ago, typhoid

fever, tuberculosis and cholera were common food borne diseases. Improvements in

food safety, such as pasteurization of milk, safe canning, and disinfection of water

supplies have conquered those diseases.

Newly recognized microbes emerge as public health problems for several reasons:

microbes can easily spread around the world, new microbes can evolve, the

environment and ecology are changing, food production practices and consumption

habits change, and because better laboratory tests can now identify microbes that were

previously unrecognized.

In the last 15 years, several important diseases of unknown cause have turned out to be

complications of food borne infections. For example, we now know that the GuillainBarré syndrome can be caused by Campylobacter infection, and that the most common

cause of acute kidney failure in children, hemolytic uremic syndrome, is caused by

infection with E. coli O157:H7 and related EHEC pathogens. In the future, other

diseases whose origins are currently unknown may turn out be related to food borne

infections.

FOOD PROCESSING ESSENTIALS

This section is not intended to cover each type of food preservation method in detail. It

is intended to remind you of the types of food preservation that are currently practiced

and to point out methods of preservation that you may be exposed to as the IIC in a

facility. You will remember some of this from the section of your training on the

Regulated Industries. Proper processing of food helps to ensure that the growth of

harmful microorganisms is controlled, reduced, or eliminated.

Preservation of foods

The basic principle of all forms of food preservation is either to slow down the activity of

disease causing bacteria, or to kill the bacteria altogether so that they do not cause

illness in the consumer of the product.

Following is a list of food preservation techniques commonly used. Not all of these are

present in a FSIS inspected slaughter/processing facility. However, as a PHV you will

most likely be exposed to the use of refrigeration, freezing, heat, and chemical

preservation in the slaughterhouse and processing environment, at a minimum.

Irradiation is just starting to be more accepted by the public, there are a few irradiation

facilities in the United States.

Types of food preservation:

- Refrigeration and freezing

- Canning

- Irradiation

- Chemical preservation

- Pasteurizing (heat)

- Pickling

- Salting
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 32

32

- Dehydration

- Fermentation

- Carbonation

- Cheese-making

- Freeze-drying

When you first report to your duty station it will be important to review the HACCP and

Sanitation SOP plans and take a tour of the facility to familiarize yourself with the

processes of the establishment. If you have questions about the processes, you can ask

the establishment, or you may contact the Policy Development Division (PDD; formerly

known as Technical Service Center) for technical guidance.

OVERVIEW OF FSIS MICROBIOLOGICAL TESTING PROGRAMS

This section will provide a brief overview of FSIS microbiological testing programs. You

will either perform or be involved with these testing programs in the establishment. This

is a very brief overview. You covered all of these in detail when you attended the FSRE

training. Remember that the establishment may have its own microbiological testing

program. You are to regularly review the records associated with the establishment’s

testing program when the testing program has relevance to the establishment’s food

safety systems.

FSIS conducts microbiological testing for Salmonella, E. coli O157:H7, and Listeria

monocytogenes. FSIS also has performance standards for Salmonella, and a pathogen

reduction regulation that requires some establishments to conduct E. coli generic testing.

Salmonella Performance Standards

First, let us review the performance standards for Salmonella. The requirements for

livestock and poultry establishments are covered in 9 CFR 310.25(b) and 381.94(b),

respectively. FSIS Directive 10,011.1 Attachment 1 contains instructions for the

Salmonella performance standards. Attachment 1 also provides background information

and answers to questions regarding FSIS Directive 10,011.1. FSIS Directive 10,230.5 is

the self-Instruction guide for collecting raw meat and poultry product samples for

Salmonella analysis for establishments.

Generic E. coli testing by establishments

The pathogen reduction regulation also covered a requirement for some establishments

to conduct generic E. coli testing and is done by the establishment [9 CFR 310.25(a) and

381.94 (a)]. Generic E. coli is an indicator organism that gives an indication if the

establishment’s sanitary dressing procedures are working effectively. The samples can

be collected using one of several methods (sponge, whole bird rinse, excision)

depending on the type of carcass. FSIS has provided resources to assist

establishments including “Guidelines of Escherichia coli Testing for Process Control

Verification in Cattle and Swine Slaughter Establishments,” and “Guidelines of

Escherichia coli Testing for Process Control Verification in Poultry Slaughter

Establishments”. These resources can be found in the FSIS Website.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 33

33

E. coli O157:H7

Escherichia coli O157:H7 is one of the pathogens included in the FSIS testing program.

While E. coli infections do not cause the largest numbers of illnesses, the illness due to

this pathogen is very severe and can result in death. The CDC now estimates that food

borne transmission of the pathogen annually causes 73,000 illnesses, resulting in more

than 2,000 hospitalizations and 60 deaths. This represents an economic burden where

the annual cost (2003) of illness due to this pathogen was approximately $405 million

dollars. FSIS issued a final rule requiring establishments to conduct a reassessment of

their HACCP plans for E. coli O157:H7. Here are some recent agency policy issuances

on E. coli O157:H7 and can be access through the Web:

“http://www.fsis.usda.gov/Regulations_&_Policies/Index.asp”.

FSIS Directive 10,010.1 ― Microbiological Testing Program for Escherichia coli

O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and

Beef Patty Components

Federal Register Docket No. 04-042N (May 26, 2005/Rules and Regulations)

HACCP Plan Reassessment for Mechanically Tenderized Beef Products.

Federal Register Docket No. FSIS-2008-0035 (October 10, 2008/Notices) –

Sampling and Testing for E. coli O157:H7 in Beef Manufacturing Trimmings.

Federal Register Docket No. FSIS 2010-0008 (March 8, 2010/Notices) – Improving

Tracing Procedures for E. coli O157:H7 Positive Raw Beef Products.

Listeria monocytogenes

During the 1980’s, L. monocytogenes (Lm) began to emerge as a problem in processed

meat and poultry products. In the 1990’s there were outbreaks of food borne illness in

which hotdogs, and possibly deli (luncheon) meats, were implicated.

Since 1999-2003, FSIS published Federal Register Notices and FSIS Notices, held

public meetings, and developed Listeria Guidelines for the industry. The FSIS risk

assessment, in conjunction with a previously released FDA/FSIS risk ranking and public

comment gathered on the topic, provided important data enabling FSIS to design a final

L. monocytogenes rule. This rule was published on June 6, 2003 and became effective

on October 6, 2003.

9 CFR 430 states that Lm can contaminate RTE products that are exposed to the

environment after a lethality treatment (destroy/kill). Lm is a hazard that an

establishment must control through its HACCP plan, or prevent in the environment

through a Sanitation SOP or other prerequisite program if it produces RTE product that

is exposed post-lethality. RTE product is adulterated if it contains Lm or if it contacts

surfaces contaminated with Lm. In order to maintain sanitary conditions necessary to

meet this requirement, an establishment producing post-lethality exposed RTE product

must comply with one of three alternatives outlined in the regulation.

Following is a very brief summary of how establishments must meet the requirements of

regulation 430. If an establishment chooses Alternative 1, they must use a post-lethality

treatment that reduces or eliminates microorganisms on product and an antimicrobial
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 34

34

agent or process that suppresses or limits the growth of Lm. If an establishment

chooses alternative 2 they can use either the post-lethality treatment of product or

antimicrobial agent or process that suppresses or limits growth; however if an

establishment chooses the antimicrobial agent or process they must also have a

sanitation program that addresses the testing of food contact surfaces. For Alternative

3, it employ sanitation measurements only and there is a higher potential risk of post

lethality contamination of the product with Lm, therefore FSIS will most likely sample at a

higher frequency than for Alternative 2 or 1. The risk of contamination with Alternative 2

is higher than the risk of contamination with Alternative 1. Theoretically, Alternative 1

should produce the safest product, and therefore, this product will be subject to the

lowest frequency of verification testing by FSIS.

The final rule contains a great deal of background information on Listeria contamination

of RTE product. Directive 10,240.4 contains instructions for inspectors who will be

verifying compliance with the 9 CFR §430 regulations, as well as procedures for

collecting product samples. The Directive that is accessible through the FSIS website

contains three attachments. In addition, FSIS has posted related documents for

Directive 10,240.4, including updated questions and answers for the interim final rule, a

compliance guideline (May 2006), as well as other resource materials. Altogether, there

are probably several hundred pages of information regarding how the regulation is

implemented, to whom it applies, and information companies should consider when

addressing Lm in their food safety systems.

This information can be accessed through the FSIS website at

http://www.fsis.usda.gov/Regulations_&_Policies/RD_10240_4/index.asp.

Agency policies are updated as information develops about the prevalence of

pathogens, food borne illness outbreaks, and industry practices. It is your responsibility

to maintain a current knowledge of Agency policies and how they affect your job duties.

This basic understanding of food microbiological principles will also help you as you

perform your regulatory responsibilities.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 35

35

REFERENCES

Literature

1. Batz, M.B., et. al. 2005. Attributing illness to Food. Emerging Infectious

Diseases, Vol. 11 (7), pp. 993-999.

2. CDC. 2006. Multistate outbreak of Salmonella Typhimurium infections

associated with eating ground beef ― United States, 2004. MMWR, Vol 55(7),

pp. 180-182.

3. CDC. 2005. Summary of Notifiable diseases ― United States, 2003. MMWR,

Vol 52(54), pp. 1-85.

4. CDC. 2004. Bovine Spongiform Encephalopathy in a diary cow ― Washington

State, 2003. MMWR, Vol. 52(53), pp. 1280-1285.

5. CDC. 2002. Outbreak of multidrug-resistant Salmonella Newport ― United

States, January-April 2002. MMWR, Vol. 51(25), pp. 545-548.

6. CDC. 2001. Norwalk-like viruses: Public health consequences and outbreak

management. MMWR 50(RR-9), pp. 1-18.

7. Dechet, A.M., et al. 2006. Outbreak of multidrug-resistant Salmonella enterica

Typhimurium definitive type 104 infection linked to commercial ground beef,

northeastern United States, 2003 − 2004. Clinical Infectious Diseases, Vol. 42,

pp. 747-752.

8. Doyle, M.P., L.R. Beuchat, and T.D. Montville (Eds). 1997. Food Microbiology:

fundamentals and frontiers. ASM Press, Washington, D.C., USA

9. Donnenberg, M.S. and T.S. Whittam. 2001. Pathogenesis and evolution of

virulence in enteropathogenic and enterohemorrhagic Escherichia coli. The

Journal of Clinical Investigation Vol. 107(5), pp. 539-548.

10. Elder, R.O., et al. 2000. Correlation of enterohemorrhagic Escherichia coli O157

prevalence in feces, hides, and carcasses of beef cattle during processing.

Proceedings of the National Academy of Science, USA, Vol. 97(7), pp. 2999-

3003.

11. Frenzen, P.D. et al. 2005. Economic cost of illness due to Escherichia coli

O157:H7 infections in the United States. Journal of Food Protection, Vol. 68(12),

pp. 2623-2630.

12. Hueston, W. and C.M. Bryant. 2005. Transmissible Spongiform

Encephalopathies. Journal of Food Science, Vol. 70(5), pp.R77-R87.

13. ILSI Research Foundation/Risk Science Institute. 2005. Achieving continuous

improvement in reductions in food borne listeriosis ― A risk based approach.

Journal of Food Protection, Vol. 68(9), pp. 1932-1994.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 36

36

14. Institute of Food Technologists: Scientific Status Summary. August 2004.

Bacteria Associated with food borne diseases, pp. 1-25.

15. Jay, J M. Modern Food Microbiology. 6th ed. 2000, Aspen Publishers, Inc,

Gaithersburg, Maryland.

16. Konkel, M.A. et al. 2001. The pathogenesis of Campylobacter jejuni-mediated

enteritis. Current Issues in Intestinal Microbiology, Vol. 2(2), pp. 55-71.

17. Neidhardt, F.C., Editor in Chief, In Escherichia coli and Salmonella: Cellular and

Molecular Biology, Second Edition. 1996 ASM Press, 1325 Massachusetts Ave.,

N.W., Washington, D.C. 20005.

18. Olive, D.M. and P. Bean. 1999. Principles and Applications of methods for DNAbased typing of microbial organisms. Journal of Clinical Microbiology, Vol.

37(6), pp. 1661-1669.

19. Park, S., et al. 2001. Escherichia coli O157:H7 as an emerging food borne

pathogen: A literature review. Critical Reviews in Biotechnology, Vol. 21(1), pp.

27-48.

20. Paton, J.C. and A.W. Paton. 1998. Pathogenesis and diagnosis of Shiga toxinproducing Escherichia coli infections. Clinical Microbiology Reviews, Vol. 11(3),

pp. 450-479.

21. Rivera-Betancourt, M., et al. 2004. Prevalence of Escherichia coli O157:H7,

Listeria monocytogenes, and Salmonella in two geographically distant

commercial beef processing establishments in the United States. Journal of

Food Protection, Vol. 67(2), pp. 295-302.

22. Ryu, J-H and L.R. Beuchat. 2005. Biofilm formation by Escherichia coli

O157:H7 on stainless steel: Effect of exopolysaccharide and curli production on

its resistance to chlorine.

23. Sivadon-Tardy, V. et al. 2006. Guillain-Barré syndrome, greater Paris area.

Emerging Infectious Diseases, Vol. 12(6). Available from

http://www.cdc.gov/ncidod/EID/vol12no06/05-1369.htm.

24. Swaminathan, B., et al. 2001. PulseNet: The Molecular Subtyping Network for

foodborne bacterial disease surveillance, United States. Emerging Infectious

Diseases Vol. 7(3), pp. 382-389.

25. Uhlich, G.A., et al. 2006. Analyses of the red-dry-rough phenotype of an

Escherichia coli O157:H7 strain and its role in biofilm formation and resistance to

antimicrobial agents.

26. van Loo, I.H.M., et al. 2007. Methicillin-resistant Staphylococcus aureus in meat

products, the Netherlands.
Disposition/Food Safety: Overview of Food Microbiology

July 8, 2011

Entry training for PHV 37

37

Other Websites

FDA Websites

“Bad Bug Book”: http://vm.cfsan.fda.gov/~mow/intro.html

“Bacteriological Analytical Manual Online”:

“http://www.cfsan.fda.gov/~ebam/bam.html”

CDC Websites:

http://www.cdc.gov/ncidod/dbmd/diseaseinfo/foodborneinfections

_g.htm

http://www.cdc.gov/foodnet/default.htm

http://www.cdc.gov/pulsenet/

http://www.cdc.gov/pulsenet/pus.htm

Other Websites:

“http://www.haccpalliance.org/alliance/foodsafety.com
214

Small Business Regulatory

Enforcement Fairness Act (SBREFA)
Office: SBREFA

26-2

215

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

SBREFA OVERVIEW .............................................................................................................4

What is....?........................................................................................................................................ 4

Two Areas of Emphasis ......................................................................................................4

SBREFA Overview..............................................................................................................5

Your Role ............................................................................................................................5

Resources...........................................................................................................................6

SBREFA KNOWLEDGE CHECK............................................................................................7

Knowledge Check 1 ............................................................................................................7

Knowledge Check 2 ............................................................................................................7

SUMMARY .............................................................................................................................7
Office: SBREFA

26-3

216

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Explain the PHV’s role in meeting the agency’s SBREFA requirements.

2. Identify effective techniques and agency resources that PHV’s can use and

provide when communicating with establishment management about assistance

with plant compliance.
Office: SBREFA

26-4

216

Slides SBREFA OVERVIEW

2-6 What is....?

Two Areas of Emphasis

1)

2)
Office: SBREFA

26-5

216

SBREFA Overview

Why is SBREFA important to the Agency?

What qualifies an establishment to be a small business?

Your Role

• Help establishment owners gain access to information that the Agency supplies

to assist them

• Identify materials/resources that are available

• Work with the FLS to get answers to the establishment owner

• Improve communication between the industry and FSIS

•

•

•

•

•
Office: SBREFA

26-6

216

Resources

What techniques/resources should you use and provide when communicating with

establishment management about assistance with plant compliance?

What additional resources are available to small and very small establishments?
Office: SBREFA

26-7

216

Slides SBREFA KNOWLEDGE CHECK

8-9 Knowledge Check 1

What are the two key areas of emphasis FSIS has for the Small Business Regulatory

Enforcement Fairness Act?

Knowledge Check 2

Which of the following (on screen) is an example of how a PHV might help FSIS meet

its SBREFA requirements?

Slides SUMMARY

10 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
221

Wellness
Office: Wellness

23-2

222

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific:.............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

INTRODUCTION ....................................................................................................................4

Defining Wellness................................................................................................................4

Wellness Video....................................................................................................................4

Wellness Video Debrief .......................................................................................................5

WELLNESS: STRESS MANAGEMENT .................................................................................6

Defining Stress....................................................................................................................6

Personal Stress...................................................................................................................8

Common Stressors............................................................................................................ 10

WELLNESS SCENARIOS .................................................................................................... 11

Scenario 1: Establishment Management........................................................................... 11

Scenario 2: Isolation at Work............................................................................................. 12

Scenario 3: Supervisor Responsibilities ............................................................................ 14

More Wellness Scenarios.................................................................................................. 15

ENSURING WELLNESS IN THE WORKPLACE.................................................................. 16

Methods of Stress Relief ................................................................................................... 16

Resources ......................................................................................................................... 17

KNOWLEDGE CHECK......................................................................................................... 17

Knowledge Check 1 .......................................................................................................... 17

Knowledge Check 2 .......................................................................................................... 17

Knowledge Check 3 .......................................................................................................... 18

Knowledge Check 4 .......................................................................................................... 18

Knowledge Check 5 .......................................................................................................... 18

SUMMARY ........................................................................................................................... 18
Office: Wellness

23-3

3

Slides LEARNING OBJECTIVES

N/A Scientific:

1. Recognize the causes and symptoms of job stress and isolation, and remedies

such as networking to create a supportive work environment.

2. Recognize the causes and symptoms of the most common, repetitive stress

injuries and ways to prevent or minimize such injuries.

Regulatory/Administrative:

1. Identify and locate agency resources available to help personnel, including

supervisors, cope with stresses related to the in-plant environment that may

lead to misconduct or workplace violence.
Office: Wellness

23-4

4

Slides INTRODUCTION

2 Defining Wellness

Discussion Question 1: What does wellness mean to you?

Discussion Question 2: How does wellness fit into the workplace?

Discussion Question 3: What are potential common aches/pains/injuries that may be

experienced on the line?

3 Wellness Video

Video Notes:
Office: Wellness

23-5

5

4 Wellness Video Debrief

What would cause a back injury to develop?

What are some steps you can take to prevent back injury?

What are some common types of Cumulative Trauma Disorders (CTDs)?
Office: Wellness

23-6

6

Slides WELLNESS: STRESS MANAGEMENT

6 - 7 Defining Stress

A stressful situation is always defined as a negative response of the body to any

demand.

Which of the following is NOT a factor to how stress may impact people in the same

situation differently?

Stress can promote curiosity and exploration.
Office: Wellness

23-7

7

Three types of stress:

1. Physical

2. Psychological

3. Psychosocial
Office: Wellness

23-8

8

8 Personal Stress

Take a few minutes to complete the Holmes and Rahe Stress Scale. Then compare

your score to the score interpretation.

Directions: Fill out the number of times that the stressor has happened to you within

the past year. Then calculate your total score.

Life Event (Stressor) Value Number of time it

happened in the past

year

Total

Death of a spouse 100

Divorce 73

Marital separation 65

Jail term 63

Death of close family member 63

Major personal injury or illness 53

Marriage 50

Fired from work 47

Marital reconciliation 45

Retirement 45

Major change in health of family

member

44

Pregnancy 40

Sex difficulties 39

Gain of new family member 39

Major business readjustment 39

Major change in financial state 38

Death of close friend 37

Change to different line of work 36

Major change in number of arguments

with spouse

35

Mortgage over $100,000 31
Office: Wellness

23-9

9

Foreclosure of mortgage or loan 30

Major change in responsibilities at

work

29

Son or daughter leaving home 29

Trouble with in-laws 29

Outstanding personal achievement 28

Spouse begins or stops work 26

Begin or end school 26

Major change in living conditions 25

Revision of personal habits 24

Trouble with boss 23

Major change in work hours or

conditions

20

Change in residence or schools 20

Major change in recreation 19

Major change in church activities 19

Major change in social activities 18

Mortgage or loan less than $10,000 17

Major change in sleeping habits 16

Major change in number of family gettogethers15

Major change in eating habits 15

Vacations, Christmas 13

Minor violations of the law 11

Your Total =
Office: Wellness

23-10

10

Score Interpretation:

9 Common Stressors

What are some common PHV-related stressors?
Office: Wellness

23-11

11

Slides WELLNESS SCENARIOS

11 Scenario 1: Establishment Management

Scenario Notes:

Question 1: What would you do in this scenario?
Office: Wellness

23-12

12

Question 2: What resources should you use in this scenario?

12 Scenario 2: Isolation at Work

Scenario Notes:

Question 1: What would you do in this scenario?
Office: Wellness

23-13

13

Question 2: What resources should you use in this scenario?

_

_

_

_
Office: Wellness

23-14

14

13 Scenario 3: Supervisor Responsibilities

Scenario Notes:

Question 1: What would you do in this scenario?
Office: Wellness

23-15

15

Question 2: What resources should you use in this scenario?

14 More Wellness Scenarios

Think of a scenario that could or has happened to you, or you have heard about, to

demonstrate causes and symptoms of negative job stress and isolation. This could be

in the slaughter/kill floor, processing, or office environment.

How would you handle this scenario?
Office: Wellness

23-16

16

Slides ENSURING WELLNESS IN THE WORKPLACE

16 Methods of Stress Relief

What can you do to relieve stress? How can this benefit both your work life and your

personal life?
Office: Wellness

23-17

17

17 Resources

Review the resources that you have access to for your wellness.

Resources Notes:

Slides KNOWLEDGE CHECK

19-23 Knowledge Check 1

Cheryl is standing at the poultry line to inspect the carcasses as they proceed by.

Cheryl is standing with slightly bent knees and relaxed shoulders. As she inspects the

poultry, she twists from her lower back to follow the poultry. Cheryl is standing in a

position that is protecting her from potential back injury?

Knowledge Check 2

Rich notices that his coworker Jim seems very depressed. Rich asks Jim what is wrong

and Jim explains that his younger brother just left rehab early without completing the

program. This is the third time his brother has tried rehab without success and Jim is

the one paying for it. Jim states that he misses his relationship with his brother and

wishes things were they way they were before his brother’s addiction. What kind of

stress is Jim exhibiting?
Office: Wellness

23-18

18

Knowledge Check 3

Match the following words with their characteristics.

• Cumulative Trauma Disorders:

• Physical Stress: 

• Psychological Stress: 

• Psychosocial Stress:

• Wellness: 

Knowledge Check 4

The Agency has benefits and services to support your wellness.

Knowledge Check 5

Who can you reach out to for wellness and stress management resources?

Slides SUMMARY

24 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
239

WELLNESS

OBJECTIVES

To demonstrate mastery of Module Subject the trainee will:

1. Define different types of stress.

2. Generate a list of coping techniques for stressors.

3. Identify personal resources for dealing with stress.

RESOURCES

Definitions of Stress

Stress researcher Hans Selye was one of the first to identify stress and its effects on the

body. He defined stress as a nonspecific response of the body to any demand. The

pioneers of stress research categorized all stress as negative or bad. Today, we

understand that stress is anything in the environment that causes us to adapt, and that a

"stressful" situation can be either happy/positive (like the birth of a baby) or sad/negative

(like the death of a loved one).

We also understand that stress isn't limited to what goes on in our thoughts. We know

that stress is a nonspecific automatic biological response to demands made upon an

individual. Scientifically speaking, stress is any challenge to homeostasis, or the body's

internal sense of balance. Stress is a biological and biochemical process that begins in

the brain and that spreads through the autonomic nervous system, causing hormone

release and eventually exerting an effect on the immune system. Simply stated, the

stress response starts in two major systems: (1) the nervous system, which reacts

almost simultaneously, and (2) the endocrine (or hormone) system, which takes longer

to react but which persists much longer. Stress sets off a complex domino effect in the

body, involving an entire series of body systems and a whole range of powerful

hormones.

We know that stress does not do the same thing to all people. One of the factors that is

involved in this difference is how the impact of stress in situations is altered by how it is

perceived by individuals who are affected by the situation. For example, while traveling

in the Middle East, Dr. Robert Eliot saw two individuals, both driving Mercedes, crash

into each other. The two men, uninjured, jumped out of their cars and began hugging

and laughing instead of yelling at each other, as Eliot would have expected. Curious

about their odd exchange, Eliot asked his interpreter what the two men were saying. The

interpreter explained that the two men were thanking Allah for the chance to meet this

way.

Plenty of evidence confirms that the way you perceive stress has a lot to do with how

stress affects you. American Institute of Stress president Paul J. Rosch likens stress to a
240

ride on a roller coaster. "There are those at the front of the car, hands over head,

clapping, who can't wait to get on again," he points out, "and those at the back cringing,

wondering how they got into this and how soon it's going to be over." Or, to put it another

way, one roller coaster passenger "has his back stiffened, his knuckles are white, his

eyes shut, jaws clenched, just waiting for it to be over. The wide-eyed thrill-seeker

relishes every plunge, can't wait to do it again."

Another difference depends on the timing of the stress. We are all more vulnerable to

the effects of stress at certain times - especially when we're already weakened by some

circumstance in our lives. Most researchers agree that the time to make major changes

in life is not the period following an already stressful event. For example, it's probably

not the best idea to move to a new town and begin a new job just after going through a

divorce. And since everyone is vulnerable to different stresses at different times, it's wise

to reduce unnecessary challenges when you're particularly vulnerable, say the

researchers.

Rosch points out that differences in perception can cause some stress to be good stress

(eustress) rather than bad stress (distress), and he uses as an example symphony

conductors. "They work long hours, travel frequently, deal with prima donnas and

sensitive artists, yet they live long and productive lives. They've got positive vibes going.

They enjoy what they're doing, have pride of accomplishment, the approbation of their

peers, and the applause of the audience, all positive stresses."

In essence, some things that are stressful also promote curiosity and exploration. They

are challenging, stimulating, and rewarding. Competitive sports are an excellent

example. It's extremely stressful, both physically and emotionally, to gear up for a

football game, worry about winning, and then pound across the field for three hours in an

attempt to do it. But many believe the rewards and the thrill are well worth the stress,

and millions of fans couldn't agree more. On the other hand, boredom and understimulation can also be distressful.

Types of Stress

Basically, there are three types of stress: physical, psychological, and psychosocial.

Physical stress involves stressors in the environment - factors such as extremes in

temperature, environmental pollution, constant noise, or electric shock. Researchers

also categorize physiological factors as physical stress. Examples include injury,

surgery, hypoglycemia, prolonged exercise, or an inadequate supply of oxygen.

Psychological stress stems from the way we feel, the attitudes we have, and the way we

react toward anything that is threatening us, whether the threat is real or imagined. As in

the example of the roller coaster, one person may react calmly, while another may

become extremely stressed.

Psychosocial stress involves stressors from interpersonal relationships, arguments or

conflicts with family members, neighbors, employers, friends, or other people around us.

Psychosocial stress may result from intense social interactions, but it can also occur

when there is isolation as a result of inadequate social interactions.

Outcomes of Stress
241

Stress is costly. Obviously, no one can put a precise price tag on the various health

costs of stress, but figures from a variety of sources give us a fairly good idea of its

devastating impact. For example, researchers at the American Institute of Stress

estimate that 75 to 90 percent of all visits to health-care providers result from stressrelated disorders. The American Heart Association says that more than half of all

Americans who die succumb to heart disease and that more than 50 million work days a

year, adding up to a whopping $8 billion, are lost annually to heart-related diseases. Just

among the nation's executives, an estimated $10 to $20 billion is lost each year through

absence, hospitalization, and early death, much of it as a result of stress. The National

Council on Compensation Insurance says that stress-related claims account for almost

one fifth of all occupational disease. Fully one-fourth of all Workman's Compensation

claims are for stress-related injuries, and researchers estimate that 60 to 80 percent of

all industrial accidents are related to stress.

Stress-related symptoms and illnesses are costing industry a conservatively estimated

$150 billion a year in absenteeism, company medical expenses, and lost productivity.

The results of a study at New Mexico State University suggest a strong relationship

between stress and absenteeism. Other studies show that stress accounts for more than

20 percent of the costs associated with high job turnover, strikes, work stoppages,

absenteeism, and decline in productivity.

Left unchecked, unremitting stress can also shorten your life. In one long-term study that

gives a particularly good measure of the effects of stress, researchers studied more than

600 people over twelve years. Researchers tested each study subject at the beginning

of the period, asking if they suffered from distress; at the end of the twelve years, they

discovered that the existence of distress at the study's outset was a good predictor of

who would die during the period of the study. Even when researchers tried to "juggle"

the results - by controlling for factors such as smoking, cholesterol levels, obesity, or

high blood pressure, or by excluding people with chronic heart disease - the figures

remained the same.

The good news is that stress doesn't have to knock you out. Research shows that some

people manage to be resilient to stress; others exhibit what scientists call "hardiness," an

ability to resist the ill-effects of stress. Research has also indicated that there are things

that help you cope better with stressors. To figure out where you stand, it's important to

know the factors that lead to stress, the physiological reactions of the body when under

stress, and the way that stress can compromise the immune system and lead to illness.

Factors Leading to Stress

While researchers recognized the presence of stress decades earlier and had

specifically linked it to disease several years earlier, it was not until early in the 1950s

that anyone was able to identify a list of specific events that contributed to stress. During

the early 1950s, University of Washington psychiatrist Thomas Holmes noted that

tuberculosis had occurred among patients after a cluster of disruptive events, such as a

death in the family, a new job, or a marriage. Based partly on that observation and partly

on his extensive research, Holmes pronounced that the single common denominator for

stress is "... significant change in the life pattern of an individual." Holmes emphasized

that stress did not cause the tuberculosis - tuberculosis bacteria had to be present - but

that stress somehow weakened the body or made it more vulnerable to the disease.
242

Branching out in his research, Holmes began to search for specific links between

disease and what he called life events, those things in life that call for the greatest

adjustment. He found that the more life events a person was subjected to within a brief

period of time, the more likely he or she was to become ill. Holmes developed a socialreadjustment rating scale along with his colleague Richard Rahe; commonly known as

the Holmes-Rahe Scale, it assigns a numerical score to the almost four dozen stressors,

or life changes, that increase the risk of disease. Subsequent research by hosts of

independent scientists has verified the accuracy of the Holmes-Rahe scale.

How to Protect Yourself from the Negative Effects of Stress

If everyone is a “victim” of stress, are there ways we can protect ourselves from the

effects of stress? Absolutely! One of the first ways, says Baylor College of Medicine

psychologist Michael Cox, is to face the stress head-on. Recognize it, and get ready to

deal with it. "Avoiding and denying that stress exists won't make it go away," he says.

"Look at different ways you can change the situation to lessen the stress, make your

decision, and face the stress head on. Action is the fastest way to reduce the level of

stress."

Following are some ideas from cardiologist Robert S. Eliot and others as to how you can

reduce the effects of stress:

• Develop what Eliot calls a game plan for your personal aspirations, both short-term

and long-term ones.

• Take a personal inventory and reestablish important priorities. You need to balance

your talents and goals, similar to the way in which you'd balance your financial

portfolio.

• Work to get things back into balance, and figure out where your long-term goals

may be losing out to short-term pressures, Eliot says.

• Be nice to yourself. Do something nice for yourself every day. Take the time to read

something you love, soak in a warm bath, take a brisk walk, or call an old friend.

• Develop a system of time management that will help you plan your day without

becoming a stressor itself. When you're scheduling your time, remember to leave

time for play, time for hobbies and friends, and time for simple relaxation. If you

have to, schedule in time for breaks.

• Just as you need to develop a game plan for your personal aspirations, Eliot

advises developing a game plan for your career or work. Especially important in

today's economy is the ability to adapt, continually assess where you are, look

ahead, and prepare for change.

• If you commute to work, make sure you plan enough time to arrive without feeling

stressed. If you can, turn your commute into something pleasant: Ride the bus

instead of driving, and take the chance to catch up on some favorite books or

magazines. If you have to drive, try out some entertaining tapes instead of the

usual radio fare.

• Once at work, try the following strategies: Instead of letting the telephone control

you, control the telephone. For example, take initiative to make calls, and block out

several periods during the day in which to return calls. Do what you can to reduce

environmental stresses at work (noise, temperature extremes, and so on). And, at

least once a day, concentrate on doing at least one task - no matter how small -

that brings you satisfaction.

• Be realistic in your expectations of your other people in your life. According to Eliot,

it's crucial to accept people for who they are and let them express their own ideas.
243

Pay attention to your physical health. Have regular checkups, and take care of

health problems promptly. If you notice unusual symptoms, have a doctor check

them out as soon as possible. Above all, believe that you are well.

• Get plenty of sleep. British researchers concluded that flexibility, spontaneity, and

originality of thought can be seriously undermined by as little as one sleepless

night.

• Eat a balanced diet; avoid alcohol, tobacco, and caffeine. During periods of

particular stress, go for a small, high-protein meal.

• Get plenty of exercise.

• Stay socially connected. According to Eliot, "Friends are not just nice, they are a

necessity." If you have problems, talk them out with a trusted friend; if you're facing

something difficult, rehearse it with a friend first. Share your feelings often.

Develop at least one confidant, someone with whom you can share your deepest

thoughts and feelings. And write your thoughts down on a regular basis. Keeping a

journal is good, but so is jotting your thoughts on scraps of paper.

• Get a pet!

• Learn to laugh at yourself, and fill your life with humor.

• When things get tough, find some way to relax. And, above all, stay flexible. There

may be more ways to cope with any situation than at first are apparent.

Understanding the Importance of Optimum Stress Levels

The level of stress under which you operate is important: if you are not under enough

stress, then you may find that your performance suffers because you are bored and

unmotivated. If you are under too much stress, then you will find that your results suffer

as stress related problems interfere with your performance.

It is important that you recognize that you are responsible for your own stress. Very

often it is a product of the way that you think. Learn to monitor your stress levels, and

adjust them up if you need to be more alert, or down if you are feeling too tense. By

managing your stress effectively you can significantly improve the quality of your life.

There is a linkage between stress and performance. Following are some tips on how

you can ensure that you perform at your best by optimizing stress levels.

The approach to optimizing stress depends on the sort of stress being experienced:

• Short term stress such as difficult meetings, sporting or other performances, or

confrontational situations. Here the emphasis is on short term management of

adrenaline to maximize performance.

• Long term stress, where fatigue and high adrenaline levels over a long period can

lead to degraded performances. Here optimizing stress concentrates on

management of fatigue, health, energy and morale.

Naturally there is some element of overlap between these.

Short term stress

The graph below shows the relationship between stress and the quality of performance

when you are in situations that impose short term stress:
244

(Please note that this graph will be a slightly different shape for different people in

different circumstances)

Where stress is low, you may find that your performance is low because you become

bored, lack concentration and motivation.

Where stress is too high, your performance can suffer from all the symptoms of shortterm stress.

In the middle, at a moderate level of stress, there is a zone of best performance. If you

can keep yourself within this zone, then you will be sufficiently aroused to perform well

while not being over-stressed and unhappy.

This graph and this zone of optimum performance are different shapes for different

people. Some people may operate most effectively at a level of stress that would leave

other people either bored or in pieces. It is possible that someone who functions

superbly at a low level might experience difficulties at a high level. Alternatively someone

who performs only moderately at low level might perform exceptionally under extreme

pressure.

Long term stress

The problems of long term, sustained stress are more associated with fatigue, morale,

and health than with short term adrenaline management.

The graph below shows the way in which performance can suffer when you are under

excessive long term stress:
245

The graph shows four major stages that you may go through in response to sustained

levels of excessive stress:

1. During the first phase you will face challenges with plenty of energy. Your

response will probably be positive and effective.

2. After a period of time you may begin to feel seriously tired. You may start to feel

anxious, frustrated and upset. The quality of your work may begin to suffer.

3. As high stress continues you may begin to feel a sense of failure and may be ill

more frequently. You may also begin to feel exploited by your organization. At

this stage you may start to distance yourself from your employer, perhaps

starting to look for a new job.

4. If high levels of stress continue without relief you may ultimately experience

depression, burnout, nervous breakdown, or some other form of serious stress

related illness.

Different people may move between these stages with different speeds under different

stress conditions.

At a simple level it may appear that a measure of 'toughness' is how well you keep on

going under extreme stress. This is simplistic. It is certainly possible to be self-indulgent

and use stress as an excuse for not pushing yourself hard enough. It is, however, also

far too easy to let yourself be pushed to a level where your work, and physical and

mental health start to suffer. The strongest and most flexible position is to actively

manage your levels of stress and fatigue so that you are able to produce high quality

work over a long period, reliably.

High performance in your job may require continued hard work in the face of high levels

of sustained stress. If this is the case, it is essential that you learn to pay attention to

your feelings. This ensures that you know when to relax, slacken off for a short period,

get more sleep, or implement stress management strategies. If you do not take feelings

of tiredness, upset or discontent seriously, then you may face failure, burn-out or

breakdown.
246

As well as paying attention to your own stress levels, it may be worth paying attention to

the stress under which people around you operate. If you are a manager seeking to

improve productivity, then failing to monitor stress may mean that you drive employees

into depression or burn-out. If this is a danger, then reduce stress for long enough for

them to recover, and then reconsider the pace you are setting.

REFERENCES

http://www.geocities.com/beyond_stretched/holmes.htm.

http://www.musc.edu/psychiatry/slater/stress1.htm.
247

WORHSHOP

1. Because stressors are rarely found in the home, an ergonomic program can

focus exclusively on job-related stress:

True

False

2. Good posture is the way we or which

causes the least amount of physical stress to the body:

a. sit, run

b. stand, walk

c. sit, stand

d. run, walk

3. Back injuries occur as a result of one injury or accident:

a. always

b. usually

c. sometimes

d. rarely

4. Two factors which can increase the risk of back injury are :

a. stress, walking

b. sitting, eating

c. high body fat, stress

d. standing, stretching

5. are not typically a result of accidents or sudden mishaps.

Rather, this type of injury develops gradually over time:

a. pulled/strained muscles

b. cumulative trauma disorders

c. broken bones

6. Keeping the muscles strong around the joints and tendons will not help prevent

cumulative trauma disorders:

True

False

7. While stress cannot be eliminated from our lives, it is best handled by being:

a. avoided

b. ignored

c. managed

8. Stress is any change (positive or negative) to which you must adjust:

True

False

9. While stress is commonly reported by American workers, most FSIS inspectors

experience a very low level of stress:

True

False
248

10. The relaxation response lowers the heart rate, breathing rate, and blood

pressure:

True

False

11. Creating a sense of control in your life is a technique for managing stress:

True

False

12. People need extra sleep when they are stressed:

True

False

13. What you eat does not have much impact upon your ability to cope with stress:

True

False

14. Strong lifestyle choices can help only minimally to neutralize the effects of

stressful life events:

True

False

15. Even small amounts of exercise result in the release of pleasure-inducing

hormones (called endorphins) that can help you cope better with stress:

True

False
249

• YOU MAY PRINT AND COPY AND USE THIS HANDOUT FOR YOUR PERSONAL OR PROFESSIONAL USE • AS IS • AS FREELY AS YOU WISH •

HOLMES AND RAHE STR ESS SCALE

·-····· · ····· ·· ···-·· -·- ·· · -· · .. ······

multiply event by the number of times you have experienced it in the last year

LIFE EVENT (STRESSOR) VALUE #/YR TOTAL

1 DEATH OF SPOUSE -------------------100 X =

2 DIVORCE 73 X =

3 MARITAL SEPARATION 65 X =

4 JAIL TERM 63 X =

5 DEATH OF CLOSE FAMILY MEMBER 63 X =

6 MAJOR PERSONAL INJURY OR ILLNESS 53 X =

7 MARRIAGE 50 X =

8 FIRED FROM WORK

9 MARITAL RECONCILIATION

10 RETIREMENT

11 MAJOR CHANGE IN HEALTH OF FAMILY MEMBER

12 PREGNANCY

13 SEX DIFFICULTIES

14 GAIN OF NEW FAMILY MEMBER ---------------

15 MAJOR BUSINESS READJUSTMENT -------------

16 MAJOR CHANGE IN FINANCIAL STATE

17 DEATH OF CLOSE FRIEND

18 CHANGE TO DIFFERENT LINE OF WORK

19 MAJOR CHANGE IN NUMBER OF ARGUMENTS WITH SPOUSE -----

2M0ORTGAGE OVER $100,000

21 FORCLOSURE OF MORTAGE OR LOAN -------------

22 MAJOR CHANGE IN RESPONSIBILITIES AT WORK ---------

23 SON OR DAUGHTER LEAVING HOME -------------

2TR4OUBLE WITH IN-LAWS

3T0ROUBLE WITH BOSS

31 MAJOR CHANGE IN WORK HOURS OR CONDITIONS --------

32 CHANGE IN RESIDENCE OR SCHOOLS ------------

33 MAJOR CHANGE IN RECREATION --------------

3M4AJOR CHANGE IN CHURCH ACTIVITIES -----------

35 MAJOR CHANGE IN SOCIAL ACTIVITIES ------------

36 MORTGAGE OR LOAN LESS THAN $10,000 -----------

37 MAJOR CHANGE IN SLEEPING HABITS

38 MAJOR CHANGE IN NUMBER OF FAMILY GET-TOGETHERS ------

39 MAJOR CHANGE IN !EATING HABITS

40 VACATIONS , CHRISTMAS

41 MINOR VIOLATIONS OF THE LAW

47 X =

45 X =

45 X =

44 X =

40 X =

39 X =

39 X =

39 X =

38 X =

37 X =

36 X =

35 X =

31 X =

30 X =

29 X =

29 X =

29 X =

=

=

=

=

=

23 X =

20 X =

20 X =

19 X =

19 X =

18 X =

17 X =

16 X =

15 X =

15 X =

13 X =

11 X =

YOUR TOTAL

R&M SEMINARS

OPINIONS AND FEELINGS ARE FREQUENTLY A PERSONAL TRIUMPH OVER GOOD THINKING

YOU DEFINE REALITY BY WHAT YOU KNOW, WHAT YOU BELIEVE, AND WHAT YOU DO ABOUT IT.

• TA-TUTOR.COM • R&M SEMINARS • RELATIONSHIP & MANAGEMENT • LEWIS QUINBY LCSW • 1671 MYRTLE AVE • EUREKA CA 95501 • (707) 443-3637 •

25 OUTSTANDING PERSONAL ACHIEVEMENT----------- 28 X

26 SPOUSE BEGINS OR STOPS WORK ------------- 26 X

27 BEGIN OR END SCHOOL 26 X

28 MAJOR CHANGE IN LIVING CONDITIONS 25 X

29 REVISION OF PERSONAL HABITS -------------- 24 X
250

Resources and Networking

OBJECTIVE

To identify resources including professional organizations, web sites, and information

useful in performing the job duties as an FSIS Public Health Veterinarian.

RESOURCE MATERIALS

The following resources will be useful to you in providing information that will help you be

more effective in performing your job duties as an FSIS Public Health Veterinarian.

1. Agricultural Research Service, http://www.ars.usda.gov. This web site contains

current research topics including food safety and animal diseases.

2. American Association of Public Health Veterinarians, http://www.aaphv.org/ This

website promotes the science, art, and practice of public health, epidemiology,

and preventive medicine.

3. American Meat Institute, http://www.meatami.org/. This web site contains news

about the meat industry and guidelines for humane handling recommended by

the industry.

4. American Meat Science Association, http://www.meatscience.org/. This web site

contains current news and research about meat.

5. Centers for Disease Control and Prevention, htpp://www.cdc.gov. This web site

contains important public health information including the MMWR (Morbidity and

Mortality Weekly Report), travel advisories, FoodNet and PulseNet current

updates.

6. CDC Morbidity and Mortality Weekly Report, htpp://www.cdc.gov/mmwr/. This

web site contains weekly disease statistics, including foodborne illnesses.

7. Center for Food Security and Public Health,

http://www.cfsph.iastate.edu/About/index.php This website promotes

preparedness for accidental or intentional introduction of diseases that threaten

food production or public health.

8. Code of Federal Regulations Online,

http://www.access.gpo.gov/nara/cfr/waisidx_08/9cfrv2_08.html#301. This web

site contains the regulations. For example, you can use it to access a copy of

the HACCP regulations which are contained in 9 CFR 417.

9. Environmental Protection Agency, htpp://www.epa.gov. This web site contains

regulatory information about water, waste management (including concentrated

animal feeding operations) and pesticides. EPA establishes the tolerance levels

FSIS uses when testing regulated products.
251

10. Federation of American Scientists: Working Group on Biological and Toxin

Weapons, http://www.fas.org/programs/ssp/bio/index.html. This web site

contains biosecurity news as well as general information at the main website on

a broad range of scientific issues.

11. Food and Drug Administration, htpp://www.fda.gov. This web site contains all of

the contacts and information about each office, news releases and current

issues, such as animal feed regulations for preventing BSE and animal drug

approvals- both found in the Center for Veterinary Medicine's webpage.

12. Food Safety and Inspection Service, htpp://www.fsis.usda.gov. This web site

contains information about FSIS. For example, you can find the following

information: vacancy announcements, job application information, emergency

contact information for all District Offices, Directives, Federal Register Notices, a

listing of upcoming public meetings, program area information, The Beacon,

recent speeches by Agency officials. Get training information and order training

CDs by searching under Browse, FSIS Employees, Workforce Training.

13. Food Safety Training and Education Alliance, htpp://www.fstea.org/. This web

site contains current educational information.

14. International Veterinary Information Service, http://www.ivis.org/home.asp. This

web site contains international training programs and curricula.

15. National Agricultural Library – Agricola Search Engine,

http://agricola.nal.usda.gov/. This web site contains everything you'll need to

search for publications and books.

16. National Cattlemen’s Beef Association, http://www.beef.org/. This web site

contains news and articles of interest to the cattle industry.

17. National Library of Medicine – Pubmed Search Engine,

http://www.ncbi.nlm.nih.gov/pubmed/. This web site contains access to millions

of scientific articles on public health.

18. North American Meat Association, http://meatassociation.com. This web site

contains news and current issues.

19. National Pork Board, http://www.pork.org/. This web site contains animal health,

welfare, environmental and meat news.

20. Office of International Epizootics (OIE), http://www.oie.int/eng/en_index.htm.

This web site contains international standards for animal health.

21. One Health Initiative, http://www.onehealthinitiative.com/ This website contains

information on collaborations and communications in all aspects of health care

for humans, animals and the environment.
252

22. ProMED-mail, http://www.promedmail.org/ This website contains reporting

system dedicated to rapid global dissemination of information on outbreaks of

infectious diseases and acute exposures to toxins that affect human health.

23. Stanford University – Highwire Medline Search, http://highwire.stanford.edu/.

This web site contains ways to obtain more scientific articles.

24. Temple Grandin’s Website on Humane Handling, http://www.grandin.com. This

website contains guidelines for humane handling, and slaughter of livestock and

poultry as well as published articles.

25. United States Animal Health Association, http://www.usaha.org/. This web site

contains information on membership, meetings and news regarding all animal

health, food safety and other scientific and regulatory issues important to USDA,

FDA, EPA and all State Veterinarians.

26. USDA, APHIS Veterinary Services, http://www.aphis.usda.gov/animal_health/.

This web site contains access to all APHIS information and special sites on BSE

and current animal disease outbreaks.

27. USDA, APHIS Veterinary Services Foreign Animal Disease Training,

http://www.aphis.usda.gov/emergency_response/NAHEM_training/index_nahem.

shtml. This web site contains information on special courses conducted at Plum

Island. Sometimes FSIS veterinarians are selected to attend through an APHIS

invitation.

28. U.S. Poultry and Egg Association, http://www.poultryegg.org/. This web site

contains information about egg safety and quality assurance programs to reduce

Salmonella.
253

In-plant Performance System &

Supervisory Tool of Assessment

Results

IPPS & STAR – Part 1
Office: IPPS/STAR Part 1

24a-2

254

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

SUPERVISOR’S ROLE....................................................................................................................... 4

ACTIVITY 1.............................................................................................................................5

Activity 1 Instructions...........................................................................................................5

Group Materials...................................................................................................................5

Presentations ......................................................................................................................6

Takeaways ..........................................................................................................................7

IPPS & STAR PART 1 KNOWLEDGE CHECK.......................................................................8

Knowledge Check 1 ............................................................................................................8

Knowledge Check 2 ............................................................................................................8

Knowledge Check 3 ............................................................................................................9

Knowledge Check 4 ............................................................................................................9

Knowledge Check 5 ............................................................................................................9

SUMMARY .............................................................................................................................9
Office: IPPS/STAR Part 1

24a-3

255

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Use FSIS Directive 4430.3 Revision 4 and FSIS Directive 4430.5 Amendment 1,

to conduct IPPS and STAR assessments.

2. Given scenarios, distinguish between on-target and off-target performance and

other employee responsibilities that a PHV oversees such as NRs, MOIs,

HACCP verification, etc. during IPPS assessments.

3. Create a follow-up plan to address an identified deficiency in employee

knowledge or performance.
Office: IPPS/STAR Part 1

24a-4

255

Slides SUPERVISOR’S ROLE

2 Supervisors are responsible for conducting both IPPS and STAR.

Why are IPPS and STAR so important?

What is the supervisor’s role in IPPS and STAR?
Office: IPPS/STAR Part 1

24a-5

255

Slides ACTIVITY 1

3 Activity 1 Instructions

• You will be split up into four groups.

• Each group will be responsible for reviewing materials and completing a Help

Tool.

• Each group will choose a leader who will distribute the workload among group

members.

• Each member will analyze their assigned part and document the essential

learning points in the Help Tool sheet.

• Within the group, each member will discuss their documented learning points.

• Each group will present their findings and gained knowledge to the rest of the

class.

4 Group Materials

Based on your group, review the materials you need to successfully complete your

task.

Group 1

• Watch video 1

• Analyze Directive 4430.3

Group 2

• Watch video 2

• Analyze Directive 4430.5

Group 3

• Watch video 3

• Analyze Department Regulation 4040-430

Group 4

• Watch videos 1 and 2

• Analyze Directives 4430.4 and 4430.5

• Focus on the comparison of IPPS and STAR
Office: IPPS/STAR Part 1

24a-6

255

Group Activity Notes:

5 Presentations
Office: IPPS/STAR Part 1

24a-7

255

6 Takeaways

What are some key takeaways about supervisors, performance management, IPPS,

and STAR?
Office: IPPS/STAR Part 1

24a-8

255

Slides IPPS & STAR PART 1 KNOWLEDGE CHECK

7-12 Knowledge Check 1

Knowledge Check 2

What are the three methods of assessing performance?

What is an In-Plant

Performance System

(IPPS)?

What is a Supervisory Tool

for Assessment Results

(STAR)?

What is performance

management?
Office: IPPS/STAR Part 1

24a-9

255

Knowledge Check 3

A Supervisory Public Health Veterinarian would be required to perform a STAR

assessment on which position?

Knowledge Check 4

According to Departmental Regulation (DR) 4040-430, the appraisal period or

performance year is comprised of the period from: .

Knowledge Check 5

Following IPPS and STAR assessment, a completed IPPS or STAR assessment sheet

should be mailed to the employee within two months.

Slides SUMMARY

13 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
262

In-plant Performance System &

Supervisory Tool of Assessment

Results

IPPS & STAR – Part 2
Office: IPPS/STAR Part 2

24b-2

263

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

NONCOMPLIANCE RECORDS (NRS) ..................................................................................4

ACTIVITY 2.............................................................................................................................4

Activity 2 Instructions...........................................................................................................4

Group Materials...................................................................................................................5

Presentations ......................................................................................................................6

Takeaways ..........................................................................................................................7

IPPS & STAR PART 2 KNOWLEDGE CHECK.......................................................................8

Knowledge Check 1 ............................................................................................................8

Knowledge Check 2 ............................................................................................................8

Knowledge Check 3 ............................................................................................................8

Knowledge Check 4 ............................................................................................................8

SUMMARY .............................................................................................................................8
Office: IPPS/STAR Part 2

24b-3

264

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Use FSIS Directive 4430.3 Revision 4 and FSIS Directive 4430.5 Amendment 1,

to conduct IPPS and STAR assessments.

2. Given scenarios, distinguish between on-target and off-target performance and

other employee responsibilities that a PHV oversees such as NRs, MOIs,

HACCP verification, etc. during IPPS assessments.

3. Create a follow-up plan to address an identified deficiency in employee

knowledge or performance.
Office: IPPS/STAR Part 2

24b-4

264

Slides NONCOMPLIANCE RECORDS (NRS)

2 Why are NRs reviewed during IPPS and STAR?

Slides ACTIVITY 2

3 Activity 2 Instructions

• You will be split up into four groups.

• Each group will be responsible for reviewing materials and completing a Help

Tool.

• Each group will choose a leader who will distribute the workload among group

members.

• Each member will analyze their assigned part and document the essential

learning points in the Help Tool sheet.

• Within the group, each member will discuss their documented learning points.

• Each group will present their findings and gained knowledge to the rest of the

class.
Office: IPPS/STAR Part 2

24b-5

264

4 Group Materials

Review the NRs. There are 10 NRs that have been written by the same CSI in the past

8 weeks. Below are the group assignments.

Group 1

• Present information from NR #1, 2, and 3

Group 2

• Present information from NR # 4, 5, and 6

Group 3

• Present information from NR # 7 and 8

Group 4

• Present information from NR #9 and 10

Group Activity Notes:
Office: IPPS/STAR Part 2

24b-6

264

5 Presentations
Office: IPPS/STAR Part 2

24b-7

264

6 Takeaways

What are some key takeaways about NRs and their role in IPPS and STAR?

_

_
Office: IPPS/STAR Part 2

24b-8

264

Slides IPPS & STAR PART 2 KNOWLEDGE CHECK

7-11 Knowledge Check 1

An example of a data source that you can review before an IPPS visit is a

Noncompliance Record (NR) to determine whether the NRs are being written in

accordance with FSIS Directive 5000.1?

Knowledge Check 2

Which of the following is NOT something you can evaluate a CSI on when reviewing

NRs? 

Knowledge Check 3

When conducting IPPS assessments, you should observe plant conditions and

compare them to inspection results and NRs on file.

Knowledge Check 4

Which of the following is NOT one of the W’s addressed in a NR?

Slides SUMMARY

12 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
270

In-plant Performance System &

Supervisory Tool of Assessment

Results

IPPS & STAR – Part 3
Office: IPPS/STAR Part 3

24c-2

271

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

INTRODUCTION ....................................................................................................................4

Observation.........................................................................................................................4

Observation (Continued) .....................................................................................................4

ACTIVITY 3.............................................................................................................................5

Activity 3 Instructions...........................................................................................................5

Group Materials...................................................................................................................5

Presentations ......................................................................................................................6

Takeaways ..........................................................................................................................7

IPPS & STAR PART 3 KNOWLEDGE CHECK.......................................................................8

Knowledge Check 1 ............................................................................................................8

Knowledge Check 2 ............................................................................................................8

Knowledge Check 3 ............................................................................................................8

Knowledge Check 4 ............................................................................................................8

SUMMARY .............................................................................................................................8
Office: IPPS/STAR Part 3

24c-3

272

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Use FSIS Directive 4430.3 Revision 4 and FSIS Directive 4430.5 Amendment 1,

to conduct IPPS and STAR assessments.

2. Given scenarios, distinguish between on-target and off-target performance and

other employee responsibilities that a PHV oversees such as NRs, MOIs,

HACCP verification, etc. during IPPS assessments.

3. Create a follow-up plan to address an identified deficiency in employee

knowledge or performance.
Office: IPPS/STAR Part 3

24c-4

272

Slides INTRODUCTION

2 Observation

When you observe the inspector on the job, as part of IPPS and STAR, what are you

looking for?

3 Observation (Continued)

Does the inspector:

❑ Perform procedures consistent with Agency policy?

❑ Make sound supportable decisions?

❑ Review and understand the plant’s HACCP, SSOP, prerequisite programs?

❑ Use aseptic procedures when collecting a sample for microbial testing?
Office: IPPS/STAR Part 3

24c-5

272

If noncompliance is found during the assessment, what should the inspector do?

Slides ACTIVITY 3

4 Activity 3 Instructions

• You will be split up into four groups.

• Each group will be provided with a scenario of inspectors performing several

inspection activities.

• Each group will choose a leader who will distribute the workload among group

members.

• Each member will analyze their assigned scenario and document the essential

learning points in the Help Tool sheet.

• Within the group, each member will discuss the scenario together, and the

leader will summarize the information on the Summary sheet.

• Each group will present their summary and gained knowledge to the rest of the

class.

5 Group Materials

Review the materials you need to successfully complete your task.

Groups 1 and 2 – Scenario 1

Groups 3 and 4 – Scenario 2

Group Activity Notes:
Office: IPPS/STAR Part 3

24c-6

272

6 Presentations
Office: IPPS/STAR Part 3

24c-7

272

7 Takeaways

What are some key takeaways about using observation for IPPS and STAR? What did

you learn from the scenarios?
Office: IPPS/STAR Part 3

24c-8

272

Slides IPPS & STAR PART 3 KNOWLEDGE CHECK

8-12 Knowledge Check 1

Which of these positions is not convered under IPPS?

Knowledge Check 2

Onsite observation of employees conducting inspection and verification procedures in

federally inspected establishments is not required during an IPPS assessment.

Knowledge Check 3

Supervisors should not observe plant conditions during IPPS assessments since the

focus of IPPS assessments are on employee actions that warrant disciplinary

action.

Knowledge Check 4

When observing an inspector for the IPPS assessment, which of the following should

you be looking for?

Slides SUMMARY

13 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
278

In-plant Performance System &

Supervisory Tool of Assessment

Results

IPPS & STAR – Part 4
Office: IPPS/STAR Part 4

24d-2

279

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

INTRODUCTION ....................................................................................................................4

IPPS and STAR Follow-Up..................................................................................................4

ACTIVITY 4.............................................................................................................................4

Activity 4: Phase 1 Instructions............................................................................................4

Questions to Ask When Conducting an IPPS Review .........................................................5

Activity 4: Phase 2 Instructions............................................................................................8

Activity 4 Discussion............................................................................................................9

Takeaways ........................................................................................................................ 10

IPPS & STAR PART 4 KNOWLEDGE CHECK .................................................................... 11

Knowledge Check 1 .......................................................................................................... 11

Knowledge Check 2 .......................................................................................................... 11

Knowledge Check 3 .......................................................................................................... 11

Knowledge Check 4 .......................................................................................................... 11

SUMMARY ........................................................................................................................... 11
Office: IPPS/STAR Part 4

24d-3

3

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Use FSIS Directive 4430.3 Revision 4 and FSIS Directive 4430.5 Amendment 1,

to conduct IPPS and STAR assessments.

2. Given scenarios, distinguish between on-target and off-target performance and

other employee responsibilities that a PHV oversees such as NRs, MOIs,

HACCP verification, etc. during IPPS assessments.

3. Create a follow-up plan to address an identified deficiency in employee

knowledge or performance.
Office: IPPS/STAR Part 4

24d-4

4

Slides INTRODUCTION

2 IPPS and STAR Follow-Up

What should you do if you noted any deficiencies during the assessment?

Slides ACTIVITY 4

3 Activity 4: Phase 1 Instructions

• Download the Activity 4 Help Tool and the questions to ask when conducting an

IPPS review sheet.

• Complete the Help Tool to use while you are conducting the IPPS/STAR review.

The tool should include 4 sections:

1. How you will prepare for an IPPS/STAR review?

2. What is the method you will use to conduct the review?

3. What are the questions that you will discuss with the IPP?

4. What will be included in the follow-up plan?

Activity Notes:
Office: IPPS/STAR Part 4

24d-5

5

Questions to Ask When Conducting an IPPS Review

Here are sample questions to use to ensure IPP are carrying out mission critical work

activities - performance elements and activities assessed, mission support,

communications, individual contributions to the team.

Food Inspector: Poultry

• What are some valid reasons to stop the line?

• What actions would you take if you see trends/patterns of bruising and

fractures?

• How would you communicate increased incidence of cadaver birds

• How would you record birds that you suspect are DOA?

• What are some indications of a bird that hung on the line as a DOA?

• What are some characteristics of a cadaver bird, one that was alive in the scald

vat?

• You could name various conditions and ask what the regulatory disposition

would be?

• Discuss localized VS generalized.

• What is a systemic disturbance?

• Why do we consider sep/tox and fecal contamination to be of public health

significance

• Explain the differences between chronic and acute

• Why is it important that the establishment record birds as plant rejects when

they use the US condemn barrel?

• What action would you take when you see excessive grease or contamination

on several carcasses?

• Discuss the difference in poultry between GCP vs HH in livestock

• When would it be appropriate to hang a carcass back for PHV disposition?

• What action should you take if the presenter or trimmer fails to clean hands or

equipment between carcasses?

• What is the purpose of AM inspection?

• Where are the typical fat deposits in a bird and what can they tell us about

overall health status?

• What is the purpose of PM inspection?

• How can you maintain positive control of a condemned product?

• What are some causes for liver condemnation?

• When IPP indicate a bird needs to go to airsacculitis salvage, what must be

removed?

• How should you report an unsafe working condition?

• How should you respond to increased incidence of birds presented with no

viscera? ( non NPIS )

• What are considered the three critical organs when making a disposition? ( non

NPIS )
Office: IPPS/STAR Part 4

24d-6

6

• How do you address improper presentation?

Food Inspector: Livestock

• What are some reasons to stop the line?

• What actions would you take if you saw evidence of multiple knocks in the skull?

• What are some reasons you might retain a carcass? Head lesions? Carcass

lesions? Visceral lesions?

• You could name various conditions and ask what the regulatory disposition

would be?

• Please explain the differences between abscesses and pyemia?

• What is the purpose of AM inspection?

• What is the purpose of PM inspection?

• What is the purpose of PPE and when should they be worn?

• Please explain the HMSA?

• Please give some causes for liver condemnations?

• Please discuss the significance of SRMs and their removal.

• How would you respond to inadequate procedures at the rail out loop? e.g.

trimming contamination, cross contamination, employee hygiene

• How would you communicate inadequate sanitary dressing or process control

issues?

• Depends on species: What lymph nodes do you incise on the swine head?

Cattle head. Cattle pluck/lungs. What do you palpate on PM viscera?

• Explain the importance if incising bile ducts in cattle? What are you looking for?

• Please explain the public health significance of fecal contamination in livestock?

• How do you address visible fecal contamination at your inspector station?

• How do you address improper presentation?

• What are some reasons that the line speed may be reduced?

• Can you name any zoonotic (transmissible to humans) diseases in livestock?

• Please give some reasons for head condemnation in livestock

• Please give some reasons for liver and or heart condemnations in livestock.

• What are some signs of a generalized condition?

• What are some signs of a septicemic carcass?

• What are some of the signs of malignant lymphoma?

• What are some of the AM and PM signs in cattle epithelioma?

CSI: Any establishment (can use any of above if in a slaughter establishment)

• What are some of the HATs tasks?

• What are the corrective action requirements for SSOP? , HACCP?

• How would an establishment bring themselves back in compliance with an SPS

insanitary condition?

• Please explain the purpose of the HAV task

• Please explain how to conduct a HACCP verification task (insert that type

slaughter etc.)

• Please explain the importance of lock out tag out.
Office: IPPS/STAR Part 4

24d-7

7

• How would you perform and record a poultry GCP task?

• When would you document an MOI vs document NR for GCPs (poultry)

• What action would you take if you saw egregious inhumane treatment of

livestock?

• Please explain the relevance of holding weekly meetings and define due

process?

• Please explain what aseptic sampling technique is?

• Why is it important to check for lab capacity before shipping a sample?

• What types of regulatory control actions can be taken and when? Either give

suggestions or have CSI give examples.

• Does the pest management control program need to be written?

• How would you respond if the establishment is unwilling to share records related

to the food safety system?

• Exports: How would you perform reinspection

• Where would you look up or access country requirements

• What are some reasons that may require supervisory communication with

regards to exports?

• What are the frequency and significance of conducting Food Defense tasks?

• How would you react to establishment testing or micro sampling data that show

results that reflect little to no process control?

• How would you respond to a positive FSIS sample result when it is an FSIS

recognized adulterant?
Office: IPPS/STAR Part 4

24d-8

8

4-5 Activity 4: Phase 2 Instructions

Video Example Notes:

Role-Playing Activity:

• Divide the class into pairs.

• Choose a Help Tool and a form from the list below:

o IPPS FI Form

o IPPS CSI Form

o STAR Form

• Each pair will role play conducting and documenting an IPPS/STAR review.

• Don’t forget to generate a follow-up plan.

• Once the first student has gone, reverse roles and repeat the scenario.

Activty Notes:
Office: IPPS/STAR Part 4

24d-9

9

5 Activity 4 Discussion

What did you learn by participating in this role-playing activity? What should you do

before, during, and after an IPPS or STAR assessment?
Office: IPPS/STAR Part 4

24d-10

10

6 Takeaways

What are some key takeaways about conducting an IPPS or STAR assessment? What

are some key takeaways about how to follow-up after an IPPS or STAR assessment?
Office: IPPS/STAR Part 4

24d-11

11

Slides IPPS & STAR PART 4 KNOWLEDGE CHECK

8-12 Knowledge Check 1

Following an IPPS and STAR assessment, a completed IPPS or STAR assessment

should be e-mailed or printed and given to the employee within two weeks.

Knowledge Check 2

If any deficiencies were noted during the assessment, which of the following is NOT a

way to follow-up?

Knowledge Check 3

After performing an IPPS assessment, the supervisor should monitor which of the

following? 

Knowledge Check 4

Which of the following is NOT a way to assess performance for the IPPS or STAR

assessments?

Slides SUMMARY

13 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
289

In-Plant Performance System (IPPS) & Supervisory Tool for

Assessment Results (STAR)

Objectives

After completing this module, you will be able to:

1. Define IPPS and STAR.

2. Identify the positions covered under IPPS and STAR.

3. Identify the relationship between IPPS, STAR, and OFO’s management control

system.

4. Identify the number of IPPS and STAR assessments that must be performed per

rating cycle.

5. Identify the relationship between IPPS assessments, STAR assessments,

progress reviews, and performance appraisals.

6. List the steps for preparing for IPPS and STAR assessments.

7. Identify the methods of assessing performance.

8. Recognize the importance of feedback.

Resources

United State Department of Agriculture Regulation 4040-430 Performance Management

FSIS Directive 4430.3 In-Plant Performance System (IPPS)

FSIS Directive 4430.5 Supervisory Tool for Assessment Result (STAR)
290

In-Plant Performance System (IPPS) 

Introduction 

The In-Plant Performance System (IPPS) is a tool that supervisors use to assess the 

performance of non-supervisory in-plant inspection program personnel. IPPS covers all 

non-supervisory in-plant inspection program personnel including Food Inspectors, 

Consumer Safety Inspectors, and Public Health Veterinarians. An IPPS review is 

conducted by Office of Field Operations (OFO) supervisors including Frontline Supervisors, 

Multi-IPPS Supervisors, Supervisory Public Health Veterinarians and Supervisory 

Consumer Safety Officers, who rate the performance of non-supervisory in-plant program 

personnel. In addition, IPPS provides the opportunity for first -hand, onsite observation of

how well an employee conducts FSIS inspection and verification procedures in federally 

inspected establishments. 

FSIS’ mission of protecting the health and welfare of consumers is set forth in the FMIA, 

PPIA, and EPIA. In-plant supervisors are responsible for ensuring that the employees 

under their supervision know how to adequately perform their jobs and are aware of the 

impact that off-target performance might have on the health and welfare of consumers. 

IPPS was first implemented on October 1, 2002. FSIS Directive 4430.3 explains the IPPS 

procedure. In 2006, FSIS launched AssuranceNet which is used to capture IPPS 

assessment findings. Some of these findings feed into organizational performance 

measures in AssuranceNet for management control purposes. 

IPPS and the Management Control System 

Performance Management is a mandatory and statutory requirement for federal agencies. 

Every Federal agency is required to have a performance management system that 

identifies and sets performance expectations for all of its employees, monitors their 

performance via progress reviews, and rates this performance by assigning a summary 

level rating. Summary level ratings are expressed as Fully Successful or Unacceptable. 

OFO uses IPPS as a tool to assist supervisors in assessing the employee’s knowledge 

of their job requirements. It is designed to provide supervisors with a structured process 

for examining the elements of a job to identify, address, and correct areas where there is 

a need for performance improvement, it also allows supervisors to provide feedback to 

the employees. Information is also extracted from the IPPS assessment sheets for use 

within the OFO’s management control system. Despite the fact that IPPS measures 

individual performance while management control is focused on organizational 

performance, there is a link between the two. If individuals are not properly executing 

mission critical functions, an organization is less likely to successfully accomplish its 

mission as whole. 

At least two IPPS assessments should be conducted for each covered employee during the 

rating cycle (October 1 – September 30). The first IPPS assessment should be conducted 

approximately 45 – 60 days after setting the performance standards, and again between 

the midpoint progress review and the final rating. IPPS assessments are used in addition 

to progress reviews and the annual performance rating. Supervisors may conduct more 
291

than two IPPS assessments during the rating cycle; they should do so if they cannot

thoroughly assess all of the IPPS performance elements within two assessments, or if they

need to follow-up on issues that were identified within previous IPPS assessments. A

performance rating is not assigned or discussed during IPPS assessments.

Non-supervisory IPP performance elements include:

1. Mission Support (Critical);

2. Communications (Critical); and

3. Individual Contributions to the Team.

OFO managers and supervisors review IPPS assessment results and provide

appropriate feedback as follows:

• The SPHV reviews 25 percent of IPPS assessments conducted by the SCSI with

at least two of these reviews accomplished by direct observation.

• The FLS reviews 10 percent of IPPS assessments conducted by the SPHV and

SCSI with 1 percent of these reviews accomplished by direct observation.

• The District Manager (DM) team reviews 10 percent of IPPS assessments

conducted by the FLS, SPHV, or SCSI with at least 1 percent of these reviews

accomplished by direct observation.

• The Executive Associate for Regulatory Operations (EARO) reviews 2 percent of

IPPS assessments that have been reviewed by the DM team.

Preparing for IPPS Assessment

Preparation is an essential aspect of any IPPS assessment. Make sure that you are

familiar with the processes and the FSIS verification activities that are conducted at the

establishment.

• Print out two IPPS forms, so that you and the employee can both take notes

during the assessment.

• Select a number of applicable elements/sub-elements to cover during the

assessment and decide how much time you want to spend on the assignment and

arrange for staffing, if necessary.

• Determine how employees are maintaining electronic information as required by

their positions.

• Review and assess Public Health Information System (PHIS) data and reports,

where applicable, to identify potential problem areas to focus on during the IPPS

assessment.

• Use Directive 4430.3 Attachment-3 which addresses data Sources for IPPS

preparation to prepare for the IPPS visit.
292

• Review all data sources to determine whether IPP responsible for maintaining the

PHIS system at the plant level are keeping the establishment profile current,

completing routine inspection tasks, properly entering data concerning scheduled

procedures performed or not performed, and entering unscheduled procedures

performed.

• Use the standard reports to determine whether trends are developing, which

indicate whether the inspectors are on or off target in performing their verification

duties.

Examples of data sources you can review before an IPPS visits include:

• Noncompliance records to determine whether the NRs are being written in

accordance with FSIS Directive 5000.1.

• Electronic Animal Disposition Report from PHIS to determine whether the

inspector or the PHV is keeping the data current and is performing the

appropriate humane handling procedures. The supervisor is to review the data to

see if humane handling procedures performed are covering all humane handling

activities over time, and that proper times are recorded for each activity.

• Food safety assessments and enforcement actions at the establishment where

the assessed employee participated in a recent food safety assessment or

enforcement action. The IPPS visit can be used to determine the inspection

personnel’s effectiveness in carrying out the verification plan and reporting on

issues identified. Review the verification plan and the inspection personnel’s

verification reports and provide feedback to the employee.

• Previous IPPS assessments to determine whether there are follow-up issues to

cover during the visit, and to ensure that the employee has completed any

remedial assigned activities prescribed at the time of the prior IPPS assessment.

• New Agency directives and notices that are relevant to the employee’s

assignment and position.

• Training reports to ensure that employees have successfully completed required

training.

Conducting an IPPS Assessment

There are 3 methods of assessing the performance of inspection program personnel:

observation, records review, and discussion. You may use one method or a combination of

these. You can observe the inspection program personnel and ask questions as they

conduct verification procedures, perform the procedures after the inspector to see if you get

the same results, or ask questions and discuss inspection procedures. Review the

documentation, reports, and correspondence in the government files. Also, be sure to

discuss inspection methods, the decision-making process, documentation, and

enforcement protocol with the inspection program personnel. Observe the conditions in the

establishment and compare them to the noncompliance reports that were written by the
293

employee being assessed. How you choose to gather information during the assessment

is up to you. However, you should be consistent in applying standards during your visits in

order to come away with a true assessment of what the employees know and how they

apply that knowledge.

When conducting an IPPS assessment, verify that the employee is:

• Applying the appropriate inspection methodology, such as observing

establishment employees conducting procedures, reviewing establishment

records, and performing tasks;

• Utilizing effective decision-making to determine whether there is noncompliance;

• Documenting their findings appropriately, if required;

• Implementing enforcement actions properly (e.g., verification plans for

suspensions and Notices of Intended Enforcement (NOIEs)), when authorized to

do so; and

• Implementing regulatory control actions.

NOTE: You don’t have to conduct IPPS visits at all establishments on an employee’s

assignment. However, you should ensure that the employee can demonstrate an

understanding of the methodology relevant to the whole assignment and an ability to

execute it.

Feedback: After completing an assessment, give the employee verbal feedback based on

what you observed during the assessment. This should be a constructive feedback

session.

Documenting an IPPS Assessment

• Complete the IPPS Assessment Form, and state whether the employee

understanding of and ability to execute regulatory requirements was satisfactory

(using Yes or No).

• Document positive performance briefly in the narrative boxes.

• Document any deficiency in the employee’s performance in a particular element

or sub element indicating that the overall employee knowledge of the job

requirement is deficient.

• Include recommended actions that the employee is to take to improve her/his

knowledge and execution of inspection methods (e.g., review relevant directives,

review Inspection Methods training module). Monitor the follow-up items to

ensure that they are accomplished.

• Provide a copy of the assessment to the employee within 2 weeks of the

assessment, by either printing a hard copy for the employee or e-mailing a PDF

copy.
294

• Keep the completed IPPS assessment forms for one year following the

termination of the previous rating cycle.

• Retain electronic copies of these in an electronic folder in your work files.

• At the appropriate time, discard or delete any electronic versions of the

assessment sheets from your computer.

IPPS Assessment Forms are not filed in the HRFO’s Official Personnel Folder or the

Employee’s Performance File. You will find that your IPPS assessment files provide

useful information at the end of the appraisal year. They will refresh your memory, help

you to make rating decisions, and serve as a history of consistently executed assessments

of employee performance. Use good judgment when combining data from the IPPS

Assessment Sheets with any other information regarding employee’s performance

Any issues of misconduct that are identified during an IPPS visit should be addressed

with your District Office. Once the IPPS Assessment form has been completed, an

electronic, read-only version or a hardcopy needs to be given to the employee within two

work weeks of the assessment.

.

Note: If an employee’s performance is unacceptable in one or more critical elements at

any time during the performance appraisal cycle, follow the directions outlined in

Departmental Regulation 4040-430 Performance Management.
295

Supervisory Tool for Assessment Results (STAR)

Introduction

The Supervisory Tool for Assessment Results (STAR) is a tool that supervisors can use to

assess the knowledge and proficiency of field level supervisory personnel. It requires

supervisory personnel to determine whether in-plant, subordinate supervisors carry out

both program activities and supervisory responsibilities, in accordance with applicable

regulatory requirements and FSIS directives and notices. STAR does not replace the

Performance Management System. The positions covered by STAR include the following:

• Supervisory Public Health Veterinarians (SPHVs),

• Supervisory Consumer Safety Inspectors (SCSI), and

• Supervisory personnel stationed at HACCP- based Inspection Models Project

(HIMP) establishments.

OFO executives, managers, and field-level supervisory personnel must conduct an

oversight review of the STAR assessments and provide feedback on them. The minimum

expectations for the review are as follows:

• The front line supervisors (FLSs) review 50 percent of the STAR assessments

conducted by the SPHV.

• The district management team reviews at least one assessment per circuit

performed by the FLS.

• The executive associates for regulatory operations (EAROs) review 5 percent of

the district management team reviews.

Preparing for STAR Assessment

Review FSIS Directive 4430.5 Supervisory Tool for Assessment Result (STAR); FSIS

Form 4430-11A; and Supervisory Tool for Assessment Results (STAR) Guideline for the

SPHV, SPHV (HIMP), SCSI. Print FSIS Form 4430-11 to use as a worksheet during

your assessment. Use the same preparation methodology you use for IPPS

assessment.

Conducting STAR Assessment

OFO field-level supervisory personnel must conduct at least one, in-person assessment

for each covered employee during the rating cycle. Supervisors have flexibility in

deciding when to conduct the assessment and whether to assess all the elements and

sub-elements during a single visit or through multiple visits over the course of the rating

cycle. Some elements, such as communication can be assessed separately from the

on-site visit.

Supervisors can use the record review method, the discussion method, and the observation

method, either singularly or in combination, while conducting the STAR assessment.

Conduct any appropriate follow-up (for example, if an employee lacks essential knowledge

of certain elements or sub-elements) and discuss the actions necessary for performance
296

improvements, such as training. 

If an employee’s performance is unacceptable in one or more critical elements at any 

time during the performance appraisal cycle, follow the directions outlined in 

Departmental Regulation 4040-430 Performance Management. Any misconduct issues 

identified during the STAR visit should be addressed with the district office. 

Documenting STAR Assessment 

Give verbal feedback to the employee upon completing the assessment. Document your 

assessment in AssuranceNet. Provide the employee with a read- only electronic copy, or 

a hardcopy of the document within two work weeks of the assessment. 
297

Workshop 1

1. IPPS is a tool that use to assess the performance of

in-plant inspection program personnel.

2. A minimum of how many IPPS assessments must be performed per rating cycle?

3. A minimum of how many STAR assessments must be performed per rating cycle?

4. What are the three methods of assessing performance?

5. IPPS and STAR assessments will replace progress reviews and performance

appraisals

a. True

b. False

6. Which of these positions is not covered under IPPS?

a. Food Inspectors

b. Public Health Veterinarians

c. Consumer Safety Inspectors

d. Supervisory Public Health Veterinarians

7. Following an IPPS and STAR assessment, a completed IPPS or STAR assessment

sheet should be mailed to the employee within two months.

a. True

b. False
298

Workshop 2

Use the information below to complete the IPPS Assessment Sheet for

Inspector Lynda Smith

Date: December 1, 2014

District Name: AtlantaBoulder

District Code: 0011

Circuit Name: Anywhere

Circuit Code: 01

Name of Supervisor: Dr. Thomas Williams

You are a new SPHV performing your first IPPS assessment of Food Inspector Lynda

Smith. You have already set the performance standards by discussing the pre-selected

performance elements in early July. You review the IPPS Assessment Sheet for Food

Inspectors and select the performance elements and sub-elements that will be covered

during the assessment. You select the sub-elements under Mission Support and

Communications, and you decide to spend four hours at Lynda’s assignment.

After reviewing the IPPS tools, you identify questions to discuss and activities to conduct

from the Food Inspector Supervisory Guide. You develop a draft plan and an outline for

the visit which will include observation and discussion. You arrange staffing for the IPPS

Assessment.

You observe Lynda performing postmortem inspection procedures at her inspection

station. She uses appropriate inspection procedures for the Streamlined Inspection

System (SIS). She instructs the inspector helper (trimmer) to remove carcasses with

improper presentation from the line and to retain them, but fails to notify the off-line

inspection program personnel when improper presentation occurs with unacceptable

regularity. She retains a carcass and viscera with a large mass in the abdominal cavity

on the designated shackle for veterinary disposition. When you ask her why she

retained the carcass, she states that she retained it because the carcass also appeared

to be emaciated.

You ask Lynda the three disposition options during postmortem inspection. She

responds appropriately. You evaluate Lynda’s decision-making process by asking her

questions regarding pathology and postmortem dispositions. While you are observing

Lynda, you also notice that she is not identifying and condemning any cadavers. She is

allowing her helper to identify cadavers and to make the dispositions. You ask her why

she is allowing her helper to identify and condemn cadavers. She explains that, since

she has difficulty identifying cadavers, she allows her helper to make that call. You

discuss the disposition criteria for cadavers with her. Also, you discuss the differences

between Lynda’s role and the inspector helper’s role during postmortem inspection.

Next, you decide to perform a correlation with her on the carcasses in her condemn can.

As you examine the condemned carcasses and parts, you ask questions that help you to

evaluate her thoughts and decision making process. Out of the twenty carcasses in her

can, there are six without cause for condemnation. When you question her about why
299

these were condemned, Lynda states that she condemned these carcasses for

septicemia/toxemia because they appeared to be very thin. You review the

condemnation criteria for septicemia/toxemia with her.

It is now time for Lynda to take a company break. Since off-line inspection personnel

are not in the evisceration department, Lynda ensures that the denaturant is placed on

the carcasses in her condemn can before leaving her station.

Following company break, Lynda returns to her inspection station. As part of her on-line

postmortem inspection duties, she verifies the removal of the contaminated carcasses

and those parts with visible fecal contamination. Although she handles the

contaminated carcasses and parts correctly, she fails to notify the off-line inspection

personnel when contamination occurs with unacceptable regularity.

You and Lynda go to the USDA office to discuss the assessment. You tell her that you

are pleased with her knowledge of the inspection procedures of the SIS inspection

system. Although you are pleased overall with her postmortem dispositions as well, you

add that you are concerned about her ability to identify cadavers and carcasses with

septicemia/toxemia. You tell her that she should retain carcasses for you when she is

uncertain about the disposition, and that she should never allow her helper to make

dispositions for her. You also discuss the relationship between her role and the helper’s.

You point out the importance of notifying off-line inspection personnel when trends are

detected such as multiple carcasses and parts with fecal contamination or presentation

issues. You ask her to give you some examples of situations in which she needs to

communicate information immediately to the off-line inspectors or to her supervisor. She

answers correctly. To assess Lynda’s knowledge of poultry good commercial practice,

you ask her to give you some examples of bird mistreatment and the actions that should

be taken in response to each, she again answers correctly.

You commit to performing weekly pathology correlations with her for the next month.

During your discussion, you discover that she has not attended the Poultry Slaughter

Inspection Training course. You contact the district office and make arrangements to

enroll her in the next session of it. You tell Lynda that she will receive her completed

IPPS assessment within two work weeks.
September

Finish conducting IPPS reviews.

Prepare tentative performance ratings

using IPPS data and other

data/information related to performance.

Send tentative ratings to reviewer for

signature.

October

Meet with employee to discuss performance

rating and sign form.

Discuss performance plan for new rating

cycle, set performance standards, and sign

form.

November

Beginning November through March

conduct at least one IPPS review for each of

your employees. *

December

Continue conducting at least one IPPS

review for each of your employees. *

January

Continue conducting at least one IPPS

review for each of your employees and

any follow up IPPS reviews you have

determined are necessary. *

February

Continue conducting at least one IPPS review

for each of your employees and any follow up

IPPS reviews you have determined are

necessary. *

March

Beginning March 1 and continuting

through March 31, conduct performance

appraisal progress review to give feedback

on performance. Do not assign a numerical

or summary level rating.

April

Beginning April through September

conduct at least one more IPPS review for

each of your employees. *

May

Continue conducting at least one more

IPPS review for each of your employees.

June

Continue conducting at least one more IPPS

review for each of your employees and

perform any follow up IPPS reviews you have

determined are necessary. *

July

Continue conducting at least one more IPPS

review for each of your employees and

perform any follow up IPPS reviews you

have determined are necessary. *

August

Continue conducting at least one more

IPPS review for each of your employees

and perform any follow up IPPS reviews

you have determined are necessary. *

*A minimum of 2 IPPS reviews per employee is required within the one year rating cycle. This schedule suggests that one be scheduled between the beginning

of the rating cycle and the mid-cycle progress review, and that the second be scheduled between the mid-cycle progress review and the final appraisal.

300
301

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

IPPS

Food Inspector – Slaughter

I. EMPLOYEE INFORMATION

Name of Employee Assessment Number

Assessment Date

District District Code

Circuit Circuit Code

Name of Supervisor

II. REVIEW

Method of Assessment: R – Records Review, D – Discussion, O - Observation

Element Assessed

Method of

Assessment Follow

Up Findings

R D O

Mission Support

1. Performs AM Inspection

a. Id and holds suspects PHV

disposition

2. Performs PM Inspection

a. Identifies abnormal conditions

b. Rejects, condemns or hold

suspects for examination by PHV

3. Identifies and/or tag carcasses

requiring further action by plant

personnel

4. Assures condemned products

are disposed of in accordance with

regulations
302

5. Monitors operational sanitation

to ensure sanitary handling and

dressing procedures are in

accordance with regulations

6. Monitors slaughter activities in

conformance with humane

handling regulations and

procedures and/or good

commercial practices.

Communications

1. Keeps supervisor informed of

critical issues in accordance with

established protocols

2. Communicates with responsible

program personnel and on line

activities, plant employee actions,

or facilities/equipment conditions

3. Communicates with plant

employees regarding line activities,

Agency policy and procedures

4. Completes administrative

reports and maintains records and

files as required
303

Additional Comments

IV. ADDITIONAL COMMENTS
304

V. REVIEWER 1 INFORMATION

Reviewer 1

Have you reviewed this IPPS Assessment?

Have you reviewed this IPPS Assessment by Observation?

Additional Comments
305

VI. REVIEWER 2 INFORMATION

Reviewer 2

Have you reviewed this IPPS Assessment?

Have you reviewed this IPPS Assessment by Observation?

Additional Comments
306

VII. REVIEWER 3 INFORMATION

Reviewer 3

Have you reviewed this IPPS Assessment?

Have you reviewed this IPPS Assessment by Observation?

Additional Comments
307

VIII. REVIEWER 4 INFORMATION

Reviewer 4

Have you reviewed this IPPS Assessment?

Have you reviewed this IPPS Assessment by Observation?

Additional Comments
308

IX. FEEDBACK REVIEW INFORMATION

Feedback
309

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

FSIS DIRECTIVE 4430.3

Revision 4 1/6/16

IN-PLANT PERFORMANCE SYSTEM (IPPS)

I. PURPOSE

This directive provides revised procedures for supervisors in the Office of Field Operations (OFO)

who conduct, document, and report on IPPS assessments. FSIS has revised this directive in its

entirety.

KEY POINTS

• Introduces a revised IPPS Assessment Form

• Introduces new guidance on conducting an IPPS

• Merges content from the IPPS Supervisory Guide

II. CANCELLATION

FSIS Directive 4430.3, Revision 3, In-Plant Performance System (IPPS), 9/11/12

III. BACKGROUND

A. IPPS provides a firsthand, onsite observation of how well employees conduct FSIS inspection and

verification procedures in federally-inspected establishments. In addition, IPPS assesses employees’

demonstrated knowledge of job requirements, appropriate regulatory decision-making, and ability to

execute inspection and verification procedures.

B. This directive is to be followed by OFO supervisors who rate the performance of non-supervisory inplant inspection program personnel (IPP). In-plant inspection positions that are subject to IPPS

assessments are identified in Attachment 1. The supervisory positions that are required to conduct IPPS

assessments include:

1. Front-line Supervisors (FLS)

2. Multi-IPPS Supervisors

3. Supervisory Public Health Veterinarians (SPHV)

4. Supervisory Consumer Safety Inspectors (SCSI)

DISTRIBUTION: Electronic; All Field OPI: OPPD

Employees
1 percent of these reviews accomplished by direct observation.

310

310

C. IPPS is a tool that supervisors use to assess the work of non-supervisory in-plant inspection

program personnel (IPP). IPPS includes the following benefits:

1. Encourages effective communication between supervisors and their

subordinates;

2. Identifies and addresses the need to improve employees’ knowledge of their job

requirements;

3. Encourages correlation with employees to ensure consistency in inspection methods

and applications;

4. Recognizes on-target or noteworthy employee performance;

5. Assists in measuring organizational performance through OFO’s performance standards;

and

6. Links IPPS assessment results and work unit meeting topics to address common or group

needs that are discovered during IPPS visits (example: matters on which supervisors find

misunderstandings or lack of program execution among multiple inspection personnel).

IV. GENERAL SUPERVISORY RESPONSIBILITIES

A. Supervisors are to conduct at least two IPPS assessments for employees covered by IPPS

during the performance rating cycle. Typically, the first IPPS assessment is conducted between

setting performance standards and the midyear progress review. The second IPPS assessment is

usually conducted between the midyear progress review and the completion of the annual

performance rating.

EXCEPTION: If an employee is supervised for part of the year, it may not be feasible for a

supervisor to conduct two assessments before the close of the rating cycle.

B. Supervisors can conduct more than two IPPS assessments during the rating year and are to do

so if they cannot thoroughly assess all of the elements and sub-elements over two assessments, or if

they have a need to follow up on issues identified in previous IPPS assessments.

C. Supervisors are to ensure that IPP are reporting inspection results in accordance with Agency

regulatory requirements, policies, and procedures.

V. OVERSIGHT AND MANAGEMENT CONTROLS

A. OFO has established a management control system that provides multi-layered, in-depth

management oversight of the public health and management activities carried out by IPP. The

management control system also provides OFO with the capability to demonstrate and verify i t s

effectiveness in protecting the public health by achieving and maintaining specific levels of

performance in its daily food safety, food defense, and management and supervisory operations.

B. To carry out this oversight, OFO managers and supervisors review IPPS assessment results and

provide appropriate feedback as follows:

1. The SPHV reviews 25 percent of IPPS assessments conducted by the SCSI with

at least two of these reviews accomplished by direct observation.

2. The FLS reviews 10 percent of IPPS assessments conducted by the SPHV and SCSI with
Block 15 on FSIS Form 4430-10. 311

311

3. The District Manager (DM) team reviews 10 percent of IPPS assessments conducted by

the FLS, SPHV, or SCSI with at least 1 percent of these reviews accomplished by direct

observation.

4. The Executive Associate for Regulatory Operations (EARO) reviews 2 percent of IPPS

assessments that have been reviewed by the DM team.

VI. IPPS AND THE PERFORMANCE MANAGEMENT SYSTEM

A. IPPS does not replace the Agency’s performance management system. OFO uses IPPS,

which applies to non-supervisory in-plant occupations, to assess employees’ knowledge of their

job requirements. IPPS:

1. Is designed to provide supervisors with a structured process to look at specific elements

of the job;

2. Is used to provide feedback to employees to identify, address, and correct areas where

there is a need for improvement in performance; and

3. Does not provide or assign a performance rating. Therefore, IPPS data can be used,

along with other data and information about an employee’s performance, to determine

the performance rating.

B. Performance management is mandated by 5 U.S.C. Chapter 43 and is a statutory

requirement for Federal agencies. Every Federal agency is required to have a performance

management system under which supervisors identify and set performance expectations and

monitor performance. FSIS monitors performance by way of a midyear progress review and

rates performance annually by assigning a summary level rating. Summary level ratings are

expressed as Fully Successful or Unacceptable.

C. Supervisors are to use their judgment when combining data from IPPS assessments that are

completed during the rating period and other information regarding an employee’s 

performance. The performance rating is to reflect the employee’s performance for the entire 

rating cycle.

D. The IPPS Assessment Form does not replace any existing performance appraisal processes

or FSIS forms. Supervisors are to continue to use AD-435E and the PRT to set performance

expectations, conduct progress reviews, and rate employees annually on their performance.

VII. TIMEFRAMES FOR CONDUCTING REQUIRED IPPS ASSESSMENTS

A. Supervisors, at their discretion, may conduct more than two IPPS assessments during the rating

year. Supervisors are encouraged to do so if they cannot thoroughly assess all the performance

elements over two assessments, or if they need to follow up on issues identified in previous IPPS

assessments.

B. For guidance purposes, the following are the general timeframes:

1. October 1 through October 30. Issue new performance standards for the beginning of

the rating cycle, sign and date Blocks 12 and 13 of FSIS Form 4430-10.

2. November 1 through February 28. Conduct the first IPPS assessment and document

results on the IPPS Assessment Form (See section IX. for the form’s availability).

3. March 1 through March 31. Conduct the midyear progress review, sign and date
312

4

4. April 1 through September 30. Conduct the second IPPS assessment and document

results on the IPPS Assessment Form.

5. October 1 through October 30. Complete the annual performance rating at the end of

the appraisal cycle and sign Blocks 19 and 20 on FSIS Form 4430-10.

VIII. IPPS ASSESSMENT PROCESS

A. When conducting IPPS assessments, supervisors are engaged in fulfilling their critical

Supervision performance element. In addition, supervisors are to fulfill requirements related to the

critical Mission Support performance element, as IPPS is a means by which supervisors ensure

inspection personnel are carrying out their critical mission-related work activities. To receive a Fully

Successful rating in these critical elements, supervisors are to successfully fulfill their responsibilities

related to the IPPS.

B. The supervisor plays a key role in ensuring that:

1. Decisions made by IPP are uniform, consistent, and in accordance with applicable statutes,

regulations, issuances, and other Agency policies; and

2. Duties performed by IPP are in accordance with prescribed inspection methods and

procedures.

C. Supervisors also are to ensure that IPP are applying the appropriate inspection methods,

using effective regulatory decision-making, documenting findings appropriately, and

implementing regulatory enforcement actions properly.

IX. ASSESSMENT CRITERIA

A. OFO supervisory personnel are to use the following steps to assess non-supervisory IPP

knowledge of their job requirements.

B. Assess the Performance Elements. The performance elements and activities are tailored to

non-supervisory in-plant inspection program occupations. The performance elements include:

1. Mission Support (Critical);

2. Communications (Critical); and

3. Individual Contributions to the Team.

C. Plan and Prepare for IPPS Assessment. Preparation is an important aspect of any IPPS

assessment. Before conducting the IPPS assessment, the supervisor is to:

1. Select a sufficient number of elements (and their sub-elements) on the IPPS Form to cover

during the IPPS assessment to ensure that all applicable elements are covered for the

positions before the end of the annual rating period.

NOTE: Make sure the mandatory critical mission support and other critical elements are covered

first.

2. Determine how employees are maintaining electronic information as required by their

positions.
313

6

3. Review and assess Public Health Information System (PHIS) data and reports, where

applicable, to identify potential problem areas to focus on during the IPPS assessment.

Attachment 3 outlines PHIS reports and other data sources supervisors can use to

prepare for an IPPS visit. Supervisors are to also review these data sources to determine

whether IPP responsible for maintaining the PHIS system at the plant level are keeping the

establishment profile current, completing routine inspection tasks, properly entering data

concerning scheduled procedures performed or not performed, and entering unscheduled

procedures performed. This data review will give the supervisor insight into the decisions

that the inspector makes regarding which procedures to perform and at what frequency.

The supervisor can use the standard reports to determine whether trends are developing,

which indicate whether the inspectors are on or off target in performing their verification

duties. Examples of data sources supervisors are to review before an IPPS visits include:

a. Review noncompliance records to determine whether the NRs are being written in

accordance with FSIS Directive 5000.1, Verifying an Establishment’s Food Safety

System.

b. Use the electronic Animal Disposition Report from PHIS to determine whether the

inspector or the PHV is keeping the data current and is performing the appropriate

humane handling procedures. The supervisor is to review the data to see if humane

handling procedures performed are covering all humane handling activities over

time, and that proper times are recorded for each activity.

c. Review food safety assessments and enforcement actions at the establishment

where the assessed employee participated in a recent food safety assessment or

enforcement action. The IPPS visit can be used to determine the inspection

personnel’s effectiveness in carrying out the verification plan and reporting on issues

identified. The supervisor is to also review the verification plan and the inspection

personnel’s verification reports and provide feedback to the employee.

4. Review feedback from previous IPPS assessments to determine whether there are follow-up

issues to cover during the visit. When a follow-up is required, supervisors are to make sure

that the employee has completed the remedial assigned activities prescribed at the time of

the prior IPPS assessment. Supervisors are to also reassess the elements and subelements on which follow-up was indicated.

5. Identify new Agency directives and notices that are relevant to the employee’s assignment

and position. In addition, supervisors are to use the IPPS assessment as an opportunity to

ensure that the employee has followed the instructions in the new directive or notice, as

required, including ensuring that any required Memoranda of Interview are in place for

required awareness meetings with establishment management, and that there is adherence

to any verification procedures or other instructions provided in the issuance.

6. Ensure that employees have successfully completed required training (examples: on-thejob training or formal training courses). Training reports are available through AgLearn at

http://www.aglearn.usda.gov/. District office personnel can provide supervisors with

training reports and information upon request.

D. When completing the IPPS Assessment Form, a supervisor is to document very briefly how

she/he prepared for the IPPS visit, including information on the data sources that he/she used.
314

6

X. METHODS FOR CONDUCTING AN IPPS ASSESSMENT

A. In general, supervisors are to use the following methods singularly or in combination when

conducting IPPS assessments:

1. Observe the employee performing verification tasks;

2. Review documentation, reports, and correspondence in the government files;

3. Observe plant conditions and compare them to inspection results and noncompliance records

on file; and

4. Ask questions about inspection methods, regulatory decisionmaking, documentation, and

enforcement procedures (e.g., types of regulatory control actions that can be taken and when;

due process) to the Agency employee as he/she performs inspection verification activities.

Provide hypothetical situations or scenarios to get the employee to describe what she/he would

do in response to the situation.

B. Supervisors are to properly plan, prepare, and execute the plan to document an effective IPPS

assessment.

NOTE: A supervisor does not have to conduct IPPS visits at all establishments on an employee’s

assignment. However, the supervisor is to ensure that the employee can demonstrate an

understanding of the methodology relevant to the whole assignment and an ability to execute it.

C. When conducting an IPPS assessment, a supervisor is to verify that the employee is:

1. Applying the appropriate inspection methodology, such as observing establishment

employees conducting procedures, reviewing establishment records, and performing tasks;

2. Utilizing effective decisionmaking to determine whether there is noncompliance;

3. Documenting their findings appropriately, if required;

4. Implementing enforcement actions properly (e.g., verification plans for suspensions and

Notices of Intended Enforcement (NOIEs)), when authorized to do so; and

5. Implementing regulatory control actions.

D. The supervisors is to meet with the employee at the end of the assessment and provide

verbal feedback on performance.

E. The supervisors is to complete the IPPS Assessment Form. The supervisor is to state

whether the employee’s understanding and ability to execute regulatory requirements was

satisfactory using Yes or No. A supervisor can document positive performance briefly in the

narrative boxes. If the supervisor finds that performance of a sub-element is unsatisfactory,

he/she is to clearly describe the deficiencies observed and discussed in documentation that is

within the character limit allotted for the narrative boxes (2000 characters).

F. The supervisor is to provide a copy of the assessment to the employee within 2 weeks of

the assessment, by either printing a hard copy for the employee or emailing a PDF copy.

G. When applicable, a supervisor’s findings are to also include recommended actions that

the employee is to take to improve her/his knowledge and execution of inspection methods

(e.g., review relevant directives, review Inspection Methods training module) and a timeframe
315

315

for completing the action.

H. The supervisor is to follow the directions outlined in DR-4040-430, Performance Management,

when an employee’s performance is unacceptable in one or more critical elements at any time

during the performance appraisal cycle.

I. The supervisor is to contact the appropriate district office for further guidance if

misconduct issues are identified during the IPPS visit.

J. The supervisor is to monitor follow-up items to ensure that they are accomplished.

K. The supervisor is to follow up on any sub-elements for which performance was found to be

unsatisfactory during the next IPPS assessment.

XI. IPPS ASSESSMENT FORM AND MAINTENANCE

A. A supervisor can download the fillable PDF IPPS Assessment Form or the Word format IPPS

Assessment Form (see example in Attachment 2) via InsideFSIS at: OFO Resources (Level 2

eAuthentication is needed to access this page).

B. This Directive will be revised and reissued with new instructions once new storing and tracking

methods for the IPPS are implemented.

NOTE: IPPS Assessment Forms are not filed in the Human Resource Operation’s official personnel

folder or the employee’s performance file.

XII. QUESTIONS

Refer questions on conducting IPPS assessments to the appropriate District Office.

Assistant Administrator

Office of Policy and Program Development
316

316

POSITIONS COVERED BY IPPS – ATTACHMENT 1

Food Inspector

Consumer Safety Inspector

Supervisory Consumer Safety Inspector

Public Health Veterinarian (VMO)

NOTE: Depending whether or not the position has supervision as a part of the assignment, the

position may be subject to IPPS or responsible for conducting IPPS assessments.
9

IPPS ASSESSMENT FORM – ATTACHMENT 2

IPPS ASSESSMENT FORM

Name of Employee Name of Supervisor

Position Title Assessment Number Assessment Date

District Circuit

How did you prepare for this IPPS?

MISSION SUPPORT

SPS/SSOP Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee is verifying compliance with SPS

and SSOP regulatory requirements in

accordance with 9 CFR 416.1 – 416.17,

Directive 5000.1., 5300.1, FSIS Directive

5030.1 and FSIS Directive 5030.2.

Assess execution of inspection methodology:

1. Employee is familiar with the

establishment’s written SSOPs.

a. Verifies establishment is

implementing and maintaining

SSOPs.

b. Based on findings, is able to

determine if establishment is

implementing procedures in

preventing insanitary conditions. Is

documenting findings in PHIS.

c. If noncompliance is found, takes

appropriate regulatory control

action and documents

noncompliance in PHIS.

2. Employee is familiar with the

establishment’s pest control procedures.

a. Verifies establishment is

implementing procedures to

control pest and rodents in

meeting the requirements of 9

CFR 416.2(a).

b. Based on findings, is able to

determine if the establishment is

preventing pest and rodents.

c. If noncompliance is found, takes

appropriate regulatory control 317
10

318

action and documents

noncompliance in PHIS.

3. The employee is familiar with other SPS

regulations regarding, facilities,

equipment, utensils sanitary operations,

and employee hygiene.

a. Is able to determine insanitary

conditions under the SPS

regulations.

b. Based on findings, is able to

determine if establishment is

preventing insanitary conditions.

c. If noncompliance is found, takes

appropriate regulatory control

action and documents

noncompliance in PHIS.

4. Employee maintains establishment profile

to ensure proper SPS/SSOP tasks assigned.

HACCP Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee verifies compliance with HACCP

regulations in accordance with Directive

5000.1., 5300.1 and 9 CFR 417.1 – 417.8.

Assess employee is executing the inspection

methodology (FSIS Directive 5000.1):

1. Is familiar with establishment’s hazard

analysis and any prerequisite programs.

a. Verifies establishment is

implementing all elements of

HACCP system.

i. Hazard analysis

ii. Critical control points

iii. Monitoring of critical

control points

iv. Recordkeeping

v. Corrective actions

vi. Verification

vii. Validation

b. Based on findings, is able to

determine compliance and

consider broader implications of

findings to the establishment’s

food safety system.

c. If noncompliance is found, takes

appropriate regulatory control

action and documents

noncompliance in PHIS.

2. Is maintaining establishment profile to

ensure proper HACCP tasks are assigned.
11

Food Defense Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. The employee is knowledgeable of

applicable directives and notices.

Assess employee is executing the inspection

methodology (FSIS Directive 5420.1):

1. Is verifying the establishment has a

functional food defense plan in

accordance with Directive 5420.1.

2. Is documenting findings in PHIS.

Sampling Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of sampling

methodology:

1. Is knowledgeable of applicable sampling

projects in establishment.

2. Understands sampling methodology for

applicable projects as outlined in FSIS

Directives and Notices.

Assess employee is executing sampling

methodology:

1. Is performing sampling collection methods

in accordance with directives applicable to

assignment.

2. Appropriately reacts to positive sampling

results.

3. Documenting all sampling in PHIS,

including scheduling.

4. Prepares and maintains reports (egg

products).

5. Is maintaining establishment profile to

ensure proper sampling projects are

assigned.

AM/PM Duties Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee understands applicable statutes,

regulations, directives and notices.

Assess employee is executing Ante-mortem

inspection methodology (Directives 6100.1 &

6100.3):

1. Performs ante-mortem inspection

appropriate for species.

a. Based on findings, makes

appropriate regulatory

determinations. If applicable, is

documenting ante-mortem

findings in PHIS.

b. Takes appropriate regulatory

control of suspects and condemns. 319
12

c. If noncompliance is found,

documents in PHIS.

Assess employee is executing Post-mortem

inspection methodology (FSIS Directive

6100.2, FSIS Directive 6100.3, & FSIS Directive

5300.1):

1. Performs post-mortem inspection

appropriate for species.

a. Based on findings, makes

appropriate regulatory

determinations. If applicable, is

documenting post-mortem

findings in PHIS.

b. Takes appropriate regulatory

control action of carcasses

needing vet dispositions.

c. Takes appropriate regulatory

control action of condemned

carcasses.

d. If noncompliance is found,

documents in PHIS.

2. Maintains establishment profile to ensure

proper documentation within PHIS/ADR.

Humane Handling Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee is knowledgeable of applicable

statutes, regulations, directives and

notices.

Assess employee is executing inspection

methodology (FSIS Directive 6900.2):

1. Ensures establishment slaughter activities

conform to humane handling regulations

and procedures and/or GCPs.

a. Takes appropriate regulatory

control action when applicable.

b. Documents noncompliances and

humane handling activitiesin PHIS.

Egg Products Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee is knowledgeable of applicable

statutes, regulations, directives and

notices.

Assess employee is executing inspection

methodology (FSIS Directive 5030.1, FSIS

Directive 5040.1):

1. Conducts egg product inspection to assure

products are in full compliance with

regulations (other than SPS). 320
13

2. Monitors the shipping and receiving of

tanker egg products.

Economic Adulteration and Labeling Verification Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee is knowledgeable of applicable

statutes, regulations, directives and

notices.

Assess employee is executing inspection

methodology (FSIS Directives 7000.1, 7230.1,

7221.1, 9900.5):

1. Ensures establishment or inspected lot (for

imports) is meeting regulatory labeling

requirements and product standards.

a. Based on findings, is able to

determine if establishment or

inspected lot is in compliance.

2. In situations of noncompliance, takes

appropriate regulatory control action and

documents in PHIS.

Export Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee is knowledgeable of applicable

statutes, regulations, directives and

notices.

Assess execution of Export Certification

methodology (FSIS Directive 9000.1):

1. Employee performs product re-inspection.

Checks for recordkeeping and

documentation for eligible country

requirements, completion of certificates,

labels and any other applicable forms.

Import Inspection Satisfactory?

(Yes/No/NA)

Comments:

Assess understanding of methodology:

1. Employee is knowledgeable of applicable

statutes, regulations, directives and

notices.

Assess employee is executing Import

Inspection methodology (Directive 9900.1):

1. Performs product re-inspection.

a. Monitors incoming shipment to

ensure presentation of the lot.

b. Appropriately controls Failure to

Present (FTP) lots.

c. Verifies required forms on

presented lots.

d. Makes appropriate determinations 321
322

14

whether the lot is passed or

rejected.

e. Appropriately marks inspected lots

“inspected and passed” or

“refused entry.”

f. Appropriately controls lots marked

“refused entry.”

g. Appropriately performs TOI and

documents verification results in

PHIS.

COMMUNICATION

Satisfactory?

(Yes/No)

Comments:

1. Employee affords industry due process in

accordance with 9 CFR 500.

2. Keeps supervisor informed in a timely

manner and in accordance with protocols.

3. Meets Agency standards for

professionalism.

4. Works cooperatively with other agency

teams and organizations.

5. Makes regulatory decisions in a nondiscriminatory and impartial manner.

6. Employee reinspecting imported lots

communicate with plant management as

required.

7. Holds weekly meetings with establishment

management to discuss pertinent topics in

accordance with Directive 5010.1.
323

16

DATA SOURCES FOR IPPS PREPARATION – ATTACHMENT 3

Below is a chart outlining the reports and other data sources, organized by subelements, you can use to prepare for an IPPS visit.

Sub-Element PHIS Reports Data in PHIS

SPS/SSOP Noncompliance

Records for an

Establishment

Task Summary and

List for an

Establishment

Tasks Regulation

Verified and

Noncompliant

Summary for an

Establishment

PHR

Noncompliances for

an Establishment

Establishment

Profile

Inspection

Verification Results

HACCP HACCP Sets for an

Establishment

Noncompliance

Records for an

Establishment

Task Summary and

List for an

Establishment

Tasks Regulation

Verified and

Noncompliant

Summary for an

Establishment

PHR

Noncompliances for

an Establishment

Establishment

Profile

Inspection

Verification Results

Food Defense Task Summary and

List of an

Establishment

Inspection

Verification Results

Sampling In-Plant Residue

Sampling Results for

an Establishment

Task Summary and

List for an

Establishment

Profile

Inspection

Verification Results
324

16

Establishment

Sample Collection

Status for an

Establishment

Sampling Form

Results for an

Establishment

Sampling Results for

an Establishment

Sampling Schedule

History for an

Establishment

Sampling Schedule

History with Results

for an Establishment

Positive Sampling

Results: HACCP

AM/PM Duties Pending Dispositions

for an Establishment

Noncompliance

Records for an

Establishment

Missing Poultry

Weights for an

Establishment

Slaughter Daily

Totals Worksheet for

an Establishment

Slaughter Zero Head

Count for an

Establishment

Establishment

Profile

Animal Disposition

Reporting

Disposition Records

Humane Handling HATS Detail and

Summary for an

Establishment

Noncompliance

Records for an

Establishment

Task Summary and

List for an

Establishment

Inspection

Verification Results
325

325

MOIs for Good

Commercial Practice

and Humane

Handling for a

District

Good Commercial

Practice Validation

for an Establishment

HATS Validation

Report for an

Establishment

Export MOIs for an

Establishment

Economic

Adulteration and

Labeling

Verification

Noncompliance

Records for an

Establishment

Task Summary and

List for an

Establishment

Tasks Regulation

Verified and

Noncompliant

Summary for an

Establishment

PHR

Noncompliances for

an Establishment

Inspection

Verification Results
326

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

CHANGE TRANSMITTAL SHEET

 DIRECTIVE

REVISION

 AMENDMENT

OTHER

FSIS DIRECTIVE

SUPERVISORY TOOL FOR ASSESSMENT RESULTS (STAR)

4430.5

AMENDMENT 1

1/26/10

PRINCIPAL CHANGE

This amendment transmits a revised Attachment 1, to instruct supervisors to upload the

completed FSIS Form 4430-11, STAR Assessment Form to the AssuranceNet

application. This change transmittal indicates updated information is incorporated into

FSIS Directive 4430.5.

FILING INSTRUCTIONS

Remove Old Page Insert New Page

11 11
327

SUPERVISORY TOOL FOR ASSESSMENT RESULTS (STAR)

I. PURPOSE

This directive:

A. Provides policy and procedures to implement the Supervisory Tool for

Assessment Results (STAR).

B. Establishes a structured system for Office of Field Operations (OFO)

supervisors to follow when conducting and documenting assessments of in-plant,

subordinate supervisory personnel.

C. Provides guidance and step-by-step instructions for conducting,

documenting, and when applicable, following up on assessment results. (See

Attachment 1.)

D. Introduces FSIS Form 4430-11A, Supervisory Tool for Assessment

Results (STAR) Guideline for the SPHV, SPHV (HIMP), SCSI, a tool that OFO

supervisors use for conducting the supervisory assessment. (See Attachment 2.)

E. Introduces FSIS Form 4430-11, Supervisory Tool for Assessment Results

(STAR) for SPHV, SPHV (HIMP), SCSI, a tool that OFO supervisors use for

documenting results of the supervisory assessment. (See Attachment 3.)

F. Establishes the minimum number of required STAR assessments to at

least one in-person assessment for each covered supervisory employee during the

performance rating cycle.

II. (RESERVED)

III. (RESERVED)
328

IV. REFERENCES

FSIS Directive 4293.1, Personnel Records

FSIS Directive 4430.1, Performance Evaluation Plan

Guide for Conducting In-Plant Performance System (IPPS) Assessments

U.S.C. Title 5, Chapter 43 – Performance Appraisal

V. ABBREVIATIONS AND FORMS

The following appear in their shortened form in this directive:

EO/CR Equal Opportunity/Civil Rights

FLS Frontline Supervisors

HIMP HACCP-Based Inspection Models Project

IPPS In-plant Performance System

OFO Office of Field Operations

SCSI Supervisory Consumer Safety Inspectors

SPHV Supervisory Public Health Veterinarians

STAR Supervisory Tool for Assessment Results

FSIS Form 4430-11A, Supervisory Tool for Assessment Results (STAR)

Guideline for the SPHV, SPHV (HIMP), SCSI

FSIS Form 4430-11, Supervisory Tool for Assessment Results (STAR) for SPHV,

SPHV (HIMP), SCSI

VI. POLICY

A. STAR requires OFO field-level supervisory personnel to determine if inplant, subordinate supervisors perform both program activities and supervisory

responsibilities, in accordance with applicable regulatory requirements and FSIS

directives and notices.

B. OFO field-level supervisors must conduct a minimum of one in-person

STAR assessment for each in-plant, subordinate supervisor during the performance

rating cycle. Field-level supervisors have flexibility in determining when to conduct the

assessment and whether to assess all elements and sub-elements during one visit or

multiple visits over the course of the rating cycle. See Attachment 1 for the STAR

supervisory guidance.

C. Some elements can be assessed separate from the onsite visit (example:

those relating to communications). The majority of the mission support element must

be assessed during the onsite visit.

D. Assessment results are noted on FSIS Form 4430.11A and summarized

and documented on FSIS Form 4430-11. The summation should provide a description

of observations and findings for each element and sub-element, and when applicable,

any remedial action needed to improve performance.
329

VII. APPLICABILITY

A. This directive applies to OFO field-level supervisory personnel who rate

the performance of in-plant, subordinate supervisory personnel. (NOTE: STAR is used

by FLSs to assess SPHVs and for SPHVs to assess SCSIs). The supervisory positions

covered by STAR include:

1. SPHV.

2. SCSI.

3. Supervisory personnel at HIMP plants.

B. STAR is not designed to assess FLSs, though FLSs will be evaluated on

how well they carry out the STAR assessments.

VIII. PROVISIONS

STAR is a tool that supervisors use to assess the knowledge and proficiency of fieldlevel supervisory personnel. STAR provides:

A. A firsthand, onsite observation of how well field-level supervisors conduct

and oversee the performance of FSIS inspection and verification procedures in federally

inspected establishments.

B. A consistent structured approach to assessing the effectiveness of inplant, subordinate supervisory personnel with respect to both program activities and

supervisory and administrative responsibilities. (NOTE: STAR does not assess plant

compliance with regulatory requirements.) Potential benefits include:

1. Encouraging effective communication between supervisors and

subordinates through the assessment and feedback process.

2. Identifying and addressing the need to improve field-level

supervisors’ knowledge of job requirements.

3. Encouraging correlation with supervisors to ensure consistency in

inspection methods and applications.

4. Identifying and addressing performance problems in accordance

with policies and procedures that are outlined in FSIS Directive 4430.1, Performance

Evaluation Plan.

5. Recognizing and rewarding on-target or noteworthy supervisory

performance.
330

6. Addressing common or group needs identified through STAR

assessment results, such as at a work unit or district meetings (example: areas in

which multiple supervisors are having difficulty understanding or executing job

requirements).

IX. STAR OVERSIGHT

To ensure consistency and effectiveness in performing daily food safety, food defense,

and management and supervisory activities, OFO executives, managers, and field-level

supervisory personnel must conduct an oversight review of STAR assessments and

provide appropriate feedback. To carry out this oversight, minimum expectations for

review of assessment results are as follows:

A. The FLS reviews 50 percent of the STAR assessments conducted by the

SPHV.

B. The district management team reviews at least 1 assessment per circuit

performed by the FLS.

C. The Executive Associate for Regulatory Operations reviews 5 percent of

the district management team reviews.

X. STAR AND THE PERFORMANCE MANAGEMENT SYSTEM

A. STAR does not replace the Agency’s Performance Management System,

though there are similarities. Both STAR and the Performance Management System 

are designed to: 

1. Encourage and maintain effective on-going communication

between supervisors and employees on the employees’ job performance. 

2. Provide critical and constructive feedback to employees on

achieving job requirements. 

3. Assist supervisors and employees in identifying, addressing, and

correcting performance problems or issues that hinder employee productivity. 

4. Assist supervisors in identifying and recognizing individual

performance contributions. 

B. Performance management is mandated by U.S.C. Title 5, Chapter 43, and

is a statutory requirement for Federal agencies. Every Federal agency is required to 

have a performance management system for all employees that identifies and sets 

performance expectations and monitors performance. FSIS monitors performance by 

way of midyear progress review and rates performance annually by assigning a 

summary level rating. Summary level ratings are expressed as fully successful or 

unacceptable. 
331

C. OFO uses STAR to assess OFO in-plant field supervisors’ knowledge of

the job requirements and to ensure competency in program and supervisory activities.

STAR assessment results are combined with other information and observations the

supervisor makes during the rating year to determine the annual performance rating.

STAR does not provide or assign a performance rating nor does it replace or serve as

an additional mid-year progress review. The assignment of ratings and the mid-year

progress review is a performance management responsibility as described in

subparagraph X. B.

XI. ADDITIONAL INFORMATION

FSIS Forms 4430-11A and FSIS Form 4430-11 can be accessed at Outlook/Public

Folders/All Public Folders/Agency Issuances/Forms/FSIS 4,000 Series. Direct all

questions on conducting STAR assessments to the OFO, Regulatory Operations staff at

202–720–3697.

Attachments

1 Supervisory Tool for Assessment Results (STAR) Guidance

2 Sample FSIS Form 4430-11A, Supervisory Tool For Assessment

Results (STAR) Guideline for the SPHV, SPHV (HIMP), SCSI

3 Sample FSIS Form 4430-11, Supervisory Tool For Assessment Results

(STAR) For SPHV, SPHV (HIMP), SCSI
332

SUPERVISORY TOOL FOR ASSESSMENT RESULTS (STAR) GUIDANCE

Responsibilities

Office of Field Operations (OFO) field-level supervisory personnel play a key role in

assuring that the decisions made and the duties carried out by in-plant field-level

supervisory personnel are uniform, consistent, and in accordance with applicable

statutes, regulations, issuances, and other Agency policy. This guidance outlines OFO

field-level supervisors’ role regarding the STAR assessment and provides instructions

for carrying out the assessment.

When conducting an STAR assessment, OFO field-level supervisory personnel are

engaged in fulfilling the critical Supervision performance element. In addition, OFO

field-level supervisory personnel are also fulfilling requirements related to the critical

Mission Support performance element in the STAR, by ensuring that in-plant field-level

supervisory personnel are carrying out their critical mission-related work activities.

For in-plant field-level supervisory personnel to be successful in these critical elements,

they must successfully fulfill their responsibilities related to the STAR.

Performance Elements

The following performance elements outline requirements that OFO field-level

supervisory personnel use to assess the in-plant field-level supervisors’ knowledge of

job requirements and their competency in the program and supervisory activities. When

conducting the STAR assessment, the supervisor must address each performance

element and sub-element during the rating cycle. The performance elements include:

• Mission Support (Critical).

• Communications.

• Supervision (Critical).

• Individual Contribution To The Team.

• EO/CR (Critical).

Each in-plant field-level supervisory personnel’s performance standards consist of a

performance element, standard (description of the Fully Successful level), and the

performance goals and measures that OFO field-level supervisory personnel must

consider when performing a STAR assessment.
333

OFO field-level supervisory personnel must:

• Consider existing circumstances and situations and use judgment in

selecting appropriate elements and sub-elements when assessing the

supervisory employee’s competency. If an activity described herein is not

one required to be performed by the subordinate supervisor, do not use

the guidance associated with it to plan and conduct the STAR

assessment. Only use the elements and sub-elements that apply.

• Use the FSIS Form 4430-11A, Supervisory Tool for Assessment Results

(STAR) Guideline for the SPHV, SPHV (HIMP), SCSI as a worksheet to

record notes.

• Review in-plant records, electronic data, samples of written responses,

e-mail instructions, and information requests to ensure accuracy,

thoroughness, consistency, and timeliness.

• Ask questions and discuss observations of in-plant field-level supervisors’

competence emphasizing strengths, weaknesses, and the need for

improvement. NOTE: OFO field-level supervisory personnel may ask the

in-plant, subordinate supervisor to demonstrate knowledge of job

requirement by performing a specific activity while the supervisor

observes.

• Provide feedback and note any on-target, off-target, and noteworthy

performance on the FSIS Form 4430-11, Supervisory Tool For

Assessment Results (STAR) Form For SPHV, SPHV (HIMP), SCSI. OFO

field-level supervisory personnel comments must be clear, concise, and

describe what was reviewed, discussed, or observed.

• Identify and reach an agreement on what in-plant field supervisory

personnel should work on and address all areas that require improvement

in work performance.

FSIS Form 4430-11A consists of providing a checklist to help OFO field-level

supervisors pinpoint specific areas to cover and a section to record notes and

observations during the assessment. Although the checklist is not all inclusive, the

information provided is intended to stimulate questions, observations, and discussions

with the subordinate supervisors about their knowledge of the job requirements, and

provide assistance in conducting and completing the assessment. The notes taken by

the supervisor during the assessment are summarized and transferred to FSIS Form

4430-11.

FSIS Form 4430-11A is available in the electronic public folder and can be accessed at

Outlook Public Folders/All Public Folders/Agency Issuances/Forms/FSIS 4,000 Series.
334

Conducting a STAR assessment

OFO field-level supervisory personnel must conduct at least one, in-person

assessment for each covered employee during the rating cycle. All elements and subelements must be assessed during the rating cycle. Supervisors have flexibility in

determining when to conduct the assessment and whether to assess all elements and

sub-elements during one visit or multiple visits over the course of the rating cycle.

(NOTE: Some elements are assessed separate from the onsite visit. The majority of

mission support elements must be reviewed during the onsite visit.) Supervisors must

use the following methods singularly, in combination, or all together when conducting

STAR assessments:

• Records Review. Review in-plant, subordinate supervisory personnel

work products such as information in electronic records and office files to

ensure accuracy, thoroughness, consistency, timeliness, and conformity

with established policies and procedures.

• Discussion. Discuss program policies and procedures to assess

supervisor’s knowledge of inspection methods, regulatory decision-making

abilities, and enforcement of policies and procedures. For further

guidance on how to effectively assess knowledge and execution of these

activities, see the Guide for Conducting In-Plant Performance System

(IPPS) Assessments. (NOTE: The work methods outlined for assessing

activities under the Mission Support element are applicable for assessing

the same activities for the in-plant supervisory personnel, if they perform

or supervise performance of those activities.)

• Observation. Observe and assess in-plant, subordinate supervisory

personnel conducting their mission support, supervisory, or

communication activities. (EXAMPLES: Observing the supervisor

conducting a verification procedure, conducting ante mortem or post

mortem inspection activities, observing the in-plant supervisor conducting

a work unit meeting, conducting an IPPS assessment, or interacting with

plant officials.)

Documenting results

When documenting STAR assessment results, OFO field-level supervisory personnel

should:

• Share verbal feedback with the employee upon completing the

assessment.

• Complete FSIS Form 4430-11, by summarizing the notes from FSIS Form

4430-11A and checking the block to identify the method(s) of assessment

used (examples: records review, discussion, or observation).
335

• Document the narrative by summarizing the notes from FSIS Form 4430-

11A to FSIS Form 4430-11. The summation should provide a description

of observations and findings for each element and sub-element, and when

applicable, any remedial action needed to improve performance

(example: require the completion of a training course, review FSIS

Directive 5,000.1, Verifying an Establishment Food Safety System).

Follow-up on results

OFO supervisors and field-level supervisory personnel, at the end of the STAR

assessment, should be prepared to discuss follow-up items with in-plant, subordinate

supervisory personnel. OFO supervisors must:

• Reassess agreements on work performance issues that in-plant

supervisory personnel were required to work on between the current

assessment and the agreed upon follow-up date.

• Indicate the follow-up training or additional visits needed, and ensure the

completion of these activities.

• Follow the procedures outlined in FSIS Directive 4430.1, Performance

Evaluation Plan, if an employee’s performance is unacceptable in one or

more critical elements at any time during the performance appraisal cycle.

• Report any identified misconduct issues during the STAR assessment by

contacting the district office for further guidance.

• Monitor follow-up items to ensure completion.

• Provide in-plant supervisory personnel with a copy of the completed

assessment sheet within 2 weeks after the STAR assessment.

Assessment Form Use and Maintenance

FSIS Form 4430-11, STAR Assessment Results Form, is an electronic form used to

document the assessment process. After completing the assessment visit, the

supervisor should:

• Summarize the information from FSIS Form 4430-11A to FSIS Form

4430-11.

• Share verbal feedback with the employee and send the employee a

completed FSIS Form 4430-11, in read-only format by e-mail, no later

than 2 weeks after the assessment.
336

• Retain an electronic copy in the electronic folder in the supervisor’s work

files. FSIS Directive 4293.1, Personnel Records, requires retention of the

electronic file for 1 year from the date of the completion of the last rating

on record. (NOTE: FSIS Form 4430-11A and FSIS Form 4430-11 are not

filed in the employee’s official personnel folder or the employee’s

performance file in Human Resource Policy (HRP).)

• Upload the completed assessment to the AssuranceNet application.

• Use judgment when determining how to factor in results documented

during the STAR assessment into determinations made on the annual

performance rating. The performance rating should reflect the employee’s

performance for the entire rating cycle. (NOTE: The STAR results should

not serve as the sole basis for performance appraisal determinations, but

can be used to inform the ratings on various performance elements.) The

Performance Management public folder in Outlook provides valuable

information for making decisions on annual performance ratings. Access

the Performance Management public folder by clicking on Outlook/Public

Folders/All Public Folders/Personnel/Performance Management/Perf

Mgmt Tools.

FSIS Form 4430-11 does not replace any existing performance appraisal processes or

FSIS forms. FSIS Directive 4430-1, Performance Plan provides guidance and

instructions for setting performance expectations, conducting progress reviews, and

rating employees annually on performance. The STAR guide and form are available in

the Agency Issuances Public Folder and can be assessed via Outlook by clicking on

Outlook/Public Folders/All Public Folders/Agency Issuances/Forms/FSIS-4000 Series.
337

SAMPLE FSIS FORM 4430- 11A, SUPERVISORY TOOL FOR

ASSESSMENT RESULTS (STAR) GUIDELINE FOR THE SPHV, SPHV

(HIMP), SCSI
338
339
340
341
342
343
344
345

SAMPLE FSIS FORM 4430- 11, SUPERVISORY TOOL FOR

ASSESSMENT RESULTS (STAR) FOR SPHV, SPHV (HIMP), SCSI
346
347
348
349
350

Non-Food Safety Consumer

Protection – Part 1
Slaughter: NFSCP - Part 1

30-2

351

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

Finished Product Standards....................................................................................................4

Finished Product Standards ................................................................................................4

Responsibilities FPS ...........................................................................................................4

Presentation of Carcasses and Parts..................................................................................5

Presentation Scenario.........................................................................................................5

Poultry Finished Product Standards .......................................................................................7

Poultry Finished Product Standards....................................................................................7

Poultry FPS Chart ...............................................................................................................8

Pre-chill ...............................................................................................................................8

Processing Test...................................................................................................................9

Trim Test ........................................................................................................................... 10

Post-Chill........................................................................................................................... 10

Pre-Chill Scenario ............................................................................................................. 11

Young Chicken Scenario................................................................................................... 14

Post-Chill Scenario............................................................................................................ 15

Livestock Finished Product Standards.................................................................................. 16

Livestock Finished Product Standards .............................................................................. 16

Salvage................................................................................................................................. 17

Salvage ............................................................................................................................. 17

Salvage Can Be Suspended if .......................................................................................... 17

Salvage Scenario: Osteomyelitis....................................................................................... 18

SUMMARY ........................................................................................................................... 19
Slaughter: NFSCP - Part 1

30-3

3

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Given a scenario involving a presentation check at a line inspector station, apply

NFS criteria to evaluate the establishment’s method of presentation.

2. Given a scenario in the poultry slaughter context, apply prescribed NFSCP

criteria to score poultry pre-chill and post-chill to verify the establishment’s

process control.

3. Using reference material or guidance material provided, apply post chill criteria

to a 10 bird sample in the field/establishment setting.

4. Explain the establishment’s responsibility when pre-chill or post-chill tests

exceed established limits.

5. Given a scenario depicting a salvage program, identify factors that could result

in the suspension of the salvage program.
Slaughter: NFSCP - Part 1

30-4

4

Slides Finished Product Standards

3 Finished Product Standards

Finished Product Standards (FPS) are criteria applied to processed birds before and

after chilling to ensure that the product being produced is consistently wholesome and

unadulterated.

Why use FPS?

Relevant policy?

4 Responsibilities FPS

Establishment

FSIS
Slaughter: NFSCP - Part 1

30-5

5

5 Presentation of Carcasses and Parts

• The establishment must ensure that the carcasses are presented for inspection.

• They must also be hung on the line in a specified manner and spaced

appropriately.

• The organs must be displayed in a specified order so that the inspector does not

have to spend time locating them before he or she performs inspection

procedures.

• Proper presentation helps to ensure consistent and accurate inspection.

• There are variations in the ways in which an establishment will present

carcasses and parts for inspection.

6 Presentation Scenario

Using the scenario below complete the Blank FSIS form provided.

You are PHV at a Meyn Maestro evisceration system establishment. During breaks

you hear the two USDA FIs chatting about the high number of birds that are being

presented without viscera.

When the line restarts, you head down to view the floor. You see carcasses presented

without viscera. You perform a directed presentation check for each of the two food

inspectors and see the following abnormalities:

Notes for inspector 1:
Slaughter: NFSCP - Part 1

30-6

6

Notes for inspector 2:

Is the establishment in control of their process?

Would this answer be different if only one carcass with viscera missing was seen?

What, if any, actions should you take?
Slaughter: NFSCP - Part 1

30-7

7

Slides Poultry Finished Product Standards

8 Poultry Finished Product Standards

Tasks covers finished product standards, rework/reprocess/salvage products, poultry

carcasses, poultry products and other articles entering or at official establishments,

examination and other requirements, returned products, and good commercial

practices for poultry slaughter.

Review common terms:

• Unit – A unit is a single poultry carcass

• Subgroup – A subgroup is a 10-unit sample collected at the same time (10 birds

for one test)

• Rework – Rework is reprocessing product to correct nonconformances that

caused the product to be identified as unacceptable.

• Cumulative sum (CUSUM) – Cumulative sum (CUSUM) is a statistical concept

used by the establishment and monitored by FSIS. CUSUM represents the

accumulated number of weighted nonconformances that exceed the tolerance in

a series of consecutive subgroups.

• Action Number – The action number is a standardized value. When CUSUM

reaches the action number, it indicates the process being tested might be out of

control (questionable control). Product action is required when CUSUM reaches

the action number.

• Start Number – The start number is a value halfway between zero and the

action number. Under certain conditions it can be used to determine the

CUSUM for the next shift and to reset the CUSUM after the action number is

reached.

Notes:
Slaughter: NFSCP - Part 1

30-8

8

9 Poultry FPS Chart

Pre-chill

• Pre-chill tests are conducted on carcasses after they pass the final wash and

before they enter the chiller.

• Each evisceration line must be tested. Each line’s results are independent of the

others.

• The time allowed to conduct a pre-chill test (both processing and trim tests) is 8

- 10 minutes.

• The frequency for pre-chill testing is two times per line per shift.

• Lighting requirements at the pre-chill station are 200 foot-candles of shadow

free light with a minimum color rendering index of 85.

Notes:
Slaughter: NFSCP - Part 1

30-9

9

Processing Test

• Processing tests determine if the dressing/evisceration process is in control.

Processing nonconformances are items which should have been removed by

machinery or establishment personnel to make the carcass acceptable as a

ready-to-cook product. These items include:

o Extraneous material

o Oil glands

o Lungs

o Intestines

o Cloacas

o Bursa of fabricius (rosebud)

o Esophagus

o Crops

o Tracheas

o Hair

o Feathers and pinfeathers

o Long shanks

• FSIS Form 6500-1
Slaughter: NFSCP - Part 1

30-10

10

Trim Test

• Trim tests determine if the trim process, which involves removal of

unwholesome lesions and conditions, is in control. Trim nonconformances which

should have been removed by establishment personnel include:

o Breast blisters

o Bruises

o Trimmable, localized tumors

o Carcasses marked for synovitis, airsacculitis, etc.

o Compound fractures

o Short hocks

o Sores, scabs, IP

o External mutilation

• FSIS Form 6500-1

Post-Chill

• The post-chill finished product procedure monitors extraneous material that

carcasses pick up during the chilling process. Birds are collected after they

leave the chiller but before they are divided into separate processes (e.g., cutup, packing, freezing).

• Each system’s results are independent of the others.

• The time allowed to complete a post-chill test is 5 - 7 minutes.

• Lighting requirements at the post-chill station are 200 foot-candles with a color

rendering index of 85.

• The test results are recorded on a post-chill fps form and CUSUM is calculated.
Slaughter: NFSCP - Part 1

30-11

11

10 Pre-Chill Scenario

Use blank form 6500-1, form 6500-2, and nonconformance criteria charts in this Folder

to complete the following scenario.
Slaughter: NFSCP - Part 1

30-12

12
Slaughter: NFSCP - Part 1

30-13

13

At an establishment under New Turkey Inspection System at the prechill location, you

select ten random birds and perform a finished product standard verification task.

While performing a pre chill you observe the following defects:

• Green bruise >1”

• trachea >1”

• Feather >1”

• Untrimmed breast blister

1. Are these processing or trim nonconformances?

2. What is the scoring? The plant’s CUSUM was 5 in processing and 1 in trim.

3. Is the establishment in compliance?

4. What would happen if the subgroup total had exceeded the absolute limit?
Slaughter: NFSCP - Part 1

30-14

14

11 Young Chicken Scenario

Complete the blank FSIS form 6500-1 and 6500-2 in this folder using the

nonconformance criteria charts and the information from the scenario below.

You are the QC technician examining 10 birds for pre-chill processing

nonconformances and trim nonconformances. Click here to view the table representing

your observations:

Notes:
Slaughter: NFSCP - Part 1

30-15

15

12 Post-Chill Scenario

Complete the blank FSIS 6500-3 using the nonconformance criteria chart and the

information from the scenario below.

You are examining 10 birds for post-chill nonconformances. Click here to view the

table representing your observations:

Notes:
Slaughter: NFSCP - Part 1

30-16

16

Slides Livestock Finished Product Standards

14 Livestock Finished Product Standards

Pertains to the requirements concerning procedure, ingredients, and other articles

used in preparation of products.

Examples of products:

• Boneless meat

• Meat carcasses

• Pork skins for popping

Video Notes:
Slaughter: NFSCP - Part 1

30-17

17

Slides Salvage

16 Salvage

The term salvage refers to the actions the establishment takes to trim away any

unwholesome or diseased portion of a carcass that is localized.

There can be many types of salvage depending on the establishment, and products

produced.

Conditions for Salvage:

• Procedure for each type

• Sanitary conditions

• Adequate facilities and personnel

• Continuous product flow

• Product available for FSIS reinspection

Notes:

17 Salvage Can Be Suspended if:

• The establishment fails to follow their salvage procedures.

• They fail to make birds available for FSIS reinspection.

• They are unable to maintain adequate product flow.

• Voluntarily they may elect in some instances, most commonly when birds are

affected with airsacculitis in high numbers. They must notify FSIS IPP of their

decision.

Notes:
Slaughter: NFSCP - Part 1

30-18

18

18 Salvage Scenario: Osteomyelitis

Last week you verified turkey osteomyelitis (OM) salvage on an OM positive flock. At

that time, you observed an employee trim a carcass with OM in the proximal tibia. That

employee removed the tibia at the stifle and attempted to put the carcass back into

production. You showed the issue to a supervisor and discussed and documented this

issue in the weekly meeting. Today you observe this happen again.

1. What is the issue?

2. What should you do?

3. Is the establishment at risk of losing the ability to perform OM salvage?
Slaughter: NFSCP - Part 1

30-19

19

Slides SUMMARY

19 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
369

Non-Food Safety

Consumer Protection –

Part 2
Processing: NFSCP – Part 2

31-2

370

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

NFSCP: Big Picture Summary ................................................................................................4

Non-Food Safety Consumer Protection (NFSCP): Big Picture............................................4

NFSCP: Big Picture Summary ............................................................................................5

NFSCP: Big Picture Summary ............................................................................................6

NFSCP: Big Picture Summary ............................................................................................6

NFSCP: Big Picture Summary ............................................................................................7

Verification Methodology for Non-Food Safety Tasks.............................................................7

Verification Methodology Tasks ..........................................................................................7

Percent Yield/Shrink/Gain ...................................................................................................8

X% Solution Labeled Products............................................................................................9

MSP/MSKP/PDBFT/PDPFT/AMR Products........................................................................9

Batter/Breading ................................................................................................................. 10

Labeling - Product Standards............................................................................................ 10

Child Nutrition (CN)/Grade Labeling/Declared Count/Vignette.......................................... 11

Net Weights....................................................................................................................... 11

Scenarios.............................................................................................................................. 12

Scenario A: Part 2 ............................................................................................................. 13

Scenario A: Part 3 ............................................................................................................. 17

Scenario B......................................................................................................................... 19

Scenario C ........................................................................................................................ 22

Knowledge Checks ............................................................................................................... 25

Knowledge Check 1 .......................................................................................................... 25

Knowledge Check 2 .......................................................................................................... 25

Knowledge Check 3 .......................................................................................................... 25

SUMMARY ........................................................................................................................... 25
Processing: NFSCP – Part 2

31-3

3

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Review Verification Methodology for Non-Food Safety Tasks and discuss in a

group which tasks may be relevant at your duty station.

2. Given a scenario involving verification tasks in the Processing context, apply

labeling regulations, FSIS Directive 7000.1, the NIST Handbook, and the

Calculation Aid to verify NFSCP compliance.

3. Given a scenario in the Processing context, provide appropriate feedback and

guidance to an IPP when he or she incorrectly performs a non-food safety

consumer protection task.

4. Given a scenario in the Processing context, identify the NFSCP noncompliance

and the task to document the NR in, whether a recall is likely, and select the

appropriate action regarding the product involved.
Processing: NFSCP – Part 2

31-4

4

Slides NFSCP: Big Picture Summary

3 Non-Food Safety Consumer Protection (NFSCP): Big Picture

Using the resource in the folder, discuss the following questions:

• What are some key regulations in regards to the labeling of meat products?

• What does it mean when a meat product is misbranded?

• If, while performing a NFSCP task, IPP observe food safety concerns, how

should they proceed?

• What steps of enforcement are to be made when a product is found to be

noncompliant with NFSCP regulations?
Processing: NFSCP – Part 2

31-5

5

4 NFSCP: Big Picture Summary

What are some key regulations in regards to the labeling of meat products?

Bonus Question: What is a generically approved label?
Processing: NFSCP – Part 2

31-6

6

5 NFSCP: Big Picture Summary

What does it mean when a meat product is misbranded?

Notes:

6 NFSCP: Big Picture Summary

If, while performing a NFSCP task, IPP observe food safety concerns, how should they

proceed?
Processing: NFSCP – Part 2

31-7

7

7 NFSCP: Big Picture Summary

What steps of enforcement are to be made when a product is found to be

noncompliant with NFSCP regulations?

Slides Verification Methodology for Non-Food Safety Tasks

9 Verification Methodology Tasks

Generally, how do IPP perform the NFSCP verification tasks?
Processing: NFSCP – Part 2

31-8

8

If, following a preliminary assessment, you have reason to believe that non-compliant

product is being or has been produced, perform a directed verification procedure and a

thorough evaluation. What are the NFSCP tasks that can be performed?

10 Percent Yield/Shrink/Gain

• Verify the requirements associated with percent yield/shrink/gain.

• Example products: bacon, BBQ meats, roasts beef, corned beef, cured beef

tongue, country ham, etc.

Video Notes:
Processing: NFSCP – Part 2

31-9

9

11 X% Solution Labeled Products

• Verify the requirements associated with X percent solution for labeled products

• Task is verifying that the percent of a solution added to a product does not

exceed the regulatory requirements

• Examples of products: cured pork products, ham patties, chopped ham, readyto-cook poultry products, turkey ham, corned beef, beef brisket, etc.

Video Notes:

12 MSP/MSKP/PDBFT/PDPFT/AMR Products

• Mechanically Separated Pork (MSP), Mechanically Separated Kind of Poultry

(MSKP), Partially Defatted Beef Fatty Tissue (PDBFT), Partially Defatted Pork

Fatty Tissue (PDPFT), and Advanced Meat Recover (AMR) products

• To verify compliance:

o Check product identification, condition ,temperature, holding

time/temperature;

o Examine bones (for example, two intact portions of bones) before and

after the meat recovery systems in order to observe condition and

conformation;

o Review establishment laboratory results and compare findings with the

appropriate regulatory standard, and

o Collect samples as directed.

Video Notes:
Processing: NFSCP – Part 2

31-10

10

13 Batter/Breading

• Verify requirements associated with batter and breading

• Examples of products: breaded products, breaded patties, breaded meat cuts,

fritters

Video Notes:

14 Labeling - Product Standards

• Verify requirements for product standards

• Examples of products: miscellaneous beef products, sausage, frankfurters,

luncheon meats, chili con carne, meat stews, tamales and others

• Finished Product Testing Job Aid

Video Notes:
Processing: NFSCP – Part 2

31-11

11

15 Child Nutrition (CN)/Grade Labeling/Declared Count/Vignette

• Verify the requirements related to false or misleading labeling or practices,

including specific prohibitions and requirements for labels and containers, and

wording on labels of immediate containers

• Examples of products: All types of products

Video Notes:

16 Net Weights

• Verify the requirements related to net weights whether the containers are catch

weight or bear a stated net content

• Examples of products: All types of products that carry a net weight statement

Video Notes:
Processing: NFSCP – Part 2

31-12

12

17 General Labeling

• Task applies to all products that bear a label

• It includes verifying the requirements related to standards of identity

• Examples of products: All products

Video Notes:

Slides Scenarios

19 Scenario A: Part 1

Video Notes:

Describe how the CSI should perform this task?
Processing: NFSCP – Part 2

31-13

13

Identify specific resources the CSI could review for this task (e.g., regulations, CDs,

directives, and notices).

20 Scenario A: Part 2

Video Notes:
Processing: NFSCP – Part 2

31-14

14

Bases on the review of the product formulation and the labeling applied to the

immediate containers and shipping containers, has the establishment produced

misbranded product?
Processing: NFSCP – Part 2

31-15

15

Bases on the review of the product formulation and the labeling applied to the

immediate containers and shipping containers, has the establishment produced

adulterated product?

Is there a food safety hazard associated with the production of the product?
Processing: NFSCP – Part 2

31-16

16

What action should the CSI take?
Processing: NFSCP – Part 2

31-17

17

21 Scenario A: Part 3

Video Notes:

Which corrective action regulations would apply in this situation?

How should the CSI document the finding of the task? What regulations would he cite?
Processing: NFSCP – Part 2

31-18

18

What action should the CSI take next?

Could what you and the CSI observed indicated an inadequate food safety system?
Processing: NFSCP – Part 2

31-19

19

What action should you take next?

22 Scenario B

Video Notes:
Processing: NFSCP – Part 2

31-20

20

How does the CSI determine the sample size?

What is the sample size of the containers that CSI should examine?

How does the CSI determine the tare sample size?

What is the initial tare sample size?

How is Maximum Average Variation (MAV) defined?
Processing: NFSCP – Part 2

31-21

21

How does the CSI calculate the MAV?

What would constitute a failure of the MAV criteria for the containers of the chicken

thigh meat?

How does the CSI calculate the individual package errors?
Processing: NFSCP – Part 2

31-22

22

How does the CSI determine if the inspection lot passes or fails the net weight

inspection?

What action should the CSI take for this inspection lot?

23 Scenario C

Video Notes:

What action should you take next?
Processing: NFSCP – Part 2

31-23

23

Would you grant the establishment’s appeal? If no, state why not? If yes, state why?
Processing: NFSCP – Part 2

31-24

24

Is the noncompliance description on the NC adequate? If not, what type of guidance

would you give the CSI for documenting noncompliance?
Processing: NFSCP – Part 2

31-25

25

Slides Knowledge Checks

24 Knowledge Check 1

True or False: MSS; MSP; PDBFT; PDPFT; PDCB; PDCP; AMRS are new industry

technologies and have no FSIS regulations or standards associated with them.

25 Knowledge Check 2

True or False: Anytime an individual unit in the lot of sampled breaded product

exceeds 30% breading, there is noncompliance.

26 Knowledge Check 3

True or False: Ingredients used in products’ formulations are to be listed on labels’

ingredients statements in the descending order of predominance.

Slides SUMMARY

27 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

394

Non-Food Safety Consumer Protection Regulatory

Requirements ― FSIS Directive 7000.1

OBJECTIVES

After completing this module, you will be able:

1. Identify the statutes and regulations that relate to non-food safety consumer

protection responsibilities.

2. Describe how to conduct the PHIS Economic/Wholesomeness tasks.

3. Explain what to do when noncompliance is observed.

4. Describe what to do when there are multiple noncompliances.

RESOURCE MATERIALS

• Federal Meat Inspection Act (FMIA)

• Poultry Product Inspection Act (PPIA)

• 9 CFR Parts 301, 313, 316, 317, 318, 319, 327, 381 Subpart P, 412, 424, 441, and 500

• FSIS Directive 5000.1 “Verifying an Establishment’s Food Safety System”

• FSIS Directive 5400.5, Attachment 5, “Inspection System Activities”

• FSIS Directive 6100.3 Ante-Mortem and Post-Mortem Poultry Inspection

• FSIS Directive 6120.1, “Finished Product Standards Program for the New Line

Speed Inspection System and the Streamlined Inspection System”

• FSIS Directive 6700.1, "Retained Water in Raw Meat and Poultry Products"

• FSIS Directive 6810.1, “Grademark Labeling on Meat and Poultry Product”

• FSIS Directive 6900.2, “Humane Handling and Slaughter of Livestock”

• FSIS Directive 7000.1 “Verification of Non-Food Safety Consumer Protection

Regulatory Requirements”

• FSIS Directive 7000.2, “Experimental and Sample Product Policy”

• FSIS Directive 7120.1 “Safe and Suitable Ingredients Used in the Production of Meat

and Poultry Products”

• FSIS Directive 7124.1, “Standards of Identity or Composition—Use of Cooked or

Cured Product”

• FSIS Directive 7160.1, “Meat Produced by Advanced Meat/Bone Separation

Machinery and Meat Recovery Systems”

• FSIS Directive 7160.2, “’Meat” Prepared Using Advanced Mechanical Meat/Bone

Separation Machinery and Meat Recovery Systems”

• FSIS Directive 7160.3, “Advanced Meat Recovery Using Beef Vertebral Raw

Materials”

• FSIS Directive 7220.1, “Food Labeling Division Policy Memoranda”

• FSIS Directive 7221.1, “Prior Labeling Approval”

• FSIS Directive 7235.1, “Mandatory Safe Handling Statements on Labeling of Raw

and Partially Cooked Meat and Poultry Products”

• FSIS Directive 7237.1 Amendment 1,“Labeling of Ingredients”

• Directive 7230.1 Ongoing Verification of Product Formulation and Labeling Targeting

Entry Training for PHV 1
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

395

the eight most common (big 8) Food Allergens

• FSIS Directive 7270.1, “Sampling and Testing Procedures for Raw Poultry Products

Labeled “Fresh’”

• FSIS Directive 7355.1, “Use of Seals for Program Samples and Other Applications”

• FSIS Directive 7620.3, “Processing Inspector’s Calculation Handbook”

• FSIS Directive 8080.1, Rev. 7,“Recall of Meat and Poultry Products”;

• FSIS Directive 10,210.1 “ Unified Sampling Form”

• Part 3, Section 3, “Import Inspection Manual of Procedures for the Species

Verification Testing Program”

• Policy Memos 42, 44A, 57A, 66C, and 84A

(http://www.fsis.usda.gov/OPPDE/larc/Policies/Policy_Memos_082005.pdf

• Food Standards and Labeling Policy Book

(http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf

• NBS Handbook 133

• NIST Handbook 44 (http://museum.nist.gov/object.asp?ObjID=55)

Additional Resources

• Start-All Programs-FSIS Applications-Tools-Calculation Aids

• FSIS Topics / Regulatory Compliance / Labeling/Label Approval / Labeling Policies

• FSIS Compliance Guidance for Label Approval (Nov 2015; PDF Only)

• A Guide to Federal Food Labeling Requirements For Meat and Poultry Products (PDF

Only)

• Compliance Guide on the Determination of Processing Aids (Apr 8, 2008; PDF Only)

• Guidance on Meaning of "Prohibited Substances" in FSIS Actions on the Use of

Ingredients in Meat and Poultry Products (Apr 8, 2008; PDF Only)

• Labeling Compliance Policy Guide on Poultry Food Product Dating (Aug 23, 2010; PDF

Only)

• Labeling Policy Guidance - Uncooked, Breaded, Boneless Poultry Products (Updated

Jan 17, 2007; PDF only)

• Letter to Industry Regarding Frozen Uncooked Poultry (Mar 20, 2006; PDF only)

• Supplemental Q and A's to Address Products Affected by FSIS Notice 75-06

Verification Instructions for Changes in Label Requirements for Uncooked and Raw,

Frozen Breaded, Boneless Poultry Products

• Information on Validation of Labeled Cooking Instructions for Products Containing Raw

or Partially Cooked Poultry | PDF

INTRODUCTION

In this module, we’ll be covering your responsibilities related to the statutes, regulations,

and directives that cover the regulatory requirements for what is called the Non-Food

Safety Consumer Protection, or NFSCP. These requirements relate to economic

adulteration and misbranding of products other than food safety. Additional information

may be obtained from the Training CD developed by FSIS Center for Learning.

FSIS’ highest priorities are protecting public health and food safety. The Agency is

ensuring that inspection program personnel (IPP) focus on food safety first followed by

food security (when specific heightened security threat condition is declared), and yet still

Entry Training for PHV 2
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

396

verify compliance with requirements that provide non-food safety protection to consumers

extended by the FMIA and PPIA. The NFSCP duties are the ones that are covered by

Public Health Inspection System Economic/Wholesomeness Tasks. These tasks are

performed to verify that the establishments are complying with regulatory requirements

designed to protect the consumer in ways other than ensuring food safety.

The Agency is making changes in the verification procedures that relates to these other

protections to ensure that they align with FSIS’ responsibilities and priorities.

STATUTES

Federal Meat Inspection Act (FMIA)

Let’s start by reviewing the statutes 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), the amount of product in the container falls 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.

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(b) states: labels must be “in distinctly legible form.” Section 607(c) states that

misleading or false labeling is to be avoided. It also indicates articles that are subject to

Entry Training for PHV 3
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

397

standards of identity must be consistent with those standards when they apply to the

article. Section 607(d) states, “No article subject to this subchapter shall be sold or

offered for sale by any person, firm, or corporation, in commerce, under any name or

other marking or labeling which is false or misleading, or in any container of a misleading

form or size, but established trade names and other marking and labeling and containers

which are not false or misleading and which are approved by the Secretary are

permitted”. 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.

Poultry Products Inspection Act (PPIA)

There are similar provisions related to the definition of the term “misbranding” in the

PPIA. Here’s an overview.

• PPIA 453(h) – Definition of “misbranded” with 12 provisions.

• PPIA 457 – Labeling and container standards. There are four parts to this section:

(a) Must bear legible labels

(b) Must comply with definitions and standards of identity; and fill of container

(c) Must not be sold under false labeling or misleading size

(d) Label may be withheld until modified so that it is not misleading or false.

REGULATIONS

The regulations related to the NFSCP requirements are extensive and detailed. We will

review the highlights of some of the key NFSCP regulations for meat and poultry products.

You will need to review the regulations on your own to become familiar with them in more

detail, as we will not cover all aspects that you need to know during this training program.

General requirements for meat products

Let’s start with some of the key regulations related to meat products. 9 CFR 317 outline

all of the regulatory requirements including labeling, marking devices, and containers.

Currently, there are forty two regulations related to NFSCP requirements for meat

products, and some of these regulations have a number of subparts.

9 CFR 317.1 states that labels are required for containers of meat products. There are a

few exceptions which are outlined in the regulation.

9 CFR 317.2 outlines the required features of labels for meat products. Here are some of

the basic requirements. The label must list the name of the product and ingredients used

in the production of the product. The name and place of business of the manufacturer

must be shown on the label. It must also contain an accurate statement of the net

quantity of the contents of the product. Just as was stated in the statutes, the label must

not be false or misleading. It must list any handling of the product that is required in order

to maintain the product in a wholesome condition. There are also some very specific

requirements for safe handling instructions for meat and meat products.

Entry Training for PHV 4
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

398

9 CFR 412.1 contains the requirements related to labeling approval. One of the key

statements is that no final labeling shall be used on any product unless the sketch

labeling of such final labeling has been submitted for approval to FSIS except for

generically approved labels authorized for use in 9 CFR 412.2. Currently, the

organizational unit responsible for handling the approval of labels is the Labeling and

Program Delivery Staff (LPDS), Office of Policy and Program Development. A sketch

label is a printers proof or the equivalent which clearly shows all labeling features,

including the size, and location. The LPDS may grant a temporary approval that extends

up to 180 calendar days. If the label is to be applied directly to a meat carcass, make

sure that the type of ink the establishment uses complies with 9 CFR 312 and 316, which

states they must be legible and of harmless material. FSIS requires the submission of

labeling applications for the following:

• Labels for temporary approval (9 CFR 412.1(c)(4)),

• Labels for products produced under religious exemption (9 CFR 412.1(c)(1)),

• Labels for products for export with labeling deviations (9 CFR 412.1(c)(2)), and

• Labels with special statements and claims (9 CFR 412.1(c)(3))

9 CFR 412.2 covers generically approved labels. IPP do not generically approve

labels. Establishments do not generically approve labels. Generically approved labels

are approved by FSIS if the label meets the criteria listed in 9 CFR 412.2(b). Therefore,

a label that meets one of the conditions of being generically approved does not have to

be submitted to FSIS for further approval. Some generically approved labels Include

labeling for:

• Products that have a standard specified, such as a standard of identity

(identifies the kind and amount of meat required in that product; e.g., hot dogs).

• A product, such as steak, that has a single ingredient. There can be no

special claims on these generically approved labels.

• Containers of products sold under government contract specifications, such

as those sold for the school lunch program.

• Consumer test products which are not intended for sale.

• Any label that was previously approved as a sketch by FSIS qualifies to be

used without any further approval.

As mentioned earlier, there are many more details regarding the regulatory requirements

for labeling meat products. For example, there are extensive requirements related to

nutritional labeling. These are found in 9CFR 317.300-317.400. Nutritional labeling is

currently required for all meat products intended for human consumption except for

t h o s e that are single ingredient, raw products, such as steaks. However, nutritional

labeling may be provided for these products on a voluntary basis. We will not review

these requirements in general, but you should take time to review the regulations and

become familiar with them, as from time to time, you will need to verify that the

establishment is complying with these requirements.

Later in this module we will review some of the basic requirements for labeling related to

products that have standards of identity. But first, let’s review some of the basic

regulatory requirements of general labeling for poultry products.

Entry Training for PHV 5
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

399

General requirements for poultry products

Just as there are a number of regulatory requirements related to the labeling of meat

products, there are also a number related to poultry products. They are found in 9 CFR

Subpart N of regulation 381, from 381.115 through 381.144. Let’s review a few of the

key parts. As we walk through these, you’ll see that they are very similar to the

regulations that we reviewed for meat products. They also match the same principles

contained in the statutes that we reviewed. Here are some highlights.

9 CFR 381.115 – Require the containers of poultry products to be labeled.

9 CFR 381.118 – Covers the requirement for ingredients statements for poultry products.

9 CFR 381.119 – States that artificial flavoring or coloring must be declared on labels of

poultry products.

9 CFR 381.120 – States that antioxidants, chemical preservatives, and other additives

must be declared on the labels of poultry products.

9 CFR 381.121 – Requires that the label shows the quantity of the contents of the

product.

9 CFR 381.122 – Requires that the label identifies the product manufacturer, packer or

distributor.

9 CFR381.124 – States that dietary food claims must be matched with appropriate

details on the label.

9 CFR 381.125 – Requires that if poultry products require special handling to maintain a

wholesome condition, these handling requirements must be listed on the label.

9 CFR 381.130 – States that false or misleading label are not permitted for poultry

products.

9 CFR 381.132 – Describes the labeling approval process. This process is the same as

the one for meat products.

9 CFR 381.133 – Covers the requirements related to generically approve labeling. Just

as was true for meat products, those products for which a standard of identity exists are

eligible for generically approved labels.

Standards of identity

Now, let’s review some of the regulatory requirements for products that are subject to

standards of identity. Remember those products can use generic labels. The

“Definitions and Standards of Identity or Composition” regulations for meat and poultry

products are found in 9 CFR 319 and 9 CFR 381 Subpart P, respectively. We won’t

cover each of the products outlined in the regulations in detail but you need to review

these regulations and become familiar with the requirements associated with each

product that is produced in the establishment where you are assigned.

Entry Training for PHV 6
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

400

The requirements in 9 CFR 319.1 cover the general labeling and preparation of

standardized meat products. This regulation states that products for which standards of

identity exist must have a label showing the products name and ingredients statement and

other information as appropriate. The 9 CFR 319.15-319.881 (Subparts B through

U) cover the specific requirements for various meat products – from raw products that

have very few, if any ingredients or preparation, to products such as cooked sausage that

may have a number of ingredients and may go through a variety of steps in preparation.

Remember that we covered some of the processing steps when we introduced you to the

regulated industry. For example, Subpart B (―Raw Meat Products) covers the following

products: chopped and ground beef, hamburger, beef patties, fabricated steak, and

partially defatted beef and pork fatty tissue. In Subpart D (―Cured Meats, Unsmoked and

Smoked) some products such as cured pork products, the regulations relate to the list of

ingredients on the label, such as binders, and the percent of water added. Also, for some

products, there are protein fat free (PFF) percentage regulatory requirements; in other

products Mechanically Separated (Species) Product may be used in accordance with

§319.6. The regulations also specify that smoking must be done with approved

nonresinous materials (§319.160). Furthermore, there are definitions in the regulations of

each of these types of products. For example, in Subpart L (―Meat Specialties, Puddings

and Nonspecific Loaves), there is a very specific definition of the meat product bockwurst

that includes details of the formulation of the product. Subpart M (―Canned, Frozen, or

Dehydrated Meat Food Products) contains a very specific definition for “hash”.

Remember that in this section of the training we are covering the labeling requirements

related to these products. There are food safety requirements for these products as well.

You will learn about the food safety requirements when you attend the Food Safety

Regulatory Essentials (FSRE) training.

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. Again, if the establishment you are assigned produces any of these

types of products, you must familiarize yourself with the specific regulations, as from time

Entry Training for PHV 7
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

401

to time you will be performing procedures to verify that these products comply with the

labeling requirements. Let’s walk through a few of these requirements briefly. 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 cover 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)

VERIFICATION METHODOLOGY FOR NON-FOOD SAFETY TASKS

If you are assigned to a large establishment, the inspection tasks for verifying that the

establishment complies with the NFSCP requirements will be performed by a Consumer

Safety Inspector (CSI) that you supervise. You may perform the economic

wholesomeness and sampling tasks when you are acting in a relief capacity for the CSI.

If you are assigned to work in establishments that are small or very small, you may

perform these duties yourself. In either case, you need to know the details of how to

perform the procedures. So, we will cover how to perform the procedures as if you were

doing them yourself.

FSIS Directive 7000.1 provides instructions for how you are to perform verification

procedures related to NFSCP requirements. While performing NFSCP tasks, it is

possible that you may uncover concerns related to an establishment’s food safety

systems, such as the Sanitation SOP or HACCP plan. When this occurs, you should

perform the food safety task as a directed procedure and take any necessary

enforcement actions. For example, if you are performing a routine labeling verification

task and discover that the establishment has issued an ingredient of public health

Entry Training for PHV 8
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

402

concern without properly declaring the ingredient, you should pursue the food safety

aspects of the findings and performed any warranted, directed food safety task as

instructed in FSIS Directive 5000.1.

Inspection program personnel are not to perform directed NFSCP verification tasks

unless, during the performance of food safety verification activities, they observe

conditions or activities that cause them to suspect that the establishment is not meeting

non-food safety regulatory requirements. If, following a preliminary assessment of such

information, you have reason to believe that non-compliant product is being or has been

produced perform a directed verification task and a thorough evaluation. Whenever an

directed verification task added to the task calendar, a pop-up dialogue screen will appear

in the Public Health Information System (PHIS). Use the dialogue screen to provide a

brief explanation of why you believe a directed task is warranted.

Performing the Economic/Wholesomeness tasks

When you move a non-food safety consumer protection task from the task list to the task

calendar, you are to perform the appropriate verification tasks by:

• observing establishment product formulation, verifying the accuracy of labeling;

• observing preparation or processing procedures;

• reviewing establishment records;

• examining product;

• checking product identification, condition and temperature;

• performing a variety of other in-plant measurements, testing and calculations;

• observing slaughter practices

Inspection personnel need only examine product when they have reason to believe that

product does not meet regulatory requirements. However, there are no designated

sampling plans or sample sizes that IPP are to use when examining products to assure

that the products meet non-food safety regulatory requirements, nor are IPP to examine

all products. They examine product to determine whether the product complies with

regulatory requirements, such as product standards, net weight standards, regulatory

maximum or minimum limits of ingredients or components, or product defects.

Inspection program personnel are to determine whether product complies with the

regulation based on production lots or process controls rather than on individual units of

product. For example, if one package of product exceeds its net weight, IPP are to

investigate whether there have been problems in the process that will cause all packages

to exceed the net weight requirements.

When you verify the condition of inspected and passed product, verify product

identification, and evaluate the product condition. That includes the product temperature

and storage. After such an assessment, you should be able to determine the extent of the

verification tasks that you may need to perform. Where effective establishment processing

controls are evident, only limited verification activity may be necessary. You should, in

these cases, direct the inspection to those parts of the processing operation that are not

covered by an establishment’s control procedures. You do not need to count individual

defects to make a judgment on a finished production lot. The condition of product should

be clearly evident and sufficient to allow inspection personnel to render a judgment that

the product is not adulterated.

Entry Training for PHV 9
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

403

Verification activities under Formulation and Labeling

Verify that the establishment is producing product in compliance with the appropriate 9

CFR reference (see Attachment 1 of Directive 7000.1) and determine whether the

product complies with the regulations by comparing the product to the relevant

regulatory requirements.

So, what should you be looking for when you observe product formulation?

• Verify that the product meets requirements that are specified in the applicable

standards of identity.

• Verify that all ingredients have been added in amounts that come within the

maximum or minimum level specified in the applicable standard.

• Verify all ingredients used in formulating the product are accurately declared on the

label in descending order of predominance and any proteinaceous substances used in

the formulation are declared in the ingredient statement.

• Verify that the product defects level are consistent with applicable standards.

• Observe establishment activities.

• Review establishment records.

Proteinaceous substances can trigger food sensitivities or allergies in certain individuals

and therefore, such substances are of a food safety concern if they are not clearly

declared in the ingredients statement. The eight most common food allergens that have

become a serious issue for the food industry include milk, eggs, fish, crustacean shellfish

(e.g., shrimp), peanuts, tree nuts (almonds, walnuts, etc.), soybeans, and wheat. The

U.S. Department of Agriculture considers the above mentioned undeclared allergens, with

the exception of wheat, as the basis for Class I or II recalls which have potential for

severe health consequences. The Recall Committee is responsible in making the

decision for which recall classification the undeclared allergen will fall under based on

their assessment of the product in question. Following are a few examples of products

with undeclared ingredients that triggered a recall. Recently, there were two products

that were retrieved from market under Class I classification. One of them was deli franks

which may have contained dry milk, and the other product was soup with meatballs and

chicken which contained cheese as the undeclared ingredient. Under Class II

classification, the product “Steak for Country Frying-Fully Cooked Cubed Steaks” was

recalled from the market due to undeclared “buttermilk blend” in the ingredient statement

on the carton.

What should you do when verifying the NFSCP requirements related to labeling?

• Review the establishment’s labeling records including any supporting

documentation such as letters from FSIS, temporary approvals, etc.

• Determine whether labeling is approved in accordance with appropriate regulations,

i.e., either approved as a sketch by the FSIS LPDS, or generically approved in

accordance 9 CFR §412.2.

• Verify that the required features are present on the labels.

• Verify that the net weight of the product is accurately reflected on its label.

• Verify that the labels are not false or misleading.

• Verify that the correct labels are applied to products.

Entry Training for PHV 10
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

404

Verification activities under Livestock Product Examination

When performing Livestock Product Examination, IPP are to verify that the establishment

complies with 9 CFR 318.2, 318.5, and 318.6. The IPP are no longer to perform activities

known as livestock carcass re-inspection, boneless meat re-inspection, and other product

re-inspection duties to verify compliance with the relevant regulations. Instead, IPP only

are to examine product that may have undergone a significant change after it was

inspected and passed (e.g., chilled in the cooler or boned). In other words, the IPP

should be able to determine the extent of the tasks needed based on conditions observed

in the establishment. Where effective establishment processing controls are evident (i.e.,

the establishment has procedures in place to examine incoming product for acceptability,

uses control programs to monitor product processing, and such controls and procedures

are documented), the IPP will limit non-food safety verification activities. In these cases

the IPP will direct their inspection to those parts of the processing operation that the

establishment does not cover by control procedures. The IPP need not count individual

defects to make a judgment on a finished production lot but need to base determinations

of product compliance by making determinations regarding product usability. The

products should not pass inspection if defects are severe or numerous enough to affect

the usability of the product. The condition of the product should be clearly evident and

sufficient to allow inspection personnel to determine that the product is in compliance. As

mentioned earlier, determinations of acceptability should be based on production lots and

process controls rather than on individual units of product.

The purpose of the product examination is to determine whether standards are being met

and the product meets the conditions as set out in the Act: “...any valuable constituent

has been in whole or part omitted or abstracted there from; or any substance has been

substituted, wholly or in part thereof, or if damage or inferiority has been concealed in any

manner; or if any substance has been added to the product or mixed or packed therewith

so as to increase its bulk or weight, or reduce its quality or strength, or make it appear

better or of greater value than it is” (21 U.S.C. 601(m) (8)).

In addition, IPP may also observe establishment’s quality control programs and review

associated records to verify whether the establishment meets regulatory requirements.

Inspection program personnel should consult with their Frontline Supervisor (FLS) for

assistance, when necessary, in determining noncompliance. The Policy Development

Division (PDS) will provide additional guidance to assist with policy questions.

Examples of noncompliance situations:

• IPPS find that a carcass in the cooler has a large and heavy blood clot that would

increase the weight of the carcass in such a way to reduce its quality, and the

establishment has failed to address the situation.

Note: The blood clot is an example of an “inferiority that has been concealed” because it

could not be seen until the carcass was chilled.

• IPP find that after the boning process the boneless product does not represent

“boneless meat” because the number of bone fragments, and the establishment has

failed to address the situation.

Entry Training for PHV 11
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

405

Verification activities under Poultry Product Examination

The Poultry Product Examination task is used to verify that the establishment complies

with the relevant regulations for poultry finished product standards (FPS), Giblet

Acceptable Quality Levels, rework product standards, inspection of received products

and returned products for slaughter. Inspection program personnel inspect raw or

unprocessed poultry products under the Poultry Product Examination.

Inspection program personnel verifying compliance with FPS are to use criteria as listed

in the regulations. They should verify compliance by performing pre-chill FPS testing,

post-chill FPS testing, reinspection of carcasses and giblets, inspection of returned

products, inspection of rework products, and condition inspection of products in the

establishment. Also, they are to perform the activities at the frequencies prescribed in 9

CFR 381.76. Each time inspection program personnel perform the FPS activities they

are to record the activities in PHIS as either routine or directed.

Sample collection for NFSCP verification

When sampling task is placed on the task calendar, conduct sampling activities as

appropriate. Inspection program personnel may perform inspector generated non-food

safety sampling activities when, during the performance of food safety verification

activities, they observe conditions or activities that cause them to suspect that the

establishment is not meeting non-food safety regulatory requirements and testing is the

only means available to determine noncompliance. For example, finished product in

which IPP cannot verify formulation and composition without laboratory testing.

Whenever you believe an inspector generated sample is warranted, notify the FLS by email explaining why you believe an inspector generated sample is warranted and receive

his or her approval before proceeding.

When inspection program personnel perform any sampling they are to inform the

establishment management when they are taking a sample and the reason why FSIS is

analyzing the sample. This notification will afford establishment management the option

to hold all product represented by the sample, pending the sample results.

Sampling tasks are documented in the Lab Sampling part of PHIS when n a non-food

safety sample is collected. However, if the sample result indicates that the product does

not comply with the regulations, the IPP document a Noncompliance Record (NR) under

the appropriate HACCP verification task.

Note: The Office of Public Health and Science (OPHS) directs food safety sampling.

When directed by OPHS to perform food safety sampling, IPP should document the

collection of the samples as a directed procedure in PHIS.

Please note that IPP will no longer receive the Species Identification Field Test (SIFT)

kits to conduct in-plant tests to determine whether product contains a species that is not

accurately declared on the product label. When IPP have concerns about the species in

a product, they are to collect the sample as follow.

• When IPP collect samples for species testing, they are to collect at least one pound

of product and put in a plastic bag supplied by the laboratory. If the product is in a

Entry Training for PHV 12
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

406

natural casing, IPP are to collect a sample of the emulsion. Thereafter, IPP are to

complete FSIS form 10,000-2 (form may be requested from Field Supply Center in

Beltsville, MD) as follows:

— Block 7 -- establishment number

— Block 13 -- date sampled

— Block 14 -- date mailed

— Block 21 -- check ‘species identification’ box

— Block 24 -- provide production lot sample and declared species

— Block 25 -- inspector name (type or print)

— Block 26 -- badge number

• IPP are to attach product label showing an ingredient statement to the 10,000-2

Form. Also, they are to:

— follow FSIS Directive 7355.1, Revision 2, “Use of Sample Seals for Laboratory

Samples and Other Applications”;

— ship the samples to the Eastern Laboratory in an insulated shipping container;

— use sufficient frozen gel packs to keep the sample cold, and

— ship via overnight contact carrier, Monday thru Friday. For samples shipped

on Fridays, be sure to mark Saturday delivery on package and include a

Saturday delivery sticker on the box.

• The results will be on the LEARN intranet site (see FSIS Directive 10,200.1) for

receipt information and sample results. The laboratory will test the product against a

panel of species anti-sera, report species results that correlate with the ingredient

statement as “Acceptable”, and report species result that indicate a species not

declared on the ingredient statement is present, or one of the species on the ingredient

statement is not present as “Not Acceptable”.

Enforcement

Product compliance determinations are made based on NFSCP regulatory requirements

(see Attachment 1 in Directive 7000.1), 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 NFSCP regulatory requirements,

there is regulatory noncompliance. As mentioned before, determinations of

noncompliance should be based on production lots or process controls rather than on

individual units of product. Use professional judgment and consult with your FLS for

assistance when necessary.

Issue an NR when product is not in compliance with NFSCP regulatory requirement, and

orally notify the establishment management of the finding. Consider any relevant factors

when determining the amount of noncompliant product involved. Factors to be considered

include factual information such as the establishment’s lot identification procedures,

receiving records, and production records, as well as those facts that can be reasonably

ascertained based on the average amount of product produced per shift or per production

line. When necessary, consult with the FLS for assistance in determining the extent of

product involvement.

Entry Training for PHV 13
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

407

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 (e.g., under-weight product, the product

does not meet requirements that are specified in the applicable standard of identity for

the product, etc.), would otherwise enter commerce (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.

Inspection program personnel are to issue NRs when they determine the process are out

of control, resulting in economically adulterated or misbranded product. Inspection

program personnel should link the NRs when noncompliances are from the same cause,

as described in FSIS Directive 5000.1and are to notify the District Office (DO) through

supervisory channels when establishment management is unwilling to meet regulatory

requirements.

The DO may notify the establishment in writing that the repeat noncompliances may lead

to a regulatory control action (9 CFR 500.1-3) that would affect the entire production of

the product in question because product may be economically adulterated or misbranded.

Whenever a regulatory control action is taken, such action will remain in place until the

DO receives written assurances from the establishment indicating what procedures the

establishment has instituted to regain and maintain process control to meet regulatory

requirements. The DO will make a determination whether those procedures appear to

correct the problem. Additionally, to determine the effectiveness

of the actions, IPP will verify that the establishment’s corrective actions are adequate

and are operating as described in the establishment’s response.

The DO should notify the Regional Manager of the Compliance and Investigations

Division whenever there is a reason to believe that non-food safety noncompliances

involve the shipment of economically adulterated or misbranded product or criminal

intent to defraud the consumer.

SPECIFIC NFSCP PROCEDURES

Now, let’s walk through each of the NFSCP procedures.

% Yield/Shrink/Gain

When performing this task, you’ll verify the requirements associated with percent

yield/shrink/gain.

Examples of products: bacon, BBQ meats, roasts beef, corned beef, cured beef tongue,

country ham, etc.

Regulations: 319.80; 319.81; 319.100; 319.101; 319.102; 319.103; 319.106; 319.107;

424.21 (c)

Directive: 7620.3

Entry Training for PHV 14
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

408

When performing the task, select an appropriate product and verify compliance with

regulatory requirements by reviewing establishment records and labels, calculating the

% yield or shrink, and comparing the result with the appropriate regulatory requirement.

You may also verify compliance by weighing a sample of product before and after the

appropriate step in the process (i.e., pumping, cooking, chilling, curing, drying, etc.),

calculating the % yield, shrink or gain, and comparing the result with the appropriate

regulatory requirement.

X% Solution Labeled Products (applies only to X% labeled products)

You will verify the requirements associated with X percent solution for labeled products.

This task relates to the regulations regarding false or misleading labeling or practices,

because you are verifying that the percent of a solution added to a product does not

exceed the regulatory requirements.

Examples of products: cured pork products, ham patties, chopped ham, ready-to-cook

poultry products, turkey ham, corned beef, beef brisket, etc.

Regulations: 317.2 (c); 317.8; 381.129, 381.169

319.104, and 319.105 (in these regulations, the sections that apply are

those covering X% label products)

Directive: 7620.3 FSIS

Issuances:

Policy Memos 57A, “Labeling Turkey Ham Products Containing Added Substances”

Policy Memos 42, “Labeling of Raw Bone-in Poultry Products Containing Solutions”

Policy Memos 44A, “Labeling of Raw Boneless Poultry Products Containing Solutions”

Policy Memos 66C, “Uncooked Red Meat Products Containing Added Substances” Policy

Memos 84A, “Cooked Red Meat Products Containing Added Substances”

When performing this task, select an appropriate product and verify compliance with X%

labeling requirements by reviewing establishment records and labels, calculating the %

added solution and comparing the results with the X% labeling declaration. You may also

verify compliance by weighing a sample of product before and after the appropriate step

in the process (i.e., pumping, curing, drying, etc.), calculating the % added solution, and

comparing the result with the X% labeling declaration.

MSP/MSKP/PDBFT/PDPFT/AMR products

You will verify one of the requirements depending on the type of product that is being

produced: Mechanically Separated Pork (MSP), Mechanically Separated Kind of Poultry

(MSKP), Partially Defatted Beef Fatty Tissue (PDBFT), and Partially Defatted Pork Fatty

Tissue (PDPFT), and Advanced Meat Recovery (AMR) products.

Regulations: 319.5; 319.15; 319.29; 318.24; 381.173

Directives: 7160.1; 7160.2; 7160.3,

Entry Training for PHV 15
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

409

When performing this task, select an appropriate product and verify compliance by

reviewing establishment records and labels, or by observing the preparation of products,

and comparing the findings to the standards listed in the regulations. Also, take samples

as directed.

To verify compliance:

• check product identification, condition, temperature, holding time/temperature;

• examine bones (for example, two intact portions of bones) before and after the

meat recovery systems in order to observe condition and conformation;

• review establishment laboratory results and compare findings with the

appropriate regulatory standard, and collect samples as directed.

Batter/Breading

You will verify the requirements associated with batter and breading.

Examples of products: breaded products, breaded patties, breaded meat cuts, fritters

Regulations: 319.880; 381.166

Directives: 7220.1; 7620.3

Resources and Examples: CD Center’s for Learning “OCP Directive 7000.1; Calculation Aid

“Tool” in FSIS Applications

Here’s what you should do when performing this task. Select an appropriate product and

verify compliance with the batter and breading regulatory requirements by reviewing

establishment records to calculate final % batter/breading and comparing the findings to

the standards listed in the regulations. You may also verify compliance by performing

batter and breading pickup tests on one or more subgroups (according to the

establishment’s QC programs) or batches of the product.

Product Standards

You will verify the requirements for product standards.

Examples of products: miscellaneous beef products, sausage, frankfurters, luncheon

meats, chili con carne, meat stews, tamales, and others (see Directive 7000.1)

Regulations: 319.15; 319.140-145; 319.160; 319.180-182; 319.260-261; 319.280-281;

319.300-313; 319.500; 319.700-703; 319.720-721; 319.760-762; 319.881;

381.156-168; 381.170-171.

Directives: 7220.1, Rev. 3; 7620.3

When performing this task select an appropriate product and verify compliance by

reviewing establishment records and labels, or observing the preparation of products

and comparing the findings to the appropriate regulatory standards. To verify some

regulatory requirements, calculations will need to be performed to determine specified

components, such as % fat, or % water.

Entry Training for PHV 16
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

410

Grade Labeling/Declared Count/Vignette

You will verify the requirements related to false or misleading labeling or practices,

including specific prohibitions and requirements for labels and containers, and wording

on labels of immediate containers.

Examples of products: All types of products Regulations:

317.2; 317.8; 381.116

Directives: 6810.1;

Resources and Example Task Verification: CD Center’s Learning .....

When performing this task, select product and verify that the labeling is used on

appropriate product and that there is a label approval on file. Remember that products

for which there is a standard of identity can use generically approved labels.

Net weights

You will verify the requirements related to net weights whether the containers are catch

weight or bear a stated net content.

Examples of products: All types of products that carry a net weight statement.

Regulations: 317.18-22; 381.121 (a-e)

References: NBS Handbook 133

NIST Handbook 44

Note: FSIS has determined that both handbooks mentioned above should

be used as the definitive references for determinations of net weight

compliance.

When performing this task, select an appropriate retail-sized packaged product and

verify net weight regulatory requirements by reviewing establishment records and

conducting net weight/drained weight checks, scale calibration checks (certification and

accuracy), and calculating average tare weights. For QC inspection verification, follow

the QC program requirements after first evaluating the program to ensure that following

the program results in compliance with net weight regulatory requirements.

General labeling

This task applies to all products that bear a label. For example, it includes verifying the

requirements related to standards of identity.

Example of products: All products

Regulations: 316; 317; 318; 319; 327.10(d); 327.26; 381; 412; 424.21; 441.10

Directives: 6700.1; 7120.1; 7235.1; 7270.1; 7620.3

Entry Training for PHV 17
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

411

When performing this task, select an appropriate product and verify that the label

contains all required information. This includes the ingredients statement is 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), restricted ingredients are used as per regulatory requirements, the label is

used on appropriate product, and that there is a label approval on file. When verifying

restricted ingredient requirements or ingredients statement compliance, observe the

establishment formulating product and compare to the approved label.

NOTE: Proteinaceous substances can cause adverse reactions (i.e., allergic and nonallergic) in certain individuals, and therefore, such substances are of a food safety

concern if not clearly declared in the ingredients statement.

When verifying imported products verify that the establishment meets the regulatory

requirements for pre-stamping.

Livestock Product Examination

The Livestock Product Examination task applies to carcasses, boneless meat, returned

products, product reconditioning, reinspection, retention, and disposal of meat products

at official establishments; and to requirements concerning procedures, ingredients, and

other articles used in preparation of products.

Examples of products: boneless meat, meat carcasses, pork skins for popping

Regulations: 318.2; 318.5; 318.6

When performing this task, select an appropriate product/procedure and verify these

regulatory requirements by reviewing establishment records and/or observe

establishment performance of activities. You may perform direct examination of the

product, if warranted, to verify that the product is not economically adulterated or

misbranded (318.2b).

Poultry Product Examination

This task covers finished product standards, rework/reprocess/salvage products, poultry

carcasses, poultry products and other articles entering or at official establishments,

examination and other requirements, returned products, and good commercial practices

for poultry slaughter.

Regulations: 381.1; 381.76; 381.78; 381.84; 381.86; 381.91(b); 381.145; 381.65 (b)

When performing this task, verify compliance by performing:

- pre-chill FPS tests;

- post-chill FPS tests:

- reinspection of carcasses and giblet;

- inspection of returned products;

- inspection of rework products; and

- condition of products in the establishment.

- observation of slaughter practices

Entry Training for PHV 18
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

412

Misbranding/Economic Adulteration Sampling, Directed and Inspector GeneratedSampling

This task covers misbranding and economic adulteration sampling. It can be directed or

inspector generated.

Examples of products: cooked sausage, Italian sausage, ground beef, hamburger,

ground pork, pH controlled product, lard, and others

Regulations: 301.2; 318.9; 318.22; 318.24; 319; 319.5; 381.1; 381 Subpart P; 381.146;

381.173; 500.3

When performing this task, randomly select an appropriate product for verification. Verify

compliance by collecting, processing and mailing samples to the designated laboratory

as directed in PHIS, or when there is a reason to believe that product does not comply

with regulatory requirements. Request permission to sample suspect product from the

FLS and notify the establishment of the sampling.

Entry Training for PHV 19
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

413

FSIS Directive 7000.1 -Verification of NFSCP Regulatory Requirements ―

Workshop

A. Choose the best answer:

1. Which of the following represents the definition of the term “misbranded” in the

Statutes?

a. A product with labeling that is false or misleading.

b. A product with a label that does not show the name and place of business

that produced the product.

c. A product that is subject to standards of identity but was not produced to

follow those standards.

d. All of the above.

2. Which of the following is NOT true about labeling approval?

a. Sketch labels must show the size, location, and final color of the label.

b. Temporary approval of labels may be granted.

c. A single ingredient product with no special claims must have label approval.

d. Some labels have generic approval.

3. If when performing an NFSCP procedure you uncover concerns related to an

establishment’s Sanitation SOP or HACCP plan, you should:

a. Perform a directed economic wholesomeness/labeling task.

b. Perform a directed food safety task.

c. Perform an inspector generated sampling task.

d. Contact the Policy Development Staff.

4. NFSCP duties cover which one of the following?

a. HACCP verification

b. economic adulteration

c. Sanitation SOP verification

d. food safety sampling

5. Which of the following represents what you should do when performing the

economic wholesomeness tasks?

a. Observe establishment product formulation, labeling, packaging, preparation,

and processing procedures.

b. Examine product and review establishment records.

c. Check product identification, condition and temperature.

d. Perform a variety of in-plant measurements, testing and calculations.

e. All of the above.

Entry Training for PHV 20
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

Entry Training for PHV 21

414

6. When observing product formulation, you should do all of the following except:

a. Verify product formulation and compliance with permitted amounts of

restricted ingredients.

b. Verify all ingredients used in formulating the product are listed on the label in

ascending order of predominance and any proteinaceous substances used in

the formulation are declared in the ingredient statement.

c. Verify compliance with standards of identity and composition regulatory

requirements.

d. Observe establishment activities and review establishment records.

7. Is the following statement TRUE or FALSE?

When verifying NFSCP requirements for labeling, you should determine

whether labeling is approved in accordance with appropriate regulations, i.e.,

either approved as a sketch by the FSIS LPDS, or generically approved in

accordance with 9 CFR 412.2.

a. TRUE

b. FALSE

8. Which one of the following should you do when establishment processing

controls appear to be effective?

a. Count defects.

b. Direct your attention to establishment records.

c. Direct your attention to areas in the process not covered by establishment

controls.

d. Review product formulation.

9. Is the following statement TRUE or FALSE?

It is appropriate to perform unscheduled NFSCP verification procedures when

you suspect regulatory requirements are not being met?

a. TRUE

b. FALSE

10. Is the following statement TRUE or FALSE?

It is not appropriate to perform inspector generated sampling unless you suspect

regulatory requirements are not being met.

a. TRUE

b. FALSE
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

Entry Training for PHV 22

415

11. Which of the following must be done first if you believe collecting an inspector

generated sample is warranted?

a. Notify the FLS by e-mail explaining why the sample is warranted.

b. Inform the DO before you take the sample.

c. Inform establishment management before you take the sample.

d. Inform establishment management of the type of analysis that will be done on

the sample.

e. All of the above.

12. Is the following statement TRUE or FALSE?

Make determinations of noncompliance on individual units of product.

a. TRUE

b. FALSE

13. What should you do when noncompliance with an NFSCP requirement is found?

a. Issue an NR.

b. Notify the establishment orally of the finding.

c. Determine the amount of noncompliant product involved.

d. Take appropriate regulatory control actions if without such action a

misbranded or economically adulterated product would be shipped from the

establishment.

e. All of the above.

14. When noncompliance is found which of the following must be considered in

determining the amount of noncompliant product involved in the noncompliance?

a. The establishment’s number of employees.

b. Sampling records.

c. Production records.

d. None of the above.

15. All of the following are appropriate regulatory control actions to take if it appears

that a product that is economically adulterated or misbranded will be shipped

from the establishment except:

a. Retention of product.

b. Rejection of equipment or facilities.

c. Stopping lines.

d. Refusing to allow the processing of specifically identified product.

e. Refusing to allow the establishment manager to leave the establishment.
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

Entry Training for PHV 23

415

16. What should you do when there are repeated violations involving the same

process and product and the establishment seems unable or unwilling to

maintain regulatory compliance?

a. Associate the NRs.

b. Notify the DO through supervisory channels.

c. If a regulatory control action is taken, maintain that action in place until the

DO receives written assurances from the establishment indicating what

procedures the establishment has instituted to regain and maintain process

control to meet regulatory requirements.

d. Conduct any follow up verification activities as directed by the DO to ensure

compliance.

e. All of the above.

17. When performing the %Yield/Shrink/Gain task to verify compliance with

regulatory requirements, you should do all of the following except:

a. Select an employee to accompany you.

b. Select an appropriate product.

c. Review establishment records and labels.

d. Calculate % yield, gain, or shrink and compare result with regulatory

compliance.

e. Be familiar with the regulatory requirements.

18. Is the following statement TRUE or FALSE?

For %Yield/Shrink/Gain you may also verify compliance by weighing a sample of

product before and after the appropriate step in the process (pumping, cooking,

chilling, curing, drying, etc.), calculating the % yield, gain, or shrink, and

comparing the result with the appropriate regulatory requirement.

a. TRUE

b. FALSE

19. What should you do when performing the X% Solution Labeled Products tak to

verify compliance with regulatory requirements?

a. Select an appropriate product for verification.

b. Review establishment records and labels, calculating the % added solution

and comparing the results with the X% labeling declaration.

c. Weigh a sample of product before and after the appropriate step in the

process (pumping, curing, drying, etc.), calculating the % added solution, and

comparing the result with the X% labeling declaration.

d. All of the above.
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

Entry Training for PHV 24

415

20. What should you do when performing the MSP/MSKP/PDBFT/PDPFT/AMR task

to verify compliance with regulatory requirements?

a. Call the DO prior to performing verification.

b. Review establishment safety records.

c. Observe the preparation of products and, compare the findings to the

standards listed in the regulations.

d. None of the above.

21. When directed to take samples while performing the

MSP/MSKP/PDBFT/PDPFT/AMR task, you should do all of the following except:

a. check product identification, condition, temperature, holding time/temperature

b. compare your finding with the closest establishment

c. review establishment laboratory results and compare findings with the

appropriate regulatory standard

d. examine bones (for example two intact portions of bones) before and after

the meat recovery system to observe condition and conformation

22. Is the following statement TRUE or FALSE?

When performing the Batter/Breading task to verify compliance with regulatory

requirements, it is not appropriate to perform batter and breading.

a. TRUE

b. FALSE

23. What should you do when performing the Product Standards task to verify

compliance with regulatory requirements?

a. Select an appropriate product for verification.

b. Review establishment records and labels, or observe the preparation of

products and compare the findings to the appropriate regulatory standards.

c. For some regulatory requirements, perform calculations to determine

specified components, such as % fat, or % water.

d. All of the above.

24. What should you do when performing the Grade Labeling task to verify

compliance with regulatory requirements?

a. Verify that labeling is used on appropriate product

b. Contact your supervisor prior to performing verification

c. Verify that there is a label approval on file at the PDS

d. Review all NRs
FSIS as a Public Health Regulatory Agency: NFSCP

5-10-2016

Entry Training for PHV 25

415

25. What should you do when performing the Net Weights task to verify compliance

with regulatory requirements

a. Select an appropriate wholesale-sized product for verification.

b. Review establishment records and conduct net weight/drained weight checks,

scale certification and accuracy, or calculate average tare weight checks.

c. For QC inspection verification, follow HACCP requirements.

d. None of the above.

26. When performing the General Labeling task to verify compliance with regulatory

requirements, you should do all of the following except:

a. Verify that the label contains all required information.

b. Verify that restricted ingredients are used as per regulatory requirements by

observing the establishment formulating product and comparing it to the

approved label.

c. Verify that there is a label approval on file.

d. Verify that the label has been used at least twice

27. What should you do when performing the Livestock Product Examination task to

verify compliance with regulatory requirements?

a. Select an appropriate product for verification.

b. Review establishment records and/or observe establishment performance of

activities.

c. You may perform direct examination of the product.

d. All of the above.

28. What should you do when performing the Poultry Products Examination task to

verify compliance with regulatory requirements

a. only perform pre-chill and post-chill FPS testing

b. perform reinspection of carcasses, giblets, and spleens

c. return reworked product

d. observes poultry slaughter practices.
419

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

WASHINGTON, DC

FSIS DIRECTIVE 7000.1 12/11/06

NOTE: DO NOT IMPLEMENT THIS DIRECTIVE UNTIL FEBRUARY 20, 2007

VERIFICATION OF NON-FOOD SAFETY CONSUMER PROTECTION

REGULATORY REQUIREMENTS

I. PURPOSE

This directive instructs inspection program personnel on how to verify that plants

comply with regulatory requirements designed to protect the consumer in ways other

than ensuring food safety. It also issues new Inspection System Procedures (ISP)

descriptions for all 04 and 05B procedures, except 04C02, Humane Handling. FSIS is

retiring procedure code 04C01, and therefore, inspection program personnel are not to

use it. Inspection program personnel are to follow FSIS Directive 6900.1, Revision 1

and 6900.2, Revision 1 when verifying humane handling requirements.

Key Points Covered

Verification activities performed by inspection program personnel are to be

predominantly food safety focused, but it is also necessary to verify compliance with

requirements that provide non-food safety protections to consumers.

Methodology and documentation for verifying that there is compliance with these

non-food safety requirements.

ll. CANCELLATIONS

FSIS Directive 5400.5, Attachment 6, “Inspection System Procedure Guide,” pages 4-1

through 4-10, 5-3 and 5-4

FSIS Directive 7110.2, Revision 1, “Update of Protein Fat Free (PFF) Instructions”

FSIS Directive 7130.3, “Inspection Procedure for Fat and Added Water in Cooked

Sausage”

FSIS Directive 7140.2, “Determining Added Water in Cooked Sausage”

FSIS Directive 7140.3, “Determining Added Water in Fresh Sausage”

FSIS Directive 7236.2, “Nutrition Labeling of Meat and Poultry Products”

FSIS Directive 7240.1, “Compliance Testing for Net Weight Labeling of Meat and Poultry

Products”

FSIS Directive 7310.6, “Bacon Yield Determinations”

DISTRIBUTION: Inspection Offices;

T/A Inspectors; TSC; Import Offices

OPI: OPPED
2

420

FSIS Directive 7330.1, “Sampling Frequencies for Cooked Sausage Produced Under a

Quality Control Program”

FSIS Directive 10,230.1, “Species Identification Sampling for Cooked Products”

MPI Manual Part 11-D and Part 18

MPI Bulletins 75-56, 78-111, 79-42, 80-4, and 83-54

Any Regional Notices, MPI Bulletins or other written instructions related to reinspection

of livestock product for reasons other than public health and food safety.

Ill. [RESERVED]

IV. REFERENCES

Federal Meat Inspection Act (FMIA)

Poultry Products Inspection Act (PPIA)

9 CFR Parts 301, 313, 316, 317, 318, 319, 327, 381 Subpart P, 424, 441, and 500

FSIS Directive 5000.1, Revision 3, “Verifying An Establishment’s Food Safety System”

FSIS Directive 5400.5, Attachment 5, “Inspection System Activities”

FSIS Directive 6120.1, “Finished Product Standards Program for the New Line Speed

Inspection System and the Streamlined Inspection System”

FSIS Directive 6700.1, "Retained Water in Raw Meat and Poultry Products"

FSIS Directive 6810.1, “Grademark Labeling on Meat and Poultry Products”

FSIS Directive 6900.1, Revision 1, “Humane Handling of Disabled Livestock”

FSIS Directive 6900.2, Revision 1, “Humane Handling and Slaughter of Livestock”

FSIS Directive 7000.2, “Experimental and Sample Products Policy”

FSIS Directive 7120.1, “Safe and Suitable Ingredients Used in the Production of Meat

and Poultry Products”

FSIS Directive 7124.1, “Standards of Identity or Composition—Use of Cooked or Cured

Product”

FSIS Directive 7140.1, “Questions and Answers Relating to Ingredients That May Be

Designated as Flavors, Flavorings, Natural Flavors or Natural Flavorings in the

Ingredients Statements on the Labels of Meat and Poultry Products”

FSIS Directive 7160.1, “Meat Produced by Advanced Meat/Bone Separation Machinery

and Meat Recovery Systems”

FSIS Directive 7160.2, “’Meat’ Prepared Using Advanced Mechanical Meat/Bone

Separation Machinery and Meat Recovery Systems”

FSIS Directive 7160.3, Revision 1, “Advanced Meat Recovery Using Beef Vertebral

Raw Materials”

FSIS Directive 7220.1, “Policy Memoranda”

FSIS Directive 7221.1, Amendment 1, “Prior Labeling Approval”

FSIS Directive 7222.1, “Inspection Requirements for Food and Nutrition Service In-plant

Control Programs”

FSIS Directive 7235.1, “Mandatory Safe Handling Statements on Labeling of Raw and

Partially Cooked Meat and Poultry Products”

FSIS Directive 7237.1, Revision 1, Amendment 1, “Labeling of Ingredients”

FSIS Directive 7270.1, Revision 1, “Sampling and Testing Procedures for Raw Poultry

Products Labeled ‘Fresh’”

FSIS Directive 7355.1, Revision 2, “Use of Sample Seals for Laboratory Samples and

Other Applications”

FSIS Directive 7620.3, “Processing Inspectors’ Calculations Handbook”
3

421

FSIS Directive 8080.1, Revision 4, Amendment 1, “Recall of Meat and Poultry Products”

FSIS Directive 10,200.1, “Accessing Laboratory Sample Information via LEARN”

FSIS Directive 10,210.1, “Unified Sampling Form”

FSIS Directive 10,520.1, Revision 1, “Pumped Bacon Sampling Program – Nitrosamine

Analysis”

Part 3, Section 3, “Import Inspection Manual of Procedures for the Species Verification

Testing Program”

Policy Memos 42, 44A, 57A, 66C, and 84A

NBS Handbook 133

NIST Handbook 44

V. BACKGROUND

FSIS’ highest priorities are protecting public health and food safety. By making the

procedural changes announced in this directive, the Agency is ensuring that inspection

program personnel focus on food safety, yet still verify other protections extended by

the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).

The Agency is making changes in the verification procedures that relate to these other

protections to ensure that they align with FSIS’ responsibilities and priorities.

VI. VERIFICATION METHODOLOGY FOR NON-FOOD SAFETY ISP CODES (ALL

04A AND 04B CODES AND 04C03 and 04C04 CODES)

A. When the Performance Based Inspection System (PBIS) schedules one of

these non-food safety procedures per one of the above codes, inspection program

personnel are to perform the appropriate verification procedure. This includes

observing establishment product formulation, verifying the accuracy of labeling,

observing preparation or processing procedures; reviewing establishment records;

examining product; checking product identification, condition and temperature; or

performing a variety of other in-plant measurements, testing, and calculations.

B. Inspection program personnel are not to perform unscheduled non-food

safety consumer protection verification procedures unless, during the performance of

food safety verification activities, they observe conditions or activities that cause them to

suspect that the establishment is not meeting non-food safety regulatory requirements.

Conversely, if while performing a scheduled non-food safety consumer protection

verification procedure inspection program personnel identify food safety concerns, they

should perform the food safety procedure as an unscheduled procedure and take any

necessary enforcement actions. For example, if an inspector is performing a routine

labeling verification procedure and discovers that the establishment has used an

ingredient of public health concern without properly declaring the ingredient, the

inspector should pursue the food safety aspects of the findings and perform the

appropriate unscheduled food safety procedures as instructed in FSIS Directive 5000.1,

Revision 3.
4

422

C. Attachment 1 to this directive reissues and replaces all of the 04 and 05B codes

from FSIS Directive 5400.5, Attachment 5. When verifying compliance with a non-food

safety requirement, inspection program personnel are to use attachment 1 to find:

1. Procedure code (column 1)

2. Examples of products (column 2)

3. Regulatory references (column 3)

4. FSIS issuance references (column 4)

5. Verification instructions (column 5)

NOTE: Lists of example products, regulatory references, FSIS issuances, and

verification instructions provide guidance. They are not “all inclusive” lists.

D. Inspection personnel need only examine product when they have reason to

believe that product does not meet regulatory requirements. However, there are no

designated sampling plans or sample sizes that inspection program personnel are to

use when examining products to assure that the products meet non-food safety

regulatory requirements, nor are inspection program personnel to examine all products.

Inspection program personnel examine product to determine whether the product

complies with regulatory requirements (see Attachment 1), such as product standards,

net weight standards, regulatory minimum or maximum limits of ingredients or

components, or product defects. If inspection program personnel find that product

exceeds any of the maximum limits, falls below the minimum requirements, or fails to

meet any of the other non-food safety regulatory requirements, there is regulatory

noncompliance. Inspection program personnel are to determine whether product

complies with the regulations based on production lots or process controls rather than

on individual units of product. For example, if one package of product exceeds its net

weight, inspection program personnel are to investigate whether there have been

problems in the process that will cause all packages to exceed the net weight

requirements.

E. Verification Activities Under 04A and 04B (Formulation and Labeling)

1. Inspection program personnel are to verify that the establishment is

producing product in compliance with the appropriate Title 9 Code of Federal

Regulations (CFR) reference (see Attachment 1).

2. Inspection program personnel are to determine whether the product

complies with the regulations by comparing the product to the relevant regulatory

requirements and determining whether:

a. the product meets requirements that are specified in the applicable

standards of identity;

b. the net weight of the product is accurately reflected on its label;

c. all ingredients have been added in amounts that come within the

maximum or minimum level specified in the applicable standard;
5

5

d. ingredients are accurately declared on the product label in descending

order of predominance; and

e. the product defect levels are consistent with applicable standards.

NOTE: When import inspectors perform inspections at official import inspection

establishments, the establishment may place the official inspection legend on

containers of imported product before inspectors complete their inspections. (9 CFR

327.10 (d)).

F. Verification Activities Under 04C03 (Livestock Product Examination)

1. Under 04C03, inspection program personnel are to verify that the

establishment complies with 9 CFR 318.2, 318.5, and 318.6. Inspection program

personnel are no longer to perform activities known as livestock carcass re-inspection,

boneless meat re-inspection, and other product re-inspection duties to verify compliance

with the relevant regulations. Instead, inspection program personnel should be able to

determine the extent of the procedures needed based on conditions observed in the

establishment. Where effective establishment processing controls are evident, (i.e., the

establishment has procedures in place to examine incoming product for acceptability,

uses control programs to monitor product processing, and such controls and procedures

are documented), inspection program personnel will limit non-food safety verification

activities. Inspection program personnel will, in these cases, direct their inspection to

those parts of the processing operation that the establishment does not cover by control

procedures. Inspection program personnel need not count individual defects to make a

judgment on a finished production lot. Inspection program personnel need to base

determinations of product compliance by making determinations regarding product

usability. The products should not pass inspection if defects are severe or numerous

enough to affect the usability of the product. The condition of product should be clearly

evident and sufficient to allow inspection personnel to determine that the product is in

compliance. The purpose of product examination that inspection program personnel are

to perform is to determine whether standards are being met. Determinations of

acceptability should be based on production lots and process controls rather than on

individual units of product. Inspection program personnel should consult with their

Frontline Supervisor for assistance when necessary.

Examples of noncompliance situations include:

a. inspection program personnel find that a carcass in the cooler has a

large and heavy blood clot that would increase the weight of carcass in such a way to

reduce its quality, and the establishment has failed to address the situation.

NOTE: The blood clot is an example of an “inferiority that has been concealed”

because it could not be seen until the carcass chilled.

b. inspection program personnel find that after the boning process, the

boneless product does not represent “boneless meat” because of the number of bone

fragments, and the establishment has failed to address the situation.
6

6

2. Inspection program personnel may also observe establishment’s quality

control programs and review associated records to verify whether the establishment

meets regulatory requirements.

3. When necessary, inspection program personnel are to consult with their

Frontline Supervisor for assistance in determining noncompliance. The Technical

Service Center (TSC) will provide additional guidance to assist with determining

noncompliance.

G. Verification Activities Under 04C04 (Poultry Product Examination)

1. Under the 04C04 procedure, inspection program personnel are to verify

that the establishment complies with the relevant regulations for poultry finished product

standards, Giblet Acceptable Quality Levels, and rework product standards. Inspection

program personnel inspect raw or unprocessed poultry products and return of

questionable poultry products under the 04C04 procedure.

2. In addition, the 04C04 procedure is used to verify conformance with good

commercial practices for poultry slaughter that comply with 9 CFR 381.65 (b), (i.e.,

thorough bleeding of the carcasses, ensuring that breathing has stopped prior to

scalding, and that blood from the killing operation is confined to a relatively small area).

3. Inspection program personnel verifying compliance with finished product

standards (FPS) are to use the criteria as listed in the regulations (see Attachment 1).

Inspection program personnel should verify compliance by performing pre-chill FPS

testing, post-chill FPS testing, reinspection of carcasses and giblets, inspection of

returned products, inspection of rework products, and condition inspection of products in

the establishment. Inspection program personnel are to perform the activities at the

frequencies prescribed in 9 CFR 381.76. Each time inspection program personnel

perform the finished product standard activities they are to record the activities in PBIS

as unscheduled.

VII. SAMPLE COLLECTION FOR NON-FOOD SAFETY CONSUMER

PROTECTION VERIFICATION (05B01)

A. PBIS will schedule non-food safety sampling under ISP code 05B01 (see

Attachment 1). Inspection program personnel may perform unscheduled non-food

safety sampling activities when, during the performance of food safety or non-food

safety verification activities, they observe conditions or activities that cause them to

suspect that the establishment is not meeting non-food safety regulatory requirements

and testing is the only means available to determine noncompliance, e.g., finished

product in which inspection program personnel cannot verify formulation and

composition without laboratory testing.

NOTE: Inspection program personnel will no longer receive the Species Identification

Field Test (SIFT) kits to conduct in-plant tests to determine whether a product contains

a species that is not accurately declared on the product label. When inspection

program personnel have concerns about the species in a product, they are to collect the

sample as described in Attachment 2. Import inspection personnel should follow the
7

7

instructions provided in the Import Inspection Manual of Procedures for the Species

Verification Testing Program.

B. When inspection program personnel perform any sampling, they are to

inform the establishment management when they are taking a sample and the reason

why FSIS is analyzing the sample. This notification will afford establishment

management the option to hold all product represented by the sample pending the

sample results.

C. Code 05B01 is the procedure code inspection program personnel should

enter on the schedule when they collect a non-food safety sample. However, if the

sample result indicates that the product does not comply with the regulations, inspection

program personnel document a Noncompliance Record (NR) (FSIS Form 5400-4) under

the appropriate ISP code, not 05B01.

NOTE: The Office of Public Health Science (OPHS) directs food safety sampling. When

directed by OPHS to perform food safety sampling, inspection program personnel

should document the collection of the samples as an unscheduled procedure under

code 05B02.

VIII. ENFORCEMENT

A. Inspection program personnel are to issue an NR when a product does not

comply with a non-food safety regulatory requirement and are to notify the

establishment orally of the finding. Inspection program personnel are to consider all

relevant factors when determining the amount of noncompliant product that is involved.

Factors inspection program personnel should consider include facts such as the

establishment’s lot identification procedures, receiving records, and production records,

as well as those facts that can reasonably be ascertained based on the average amount

of product produced per shift or per production line. When necessary, inspection

program personnel will consult with their Frontline Supervisor for assistance in

determining the extent of product involvement.

B. Inspection program personnel are to 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

they determine that misbranded or economically adulterated product, e.g., under-weight

product, the product does not meet requirements that are specified in the applicable

standard of identity for the product, etc., would otherwise enter commerce (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.

C. Inspection program personnel are to issue NRs when they determine the

processes are out of control, resulting in economically adulterated or misbranded

product. Inspection program personnel should link the NRs when noncompliances are

from the same cause, as described in FSIS Directive 5000.1, Revision 3 and are to

notify the District Office (DO) through supervisory channels when plant management is

unwilling or unable to take necessary steps to re-establish control of its process

necessary to meet regulatory requirements.
8

8

D. The DO is to notify the establishment, in writing, that repeated

noncompliances may lead to a regulatory control action (9 CFR 500.1-3) that would

affect the entire production of the product in question because product may be

economically adulterated or misbranded. Whenever inspection program personnel take

such regulatory control action, the action will remain in place until the DO receives

written assurances from the establishment as to what procedures the establishment has

instituted to regain and maintain the control of its process necessary to meet regulatory

requirements. The DO will make a determination whether those procedures appear to

correct the problem. Additionally, to determine the effectiveness of the actions,

inspection program personnel will verify that the establishment’s corrective and

preventive actions are adequate and are operating as described in the establishment’s

response.

E. The DO should notify the Regional Manager of the Compliance and

Investigations Division whenever there is reason to believe that non-food safety

noncompliances involve the shipment of economically adulterated or misbranded

product or criminal intent to defraud the consumer.

Questions are to be directed to the Technical Service Center at 1-800-233-3935.

Assistant Administrator

Office of Policy, Program, and Employee Development

Attachments
9

9

Attachment 1

Procedure Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Code Responsibilities

04A01 Parts Directive 7620.3

“Processing

Inspectors’

Calculations

Handbook”

Chapters 11, 12, &

13; % gain,

%shrink & %yield

Inspection program personnel are

to select an appropriate product

and verify compliance with

regulatory requirements by

reviewing establishment records

and labels, calculating the % yield

or shrink, and comparing the result

with the appropriate regulatory

requirement. In addition,

inspection program personnel are

to verify compliance by weighing a

sample of product before and after

the appropriate step in the process

(i.e., pumping, cooking, chilling,

curing, drying, etc.), calculating

the % yield or shrink, and

comparing the result with the

appropriate regulatory

requirement.

%Yield/Shrink/Gain Bacon 319.107

Barbecued meats 319.80

Roast beef parboiled 319.81

and steam roasted

Corned beef 319.100

Corned beef brisket 319.101

Corned beef round 319.102

and other corned beef

cuts

Cured beef tongue 319.103

Country ham,

Country style ham, 319.106

Dry cured ham,

Country style pork

shoulder, and

Dry cured pork

shoulder

Tenderizing agents 424.21 (c)
10

10

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

04A02 Parts Inspection program personnel

are to select an appropriate

product and verify compliance

with X% labeling requirements

by reviewing establishment

records and labels, calculating

the % added solution and

comparing the results with the

X% labeling declaration. In

addition, inspection program

personnel are to verify

compliance by weighing a

sample of product before and

after the appropriate step in the

process (i.e., pumping, curing,

drying, etc.), calculating the %

added solution, and comparing

the result with the X% labeling

declaration.

X% Solution Cured pork products 319.104*

Labeled Directive 7620.3,

Products* Ham patties, 319.105* “Processing Inspectors’

chopped ham, Calculations Handbook”

*NOTE:

Applies only

to X%

Labeled

Products

pressed ham,

spiced ham and

similar products

*NOTE:

Applies only

to sections of

319.104 and

319.105

covering X%

labeled

products

Chapter 10, “Products

Labeled “X% Water” or

“X% of Weight Is Added

Ingredients”

Policy Memos:

57A, “Labeling Turkey

Ham Products

Containing Added

Substances”

42, “Labeling of Raw

Bone-in Poultry Products

Ready-to-cook poultry Containing Solutions”

products to which

solutions are added 44A, “Labeling of Raw

Boneless Poultry

Turkey ham products Products Containing

containing added water Solutions”

Corned beef, beef brisket,

corned beef round and

381.129 66C, “Uncooked Red

Meat Products

tongue and other beef cuts Containing Added

to which solutions are Substances”

added 381.169

84A, “Cooked Red Meat

False or misleading Products Containing

labeling or Added Substances”

containers 317.2 (c)

Ready-to-cook poultry

products to which

solutions are added

317.8

Labels, definition;

required features

False and misleading

labeling or practices,

generally
11

11

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

04A03 –

MSP/MSKP/

PDBFT/

PDPFT/AMRS

Mechanically separated

pork

Mechanically separated

kind of poultry

Partially defatted beef

fatty tissue

Partially defatted pork

fatty tissue

Advanced meat recovery

products

Parts

319.5

381.173

319.15

319.29

318.24

Directive 7160.1,

“Meat Produced

by Advanced

Meat/Bone

Separation

Machinery and

Meat Recovery

Systems”

Directive 7160.2

“ ‘Meat’ Prepared

Using Advanced

Mechanical

Meat/Bone

Separation

Machinery and

Meat Recovery

Systems”

Directive 7160.3,

Revision 1

“Advanced Meat

Recovery Using

Beef Vertebral

Raw Materials”

Inspection program personnel are

to select an appropriate product and

verify compliance by reviewing

establishment records and labels, or

by observing the preparation of

products, and comparing the

findings to the standards listed in

the regulations. In addition,

inspection program personnel are to

take samples as directed.

To verify compliance, inspection

program personnel should:

-check product identification,

condition, temperature, and holding

time/temperature.

-examine bones (for example, two

intact portions of bones) before and

after the meat recovery systems in

order to observe condition and

conformation.

-review establishment laboratory

results and compare findings with

the appropriate regulatory standard.

-take samples as directed
12

12

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

04A04 –

Batter/Breading Breaded products

Breaded patties

Breaded meat cuts

Breaded poultry cuts

Fritters

Parts

319.880

381.166

Directive 7620.3,

“Processing

Inspectors’

Calculations

Handbook”,

Chapter 14,

“ Miscellaneous

Calculations”

Directive 7220.1

Policy Memo 089

“ Use of the Term

“Breaded” on

Labels for

“Fritters”

Inspection program personnel are

to select an appropriate product,

verify compliance with the batter

and breading regulatory

requirements by reviewing

establishment records to calculate

final % batter/breading, and

comparing the findings to the

standards listed in the regulations.

In addition, inspection program

personnel are to verify compliance

by performing batter and breading

pickup tests on one or more

subgroups (according to the plant’s

QC programs) or batches of the

product.
13

13

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

04B01 Parts Inspection program

Product Miscellaneous beef products 319.15 personnel are to select an

Standards Directive 7620.3, appropriate product and

Sausage 319.140 “Processing verify compliance by

Fresh pork sausage 319.141 Inspectors’ reviewing establishment

Fresh beef sausage 319.142 Calculations records and labels, or

Breakfast sausage 319.143 Handbook” observing the preparation of

Whole hog sausage 319.144 products and comparing the

Italian sausage 319.145 Directive 7220.1, findings to the appropriate

Smoked pork sausage 319.160 “Policy regulatory standards.

Frankfurters and similar products 319.180 Memoranda”

Cheesefurters and similar products 319.181 To verify some regulatory

Braunschweiger, Liver sausage, or requirements, inspectors will

Liverwurst 319.182 need to perform calculations

Luncheon meat to determine specified

Meat loaf 319.260 components, such as % fat, or

Scrapple 319.261 % water.

Brockwurst 319.280

Chili con carne 319.281

Chili con carne w/beans 319.300

Hash 319.301

Corned beef hash 319.302

Meat stews 319.303

Tamales 319.304

Spaghetti with meat balls and 319.305

sauce, spaghetti with meat and 319.306

sauce, and similar products

Spaghetti sauce with meat

Tripe with milk 319.307

Beans with frankfurters in 319.308

sauce, sauerkraut with wieners 319.309

and juice and similar products

Lima beans with ham in sauce, beans

with ham in sauce, beans with bacon 319.310

in sauce, and similar products
14

14

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

04B01 Parts Inspection program personnel

(Continued) Chow mein vegetables with 319.311 are to select an appropriate

meat and chop suey Directive 7620.3, product and verify compliance

vegetables with meat “Processing by reviewing establishment

Pork with barbecue sauce and 319.312 Inspectors’ records and labels, and/or

beef with barbecue sauce Calculations observing the preparation of

Beef with gravy and gravy 319.313 Handbook” products and, comparing the

with beef findings to the appropriate

Meat pies 319.500 Directive 7220.1, regulatory standards.

Margarine or Oleomargarine 319.700 “Policy

Mixed fat shortening 319.701 Memoranda” To verify some regulatory

Lard, leaf lard 319.702 requirements, inspection

Rendered animal fat or 319.703 program personnel will need to

mixture thereof calculate specified components,

Meat extract 319.720 such as % fat, or % water.

Fluid extract of meat 319.721

Deviled ham, deviled tongue 319.760

and similar products

Potted meat food product and 319.761

deviled meat food product

Ham spread, tongue spread and 319.762

similar products

Liver meat food products 319.881

Poultry meat content standards for 381.156

certain poultry products

Canned boned poultry and 381.157

baby or geriatric food

Poultry dinners and pies 381.158

Poultry rolls 381.159

(Kind) burgers; (Kind) patties 381.160

(Kind) A La Kiev 381.161

(Kind) steak or fillet 381.162

(Kind) baked or (Kind) 381.163

roasted

(Kind) barbecued 381.164

(Kind) barbecued prepared 381.165

with moist heat
15

15

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

04B01

(Continued) Other poultry

dishes and

specialty items

Maximum % of

skin in certain

poultry products

Parts

381.167

381.168

Directive 7620.3,

“Processing

Inspectors’

Calculations

Handbook”

Inspection program personnel are

to select an appropriate product and

verify compliance by reviewing

establishment records and labels,

and/or observing the preparation of

products, and comparing the

findings to the appropriate

regulatory standards.

Standards for

kinds and classes,

and for cuts of

raw poultry

381.170

Directive 7220.1,

“Policy

Memoranda”

To verify some regulatory

requirements, inspectors will need

to perform some calculations to

determine specified components,

such as % fat, or % water.

Definition and

standard for

turkey ham

381.171
16

16

Procedure Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Code Responsibilities

04B02

CN/Grade

Labeling/Declared

Count/Vignette

False or

misleading

labeling or

practices generally:

specific

prohibitions and

requirements for

labels and containers

Wording on

labels of

immediate

containers

Parts

317.2

317.8

381.116

Directive 6810.1

“Grademark

Labeling on Meat

and Poultry

Products”

Directive 7222.1

“Inspection

Requirements for

Food and Nutrition

Service In-plant

Control Programs”

Inspection program personnel are

to select product and verify that

the product’s label is correct and a

label approval is on file.
17

17

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References*

Inspection Personnel

Responsibilities

04B03 – Net All products must carry a net Parts NBS Handbook Inspection program

weight weight statement and meet the net 133 personnel are to select an

weight requirements whether the appropriate retail-sized

containers are catch weighed or NIST Handbook product and verify net weight

bear a stated net content. 44 regulatory requirements by

reviewing establishment

Quantity of contents * FSIS has records and conducting net

labeling determined weight/drained weight, scale

Definitions and procedures for 317.18 inspectors are to calibration, or tare weight

determining net weight compliance use NBS checks.

Scale requirements for 317.19 handbook 133 and

accurate weights, repairs, NIST Handbook For QC inspection

adjustments, and replacement after 44 as the verification, inspection

inspection 317.20 definitive program personnel are to

Scales: testing of references for follow the QC program

Handling of failed product determinations of requirements after evaluating

quantity of contents 317.21 net weight the program to ensure that

labeling 317.22 compliance. following the program results

Definitions and procedures 381.121a in compliance with net

for determining net weight weight regulatory

compliance 381.121b requirements.

Scale requirements for

accurate weights, repairs,

adjustments, and replacement after 381.121c

inspection Scales: testing of

Handling of failed product

381.121d

381.121e
18

18

Procedure Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Code Responsibilities

04B04 This procedure is Parts Inspection program personnel are

General Labeling applicable to all products to select an appropriate product

that bear a label. 316 Directive 7620.3, and verify that:

Marking Products “Processing

and their Containers 317 Inspectors’ 1. the label contains all

Labeling, Marking Calculations required information;

Devices, and Containers Handbook”

Entry into Official 318 2. the ingredients statement is

Establishments; Directive 7120.1 accurate, (i.e., that all

Reinspection and 319 “Safe and Suitable ingredients are listed in

Preparation of Ingredients Used in descending order of

Products the Production of predominance);

Meat and Poultry

Limitations with respect 319.6 Products” 3. the label declares any

to use of mechanically- proteinaceous substances*

separated species used in the ingredients

statement;

Pre-stamping of 327.10(d) Directive 6700.1,

imported product 327.26 “Retained Water in 4. the establishment used

Raw Meat and restricted ingredients as per

Definitions and 381 Poultry Products” regulatory requirements;

Standards of Identity

or Composition Directive 7235.1, 5. the label is used on

Subpart N Labeling “Mandatory Safe appropriate product; and

and Containers Handling Statements

on Labeling of Raw 6. a label approval is on file.

Limitations with respect 381.174 and Partially

to use of Mechanically Cooked Meat and Verify the establishment meets

Separated (Kind of Poultry Products” the regulatory requirements for

Poultry) pre-stamping of imported product

Directive 7270.1,

Food Ingredients and 424.21 Revision 1, When verifying restricted

Sources of “Sampling and ingredient requirements or

Radiation Testing Procedures ingredient statement compliance,

for Raw Poultry inspection program personnel are

Consumer Protection 441.10 Products Labeled to observe the establishment

Standards: Raw ’Fresh’” formulating product and compare

Products to the approved label.

* NOTE: Proteinaceous

substances can cause adverse

reactions (i.e., allergic and nonallergic) in certain individuals,

and therefore, such substances are

of a food safety concern if not

clearly declared in the ingredients

statement.
19

19

Procedure Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Code Responsibilities

04C02

Humane Handling

and Slaughter

(Livestock)

The establishment meets

the criteria set forth in

the regulations to ensure

the humane handling and

slaughter of livestock.

The establishment takes

action when either the

establishment or FSIS

determines that the

establishment has not

met the regulatory

requirements.

Parts

313

500.1,

500.2,

500.3

Directive 6900.1,

Revision 1,

“Humane Handling

of Disabled

Livestock”

Directive 6900.2,

Revision 1,

“Humane Handling

and Slaughter of

Livestock”

FR Notice

(September 9, 2004)

systematic approach

Verify compliance with the

following categories:

• adequate measures for

inclement weather

• truck unloading

• water and feed

availability

• handling during antemortem inspection

• handling of suspect and

disabled animals

• electric prod/alternative

object use

• observations for slips

and falls

• stunning effectiveness

• check for conscious

animals on the rail

• check for sensibility
20

20

Procedure Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Code Responsibilities

04C03

Livestock Product

Examination

Boneless meat

Meat carcasses

Pork skins for popping

Returned products

Product reconditioning

Reinspection,

retention, and

disposal of meat

products at official

establishments

Requirements

concerning

procedures

Requirements

concerning

ingredients and

other articles used

in preparation of

products

Parts

318.2

318.5

318.6

Inspection program personnel are

to select an appropriate

product/procedure and verify

these regulatory requirements by

reviewing establishment records

and/or observing plant

performance of activities.

Inspection program personnel

are to examine product to

determine whether it is

economically adulterated or

misbranded (318.2b).
21

21

Procedure Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Code Responsibilities

04C04 Inspection program personnel

are to verify compliance by

performing:

- pre-chill FPS testing

- post-chill FPS testing

- reinspection of carcasses,

giblets

- inspection of returned products

- inspection of rework products

- condition inspection of products

in establishment

- observation of slaughter

practices

Poultry Product Parts

Examination

Finished Product 381.76

Standards

Rework/Reprocess/ 381.78

Salvage Products 381.91 (b)

Poultry Carcasses 381.84

Poultry Products and 381.86

other articles entering or

at official 381.145

establishments; 381.1

examination and other

requirements

Returned Products

Good commercial 381.65 (b)

practices for poultry

slaughter
22

22

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

05B01 – Cooked sausage Parts Inspection program personnel

are to randomly select an

appropriate product for

verification. To verify

compliance, inspection

program personnel are to select

and process samples and mail

to the designated laboratory as

scheduled, or when there is

reason to believe that product

does not comply with

regulatory requirements.

Misbranding/eco- (Maximums 30% fat 301.2

nomic adulteration and 40% fat +added 381.1 Directive 10,210.1,

sampling, directed water) Amendments 3 and

and unscheduled Cooked sausage 5,

sampling (10% added water) “Unified Sampling

Italian sausage (fat) Form”

Smoked pork sausage

(fat) Directive 7355.1,

Ground beef/ Revision 2

hamburger/ground pork “Use of Sample

(fat) Seals for

Corned beef hash (fat and Laboratory Samples

moisture) and Other

pH controlled product Applications”

Moisture-protein

controlled product

Lard, leaf lard

Advanced meat recovery

products

Mechanically-separated

species

Determination of added 318.22

water in cooked sausages

Definitions and standards

of identity or composition 319

Definitions and standards

of identity or composition

Samples of products to be 381 Subpart P

taken for examination

Sampling at official

establishments 318.9

Compliance procedures 381.146

for meat derived from

advanced meat/bone 318.24

separation machinery and

recovery systems

Mechanically-separated

species 319.5

Mechanically-separated

(kind) 381.173

Withholding actions

500.3
23

441

Procedure

Code

Example

Products

9 CFR

References

FSIS Issuance

References

Inspection Personnel

Responsibilities

05B02 –

Food Safety/Public

Health

Directed Sampling

pH controlled product

Moisture-protein

controlled product

Parts

301.2

318.9

381.1

Directive 10,210.1,

Amendment 1,

“Unified Sampling

Form”

Directive 7355.1

Revision 2,

“Use of Sample

Seals for

Laboratory Samples

and Other

Applications”

Directive 10,240.3,

“Microbial

Sampling of Readyto- Eat (RTE)

Products for the

FSIS Verification

Testing Program”

Directive 10,520.1,

Revision 1,

“Pumped Bacon

Sampling ProgramNitrosamine

Analysis”

Inspection program personnel

are to verify compliance by

collecting, processing and

mailing samples (bacon,

species testing, Escherichia

coli 0157:H7, Salmonella,

Listeria, advanced meat

recovery products,

mechanically-separated

species, etc.) to the designated

laboratory, upon request from

computer-generated

instructions, or upon

instructions from the Frontline

Supervisor or District Office,

or Washington Headquarters.

Mechanically-separated

pork/poultry

Advanced meat recovery

products

Ready-to-eat products

Ground beef

Bacon/Nitrosamine

analysis

Samples of products to be

taken for examination

381.146

Sampling at official

establishments
24

442

Attachment 2

Instructions for Submission of Samples for Species Identification

When inspection program personnel collect samples for species testing, they are to

collect at least one pound of product and put it in a plastic bag supplied by the

laboratory. If the product is in a natural casing, inspection program personnel are to

collect a sample of the emulsion.

1. Inspection program personnel are to complete FSIS Form 10,000-2 (form may

be requested from Field Supply Center in Beltsville, MD) as follows:

• Block 7 -- establishment number

• Block 13-- date sampled

• Block 14—date mailed

• Block 21—check ‘species identification’ box

• Block 24—provide production lot sampled

• Block 24—provide declared species

• Block 25—inspector name (type or print)

• Block 26—badge number

2. Inspection program personnel are to attach a product label showing an

ingredient statement to the 10,000-2 Form.

3. Inspection program personnel are to:

a. follow FSIS Directive 7355.1, Revision 2, Use of Sample Seals for

Laboratory Samples and Other Applications;

b. ship the sample to the Eastern Laboratory in an insulated shipping

container;

c. use sufficient frozen gel packs to keep the sample cold’ and

d. ship via overnight contract courier, Monday thru Friday. For samples

shipped on Fridays, be sure to mark Saturday delivery on package and

include a Saturday delivery sticker on the box.

The results will be on the LEARN intranet site (see FSIS Directive 10,200.1) for

receipt confirmation and sample results.

The laboratory will test the product against a panel of species anti-sera, report

species results that correlate with the ingredient statement as “Acceptable”, and report

species results that indicate a species not declared on the ingredient statement is

present, or one of the species on the ingredient statement is not present as “Not

Acceptable”.
443

Hazard Analysis and Critical Control

Point (HACCP) Verification
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-2

444

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative: ..................................................................................................3

HACCP VERIFICATION INTRODUCTION.............................................................................4

Kickoff Activity: HACCP Refresher......................................................................................4

HACCP TASK SCENARIOS...................................................................................................9

Scenarios: Introduction........................................................................................................9

Scenarios .......................................................................................................................... 11

Scenario 1: HAV Task ....................................................................................................... 11

Scenario 1: HAV Task (Continued) ................................................................................... 11

Scenario 1: Discussion...................................................................................................... 16

Scenario 2: HACCP Task.................................................................................................. 18

Scenario 2: HACCP Task (Continued) .............................................................................. 18

Scenario 2: Discussion...................................................................................................... 19

Scenario 3 ......................................................................................................................... 21

Scenario 3: Discussion...................................................................................................... 21

Scenarios: Conclusion....................................................................................................... 23

Scenarios: Conclusion (Continued)................................................................................... 26

KNOWLEDGE CHECK......................................................................................................... 27

Knowledge Check 1 .......................................................................................................... 27

Knowledge Check 2 .......................................................................................................... 27

Knowledge Check 3 .......................................................................................................... 27

SUMMARY ........................................................................................................................... 27
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-3

3

Slides LEARNING OBJECTIVES

N/A Scientific:

1. Given a scenario, use the verification methods in FSIS Directive 5000.1 Rev. 4

to determine whether an establishment meets HACCP regulatory requirements

for a specific production.

2. Given a scenario, use the verification methods in FSIS Directive 5000.6 Rev. 1

to determine whether an establishment’s HACCP prerequisite program

adequately prevents identified hazards.

3. Given a scenario, use the verification methods in FSIS Directive 5000.6 Rev. 1

to determine whether an establishment’s records for its HACCP prerequisite

programs support decisions made during the establishment’s hazard analysis to

designate particular hazards as Not Reasonably Likely to Occur (NRLO).

4. Given a scenario, use the verification methods in FSIS Directive 5000.6 Rev. 1

and the Meat and Poultry Hazards and Controls Guide to analyze the adequacy

of an establishment’s hazard analysis.

5. Given a scenario, use the verification methods in FSIS Directive 5000.1 Rev. 4

to verify that an establishment’s corrective actions meet regulatory requirements

when a deviation from a critical limit occurs at a critical control point (CCP).

6. Given a scenario, use the verification methods in FSIS Directive 5000.1 Rev. 4

to verify that an establishment’s corrective actions meet regulatory requirements

when an unforeseen hazard occurs.

Regulatory/Administrative:

[None for this topic in this context.]
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-4

4

Slides HACCP VERIFICATION INTRODUCTION

3 Kickoff Activity: HACCP Refresher

Let’s refresh our memory about the key points we remember about a HACCP task from

Inspection Methods.

Fill in the nine steps:
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-5

5

Compare your answer:
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-6

6

Additional information:
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-7

7
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-8

8
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-9

9

Slides HACCP TASK SCENARIOS

5 Scenarios: Introduction

On the following pages, you will be given three scenarios. Work in small groups to go

through each scenario. Proceed at your own pace. Read each scenario and answer the

corresponding questions.

Before you begin, open up the folder of FSIS resources. Keep them open on your

computer as you may need them to refer to as you complete the scenarios.

• 9 CFR 310.22.pdf

• 9 CFR 416 (416.1-416.6) - SPS-1.pdf

• 9 CFR 416 (416.11-416.17) - Sanitation SOP.pdf

• 9 CFR 417.pdf

• 9 CFR 424.21.pdf

• FSIS Compliance Guideline - HACCP Systems Validation.pdf
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-10

10

• FSIS Directive 5000.1.pdf

• FSIS Directive 5000.6.pdf

• FSIS Directive 6410.1.pdf

• FSIS Directive 6420.2.pdf

• FSIS Directive 7120.1.pdf

• FSIS Meat and Poultry Hazards and Controls Guide.pdf
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-11

11

6 Scenarios

You are a PHV assigned to Ideal Beef, Establishment 38. Ideal Beef is a one shift

combination beef slaughter and processing establishment that typically slaughters

approximately 250-350 head of cattle per day, fabricates beef, and produces ground

beef.

7 Scenario 1: HAV Task

A quarterly Hazard Analysis Task (HAV) is scheduled to be performed. You decide to

perform the HAV task on the establishment’s beef slaughter process. You request

Ideal Beef’s slaughter hazard analysis (HA) and HACCP plan, any Standard Operating

Procedures (SOPs) or pre-requisite programs and associated records, and other

supporting documentation.

8 Scenario 1: HAV Task (Continued)

You review the following:

• Hazard Analysis (HA)

• HACCP Plan

• Cattle Age SOP
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-12

12

• Supporting Documentation: Estimating Cattle Age Using Dentition and FSIS

BSE Information

• Receiving Log

• Cattle Age SOP Form

• Corrective Action Logs

1. List the steps of an HAV task (Hint: Refer to the HAV Task Job Aid and FSIS

Directive 5000.6).
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-13

13

2. Is it appropriate to perform the HAV task on the slaughter process?

3. Which establishment documents would you request to review?
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-14

14
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-15

15
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-16

16

9 Scenario 1: Discussion

Based on your review and performance of HAV task:

1. Is the establishment’s HA adequate?

2. Does the establishment have appropriate supporting documentation for the

hazards identified in the HA?

3. Does the establishment’s execution of SOPs or pre-requisite programs and

recorded data continue to support decisions made in the HA?

4. Did you observe noncompliance? Why or why not? If so, draft an NR using Form

5400-4 (on the following page).
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-17

17
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-18

18

10 Scenario 2: HACCP Task

A Slaughter HACCP verification task is scheduled for today. The establishment

defines a “specific production” as all beef carcasses slaughtered and dressed on a

shift. You review the establishment’s HACCP plan and any SOPs or pre-requisite

programs associated with cattle slaughter.

11 Scenario 2: HACCP Task (Continued)

You decide to perform a Slaughter HACCP verification task for the specific production

for 05/23/2018.

• Beef Slaughter HACCP Information.pdf

• Corrective Action Logs.pdf

• Organic Acid Spray Log. pdf

Keep in mind: Refer to the 9 steps you would follow to perform the HACCP verification

task that you listed previously.
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-19

19

12 Scenario 2: Discussion

Based on your performance of the task:

1. Which verification activity(ies) did you use?

2. Did the establishment meet all regulatory requirements for the specific

production for 5/23/2018?

3. Did you observe noncompliance? Why or why not? If so, draft an NR using Form

5400-4 (on the following page).
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-20

20
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-21

21

13 Scenario 3

While continuing your Slaughter HACCP Verification task, you discover that Fred

Murtz, Ideal Beef's QA Technician, found one tongue to have tonsillar material.

14 Scenario 3: Discussion

Review any establishment records associated with the incident and answer the

questions below:

• Corrective Action Logs.pdf

• Pre-Shipment Review Log.pdf

• Zero Tolerance Check Form. pdf

1. Based on your review of the documentation from 5/23/2018, did the

establishment take the corrective action required by the regulations?
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-22

22

2. Did you observe noncompliance? Why or why not? If so, draft an NR using Form

5400-4.
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-23

23

15 Scenarios: Conclusion

Now that you have reviewed all of the information available to you, compare the NRs

that you wrote to these example NRs.

NR #1
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-24

24

NR #2
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-25

25

Looking back, do you have an issue with the actions that the establishment took?

If so, document the noncompliance on Form 5400-4.
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-26

26

16 Scenarios: Conclusion (Continued)

Yes! What was the noncompliance you found?

Compare your new NR with this sample one.

NR #3
Slaughter: Hazard Analysis and Critical Control Point (HACCP)

23-27

27

Slides KNOWLEDGE CHECK

17-20 Knowledge Check 1

Match the definition with the correct term.

• Provides IPP with an approach to verify • HACCP Task

establishments’ compliance with certain

requirements of 9 CFR 417, including

foundational elements such as flow charts,

decision making documents, supporting

documentation and supporting data.

• Provides IPP with an approach to verify • HAV Task

compliance with the implementation of

establishments’ HACCP plans as required by

9 CFR 417.

Knowledge Check 2

The main role of inspectors (FSIS) is verification. What is the purpose of verification?

Knowledge Check 3

Where should critical control points (CCPs) be located?

Slides SUMMARY

21 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 1

470

5000.1 Walk Through

OBJECTIVES

To demonstrate mastery of Directive 5000.1, the trainee will:

1. Describe the inspection verification procedures performed to verify establishment

compliance with the Sanitation Performance Standards.

2. Describe the inspection verification procedures performed to verify establishment

compliance with Sanitation SOP regulations.

3. Describe the inspection verification procedures performed to verify establishment

compliance with HACCP regulations.

4. Identify the procedure performed to verify compliance with generic E. coli

requirements.

5. Describe the responsibility for inspection personnel to verify compliance with the

Salmonella and Campylobacter performance standards.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 2

2

Sanitation Performance Standards

9 CFR 416.1 – 416.6

SPS REGULATIONS

§416.1 General Rules.

Each official establishment must be operated and maintained in a manner sufficient

to prevent the creation of insanitary conditions and to ensure that product is not

adulterated.

The regulation requires establishments to operate in a sanitary environment. Performance

standards stated in the regulations are results-oriented, allowing the establishment flexibility

in achieving the specified results. Simply put, the results expected are defined in the

regulation but the means or methods to achieve the results are not specified. Although

establishments can use different and varying means to meet the performance standards, the

required results are always the same – establishments must operate under sanitary

conditions in a manner that ensures product is not adulterated and in a way that does not

interfere with FSIS inspection and enforcement of such standards.

Proper and effective sanitation practices and conditions are an essential part of all safe food

manufacturing processes. Insanitary facilities and equipment and poor food handling and

personal hygiene practices by employees create an environment in which pathogens and

other food safety hazards can contaminate and adulterate products. Consequently, proper

sanitation is a fundamental requirement under both the Federal Meat Inspection Act (FMIA)

and the Poultry Products Inspection Act (PPIA).

The Sanitation Performance Standards regulations significantly reduce the number of

sanitation regulations and consolidate the sanitation requirements for both meat and poultry

into part 416. This consolidation not only simplifies the sanitation regulation for the user, but

also establishes uniform sanitation performance standards that would provide flexibility to

establishments while maintaining the rigorous sanitation standards necessary to ensure

food safety. The establishment’s responsibility for maintaining sanitary conditions and

preventing the contamination and adulteration of product remains unchanged.

For the HACCP and Sanitation SOP requirements to be successful, FSIS believes that it

must reduce its reliance on detailed, command-and-control regulations. Command-andcontrol regulations prescribe step-by-step procedures establishments must use toward the

goal of safe meat and poultry products. Such regulations can be incompatible with HACCP

and Sanitation SOP requirements to the extent that they deprive establishments of the

flexibility to innovate and deter them from assuming their full share of responsibility for food

safety.

Insanitary conditions are defined as “a state, condition or occurrence in which any edible

meat or poultry products may become contaminated or adulterated through exposure,

slaughter, processing, handling, and packaging or by any other means.”

§416.2 Establishment grounds and facilities.

(a) Grounds and pest control. The grounds about an establishment must be

maintained to prevent conditions that could lead to insanitary conditions,
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 3

3

adulteration of product, or interfere with inspection by FSIS program

employees. Establishments must have in place a pest management program to

prevent the harborage and breeding of pests on the grounds and within

establishment facilities. Pest control substances used must be safe and

effective under the conditions of use and not be applied or stored in a manner

that will result in the adulteration of product or the creation of insanitary

conditions.

Proper maintenance of the grounds around an establishment is essential for ensuring good

sanitation. Establishments are responsible for preventing sources of adulteration of product

even if the cause of the adulteration originates from conditions outside the designated

boundaries of the establishment.

Establishments must implement and maintain an integrated pest control program to

eliminate the harborage and breeding of pests on the grounds and within the establishment

facilities and must safely and effectively use interventions, such as pesticides, fumigants,

and rodenticides. This regulation does not require the integrated pest control program to be

a written document. This regulation does not require that pest control substances be

approved by FSIS prior to use.

The performance standards regulations also require the establishment to be responsible for

the safe and effective use and storage of pesticides. Product must not be adulterated by the

misapplication of pest control products. It is the establishment’s responsibility to ensure that

Environmental Protection Agency (EPA) requirements under the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA) are followed, including the application of a pesticide

or the safety of a chemical. Pesticides must also be properly stored, labeled, and applied in

accordance with label instructions. It is important that such supporting documentation is on

file in the establishment file.

Examples of failure to meet grounds and pest control performance standards are:

• an accumulation of old equipment outside providing harborage for rodents and

insects

• storage of pesticides in an open container next to food ingredients

(b) Construction.

(1) Establishment buildings, including their structures, rooms, and

compartments must be of sound construction, be kept in good repair,

and be of sufficient size to allow for processing, handling, and storage

of product in a manner that does not result in product adulteration or

the creation of insanitary conditions.

(2) Walls, floors, and ceilings within establishments must be built of

durable materials impervious to moisture and be cleaned and sanitized

as necessary to prevent adulteration of product or the creation of

insanitary conditions.

(3) Walls, floors, ceilings, doors, windows, and other outside openings

must be constructed and maintained to prevent the entrance of vermin,

such as flies, rats, and mice.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 4

4

FSIS does not require establishments to be innovative in regard to facility construction or

layout. The performance standards for construction do, however, provide establishments,

regardless of size, the flexibility to design facilities and equipment in the manner they deem

best to maintain the required sanitary environment for food production.

Buildings, walls, ceilings, and floors must be sound and in good repair to prevent insanitary

conditions or the adulteration of product. The walls, floors, and ceilings should be made of

durable materials impervious to moisture.

Example of failure to meet performance standards:

• flaking or chipping paint on the walls or ceilings of edible product areas

• holes in glass board permitting moisture to penetrate the wood behind it

Doors and windows must also close properly and prevent the entrance of vermin.

Example of failure to meet performance standard:

• gaps around the outside doors

(4) Rooms or compartments in which edible product is processed,

handled, or stored must be separate and distinct from rooms or

compartments in which inedible product is processed, handled, or

stored, to the extent necessary to prevent product adulteration and the

creation of insanitary conditions.

Establishments can process, handle, or store edible and inedible product in the same room

as long as they are separated by time or space, in a manner that prevents the adulteration

of the edible product or the creation of insanitary conditions.

Example of failure to meet performance standard:

• grinding meat and storing condemned product together in a room too small to keep

employees and products separated

(c) Light.

Lighting of good quality and sufficient intensity to ensure that sanitary

conditions are maintained and that product is not adulterated must be

provided in areas where food is processed, handled, stored, or examined;

where equipment and utensils are cleaned; and in hand-washing areas,

dressing and locker rooms, and toilets.

Specific regulatory requirements for lighting combine the meat and poultry lighting

requirements into one performance standard. However, FSIS has reserved specific lighting

requirements in meat establishments at postmortem inspection stations and in poultry

establishments at the postmortem inspection stations and at reinspection stations (§ 307.2

and § 381.36 et seq).

While establishments have flexibility in providing lighting, illumination must be adequate in

quality and quantity, and well distributed. It must allow for proper monitoring of sanitary

conditions and processing conditions, and for examination of product for evidence of

adulteration.

Examples of failure to meet performance standard:

• low lighting in the gizzard peeling area that prevents inspection of the product
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 5

5

• shadows on carcasses at final rail inspection preventing inspection of product

(d) Ventilation.

Ventilation adequate to control odors, vapors, and condensation to the

extent necessary to prevent adulteration of product and the creation of

insanitary conditions must be provided.

The Agency does not expect the establishment to completely eliminate all odors, vapors,

and condensation. However, establishments must control ventilation to prevent adulteration

of the environment that, in turn, can lead to adulteration of product or the creation of

insanitary conditions.

Examples of failure to meet performance standard:

• diesel fumes from parked trucks being drawn into the establishment at receiving

areas.

• excessive odors from condemned/inedible rendering area spreading onto slaughter

floor.

(e) Plumbing.

Plumbing systems must be installed and maintained to:

(1) Carry sufficient quantities of water to required locations throughout

the establishment;

(2) Properly convey sewage and liquid disposable waste from the

establishment;

It is the responsibility of the establishment to ensure that plumbing and sewage systems

provide an adequate supply of potable water to the establishment to prevent product

adulteration or creation of insanitary conditions.

Example of failure to meet performance standard:

• inadequate water pressure for cleanup

• plumbing system not providing adequate floor drainage

It is the responsibility of the establishment to ensure that plumbing and sewage systems

remove waste and sewage from the establishment without adulterating product or creating

insanitary conditions.

Example of failure to meet performance standard:

• plugged sewer line preventing cleanup water from draining from the establishment

(3) Prevent adulteration of product, water supplies, equipment, and

utensils and prevent the creation of insanitary conditions throughout

the establishment;

The design, installation and maintenance of an adequate plumbing system are key

responsibilities of the establishment. Because plumbing systems carry water into

establishments and convey water from the establishments, problems with plumbing systems

can easily cause product contamination or adulteration.

Example of failure to meet performance standard:
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 6

6

• dead-end pipes on potable water lines

(4) Provide adequate floor drainage in all areas where floors are subject

to flooding-type cleaning or where normal operations release or

discharge water or other liquid waste on the floor;

(5) Prevent back-flow conditions in and cross-connection between

piping systems that discharge waste water or sewage and piping

systems that carry water for product manufacturing; and

Floor drainage must be adequate to prevent the spread of contaminants into the production

environment during cleaning and normal operation.

Example of failure to meet performance standard:

• a stopped up drain in the cooler

Cross-connection between potable and non-potable water is not acceptable. The plumbing

system must be installed and maintained to prevent adulteration. Back-flow devices must

also be used as appropriate to prevent cross contamination of potable water sources.

Example of failure to meet performance standard:

• a water hose nozzle left submerged in the evisceration flow away drain

(6) Prevent the backup of sewer gases.

Example of failure to meet performance standard:

• sewer gas emitting from a floor drain in the smokehouse area

(f) Sewage disposal.

Sewage must be disposed into a sewage system separate from all other

drainage lines or disposed of through other means sufficient to prevent

backup of sewage into areas where product is processed, handled, or stored.

When the sewage disposal system is a private system requiring approval by a

State or local health authority, the establishment must furnish FSIS with the

letter of approval from that authority upon request.

The establishment must ensure that sewage does not back up into processing areas.

Documentation from a State or local authority approving private sewage disposal systems

must be on-site and available to FSIS upon request.

Example of failure to meet performance standard:

• establishment has no documentation on file from state or local health authority for

approval of private sewer or system

(g) Water supply and water, ice, and solution reuse.

(1) A supply of running water that complies with the National Primary

Drinking Water regulations (40 CFR part 141), at a suitable temperature

and under pressure as needed, must be provided in all areas where

required (for processing product, for cleaning rooms and equipment,

utensils, and packaging materials, for employee sanitary facilities, etc.).

If an establishment uses a municipal water supply, it must make
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 7

7

available to FSIS, upon request, a water report, issued under the

authority of the State or local health agency, certifying or attesting to

the potability of the water supply. If an establishment uses a private well

for its water supply, it must make available to FSIS, upon request,

documentation certifying the potability of the water supply that has

been renewed at least semi-annually.

The water performance standard requires that potable water comply with EPA’s National

Primary Drinking Water regulations. Certifications of water potability provided by the state or

local governments or other responsible entities are evidence that the establishment meets

the EPA requirements.

Some meat and poultry establishments use private wells for their water supply. EPA does

not require testing for these water sources, but FSIS requires it semi-annually. Generally,

State or local governments do not test private wells for potability. Establishments can obtain

such documentation from private laboratories.

Example of failure to meet performance standard:

• no documentation on file demonstrating that the municipal water supply complies with

the National Primary Drinking Water regulations

(2) Water, ice, and solutions (such as brine, liquid smoke, or propylene

glycol) used to chill or cook ready-to-eat product may be reused for the

same purpose, provided that they are maintained free of pathogenic

organisms and fecal coliform organisms and that other physical,

chemical, and microbiological contamination have been reduced to

prevent adulteration of product.

FSIS expects establishments to produce ready-to-eat products that are free of pathogens;

therefore, reuse water used to chill or cook ready-to-eat product must be free of pathogens.

In many cases establishments monitor water reuse activities as part of their HACCP plans

because the water treatments or conditioning can eliminate or reduce hazards they have

determined to be reasonably likely to occur. The requirement that water be reused only "for

the same purpose" refers to reusing water from the ready-to-eat area only in the ready-to

eat area, and reusing water from the not-ready-to-eat areas only in not-ready-to-eat areas.

For example, chiller water or water from the final bird washer that is reconditioned can be

reused in the scalder.

Example of failure to meet performance standard:

• reusing brine solution without filtering or treating

(3) Water, ice, and solutions used to chill or wash raw product may be

reused for the same purpose provided that measures are taken to

reduce physical, chemical, and microbiological contamination so as to

prevent contamination or adulteration of product. Reuse that which has

come into contact with raw product may not be used on ready-to-eat

product.

Establishments can reuse water in a manner that does not adulterate product or create

insanitary condition. For example, an establishment’s recirculating water in a chill tank for
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 8

8

raw poultry might add chlorine to the water to reduce the number of pathogens. An

establishment reusing ice to chill raw poultry might bag the ice to prevent it from contacting

product. The performance standards allow the reuse of water in numerous processing

contexts, as long as the establishment takes actions necessary to ensure that the water

does not adulterate product and that sanitation is not compromised.

Example of failure to meet performance standard:

• reusing ice from wax lined boxes to chill salvage parts without bagging it

(4) Reconditioned water that has never contained human waste and that

has been treated by an onsite advanced wastewater treatment facility

may be used on raw product, except in product formulation, and

throughout the facility in edible and inedible production areas, provided

that measures are taken to ensure that this water meets the criteria

prescribed in paragraph (g)(1) of this section. Product, facilities,

equipment, and utensils coming in contact with this water must

undergo a separate final rinse with non-reconditioned water that meets

the criteria prescribed in paragraph (g)(1) of this section.

Some establishments recondition their water through an advanced wastewater treatment

facility, either onsite or under contract. To prevent establishments from using water from

sewage lines, reconditioned water must never have contained human waste. Because

reconditioned water is of high quality, it can be used on raw product, except in product

formulation, and throughout the facility in edible and inedible production areas. Product,

facilities, and equipment coming in contact with this reconditioned water must undergo a

separate final rinse with potable, non-reconditioned water.

FSIS believes it is likely that most establishments will use the reconditioned water in this

provision to wash equipment, floors, and carcasses on the kill floor, all of which can easily

be rinsed.

Example of failure to meet performance standard:

• no final potable water rinse on product after using reconditioned water

(5) Any water that has never contained human waste and that is free of

pathogenic organisms may be used in edible and inedible product

areas, provided it does not contact edible product. For example, such

reuse water may be used to move heavy solids, to flush the bottom of

open evisceration troughs, or to wash antemortem areas, livestock

pens, trucks, poultry cages, picker aprons, picking room floors, and

similar areas within the establishment.

Any water can be used for any purpose in edible or inedible product areas, provided it:

• has never contained human waste.

Establishments must not reuse water from sewage lines, therefore, it is required that

the reuse water never have contained human waste.

• has been conditioned to be free of pathogenic organisms.

Reuse water must be free of pathogenic organisms to prevent their spread

throughout the establishment, which could lead to cross-contamination of product.

• does not contact edible product.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 9

9

Reuse water might contain coliforms or chemical or physical contaminants, so it

cannot contact edible product.

Example of failure to meet performance standard:

• using treated or untreated water from the employee welfare area to clean antemortem

pens.

(6) Water that does not meet the use conditions of paragraphs (g)(1)

through (g)(5) of this section may not be used in areas where edible

product is handled or prepared or in any manner that would allow it to

adulterate edible product or create insanitary conditions.

To prevent contamination or adulteration of the product, establishment must not use water

contaminated with pathogens, chemicals, or physical contaminants in edible product areas.

Example of failure to meet performance standard:

• using reuse water not meeting conditions of (g)(1) through (g)(5) to flush evisceration

troughs in edible product areas

(h) Dressing rooms, lavatories, and toilets.

(1) Dressing rooms, toilet rooms, and urinals must be sufficient in

number, ample in size, conveniently located, and maintained in a

sanitary condition and in good repair at all times to ensure cleanliness

of all persons handling any product. They must be separate from the

rooms and compartments in which products are processed, stored, or

handled.

OSHA standards (29 CFR 1910.141) for lavatories must be followed when establishments

are constructed or remodeled. FSIS does not regulate the number of lavatories required.

The establishment must maintain lavatory facilities in good repair and in a sanitary manner.

Example of failure to meet performance standard:

• used toilet tissue piled on the floor in the welfare facility

(2) Lavatories with running hot and cold water, soap, and towels must

be placed in or near toilet and urinal rooms and at such other places in

the establishment as necessary to ensure cleanliness of all persons

handling any product.

Example of failure to meet performance standard:

• no hot water or soap in the toilet area

(3) Refuse receptacles must be constructed and maintained in a manner

that protects against the creation of insanitary conditions and the

adulteration of product.

Leaking refuse receptacles allow the spread of pathogenic organisms into the environment,

which could then lead to cross-contamination of product and product areas.

Example of failure to meet performance standard:
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 10

10

• holes in the bottom of trash receptacle in the dressing room with liquids draining onto

the floor.

§ 416.3 Equipment and utensils.

(a) Equipment and utensils used for processing or otherwise handling edible

product or ingredients must be of such material and construction to facilitate

thorough cleaning and to ensure that their use will not cause the adulteration

of product during processing, handling, or storage. Equipment and utensils

must be maintained in sanitary condition so as not to adulterate product.

Establishments may select any method to clean utensils and equipment as long as they are

maintained in a sanitary condition.

Example of failure to meet performance standard:

• meat residues from previous days use on the underside of a product transfer belt

(b) Equipment and utensils must not be constructed, located, or operated in a

manner that prevents FSIS inspection program employees from inspecting the

equipment or utensils to determine whether they are in sanitary condition.

Equipment and utensils must be designed in a manner that allows FSIS inspection

personnel to view them for compliance with sanitary requirements. They must be located so

that they are safely accessible to inspection prior to and during operation.

Example of failure to meet performance standard:

• a piece of equipment is constructed in a manner that prevents thorough cleaning Ex:

a splashguard located over the auger to the meat grinder that prevents access the

equipment for inspection

• when equipment is installed preventing inspection from making a sanitary condition

determination

(c) Receptacles used for storing inedible material must be of such material and

construction that their use will not result in the adulteration of any edible

product or in the creation of insanitary conditions. Such receptacles must not

be used for storing any edible product and must bear conspicuous and

distinctive marking to identify permitted uses.

Inedible receptacles used for storing inedible product must be properly and conspicuously

marked.

Example of failure to meet performance standard:

• unmarked inedible barrels

§416.4 Sanitary operations.

(a) All food-contact surfaces, including food-contact surfaces of utensils and

equipment, must be cleaned and sanitized as frequently as necessary to

prevent the creation of insanitary conditions and the adulteration of product.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 11

11

Generally, establishments clean their operations once a day; however, some establishments

conduct chemical cleanup procedures less than once a day. Such extended cleanup

procedures should be incorporated into the firm’s Sanitation Standard Operating Procedures

(Sanitation SOP ) (See § 416.12). To ensure that extended cleanup procedures prevent

insanitation and the adulteration of product, establishments might conduct microbiological

testing to evaluate the effectiveness of the extended cleanup.

Example of failure to meet performance standard:

• accumulation of fat on a belt rubbing against metal guard creating oxidized fat on the

belt

(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the

operation of the establishment must be cleaned and sanitized as frequently as

necessary to prevent the creation of insanitary conditions and the adulteration

of product.

During the normal course of operations meat and poultry products should not come in

contact with non-food contact surfaces. If non-food contact surfaces are not properly

cleaned and sanitized, insanitary conditions could result, leading to potential adulteration of

product.

Example of failure to meet performance standard:

• dried meat scraps on a wall located away from product but in a production area

(c) Cleaning compounds, sanitizing agents, processing aids, and other

chemicals used by an establishment must be safe and effective under the

conditions of use. Such chemicals must be used, handled, and stored in a

manner that will not adulterate product or create insanitary conditions.

Documentation substantiating the safety of a chemical’s use in a food

processing environment must be available to FSIS inspection program

employees for review.

It is required that meat and poultry products be neither adulterated nor misbranded through

the misuse of proprietary substances and nonfood compounds. Documentation

substantiating the safety of a chemical’s use in a food-processing environment must be

available for FSIS review. The documentation can vary with the nature and intended use of

that chemical. For example, the establishment should have documentation showing that a

pesticide used in the establishment is registered with EPA, and the label information for the

pesticide should be on file. For a chemical sanitizer used on food contact surfaces, an

establishment should have documentation showing that the compound complies with the

relevant Food and Drug Administration (FDA) regulations in 21 CFR 178.1010. (Sanitizers

meeting FDA requirements are usually identified as “Food Grade.”). Meat and poultry

establishments must ensure that all proprietary substances and nonfood compounds are

safe for their intended use and used appropriately.

Example of failure to meet performance standard:

• no documentation showing that the sanitizers used in the facility are safe as used

(d) Product must be protected from adulteration during processing, handling,

storage, loading, and unloading at and during transportation from official

establishments.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 12

12

As product moves through the process there might be elements in the environment that

could adulterate it. Employees who move and handle product improperly are another

possible source of contamination. The establishment must decide, depending upon the

situation and the circumstances within the establishment, how the product should be

protected through all phases of the process. For example, the establishment might cover

the product when it is stored in the cooler to prevent contamination.

Example of failure to meet performance standard:

• combos stored in tiered storage racks not appropriately covered creating an

insanitary condition

§416.5 Employee hygiene.

(a) Cleanliness. All persons working in contact with product, food- contact

surfaces, and product-packaging materials must adhere to hygienic practices

while on duty to prevent adulteration of product and the creation of insanitary

conditions.

The performance standards allow establishments to develop alternative or innovative means

to ensure that employee hygiene practices do not result in product adulteration or

contamination.

Example of failure to meet performance standard:

• an employee wiping his runny nose on the sleeve of his smock

(b) Clothing. Aprons, frocks, and other outer clothing worn by persons who

handle product must be of material that is disposable or readily cleaned. Clean

garments must be worn at the start of each working day and garments must be

changed during the day as often as necessary to prevent adulteration of

product and the creation of insanitary conditions.

The sanitation performance standards require establishments to develop acceptable policies

for prescribing when garments must be changed during the day to prevent contamination or

adulteration of product.

Example of failure to meet performance standard:

• an employee wearing a soiled smock from the raw product area entering the sausage

drying room

(c) Disease control. Any person who has or appears to have an infectious

disease, open lesion, including boils, sores, or infected wounds, or any other

abnormal source of microbial contamination, must be excluded from any

operations which could result in product adulteration and the creation of

insanitary conditions until the condition is corrected.

FSIS has authority to take action against any unhygienic practice that could result in

insanitary conditions or adulterated product. This includes handling procedures that might

contaminate edible products or create insanitary conditions.

Example of failure to meet performance standard:

• an employee handling edible product with an open sore on her forearm
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 13

13

§416.6 Tagging insanitary equipment, utensils, rooms or compartments.

When an FSIS program employee finds that any equipment, utensil, room, or

compartment at an official establishment is insanitary or that its use could cause the

adulteration of product, he will attach to it a “U.S. Rejected'' tag. Equipment, utensils,

rooms, or compartments so tagged cannot be used until made acceptable. Only an

FSIS program employee may remove a “U.S. Rejected'' tag.

It is appropriate to take regulatory control action, which may include tagging affected areas,

when an official establishment operates in a manner that leads to insanitary conditions or

product adulteration. Regulatory control actions should remain in effect until the

establishment has taken corrective action and has proposed effective preventive measures.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 14

14

Sanitation Standard Operating Procedures

9 CFR 416.11— 416.17

SANITATION SOP REGULATIONS

§416.11 General Rules

Each establishment shall develop, implement, and maintain written standard

operating procedures for sanitation (Sanitation SOP’s) in accordance with the

requirements of this part.

The establishment is responsible for developing, implementing, and maintaining written

sanitation standard operating procedures (Sanitation SOPs) that meet the requirements of

part 416. FSIS believes that effective establishment sanitation is essential for food safety

and for successful implementation of HACCP. Insanitary facilities or equipment, improper

personal hygiene, and similar insanitary practices create an environment conducive to

contamination of products. Direct and substantial links exist between inadequate sanitation

and the contamination of meat and poultry products by pathogenic bacteria. Sanitation SOP

clearly defines the establishment’s responsibility to consistently follow effective sanitation

procedures that will substantially minimize the risk of product contamination and

adulteration.

§416.12 Development of Sanitation SOP’s

(a) The Sanitation SOP’s shall describe all procedures an official establishment

will conduct daily, before and during operations, sufficient to prevent direct

contamination or adulteration of product(s).

It is a regulatory requirement that the establishment have written Sanitation SOPs

describing the daily procedures conducted before and during operations to prevent direct

contamination or adulteration of products.

IPP need to be able to read and understand the Sanitation SOP. This means that Sanitation

SOPs written in a foreign language may need to be translated into English.

(b) The Sanitation SOP’s shall be signed and dated by the individual with

overall authority on-site or a higher level official of the establishment. This

signature shall signify that the establishment will implement the Sanitation

SOP’s as specified and will maintain the Sanitation SOP’s in accordance with

the requirements of this part. The Sanitation SOP’s shall be signed and dated

upon initially implementing the Sanitation SOP’s and upon any modification to

the Sanitation SOP’s.

The Sanitation SOP written procedure is signed and dated by an official with overall

sanitation authority or a higher-level official of the establishment. It is not required that the

person be listed on the Grant of Inspection or the PBIS establishment profile. Written

procedures must be signed upon initiation and whenever they are modified. For example,

the establishment manager might sign the Sanitation SOP.

(c) Procedures in the Sanitation SOP’s that are to be conducted prior to

operations shall be identified as such, and shall address, at a minimum, the

cleaning of food contact surfaces of facilities, equipment, and utensils.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 15

15

The written procedures must identify pre-operational sanitation procedures. At a minimum,

Sanitation SOPs must address the cleaning of food contact surfaces of facilities, equipment,

and utensils. The regulation does not specify how much detail Sanitation SOPs must

contain. For example, the Sanitation SOP may describe the pre-operational procedures as

follows. “The food contact surfaces in the facility will be cleaned with hot soapy water.

Equipment that can be disassembled will be taken apart prior to cleaning. After cleaning, a

sanitizer will be applied to product contact surfaces followed by a potable water rinse.”

When followed the procedures should be sufficient to ensure prevention of direct product

contamination or adulteration.

(d) The Sanitation SOPs shall specify the frequency with which each procedure

in the Sanitation SOPs is to be conducted and identify the establishment

employee(s) responsible for the implementation and maintenance of such

procedure(s).

The Sanitation SOP must contain:

• the frequency the procedures in the Sanitation SOP are conducted

• identification of the employee(s) responsible for the implementation and maintenance

of the Sanitation SOPs (does not have to be the people performing the activities but

the person responsible).

Establishments may identify individual(s) by name or job title. The individuals or positions

identified do not have to have separate lines of authority from the production process.

Production employees, lead line personnel, department forepersons, etc. may be identified.

The employee(s) identified may or may not be the employee who actually performs the

activities.

For example, the Sanitation SOP might specify that overheads are wiped every half-hour of

operation to prevent product contamination or adulteration. The QA technician might be the

person responsible for monitoring this procedure, but the QA manager is responsible for the

overall implementation of Sanitation SOP.

§416.13 Implementation of SOP’s

(a) Each official establishment shall conduct the pre-operational procedures in

the Sanitation SOP’s before the start of operations.

Establishments are responsible for implementing the Sanitation SOP daily. They must

perform their procedures before the start of operations as prescribed in their written preoperational procedures. An establishment may have several departments, starting at

different times during the approved hours of operation. They may perform their preoperational procedures at staggered times prior to the approved starting time. In other

words, the establishment does not have to perform pre-operational procedures in all the

departments prior to starting operations in any one department.

(b) Each official establishment shall conduct all other procedures in the

Sanitation SOP’s at the frequencies specified.

Establishments are responsible for the daily implementation of all procedures identified in

the Sanitation SOP that occur during operations. An example procedure is a Sanitation SOP

that includes a procedure for using a footbath prior to entering the ready-to-eat area.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 16

16

(c) Each official establishment shall monitor daily the implementation of the

procedures in the Sanitation SOP’s.

Establishments must monitor the Sanitation SOP procedures they conduct daily to ensure

they effectively prevent direct product contamination or adulteration. For example, an

establishment might have a procedure that calls for cleaning and examining all equipment

prior to operations and a monitoring procedure that includes examining a random selection

of representative equipment prior to operations.

§416.14 Maintenance of Sanitation SOP’s

Each official establishment shall routinely evaluate the effectiveness of the Sanitation

SOP’s and the procedures therein in preventing direct contamination or adulteration

of product(s) and shall revise both as necessary to keep them effective and current

with respect to changes in facilities, equipment, utensils, operations, or personnel.

Establishments should routinely evaluate the content and effectiveness of the Sanitation

SOP and modify it accordingly. The Sanitation SOPs must be kept current. When facilities,

personnel, or operations change, the establishment must still prevent direct product

contamination and adulteration. For example, if the establishment changed their operations

by expanding the facility and adding new pieces of equipment, they must reevaluate their

written procedures and, if necessary, make changes to effectively prevent direct

contamination or adulteration of product.

§416.15 Corrective Actions

(a) Each official establishment shall take appropriate corrective action(s) when

either the establishment or FSIS determines that the establishment’s SOP’s or

the procedures specified therein, or the implementation or maintenance of the

Sanitation SOPs, may have failed to prevent direct contamination or

adulteration of product(s).

The establishment must take corrective actions any time the establishment or FSIS

determines that the Sanitation SOP has failed to prevent direct product contamination or

adulteration of product. Sanitation SOP failure can be the result of either not implementing

or not maintaining the Sanitation SOP, and it can occur before or during operations. This

applies to contamination or adulteration of direct product contact surfaces or direct product

zones found by the establishment or FSIS procedures before or during operations. For

example, in a poultry cut-up operation, the establishment has a procedure for the salvage of

product that contacts the floor written into its Sanitation SOP. The Sanitation SOP says that

the product will be removed from the floor promptly by an employee in the cut-up area and

trimmed, washed, and treated with a chlorine rinse before it is returned to production. The

Sanitation SOP further states that this procedure will be monitored once per hour by the QC

technician. If the procedure were followed as written, corrective actions would not have to

be implemented. However, if during a monitoring procedure the QC technician finds that the

procedure is not followed, corrective actions must be implemented.

(b) Corrective Actions include procedures to ensure appropriate disposition of

product(s) that may be contaminated, restore sanitary conditions, and prevent

the recurrence of direct contamination or adulteration of product(s), including

appropriate reevaluation and modification of the Sanitation SOP’s or the

procedures specified therein.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 17

17

Establishments must initiate corrective actions when either the establishment or FSIS

determines implementation of the procedures fails to prevent direct product contamination or

adulteration. Establishments must implement all three parts of the corrective action, i.e.,

they must:

• dispose of contaminated or adulterated product appropriately

• restore sanitary conditions

• prevent recurrence of failure

Corrective actions may also include reevaluation and modification of the Sanitation SOP or

the procedures specified in it; however, it might not be necessary to modify the Sanitation

SOP in every case.

The establishment is not required to document specifics in the Sanitation SOP regarding

exactly which corrective actions will be taken in every single possible case of contamination

or adulteration. They must, however, address all three parts of corrective action and include

these actions in the records if product contamination or adulteration occurs.

§416.16 Recordkeeping requirements

(a) Each official establishment shall maintain daily records sufficient to

document the implementation and monitoring of the Sanitation SOP’s and any

corrective actions taken. The establishment employee(s) specified in the

Sanitation SOP’s as being responsible for the implementation and monitoring

of the procedure(s) specified in the Sanitation SOP’s shall authenticate these

records with his or her initials and the date.

Establishments must maintain daily records that document they are carrying out the

sanitation procedures outlined in the Sanitation SOP, including the corrective actions taken.

Establishment management may exercise flexibility in designing records. There is no set

format, and records do not have to be included in the written Sanitation SOP.

For example, the SSOP might describe a hygienic procedure where all employees must

wash their hands after returning from break and that the QC manager is responsible for

monitoring the procedure. The record should document that employees were monitored

after break before returning to work. If an employee was observed returning to work without

washing his hands, a description of the incident and the three parts of corrective actions

taken by the establishment must be documented.

(b) Records required by this part may be maintained on computers provided

the establishment implements appropriate controls to ensure the integrity of

the electronic data.

Records may be maintained on a computer in lieu of hard copy as long as they are

accessible to inspection personnel. The establishment must prevent tampering with the

electronic records. It is up to them to determine how to ensure integrity of the electronic

data.

(c) Records required by this part shall be maintained for at least 6 months and

made accessible available to FSIS. All such records shall be maintained at the

official establishment for 48 hours following completion, after which they may
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 18

18

be maintained off-site provided such records can be made available to FSIS

within 24 hours of request.

All Sanitation SOP records generated must be retained for six months. For oversight and

enforcement purposes FSIS requires access to all establishment sanitation records. The

establishment is required to keep records on-site for 48 hours and make them available to

FSIS upon request. Afterwards, records may be stored off-premises as long as they can be

provided to FSIS within 24 hours of a request for them.

§416.17 Agency verification

FSIS shall verify the adequacy and effectiveness of the Sanitation SOP’s and the

procedures specified therein by determining that they meet the requirements of this

part. Such verification may include:

(a) Reviewing the Sanitation SOP’s;

(b) Reviewing the daily records documenting the implementation of the

Sanitation SOP’s and the procedures specified therein and any corrective

actions taken or required to be taken;

(c)Direct observation of the implementation of the Sanitation SOP’s and the

procedures specified therein and any corrective actions taken or required to

be taken; and

(d) Direct observation or testing to assess the sanitary conditions in the

establishment.

FSIS verifies that Sanitation SOPs are developed, implemented, maintained, and that they

are effective. FSIS also verifies that the establishment maintains daily records.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 19

19

Hazard Analysis and Critical Control Point (HACCP) System

9 CFR 417.1 — 417.8

HACCP REGULATIONS

§417.1 Definitions.

For purposes of this part, the following definitions shall apply:

Corrective action. Procedures to be followed when a deviation occurs.

Critical control point. A point, step, or procedure in a food process at which

control can be applied and, as a result, a food safety hazard can be prevented,

eliminated, or reduced to acceptable levels.

Critical limit. The maximum or minimum value to which a physical, biological,

or chemical hazard must be controlled at a critical control point to prevent,

eliminate, or reduce to an acceptable level the occurrence of the identified

food safety hazard.

Food safety hazard. Any biological, chemical, or physical property that may

cause a food to be unsafe for human consumption.

HACCP System. The HACCP plans in operation, including the HACCP plan

itself.

Hazard. SEE Food Safety Hazard.

Preventive measure. Physical, chemical, or other means that can be used to

control an identified food safety hazard.

Process-monitoring instrument. An instrument or device used to indicate

conditions during processing at a critical control point.

Responsible establishment official. The individual with overall authority onsite or a higher level official of the establishment.

Above are the regulatory definitions for these specific terms when used throughout

regulation 417.

§417.2 Hazard Analysis and HACCP Plan.

(a) Hazard analysis.

(1) Every official establishment shall conduct, or have conducted for it,

a hazard analysis to determine the food safety hazards reasonably likely

to occur in the production process and identify the preventive

measures the establishment can apply to control those hazards. The

hazard analysis shall include food safety hazards that can occur before,

during, and after entry into the establishment. A food safety hazard that

is reasonably likely to occur is one for which a prudent establishment

would establish controls because it historically has occurred, or

because there is a reasonable possibility that it will occur in the
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 20

20

particular type of product being processed, in the absence of those

controls.

With the implementation of the Pathogen Reduction/HACCP (PR/HACCP) regulation, each

federally inspected establishment either conducted or had conducted for it a hazard

analysis. At a minimum a hazard analysis must be developed for each processing category

in the establishment. The purpose of the hazard analysis is to identify biological, chemical,

and physical hazards reasonably likely to occur in the process and to identify preventive

measures to control those hazards. Regulation 417.1 defines preventive measures as

physical, chemical, or other means that can be used to control an identified food safety

hazard. FSIS is unaware of any meat or poultry production process that can be deemed

categorically to pose no food safety hazards. All three types of hazards (biological,

chemical, or physical) must be considered at all steps in the process, e.g. receiving, storage,

and grinding.

(2) A flow chart describing the steps of each process and product flow

in the establishment shall be prepared, and the intended use or

consumers of the finished product shall be identified.

The flow chart is often a simple schematic picture of the process used to produce the

product for an example of process flow charts refer to “Regulated Industries” module, p 30-

42). The establishment should verify the process flow chart by walking through the

establishment and comparing the steps in the process to the flow chart. Examples of steps

in a slaughter process might include antemortem, stunning, head removal, evisceration,

carcass splitting, final trim, and cooling. Steps in a processing establishment might include

receiving, formulation, cooking, and cooling. Examples of steps that have been overlooked

by establishments are returned product and rework.

The establishment should consider whether “at risk” populations, such as the elderly or

children, are intended consumers of the product.

(3) Food safety hazards might be expected to arise from the following:

(i) Natural toxins;

(ii) Microbiological contamination;

(iii) Chemical contamination;

(iv) Pesticides;

(v) Drug residues;

(vi) Zoonotic diseases;

(vii) Decomposition;

(viii) Parasites;

(ix) Unapproved use of direct or indirect food or color additives; and

(x) Physical hazards

FSIS believes an establishment should consider the ten areas above when performing a

hazard analysis.

The establishment should consider all potential food safety hazards at all steps in the

process. If an establishment determines that a food safety hazard is reasonably likely to

occur, they must address it with a critical control point somewhere in the process. During

the initial stages of the hazard analysis, the establishment might list many different potential

hazards. During assessment, however, they might find that many hazards are not
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 21

21

reasonably likely to occur. For example, an establishment might determine that product

contamination is a potential hazard at the receiving step. After assessing the situation, the

establishment determines that this is not a food safety hazard likely to occur in the process

because they have a procedure in their Sanitation SOP that addresses the situation.

(b) The HACCP plan.

(1) Every establishment shall develop and implement a written HACCP

plan covering each product produced by that establishment whenever a

hazard analysis reveals one or more food safety hazards that are

reasonably likely to occur, based on the hazard analysis conducted in

accordance with paragraph (a) of this section, including products in the

following processing categories:

(i) Slaughter—all species.

(ii) Raw product—ground.

(iii) Raw product—not ground.

(iv) Thermally processed—commercially sterile.

(v) Not heat treated—shelf stable.

(vi) Heat treated—shelf stable.

(vii) Fully cooked—not shelf stable.

(viii) Heat treated but not fully cooked—not shelf stable.

(ix) Product with secondary inhibitors—not shelf stable.

(2) A single HACCP plan may encompass multiple products within a

single processing category identified in this paragraph, if the food

safety hazards, critical control points, critical limits, and procedures

required to be identified and performed in paragraph (c) of this section

are essentially the same, provided that any required features of the plan

that are unique to a specific product are clearly delineated in the plan

and are observed in practice.

Every product must be produced under a HACCP plan when a hazard analysis reveals a

food safety hazard likely to occur within the process. The establishment may develop one

HACCP plan to control hazards for all products in the same processing category. For

example, if an establishment produces different fully cooked products such as franks and

cooked beef, they could be included in the same HACCP plan.

An establishment may develop one HACCP plan for a product that passes through multiple

process categories. As an example, if an establishment slaughters and produces cut-up

chicken, the product passes through both “slaughter” and “raw intact” (raw not ground)

processes. The establishment may use two HACCP plans or it may address the entire

slaughter and cut-up process under one HACCP plan. If an establishment slaughters

chickens, produces cut-up chicken, and produces mechanically separated chicken, it would

need a minimum of two HACCP plans.

The processing category is determined by the product label when it leaves the

establishment. For example, certain products such as country hams and lard may be in

different processing categories depending on the establishment process and l

(3) HACCP plans for thermally processed/commercially sterile products

do not have to address the food safety hazards associated with

microbiological contamination if the product is produced in accordance
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 22

22

with the requirements of part 318, subpart G, or part 381, subpart X, of

this chapter.

Establishments producing thermally processed commercially sterile products are not

required to address microbiological hazards if the product is produced in accordance with

the canning regulations. However, the hazard analysis must still consider physical and

chemical hazards at every step in the process because the current canning regulations

exclusively address microbial hazards. For example, if the establishment determines foreign

material is a food safety hazard likely to occur in the process, there must be a CCP

somewhere in the process to control foreign material.

(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

(1) List the food safety hazards identified in accordance with paragraph

(a) of this section, which must be controlled for each process.

Each establishment must provide a list of the food safety hazards identified while conducting

the hazard analysis. Some commonly identified hazards are pathogens such as Listeria, E.

coli O157:H7, and foreign material, such as metal.

(2) List the critical control points for each of the identified food safety

hazards, including, as appropriate:

(i) Critical control points designed to control food safety hazards that

could be introduced in the establishment, and

(ii) Critical control points designed to control food safety hazards

introduced outside the establishment, including food safety hazards

that occur before, during, and after entry into the establishment;

If a food safety hazard is identified in the hazard analysis, and is determined to be

reasonably likely to occur, there must be a critical control point somewhere in the process to

address it. As an example, if a biological hazard is identified at the receiving step in an

establishment that produces fully cooked product, the CCP to control the hazard might be

lethality at the cooking.

(3) List the critical limits that must be met at each of the critical control

points. Critical limits shall, at a minimum, be designed to ensure that

applicable targets or performance standards established by FSIS, and

any other requirement set forth in this chapter pertaining to the specific

process or product are met;

Regulation 417.1 defines a critical limit as the minimum or maximum value to which a

physical, biological, or chemical hazard must be controlled at a critical control point to

prevent, eliminate or reduce to an acceptable level the occurrence of the identified food

safety hazard. (Note: critical limits may also be expressed as a range if the decision making

documents support that limit, such as in the case of the use of lactic acid as an antimicrobial

intervention. If the establishment utilizes FSIS Directive 7120.1 to support the critical limit

for lactic acid, the range would be 2% to 5% lactic acid in solution.) Critical limits are

expressed as numbers or specific parameters and need to be measurable. Establishments

must have documents supporting the selection of CCPs and critical limits. The documents

should be scientific, regulatory, or technical, and show that when the critical limits are

achieved, the product produced will be safe.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 23

23

For example, an establishment that slaughters 4-pound birds put a CCP in the cooler 4

hours post-evisceration. The critical limit is that the average internal temperature of three

carcasses must be 40o F or less. While performing a monitoring check the establishment

records temperatures of 39o F, 39 o F, and 42 o F. The average for the three is 40 o F. The

average temperature critical limit does not meet the regulatory requirement of 417.1

because each carcass must meet the 40o F critical limit.

(4) List the procedures, and the frequency with which those procedures

will be performed, that will be used to monitor each of the critical

control points to ensure compliance with the critical limits;

The monitoring procedures and frequencies in the HACCP plan must describe a planned

sequence of observations or measurements to assess whether a CCP is under control and

to produce an accurate record for use in future verification. Reading the monitoring

procedures and frequencies in the HACCP plan should allow visualization of what is taking

place during the monitoring of a CCP. The establishment should use monitoring records to

track process control. Continuous monitoring is always preferred when feasible. For

example, an establishment, which uses a smokehouse to cook hams, may use a continuous

time and temperature recording device to chart the time and temperature of the product in

the ovens as it is cooked. When continuous monitoring is not possible, discontinuous

monitoring must be performed often enough to show that the process is under control. An

example of a continuous operation with discontinuous monitoring is an establishment that

cooks chicken patties on a conveyor and measures the internal temperature of 10 patties

every 30 minutes.

(5) Include all corrective actions that have been developed in

accordance with §417.3(a) of this part, to be followed in response to any

deviation from a critical limit at a critical control point; and

The HACCP plan must contain the corrective actions taken when a deviation from a critical

limit occurs. An establishment may simply state “the regulatory requirements of 417.3(a) will

be met when a deviation occurs” to satisfy this regulatory requirement. A prudent

establishment would consider the different causes of a deviation and work through

scenarios to address them. This additional information is not required to be part of the

official HACCP plan.

(6) Provide for a recordkeeping system that documents the monitoring

of the critical control points. The records shall contain the actual values

and observations obtained during monitoring.

The HACCP plan shall list the records used to document monitoring critical control points.

Records must contain actual values and observations obtained during monitoring. An

example of such a HACCP record is the monitoring log. Actual values and observations

must be entered on the monitoring log at the time the event occurs.

(7) List the verification procedures, and the frequency with which those

procedures will be performed, that the establishment will use in

accordance with §417.4 of this part.

Verification procedures and frequencies must be present in the HACCP plan. The

verification procedures should be very clear. Anyone reading the verification procedures in
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 24

24

the HACCP plan should be able to visualize what takes place when the verification

procedure is performed.

(d) Signing and dating the HACCP plan.

(1) The HACCP plan shall be signed and dated by the responsible

establishment individual. This signature shall signify that the

establishment accepts and will implement the HACCP plan.

(2) The HACCP plan shall be dated and signed:

(i) Upon initial acceptance;

(ii) Upon any modification; and

(iii) At least annually, upon reassessment, as required under §417.4 (a)

(3) of this part.

The HACCP plan must be signed and dated when the establishment develops and

implements the HACCP plan, when it is modified, and to indicate the annual reassessment

has been performed.

(e) Pursuant to 21 U.S.C 456, 463, 608, and 621, the failure of an establishment

to develop and implement a HACCP plan that complies with this section, or to

operate in accordance with the requirements of this part, may render the

products produced under those conditions adulterated.

If an establishment does not develop and implement a HACCP plan as required by Part 417

of the regulations, any product produced without a HACCP plan may be determined to be

adulterated.

§417.3 Corrective actions.

(a) The written HACCP plan shall identify the corrective action to be followed in

response to a deviation from a critical limit. The HACCP plan shall describe the

corrective action to be taken, and assign responsibility for taking corrective

action, to ensure:

(1) The cause of the deviation is identified and eliminated;

(2) The CCP will be under control after the corrective action is taken;

(3) Measures to prevent recurrence are established; and

(4) No product that is injurious to health or otherwise adulterated as a

result of the deviation enters commerce.

When there has been a deviation from a critical limit, the establishment must implement all

four parts of corrective actions. They must:

• identify and eliminate the cause of the deviation

• ensure the CCP is under control after the corrective action is taken

• prevent recurrence of the deviation

• ensure that no product injurious to health or otherwise adulterated enters commerce

Affected product is generally considered to be that produced since the last acceptable

monitoring result recorded by the establishment.

(b) If a deviation not covered by a specified corrective action occurs, or if

another unforeseen hazard arises, the establishment shall:

(1) Segregate and hold the affected product, at least until the

requirements of paragraphs (b)(2) and (b)(3) of this section are met;
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 25

25

(2) Perform a review to determine the acceptability of the affected

product for distribution;

(3) Take action, when necessary, with respect to the affected product to

ensure that no product that is injurious to health or otherwise

adulterated, as a result of the deviation, enters commerce;

(4) Perform or obtain reassessment by an individual trained in

accordance with §417.7 of this part, to determine whether the newly

identified deviation or other unforeseen hazard should be incorporated

into the HACCP plan.

If a deviation from a critical limit occurs that is not covered by a specified corrective action or

if an unforeseen hazard is identified, the establishment must implement the following

corrective actions:

• segregate and hold the affected product, at least until the requirements of paragraphs

(b)(2) and (b)(3) of this section are met;

• perform a review to determine the acceptability of the affected product for distribution;

• take action, when necessary, with respect to the affected product to ensure that no

product that is injurious to health or otherwise adulterated, as a result of the deviation

enters commerce;

• perform or obtain reassessment by an individual trained in accordance with § 417.7 of

this part, to determine whether the newly identified deviation or other unforeseen

hazard should be incorporated into the HACCP plan.

(c) All corrective actions taken in accordance with this section shall be

documented in records that are subject to verification in accordance with

§417.4 (a)(2)(iii) and the recordkeeping requirements of §417.5 of this part.

Whatever an establishment does to fulfill all four parts of corrective action should be

documented in the HACCP records. The records must be available for FSIS review.

§417.4 Validation, Verification, Reassessment.

(a) Every establishment shall validate the HACCP plan's adequacy in

controlling the food safety hazards identified during the hazard analysis, and

shall verify that the plan is being effectively implemented.

(1) Initial validation. Upon completion of the hazard analysis and

development of the HACCP plan, the establishment shall conduct

activities designed to determine that the HACCP plan is functioning as

intended. During this HACCP plan validation period, the establishment

shall repeatedly test the adequacy of the CCP's, critical limits,

monitoring and recordkeeping procedures, and corrective actions set

forth in the HACCP plan. Validation also encompasses reviews of the

records themselves, routinely generated by the HACCP system, in the

context of other validation activities.

It is the establishment’s responsibility to develop a HACCP plan and to ensure its adequacy.

Establishments may use independent consultants, process authorities, or employees trained

as per 417.7 to develop and validate the plan. Validation means scientifically demonstrating

that a HACCP system, as designed, effectively controls the food safety hazards identified in
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 26

26

the hazard analysis. While no particular validation method must be used, the data

assembled to support a HACCP plan are usually of two types:

• theoretical principles from process authorities, scientific data etc.

• in-plant observations, measurements, test results, or other information demonstrating

that control measures achieve the intended food safety objective

Validation must demonstrate that the HACCP plan is scientifically sound. Establishments

must support the critical limits selected. They may use Appendices A or B (“Compliance

guidelines for cooling heat-treated meat and poultry products”), modeling programs, or other

scientific support for their critical limits. For example, a slaughter establishment with steam

pasteurization has a CCP with a critical limit at 180o F for 10 seconds at the carcass surface.

The establishment supported this critical limit with a scientific journal article that indicated

steam applied at 180o F for 10 seconds to the carcass surface reduces pathogens by 1 log.

The establishment also had records demonstrating their ability to meet the parameters of

steam at 180o F for 10 seconds on the carcass surface.

FSIS believes validated data for any HACCP plan must also include some practical data or

information reflecting initial validation in implementing the HACCP plan. Validation must

demonstrate that the monitoring can be performed by the establishment as per the HACCP

plan and when the monitoring is performed the establishment can meet the critical control

points and critical limits.

(2) Ongoing verification activities. Ongoing verification activities

include, but are not limited to:

(i) The calibration of process-monitoring instruments;

(ii) Direct observations of monitoring activities and corrective actions;

and

(iii) The review of records generated and maintained in accordance with

§ 417.5(a)(3) of this part.

Verification procedures must ensure the HACCP plan functions as intended. All plans must,

at a minimum, include three types of ongoing verification: calibration of process monitoring

equipment, observation of monitoring activities and corrective actions, and records review,

except for cases where one or more of the minimum ongoing verification activities are not

necessary. Such scenarios may be when there are no process monitoring devices used

(e.g. visual inspection at zero tolerance CCP), or in a one person operation where direct

observation can not be performed. Validation and reassessment are two additional types of

verification.

For example, a verification procedure for equipment calibration might look like this: “A handheld dial thermometer is placed in slush ice water and calibrated to within 1

o of 32o F.” The

establishment should have supporting data that this procedure effectively calibrates dial

thermometers.

(3) Reassessment of the HACCP plan. Every establishment shall

reassess the adequacy of the HACCP plan at least annually and

whenever any changes occur that could affect the hazard analysis or

alter the HACCP plan. Such changes may include, but are not limited to,

changes in: raw materials or source of raw materials; product

formulation; slaughter or processing methods or systems; production

volume; personnel; packaging; finished product distribution systems;
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 27

27

or, the intended use or consumers of the finished product. The

reassessment shall be performed by an individual trained in accordance

with §417.7 of this part. The HACCP plan shall be modified immediately

whenever a reassessment reveals that the plan no longer meets the

requirements of §417.2(c) of this part.

HACCP plans are dynamic and evolving. The establishment should reassess its HACCP

plan whenever any significant change in the processing environment occurs. Changes in

product formulation, addition or removal of equipment, an increase in the amount of

production, and the addition of new customers are just a few examples of instances when

an establishment needs to reassess. The HACCP plan must be immediately modified if the

reassessment reveals that the plan is no longer adequate. The individual performing the

reassessment must be trained as per 417.7. FSIS believes that reassessment

encompasses the different types of evaluation, from re-analyzing the verification procedures

for an updated CCP to repeating the validation procedures when necessary.

(b) Reassessment of the hazard analysis. Any establishment that does not

have a HACCP plan because a hazard analysis has revealed no food safety

hazards that are reasonably likely to occur shall reassess the adequacy of the

hazard analysis whenever a change occurs that could reasonably affect

whether a food safety hazard exists. Such changes may include, but are not

limited to, changes in: raw materials or source of raw materials; product

formulation; slaughter or processing methods or systems; production volume;

packaging; finished product distribution systems; or, the intended use or

consumers of the finished product.

Even if an establishment previously did not have a HACCP plan, changes such as product

formulation, new slaughter or processing methods, or the use of new raw materials should

cause the establishment to reassess its hazard analysis. If any changes result in

identification of a food safety hazard, the establishment should then develop a HACCP Plan.

For example, an establishment received pork pellets cooked by another establishment. The

producing establishment certified that lethality adequate to control the pathogen of concern

was applied, that the product was tested, and that sample results were negative. The

receiving establishment addressed employee hygiene and product handling in the Sanitation

SOP. The receiving establishment determined there were no food safety hazards likely to

occur in the process of popping and packaging the pellets, so they did not have a HACCP

plan for the process. At a later time the establishment decided to start popping raw pork

skins. When the incoming materials changed, the establishment reassessed the hazard

analysis to determine if a food safety hazard was likely to occur.

§417.5 Records.

(a) The establishment shall maintain the following records documenting the

establishment's HACCP plan:

(1) The written hazard analysis prescribed in §417.2(a) of this part,

including all supporting documentation;

The hazard analysis and all supporting documents must be in the establishment file.

Supporting documentation varies from establishment to establishment because the decision

making process differs. Examples of supporting data establishments might have for the

hazard analysis are historical data and scientific journal articles.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 28

28

(2) The written HACCP plan, including decision making documents

associated with the selection and development of CCP's and critical

limits, and documents supporting both the monitoring and verification

procedures selected and the frequency of those procedures.

The establishment must have supporting data for CCPs and critical limits. Supporting data

may include FSIS regulations, FSIS Guidelines, the FDA food code, journal articles from

reputable publications, etc. Establishments may use universities, extension services, and

industry associations for assistance in gathering supporting documentation. One example of

supporting data for a critical limit is using Appendix B to support a stabilization CCP.

The establishment must also have supporting documentation for their monitoring

procedures. The establishment must be able to support that the monitoring frequency is

adequate to demonstrate process control.

This regulation also requires the establishment to have supporting documentation for

verification procedures and frequencies listed in the HACCP plan. The establishment must

have documents that explain how the verification procedures were determined and what

information was used to determine the frequencies for these procedures.

(3) Records documenting the monitoring of CCP's and their critical

limits, including the recording of actual times, temperatures, or other

quantifiable values, as prescribed in the establishment's HACCP plan;

the calibration of process-monitoring instruments; corrective actions,

including all actions taken in response to a deviation; verification

procedures and results; product code(s), product name or identity, or

slaughter production lot. Each of these records shall include the date

the record was made.

This regulation lists specific information that the establishment must document on their

records when HACCP activities are performed. When monitoring each CCP and its critical

limits, actual values must be recorded, e.g. times, temperatures, or other quantifiable values.

The establishment must also document all corrective actions, calibration of processmonitoring instruments, and verification procedures and frequencies.

(b) Each entry on a record maintained under the HACCP plan shall be made at

the time the specific event occurs and includes the date and time recorded,

and shall be signed or initialed by the establishment employee making the

entry.

The establishment shall make all entries on the records at the time the specific event occurs

and sign or initial the entry. Each time a monitoring procedure is performed, the

establishment must record the time, product identity, actual value and initials of the person

performing the monitoring. Example: date: 9/9/01, time: 8:02 a.m., product identity: Lot A6 -

chicken carcasses, actual value: 39oF, initials: MPT. When the establishment performs a

verification procedure, the records must include the verification procedure performed and

the results of that procedure, as well as the date, time and initials or signature of the person

performing verification. For example, when the establishment performs a direct observation,

the record entry might show “direct observation performed, monitoring performed as per the

HACCP plan”.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 29

29

(c) Prior to shipping product, the establishment shall review the records

associated with the production of that product, documented in accordance

with this section, to ensure completeness, including the determination that all

critical limits were met and, if appropriate, corrective actions were taken,

including the proper disposition of product. Where practicable, this review

shall be conducted, dated, and signed by an individual who did not produce

the record(s), preferably by someone trained in accordance with §417.7 of this

part, or the responsible establishment official.

Before shipping product, an establishment must review all records associated with the

production of that product. As part of the pre-shipment review the establishment needs to

insure that all critical limits have been met and all corrective actions are taken, if necessary.

There are many ways an establishment can perform pre-shipment review. They may

perform it on a time basis, on specific production, or continuously as the product goes

through the process. For example, an establishment might conduct pre-shipment review

every hour and conduct records review verification daily. If the pre-shipment review is

performed continuously, it is possible that the only documentation on the records at the time

of review will be monitoring entries. If monitoring records are the only ones available, the

review still satisfies the regulatory requirement. In addition, the frequency at which the

verification procedures are performed may not correspond to the frequency at which the preshipment review is performed. The verification procedures should be reviewed, if available,

at the time the pre-shipment review is performed.

(d) Records maintained on computers. The use of records maintained on

computers is acceptable, provided that appropriate controls are implemented

to ensure the integrity of the electronic data and signatures.

The establishment may maintain records on computer provided they have controls to protect

record integrity. Even though the establishment is keeping records on the computer, they

must be readily accessible to Agency personnel.

(e) Record retention.

(1) Establishments shall retain all records required by paragraph (a)(3)

of this section as follows: for slaughter activities for at least one year;

for refrigerated product, for at least one year; for frozen, preserved, or

shelf-stable products, for at least two years.

(2) Off-site storage of records required by paragraph (a)(3) of this

section is permitted after six months, if such records can be retrieved

and provided, on-site, within 24 hours of an FSIS employee's request.

(f) Official review. All records required by this part and all plans and

procedures required by this part shall be available for official review and

copying.

It is the establishment’s responsibility to maintain the records for the required amount of time

per the regulation. If the establishment chooses to store the records off-site after 6 months,

then the establishment must be able to provide them, upon request, within 24 hours. If the

records are kept on-site after the first 6 months, they must be available upon request. Both
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 30

30

the hazard analysis and HACCP plan should be available upon request. If an FSIS

inspector working the second shift at an establishment, requests a copy of the HACCP plan,

the establishment should be able to provide it to the inspector at that time.

All of the records specified by 417.5 must be available to FSIS upon request. Along with the

records, a prudent establishment would keep the HACCP plan corresponding to those

records if changes at some point have been made to the HACCP plan.

§417.6 Inadequate HACCP Systems.

A HACCP system may be found to be inadequate if:

(a) The HACCP plan in operation does not meet the requirements set forth in

this part;

(b) Establishment personnel are not performing tasks specified in the HACCP

plan;

(c) The establishment fails to take corrective actions, as required by §417.3 of

this part;

(d) HACCP records are not being maintained as required in §417.5 of this part;

or

(e) Adulterated product is produced or shipped.

If establishment personnel do not perform procedures as specified in the HACCP plan, if

corrective actions are not taken, or if HACCP records are not maintained, the HACCP

system may be inadequate. For example, an establishment had several deviations from a

critical limit. When implementing corrective actions, they failed to address 417.3(a)(3),

“measures to prevent recurrence are established.” If the establishment repeatedly did not

meet that regulatory requirement, the system could be deemed inadequate as per 417.6(c).

§417.7 Training.

(a) Only an individual who has met the requirements of paragraph (b) of this

section, but who need not be an employee of the establishment, shall be

permitted to perform the following functions:

(1) Development of the HACCP plan, in accordance with §417.2(b) of

this part, which could include adapting a generic model that is

appropriate for the specific product; and

(2) Reassessment and modification of the HACCP plan, in accordance

with §417.3 of this part.

(b) The individual performing the functions listed in paragraph (a) of this

section shall have successfully completed a course of instruction in the

application of the seven HACCP principles to meat or poultry product

processing, including a segment on the development of a HACCP plan for a

specific product and on record review.

Training is essential to the success of HACCP. The establishment must use trained

individuals to develop, conduct reassessments of, and make modifications to HACCP plans.

It is not required that the individual be an employee of the establishment or be on-site for the

establishment to operate.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 31

31

§417.8 Agency verification.

FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP

plan meets the requirements of this part and all other applicable regulations. Such

verification may include:

(a) Reviewing the HACCP plan;

(b) Reviewing the CCP records;

(c) Reviewing and determining the adequacy of corrective actions taken when

a deviation occurs;

(d) Reviewing the critical limits;

(e) Reviewing other records pertaining to the HACCP plan or system;

(f) Direct observation or measurement at a CCP;

(g) Sample collection and analysis to determine the product meets all safety

standards; and

(h) On-site observations and record review.

FSIS uses various steps to verify that HACCP plans are adequate. These are further

described in FSIS Directives 5000.1 and 5400.5.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 32

32

Process Control Verification

E. coli Testing – LIVESTOCK

§310.25 Contamination with microorganisms; process control verification criteria and

testing; pathogen reduction standards.

(a) Criteria for verifying process control; E. coli testing.

(1) Each official establishment that slaughters livestock must test for

Escherichia coli Biotype 1 (E. coli) Establishments that slaughter more

than one type of livestock or both livestock and poultry, shall test the

type of livestock or poultry slaughtered in the greatest number.

FSIS requires all livestock slaughter establishments to conduct microbial testing for generic

E. coli, Biotype 1, an E. coli specie that is commonly found in the intestinal tract of food

animals. Generic E. coli is an excellent indicator of fecal contamination, which is the primary

pathway for contamination of meat and poultry with pathogens such as E. coli O157:H7,

Salmonella, and Campylobacter. The testing requirement helps establishments determine

the adequacy of their process control for fecal contamination. Using an Agency baseline

study FSIS established verification performance criteria that reflect the prevalence of E. coli

contamination on carcasses. Not all species tested by establishments have performance

criteria available. The Agency is currently conducting field surveys to develop additional

criteria.

FSIS E. coli criteria are guidelines, not regulatory standards. FSIS does not use company

test results by themselves to take regulatory action. E. coli test results are considered in

conjunction with other information. The company test results can support more objective

assessments and help determine whether establishments meet current statutory

requirements for sanitation and the prevention of adulteration. The generic E. coli test

results play an integral role in the successful implementation of HACCP in livestock

slaughter establishments.

If the establishment only slaughters one species and it is not listed in the E. coli regulations,

the establishment is not required to test for generic E. coli.

The establishment must test the species that it slaughters in greatest number (major

species) and that is listed in the regulations. When the major species slaughtered in a

multiple-species slaughter establishment is not required by regulation to be tested the

establishment must test the species produced in the next greatest number that is listed in

the E. coli regulations.

§ 310.25 (a)(1) Continued

The establishment shall:

(i) Collect samples in accordance with the sampling techniques,

methodology, and frequency requirements in paragraph (a)(2) of this

section;

(ii) Obtain analytic results in accordance with paragraph (a)(3) of this

section; and

(iii) Maintain records of such analytic results in accordance with

paragraph (a)(4) of this section.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 33

33

(2) Sampling requirements.

(i) Written procedures. Each establishment shall prepare written

specimen collection procedures which shall identify employees

designated to collect samples, and shall address location(s) of

sampling, how sampling randomness is achieved, and handling of the

sample to ensure sample integrity. The written procedure shall be made

available to FSIS upon request.

§ 310.25 (a)(2)(i) requires that the establishment identify the employee(s) who will collect

samples. The establishment procedure may simply designate a company position or title to

identify the sample collector.

The regulation also requires that carcasses be selected at random. The establishment

determines the methods by which randomness is achieved. For example, random number

tables, computer-generated random numbers, or drawing cards may be used. In cattle, each

half-carcass represents one unit eligible for sampling. Both the “leading” and “trailing” sides

of a carcass should have an equal chance of being selected within the designated time

frame. In swine, each whole carcass represents one unit eligible for sampling.

The location requirement in the regulation refers to the place within the establishment where

the sample is collected. The half-carcass or carcass eligible for sampling should be

selected from those in the cooler 12 or more hours after slaughter. The location of selection

may also be at the transfer chain, a rail, or a similar place that contains carcasses that have

chilled 12 hours or more. In cases where the carcasses are inaccessible in the cooler, or

employee safety is jeopardized, it is acceptable to select random samples before carcasses

enter the cooler. Selected carcasses may be chilled in a more accessible area and sampled

after 12 hours. Similar random sample selection methods are used in establishments

conducting hot-boning operations, but the samples are selected after the final wash.

If more than one shift is operating at the establishment, the sample can be taken from either

shift, provided the sample selection time is based on the appropriate sampling frequency.

The half-carcass or carcass for sampling must be selected at random from all the eligible

half-carcasses or carcasses. The time of sampling is based on the appropriate sampling

frequency. Sample selection method in establishments conducting hot-boning operations on

whole or split carcasses are selected at the end of the slaughter line prior to chilling.

Finally, the written procedure must declare the actions the establishment will take to ensure

the sample is handled in a manner that protects the integrity of the sample.

(ii) Sample collection. The establishment must collect samples from all

chilled livestock carcasses, except those boned before chilling (hotboned), which must be sampled after the final wash. Samples must be

collected in the following manner;

(A) For cattle, establishments must sponge or excise

tissue from the flank, brisket and rump, except for hide-on

calves, in which case establishments must take samples

by sponging from inside the flank, inside the brisket, and

inside the rump.

(B) For sheep, goat, horse, mule, or other equine

carcasses, establishments must sponge from the flank,
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 34

34

brisket and rump, except for hide-on carcasses, in which

case establishments must take samples by sponging from

inside the flank, inside the brisket, and inside the rump.

(C) For swine carcasses, establishments must sponge or

excise tissue from the ham, belly and jowl areas.

§ 310.25 (a)(2)(ii) requires carcasses to be hot-boned be sampled after the final wash.

There are two sampling methods an establishment may use to collect E. coli samples:

excision sampling and sponging. Establishments slaughtering cattle and swine may choose

either method. These are described as follows:

1. Excision sampling involves aseptically cutting a surface section from the carcass (8 x

6 x 1⁄2 inch thick for beef and 10 x 5 x 1⁄2 inch thick for swine) and either sending the

excision sample for laboratory analysis or running the analysis in-house. Excising

tissue from a carcass is a destructive method of sampling.

2. Sponging involves aseptically swabbing a sterile sponge on a surface of the carcass

(10 cm x 10 cm for beef, swine, and equines; and 10 cm x 5 cm for sheep and goats)

and either sending the sponge to the laboratory for analysis or running the analysis

in-house. Sponging is a nondestructive method of sampling.

Samples must also be taken from specific sites on cattle and swine carcasses, sheep, goat,

horse, mule, or other equine carcasses. The three sites from which either excision or

sponging samples must be taken on cattle carcasses are the:

• Flank

• Brisket

• Rump

In the case of hide-on calves, sheep, goats, horses, mules, or other equines the three sites

from which sponging samples must be taken are inside the:

• Flank

• Brisket

• Rump

In the case of swine, the three excision or sponging samples must be taken from the:

• Belly

• Ham

• Jowls

FSIS assumes that meat establishments following the "Guidelines for E. coli testing for

Process Control Verification in Cattle and Swine Slaughter Establishments" will conduct their

sampling in a manner that does not jeopardize the integrity of the sample or the reliability of

the test results. Because these guidelines are not regulatory requirements, the

establishment may choose to use a comparable sampling technique and not be out of

compliance.

(iii) Sampling frequency. Slaughter establishments, except very low

volume establishments as defined in paragraph (a)(2)(v) of this section,

must take samples at a frequency proportional to the volume of

production at the following rates:
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 35

35

(A) Cattle, sheep, goats, horses, mules, and other equines: 1 test

per 300 carcasses, but, a minimum of one sample during each

week of operation.

Swine: 1 test per 1,000 carcasses, but a minimum of one sample

during each week of operation.

The required frequency of E. coli testing is based on production volume.

(iv) Sampling frequency alternatives. An establishment operating under

a validated HACCP plan in accordance with §417.2(b) of this chapter

may substitute an alternative frequency for the frequency of sampling

required under paragraph (a)(2)(iii) of this section if,

(A) The alternative is an integral part of the establishment's

verification procedures for its HACCP plan and,

(B) FSIS does not determine, and notify the establishment in

writing, that the alternative frequency is inadequate to verify the

effectiveness of the establishment's processing controls.

In some cases an establishment operating under a validated HACCP plan may substitute an

alternative frequency for the frequency in the regulation. This is allowed when the alternative

frequency is an integral part of the establishment’s verification procedures for its HACCP

plan. An example is the case in which E. coli testing is built into a critical control point in the

HACCP plan. The m/M criteria or the statistical process control upper limit is the critical limit

for the CCP. The establishment that slaughters 9,000 cattle per year includes alternative

testing frequency in the HACCP plan to sample once per week for a total of 52 samples per

year, not 30 samples as would be required by the 1 test per 300 carcasses frequency.

In smaller establishments slaughtering no more than 50 animals per year, not more than

25% of the carcasses will be sampled.

(v) Sampling in very low volume establishments.

(A) Very low volume establishments annually slaughter no more

than 6,000 cattle, 6,000 sheep, 6,000 goats, 6,000 horses, mules

or other equines, 20,000 swine, or a combination of livestock not

exceeding 6,000 cattle and 20,000 total of all livestock. Very low

volume establishments that collect samples by sponging shall

collect at least one sample per week, starting the first full week

of operation after June 1 of each year, and continue sampling at

a minimum of once each week the establishment operates until

June 1 of the following year or until 13 samples have been

collected, whichever comes first. Very low volume

establishments collecting samples by excising tissue from

carcasses shall collect one sample per week, starting the first

full week of operation after June 1 of each year, and continue

sampling at a minimum of once each week the establishment

operates until one series of 13 tests meets the criteria set forth in

paragraph (a)(5)(i) of this section.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 36

36

SPECIES VERY LOW VOLUME REQUIREMENT

Cattle Annually slaughter < 6,000 head

Horses, Mules, Equines Annually slaughter < 6,000 head

Sheep, Goats Annually slaughter < 6,000 head

Swine Annually slaughter < 20,000 head

Whether the establishment collects samples by sponging or the excision method, the

regulation requires that at least one sample be collected each week of the year that the

establishment slaughters. The sample year begins on June 1 of each year. Starting the first

full week of operation after June 1st the establishment must collect samples as required until

13 samples and test results have been accumulated.

There is no regulatory limitation on the maximum number of tests that can be performed

weekly to meet the thirteen tests requirement of § 310.25 (a)(2)(iv). It is hypothetically

possible for the establishments to collect all thirteen samples in one week and meet

regulatory requirement for the production year.

(B) Upon the establishment's meeting requirements of paragraph

(a)(2)(v)(A) of this section, weekly sampling and testing is

optional, unless changes are made in establishment facilities,

equipment, personnel or procedures that may affect the

adequacy of existing process control measures, as determined

by the establishment or FSIS. FSIS determinations that changes

have been made requiring resumption of weekly testing shall be

provided to the establishment in writing.

After the initial 13 tests are completed for the production year, further E. coli testing is

optional for the establishment. However, if the establishment determines that there have

been changes (remodeling, new equipment, new employees, or new procedures) that affect

how well the process works, the establishment must resume weekly testing. Another series

of 13 tests can establish the effectiveness of the changed process.

If FSIS determines there have been changes that affect the process, the information must

be provided to the company in writing. The establishment would then be required to resume

E. coli testing to judge the process control.

(3) Analysis of samples. Laboratories may use any quantitative method

for analysis of E. coli that is approved as an AOAC Official Method of

the AOAC International (formerly the Association of Official Analytical

Chemists) or approved and published by a scientific body and based on

the results of a collaborative trial conducted in accordance with an

internationally recognized protocol on collaborative trials and

compared against the three tube Most Probable Number (MPN) method

and agreeing with the 95 percent upper and lower confidence limit of

the appropriate MPN index.

(4) Recording of test results. The establishment shall maintain accurate

records of all test results, in terms of CFU/cm2 of surface area sponged

or excised. Results shall be recorded onto a process control chart or

table showing at least the most recent 13 test results, by type of
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 37

37

livestock slaughtered. Records shall be retained at the establishment

for a period of 12 months and shall be made available to FSIS upon

request.

(5) Criteria for evaluation of test results.

(i) An establishment excising samples from carcasses is operating

within the criteria when the most recent E. coli test result does not

exceed the upper limit (M), and the number of samples, if any, testing

positive at levels above (m) is three or fewer out of the most recent 13

samples (n) taken, as follows:

Table 1. --Evaluation of E. coli Test Results

Cattle and swine slaughter establishments may choose either excision or sponge sampling,

however, the performance criteria of “m” (minimum value) and “M” (maximum value) is

currently only available for excision samples. Table 1 above shows the “m” and “M” values

for E. coli performance criteria set forth by the Agency for the species that have had a

baseline study completed.

Establishments must document or record E. coli test results. Each test result must be

recorded in terms of colony forming units per square centimeter (cfu/cm2) for excision and

sponging results. As stated earlier, the E. coli performance criteria, or “m” and “M”, are not

enforceable regulatory standards.

E. coli test result levels are separated into three categories for the purpose of process

control verification:

• acceptable, marginal (represented by “m”)

• unacceptable (represented by “M”)

Marginal results (“m”) are those within the worst 20% of overall industry performance in

terms of E. coli counts. More than three marginal results in the last 13 tests are deemed

unacceptable.

Results above “M” are within the worst 2% of overall industry performance. Any single test

result exceeding “M” is deemed unacceptable.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 38

38

The “m” and “M” values are applied to a moving window of 13 test results. Only the last 13

test results are evaluated to determine if the performance criteria are met. Any single test

result exceeding “M” is unacceptable. More than three results exceeding the marginal limit in

the last 13 tests is also unacceptable.

The establishment may elect to use a table type form or a control chart to plot E. coli results.

Examples of these types of documents follow.

The above example is a control chart. The E. coli test results are plotted vertically using the

E. coli CFU/cm2 axis. Each sample result is plotted, starting at Test Number “1” in the

horizontal axis and moving to the right. The heavier dark line (at 100 CFU/cm2) represents

the upper limit of the marginal range or big “M”. The lighter dark line (at 0 CFU/cm2)

represents the lower limit of the marginal range or little “m”.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 39

39

This is an example of a table form. The E. coli test results are entered from the top down as

they are received. The results are evaluated using a moving window of the last thirteen

samples collected. Example: Test #1 thru 13, 2 thru 14, 3 thru 15, 4 thru 16, etc., would be

used to determine if the E. coli test results meet the m/M criteria. With each new test result

recorded the window would move ahead one result so that a set of thirteen sample results is

maintained at all times. The column “Result unacceptable” is marked “yes” if the upper

control limit (“M”) has been exceeded and the column “Results marginal” is marked “yes” if

the result of the E. coli sample is above the lower control limit (”m”), but not above “M”. The

“number marginal or unacceptable in the last 13” column tracks the number of results in the

marginal range within the last thirteen results.

To illustrate the use of E. coli performance criteria, E. coli sample results covering a period

of seventeen tests have been plotted on each of the two types of formats previously

illustrated. The data plotted on both forms is from an establishment that slaughters cattle

and samples were taken using the excision method (refer to Figure 1 and Figure 2).

Figure 1
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 40

40

Figure 2

The following observations can be made from the above data. First, test number eleven

documents the fourth test result in the marginal (“m”) range. Therefore, the establishment

has entered an unacceptable process control status because the fourth marginal result

exceeds the limit of no more than three marginal results in the past 13 consecutive tests.

Secondly, tests number twelve and thirteen are negative, therefore, in the acceptable

range. However, if you consider the last 13 test results, or the 13-test moving window,

there are still more than three results in the marginal range. The company has marked its

record to show that it is still in a failing mode because of the four marginal test results. In

reality this is not an unacceptable result because tests twelve and thirteen are negative,

indicating the process is back in control. The failure documented on the table for tests

twelve and thirteen cannot be gleaned as evidence of a new problem. The log or

documentation of corrective action taken for the first failure at test number eleven should

be adequate to verify that the problem was addressed.

Third, at test number fourteen the number of marginal results in the last thirteen tests

window is reduced to three. The marginal result for test number one is dropped and

replaced by an acceptable result as the 13-test window moves ahead one line; i.e. the

moving window is tests 2 through 14.

The fourth observation possibly made from the data annotated on the records is that the test

result for test number seventeen exceeds 100 cfu/cm2, the “M” value for cattle. Any result

over 100 cfu/cm2is automatically unacceptable. It only takes one test in the “M” range to

indicate the establishment may not have adequate process control.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 41

41

(ii) Establishments sponging carcasses shall evaluate E. coli test

results using statistical process control techniques.

If the sponging method is selected, the establishment must use statistical process control for

evaluating test results.

If the cattle or swine establishment is using the sponge technique, statistical process control

must be used, not the “m” and “M” criteria. Charts or tables of the sample results must show

at least the most recent 13 test results, if they are available.

(6) Failure to meet criteria. Test results that do not meet the

criteria described in paragraph (a)(5) of this section are an

indication that the establishment may not be maintaining

process controls sufficient to prevent fecal contamination. FSIS

shall take further action as appropriate to ensure that all

applicable provisions of the law are being met.

Whenever an establishment determines that its E. coli test results do not meet “m” and “M”

performance criteria it must take corrective action to bring the process back into control. In

the case of establishments using statistical process control, when E. coli test results do not

meet E. coli limits set by the establishment, corrective action to regain process control must

be taken.

Although the establishment is required to make corrections to its process to regain control of

contamination, it is not required to document those corrective actions.

(7) Failure to test and record. Inspection shall be suspended in

accordance with rules of practice that will be adopted for such

proceedings upon a finding by FSIS that one or more provisions

of paragraphs (a) (1)-(4) of this section have not been complied

with and written notice of same has been provided to the

establishment.

When establishments do not evaluate their test results §310.25(a)(5), they might not be

maintaining process controls sufficient to prevent fecal contamination. The District Office will

be notified of these instances. District management and will decide what further action

should be taken to ensure all applicable provisions of the law are being met.

Microbiological Sampling for Poultry Slaughter (other than Ratite) Operations

The purpose of the new sampling requirements is to ensure that establishments monitor and

evaluate the effectiveness of their procedures to prevent contamination of carcasses by

enteric pathogens and visible fecal material on an ongoing basis. Fecal contamination is a

principal source of pathogenic organisms that contaminate poultry carcasses. Under the

Modernization of Poultry Slaughter Inspection final rule establishments that slaughter

poultry, other than ratites, are required to perform microbiological sampling and analysis, for

example, testing for Salmonella, Campylobacter, or indicator organisms such as aerobic

plate count (APC), total coliform, Enterobacteriaceae, and Escherichia coli, Biotype I, also

known as generic E. coli.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 42

42

Because establishments have differences in their operations, each establishment has the

flexibility to develop a sampling plan and determine the microbial organism that will

accurately monitor the effectiveness of its process control procedures.

Microbiological test results that represent the level of microbiological contamination at key

steps in the slaughter process are necessary for the establishment to provide

comprehensive objective evidence to demonstrate process control. Process control consists

of the programs and procedures that an establishment implements to ensure its process

prevents contamination of poultry carcasses and parts, including contamination with

pathogens and fecal material. Process control also ensures that the resulting product meets

applicable standards or definitions.

Inspection Program Personnel (IPP) Responsibilities

In poultry slaughter establishments (other than ratite), IPP are to conduct verification tasks,

as outlined in Directive 5000.1 following the verification instructions in Notice 64-14. The

PHIS verification task that IPP perform depends on how the establishment has incorporated

its written procedures for preventing contamination of carcasses and parts by enteric

pathogens and fecal contamination throughout the entire slaughter and dressing operation

in its HACCP system. For instance:

• If the establishment’s written procedures are part of its HACCP plan, IPP are to verify

HACCP regulatory requirements by performing the Slaughter HACCP verification

task when it has been scheduled in PHIS.

• If the establishment’s written procedures are part of its Sanitation SOPs, IPP are to

verify that the establishment meets all Sanitation SOP regulatory requirements by

performing the Operational SSOP Review and Observation task when it has been

scheduled in PHIS.

• If the establishment’s written procedures are part of another prerequisite program or

other control measures, IPP are to verify the implementation of such program by

performing the Slaughter HACCP verification task when it has been scheduled in

PHIS.

IPP are to perform the appropriate PHIS verification task on a routine basis at the frequency

specified in the establishment’s task list. IPP are also to initiate a directed verification task if

they observe noncompliance with the requirements in 381.65(g) and (h) while performing

other tasks or when instructed to do so by supervision or other policy issuances.

IPP are to verify that the poultry slaughter establishment:

• Developed a written sampling program that identifies the specific microorganisms

being tested and location/frequency where samples are collected,

• Incorporated its written sampling program for preventing contamination by enteric

pathogens into its HACCP system,

• Implements and maintains its written sampling program,

• Maintains scientific and technical documentation to support the decisions that the

establishment made in designing the sampling program,
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 43

43

• Maintains daily records documenting the implementation and monitoring of its

procedures including sample results

Microbiological Sampling and Analysis Verification

Each poultry slaughter establishment’s written procedures for preventing contamination of

carcasses and parts with enteric pathogens and fecal material must include sampling and

analysis for microbial organisms.

The regulations require each establishment to maintain scientific and technical

documentation to support the judgments that the establishment made in designing the

sampling program. The regulations prescribe the minimum requirements for the location and

frequency of sampling, based on the establishment size and production volume. Each

establishment must maintained daily records to document the implementation and

monitoring of their procedures including records documenting the test results of its sampling

plan.

Note: Establishments may use Salmonella Initiative Program (SIP) microbial data as part of

their sampling plan to monitor their process control, provided they meet minimum

frequencies and location requirements.

A Microbiological Testing of Raw Poultry Summary Chart (Attachment 2 of this handout) is

provided as a reference for the establishment size, sampling frequencies, and sampling

locations requirements. It is a quick and easy inspection aid when conducting the PHIS

verification task.

IPP must understand what each statement of the regulation means in order to conduct the

appropriate PHIS verification task. IPP address the requirements of 9 CFR 381.65(g) and (h)

as follows:

1. Sampling requirements – Microbial Indicator Organism paragraph (g) of

section 381.65

Each establishment must develop its own sampling program/procedure that identifies the

specific microbiological organisms (i.e., Salmonella, Campylobacter, or other enteric

organisms) for which the establishment will test to monitor the effectiveness of its process

control procedures that prevent contamination of carcasses and parts with enteric

pathogens and fecal material.

Note: Very small and very low volume poultry slaughter establishments (as defined below)

operating under Traditional Inspection can choose to continue conducting generic E. coli

testing at post-chill to meet the requirements under the Modernization of Poultry Slaughter

Inspection final rule. FSIS considers the requirements under the former §381.94(a)

regulations for generic E. coli testing of poultry to be scientifically validated “safe harbor”

for monitoring process control.

2. Sampling requirements – location (paragraph (g)(1) and paragraphs (g)(1)(i)

and (ii) of section 381.65) and technique

Poultry slaughter establishments are codified by size and annual slaughter volume,

according to regulation 381.65(g)(1)(i) and (ii), and FSIS Notice 64-14.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 44

44

• Very small establishments are establishments with fewer than 10 employees or

annual sales of less than $2.5 million.

• Very low volume (VLV) establishments annually slaughter no more than 440,000

chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, 60,000

squabs or a combination of all types of poultry not exceeding 60,000 turkeys and

440,000 birds total.

The location refers to the place within the establishment where the sample is collected.

Very small establishments and VLV establishments operating under Traditional inspection

are required to collect samples for microbial organisms at the post-chill point in the

process. All other establishments must collect samples at both the pre-chill and post-chill

locations.

The pre-chill location for sampling is any point in the slaughter process from re-hang to just

prior to the chiller. The post-chill location for sampling is a point in the slaughter process

after the carcass exits the chiller and after all slaughter interventions are completed, which is

the same point in the process that FSIS collects samples for Salmonella and Campylobacter

verification testing.

Carcasses must be selected at the required points in the process (pre and post chill). At the

post-chill site, samples should be collected after the final wash and the application of any

final antimicrobial interventions. A drip time of at least 60 seconds should be observed

before sample collection to prevent excessive antimicrobial carryover in the collected

sample.

Note: Antimicrobials used during processing steps may make it harder to detect live bacteria

in the collected sample if the carcass is not allowed adequate drip time before collecting the

sample. Consequently, antimicrobial carryover (residual) can result in altered test results

(lower bacterial counts), may invalidate the test results, and may not provide a true

representation of the establishment’s process control.

The sampling methods for collecting carcass samples may include the nondestructive

sponge technique for sample collection from turkeys and geese (back and thigh) and a

whole bird rinse technique for sample collection from chickens, guineas, ducks, geese, and

squabs. All carcass samples should be taken using aseptic techniques.

The establishment must provide scientific or technical support for their sampling technique

and sample site on the carcass. If IPP have concerns with the establishment’s support, they

should contact the District Office through supervisory channels.

3. Sampling requirements – frequency paragraphs (g)(2)(i) and (ii) of section

381.65

VLV establishments must collect and analyze samples at least once during each week of

operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples,

a VLV establishment can demonstrate that it is effectively maintaining process control, it

may modify its sampling plan. In this case the establishment would need to document the
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 45

45

changes and maintain documentation showing that the changes allow the establishment to

continue to effectively monitor process control.

Seasonal VLV operations must complete all microorganism testing during whichever months

it operates. For example, a seasonal duck slaughter establishment that operates from

September through December must begin testing during its first full week of operations and

complete 13 tests before operations end in December.

All other establishments (including very small establishments) must collect and analyze a

pair of samples, one at pre-chill and one at post-chill, at the following frequencies:

• Chickens: once per 22,000 carcasses but at a minimum of once during each week of

operation;

• Turkeys, ducks, geese, guineas, and squabs: once per 3,000 carcasses but at a

minimum once each week of operation.

Slaughter volume does not always match frequency rates in the regulations. Establishments

should account for extra slaughter volume. This can be done by conducting additional

microbiological tests. For example, a chicken establishment that slaughters 40,000 birds per

day should test at least once a day at the 22,000 birds per test frequency. However, the

remaining 18,000 birds should also be accounted for to monitor process control. To account

for the extra slaughter volume, the establishment could “carry over” the 18,000 extra birds to

the next day’s volume and conduct two (2) microorganism tests on the second day.

4. Random selection of carcasses

Samples should be collected randomly at the frequency determined by the establishment as

part of its sampling plan. At a minimum, the establishment must collect samples at the

frequency specified under 9 CFR 381.65(g)(2). If more than one shift is operating at the

establishment, the sample can be taken on any shift. Different methods of selecting the

specific carcass for sampling could be used, but the method used should include the use of

random numbers to ensure that testing data is not biased. Examples of methods include

random number tables, calculator or computer-generated random numbers, or drawing

cards.

The carcass that is sampled should be selected at random from all eligible carcasses. If

there are multiple lines or chillers, randomly select the line or chiller for sample collection for

that interval. Each line or chiller should have an equal chance of being selected at each

sampling interval within the relevant time frame (based on the sampling frequency for the

plant).

The establishment must provide scientific or technical support the decisions it made in

designing the sampling program.

5. Sample analysis and testing method

To obtain the most accurate results, samples should be analyzed as soon after collection as

possible. If samples must be transported to an off-site laboratory, they should be

refrigerated and then shipped refrigerated, on the same day they were collected, via an
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 46

46

overnight delivery or courier service to the laboratory. A sample should arrive at the

laboratory and be analyzed no later than the day after it is collected.

In addition, establishments should ensure that microbiological testing is reliable and meets

its food safety needs. Each establishment needs to determine whether sample analysis will

be performed by an outside or on-site laboratory. FSIS has available the compliance

guideline “Establishment Guidance for the Selection of a Commercial or Private

Microbiological Testing Laboratory” if the establishment decides to use an outside laboratory

to analyze microbiological samples. This guidance document should be particularly useful to

very small establishments when they are selecting a commercial or private laboratory to

analyze establishment microbiological samples.

FSIS has also made available a list of Foodborne Pathogen Test Kits Validated by

Independent Organizations for the detection of relevant foodborne pathogens (i.e.,

Salmonella, Campylobacter, E. coli O157:H7, and Listeria spp. including L.

monocytogenes). This list is intended to be informational and is not an endorsement or

approval of any particular testing method, regardless of its inclusion in the list.

Poultry slaughter establishments (other than ratite) must include the analysis of microbial

organisms in their sampling procedures as part of their HACCP system (381.65(g)).

Therefore, scientific and technical documentation must be provided to support the design of

the sampling program. The Agency recommends that the industry follow the guidelines in

the document titled “FSIS Compliance Guideline: HACCP Validation” published on May

2013. The documentation can be found in the FSIS website at:

http://www.fsis.usda.gov/wps/wcm/connect/a70bb780-e1ff-4a35-9a9a3fb40c8fe584/HACCP_Systems_Validation.pdf?MOD=AJPERES

IPP are to review the establishment’s written programs, scientific and technical support, and

records to verify that the laboratory analyzes the samples using an AOAC Official Method or

one validated by another recognized independent testing body. When in doubt about

whether the laboratory testing procedure is acceptable, IPP should go through the

supervisory chain-of-command to the District Office for assistance.

6. Records of test results – paragraphs (g)(2)(iii) and (h) of section 381.65

Official poultry slaughter establishments must maintain daily records documenting the

implementation and monitoring of its procedures required under paragraph (g) including

accurate records of all test results from its sampling plan for at least one year. These

records can be maintained in an electronic format on a computer, provided there are

measures in place to ensure the integrity of the electronic data. These records must be

readily accessible for review by IPP upon request.

IPP are to verify that the establishment maintains daily records documenting the

implementation and monitoring of its procedures, makes these records available for IPP to

review and retains these records for one year, and implements appropriate controls to

ensure the integrity of electronic data if records are maintained on computers
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 47

47

7. Criteria for evaluation of test results

Poultry slaughter establishments should use statistically valid approach or statistical process

control (SPC) to interpret their microbiological test results as previously discussed in this

handout. Establishments gather initial test results and set the upper control limit that is used

to assess whether the slaughter process is under control. As long as the test results remain

below the upper control limit, the slaughter process is considered under control.

In cases where an establishment does not have the resources or capacity to develop and

implement their own statistical control limits or procedures, establishments can utilize the

results from FSIS nationwide livestock or poultry surveys. The tables below demonstrate the

indicator organism median values for chickens and turkeys.

An establishment sample value that is higher than the corresponding one listed in the table

indicates the establishment may not be maintaining process control and may be less likely

to meet applicable performance standards. Sample values lower than the one listed in the

table indicate the establishment may be maintaining process.

SPC usually includes the use of a control chart, which plots data over time but also displays

an upper control limit for specific measurements and a centerline (the average), above and

below which there is an equal number of sample results. A sample result above the upper

control limit would indicate the likely presence of a special cause of variation that should be

addressed. Results within control limits indicate simply that the process is in control.

The example below shows a SPC chart for a poultry slaughter operation which plots test

results for an indicator organism in terms of sample number, along the horizontal X-axis,

against Log cfu/ml on the Y-axis. This chart illustrates a pattern of an indicator organism test

results that would be seen in a well-controlled system. In a well controlled system, the

majority of the test results will be clustered around a central value (the average). It is

important to note that even in a well-controlled system there is some frequency of isolated

results above the acceptable level.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 48

48

As part of its process control procedures, an establishment should define the actions it will

take if the microbiological test results obtained through its sampling are above the limits it

has set. The establishment should delineate what its actions will be, who will take each

action, how the outcome of these actions will be documented, and how it will be verified.

FSIS has made available the FSIS Compliance Guidelines for the Control of Salmonella and

Campylobacter in Raw Poultry. The guidelines summarize known control points for

Salmonella and Campylobacter in the pre- and post-harvest production process.

Establishments should use this compliance guide to improve management practices, to

ensure effective dressing operations and to assist in investigating when there is a loss of

control of the slaughter process.

When IPP review the establishment’s records that document its microbiological test results,

they should look for trends in the test results that indicate a loss of process control. For

example, IPP are to look for:

• A significant number of test results that exceeded the establishment’s upper control

criteria, if the establishment has such criteria,

• Instances where the test results exceed the establishment’s criteria by a large

amount over a relatively short period of time (e.g., days or weeks); or

• Test results that show a trend of worsening performance over a relatively long period

of time (e.g., days, months, seasonal).

Very Small or Very Low Volume Establishments that Slaughter Poultry under

Traditional Inspection Using the Safe Harbors to Monitor Process Control

The Agency considers former provisions 381.94(a)(2)(i), (a)(3), and (a)(5)(i) as safe harbors

if very small and very low volume establishments slaughter poultry under Traditional

Inspection chooses to test for generic E. coli at post chill as the indicator microorganism.

Log (cfu/ml)
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 49

49

These establishments use the M/m values in the following table and a moving window of the

last 13-documented test results to evaluate process control.

Type of

poultry

Lower limit of

marginal

range (m)

Upper limit of

marginal

range (M)

Number of

Samples

tested (n)

Maximum number

permitted in the

Marginal range

Chickens 100 cfu/ml 1,000 cfu/ml 13 3

An establishment is operating within the criteria when the most recent generic E. coli test

result does not exceed the upper limit (M), and the number of samples, if any, testing

positive at levels above (m) is three or fewer out of the most recent 13 samples (n) taken.

Whenever a prudent poultry slaughter establishment determines that its generic E. coli test

results do not meet m/M performance criteria, it should take necessary actions to bring the

slaughter process back into control.

8. Sample Integrity

Even though the regulatory requirements in 9 CFR 381.65(g) for poultry slaughter

microbiological testing programs do not specifically address the handling of the samples to

ensure sample integrity, a prudent establishment should include a description of how

samples are handled ensure the sample integrity. Remember, the regulation requires each

poultry slaughter establishment to incorporate their written procedures in its HACCP system

which must comply with the 9 CFR 416 or 417 regulations.

Poultry Slaughter Operations and Procedures – 381.65(g) and 381.65(h)

Sec. §381.65 Operations and procedures, generally

(g) Procedures for controlling contamination throughout the slaughter and dressing

operation. Official poultry slaughter establishments must develop, implement, and maintain

written procedures to prevent contamination of carcasses and parts by enteric pathogens

and fecal contamination throughout the entire slaughter and dressing operation.

Establishments must incorporate these procedures into their HACCP plans, or sanitation

SOPs, or other prerequisite programs. At a minimum, these procedures must include

sampling and analysis for microbial organisms in accordance with the sampling location and

frequency requirements in paragraphs (g)(1) and (2) of this section to monitor their ability to

maintain process control.

(1) Sampling locations. Establishments, except for very small establishments operating

under Traditional Inspection or very low volume establishments operating under Traditional

Inspection must collect and analyze samples for microbial organisms at the pre-chill and

post-chill points in the process. Very small establishments operating under Traditional

Inspection and very low volume establishments operating under Traditional Inspection must

collect and analyze samples for microbial organisms at the post-chill point in the process.

(i) Very small establishments are establishments with fewer than 10 employees or annual

sales of less than $2.5 million.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 50

50

(ii) Very low volume establishments annually slaughter no more than 440,000 chickens,

60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, or 60,000 squabs.

(2) Sampling frequency. (i) Establishments, except for very low volume establishments as

defined in paragraph (g)(1)(ii) of this section, must, at a minimum, collect and analyze

samples at a frequency proportional to the establishment’s volume of production at the

following rates:

(A) Chickens. Once per 22,000 carcasses, but a minimum of once during each week of

operation.

(B) Turkeys, ducks, geese, guineas, and squabs. Once per 3,000 carcasses, but at a

minimum once each week of operation.

(ii) Very low volume establishments as defined in paragraph (g)(1)(ii) of this section must

collect and analyze samples at least once during each week of operation starting June 1 of

every year. If, after consecutively collecting 13 weekly samples, a very low volume

establishment can demonstrate that it is effectively maintaining process control, it may

modify its sampling plan.

(iii) Establishments must sample at a frequency that is adequate to monitor their ability to

maintain process control for enteric pathogens. Establishments must maintain accurate

records of all test results and retain these records as provided in paragraph (h) of this

section.

(h) Recordkeeping requirements. Official poultry slaughter establishments must maintain

daily records sufficient to document the implementation and monitoring of the procedures

required under paragraph (g) of this section. Records required by this section may be

maintained on computers if the establishment implements appropriate controls to ensure the

integrity of the electronic data. Records required by this section must be maintained for at

least one year and must be accessible to FSIS.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 51

51

Salmonella and Campylobacter Performance Standards Verification

Testing

Introduction

The pathogen reduction program is an integral part of the FSIS food safety strategy. It

stimulates improvements in food safety practices by establishing guidelines and ensuring

proper process control. FSIS established performance standards for Salmonella in July

1996, as part of the Pathogen Reduction; Hazard Analysis Critical Control Point

(PR/HACCP) Systems; final rule.

In May 2010, FSIS published a Federal Register Notice (Docket No. FSIS-2009-0034) The

PR/HACCP Final Rule established Salmonella performance standards that are used to

verify process control in meat and poultry slaughter and processing establishments that

produced certain classes of product (9 CFR 310.25(b)(1) and 381.94(b)(1), respectively).

The performance standards were developed using national baseline studies conducted

before the rule’s implementation. Only the performance standards for livestock carcasses

and certain raw ground meat products (9 CFR 310.25(b)) are still applicable.

Since then, FSIS has conducted additional prevalence and risk assessments for pathogens

in FSIS regulated products, revised the performance standards to meet public health goals,

and has published a number of Federal Register Notices (FRN).

• FSIS published new performance standards in 2010 and 2011 for Salmonella and

Campylobacter for chilled carcasses in young chicken (broiler) and turkey slaughter

establishments. The Agency has identified Campylobacter as part of FSIS’s

pathogen reduction strategy and established Campylobacter performance standards

for poultry carcasses.

• In December 2012, FSIS informed establishments that produce not ready-to-eat

(NRTE) ground or otherwise comminuted chicken and turkey products that they were

required to reassess their HACCP plans (FRN Docket No. 2012-0007; April 21,

2014) as a result of two multi-state outbreaks linked to ground turkey products. FSIS

also expanded the Salmonella sampling beyond ground chicken and turkey to

include all forms of non-breaded, non-battered comminuted Not-Ready-to-Eat

(NRTE) poultry products to determine the prevalence of Salmonella and

Campylobacter in NRTE comminuted poultry, and to develop pathogen reduction

performance standards for these products.

• In 2014, FSIS published the Modernization of Poultry Slaughter Inspection; Final

Rule (Federal Register Docket No. FSIS-2011-0012; August 21, 2014) to facilitate

pathogen reduction in poultry products, improve the effectiveness of poultry

slaughter inspection, make better use of Agency’s resources, and remove

unnecessary regulatory obstacle to innovation. In this publication, FSIS informed

industry that it was removing the codified Salmonella pathogen reduction

performance standards for poultry (9 CFR 381.94(b)). Furthermore, in another

publication (Federal Register Docket No. FSIS-2012-0038; June 5, 2014), FSIS

announced that it will analyze for Salmonella all raw beef samples collected for shiga
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 52

52

toxin-producing E. coli (STEC) analysis including the follow-up samples in response

to STEC positive results. In addition, the raw ground beef samples portion for

Salmonella analysis increased from 25 grams to 325 grams. FSIS will gather data

necessary to determine the prevalence of Salmonella in ground beef and beef trim to

propose new performance standards for ground beef.

• In January 2015, the Agency identified new Salmonella and Campylobacter

performance standards for raw chicken parts and NRTE comminuted poultry

products. (FRN Docket No. FSIS-2014-0023; January 26, 2015). It also announced

that it will use the results of routine sampling throughout the year, using a moving

window approach, to assess whether the establishment’s processes are effectively

addressing pathogens on poultry carcasses and other products derived from these

carcasses. In this publication, FSIS is also implementing an exploratory sampling of

raw pork products for pathogens of public health concern, as well as indicator

organisms.

Why Salmonella and Campylobacter?

Salmonella was selected as the target pathogen because it is the leading cause of

foodborne illness among enteric pathogens, it is present at varying frequencies on all types

of raw meat products, and it can easily be tested for in a variety of products. Furthermore,

improvements in process control that result in reductions in Salmonella are expected to

result in reductions of other pathogens found in the intestines of animals.

Campylobacter species, specifically C. jejuni and C. coli, are most often isolated from the

intestinal tract of poultry as well as in poultry products. Campylobacter bacteria are the

second most frequently reported cause of food borne illness, and Campylobacter jejuni is

the most common strain causing illness.

Salmonella and Campylobacter can be transmitted to humans by eating foods contaminated

with animal feces. The goal of the newly revised Salmonella and Campylobacter testing

program is to protect the consumer from contaminated products, especially from fecal

contamination, by verifying that each establishment’s performance meets the new

performance standards for poultry as well as the Salmonella performance standard for meat

products as codified in 9 CFR 310.25(b). In addition to reporting individual Salmonella and

Campylobacter sample results to establishments, FSIS posts nationwide Salmonella and

Campylobacter data on its website on a quarterly basis.

FSIS collects raw meat and poultry products samples from establishments and test the

samples for Salmonella and Campylobacter to verify that establishments are meeting the

pathogen reduction performance standards. Pathogen reduction performance standards for

raw products are an essential component of FSIS food safety strategy as they provide a

direct measure of progress in controlling and reducing the most significant hazards

associated with raw meat and poultry products. Accordingly, the collection of samples in

establishments by inspection program personnel is a significant Agency priority.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 53

53

Salmonella and Campylobacter Verification Testing

Testing is conducted in plants by FSIS personnel, who collect both carcass and ground

product samples.

The Salmonella and Campylobacter verification sampling is conducted in establishments by

FSIS inspection program personnel (IPP). IPP will collect samples using on-going

scheduled sampling (routine sampling) using a moving window approach to assess process

control for all Salmonella performance standards.

It is important for IPP in establishments slaughtering or producing raw intact or raw nonintact chicken and turkey products to update the establishment’s Public Health Information

System (PHIS) profile information as per FSIS Notice 12-15. The Agency has made

changes to the product group options in the PHIS establishment profile to identify

establishments that produce specific types of raw intact and non-intact chicken and turkey

products.

Products Eligible for Sampling

Raw ground products, sampled and analyzed for Salmonella include:

• Ground and chopped raw meat from cattle carcasses (beef or veal which may or

may not contain added ingredients, spices, or seasonings), that meet the standards

of identity for ground and chopped beef (9 CFR 319.15(a)) and hamburger (9 CFR

319.15(b)). Sampled products may contain meat derived from advanced meat

recovery (AMR) systems, but AMR meat by itself is not sampled.

– Products that are not sampled in this program include beef patties as defined

in 9 CFR 319.15(c), and fabricated steaks and similar products as defined in

9 CFR 319.15(d).

Note: Salmonella verification sample sets for raw ground beef products have been

discontinued with the exception at establishments that recently exceeded the

performance standard and are in ‘Category 3’ (FSIS Notice 28-14). FSIS also

discontinued collecting MT43S samples in very low volume grinding establishments.

In addition, raw beef samples collected for STEC analysis are also analyzed for

Salmonella.

Note: FSIS is not currently sampling and testing for Salmonella in steers or heifers,

cows or bulls, or market hogs per FSIS Directive 10,250.1.

IPP also collect the following poultry samples, using a moving window sampling approach,

to be analyzed for both Salmonella and Campylobacter as described in Directive

10,250.1, Notice 22-15, and FSIS Notice 31-15.

• Poultry carcasses

– young chicken carcasses including broilers, fryers, roasters, and Cornish

game hens, as described in 9CFR 381.170(a), and

– young turkey carcasses
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 54

54

• NRTE comminuted poultry

NRTE comminuted poultry is any non-breaded, non-battered, raw NRTE chicken or

turkey product that has been processed to reduce the particle size which may or may

not contain added ingredients. NRTE comminuted poultry includes:

(1) ground (Ground product group category) – ground chicken or turkey for any

purpose (e.g., packed for consumer or for any type of further processing); or

(2) mechanically separated (Mechanically Separated product group) –

mechanically separated chicken or turkey, as defined in 9 CFR 381.173; or

(3) hand or mechanically-deboned and further chopped, flaked, minced, or

otherwise processed to reduce particle size. Chicken or turkey product, other

than ground or mechanically separated falls under the Other Non-intact

product group. These products include:

– NRTE comminuted chicken product may be derived from any age

chicken, including young chickens (broilers, fryers, and roasters), fowl,

capons, and roosters, as defined in 9 CFR 381.170(a)(1); and

– NRTE comminuted turkey product may be derived from any age turkey,

including young turkeys, yearling turkeys, and old turkeys, as defined in 9

CFR 381.170(a)(2).

Note: These products include final (consumer-ready) products or intermediary product for

further processing as NRTE product that are destined for sale as NRTE product for

consumers.

Note: The Agency does not collect samples of chickens/turkeys or chicken/turkey products

produced under a religious exemption and not bearing the mark of inspection. Products from

any product class diverted for pet food manufacture without the mark of inspection are also

not sampled. In addition, FSIS does not currently sample eligible product for Salmonella

testing from poultry establishments that produces less than 1,000 pounds per day.

As explained in the January 26, 2015 Federal Register Notice (Docket Number FSIS-2014-

0023), FSIS began exploratory sampling of chicken parts as well as of raw pork products for

pathogens of public health concern as instructed in FSIS Notice 16-15 and FSIS Notice 23-

15 .

• Raw Chicken Parts Sampling Project: FSIS Notice 16-15 instructs IPP to collect raw

chicken parts (finished product) to be analyzed for Salmonella and Campylobacter.

Chicken parts that are subject to sampling include those that are non-intact (that

have been needle injected with clear liquid or marinated in a clear solution,

mechanically tenderized, vacuum tumbled, or similarly processed; refer to

Attachment 1 of the notice). Definitions are found in 9 CFR 381.170(b), Standards for

kinds and classes, and for cuts of raw poultry. Eligible chicken parts for sample

collection include:

— Legs: whole legs (no backbone attached), drumsticks, thighs, and cut up or

portioned leg meat (3/4 inch larger in at least one dimension),

— Breasts: whole and half breasts (with or without ribs), boneless and skinless

breasts, tenderloins and tenders, and cut up portioned breast meat (3/4 inch

larger in at least one dimension), and
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 55

55

— Wings: whole wings (with or without the wing tip), mixed wing sections,

drummettes, mid-sections (flats), wing tips, and boneless wings

Note: Chicken half carcasses and quarter carcasses are not eligible for collection

under this sampling program.

• Raw Pork Products Exploratory Sampling Project (RPPESP): As stated in FSIS

Notice 23-15, IPP are to collect samples at establishments that produce raw pork

products as part of the nationwide RPPESP. These samples are analyzed for

Salmonella as well as for indicator organisms. The eligible raw pork products include:

— Raw intact pork products – retail cuts, tray ready cuts, foodservice cuts, or

portion cuts prepared for consumers that have not been tenderized, injected,

pumped, or vacuum tumbled; and

— Raw non-intact pork products – retail cuts, tray ready cuts, foodservice cuts, or

portion cuts prepared for consumers that have been tenderized, injected,

pumped, or vacuum tumbled; ground pork, mechanically separated pork, AMR

pork, pork sausage, patties or other formed products; and other comminuted

pork.

Circumstances in Which Sampling is not Warranted

Even though most raw meat and poultry products are subject to Salmonella testing, there is

a narrow set of circumstances in which sampling is not warranted. According to FSIS

Directive 10,250.1, when an establishment processes all its products into ready-to-eat (RTE)

product or diverts all of its raw products to another federally-inspected establishment for

further processing into a RTE product, FSIS will exclude the establishment from the

Salmonella verification testing program.

If an establishment claims that all products are processed into RTE product, IPP are to verify

this during the performance of a HACCP procedure, by observing that all the products are

actually further processed into RTE product in the establishment, or by reviewing records to

ensure that all products are further processed into RTE products in the establishment.

The Performance Standards

FSIS replaced its existing Salmonella sampling set-approach with a routine sampling

approach for ALL FSIS-regulated products subject for Salmonella and Campylobacter

verification testing. This includes broiler and turkey carcasses, chicken parts, comminuted

poultry, ground beef (tested for Salmonella only), and beef manufacturing trimmings (tested

for Salmonella only). Salmonella and Campylobacter performance standard verification

samples are taken as part of a moving window and the results are used to determine if an

establishment is meeting the performance standard on a continuous basis. When assessing

process control under a moving window approach, FSIS intends to evaluate, over a certain

period of time, a number of sequential results from a single establishment. Thus, given the

fixed timeframe of one year (52 weeks) for which an establishment has been sampled, FSIS

would assess the first moving window by evaluating the number of samples taken within the

52-week period.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 56

56

As an example, if an establishment has five Salmonella positives within 52 samples (one

sample per week for a year), then the establishment passed the performance standard if the

performance standard allows five positive samples among 52 samples. When the next

sample is taken (week 53, in this example), the moving window would shift forward the fixed

timeframe of one year (52 weeks); that is, the original week 1 (and the original first sample)

is excluded, while the most recent week is included in the new 52-week moving window.

This shifting is repeated with each new week and allows FSIS to continuously assess the

process control of an establishment.

The charts below shows the maximum acceptable percent positive results or number of

positives results allowed in the moving window before the establishment fails to meet the

performance standard. A test is considered positive when any Salmonella or Campylobacter

organisms are found.

Salmonella/Campylobacter Performance Standards for Poultry

Product Maximum Acceptable

% Positive

Performance Standard

Salmonella Campylobacter Salmonella Campylobacter

Broiler

Carcasses^

7.5 10.4 5 of 51 8 of 51

Turkey

Carcasses^

1.7 0.79 4 of 56 3 of 56

Comminuted

Chicken*

25.0 1.9 13 of 52 1 of 52

Comminuted

Turkey*

13.5 1.9 7 of 52 1 of 52

Chicken Parts* 15.4 7.7 8 of 52 4 of 52

^ The maximum percent positive for Salmonella and Campylobacter under the performance

standards for young chicken and turkey carcasses is listed in FSIS Directive 10,250.1

* Developed proposed performance standards published in the FRN Docket No. FSIS-2014-0023

Note: The new Salmonella performance standards are to be applied to sample results in place of the

performance standards for young chickens (as broilers) and ground chicken and ground turkey

codified in 9 CFR 381.94(b).

For highest-volume establishments, FSIS expects to collect 52 samples within the 52-week moving

window. In this case, to assess process control (at establishments producing products with

performance standards measured in 52 samples), one need only to count the number of positives test

results within the 52-week moving window. For example, the proposed performance standard for

Salmonella in raw chicken parts is eight positives out of 52 samples. Assuming that 52 samples were

collected from the establishment within a 52-week moving window, if the establishment has eight or

fewer Salmonella positives within that 52-week timeframe, then it would pass the performance

standard. If, on the other hand, the establishment has nine or more Salmonella positives within that

same 52-week timeframe, then it would fail the performance standard.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 57

57

To assess process control in establishments that FSIS samples less often than weekly (i.e., lower

volume establishments), FSIS will assess establishment performance (as percent positive) based on

the (likely variable) number of samples collected and positive results within the 52-week moving

window. To illustrate this point, if a small establishment producing raw chicken parts is sampled fewer

than 52 times in the 52-week moving window, only 26 times, for example, with three of those samples

testing positive for Salmonella, 26 will be the denominator while three be the numerator. This gives

the establishment a percent positive of 11.5 ((3 ÷ 26) X 100 = 11.5%). In this example, the resulting

percent positive is less than 15.4, the acceptable percent positive for the proposed performance

standards for Salmonella in raw chicken parts. As such, the establishment would pass the

performance standard.

Salmonella Performance Standards for Ground Beef

1

Product

class Pathogen Performancestandard

Number

of

samples

tested

Sampling

Method

Maximum

number

of

positives

to

achieve

standard

Revised

Standard

Implemented

Ground

Beef Salmonella 7.5% 53

One

sample

per

event

5 N/A

1 As per Directive 10,250.1

For ground beef, an establishment can have no more than 5 positive sample results out of

53 samples in the moving window.

Sampling Procedures

The purpose of the Salmonella and Campylobacter verification sampling program is to verify

the establishment’s process control for all applicable products. All eligible products

produced at an establishment will be scheduled for sampling during the month under routine

sampling. For example, if an establishment produces more than one product type (chicken

carcasses, chicken parts, and NRTE comminuted chicken) that is eligible for sampling, then

all of those products will be scheduled for sampling during the month. IPP are to collect

samples in accordance with the step-by-step directions found in FSIS Directive 10,250.1

and FSIS notices for all product classes including young chicken and turkey carcasses.

Salmonella and Campylobacter verification sampling is a directed sampling task. Taking

into account risk factors including production volume and past establishment testing

performance (i.e., positive Salmonella and Campylobacter test results), FSIS will establish

the sampling frequency accordingly for a particular establishment. The Public Health

Information System (PHIS) displays sampling tasks (including the sampling project code) on

the establishment task list for the sampling programs that apply to the establishment.

The specific sampling methodologies for the product classes to be sampled are explained in

detail in FSIS Directive 10,250.1 and applicable FSIS notices.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 58

58

IPP collect samples using a carcass sponge swab, a whole bird rinse, or taking a specific

amount of ground/comminuted product using the sampling technique as described in FSIS

Directive 10,250.1 and in published FSIS notices. Even though the Agency is not collecting

livestock carcasses samples, the sampling procedures for cattle and hog carcasses are also

included in the directive in case they are needed for special purposes.

Turkey carcasses are sampled using a sponge sample technique. Sponge sampling of

turkey carcasses uses two sponges, one that is analyzed for Salmonella and the other for

Campylobacter. Sponge sample sites are to the left and right of the back and thigh as per

instructions delineated in the directive.

Chicken carcasses are sampled using whole bird rinses; IPP are to collect 100 ml rinsate.

Note: For poultry carcasses, at the post-chill sampling location, IPP are to determine a

random time at which the carcass will reach the end of the drip line or the equivalent point in

air-chill systems. IPP are to randomly select a poultry carcass from the post-chill area (after

all interventions have taken place) and to allow drip time to prevent dilution of the sample.

Chicken parts are sampled by collecting approximately 120 ml of rinsate from 4 lbs. ± 10%

of the eligible raw chicken parts.

The amount of ground product collected (final package or aseptically when not in final

package) by the IPP will depend on the sampling project code as follows:

• Ground beef products, as well as raw beef trim samples collected for routine and

follow-up projects for E. coli O157:H7 and other STECs are sampled as per

instructions in FSIS Directive 10,010.1.

• NRTE comminuted poultry products are sampled by collecting sufficient product to fill

the two provided Whirl-Pak bags up to the fill-line indicated on each bag, following

the instructions as described in FSIS Notice 31-15. The total weight of the two bags

of samples should be approximately two pounds. This larger sample size will provide

consistency as the Agency moves toward analyzing each sample for both

pathogens.

For the RPPESP, IPP will be collecting fresh, not frozen, raw pork samples in final

packaging, whenever possible, corresponding to 2 lbs.

In establishments that produce more than one type of product subject to testing, all eligible

products produced will be scheduled for sampling during the month under routine sampling.

Defining Categories

If the sample under the routine Salmonella verification sampling meets the Salmonella and

Campylobacter performance standards (i.e., the maximum acceptable percent positive

allowed under the moving window approach), it passes. If the sample results in the moving

window exceed the maximum percent positive allowed, the establishment has not met the

performance standard.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 59

59

FSIS uses categories in evaluating an establishment’s level of process control and for

scheduling Salmonella and Campylobacter performance standard verification testing. For

all products sampled under routine Salmonella verification sampling, FSIS has modified the

time component of the categories definitions as follows:

Category 1 – Consistent Process Control: Establishments that have achieved 50 percent

or less of the performance standard during all completed 52-week moving windows over the

last six months. This performance demonstrates the best process control for this

pathogen.

Category 2 –Variable Process Control: Establishments that meets the standard for all

completed 52-week moving windows but have results greater than 50 percent of the

standard during any completed 52-week moving window over the last six months. This

performance demonstrates intermediate process control for this pathogen.

Category 3 – Highly Variable Process Control: Establishments that have exceeded the

performance standard during any completed 52-week moving window over the last six

months. This performance demonstrates the least process control for this pathogen and

means the establishment has failed the Salmonella performance standard.

The Agency will also post the following information on the FSIS Web site:

http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-andreports/microbiology/salmonella-verification-testing-program/.

• Beginning July 1, 2015, FSIS will begin web-posting individual establishment

category information for chicken and turkey carcasses.

• Until July 2015, FSIS will continue to web-post existing Category 3 poultry carcass

establishments.

• The Agency will post aggregate reports quarterly showing the categories 1/2/3

distribution for each relevant product class subject to FSIS Salmonella and

Campylobacter testing, as applicable.

– FSIS will continue to post aggregate reports for chicken and turkey slaughter

establishments showing category distribution for current performance

standards for carcasses.

– Starting in March 2015, FSIS will begin posting aggregate reports showing

the category 1/2/3 distribution for chicken parts as data becomes available,

and comminuted chicken and turkey using historical data and new results

beginning in March based on the proposed performance standards.

Agency Actions

Under the new performance standards and under the new moving window approach, when

an establishment does not meet a performance standard (i.e., the number of positive

samples within a specified timeframe exceeds the maximum acceptable for that product

class), FSIS will immediately conduct follow-up samples that will be analyzed for both

Salmonella and Campylobacter, where applicable. Specifically, either 16 or eight follow-up

samples will be collected depending on the size and production volume of the
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 60

60

establishment. The Agency will analyze the follow-up sampling data independent of the

moving window approach to assess whether the establishment is making or has made

changes to its food safety system to improve its process control.

In addition, when the establishments do not meet the performance standards, FSIS will

conduct a for-cause Food Safety Assessment (FSA) at the establishment that produced the

product.

Even when establishments meet the performance standards, if FSIS Salmonella or

Campylobacter verification testing data from an establishment show a high number of

positives or serotypes of human health significance, FSIS may perform Incident

Investigation Team testing or conduct a for-cause FSA that includes collection of samples or

take other appropriate actions (additional sanitary dressing verification procedures) at the

establishment that produce the product.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 61

61

Salmonella Regulations, Livestock, 310.25(b)

Sec. 310.25 Contamination with microorganisms; process control verification criteria

and testing; pathogen reduction standards.

(b) Pathogen reduction performance standard; Salmonella. (1) Raw meat product

performance standards for Salmonella. An establishment's raw meat products, when

sampled and tested by FSIS for Salmonella, as set forth in this section, may not test positive

for Salmonella at a rate exceeding the applicable national pathogen reduction performance

standard, as provided in Table 2:

Table 2--Salmonella Performance Standards

Class of product

Performance Standard

(percent positive for

Salmonella)a

Number of

samples

tested

(n)

Maximum

number of

positives to

achieve

Standard

(c)

Steers/heifers...................

Cows/bulls........................

Ground beef .....................

Hogs...............................

Fresh pork sausages...........

1.0%

2.7%

7.5%

8.7%

b N.A.

82

58

53

55

N.A.

1

2

5

6

N.A.

a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on

the indicated raw product based on data developed by FSIS in its nationwide microbiological

data collection programs and surveys. Copies of Reports on FSIS's Nationwide

Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in

determining the prevalence of Salmonella on raw products are available in the FSIS Docket

Room.

b Not available; values for fresh pork sausage will be added upon completion data collection

programs for those products.

(2) Enforcement. FSIS will sample and test raw meat products in an individual

establishment on an unannounced basis to determine prevalence of Salmonella in such

products to determine compliance with the standard. The frequency and timing of such

testing will be based on the establishment's previous test results and other information

concerning the establishment's performance. In an establishment producing more than one

class of product subject to the pathogen reduction standard, FSIS may sample any or all

such classes of products3.

3 A copy of FSIS's ``Sample Collection Guidelines and Procedure for Isolation and Identification

of Salmonella from Meat and Poultry Products'' is available for inspection in the FSIS Docket

Room.

(3) Noncompliance and establishment response. When FSIS determines that an

establishment has not met the performance standard:

(i) The establishment shall take immediate action to meet the standard.

(ii) If the establishment fails to meet the standard on the next series of compliance tests

for that product, the establishment shall reassess its HACCP plan for that product and take

appropriate corrective actions.
FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through

08/17/2015

Entry Training for PHV 62

62

(iii) Failure by the establishment to act in accordance with paragraph (b)(3)(ii) of this

section, or failure to meet the standard on the third consecutive series of FSIS-conducted

tests for that product, constitutes failure to maintain sanitary conditions and failure to

maintain an adequate HACCP plan, in accordance with part 417 of this chapter, for that

product, and will cause FSIS to suspend inspection services. Such suspension will remain in

effect until the establishment submits to the FSIS Administrator or his/her designee

satisfactory written assurances detailing the action taken to correct the HACCP system and,

as appropriate, other measures taken by the establishment to reduce the prevalence of

pathogens.
532

Export Certification
Office: Export Certification

33-2

533

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

Scientific..............................................................................................................................3

Regulatory/Administrative ...................................................................................................3

EXPORT REVIEW..................................................................................................................4

Purpose of Export Certification............................................................................................4

FSIS Directive 9000.1 .........................................................................................................4

Review Questions ...............................................................................................................5

SCENARIO.............................................................................................................................6

Scenario – Part 1.................................................................................................................6

Scenario 1 – Part 1 (continued)...........................................................................................6

Question 1...........................................................................................................................7

Questions 2 & 3...................................................................................................................7

Question 4...........................................................................................................................8

Scenario – Part 2.................................................................................................................8

Scenario – Part 2 (continued)..............................................................................................8

Scenario – Part 2 (continued)..............................................................................................9

Question 5...........................................................................................................................9

FSIS Directive 9000.1 and FSIS Form 9060-6 ....................................................................9

Scenario – Part 3............................................................................................................... 10

Question 6......................................................................................................................... 10

Scenario – Part 4............................................................................................................... 10

Questions 7 & 8................................................................................................................. 11

FSIS Directive 9000.1: Replacement Certificates.............................................................. 11

FSIS Directive 9000.1: Replacement Certificates (continued)........................................... 12

Scenario – Part 5............................................................................................................... 13

Question 9......................................................................................................................... 13

Scenario – Part 6............................................................................................................... 14

Question 10....................................................................................................................... 14

FSIS Directive 9000.1: FSIS Form 9060-5 ........................................................................ 14

Scenario – Part 7............................................................................................................... 15

Scenario – Part 7 (continued)............................................................................................ 16

Question 11....................................................................................................................... 16

You Signed!....................................................................................................................... 16

FSIS Directive 9000.1: Certifying Official Recap ............................................................... 17

SUMMARY ........................................................................................................................... 17
Office: Export Certification

33-3

3

Slides LEARNING OBJECTIVES

N/A Scientific:

[None for this topic in this context.]

Regulatory/Administrative:

1. Demonstrate facility in using the Export Library and FSIS Directive 9000.1 for

the following:

• Locating requirements of individual countries

• Locating instructions for export certification

• Locating documents used in export certification

2. Identify the appropriate export circumstances for the following:

• Letterhead certificate

• Replacement certificate

• Transit certificate

• Continuation form

• Export certificates that cannot be certified

3. Recognize CSI inspection activities for export certification, evaluate the

accuracy and completeness of sample applications and certificates, and

distinguish the CSI’s role from the PHV’s role in export certification.

4. Describe some circumstances where you are justified in your refusal to sign an

export certificate and the follow-up actions you would take in documenting this.

5. Recognize accountable items in export certification, such as stamps, logs, and

other documents.
Office: Export Certification

33-4

4

Slides EXPORT REVIEW

2 Purpose of Export Certification

• Instills confidence in US meat and poultry products worldwide

• FSIS is authorized to issue official certificates for export of inspected and

passed products to any foreign country

• Certification activities verify that all products are wholesome and the

requirements of the importing country are met

3 FSIS Directive 9000.1

• FSIS Directive 9000.1:

o Provides clear set of instructions for Inspection Program Personnel

o Clarifies purpose of Export Library

o Clarifies inspection verification activities for FSIS Form 9060-6 and FSIS

Form 9060-5
Office: Export Certification

33-5

5

4 Review Questions

What is the 9060-6?

❑ Export certificate

❑ Export certificate checklist

❑ Application for export

Who fills out the 9060-6?

❑ CSI

❑ FI

❑ PHV

What is the 9060-5?

❑ Application for export

❑ Export certificate checklist

❑ Export certificate

Who verifies the information on the 9060-5 is correct and signs with professional

degree if indicated?

❑ PHV

❑ CSI

❑ FI

How does the PHV verify information is accurate with regards to country requirements

prior to signing?

❑ Consult online export library

❑ Read all FSIS directives

❑ Phone a friend
Office: Export Certification

33-6

6

Slides SCENARIO

5 Scenario – Part 1

You, Jim Bakeon, are a new PHV at a young chicken slaughter establishment. It is the

third day at your duty station and the phone rings at 8:00am. It's a consigner, Benjamin

Waffle, from an ID warehouse requesting that some export documents be presented

for your review and signature around 1:00pm today. He mentions that there will be a

replacement certificate accompanying the folder since the original was lost. You

vaguely remember something about replacement certificates from your training but

have your FLS on speed dial just in case. He asks if he can come back around 3:00pm

to pick them up.

6 Scenario 1 – Part 1 (continued)

When you come back to the office from giving afternoon breaks, you notice some

folders on your desk and open them up. When looking through the documents and

reading the export application, you get an uncomfortable feeling and realize that these

ham products weren't even produced at your duty station.
Office: Export Certification

33-7

7

7 Question 1

1. True or False: You can refuse to sign an export certificate based on the fact that

the products being shipped weren’t produced at your duty station or inspected

by IPP at the current establishment.

8 Questions 2 & 3

2. What are some options that you have to ensure or gain familiarity with the

products involved?

3. Does the Certifying Official have to be directly associated with the inspection of

the product?
Office: Export Certification

33-8

8

9 Question 4

4. Can the Certifying Official refuse to sign FSIS Form 9060-5?

10 Scenario – Part 2

You decide to call the CSI from the originating federally inspected establishment since

this is your first time conducting exports. You call over to est-711 Hog Heaven and CSI

Peg Benedict assures you that she has been performing inspection for over 20 years.

11 Scenario – Part 2 (continued)

She states that hogs are receiving ante-mortem and post-mortem inspection as

evidenced by HATS activities in PHIS and that the line is fully staffed with FIs. She

sends you some sampling results and says you can call her back any time if you need

help.
Office: Export Certification

33-9

9

12 Scenario – Part 2 (continued)

Then you decide to call the federally inspected processed ham facility where the

carcasses were further processed and cured into diced ham. CSI Mary Nara answers

the phone and says that she has been performing export activities for over 5 years as

well as preparing export applications independently for a few years. She mentions that

all of the FSIS micro results in the last year have been negative, they have a very good

history of SPS and SSOP compliance and have had no recalls or consumer complaints

since she has worked there.

14 Question 5

5. You ask Inspector Nara if the boxes for export were stamped in her presence

and she replies, “No, they are pre-stamped by establishment employees.” Is this

acceptable?

15 FSIS Directive 9000.1 and FSIS Form 9060-6

• Sign application for export

• Retain copy and documents for filing

• Provide FSIS Form 9060-5 (export certificate)

• Issue export stamp

• Allow establishment to stamp product

• After stamping, secure export stamp
Office: Export Certification

33-10

10

15 Scenario – Part 3

You are satisfied that the export application is properly and accurately filled out and are

comfortable after speaking to all IPP involved with producing the product. You now

move on to the export certificate which is what you (Jim Bakeon), the PHV or Certifying

Official, will sign.

16 Question 6

6. What are some other PHV responsibilities in reviewing the export certificate?

17 Scenario – Part 4

Now you turn your attention to the replacement certificate, often referred to as the “in

lieu of” certificate.
Office: Export Certification

33-11

11

18 Questions 7 & 8

7. What is a replacement certificate?

8. What are some reasons that a replacement certificate may be issued?

19 FSIS Directive 9000.1: Replacement Certificates

• FSIS Form 9060-6 is submitted to request new FSIS Form 9060-5

• If possible, must accompany original and all supporting documents

• If original was lost, letter from the exporter to the Certifying Official stating that

original will be returned if found
Office: Export Certification

33-12

12

20 FSIS Directive 9000.1: Replacement Certificates (continued)

Before signing replacement certificates, verify the following:

• Statement "Issued in lieu of certificate # ."

• The export mark on the product covered by this certificate shows certificate #

• Obtains superseded certificate (if possible)

• Statement "Superseded by certificate # ."

• Attaches to Inspector copy and files
Office: Export Certification

33-13

13

21 Scenario – Part 5

You review the replacement certificate:

22 Question 9

9. Based on your review, are you going to sign the 9050-5? Why or why not?
Office: Export Certification

33-14

14

23 Scenario – Part 6

You contact the exporter and they promptly return to your duty station. You explain

your reasoning behind your refusal to sign the export certificate. They ask if they can

return tomorrow with the corrected forms. You say you will see them tomorrow.

24 Question 10

10.What are the required actions after you, PHV Jim Bakeon (the Certifying

Official), have refused to sign the 9060-5?

25 FSIS Directive 9000.1: FSIS Form 9060-5

Refusal to sign Export Certificates:

• If there are questions about:

o FSIS Form 9060-6

o FSIS Form 9060-5

o Letterhead Certificates

o Any other documentation
Office: Export Certification

33-15

15

For questions on any of the documentation, contact:

• The exporter

• The Inspection Program Personnel

• The Policy Development Staff

26 Scenario – Part 7

The consigner returns the following day with the correct forms with the corrected dates.

You have discussed the issue with your FLS and you are ready to sign. The CSI has

taken the last government pen to evisceration for pre-chill tests. You find a pen in your

drawer and sign.
Office: Export Certification

33-16

16

27 Scenario – Part 7 (continued)

The 9060-5 looks like this:

28 Question 11

11.Is this acceptable?

29 You Signed!
Office: Export Certification

33-17

17

30 FSIS Directive 9000.1: Certifying Official Recap

As the Certifying Official, your responsibilities include:

• Receiving completed FSIS Form 9060-6

• You may or may not have inspected the product

• Verifying other documentation as required by importing country, Letterheads,

and FSIS Form 9060-5

• Verifying all information through the Export Library

• Signing originals in anything other than black ink

• Using your professional degree, if required

Slides SUMMARY

31 Review your score on the Summary screen and notes about this topic. Make note of

any areas that you need to work on.

Please note that this score does not count toward your overall class grade. Rather, it

helps you identify which areas you may need to study more in preparation for your

exams. Your overall class grade only consists of the daily quizzes, midterm exam, and

final exam. Any scores you receive on Knowledge Check questions or course activities

are not counted. They are for your use only.
549

Export Certification

Objectives

After completing this module, you will be able to:

1. Locate and access current export information and USDA partner websites

on the Internet.

2. Evaluate and verify all information on FSIS Form 9060-6 and FSIS Form

9060-5.

3. Describe how to perform the Inspection Verification Procedures outlined in

FSIS Directive 9000.1, FSIS Directive 9040.1, and FSIS Notice 38-14

4. List the reasons why a Certifying Official would not sign an FSIS Form

9060-5

5. Generate and file Memoranda of Interviews related to Export Certification.

6. Describe the required AMS documents for Export Verification and Less

Than 30 Months of Age Verification Quality System Assessment Programs

(EV/QSA).

7. Describe the notification procedure if an establishment fails to meet the

requirements of its approved EV/QSA Program.

8. Conduct export certification duties according to Agency guidance.

Resource Materials

• FSIS Directive 9000.1 Export Certification

• FSIS Directive 9000.2 – Inspection and Export Certification of Livestock

Intestines or Casings

• FSIS Directive 9010.1 Export Products returned to the US

• FSIS Directive 9040.1 Re-inspection of Product

• FSIS Notice 35-15 PHIS Modification in Preparation for the Implementation of

Export Certification within PHIS

• FSIS Notice 24-15 Export of Product with a Country Label Designation

Different from the Export Certificate Designation

• FSIS Notice 19-15 Requirement for a Special Certification Statement For

Export of Raw Poultry and Raw Poultry Product To Canada

• FSIS Notice 61-14 Clarification of Re-Inspection Procedures for Product

presented for Export at Official Establishments

• FSIS Notice 38-14 Certifying Products under Export Verification and Less

Than 30 Months of Age Verification Quality System Assessment (EV/QSA)

Programs

• FSIS Notice 30-13 Verification and Enforcement Activities Related to Export

Certification Reimbursable Services (expired)

• FSIS Export Library
550

• ImportExport@fsis.usda.gov

• askFSIS

Web sites

Export Library

FSIS Policy Development Division

Agriculture Marketing Service

Introduction

Before we get into the details regarding export certification, let’s cover some

basics. First, what is meant by the term “export?” The Webster’s Dictionary

definition of the word “export” is, “to send goods from one country to another for

the purpose of sale.” In this case, we are interested in meat, poultry, and egg

products which are inspected and passed for wholesomeness by FSIS at official

FSIS slaughter and processing establishments, and approved cold storage

establishments that are being exported from the U.S. to other countries

throughout the world.

What is the purpose of export certification? The export certification process

provides assurance that US meat and poultry products are in compliance with the

importing country’s requirements. As the competent authority, FSIS issues

official certificates for export of inspected and passed products to any foreign

country. The certification activities performed by Inspection Program Employees

verify that all requirements of the importing country are met.

Statutory and Regulatory References

Federal Meat Inspection Acts 21 U.S.C 615-618

21 USC 615 – Inspection of carcasses and parts offered for export

21 USC 616 – Authorizing inspectors and certificates

21 USC 617 – Clearance prohibited to vessel without certificate

21 USC 618 – Certificates and copies

Let’s review the regulatory references related to your export certification duties.

There are several provisions of the FMIA related to exported product.
551

21 USC 615 states: “The Secretary shall also cause to be made a careful

inspection of the carcasses and parts thereof of all cattle, sheep, swine, goats,

horses, mules, and other equines, the meat of which, fresh, salted, canned,

corned, packed, cured, or otherwise prepared, is intended and offered for export

to any foreign country, at such times and places and in such manner as he may

deem proper.” This gives FSIS the authority to conduct inspections of products

to be exported.

21 USC 616 states that the Secretary may appoint inspectors who will be

authorized to give an official certificate stating the condition of the meat that is

inspected.

21 USC 617 indicates that any shipper must have a certificate that indicates the

meat to be shipped is sound and wholesome at the time of shipping.

21 USC 618 states that the official certificates of the condition of the meat be

distributed to FSIS, the owner/shipper, and the vessel that will transport the meat

to another country.

Livestock Regulations:

9 CFR 322.1 – Marking products for export

9 CFR 322.2 – Issuing export certificates

9 CFR 322.3 – Transferring products for export

9 CFR 322.4 – Clearance of vessels and transportation

Now, let’s review the regulations that relate specifically to your export duties.

There are a number of regulations that relate to export certification. We will

highlight a few of the most significant ones. First, let’s review the regulations that

cover products from livestock. 9 CFR 322.1 covers marking products for export

using official stamps. 9 CFR 322.2 has some general instructions about issuing

export certificates. The certification process shows that the product has been

inspected and passed, and is not adulterated or misbranded. 9 CFR 322.3

addresses the transfer of products from tanks to containers on vessels. 9 CFR

322.4 states that vessels or carriers destined to a foreign country cannot receive

or transport edible products unless or until an official export certificate has been

issued. Exceptions to this are inspected and passed ship stores, and not more

than 50 pounds of inspected and passed product for the exclusive use of the

consignee that are not for distribution or sale.

Poultry Regulations:

9 CFR 381.104 – Official marks
552

9 CFR 381.105 – Certification process

9 CFR 381.106 – Certificate form

9 CFR 381.107 – Country requirements

9 CFR 381.104 through 112 cover the export requirements related to poultry

products. We will just highlight the requirements in 381.104 through 107. 9 CFR

381.104 shows the official mark of inspection used for poultry products that have

been inspected and passed and will be exported. 9 CFR 381.105 explains the

process of export certification. Just as was true for establishments under the

livestock regulations, establishments that produce poultry products for export

must apply for this service. 9 CFR 381.106 covers the specific form used for

export certification. 9 CFR 381.107 explains that the exporter is responsible for

providing any unofficial documentation needed by the foreign country where the

product will be shipped. It indicates that these certificates may cover articles that

are exempted from the definition of poultry product.

Export Directives and Notices

Now, let’s look at an overview of the specific instructions outlined in FSIS

Directives and Notices regarding your responsibilities for export certification.

FSIS Directive 9000.1 – Export Certification covers the FSIS forms and

verification activities related to export certification. We will review the FSIS

Forms and the instructions contained in this directive in detail.

FSIS Directive 9000.2 – Inspection and Export Certification of Livestock

Intestines or Casings covers how to decide if casings or intestines are eligible for

the mark of inspection and how to certify them for export. There are special

requirements for certifying casings that are not covered in this training material.

FSIS Directive 9000.6 – Export Certification of Egg Products From Other Than

Official Egg Products Plants gives instruction for issuing certificates for egg

products exported from locations other than where they were produced. There

are special requirements for certifying egg products for export that are not

covered in this training material.

FSIS Directive 9010.1 – Export Products returned to the US covers export

product returned to the U.S. It might be refused by the foreign government,

rejected by the buyer, or returned for a number of other reasons. Regardless of

the reason, if exported product is returned to an establishment in your

assignment, the District Office may ask you to verify that the returned product is

not adulterated or misbranded. This directive will not be covered in detail in this

course.
553

FSIS Directive 9040.1 – Re-inspection of Product intended for Export provides

instructions for performing a sensory evaluation or re-inspection of product to

determine the eligibility of the product for export. The purpose of this reinspection is to determine if the product has become adulterated or

unwholesome after production and during storage.

FSIS Directive 12,600.1 Voluntary Reimbursable Inspection Services addresses

non-mandatory services for which the Agency receives reimbursement.

FSIS Directive 12,600.2 Reimbursable Overtime Inspection Services at Meat and

Poultry Establishments provides instruction on how to determine whether

overtime inspection services need to be provided and how to do so during

reimbursable overtime periods.

FSIS Notice 35-15-PHIS Modification in Preparation for the Implementation of

Export Certification within PHIS provides instruction to IPP regarding the new

menu that appeared in PHIS on June 28, 2015. Upon activation of the electronic

certification system this function will be turned on. It currently is non-functional.

The menu is on the left navigational menu and includes Export approvals and

9060 Application with sub-menus.

FSIS Notice 24-15- Export of Product with a Country Label Designation Different

from the Export Certificate Designation covers export eligibility for products that

have labels showing that the product was produced to meet a specific country’s

requirements. Several countries designate additional labeling requirements,

which are included in the Export Library. These additional labeling statements

must be placed on or within cartons or packages intended for export and are

applied in addition to U.S. labeling requirements. The primary purpose of these

labeling requirements is to make clear that the product(s) have been processed

under conditions that meet that country’s import requirements. It does not say,

nor is it intended to mean, that the consignment may be exported only to the

country designated on the label.

IPP may issue original or replacement export certification documents for the

export of products that bear labels designating a different country. These

products may be exported to:

1. The designated country, provided all pertinent Export Library requirements

have been met for the country designated on the label; or,

2. Any other country provided all pertinent Export Library requirements to export

the product to that country have been met. Before signing the certificates, IPP

are to advise the exporters to work closely with the importer for information

regarding eligibility of the product.
554

FSIS Notice 19-15-Requirement for a Special Certification Statement for Export

of Raw Poultry and Raw Poultry Product to Canada-Provides PHVs instructions

for including a special certification statement in the remarks section of the

Certification for Export of Meat and Poultry Products to Canada (FSIS Form

9135) or on FSIS Letterhead Certificate. Required when certifying raw poultry or

raw poultry products to Canada indicating they are free of Highly Pathogenic

Avian Influenza.

FSIS Notice 61-14-Clarification of Re-Inspection Procedures for Product

presented for Export at Official Establishments-This notice clarifies what reinspection procedures to perform when product for export is presented at official

establishments.

FSIS Notice 38-14 – Certifying Products under Export Verification and Less Than

30 Months of Age Verification Quality System Assessment (EV/QSA) Programs

provides instructions for carrying out FSIS’ export certification for meat and

poultry products produced and exported under EV/QSA programs.

FSIS Notice 30-13 – Verification and Enforcement Activities Related to Export

Certification and Reimbursable Services covers under what circumstances IPP

charge for reimbursable services when performing export certification activities.

It also covers how to document noncompliance and when voluntary export

certification reimbursable services can be denied or withdrawn by the District

Office (expired).

EXPORT CERTIFICATION

FSIS Directive 9000.1 Export Certification.

This Directive provides a clear set of standards for the District Offices and

Inspection Personnel to follow. As specified in FSIS regulations, upon application

by an exporter (applicant), an FSIS inspection program employee is authorized to

issue official export certificates for the shipment of inspected and passed products

to any foreign country. This directive also states the importance of reviewing the

importing country’s requirements in the Export Library prior to signing documents

and certificates.

FSIS Form 9060-6 Application for Export

The applicant provides a completed FSIS Form 9060-6 (Application for Export) to

an inspection program employee.
555

Upon receiving an application for export, an inspection program employee reviews

the application to verify that it is complete and that all pertinent information is

included.

Verification activities include that the requirements of the receiving country have

been met. If there are any questions regarding the importing country’s

requirements, visit the Export Library or call the Import/Export Coordination

and Policy Development Staff, OPPD, at ImportExport@fsis.usda.gov or at

(855) 444-9904.

If there are concerns that each product listed on the application is eligible for export

to the country listed on the application:

1. Discuss concerns with exporter

2. Document a Memorandum of Interview addressing what was discussed,

and whether the concerns were adequately addressed

3. Provide a copy of the Memorandum of Interview to the applicant and

maintain a copy in the inspection files.

Perform a sensory evaluation of the product to determine its eligibility for export.

Observe product for off-condition odor, torn or damp cartons which may indicate

that it is or may become adulterated or unwholesome.

1. If there are signs of insanitary product handling and storage, examine the

product per FSIS Directive 9040.1.

2. Take any necessary actions when the product may be adulterated as

provided in FSIS Directive 5000.1 (at official establishments) or FSIS

Directive 8410.1 (at non-official establishments).

3. If there is any reason to question whether the products are properly

identified and labeled to meet FSIS regulatory requirements and the

requirements of the importing country, examine the product as set out in

FSIS Directive 9040.1. If the product is not properly labeled or

misbranded, take the appropriate action as provided in 9 CFR 500 and

FSIS Directive 5400.5, (at official establishments) or FSIS Directive

8410.1 at non-official establishments).

4. If the product in the container or the labeling of the product does not meet

the requirements of the importing country, discuss the concerns with the

applicant and prepare a Memorandum of Interview.

Verify that the foreign language sticker, if required, shows no wording other

than what is shown on the approved label. Also, verify that the exporter,

supplying the foreign language sticker, has a letter which certifies that the

sticker is an accurate translation of the wording on the approved label.
556

After verifying the information on the application for export is correct,

performing a sensory evaluation of the product, and determining that the

product is properly labeled, then complete the following steps.

1. Sign the application.

2. Retain a copy of the application and any accompanying documents for

filing.

3. Return the originals to the applicant.

4. Provide FSIS Form 9060-5 (export certificate) for completion by the

exporter.

5. Issue the export stamp.

6. Allow the establishment to stamp product.

7. Secure the stamp after the establishment finishes stamping the

product.

Under some conditions, pre-stamping of product is allowed. Pre-stamping is

when the establishment stamps the boxes and completes the export certificate

when you are not present. First, verify the establishment has identified an

employee who is responsible for the custody of the stamp and the certificate.

Then, verify the establishment has procedures to make sure the stamp will be

applied in a clear and legible fashion only on boxes that are in sound condition.

Remember that boxes that are torn or damp may indicate that product is not

wholesome. Then, determine that the establishment is aware that the stamp

must be returned once they complete stamping the product. If at any time you

feel it is necessary, you can re-inspect the product that was pre-stamped.

Computer Generated Stamps

An establishment may use a computer generated export stamp (sticker) as long

as the establishment identifies the number of stickers produced before applying

them to product and provides the inspection program employee with any unused

stickers.

Letterhead Certification

In some cases, USDA/FSIS letterhead certification is necessary and is issued for

certain products when specified in the individual country requirements. This

information can be found in the Export Library. If the exporter submits a

letterhead certificate along with the export certificate, verify that:

1.The current version of the letterhead certificate found in the Export

Library was submitted.

2. No statements on the letterhead certificate have been changed.
557

3. The letterhead certificate is dated by the exporter.

4.Any certification required by another USDA Agency (e.g., AMS) is

provided along with the completed letterhead.

After reviewing the documents and before signing the certificate:

1. Check the certificate for accuracy and corrections.

2. Check the boxes indicating that the animal received ante- and postmortem inspection.

3. Check for attachments and ensures that the exporting firm has lined-out

any unused space.

4. Do not initial minor erasures or alterations, unless this is acceptable to a

foreign country. (See Export Library to verify if receiving country permits

erasures or alterations). Most countries do not allow this, or the use of

white out. It is best to reissue the certificate if there are errors.

Sign the original certificate in the signature block in other than black ink, all

continuation sheets, and other certifications, including letterhead certifications. If

the importing country requires a PHV’s signature, the certifying official is to

include his or her professional degree.

Do not stamp the certificate with the export stamp unless required by a receiving

country as specified in the Export Library.

Refusal to Sign Export Certificates

Do not sign the certificate if there are questions about the information on FSIS

Form 9060-6, FSIS Form 9060-5, or any other certificates, including letterhead

certificates. Contact the inspection program employee who signed the

application, the exporter, or the Export Program Staff to address all questions.

Any communication that the certifying official has with the exporter should be

documented in a Memorandum of Interview. If a certifying official refuses to sign

a certificate, the reasons for refusal will be reviewed by the next-line supervisor.

Based on the review, the next-line supervisor will take further actions.
558

Replacement Certificates

A certificate replacing an original export certificate is a re-certification of the

product’s condition at the time of the initial export certification. A

replacement certificate for a lot does not represent that lot’s current condition. A

replacement certificate may be issued in situations such as, but not limited to:

1. The original certificate did not carry required information

2. The original certificate carried incorrect information

3. The name of the consignee or exporter has changed

4. The certificate has been lost

The replacement certificate must be dated with the same issuing date as that

shown on the original certificate

FSIS Form 9060-6 is submitted to request a new certificate and must be

accompanied by (if possible) the original and all copies of the original certificate.

Exception: In the case of lost certificates, the exporter should provide a letter of

assurance to the certifying official stating the certificate will be returned if found.

Before signing a replacement certificate, an inspection program employee:

1. Verifies that the following statement is in the top left margin or in the

“Remarks” block of the new certificate: “Issued in lieu of” certificate no.

. The export mark on the product covered by this certificate

shows certificate no. .”

2. Obtains the superseded certificate (if possible), and:

3. Verifies that it is marked in the left margin or in the “Remarks” block

with the number of the certificate which supersedes it (e.g., “Superseded

by No. ”)

4. Attaches it to the “inspector’s” copy of the replacement certificate

and files it in the government office.

Inventory and Accountable Items

Official export stamps must be controlled at all times. Export certificates, stamps,

and pertinent inventory records must be maintained under official government

lock or seal when not in use. The inspection program employee does not have to

be present in order for the establishment to apply the export stamp to boxes.

However, when the stamp is not in use, it must be secured by FSIS personnel.
559

The inspection program employee at each establishment must maintain an

accurate inventory record of export certificates issued and voided certificates.

Re-inspection of Product intended for Export

FSIS Directive 9040.1 Re-Inspection of Product intended for Export

This directive provides inspection program personnel with the procedures for reinspecting product that has been presented for export. These responsibilities

and procedures apply whether the product is located at the establishment or offsite at a non-official establishment, such as a cold storage facility. This directive

was revised to provide for the examination of boxes or containers in situations

where inspection program personnel have a reason to question whether the

product as labeled meets the importing country’s requirements.

9 CFR 322.2 and 381.105, provide for the re-inspection and certification of

products for export. The purpose of re-inspection is to verify the product’s safety,

wholesomeness, identity, and eligibility for export.

Inspection program personnel conduct a re-inspection of product for export after

they receive and review FSIS Form 9060-6, Application for Export. As set out in

FSIS Directive 9000.1 Export Certification, inspection program personnel are to

verify that each product listed on the application complies with the meat and

poultry products regulations and the importing country’s requirements.

Remember to check the Export Library for updates.

If the application is in order, inspection program personnel perform an

organoleptic examination of the shipping cartons for signs of poor product

handling, or storage. If the cartons are sound, inspection program personnel

proceed by following the instructions in FSIS Directive 9000.1, sign FSIS Form

9060-6, and issue FSIS Form 9060-5 and the export stamp.

FSIS responsibilities when product is determined to be unsound or

unwholesome

If inspection program personnel find signs of poor product handling and storage

while conducting the organoleptic examination of the shipping cartons at either

official or non-official establishments, they are to take the following steps.

1. Do not sign the application.

2. In official establishments and non-official establishments, randomly select up

to 5 percent of the boxes or containers. In considering the percentage of boxes

to select, inspection program personnel should consider the basis for their

concern and the need to expose the contents of boxed product to the

environment.
560

In an official establishment, request the applicant to open the selected sample

of boxes or containers in a manner that will not create insanitary conditions or

lead to product adulteration.

At official establishments when any of the product is determined to be unsound

or unwholesome, issue a Non-Compliance Record under the appropriate HACCP

Verification task and take the appropriate enforcement actions described in FSIS

Directive 5000.1.

In a non-official establishment, request the applicant to open the selected

sample of the boxes or containers in a sanitary environment, or have the

selected samples of the boxes or containers moved to a facility where boxes can

be opened in a sanitary environment.

At a non-official establishment, if the product is found to be adulterated,

unwholesome, damaged, mislabeled or misbranded, do not sign the export

application (FSIS Form 9060-6) for the export certificate and not issue a blank

export certificate (FSIS Form 9060-5). Not signing these documents is the

regulatory control.

At official and non-official establishments, when the establishment refuses to

open the boxes, do not to sign the application and document in a Memorandum

of Interview why the applicant will not open the boxes. Provide a copy of the

memorandum to the applicant and maintain a copy in the inspection files.

FSIS responsibilities when the information of FSIS Form 9060-6 does not

meet requirements.

If inspection program personnel have reason to question whether the product is

properly identified and labeled to meet the importing country’s requirements, use

the inspection methodology outlined in FSIS Directives 5400.5 and 5000.1.

Re-inspect the open boxes to ensure that it is properly labeled, not misbranded

and is eligible for export to the country listed on the application.

Take and document enforcement or detention actions if necessary.

FSIS responsibilities, in official or non-official establishment, if product in

the container or the labeling does not meet the importing country’s

requirements.

1. Discuss concerns with the Applicant.

2. Document a Memorandum of Interview.

3. Provide a copy of the Memorandum to the Applicant and maintain a copy in

the inspection files.

Direct questions to the Import/Export Coordination and Policy Development Staff,

IECPDS, at ImportExport@fsis.usda.gov or at (855) 444-9904.
561

Certifying Products under Export Verification and Quality

System Assessment (EV/QSA) Programs

Notice 38-14 provides IPP with revised instructions for effecting FSIS’

certification process for meat products exported under EV/QSA programs. The

need for an EV/QSA program to produce meat and poultry products exported to

a country is identified in the destination country’s requirements, which are

documented in the Export Library.

The AMS Quality Assessment Division administers the EV/QSA programs. The

Quality Assessment Division is responsible for reviewing and approving

companies as eligible suppliers of meat and meat products under the EV/QSA

programs and for maintaining approved supplier lists and product lists for

individual countries. The EV/QSA programs outline the specified product

requirements for individual countries. See the web page link below for additional

information:

http://www.ams.usda.gov/lsg/lsarc.htm

Approval of establishments under an EV/QSA Program and related FSIS

Responsibilities

When an establishment requests to be approved for participation in an AMS

EV/QSA program, AMS will advise the Import Export Coordination and Policy

Development Staff, OPPD, via e-mail of the establishment’s request at

ImportExport@fsis.usda.gov.

1. Upon receipt of the AMS e-mail, IECPDS is to acknowledge receipt of

the notification by replying to the e-mail at

QAD.AuditService@ams.usda.gov. .

2. IECPDS is to forward the AMS e-mail to the District Office

(DO) where the establishment is located.

3. The DO is to ensure that any IPP, who may be involved with the

certification of product for export under an EV/QSA program, receive

appropriate training prior to conducting EV/QSA-related exports.

If the establishment passes the initial AMS audit and is approved for an EV/QSA

program, IECPDS will receive an electronically-transmitted copy of the audit.

IECPDS is to promptly notify the DO of the approval. If AMS finds minor

deficiencies that don’t affect the establishment’s eligibility to participate in the

program, IECPDS should email the DO with that information. The DO should

then instruct you to be aware of the deficiencies. At the first weekly meeting after

receiving such a report, you should ask establishment managers about changes
562

made in response to the AMS report and what effect the changes had on their

program. Contact your supervisor if you have concerns that the establishment is

not adequately addressing deficiencies.

As a requirement of an approved EV/QSA program, the establishment is to

maintain a copy of all EV/QSA program audit reports. These audit reports

must be made available to FSIS review when needed. .

If an establishment is delisted by AMS, EPS will be notified of the delisting by

AMS. IECPDS is to notify the DO via e-mail, and the DO is to notify the affected

in-plant IPP.

Verification Procedures for EV/QSA Programs

IPP are to determine whether the establishment has an AMS-approved EV/QSA

program. This determination can be made by asking the establishment whether

it has such a program at the weekly meeting and by accessing the FSIS Export

Library (Export Requirements for Countries with an Approved USDA Export

Verification Program) and following the links to the AMS web site that maintains

the list of approved establishments. See the following link:

http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exportingproducts/EV-Programs

IPP are to be aware of the location and contents of the establishment’s approved

EV/QSA program Quality Systems Assessment (QSA) Manual to verify export

requirements relating to proper execution of the program.

IPP will find a list of products intended for export approved under the EV/QSA

Program in the establishment’s QSA Manual as required under the EV/QSA

program. The list is to include all items that are intended for export, the specific

product code numbers, and a detailed description of each item. Maintaining this

information is an AMS requirement as part of an approved EV/QSA program.

The unique product identification system can be accessed by authorized FSIS

inspection personnel from http://inside.fsis.usda.gov/fsis/public/static/index.jsp.

In situations where a supplier and fabricator are separate establishments, the

fabricator is to maintain a list of establishments that are approved EV/QSA

suppliers, as required by AMS. In addition, AMS requires that the fabricator

maintain a list of products that each EV/QSA supplier is approved to provide

under its approved EV/QSA program. As part of the approved EV/QSA

program, these establishment records are subject to FSIS review.

If, based on their verification activities, IPP are concerned that an AMS-approved

EV/QSA establishment is not properly executing its EV/QSA program (for
563

example, attempting to ship product that is not eligible for the importing country),

they are not to sign export applications for the product in question and are to:

1. Notify AMS at QAD.AuditService@ams.usda.gov and provide the

following information in the notification:

• Establishment name, address, and number;

• Product type, product code, and quantity of product;

• Date of production, lot number, and shift;

• Date and nature of observation;

• Name of country for which product is intended;

• Export certificate number (if applicable);

• Any other information to verify claim; and

• Name of IPP documenting concerns.

2. Send a courtesy copy of the notification to their immediate FSIS

supervisor and to IECPDS (ImportExport@fsis.usda.gov) and maintain

a copy of the message in the inspection office export file.

3. Take the appropriate enforcement actions and issue a Non-compliance

Record if any of the problems with the EV/QSA requirements are also

regulatory non- compliance.

Verification Procedures for Product Intended for Export under

EV/QSA Programs

Upon receiving FSIS Form 9060-6, Application for Export Certificate, IPP

are to verify that (following the procedures in FSIS Directive 9000.1):

1. The establishment is on the AMS EV/QSA list as approved to export to

the importing country, and that the product was derived from animals

slaughtered after the date the establishment received AMS approval to

export that type of product to that country; and

2. Each of the products listed on the application is eligible for export to the

country under the country specific EV/QSA program, and each product

is produced under an AMS EV/QSA program.

After determining that the establishment itself is eligible to export to the

importing country, and that the specific products are eligible to be exported to

that country, IPP are to re-inspect the product as set out in FSIS Directives

9000.1 and 9040.1.

If the application or product is not acceptable (for reasons such as, the

application is not complete, or the regulatory requirements have not been met),

IPP are not to sign the application and are to notify AMS that the establishment
564

is not properly executing its EV/QSA program, using the procedure listed in the

above section.

When you receive the appropriate export certification documents, verify that the

documents are complete and accurate, and that the EV/QSA program

requirements were met.

If any of the documents are not accurate,

• Notify the establishment and explain the problem;

• Document the problem in a memorandum of interview; and

• Maintain copies of the documents in question and the

memorandum of interview in the government file.

If all the documents are acceptable, sign all certifications and keep a copy in the

government file along with the certifications.

All time involved with EV/QSA-related verification activities is charged as a

reimbursable service, even when these activities are conducted these activities

during the established tour of duty. Supervisory personnel are to ensure that

IPP are appropriately billing the establishment for these activities. (See FSIS

Directives 9000.1; 12,600.1; and 12,600.2.)
565

Day in the Life: Poultry
Day in the Life: Poultry

34-2

566

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................4

INTRODUCTION AND PREPARATION (5:00 AM).................................................................5

A. Scenario Introduction......................................................................................................5

PRE-OPERATIONAL REVIEW AND OBSERVATION TASK (5:15 AM) ................................8

B. Pre-Operational Task Introduction ..................................................................................8

C. Agenda for the Day....................................................................................................... 10

SPS VERIFICATION (7:45 AM)............................................................................................ 10

D. Verifying Establishment Compliance ............................................................................ 11

E. Giving Breaks................................................................................................................ 11

ZERO TOLERANCE VERIFICATION (9:00 AM) .................................................................. 12

F. Performing a Poultry Zero Tolerance Task ................................................................... 12

FI ANN BLACK (10:00 AM)................................................................................................... 13

G. Personnel Situation ...................................................................................................... 13

H. Export Process ............................................................................................................. 14

I. Export Process Conclusion ............................................................................................ 15

SPS VERIFICATION (11:15 AM).......................................................................................... 16

J. Regulatory Control Action (RCA)................................................................................... 16

K. RCA Solution ................................................................................................................ 16

HACCP & NRS (12:00 PM)................................................................................................... 16

L. Food Defense Tasks Assessment................................................................................. 18

ZERO TOLERANCE CHECKS (12:20 PM) .......................................................................... 21

M. Salmonella and Campylobacter Testing....................................................................... 21

N. Evisceration Machine.................................................................................................... 22

PRE-CHILL TEST (1:00 PM) ................................................................................................ 24

O. Pre-Chill Test................................................................................................................ 24

P. Sampling at the Pre-Chill Station .................................................................................. 24

Q. Pre-Chill Sampling Task Results .................................................................................. 25

R. Finished Product Standards Testing............................................................................. 25

S. Another Poultry Zero Tolerance Task ........................................................................... 27

VERIFICATION OF ESTABLISHMENT’S CORRECTIVE ACTIONS (1:30 PM)................... 27

T. Ante-Mortem Inspection and Environmental Conditions ............................................... 29

LIVE HANG (1:45 PM).......................................................................................................... 32

U. Condemning DOA Birds ............................................................................................... 32

V. Solution to U.S. Reject Tag........................................................................................... 33

BREAK (2:20 PM)................................................................................................................. 34

W. Remaining Afternoon Agenda...................................................................................... 34
Day in the Life: Poultry

34-3

3

GCP & MOIS (3:00 PM)........................................................................................................ 35

X. SSOP Review and Observation Task ........................................................................... 36

Y. Process Control Charts................................................................................................. 36

CONCLUSION (4:00 PM) ..................................................................................................... 37

Z. Agenda Accomplished! ................................................................................................. 37

Additional Conclusion Notes ............................................................................................. 37
Day in the Life: Poultry

34-4

4

LEARNING OBJECTIVES

1. Apply the course concepts learned so far to successfully complete the day in the

life: poultry scenario.
Day in the Life: Poultry

34-5

5

INTRODUCTION AND PREPARATION (5:00 AM)

A. Scenario Introduction

Brainstorm answers to the following questions and mark your answers below.

How are you going to prepare for this IPPS assessment?
Day in the Life: Poultry

34-6

6

What are you going to evaluate and how?

What resources would you want?
Day in the Life: Poultry

34-7

7

Review each of the following documents. You can take notes here.

Directive 4430.3 Rev 4

IPPS Supervisory Guide

IPPS Assessment Form

CSI Nickels’ First IPPS

Which of the documents did you find most helpful and why?
Day in the Life: Poultry

34-8

8

What elements or sub-elements are you required to assess during the second IPPS

assessment for CSI Nickels, assuming that you do not plan to conduct another IPPS

assessment during this rating year?

Are there other elements that you want to assess?

PRE-OPERATIONAL REVIEW AND OBSERVATION TASK (5:15 AM)

B. Pre-Operational Task Introduction

Is the response that CSI Nickels provided correct? Why or why not?
Day in the Life: Poultry

34-9

9

NR Documenting the Noncompliance Notes:

You review CSI Nickels’ finalized NR. What methods have you used to assess CSI Nickels’

performance so far?

What, if any, feedback do you give her?

What does the IPPS form look like at this point?
Day in the Life: Poultry

34-10

10

C. Agenda for the Day

What methods would you use to assess CSI Nickels’ performance of AM inspection?

As you and Wanda are leaving the ante-mortem inspection area, you see these cages. What

concerns do you have?

Looking at the chickens, which set of cages do you think they came from?

Is CSI Nickels’ response (regarding the FSIS Directive that provides guidance on how to verify

poultry slaughter establishments maintain adequate procedures for preventing contamination

with fecal material and enteric pathogens throughout the slaughter process) true or false?

SPS VERIFICATION (7:45 AM)

What does the IPPS form look like at this point?
Day in the Life: Poultry

34-11

11

D. Verifying Establishment Compliance

Has CSI Nickels answered correctly?

NR AAA8149126070216N/1 Notes:

What does the IPPS form look like at this point?

E. Giving Breaks

What element(s) have you just evaluated?

What does the IPPS form look like at this point?
Day in the Life: Poultry

34-12

12

ZERO TOLERANCE VERIFICATION (9:00 AM)

F. Performing a Poultry Zero Tolerance Task

After reviewing CSI Nickels’ NR, answer the following questions.

CSI Nickels’ NR Notes:

Was proper inspection technique followed for performing the Poultry Zero Tolerance task?

Is the RCA supportable?

Is the NR supportable?

Is the NR clear and concise, and does it contain a good description of the noncompliance?

What does the IPPS form look like at this point?
Day in the Life: Poultry

34-13

13

FI ANN BLACK (10:00 AM)

G. Personnel Situation

Group Discussion:
Day in the Life: Poultry

34-14

14

H. Export Process

What guidance would you look at to see if CSI Nickels is performing the export certification

task correctly?

Is the product (boneless skinless chicken breasts) eligible for export to Cambodia?

Are there any additional requirements that must be met?

Compare the Export Certificate to the application and export library. Then answer the following

questions.

• Are all the requirements met and is the documentation acceptable?

• Are appropriate boxes checked?
Day in the Life: Poultry

34-15

15

• Is unused space lined out?

• Why is this important?

I. Export Process Conclusion

What method(s) did you use to verify CSI Nickels’ performance for Export Certification on the

IPPS assessment?

What does the IPPS form look like at this point?
Day in the Life: Poultry

34-16

16

SPS VERIFICATION (11:15 AM)

J. Regulatory Control Action (RCA)

Notes:

K. RCA Solution

NR AAA8149126070216N/2 Notes:

HACCP & NRS (12:00 PM)

NR AAA8149896060216N/1 Notes:

NR AAA8149569062116N/1 Notes:
Day in the Life: Poultry

34-17

17

• Since the above two NRs were associated, what other documentation of due process

should be available?

• What method did you use to assess this during the IPPS? _

What does the IPPS form look like at this point?

• So far, do you have any concerns about CSI Nickels?

• Do you have any concerns about the establishment?
Day in the Life: Poultry

34-18

18

L. Food Defense Tasks Assessment

FSIS Directive 5420.1, Revision 10 Notes:

• How can you assess CSI Nickels on her knowledge of this directive without observing

her perform it?

• Would it be appropriate to let CSI Nickels have a copy of the new revision of the

directive while you assess her on its contents?
Day in the Life: Poultry

34-19

19

• What three questions would you pose to CSI Nickels to assess her knowledge of the

directive?
Day in the Life: Poultry

34-20

20

• Since there have been changes in policy, would your questions focus on these

changes?

• Come up with one scenario to pose to CSI Nickels to assess her knowledge of the new

revision of the directive and share it.
Day in the Life: Poultry

34-21

21

What does the IPPS form look like at this point?

ZERO TOLERANCE CHECKS (12:20 PM)

M. Salmonella and Campylobacter Testing

What series of FSIS Directive gives guidance to IPP concerning sampling?

What directive gives guidance to IPP concerning Salmonella/Campylobacter sampling?

Did she put on the gloves correctly to perform sampling? _

What immediate feedback do you give?

• Given what you’ve seen today in CSI Nickels’ current and previous NRs, is there a

question you’d like to have answered about any previous FSIS sample results?
Day in the Life: Poultry

34-22

22

• If so, what questions do you have?

• Where would you find answers to those questions?

• What does the IPPS form look like at this point?

N. Evisceration Machine

What did you observe at each step of the process?

• This employee is helping to manually eviscerate birds incompletely eviscerated by

machine.
Day in the Life: Poultry

34-23

23

• These birds are being rinsed on the evisceration line by Outside Bird Wash 1.

• These birds are also being rinsed on the evisceration line in the next two pictures by

Outside Bird Wash 2.

• This bird is also receiving a rinse on the evisceration line by Outside Bird Wash 3.
Day in the Life: Poultry

34-24

24

Is there noncompliance in any of these pictures?

PRE-CHILL TEST (1:00 PM)

O. Pre-Chill Test

Did CSI Nickels answer correctly (regarding the lighting requirement for FPS re-inspection

stations)?

P. Sampling at the Pre-Chill Station

• Carcass 1 Notes:

• Carcass 2 Notes:

• Carcass 4 Notes:

• Carcass 5 Notes:
Day in the Life: Poultry

34-25

25

• Carcass 8 Notes:

• Carcass 10 Notes:

Q. Pre-Chill Sampling Task Results

• What is the subgroup total for this Pre-chill Sampling Task?

• How would you respond to the CSI Wanda not scoring correctly?

R. Finished Product Standards Testing

Finished Products Standards Table Notes:
Day in the Life: Poultry

34-26

26

Finished Products Standards Testing Chart Notes:
Day in the Life: Poultry

34-27

27

Did CSI Nickels answer correctly?

S. Another Poultry Zero Tolerance Task

NR AAA81493900070216N Notes:

VERIFICATION OF ESTABLISHMENT’S CORRECTIVE ACTIONS (1:30 PM)

• Is the required information included in the NR?

• Is the NR properly associated to the past previous noncompliance?
Day in the Life: Poultry

34-28

28

• Are the correct regulations cited in the NR?

• Based on what is documented in the NR, is there anything else that CSI Nickels is

required by policy to do?

• Beyond what is required by policy, is there anything else you or CSI Nickels might want

to do because of facts documented in the NR?
Day in the Life: Poultry

34-29

29

T. Ante-Mortem Inspection and Environmental Conditions

What could have caused this?

Review the following documents and then answer the question below.

1. FSIS PHIS Directive 6100.3, Ante-Mortem and Post-Mortem Poultry Inspection

2. FSIS Notice 44-16, Instructions for Writing Poultry Good Commercial Practices

Noncompliance Records and Memorandum of Interview Letters for Poultry

Mistreatment
Day in the Life: Poultry

34-30

30

3. FSIS Directive 6000.1, Rev. 1, Responsibilities Related to Foreign Animal Diseases

(FADs) and Reportable Conditions

4. FSIS Directive 6020.1, Rev. 1, Enhanced Inspection of Poultry in Response to a

Notification of a Highly Pathogenic Avian Influenza Outbreak

What Agency issuance would not be helpful in making this decision?

• What should you do?

• What questions might you want to ask?
Day in the Life: Poultry

34-31

31

• The main question, perhaps, is: is the cause of so many birds dying a

FAD, bioterrorism event, or environmental? To determine this the PHV may ask:

o What is the onsite holding area like?

o Is there shelter?

o Are the birds crowded on the truck (overheating)?

o Were any boards or tarps that restrict air circulation left on the trucks after

arrival?

o Are the fans used to cool the birds upon arrival operating correctly?

o How many birds are in this lot?

o How does the establishment determine lots?

o Where did these birds come from?

o How long were they hauled?

o How many trucks are hauling birds from the same source?

o How many other trucks, if any, have been presented like this to the

establishment with 50% or other high numbers of DOAs?

o What was the weather like where they came from?

o Have we been notified of a HPAI or other reportable animal disease outbreak by

APHIS and the District Office?

o What are the AM symptoms of the birds if any are still alive?

o Are they gasping, exhibiting sinusitis, any discharges, coughing, diarrhea, ocular

swelling, neurological signs, etc.?

o Has there been indication or notification that the birds have been exposed to

toxins in the feed or in some other manner?

o Has notification of a food defense threat to the food and agricultural sector been

issued?

If you determine that the deaths are due to environmental causes, does the HMSA apply?

Based on the observations of the truck, you conclude that the likely cause of the high death

rate of the birds is due to:
Day in the Life: Poultry

34-32

32

Would it be wrong to inform your supervisor and get guidance on whether APHIS should be

contacted?

Should you contact the DVMS?

Are you going to document this event? If so, how?

LIVE HANG (1:45 PM)

U. Condemning DOA Birds

The hanging of DOAs on the live hang line is:
Day in the Life: Poultry

34-33

33

What regulatory citation covers the disposition of poultry DOAs?

What should you do and in what order?

V. Solution to U.S. Reject Tag

The noncompliance above should be documented in a:
Day in the Life: Poultry

34-34

34

NR AAA8149138070216N/1 Notes:

BREAK (2:20 PM)

W. Remaining Afternoon Agenda

• What do you have left to do?
Day in the Life: Poultry

34-35

35

• How would you prioritize these tasks?

GCP & MOIS (3:00 PM)

According to the policy guidance in FSIS Notice 44-16, what information should you capture in

the GCP MOI?
Day in the Life: Poultry

34-36

36

X. SSOP Review and Observation Task

Based on what you observe in the cut-up/debone department, is this a noncompliance?

What corrective actions are required?

The most recent noncompliance with the same cause was documented four months ago.

Should this noncompliance be associated?

NR AAA8249990270216N Notes:

Y. Process Control Charts

Did CSI Nickels answer correctly?
Day in the Life: Poultry

34-37

37

What does the IPPS form look like at this point?

CONCLUSION (4:00 PM)

Z. Agenda Accomplished!

It’s been a long day and a busy day, but a productive day.

• You’ve done an IPPS assessment and provided feedback.

• You’ve watched CSI Nickels document a lot of noncompliance with 9 CFR 381.65(g)

and 9 CFR 417.5(a)(1), plus 417.2(c)(4).

• You’ve written a GCP MOI and documented noncompliance with 9 CFR 416.4(d) and

381.71(a).

• You’ve handled a potential disciplinary problem.

• You’ve consulted with the FLS and the DVMS.

• You’ve helped protect the public’s health.

Additional Conclusion Notes:
602

Day in the Life: Beef
Day in the Life: Beef

35-2

603

TABLE OF CONTENTS

LEARNING OBJECTIVES ......................................................................................................3

ANTE-MORTEM INSPECTION (9:00 AM)..............................................................................4

HUMANE HANDLING (10:25 AM)..........................................................................................9

MAKING DISPOSITIONS (11:30 AM)................................................................................... 10

A. Disposition 1 ................................................................................................................. 10

B. Disposition 2 ................................................................................................................. 11

C. Disposition 3 ................................................................................................................. 12

PERSONNEL SITUATION (1:00 PM)................................................................................... 13

ZERO TOLERANCE VERIFICATION (2:05 PM) .................................................................. 14

COLLEAGUE PHONE CALL (2:45 PM)................................................................................ 15

SPLIT SAW SITUATION (3:30 PM)...................................................................................... 16

END OF DAY WRAP-UP (4:30 PM) ..................................................................................... 16
Day in the Life: Beef

35-3

3

LEARNING OBJECTIVES

1. Apply the course concepts learned so far to successfully complete the day in the

life: poultry scenario.
Day in the Life: Beef

35-4

4

ANTE-MORTEM INSPECTION (9:00 AM)

It is right before the company mid-morning break and it’s already been a long morning. It’s

been raining over the vast majority of your part of the country for the last three days and

you’re tired of gray skies. Luckily, the establishment has plenty of cattle to start as 2/3 of the

pens were filled last night before 6:00 PM for today’s slaughter. About half of those were

hauled from feedlots over 100 miles away.

Dr. Wright, the PHV who has been conducting ante-mortem inspection, enters. Dr. Wright

informs you that the drains of two pens in the ante-mortem area were plugged, resulting in

quite a mess but fortunately, the drains are now unplugged. You remember that the same

thing happened last week and ask if this will be documented. Dr. Wright says that it isn’t

necessary as the problem is not being alleviated.

CSI Jones walks into the office and tells you that he just performed a Livestock Zero

Tolerance task. During the task, he found a 2 inch by 3 inch fecal smear on the brisket of the

fourth beef carcass he randomly selected during the task. He verbally informed establishment

management of the noncompliance and is going to document the noncompliance in PHIS.

Answer the following questions based on the information provided to you during the scenario.

1. Do any of the previously stated factors possibly have an effect on the expected levels

of hide contamination of the cattle?

2. Since there was a Zero Tolerance failure, according to FSIS policy, what else must be

done?
Day in the Life: Beef

35-5

5

3. What other questions do you have pertaining to the Livestock Zero Tolerance task

noncompliance?

4. Would it make a difference if this is the first Zero Tolerance failure in the last three

months versus the fourth Zero Tolerance failure in the last month? If so, why?

5. If this is the first failure in 3 months, what is/are the correct regulatory citation(s) for the

noncompliance?
Day in the Life: Beef

35-6

6

6. If this is the fourth failure in the last month, might there be additional regulatory

citations? If so, what are they apt to be?

7. If this is the fourth failure in the last month, what other documentation would you expect

to find other than additional NRs?

8. What else, although not required by FSIS policy, might you want to do? Hint: What

other task might you want to perform?
Day in the Life: Beef

35-7

7

9. What microbial data would you want to look at?

10.Is there any review and observation verification that you might want to perform

associated with the microbial data?

11.How are you going to divide the responsibility of performing the tasks?
Day in the Life: Beef

35-8

8

12.What effect might the drain problem in ante-mortem have on this situation?

13.Is there anything that you need to talk about with Dr. Wright?

14.Are there any disciplinary actions that you need to take with Dr. Wright?
Day in the Life: Beef

35-9

9

HUMANE HANDLING (10:25 AM)

That same morning, you are verifying HAT Category VIII, Stunning Effectiveness, as a part of

your Livestock Humane Handling task. You are observing an establishment employee stun

cattle in the knocking box. You observe the employee effectively stun twelve cattle in a row on

the first attempt using a pneumatically operated penetrating captive bolt stunner.

The next animal, a steer, enters the stunning area and is restless, throwing its head. The

employee does not chase the steer's head, waiting until it calms down before attempting to

stun it. When the employee attempts to stun it, the steer moves its head at the last second,

and the bolt penetrates the forehead off-center. The steer is bleeding from the head and

vocalizes loudly. The employee remains calm and immediately stuns the steer again,

rendering the steer insensible.

You have verified that the establishment has a robust systematic approach for humane

handling and slaughter, as well as a good history of properly stunning animals.

Does this represent noncompliance?

If it is a noncompliance, is it egregious?

What action should be taken by inspection personnel?
Day in the Life: Beef

35-10

10

MAKING DISPOSITIONS (11:30 AM)

Moments ago, you are notified that there are three cattle that have been railed out for

disposition. You go to the disposition area. A Food Inspector tells you that all three animals

are form the same lot of cattle and that many of them in the lot have abscesses.

A. Disposition 1

You examine the carcass and viscera of the first animal, a steer. There are multiple wellencapsulated abscesses in the lungs and liver, some of which have been broken during

evisceration and are draining pus. There are two well-encapsulated abscesses attached to the

pleura. There are four well-encapsulated abscesses attached to the peritoneum. The kidneys

both have white areas indicating past infarcts. The carcass is well fleshed and all other viscera

are normal.

Go through your disposition thought process and determine what disposition you would make

on this steer.

Based on what you see, what disposition would you make on this carcass?
Day in the Life: Beef

35-11

11

B. Disposition 2

You examine the carcass and viscera of the second animal, a heifer. The cranial and ventral

aspects of the lungs are bluish and consolidated, involving approximately 1/2 of the lung.

There is some organized fibrin on the pleural surfaces of the lung and thorax. The

tracheobronchial and mediastinal lymph nodes are enlarged, but have normal architecture

with no hemorrhage. Other lymph nodes are normal. There are two well-encapsulated

abscesses in the liver. There is a small hemorrhage surrounding a small diameter puncture

wound in the left chuck area with a slightly larger hemorrhage deeper in the chuck. The

kidneys, spleen, peritoneum, and all other viscera are normal. The carcass is well fleshed.

Go through your disposition thought process and determine what disposition you would make

on this heifer.

Based on what you see, what disposition would you make on this carcass?
Day in the Life: Beef

35-12

12

C. Disposition 3

You examine the carcass and viscera of the third animal, a steer. There are multiple wellencapsulated abscesses in the liver. Some of these abscesses have red rings around them.

There are several well-encapsulated abscesses on the dorsal 1/3 of the lung. There are 6-8

ecchymotic hemorrhages on the dorsal lung and multiple petechial hemorrhages on the dorsal

lung. The mediastinal lymph nodes are enlarged, edematous, and reddened. You observed a

few petechial hemorrhages on their cut surfaces. The heart has petechial hemorrhages on the

outer surface of the heart cap and a few petechial hemorrhages on the kidneys and

peritoneum. The carcass is well fleshed and all other viscera are normal.

Go through your disposition thought process and determine what disposition you would make

on this steer.

Based on what you see, what disposition would you make on this carcass?
Day in the Life: Beef

35-13

13

Would you take tissues for residue testing on any of the above cattle?

If so, which ones?

PERSONNEL SITUATION (1:00 PM)

As you are leaving the disposition area, FI Garcia approaches you and tells you that FI

Shaunessy is in a good mood today because her date with an establishment QA went well last

night.

Is there something you need to do at this point? If so, what?
Day in the Life: Beef

35-14

14

ZERO TOLERANCE VERIFICATION (2:05 PM)

CSI Jones tells you that while performing a Review and Observation verification of the

establishment’s corrective actions for the zero tolerance failure in the cooler, he found two

carcasses in the cooler with scattered specks of rail dust on them.

Is this a noncompliance?

If so, how would it be documented?

What regulation would be cited?

If this noncompliance had occurred previously in the last two or three months, what other

regulation would be cited?
Day in the Life: Beef

35-15

15

COLLEAGUE PHONE CALL (2:45 PM)

You get a phone call from a colleague new to the agency, assigned to a hog slaughter

operation. Your colleague says that they just got back in from performing ante-mortem

inspection and saw some weird lesions on some of the hogs. They say they are emailing you

some pictures they took and want your advice on what they should do.

Below is the email from your colleague.
Day in the Life: Beef

35-16

16

After looking at your colleague’s pictures of the hogs, what should you advise him to do?

SPLIT SAW SITUATION (3:30 PM)

You observe that an establishment employee hits an abscess with the split saw while splitting

a carcass and then proceeds to split the next carcass without cleaning or sanitizing the split

saw.

Is this a noncompliance?

If so, what regulation would apply and how would you document it?

END OF DAY WRAP-UP (4:30 PM)

The FLS calls half an hour before the end of your shift and asks how your day is going. How

would you respond?
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 1

618

Homeland Food Defense

OBJECTIVES

The objectives for this module are:

1. Describe the risk that intentional contamination presents to meat, poultry, and

egg products establishments.

2. Discuss potential public health, psychological, social, and economic

consequences associated with attacks on the food supply.

3. Define key food defense terms.

4. Describe historical events that highlight the need for concern and action

regarding protecting the food supply against intentional contamination.

5. Discuss why food defense and emergency response functions of FSIS fit with the

Agency’s mission of ensuring that meat, poultry, and egg products are safe,

wholesome, and correctly labeled and packaged.

6. Identify some of the food defense and emergency response activities FSIS is

doing to meet the challenges of food defense.

7. Explain steps FSIS is taking to promote the adoption of preventive strategies by

the private industries to ensure the security of the U.S. meat, poultry, and egg

products supply.

8. Describe the purpose of each food defense procedure with respect to identifying

potential food defense vulnerabilities in a meat, poultry, or egg products

establishment.

9. Identify the steps taken to encourage an establishment to enhance its food

security measures when food defense vulnerabilities are identified.

REFERENCES

1. “Perspectives on Food Security,” FSIS News and Notes, Dr. Elsa Murano,

10/31/2003

2. The Centers for Disease Control; Disease Category webpage

3. Directive 5420.1, “Food Defense Verification Procedures and National Terrorism

Advisory System Alert Response for the Office of Field Operations”

4. Protecting America’s Meat, Poultry and Egg Products: A Report to the Secretary

on the Food Security Initiatives of the FSIS, January 31, 2003

5. Food Defense Guidelines for Slaughter and Food Processing Establishments,

USDA, FSIS publications

6. Security Guidelines for the Transportation and Distribution of Meat, Poultry and

Egg Products and Consumers, USDA, FSIS publications

7. FSIS General Food Defense Plan, USDA, FSIS publications
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 2

2

8. Food Defense Self Assessment Checklist for Slaughter and Processing Facilities,

USDA, FSIS publications

INTRODUCTION

This module will address food defense activities in FSIS. First, we will cover an

overview of what food defense means and what activities FSIS has taken to ensure that

meat, poultry, and egg products are protected from intentional harm. Then, we will talk

about your role and inspection activities that are related to food security.

Let us start by reviewing the mission and vision of FSIS, because this infrastructure is

tasked with addressing food terrorism. As you know, FSIS is USDA’s public health

regulatory agency that ensures meat, poultry and egg products are safe, wholesome,

and accurately labeled. These products account for one third of consumer spending for

food with an annual retail value of $120 billion.

The FSIS infrastructure is extensive. There are approximately 6,500 federally inspected

and 2,550 state-inspected meat and poultry (slaughter and processing) establishments

in the United States. There are over 7,600 inspectors assigned to the federally

inspected establishments and import facilities alone. There are approximately 1,200

veterinarians assigned to work in one or a number of federally inspected meat and

poultry establishments. We have an enormous responsibility to ensure that we provide

the safest food possible for the American public.

Prior to September 11, FSIS focused primarily on protecting meat, poultry, and egg

products from contamination that is not premeditated but unintentional. The events of

September 11, 2001, brought the issue of the vulnerability of our food supply to the

forefront. Tommy Thompson, a former Secretary of the Department of Health and

Human Services (DHHS), has stated, “For the life of me, I cannot understand why the

terrorists have not attacked our food supply because it is so easy to do”. Bill Frist, a

physician, former Senator, and one of the original sponsors of the Bioterrorism

Preparedness Act signed into law in 2002, has stated that “...as we consider

bioterrorism, we are most vulnerable in our food supply.”. We in FSIS must make

consideration of the “unusual” a part of how we routinely conduct business by remaining

ever vigilant of possible attacks on the food supply and wary of situations that appear out

of the ordinary. We must accept the fact that an attack on our food supply is plausible.

This means that FSIS has had to add functions to protect the food supply against

intentional harm.

Here are reasons why the food supply is a plausible and possible target:

• With low security of facilities and personnel, it could be an easy target.

• One hundred percent of our population eats 100% of the time.

• Food terrorism can cause sickness and death.

• Food terrorism can cause disruptions in the food supply without deaths.

• Food terrorism can destroy brand names.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 3

3

• It can be used for economic gains on the futures markets.

• It may be difficult to distinguish between intentional, deliberate contamination

designed to harm people and the situations that occur unintentionally.

FOOD DEFENSE TERMINOLOGY

Food Security – When 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 Terrorism – an act or threat of deliberate contamination of food for human

consumption with chemical, biological or radio nuclear agents for the purpose of causing

injury or death to civilian populations or disrupting social, economic, or political stability.

Within FSIS, food terrorism is further focused down to how terrorism relates to meat,

poultry and egg products.

Food Defense – is safeguarding the food supply against intentional acts of tampering or

contamination. Food defense encompasses a broad range of considerations.

Defending food from intentional contamination requires measures in addition to food

safety because it is hard to predict how the terrorist might manage an attack on the food

in a particular operation. Therefore, a HACCP plan will not necessarily protect against

intentional contamination. However, a food defense plan considers how someone might

get into a particular operation and how some agent could be added to the process.

Such vulnerable areas are not likely to be identified in a HACCP plan. Dealing with

issues involving the possible intentional contamination of food due to a terrorist act

requires addressing these factors:

• Physical security of buildings,

• Surveillance activities to identify/prevent acts intended to disrupt the food supply,

• Personnel security, and

• Emergency response

Food Safety – is 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. While the United States has a well-functioning food safety infrastructure

to protect the public against the unintentional contamination of food, food defense

encompasses a broader range of considerations.

Critical Infrastructure – The Patriot Act of 2001 defined critical infrastructures 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 critical infrastructures specified by the Patriot Act of 2001 were:
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 4

4

• Agriculture and Food

• Water

• Public Health

• Emergency Services

• Government

• Defense Industrial Base

• Information and Telecommunications

• Energy

• Transportation and Shipping

• Banking and Finance

• Chemical/Hazardous Material Industry

• Postal Service

• National monuments and icons

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.

Agricultural Bioterrorism - use of biological, chemical, radiological, or other agents

against food and fiber production to produce fear, cause economic damage, harm public

health, or have some other adverse impact.

Incident Command System (ICS) – a nationally established management system used

to respond effectively to an emergency involving one or more jurisdictions.

EXAMPLES OF ATTACKS ON THE FOOD SUPPLY

History has shown that terrorists can, and will, use food as a weapon. A review of a few

noteworthy intentional food borne disease outbreaks provides:

• the kinds of foods and the points in their production where intentional

contamination could have catastrophic consequences

• the potential magnitude of the public health impact of a carefully planned

intentional attack on the food supply, and

• some of the types of individuals and their motivations for intentionally attacking

the food supply

In 1972, members of a U.S. fascist group called Order of the Rising Sun were found in

possession of 30-40 kilograms of typhoid bacteria cultures, with which they planned to

contaminate water supplies in Chicago, St. Louis, and other Midwestern cities.

In 1984, two members of an Oregon cult headed by Bhagwan Shree Rajneesh cultivated

Salmonella (food poisoning) bacteria, and used it to contaminate restaurant salad bars in
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 5

5

an attempt to affect the outcome of a local election. Although some 751 people became

ill, and 45 were hospitalized; there were no fatalities.

In early March 1989, someone created a scare that grapes from Chile imported into the

USA would be contaminated with cyanide. On March 11, the United States Food and

Drug Administration (FDA) spotted three suspicious-looking grapes on the docks in

Philadelphia, in a shipment that had just arrived from Chile. Two of the grapes had

puncture marks. They were tested and found to contain low levels of cyanide. The FDA

impounded 2 million crates of fruit at ports across the country and warned consumers

not to eat any fruit from Chile, which included most of the peaches, blueberries,

blackberries, melons, green apples, pears, and plums that were on the market at the

time.

October 1996, a former laboratory employee at the St. Paul Medical Center in Dallas,

pleaded guilty to engaging in her own personal act of food-borne terrorism by

intentionally contaminating pastries. She had access to the highly toxic bacteria,

Shigella dysenteriae, stored in the laboratory; she contaminated the pastries and left

them in an employee break room, and she sent a bogus e-mail message from her

supervisor’s computer notifying laboratory employees of the free snacks in the break

room. Her activities were discovered when she tried to alter hospital records to cover

her tracks.

In 1996, police received an anonymous call from a worker at a rendering establishment

in Wisconsin. The caller said liquid fat from the establishment had been contaminated.

It was determined that chlordane was the contaminant, an organochlorine pesticide that

is environmentally stable, accumulates in the fat of animals, and is considered a food

adulterant at very low levels (0.3 ppm in animal fat). This fat found its way to feed

manufacturers and eventually onto nearly 4,000 farms in Wisconsin, Minnesota,

Michigan and Illinois. Within two days, all major customers were notified and the feed

was replaced. Luckily, milk samples taken from some of the dairy herds that had eaten

the affected feed were negative or contained levels well below those that which poses a

health hazard to humans. Total costs for disposing of the contaminated feed (4,000

tons) and fat (500,000 pounds) was almost $4 million; however, as numerous state and

federal agencies became involved in dealing with this issue, the final price tag was likely

much higher.

On January 3, 2003, the Michigan Department of Agriculture's Food and Dairy Division

and the U.S. Department of Agriculture were notified by a supermarket of a planned

recall of approximately 1,700 pounds of ground beef because customers had

complained of illness after eating the product. The contaminant in the ground beef

returned by customers with reported illness was identified as nicotine from nicotinebased pesticide used by the supermarket. An employee of the supermarket was

arrested and charged with deliberately poisoning the ground beef at the supermarket.

LESSONS LEARNED FROM VULNERABILITY ASSESSMENTS

Being aware of what terrorists do, how they do it, when and where they do it can help us

be more effective in identifying and preventing their activities. How can a terrorist

organization gain technical capability? Can they recruit American food system workers?

Can they gain knowledge by talking with food system workers using what appear to be
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 6

6

simple and innocent questions about their jobs while sitting at a baseball game or

standing in line at a grocery store? Food system workers are a prime information target;

and, that includes you. What must a terrorist have to carryout an attack? A terrorist must

have the following to conduct food terrorism activities:

• Have access to the food for a sufficient amount of time to tamper with it;

• Be technically capable of introducing a contaminant;

• Be able to perform the operation without discovery; and

• Be competent enough to avoid detection of the adulterated product down stream in

the production's distribution life cycle.

Based upon its vulnerability assessments, FSIS has identified foods with certain

characteristics as being at higher risk of intentional contamination. These characteristics

include large batch size, uniform mixing, short-shelf life, and ease of access. Large

batch size places a food product at high risk because it facilitates the contamination of a

large quantity of product all at the same time. In turn, a large number of individuals may

consume the contaminated product. The larger the number of consumers the greater is

the potential for a larger number of deaths or illnesses. For instance, contamination of a

5,000-gallon commercial kettle could negatively affect a much larger number of

individuals than contamination of a 5-gallon food service pot. Uniform mixing places a

product at high risk for contamination because adding agents before or during mixing

steps results in contamination of all of the servings in a batch, improving the efficiency of

an attack. Short shelf life places a food product at risk because these products may be

consumed before public health officials are able to identify the cause of illness and to

take action to prevent further illnesses. Ease of access increases a products risk for

adulteration because carrying out an act requires access to the product or its raw

materials. The more accessible a site the more likely it will be a target.

The intentional food contamination incidents above also provide some examples of the

types of individuals that might be motivated to adulterate food products.

• Attacks from internal sources are possibly the most difficult to prevent because

they typically know what procedures are followed in the establishment and often

know how to bypass many security controls that would detect or delay an

external intruder. Disgruntled insiders are generally motivated by their own

emotions and self-interests. They may be mentally unstable, operating

impulsively with minimal planning. This may be the most difficult group to stop

because they may have legitimate access to the product.

• Criminals who are sophisticated may possess relatively refined skills and tools

and are generally interested in high-value targets. Unsophisticated criminals

have more crude skills and tools and typically have no formal organization. They

are generally interested in targets that pose a low risk of detection.

• Protestors are usually politically or issue-oriented. They generally act out of

frustration, discontent, or anger. They are primarily interested in publicity for their

cause, and, as a result generally do not intend to injure people, but may be
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 7

7

superficially destructive. They are usually unsophisticated in their tactics and

planning. However, some protest groups have adapted tactics similar to

terrorists. In this way, they may be moderately sophisticated and moderately

destructive. In fact, they may target individuals for harm.

• Subversives, also known as saboteurs, assassins, guerrillas, or commandos are

sophisticated, highly skilled, and capable of meticulous planning. Subversives

typically operate in small groups with objectives including death, destruction, and

targeting personnel, equipment, and operations.

• Terrorists are usually politically or ideologically oriented. They typically work in

small, well-organized groups. They are typically well funded, sophisticated, and

capable of efficient planning. Terrorists may use other types of aggressors to

accomplish their goals. Their objectives include death, destruction, theft, and

publicity.

CONSEQUENCES / IMPACTS

Food security has economic, health, societal, psychological, and political significance.

Deliberate contamination of the food supply could cause significant public health

consequences and widespread public fear. It could also have a devastating economic

impact and result in the loss of public confidence in the safety of our food and in the

effectiveness of government.

Intentional and unintentional breeches in food security could have a significant effect on

health care expenses, lost wages, consumer confidence, trade embargoes, etc. The

Centers for Disease Control and Prevention (CDC) reports there are three types of

economic effects that may be generated by an act of food terrorism:

• Direct economic losses attributable to responding to the act including: medical

costs, lost wages for the victims, containment, decontamination and disposal costs

• Indirect multiplier effects from compensation paid to affected producers and the

losses suffered by affiliated industries, such as suppliers, transporters, distributors,

etc.

• International costs in the form of trade embargoes imposed by trading partners

FSIS FOOD DEFENSE STRATEGY

The nation's awareness of terrorism has been heightened and there is an intense focus

on ensuring the protection of the nation's critical infrastructures. Section 332 of the

Public Health Security and Bioterrorism Act of 2002 established that the Secretary of

Agriculture might utilize existing authorities granted by the FMIA, PPIA, and EPIA to give

high priority to enhancing and expanding the capacity of FSIS to conduct activities

related to food defense. Homeland Security Presidential Directive (HSPD) 7 established

a national policy for Federal departments and agencies to identify and prioritize critical

infrastructures and key resources and to protect them from terrorist attacks. HSPD-9

established a national policy to defend the agriculture and food system against terrorist
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 8

8

attacks, major disasters, and other emergencies. HSPD-9 outlines roles and

responsibilities for USDA, DHHS, and the Environmental Protection Agency (EPA) in

planning for, preventing, and responding to such emergencies.

An example of applying the expectations of Section 332 of the Bioterrorism Act occurred

at the beginning of the war in Iraq when the federal government was on heightened alert.

We had real concern that our nation would be the subject of a terrorist attack in

retaliation for the war. “Liberty Shield” was the code word for the government’s

heightened alert reactions. During that time, FSIS put into effect a number of

“prevention” measures that would be the basis of our future actions and response to

changes in threat conditions. For example, Inspectors-In-Charge (IICs) initiated new

security-based inspection measures as part of the Public Health Inspection System

(PHIS). Import inspectors also increased security oversight. Laboratory sampling was

increased so that 50% of all samples included analysis for a threat agent, and the

Consumer Complaint Monitoring System (CCMS) increased its coverage. FSIS

epidemiologists enhanced their surveillance efforts for human illnesses, looking for

possible links to unusual disease signs.

During Operation Liberty Shield, instructions were provided to field Public Health

Veterinarians and inspectors to replace certain Non-Food Safety Consumer Protection

inspection procedures with targeted inspection and sampling for a dozen or so

biological, chemical, or radiological agents. Since then, FSIS continues to randomly test

for these agents on an ongoing basis to maintain surveillance and monitoring for

terrorism.

The example of Operation Liberty Shield points to the fact that efforts to improve the

security of the food supply in particular must focus on prevention, early detection,

containment of contaminated product, and mitigation and remediation of any problems

that do occur. These efforts are not without significant challenges, including the

following:

• There is no strong statutory authority to mandate security measures.

• As a discipline, food defense is in its infancy; therefore, development of education

and training, surveillance methods, and data analysis techniques is ongoing.

• Many points along the farm-to-table continuum could be targets of agricultural

bioterrorism in general and food terrorism specifically.

FSIS created the Office of Data Integration and Food Protection (ODIFP) in 2002 to

coordinate the Agency’s food defense activities. The mission of ODIFP is to develop

and coordinate all FSIS activities to prevent, prepare for, respond to, and recover from

non-routine emergencies resulting from intentional and non-intentional contamination

affecting meat, poultry, and egg products. ODIFP serves as the agency's central office

for homeland security issues and ensures coordination of its activities with the USDA

Homeland Security Office, the White House, the Department of Homeland Security

(DHS), the Food and Drug Administration (FDA), and other Federal and State

government agencies with food-related responsibilities, and industry. ODIFP has a

comprehensive strategy for dealing with food defense challenges including:

• Vulnerability assessments
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 9

9

• Emergency preparedness and continuity of operations (COOP) planning

• Surveillance and data analysis, including predictive analytics

• Outreach and training

• Promoting food defense research

Vulnerability assessments, which are similar to risk assessments, help to prepare for,

prevent, and mitigate the effects of an attack on the food supply in several ways. First,

they can be used to identify products most at risk for adulteration. Second, they can be

used to identify likely threat agents for attacking the food supply. Third, they can identify

potential sites of contamination within a food processing system that are the most

attractive targets. Finally, they can facilitate the development of countermeasures to

minimize or reduce risks. In doing so, vulnerability assessments can focus limited

resources towards the foods and agents of greatest concern.

In response to President Bush’s issuance of the Homeland Security Presidential

Directive that called for establishing a single, comprehensive national incident

management system FSIS along with other agencies, have adopted the Incident

Command System (ICS). ICS was designed in the early ’70s. It is a standardized onscene incident management concept that allows responders from multiple agencies to

adopt a flexible, integrated organizational structure to cope with an emergency. The

organizational structure is specific to the ICS concept, and does not necessarily align

with the organizational structure of any of the responding agencies. Thus, the Incident

Commander, and those he/she commands, may not all be from one agency or the head

of any particular agency. ICS utilizes the skills of those most qualified to take command

of the particular situation until the emergency has been abated. In order to ensure a

seamless FSIS response, certain FSIS employees (DO and above) have been required

to complete the ICS training. ICS courses are available through AgLearn. To date,

FSIS has entered into cooperative agreements with the Department of Homeland

Security, the Department of Health and Human Services Food and Drug Administration

and the National Association of State Departments of Agriculture’s (NASDA) to ensure

that a prevention and response mechanism between federal and state agencies could

be enacted under the ICS system.

ODIFP developed the FSIS supplement to the USDA’s Continuity of Operations Plan

(COOP). A COOP identifies critical essential functions, succession and delegation of

authority, and essential documents, and then attempts to define how the Agency will

maintain mission critical functions and capabilities, communications, and security under

non-routine circumstances. Examples of non-routine circumstances might be a largescale attack on the country, a natural disaster, or an avian influenza pandemic (more

examples given below). If there were an attack on headquarters in Washington, DC for

example, the headquarters COOP enables other parts of the Agency to take over the

functions of headquarters at other locations. Regarding an avian influenza pandemic,

ODIFP has done extensive planning to ensure the safety and health of FSIS employees

and the delivery of essential functions. More generally, FSIS has identified and

developed response plans to help protect employees from exposure to bioterrorism

agents, including procurement of analytical detection equipment.

FSIS has established the Emergency Management Committee (EMC), a standing

committee that may be activated at anytime to address and manage the Agency’s
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 10

10

response to a non-routine incident involving the adulteration of FSIS–regulated product

or to manage a significant event or potential public health issue that requires

coordination and sharing of resources among program areas. The National

Biosurveillance Information System (NBIS) tracks and manage significant incidents. A

significant incident presents a grave or potentially grave threat to public health involving

FSIS-regulated product. Examples of significant incidents include the following:

• Widespread, or life-threatening, human illnesses potentially implicating FSISregulated product;

• Deliberate contamination of FSIS-regulated product;

• Threat alerts that there is an “imminent threat” or “elevated threat” specific to the

food and agricultural sector;

• Widespread animal disease with potentially significant public health implications for

FSIS-regulated product;

• Ineligible foreign product in the United States

• High risk products in the US as identified by Customs and Border Protection;

• Suspicious activities observed by program personnel while performing their normal

duties.

• Natural disasters (e.g., hurricanes, tornadoes, earthquakes);

• Terrorist attacks on the nation’s critical infrastructures; and

• Other Incidents of National Significance (INS) that result in the activation of the

Emergency Support Function -11 (ESF-11), which are described in the Agriculture

and Natural Resources Annex to the National Response Plan

From time-to-time, the EMC may need to form an Incident Investigation Team (IIT) to

investigate and provide information regarding a particular emergency incident. These IIT

reviews typically would be in response to an illness or outbreak in which a meat, poultry,

or egg product produced by the establishment has been implicated; significant or

repetitive contamination or adulteration incidents; or repetitive microbiological sampling

failures as a result of either the Agency or establishment testing (e.g., Escherichia coli

O157:H7, Listeria monocytogenes, or Salmonella). These teams would utilize specially

developed protocols and methodologies to gather the necessary information.

FSIS also has a number of surveillance activities underway. For example, FSIS

continues to enhance the CCMS. The CCMS is a surveillance system that monitors and

tracks food-related consumer complaints. It is a potentially powerful tool in serving as a

sentinel system for terrorist attacks on the food supply. FSIS also participates in

FoodNet, and maintains a regulatory sampling database. FSIS has a liaison at the CDC

in Atlanta. Some of these are activities were established for food safety reasons, but

can be used for food security as well.

The Office of Public Health Science (OPHS) Epidemiology Officers offer another source

for surveillance. The Epidemiology Officers with District Offices oversight have taken on

an important surveillance and response role for food defense, as part of their
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 11

11

responsibilities. They conduct regular surveillance activities, and have specialized roles

to respond to food defense emergencies.

Enhanced laboratory capability was established with FERN (The Food Emergency

Response Network). FERN was established in February of 2005. Working with FDA,

FERN’s mission is to expand and manage an existing group of more than 90 federal,

state, and local laboratories with the capability to detect and identify biological, chemical,

and radiological agents. FERN is located alongside the FSIS Eastern Lab. In its own

laboratories, FSIS has conducted security assessments, improved security, obtained

screening equipment and methods for threat agents, and developed protocols that

ensure proper chain of custody and other controls on all samples taken at official

establishments. FSIS continues to develop a Biosafety Level 3 laboratory to test for

threat agents in food products (such as Mycobacterium tuberculosis, St. Louis

encephalitis, and Bacillus anthracis).

For international food defense, the activities are as follows:

• Conducting vulnerability assessments of imported products

• Participating in the Federal-wide International Trade Data System (ITDS), a

multi-department, multi-agency initiative to establish a single, automated system

for sharing data on the inspection and certification of products moving in foreign

commerce

FSIS workforce training in food defense has primarily focused on prevention of terrorist

activities, rather than responding to an event. The training covered a multi-dimensional

team approach to homeland security – involving the interaction of personnel at the local,

state, federal, and private sector; and, reinforced reporting lines for suspicious activities.

It also focused on our field employees.

Currently available training materials include FSIS Directives 5420.1 that provides

instruction on policy for field personnel. PHV trainees need to read FSIS Directive

5420.1 on Food Defense Verification. There may still be computer-based food defense

training on CDs available in establishments; however, much of the information is

outdated and the training is in the process of being updated. An online course on food

defense awareness developed cooperatively by the FDA and USDA is available at

http://www.fda.gov/ora/training/orau/FoodSecurity/default.htm.

For those interested in ICS training, which is currently not mandatory for in-plant

inspection personnel, AgLearn offers several courses on ICS. AgLearn can be

accessed through http://www.aglearn.usda.gov. USDA eAuthentication credentials are

required to login.

Training and education initiatives for industry are discussed below under the heading

Industry Outreach.

FSIS has identified high priority areas for research and development pertaining to food

defense, such as testing methods for certain threat agents. The agency is working with

Department of Homeland Security’s National Biodefense Analysis and Countermeasures

Center (NBACC) and the interagency Technical Support Working Group (TSWG) on
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 12

12

several studies pertaining to the use of certain threat agents in food. The results of

these research activities influence the agency's capability to test for different threat

agents, the amount of testing, and which agents to test for, and informs vulnerability

assessments.

INDUSTRY OUTREACH

There currently are no regulatory requirements specific for food defense; however, FSIS

encourages the private industry to develop and implement food defense plans aimed at

minimizing their risk of a food terrorism incident. Key components of such food defense

plans are:

• Improve physical security to limit unauthorized access

• Improve personnel security

• Conduct food defense awareness training for employees

• Monitor product loading, unloading, and silo/tanker cleaning

• For transportation firms - confirm eligibility, training, and background information

of both company and contract drivers

• Enhance process security thru system monitoring procedures

• Monitor water/ice used in emulsification and solution preparation processes

• Require product integrity and chain of custody information

• Use tamper-evident packaging for products

• Enhance recall systems to ensure food that has been intentionally adulterated

can be accurately and efficiently tracked and detained

FSIS routinely conducts Regulatory Education and “How To” sessions, which include

presentations and hands-on workshops on food defense. The food defense

presentation is intended to heighten awareness, and encourage processors to seriously

consider the potential for and consequences of attacks on the food supply so that they

will implement strategies designed to minimize the chances of such an attack. In an

effort to help private industry minimize their risk, FSIS has developed publications to

promote food defense activities by all food businesses. These publications encourage

industry to take steps to ensure the security of their operations, and have been designed

to be especially helpful to small and very small establishments that may not have the

resources of larger corporations. Currently available food defense publications are

summarized below.

• Food Defense Self-Assessment Checklist for Slaughter and Processing

Facilities: created this self-assessment instrument to provide a tool for

establishments to assess the extent to which they have secured their operations.

• Food Defense Guidelines for Slaughter and Processing Establishment: created

to assist Federal and State inspected establishments that produce meat, poultry,

and egg products in developing preventive food defense measures. While many

establishments may utilize guidelines from other government and private sector
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 13

13

organizations and agencies, businesses and establishments that do not have

access to this specialized security-planning advice should find these guidelines

helpful in improving and preparing food security plans. These guidelines are

currently voluntary, but establishment officials will be well served by adopting and

implementing them because they are developed to meet the particular needs of

meat, poultry, and egg producing establishments. FSIS has provided these

guidelines to its field employees who will assist in directing establishments that

seek further clarification or advice.

• General Food Defense Plan: FSIS has urged establishments to develop

functional food defense plans with control measures to help prevent intentional

adulteration of products. A functional food defense plan has the following

characteristics:

— it is written

— the measures described in the plan are implemented

— the measures are periodically tested

— the plan is reviewed at least annually and revised if needed

If the establishment is not implementing elements of its plan, inspection program

personnel cannot take action on that fact because there is no regulatory

requirement for such plans.

• Guidelines for Transportation and Distribution of Meat, Poultry, and Egg

Products: Similar to the “FSIS Security Guidelines for Food Processors,” these

guidelines are voluntary and designed to assist small shippers and distributors by

providing a list of safety and security measures that these entities should take to

strengthen their food safety and food security plans. Protecting food during

transportation and storage is a critical component in our defense against all types

of food borne contaminants. These guidelines address points in the

transportation and distribution process where potential contaminants could be

introduced, including loading and unloading, and in-transit storage. FSIS

encourages shippers, transporters, distributors, and receivers to develop and

implement controls to prevent contamination of products through all phases of

distribution, and to have plans in place in the event of accidental or deliberate

contamination. Both of these guidelines are available on the FSIS website in

several languages.

These publications are available for download at the following web address:

By clicking on the following link Food Defense and Emergency Response or type

http://www.fsis.usda.gov/wps/portal/fsis/topics/food-defense-defense-and-emergencyresponse

If you have questions or need clarification about the above referenced, materials you

can call the FSIS Policy Development Division at 800-233-3935 or electronically post a

question at http://askfsis.custhelp.com.

While functional food defense plans are not mandatory, they are strongly encouraged

and sometimes may be required by a processor’s customers in the supply chain. Food
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 14

14

defense plans do not need to be lengthy to be effective. In fact, depending on the

complexity of an operation, the plan may be as short as one page. The three basic

steps in developing a food defense plan are:

1. Assess the operation for possible vulnerabilities

2. Develop a plan to minimize identified vulnerabilities

3. Implement the plan

In addition to the resources that FSIS provides, the Food Defense Verification (FDV)

tasks described below are a means by which inspection personnel can help an

establishment identify potential vulnerabilities in a particular operation and encourage

establishment management to take action to minimize those vulnerabilities.

THE NATIONAL TERRORISM ADVISORY SYSTEM

On January 27, 2011, the Department of Homeland Security (DHS) announced that it

would discontinue the color-coded Threat Condition alerts of the Homeland Security

Advisory System. On April 27, 2011, DHS initiated a new system, the National

Terrorism Advisory System (NTAS). Under the new NTAS system, DHS coordinates

with other federal entities to issue formal, detailed alerts when the Federal government

receives information about a specific or credible terrorist threat. These alerts include a

clear statement that there is an “imminent threat” or “elevated threat”. The alerts also

provide a concise summary of the potential threat, information about actions being taken

to protect public safety, and recommended steps that individuals, communities,

businesses, and governments can take.

The NTAS alerts are based on the nature of the threat. In some cases, alerts are sent

directly to law enforcement or affected areas of the private sector. In others, alerts are

issued more broadly to the American people through official and media channels –

including a designated DHS webpage (www.dhs@gov/alerts), as well as social media

tools, including Facebook and Twitter (@NTASAlerts). Additionally, NTAS has a “sunset

provision”, meaning that individual threat alerts are issued with a specified end date.

Alerts may be extended if new information becomes available or if the threat evolves

significantly.

FSIS DIRECTIVES

Now, let us talk more specifically about your duties related to food defense. Your duties

are covered in FSIS Directives. There are eleven FSIS Directives related to Homeland

Security:

• 5420.1 – Food Defense Verification Tasks and Threat Notification Response

Procedures for the Office of Field Operations

• 5420.2 – Homeland Security Threat Condition Response: Handling of FSIS

Laboratory Samples under Declared Heightened Threat Conditions
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 15

15

• 5420.3 – Food Defense Surveillance Procedures and National Terrorism Advisory

System Alert Response for the Office of Program Evaluation, Enforcement and

Review

• 5420.5 – Homeland Security Threat Condition Response: Intelligence Reports and

Communications

• 5420.6 – Homeland Security Threat Condition Response: Information Technology

Monitoring Procedures

• 5420.7 – Homeland Security Threat Condition Response: Human Health Monitoring

and Surveillance

• 5420.8 – Homeland Security Threat Condition Response: Communication and

Public Affairs Procedures

• 5500.2 – Significant Incident Response

• 5500.3 – Incident Investigation Team Reviews

• 5500.4 – Products Intentionally Adulterated with Threat Agents

When reviewing any of these Directives, make sure that you have the most recently

issued version by downloading the particular Directive from the FSIS website or from

PHIS – Home Page – My Dashboard tab. These may be modified frequently to reflect

new threat information gained through intelligence gathering activities conducted

worldwide. Therefore, it is imperative that you review these Directives following

notification of any modifications or updates.

FSIS conducts verification activities throughout the food production process. The food

production process consists of a series of processes along the farm to table chain. The

order of these processes is:

• Production – is the growth of food products and shipment of the products to the

slaughter or processing facilities. The shipping portion of this process also

accounts for imported products, which is reviewed by the FSIS Office of

International Affairs.

• Processing – is the slaughter and processing steps of the chain.

• Distribution – is the movement of the processed product into commerce.

• Retail/Consumption – the final step when the product reaches the retail service

industry (institutional facilities and/or grocers).

Obviously, the FSIS in-plant inspection team’s major area of responsibility falls within the

processing part of the system. The first Directive in the series outlines the duties that

are relevant to the in-plant inspection team under an imminent threat or elevated threat

alert. The other Directives cover the duties of other FSIS officials regarding distribution,

communications, information technology, human health monitoring, public affairs, etc.

As a PHV, you should familiarize yourself with these other important directives, if it

applies to your duties.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 16

16

Let us look at Directive 5420.1 in more detail. First, this directive describes Food

Defense Verification (FDV) tasks that Inspection Program Personnel (IPP) is to perform

and the frequency with which these procedures are to be performed in the Public Health

Information System (PHIS). These tasks have a priority 6 in the Establishment Task

List. The frequency with which these tasks are to be performed is based on factors that

affect the vulnerability to intentional adulteration:

• Nature of the food product – in general, the following characteristics are

associated with foods most vulnerable to intentional adulteration:

— large batch size

— uniform mixing

— short shelf life

— accessibility to the product

• Product volume – establishments that produce a greater volume of product may

be a more desirable target for intentional adulteration because a greater volume

of adulterated product can lead to greater public health consequences.

In addition, the directive describes additional actions that are required when DHS issues

an NTAS alert. The purpose of these verification tasks is to identify potential

weaknesses in the food defense of an establishment that could make it vulnerable to

deliberate contamination. A potential weakness can be any part of the food production

system where a measure should be implemented to protect it from deliberate

contamination, but such a measure is found to be missing or not in place. Examples

may include unrestricted access to water system or to a processing room, uncontrolled

access to a restricted ingredient area, to mention a few.

Directive 5420.1 describes the actions that the FSIS Office of Data Integration and Food

Protection (ODIFP) will take to notify employees, stakeholders, and the public, as

appropriate, when DHS issues an NTAS alert or when an NTAS alert ends. Inspectorsin-Charge (IIC) are to ensure that any notifications distributed to field employees

pursuant to this directive are available to food inspectors, and inform establishment of

the NTAS alert status. In case of significant incident, the FSIS Emergency Management

Committee may be alerted or activated and other response actions taken pursuant to

Directive 5500.2, Significant Incident Response.

When the Federal government receives information about a specific or credible terrorist

threat to food or agriculture, the frequency with which FDV tasks are performed will

increase, and additional actions may be needed to reduce the threat of intentional

adulteration of food products. Given what is required in responding to a credible threat

of a terrorist attack, IPP must clearly understand their roles and what will be required of

them to respond properly to that threat.

All IPP in meat and poultry establishments and processed egg products plants are to

perform FDV tasks listed in Directive 5420.1 and documented in PHIS. Following is a

brief description of each:

• Water System FDV Task: to assess vulnerable points for this task, IPP are to

verify whether the establishment restricts access to water systems and

associated activities on the premises.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 17

17

• Processing/Manufacturing FDV Task: to assess vulnerable points for this task,

IPP are to verify whether the establishment restrict access to processing and

manufacturing areas and associated activities on the premises

• Storage Areas FDV Task: to assess vulnerable points for this task, IPP are to

verify that storage areas are secure from intentional adulteration activities.

• Shipping and Receiving FDV Task: to assess vulnerable points for this task, IPP

are to verify whether the establishment restrict access to shipping and receiving

areas and activities on the premises.

PHIS will automatically generate the minimum number of routine FDV tasks to the

Establishment Task List (one per week), unless a Threat Notification is issued. Table 1

provides the frequency for which IPP are to perform FDV tasks based on threat

notification status. Following is a summary version of Table 1 as per Directive 5420.1

followed by a description for each notification status:

Establishment

Details

No Threat

Notification has

been issued

Elevated Threat

Notification has

been issued

Imminent Threat

Notification has

been issued

Domestic

Establishments – Most

Vulnerable;

High Volume

One / week

Four / day + the

routinely

scheduled weekly

task

Four / day + the

routinely

scheduled weekly

task

Domestic

Establishments – Most

Vulnerable;

Low Volume

One / week

two / day + the

routinely

scheduled weekly

task

Four / day + the

routinely

scheduled weekly

task

Domestic

Establishments –

Least Vulnerable;

Regardless of Volume

One / week

Two / day + the

routinely

scheduled weekly

task

Four / day + the

routinely

scheduled weekly

task

No Active NTAS Alerts or No Threat Notification has been issued:

• IPP in meat and poultry establishments that produce most vulnerable products in

high volume establishments are to perform one routine FDV task per week.

Establishment details: are domestic establishments producing any product other

than thermally processed – commercially sterile product (i.e., most vulnerable) in

a combined volume greater than 12,000 lbs. /day for meat and poultry (i.e., high

volume).

• IPP in meat and poultry establishments that produce most vulnerable products in

low volume establishments are to perform one routine FDV task per week.

Establishment details: are domestic establishments producing any product other

than thermally processed – commercially sterile product (i.e., most vulnerable) in

a combined volume less than 12,000 lbs. /day for meat and poultry (i.e., low

volume).
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 18

18

• IPP in meat and poultry establishments that produce least vulnerable products at

any volume are to perform one routine FDV task per week. Establishment details:

are domestic establishments producing thermally processed – commercially

sterile product (i.e., least vulnerable) regardless of volume.

When threats has been issued, in addition to routinely schedule FDV tasks, IPP are to

schedule the prescribed number of directed FDV tasks, identified in Table 1, to their task

calendar for the types of product being produced and claim those tasks that day, unless

otherwise directed by the DO.

NTAS Alert with Elevated Threat Notification has been issued:

• IPP in meat and poultry establishments that produce most vulnerable products in

high volume establishments are to perform four FDV tasks per day in addition to

the routinely scheduled weekly task. Establishment details: are domestic

establishments producing any product other than thermally processed –

commercially sterile product (i.e., most vulnerable) in a combined volume greater

than 12,000 lbs. /day for meat and poultry (i.e., high volume).

• IPP in meat and poultry establishments that produce most vulnerable products in

low volume establishments are to perform two FDV tasks per day in addition to

the routinely scheduled weekly task. Establishment details: are domestic

establishments producing any product other than thermally processed –

commercially sterile product (i.e., most vulnerable) in a combined volume less

than 12,000 lbs. /day for meat and poultry (i.e., low volume).

• IPP in meat and poultry establishments that produce least vulnerable products at

any volume are to perform two FDV tasks per day in addition to the routinely

scheduled weekly task. Establishment details: are domestic establishments

producing thermally processed – commercially sterile products (i.e., least

vulnerable), regardless of volume.

NTAS Alert with Imminent Threat Notification has been issued:

• IPP in meat and poultry establishments that produce most vulnerable products in

high volume establishments are to perform four FDV tasks per day in addition to

the routinely scheduled weekly task. Establishment details: are domestic

establishments producing any product other than thermally processed –

commercially sterile product (i.e., most vulnerable) in a combined volume greater

than 12,000 lbs. /day for meat and poultry (i.e., high volume).

• IPP in meat and poultry establishments that produce most vulnerable products in

low volume establishments are to perform four FDV tasks per day in addition to

the routinely scheduled weekly task. Establishment details: are domestic

establishments producing any product other than thermally processed –

commercially sterile product (i.e., most vulnerable) in a combined volume less

than 12,000 lbs. /day for meat and poultry (i.e., low volume).

• IPP in meat and poultry establishments that produce least vulnerable products at

any volume are to perform four FDV tasks per day in addition to the routinely

scheduled weekly task. Establishment details: are domestic establishments
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 19

19

producing thermally processed – commercially sterile products (i.e., least

vulnerable), regardless of volume.

Note: Frequency of task performance based on nature of the food product and product

volume, recognizing that certain product types produced at higher volumes may be more

vulnerable to intentional adulteration. For establishments producing multiple product

types and volumes, additional tasks should be scheduled based on the most vulnerable

product produced (i.e., products other than thermally processed – commercially sterile

product and products produced at a higher volume per day).

DOCUMENTING FOOD DEFENSE VERIFICATION ACTIVITIES

When IPP perform a FDV task and do not find a food defense vulnerability or concern,

they are to record the task as performed in the computerized Public Health Inspection

System (PHIS).

When IPP perform a FDV task, and find that there is a food defense vulnerability or food

defense concern, but that there is no evidence of product adulteration, they are to record

the task as performed and document a Food Defense MOI. If there is evidence of

product adulteration, IPP will schedule and perform a directed HACCP, SSOP or other

appropriate inspection task to record the observed non-compliance citing the applicable

regulations.

Note: As per Directive 5500.4, when IPP become aware of a situation involving

product that has been intentionally adulterated with threat agents (biological,

chemical, or radiological materials), the IPP should verify and ensure that the

product is not disposed of until they have been notified by the Incident

Commander through supervisory channels that the agency’s investigation is

complete.

In cases where food defense vulnerability is identified, there are additional steps

inspection personnel must take. These include:

• verbally notifying establishment management and discussing the findings (NOTE:

This can take place at the next weekly meeting), and

• completing FSIS Form 5420-1, Food Defense Memorandum of Interview (MOI),

in PHIS and record the establishment response after discussing the findings;

provide establishment’s management with a copy of the completed FSIS Form

5420-1.

If the same vulnerability is found a second and third time, the same procedures are

followed. If after the third occurrence, though, the establishment expresses no intention

of addressing the situation, then inspection personnel should notify the District Office

through supervisory channels. Inspection program personnel are not to further review or

document the specific potential vulnerability identified in the three repeat MOIs until the

District Office provides further instructions. If the procedure is randomly selected,

inspection program personnel are to direct verification procedures to establishment

activities other than the one specifically identified in the third MOI. The District Office will

request the ODIFP review the situation and provide further guidance.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 20

20

ACCESS TO AN ESTABLISHMENT’S FOOD DEFENSE PLAN

As mentioned previously, FSIS encourages establishments to develop a functional food

defense plan; however, there is currently no regulatory requirement for food defense

plans. As such, an establishment does not have to provide IPP access to its food

defense plan or any associated documents (e.g., employee personnel files). It is

beneficial if inspection personnel are permitted access to the plan, as it may be useful in

determining specific verification activities when performing the food defense verification

tasks. If the establishment shares its plan, do not keep or make copies of the written

plan. Inspection personnel also cannot show or share anything about the plan with any

outside source because it includes sensitive security information.

If the establishment has a functional food defense plan, IPP need to update the

establishment’s profile; review annually. In addition, at least annually, IPP will receive an

alert through PHIS indicating that the Food Defense Survey task has been added to the

establishment task list. When the IPP schedules the task and claims it, the “Qnaire” tab

will be active, indicating the presence of a questionnaire. IPP will enter the answers to

all the questions and record the task as completed. The IPP are to complete the Food

Defense Plan Survey task in lieu of performing one FDV task

SUMMARY

Defending the food supply against intentional attacks is a critical function. FSIS field

personnel both in and outside of establishments serve as an early alert system.

Implementation of FDV 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 hr. emergency hotline at 1-866-395-9761.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 21

21

WORKSHOP

FSIS FOOD SECURITY GUIDELINES TO INDUSTRY

Approximate time for this unit: 1 hour

INSTRUCTIONS:

Break up into small groups (e.g., 5-6 persons). First, individually review the Workshop

checklist. Take about 15 minutes to complete it with one specific establishment in mind.

As you review the Food Defense Self Assessment Checklist for Slaughter and

Processing Facilities, think about how you would share the information on the checklist

with an establishment representative. Remember that the Food Defense Guidelines are

voluntary. They are not required by regulation. Then, as a group take about 15 minutes

to discuss how you would share the information on the checklist with an establishment

representative. For example, give your group members a brief description of the

establishment you had in mind when completing the checklist. Then, pick 1-3 areas to

discuss with the establishment representative. Share ideas about how you would

encourage establishment management to take steps to adopt measures outlined in the

Food Defense Guidelines.

(See checklist in the training materials.)

Note: The checklist is intended to be used as a training tool. It is not an official Agency

form.

ESTABLISHMENT INCIDENT SCENARIO

Approximate time for this unit: 1 hour

Working in small groups of 5-6 people each, you are going to be read a scenario about a

reported in establishment incident. This scenario is realistic, in that something very

much like this has happened in an FSIS-regulated establishment. Then, each group will

develop their response. Someone in each group should record group decisions, and be

prepared to report them for the group.

You have 20 minutes to answer these questions in your group:

Regardless of whether you were talking to the inspector on the phone or in the

establishment with the inspector:

What questions would you ask?

What actions would you advise the inspector to take, or if you were there, what actions

would you take?
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 22

22

QUESTIONS

INSTRUCTIONS:

Based on the information provided in the presentation and your training materials, select

the most appropriate response for each of the following items.

1. Food defense is:

a. intentional contamination of food

b. planning to protect physical facilities, surveillance and monitoring activities,

personal and emergency procedures

c. making sure people are happy

d. giving all FSIS officials secret powers to enforce food safety

2. The Centers for Disease Control and Prevention (CDC) has: (See Appendix

below)

a. three categories of biological agents: 1, 2 and 3

b. put those biological agents that are easily disseminated from person-toperson, result in high mortality and have a potential for major public health

impact in Category A

c. put Brucellosis, Glanders, Q-Fever, Staphylococcal enterotoxin,

Salmonella, E. coli O157:H7 and Shigella in the highest category for

biological threat agents

d. categorized emerging pathogens that can be engineered for mass

dissemination as Category B (e.g., Nipah and Hanta viruses)

3. FSIS has food defense initiatives in the following areas:

a. works closely with the White House and Department of Homeland Security

to coordinate food defense efforts

b. has three laboratories and one special microbial outbreak laboratory that

ensure proper chain of custody and other controls on all samples taken at

official establishments

c. been training the entire workforce on how best to prevent terrorists activities

rather than responding to an event after the fact

d. conducted Operation Liberty Shield and replaced certain inspection tasks

that were not related to food safety with targeted inspection and sampling

for approximately a dozen biological, chemical and/or radiological agents

and continues to randomly test for these agents on an on-going basis

e. All of the above

4. Which of the following should IICs do in a NTAS Alert with Imminent Threat to

Food or Agriculture?

a. Tell the establishment that everyone must go home to protect themselves

b. Report potential breaches to the Department of Homeland Security

c. Observe incoming animals for unusual signs and report it to APHIS only

because they are in charge of animal health and not FSIS

d. Conduct all FDV tasks
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 23

23

APPENDIX: BIOTERRORISM OVERVIEW

There are multiple components to bioterrorism. Beyond just food terrorism, bioterrorism

is often defined as the use of biological agents that target humans, plants, or animals;

and, was exemplified in anthrax letters that were used in 2001 against the American

people. In addition, other terrorism components such as conventional, radiological,

nuclear, chemical, and cyber are typically directed at the human population. This

appendix discusses various components of bioterrorism. It is important for the FSIS PHV

to be aware of these bioterrorism components from a professional perspective as well as

from the standpoint of serving as a first line defense. They will be monitoring animal

diseases of great economic significance (e.g., foreign animal diseases) that could be

initiated through an act of terrorism causing public health threats that could be

introduced through the food supply.

Types of Agents Used by Terrorists

Weapons of Mass Destruction:

Terrorists often use Weapons of Mass Destruction. These include chemical, biological,

radiological agents, or high yield explosives. Some examples of chemical weapons

used by terrorists are arsenic, cyanide, and pesticides. Examples of biological weapons

that terrorists use include anthrax, botulinum, and toxin. Radiological weapons

examples used by terrorists include Cesium-137, Strontium-90, and Cobalt-60. When

Weapons of Mass Destruction (WMDs) are used, there are four possible areas of

impact. They include harm to the economy, disruption of society, psychological

disturbance, and political disturbance.

Chemical agents

Biological compounds used as chemical agents: You should be aware of some of the

typical ways in which the chemical agents used by terrorists affect the human body.

Here are some examples:

Vesicants: Terrorists may use a biological agent that acts as a vesicant such as

a powder. These agents burn and blister the skin or any other part of the body

they contact. They act on the eyes, mucous membranes, lungs, skin, and bloodforming organs. They damage the respiratory tract when inhaled and cause

vomiting and diarrhea when ingested. Examples of biological agents that have

this effect are Sulfur mustard in its pure state is colorless and odorless. It is

extremely toxic to the unprotected eyes, skin, and respiratory system. If a victim

survives the initial encounter, the mustard continues to destroy the body’s

immune defenses and can complicate treatment of acquired infection. Nitrogen

mustards are more toxic than sulfur mustards and are easily manufactured.

Lewisite placed on the skin causes immediate burning sensation, and its odor is

readily apparent. Severe damage to the eyes occurs almost immediately after

exposure. Lewisite vapors irritate the mucosa of the nasal and upper respiratory

system. Lewisite is absorbed into the body, and distributed as a systemic poison

to various organs.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 24

24

Blood: Biological agents also affect the blood. A typical effect of a biological

agent is that they prevent blood from carrying O2 effectively. For example,

arsenic can be reacted with zinc and sulfuric acid to form arsine, which is a

colorless gas with an unpleasant odor similar to garlic. Arsine is a blood agent

but it is referred to as a nerve poisoning due to its secondary effects. Arsine

causes the destruction of red blood cells and subsequently the tissues of the

kidney, liver, and spleen. Arsine is used today for industrial processing of gallium

arsenide chips in the semiconductor industry.

Choking/Pulmonary: These biological agents cause choking and affect the

pulmonary system in humans, but they are not food related.

Incapacitating: Some biological agents that can be introduced in food can

incapacitate the individuals affected. For example, BZ, 3-quinuclidinyl benzylate,

is a member of the belladonna group of compound (glycolates) that includes

atropine, scopolamine, and many others.

Emetics: In many cases, chemical agents, when ingested or inhaled, induce

vomiting. Among the vomiting agents that have the most significant effects are

diphenylchlorarsine (DA), diphenylcyanoarsine (DC), and adamsite (DM). These

agents can be dispersed as aerosols and produce their effects by inhalation.

Some minor eye irritation also might occur. Emetics produce a feeling of pain and

sense of fullness in the nose and sinuses. This is accompanied by a severe

headache, intense burning in the throat, tightness and pain in the chest, irritation

of the eyes and lacrimation. Coughing is uncontrollable, and sneezing is violent

and persistent. Nausea and vomiting are prominent. Mild symptoms, caused by

exposure to very low concentrations, resemble those of a severe cold. The onset

of symptoms may be delayed for several minutes after initial exposure, especially

with DM. Therefore, effective exposure may occur before the presence of the

smoke is suspected. If a protective mask is available and put on by an individual

after these symptoms are noticed, the symptoms will increase for several

minutes, despite adequate protection. Consequently, the victim may believe the

mask to be ineffective, and by removing it, cause further exposure. On leaving

the scene of the attack, the victim's symptoms subside rather rapidly, and the

severe discomfort vanishes after about one-half hour. At high concentrations,

effects may last for several hours. Because of their arsenical properties, when

these chemical agents are introduced, the affected foods become poisonous.

Tearing: The chemical agents used for terrorism that cause tearing are not

typically introduced through food.

Nerve agents: Some of the nerve agents that can be used by terrorists to affect food

products include the following:

• Tabun (GA) - volatile, liquid/vapor

• Sarin (GB) - volatile, liquid/vapor

• Soman (GD) - volatile, liquid/vapor

• VX - low volatility, liquid

• Pesticides - methyl parathion, malathion, diazinon
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 25

25

All of these agents are cholinesterase inhibitors when they are ingested or inhaled.

Cholinesterase is an enzyme needed for the proper functioning of the nervous systems

of humans, other vertebrates, and insects. They are all pesticides, which act like

organophosphates and carbamates to inhibit cholinesterase. Nerve agents are the most

toxic and rapidly acting of the known chemical warfare agents. They are similar to

pesticides, called organophosphates, based on their properties and the kinds of harmful

effects they cause. However, nerve agents are much more potent than organophosphate

pesticides.

Heavy metals: Heavy metals can also be used by terrorists to affect food products. The

most dangerous ones include the following:

• Arsenicals

• Mercury

• Cyanide

• Thallium

Arsenic: The primary symptoms of acute inorganic arsenic poisoning in humans are

painful dysesthesias, decreased deep tendon reflexes, decreased pain, touch, and

temperature sensation. Individuals who have arsenic poisoning may also experience

nausea, anorexia, vomiting, epigastric and abdominal pain, and diarrhea. These

symptoms are so severe that they often end in death. Chronic exposure to low levels

of arsenic has led to nasal septum perforation, dermatological symptoms (lesions,

necrosis, etc.), and an increase in the incidence of lung and lymphatic cancers.

Mercury: The heavy metal mercury is not well absorbed by the human gastro

intestinal tract, but there is good pulmonary absorption of mercury vapors, especially

methyl mercury.

Cyanide: Cyanide is rapidly absorbed from the stomach, lungs, mucosal surfaces,

and unbroken skin; is a rapidly acting poison that can exist in various chemical forms.

Examples of simple cyanide compounds include hydrogen cyanide, sodium cyanide,

and potassium cyanide. Hydrogen cyanide is a colorless gas with a faint, bitter,

almond-like odor. Sodium cyanide and potassium cyanide are both white solids with a

bitter, almond-like odor in damp air. Cyanide and hydrogen cyanide are used in

electroplating, metallurgy, in the production of chemicals, photographic development,

making plastics, fumigating ships, and some mining processes. Effects begin within

seconds of inhalation and within 30 min of ingestion. A bitter almond odor may be

detected on the breath. Later effects include coma, convulsions, paralysis, respiratory

depression, pulmonary edema, arrhythmias, bradycardia, and hypotension. Antidotal

therapy: Amyl nitrite, sodium nitrite, and sodium thiosulfate with high-dose oxygen

should be given as soon as possible.

Thallium: Thallium is a toxic heavy metal. Most cases of thallium toxicity occur after

oral ingestion. Gastro intestinal decontamination, activated charcoal, and Prussian

blue (potassium ferric hexacyanoferrate) are recommended in thallium ingestion.

Biological Agents and Toxins
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 26

26

Before discussing the diseases, it is important to understand the weaponization of an

agent. If an agent has been “weaponized”, characteristics of the pathogen may have

been altered to make it a more effective weapon.

For example:

• the transmission of a pathogen may be enhanced or the virulence increased;

• the organism may have been altered to make it resistant to antibiotics it would

otherwise be susceptible to;

• may allow an organism to evade the normal protective immunity induced by

vaccine, or it may even alter the clinical signs; it is difficult to know

However, when evaluating these agents, and what we currently know about them is still

important for our enhanced awareness.

The CDC divides biological agents and toxins into three categories:

• Category A - High priority

• Category B - Second highest priority

• Category C - Third highest priority

Be aware that the CDC changes the agents listed in these categories as additional

information becomes available. Let us discuss each of these in more detail.

Category A

The biological agents and toxins that fall into Category A can be easily disseminated, or

transmitted person-to-person. They cause high mortality, with potential for major public

health impact. Their introduction might result in public panic, and social disruption. They

require special action for public health preparedness. Following are the agents and

toxins that are currently listed in Category A:

• Anthrax (Bacillus anthracis)

• Botulism (Clostridium botulinum toxin)

• Plague (Yersinia pestis)

• Smallpox (Variola major)

• Tularemia (Francisella tularensis)

• Viral hemorrhagic fevers (e.g., Ebola)

Anthrax

Anthrax results from infection by Bacillus anthracis, a spore forming gram-positive

aerobic rod. Anthrax can be found as a spore in the soil worldwide; it is particularly

common in parts of Africa, Asia, and the Middle East. In the United States, foci of

infection occur in South Dakota, Nebraska, Mississippi, Arkansas, Texas, Louisiana, and

California, with smaller areas in other states.

Spores can remain viable for decades in the soil or animal products, such as dried or

processed hides, and wool. Spores can also survive for 2 years in water, 10 years in
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 27

27

milk, and up to 71 years on silk threads. However, the vegetative organisms are thought

to be destroyed within a few days during the decomposition of unopened carcasses

(exposure to oxygen induces spore formation).

There are three forms of the disease in humans:

1) Cutaneous anthrax that develops after skin infections – this form is characterized by a

papular skin lesion, which becomes surrounded by a ring of fluid-filled vesicles (as

shown in picture). Most lesions (malignant carbuncle) are non-painful and resolve

spontaneously; but disseminated, fatal infections occur in approximately 20% of cases.

2) Intestinal anthrax develops after eating contaminated meat. The initial symptoms may

be mild malaise and gastrointestinal symptoms. Severe symptoms can develop and

rapidly progress to shock, coma, and death.

3) Pulmonary anthrax occurs after inhaling spores in contaminated dust. Natural

infections are mainly seen among workers who handle infected hides, wool, and furs

(Wool Sorter’s Disease). Symptoms may include fever, tiredness, and malaise; a

nonproductive cough and mild chest pain may be present. Thereafter follows an acute

onset of severe respiratory distress, with fatal septicemia and shock within one to two

days. Fatalities may be prevented if treated early; however when symptoms are flu-like

and non-specific, early treatment is not sought.

In animals, sheep, cattle, and horses are very susceptible, while dogs, rats, and

chickens are resistant to disease. In ruminants, sudden death may be the only sign.

However, the disease may manifest as flu-like symptoms; chronic infections often have

edema.

In the 1950’s and 1960’s, B. anthracis was part of the U.S. bioweapons research

program. In 1979, there was an accidental release of aerosol anthrax from a military

compound in the Soviet Union. The neighboring residents experienced high fevers,

difficulty breathing, and a large number died. Fatality estimates ranged from 200-1,000.

In 1992, Russian President Boris Yeltsin finally acknowledged that the release occurred

from a large-scale military research facility. In 1991, Iraq admitted it had done research

on B. anthracis as a bioweapon.

There are several characteristics of B. anthracis make it attractive as a bioweapon. It is

widely available and relatively easy to produce. The spores are infective, resistant, and

remain infective when aerosolized. A lethal dose for inhalation of spores is low and

mortality is high; the case-fatality rate for inhalational anthrax could approach 100%.

Untreated pulmonary and intestinal infections are usually fatal, especially, if recognized

too late for effective treatment. Person-to-person transmission of anthrax is very rare

and has been reported only in cases of cutaneous anthrax.

Vaccines are available for humans who have a high risk of infection. The efficacy of the

vaccine against inhalation of B. anthracis is unknown, and reactogenicity of the vaccine

is mild to moderate. Vaccines are available for livestock. Natural strains of B. anthracis

are usually susceptible to a variety of antibiotics, but effective treatment depends on

early recognition of the symptoms. Treatment for cutaneous anthrax is usually effective,

but pulmonary and intestinal forms are difficult to recognize and mortality rates are much

higher. Prophylactic antibiotics are appropriate for all exposed humans. Anthrax spores
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 28

28

are resistant to heat, sunlight, drying, and many disinfectants, but are susceptible to

sporicidal agents or sterilization.

Botulism

Toxins produced by Clostridium botulinum cause botulism, or “limber neck” in waterfowl.

It is a gram positive, spore-forming, toxin-producing obligate anaerobic bacillus. The

spores are ubiquitous in soil.

A German physician, Justinius Kerner in 1793, first discovered botulism. He called the

substance “wurstgift”, and found it in spoiled sausages. During this period, sausage was

made by:

1. filling a pig’s stomach with meat and blood,

2. boiling it in water; then

3. storing it at room temperature, which were ideal conditions for clostridial spores

to survive

Botulism gets it name from “botulus”, which is Latin for sausage.

United States federal regulations for food preservation resulted following several

outbreaks of botulism. In the U.S., botulism spores germinate and release seven

different antigenic types of neurotoxins; classified as A through G. Different neurotoxin

types affect different species.

Only a few nanograms of the toxin can cause severe illness; and, all cause flaccid

paralysis. Neurologic clinical signs, including generalized weakness, dizziness,

dysphagia, and flaccid paralysis are similar in all species affected. In humans,

gastrointestinal symptoms may precede the neurologic symptoms because the

preformed toxin is ingested. In animals, many species of mammals and birds can be

affected. Clinical disease is most often in wildfowl, poultry, mink, cattle, sheep, and

horses. Ruminants and horses will often drool, while humans experience dry mouth.

Paralysis of the respiratory muscles leading to death may occur in 24 hours in severe

cases. Waterfowl are especially sensitive; pigs, dogs, and cats are moderately resistant.

Botulinum toxins are known to have been weaponized by several countries and terrorist

groups in the past. It was part of the U.S. bioweapons program. Iraq has produced large

volumes of this toxin, and the Aum Shinrikyo cult in Japan tried to use it unsuccessfully

in 1990. The botulinum toxins are relatively easy to produce and transport. Botulinum

toxin is extremely potent and lethal; and, is the single most poisonous substance known.

Signs of a deliberate release of the toxin; either via aerosol, food, or water, is expected

to cause clinical illness similar to food borne illness. Additionally, uncommon toxin types,

such as C, D, F, or G, may be the culprits; and thus, raise suspicion of an intentional

release.

In endemic areas, toxoids are typically used in horses, cattle, sheep, and goats; and

investigational toxoids for high-risk laboratory workers are available. However, these

toxoids are not effective for post-exposure prophylaxis. Botulinum antitoxin (trivalent) is

sometimes used in animals, but response depends on the type of toxin causing the

disease and the species of animal. In humans, if given early, the antitoxin may decrease

the severity of disease and shorten the duration of symptoms. It has severe side effects,
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 29

29

and is only used on a case-by-case basis. The U.S. Army has an investigational

heptavalent antitoxin. Antibiotics may be warranted if a wound is involved, but immediate

intensive care may be the only treatment. Botulinum toxins can be inactivated by

sunlight in 1 to 3 hours; as well as bleach, sodium hydroxide, or chlorinated water. The

spores are very resistant in the environment but moist heat (120°C for at least 15 min)

will destroy them.

Tularemia

Tularemia, or “rabbit fever”, is caused by Francisella tularensis, a gram negative

bacteria. The disease can be transmitted by:

• ingestion of infected, undercooked meat (rabbit);

• bites from infected ticks, and less commonly deerflies;

• through direct contact with blood or tissues of infected animals (especially

rabbits); and

• inhalation of contaminated dust

Initial symptoms are flu-like; and they include fever, chills, headache, and myalgia. In

humans, there are six clinical forms of tularemia – glandular and ulceroglandular are the

most common presentation of this disease. An ulcer may or may not be present at site of

infection, and local lymph nodes are enlarged.

Oculoglandular occurs when conjunctiva become infected by rubbing eyes with

contaminated fingers, or by splashing contaminated materials in the eyes. The

oropharyngeal presentation is caused by ingestion of organism in contaminated food

(undercooked meat), or water.

Typhoidal and pneumonic forms usually occur following inhalation, or hematogenous

spread of the organism. Both of these forms tend to present as atypical pneumonia; and

most fatalities occur with these forms, and can be as high as 30-60% if untreated.

In animals, the full spectrum of clinical signs is not known. Sheep, young pigs, horses,

dogs, and cats are susceptible to tularemia. Signs of septicemia such as fever, lethargy,

anorexia, and coughing are most commonly seen. In wildlife, clinical disease is not often

seen and animals are found dead or moribund. However, when infected hares and

cottontails are observed, they behave strangely in that they are easily captured because

they run slowly, rub their noses and feet on the ground, experience muscle twitch, are

anorectic, have diarrhea, and are dyspneic. These lagomorphs are an important

reservoir for human infection. Older swine and bovine seem to be resistant to disease

and are asymptomatic.

In the 1950-60’s, the United States military developed weapons that aerosolized F.

tularensis, and it is suspected that other countries may have included this organism in

their bioweapons research program as well. There are many characteristics that make F.

tularensis a good agent for bioterrorism. It is stable, survives in mud, water, and dead

animals for long periods; has previously been stabilized as a bioweapon. Only a low

dose is needed to cause inhalational disease. Case fatality rates of the typhoidal and

pneumonic forms are reported to be 30-60% if untreated. In 1969, the World Health

Organization (WHO) estimated that if 50kg of virulent F. tularensis particles were
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 30

30

aerosolized over a city with 5 million people, the result would be 250,000 illnesses and

19,000 deaths. Recently, the CDC estimated the economic losses associated with an

outbreak of tularemia to be $5.4 billion for every 100,000 people exposed.

Person-to-person transmission has not been documented with a tularemia infection; so,

secondary spread is of little concern. However, infectious organisms can be found in

blood and other tissues; care must be taken when handling infected material. Antibiotics

are generally effective if given early in the infectious process, and as a prophylaxis.

There is a live attenuated vaccine (given intradermally or by scarification) that is

available to individuals at high risk for exposure to the bacteria. The vaccines efficacy

against high dose respiratory challenge is unknown. Disinfection of the bacteria is easily

accomplished with many common disinfectants. However, the bacteria are stable at

freezing temperatures for months to years.

Category B

The biological agents and toxins that fall into Category B are moderately easy to

disseminate. They cause moderate morbidity, and low mortality. They require specific

enhancements of the CDC's diagnostic capacity, and enhanced disease surveillance.

The following agents and toxins are in Category B:

• Brucellosis (Brucella spp)

• Epsilon toxin (Clostridium perfringens)

• Food threats (Salmonella, E. coli O157:H7, Shigella)

• Glanders (Burkholderia mallei)

• Melioidosis (Burkholderia pseudomallei)

• Psittacosis (Chlamydia psittaci)

• Q Fever (Coxiella burnetii)

• Ricin toxin (castor beans)

• Staphylococcal enterotoxin

• Typhus (Rickettsia prowazekii)

• Viral encephalitis (VEE, WEE, EEE)

• Water safety threats (Vibrio cholera, Cryptosporidium parvum)

Brucellosis

Brucellosis, or undulant fever, is caused by various species of Brucella, a gram negative,

facultative intracellular rod. The organism can persist in the environment and indefinitely

if frozen in aborted fetuses or placentas. Transmission occurs thru:

• Ingestion-of infected food, or consuming infected unpasteurized milk or dairy

products,

• Inhalation-of infectious aerosols (a means of infection in abattoirs); or

• Contact with infected tissues through a break in the skin or mucous membranes.

Brucellosis can involve any organ or organ system, and have a very insidious onset with

varying clinical signs. The one common sign in all patients is an intermittent/irregular

fever with variable duration; thus, the term undulant fever.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 31

31

There are three forms of the disease in humans. In the acute form (<8 weeks from

illness onset), symptomatic, nonspecific, and flu-like symptoms occur. The undulant

form (< 1 yr. from illness onset and symptoms) include undulant fevers, and arthritis. In

the chronic form (>1 yr. from onset), symptoms may include chronic fatigue-like

syndrome and depressive episodes. Illness in people can be very protracted and

painful; and can result in an inability to work, and loss of income. In animals, the clinical

signs are mainly reproductive, such as abortions, epididymitis, orchitis, and fistulous

withers in horses.

The following indicates the Brucella species, the bacterial host, and human

pathogenesis:

• B. abortus > cattle, bison, elk or horses > yes

• B. melitensis > goats, sheep or cattle > yes

• B. suis > swine, hares, reindeer, caribou, or rodents > yes

• B. canis > dogs, or other canids > yes

• B. ovis > sheep > no

In the 1950’s when the U.S. bioweapons research program was active, Brucella suis

was the first agent weaponized. The World Health Organization prepared a bioterrorism

scenario looking at aerosolized B. melitensis (which has more serious consequences for

humans than B. suis) spread along a line with the prevailing winds with optimal

meteorological conditions. It was assumed that the infectious dose to infect 50 (ID50)

percent of the population would require inhalation of 1,000 vegetative cells. The case

fatality rate was estimated to be 0.5% with 50% of the people being hospitalized and

staying an average of seven days. It is highly infective, and moderately stable in this

form. Incubation period in humans is one week up to several months, which often

complicates the diagnosis due to the latency of clinical signs. Person-to-person

transmission is very rare.

Prolonged antibiotics are necessary to penetrate these facultative intracellular

pathogens. Combination therapy has shown the best efficacy for treatment in humans.

Vaccinating calves has helped eliminate infection in these animals, thus decreasing

possible exposure to humans. Strict adherence to federal laws of identifying,

segregating and/or culling infected animals is essential to success. Properly protect

yourself to prevent exposure to tissues and body secretions of infected animals by

wearing gloves, masks, goggles, and coveralls. Pasteurization or boiling milk and

avoidance of unpasteurized dairy products will help decrease human exposure to

brucellosis. The organism is susceptible to many disinfectants.

Equine Encephalitis

Encephalitis is the only viral group in the list of Category B agents. This group of equine

encephalitis viruses is RNA viruses in the Alphavirus genus. Eastern, Western, and

Venezuelan Equine Encephalitis viruses are transmitted by mosquitoes.

The female mosquito takes a blood meal from a viremic host, generally birds for EEE

and WEE, and birds and horses for VEE. The virus replicates in the salivary glands of

the mosquito and is transmitted back to birds or to dead end hosts, such as humans and

horses, where overt disease occurs. In humans, infections can be asymptomatic or
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 32

32

cause flu-like illness. In a small proportion of cases viral encephalitis can occur, and

lead to permanent neurological damage or death.

Horses, donkeys and mules have similar clinical signs as humans. The disease in these

animals often precedes human cases by several weeks. EEE and VEE have mortality

rates of 40-90%; WEE has a lower mortality rate, ranging from 20-30%. Birds are

asymptomatic carriers. The detection of viremia in sentinel birds is detected via ELISA.

VEE was tested in the U.S. bioweapons program in the 1950s and 1960s. It is thought

that other countries have also weaponized VEE. All U.S. stocks of VEE were destroyed,

along with the other agents that were part of the program. VEE can be produced in

large amounts by unsophisticated and inexpensive systems. The virus can be

aerosolized or spread by releasing infected mosquitoes. Humans are highly susceptible.

Approximately 90-100% of exposed individuals could become infected and have clinical

signs, although most are mild. Equids would also be susceptible, and disease would

occur simultaneously with human disease. There is a low overall human case-fatality

rate.

Antibiotics are not effective for treatment, and there are no effective antiviral drugs

available. Treatment involves supportive care. There is a trivalent formalin inactivated

vaccine available for horses for WEE, EEE, and VEE in the United States; but the

human vaccines is limited to those who are researchers, and at a high risk of exposure.

All of the virus types are unstable in the environment.

Category C

The agents that fall into Category C include emerging pathogens that could be

engineered for mass dissemination in the future because of availability, ease of

production and dissemination, the potential for high morbidity and mortality rates, and

major health impact. Following are the agents that fall into Category C:

• Nipah virus

• Hanta virus

Nipah

Nipah virus (a Paramyxovirus) was discovered in Malaysia in 1999, and causes a severe

respiratory disease in pigs and severe encephalitis in humans. The reservoir for the

virus is thought to be fruit bats, which are called flying foxes. Suspected transmission of

the virus occurs from bats roosting in fruit trees close to pig confinements. The virus

then spreads rapidly through the swineherd by direct contact, or aerosolization (usually

coughing). It can then be passed to humans, dogs, cats and other species.

Transmission can also occur from direct contact with infected body fluids. To date, no

person-to-person, or bat-to-person transmission, has been reported. In humans, the

incubation period is 3-14 days. Initial symptoms include fever, headache, dizziness,

drowsiness, disorientation and vomiting. Some cases show signs of respiratory illness.

In severe cases, rapidly progressive encephalitis can occur, with a mortality rate of 40%.

In swine, Nipah virus is highly contagious and easily spread. Many pigs are

asymptomatic. Clinical signs include acute fever (>104 ̊ F), tachypnea and dyspnea with
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 33

33

open mouth breathing, and a loud, explosive barking cough may be noted.

Occasionally, neurological signs can occur. Clinical signs in pigs were noted 1-2 weeks

before illness in humans making swine a sentinel for human disease. Disease in other

animal species is poorly documented. Other species demonstrate respiratory and

neurological signs.

Nipah virus is described as an emerging pathogen with potentially high morbidity and

mortality, as well as a major health impact. Currently transmission of the disease

involves close contact with pigs, but aerosolization may be a possible bioterrorism

method of dispersal. The potential for this virus to infect a wide range of hosts and

produce significant mortality in humans makes this virus a public health concern.

Nipah virus is a very dangerous pathogen and is classified as a Biolevel 4 agent. If you

suspect an outbreak, contact your state veterinarian and state public health veterinarian

IMMEDIATELY! Avoid all contact with potentially infected species (pigs, dogs, cats) until

the proper authorities are consulted. Detergents can readily inactivate Nipah virus.

Routine cleaning and disinfection with sodium hypochlorite, or several commercially

available detergents, is expected to be effective.

Radiological/Nuclear Agents

“Nuclear” involves a fission reaction (nuclear weapon, nuclear power plant, satellites,

and waste processing facility). It requires special nuclear material, such as plutonium

and/or uranium. “Radiological” involves radionuclides, which can be dispersed or

deposited. Accidents such as the reactors at Three Mile Island in Pennsylvania (small

release) and Chernobyl in Russia (large catastrophic release), have taught us about the

effects on the agriculture and the food supply. Those lessons focus on making decisions

to evacuate if establishment conditions worsen or remain unstable. Additionally, the

federal government has extensive plans, and practices emergency response around

nuclear facilities in the U.S.

Targets and Pathways

There are many methods of delivery and points in the agriculture process that an agent

could be introduced. Covert, or stealth, introductions will go unnoticed for a longer

period than overt introduction because we will be treating it as if it occurred under natural

conditions. The simultaneous release of three to four highly contagious, foreign animal

pathogens in several locations around the country at key points would be overwhelming.

High-density population areas represent tempting terrorist targets. Most lack even

rudimentary monitoring capabilities. Some examples include:

• Urban population centers,

• Business centers,

• Transportation nodes,

• Special events (e.g., political conventions, Super Bowl, Olympics, etc.), or

• Agribusiness and national food supply infrastructure.
FSIS as a Public Health Regulatory Agency: Homeland Food Defense

08/04/2015

Entry Training for PHV 34

34

Terrorists can exploit multiple pathways. They can introduce biological, radiological,

chemical, or other types of harmful agents into the population in a variety of ways,

including:

• Air dispersion (line and point source),

• Public transportation,

• Water supplies,

• Food distribution systems, and

• Mail distribution systems

Consequences

While the topic of food defense is highly concerned with the intentional introduction of

foreign agents, there is the possibility that international travelers might bring one or more

microbial agents into the U.S. accidentally. At first onset, an intentional outbreak of a

disease in animals or crops is hard to differentiate from a natural outbreak, which delays

finding the true source. False claims and hoaxes can be introduced to diminish public

confidence in food safety for particular commodities or products. A false report of one

case of BSE occurring in the U.S. would send the beef industry into a tailspin for a brief

time, losing perhaps tens of millions of dollars or more in overall costs. Foreign trading

partners might hear of the rumor and implement a trade ban. The perpetrator relies

upon the media to do the damage for him/her by spreading the rumors and presenting

fiction as fact. Clues generated by an outbreak might point toward an intentional

introduction.

The impact and consequences from a foreign animal disease such as Foot and Mouth

Disease (FMD) in the U.S. could be severe. Harsh restrictions on movement would be

enacted. We would see road closures, quarantined farms, and animal movement

ceased. Access to campsites, state parks, wilderness areas, lakes, city parks, and zoos

may be denied.

The psychological impact and mental health of livestock producers, veterinarians and

the local community could be negatively affected if entire herds are quarantined and

destroyed. Some of the images the outbreak produces could shock the public and alter

their buying habits as consumers. It is unlikely that a terrorist attack would create mass

food shortages, but movement restrictions could complicate availability temporarily.
USDA/Food Safety and Inspection Service

December 2007

652

Food Defense Self-Assessment Checklist for

Slaughter and Processing Plants

Outside Security

1. What food defense measures does your plant have in place for the exterior of the

building?

Yes No N/A

Are the plant’s grounds secured to prevent entry by unauthorized persons (e.g., by

locked fence, gate or entry/exit doors)?

Is there enough lighting outside the building to properly monitor the plant at

night/early morning?

Do emergency exits have self-locking doors and/or alarms?

2. Are the following secured with locks, seals, or sensors when unattended (after

hours/weekends) to prevent entry by unauthorized persons?

Yes No N/A

Outside doors and gates?

Windows?

Roof openings?

Vent openings?

Trailer (truck) bodies?

Tanker truck hatches?

Railcars?

Bulk storage tanks/Silos?

3. Does your facility have food defense procedures for people and/or vehicles entering

the plant and/or parking in your lot?

Yes No N/A

Does the property have a controlled or guarded entrance?

Are employee vehicles identified using placards, decals, or some other form of

visual identification?

Are authorized visitor/guest vehicles identified using placards, decals, or some

other form of visual identification?
USDA/Food Safety and Inspection Service

December 2007

653

General Inside Security

4. Does your facility have food defense measures inside the establishment?

Yes No N/A

Is there an emergency lighting system in the facility?

Does your plant have monitored security cameras (CCTV)?

Does your plant have an emergency alert system that is tested regularly?

Are the locations of controls for emergency alert systems clearly marked?

Are all restricted areas (i.e., areas where only authorized employees have access)

clearly marked?

Are visitors, guests, and other non-employees (e.g., contractors, salespeople,

truck drivers) restricted to non-product areas unless accompanied by an

authorized employee?

Does local law enforcement (including the fire department) have up-to-date

copies of facility layouts/blueprints?

Are procedures in place to check toilets, maintenance closets, personal lockers,

and storage areas for suspicious packages?

Do you regularly take inventory of potentially dangerous tools and utensils (e.g.,

knives)?

Do you regularly take inventory of keys to secured/sensitive areas of the

facility?

Are ventilation systems constructed in a manner that provides for immediate

isolation of contaminated areas or rooms?

5. Are the controls for the following systems restricted (e.g., by locked door/gate or

limiting access to designated employees) to prevent access by unauthorized persons?

(Helpful information is provided at the following website:

www.cdc.gov/niosh/bldvent/2002-139.html)

Yes No N/A

Heating, Ventilation, and Air Conditioning systems?

Propane Gas?

Water systems?

Electricity?

Disinfection systems?

Clean-in-place (CIP) systems or other centralized chemical systems?

6. Does your plant collect and analyze samples in-house for microbiological, chemical

or physical hazards?

Yes

No [Go to Question 8]
USDA/Food Safety and Inspection Service

December 2007

654

7. Which of the following food defense procedures does your facility have in place for

its in-plant laboratory facilities, equipment, and operations?

Yes No N/A

Is access to the in-plant laboratory facility restricted to authorized employees?

(e.g., by locked door, pass card, etc.)

Is a procedure in place to control receipt of samples received from other

establishments?

Is a procedure in place to receive and securely store reagents?

Is a procedure in place to control and dispose of reagents?

8. Does your facility use a computer system to monitor processing operations?

Yes

No [Go to Question 10 under Slaughter and Processing Security]

9. Does your facility have food defense procedures in place for its computer systems?

Yes No N/A

Is the access to the system password-protected? (Helpful information is

provided at the following website: http://www.umich.edu/~policies/pwsecurity.html)

Are firewalls built into the computer network?

Is the system using a current virus detection system?

Slaughter and Processing Security

10. Which of the following food defense procedures does this facility have in place for its

slaughter and processing operations?

Yes No N/A

Is access to product production/slaughter and holding pen areas restricted to

establishment employees and FSIS inspection personnel only?

Are lines that handle and transfer products, water, oil, or other ingredients

monitored to ensure integrity?

Are packages of ingredients examined for evidence of tampering before use?

Is access to in-plant irradiation equipment and materials restricted?

Are records maintained to allow easy trace-back of raw materials to suppliers?

Are records maintained so as to allow easy trace-forward of finished products to

vendors?
USDA/Food Safety and Inspection Service

December 2007

655

Storage Security

11. Which of the following food defense procedures does your facility have in place for

its storage areas?

Yes No N/A

Is access to raw product storage areas, including cold and dry storage areas

restricted (e.g., by locked door/gate or other) to designated employees?

Is an access log maintained for raw product storage areas?

Is access to non-meat ingredient storage areas restricted to designated

employees only?

Is an access log maintained for non-meat ingredient storage areas?

Is access to finished product storage areas restricted to designated employees?

Is access to external storage facilities restricted to designated employees only?

Do you conduct regular security inspections of storage facilities (including

temporary storage vehicles)?

Do you maintain records on facility security inspections results?

Is the inventory of restricted ingredients (i.e., nitrites, etc) checked against the

actual use of such ingredients on a regular basis?

Are product labels and packaging held in a controlled manner to prevent theft

and misuse?

Is the inventory of finished products regularly checked for unexplained

additions and withdrawals from existing stock?

12. Which of the following food defense procedures does your facility have in place for

the storage of hazardous materials/chemicals such as pesticides, industrial chemicals,

cleaning materials, sanitizers, and disinfectants?

Yes No N/A

Is the access to inside and outside storage areas for hazardous

materials/chemicals such as pesticides, industrial chemicals, cleaning materials,

sanitizers, and disinfectants restricted in some manner to allow use by

designated employees only?

Is a regular inventory of hazardous materials/chemicals maintained?

Are discrepancies in daily inventory of hazardous materials/chemicals

immediately investigated?

Are the storage areas for hazardous materials/chemicals constructed and safely

vented in accordance with national or local building codes?

Is a procedure in place to receive and securely store hazardous chemicals?

Is a procedure in place to control disposition of hazardous chemicals?
USDA/Food Safety and Inspection Service

December 2007

656

Shipping and Receiving Security

13. Does your facility have food defense procedures in place for its shipping and

receiving operations? (Helpful information is provided at the following website:

http://www.fsis.usda.gov/oa/topics/transportguide.htm)

Yes No N/A

Are trailers on the premises maintained under lock and/or seal when not being

loaded or unloaded?

Are tanker trucks on the premises maintained under lock and seal when not

being loaded or unloaded?

Is the loading and unloading of vehicles transporting raw materials, finished

products, or other materials used in food processing closely monitored?

14. Does your facility have food defense procedures in place for handling outgoing

shipments?

Yes No N/A

Are outgoing shipments sealed with tamper-evident seals?

Are the seal numbers on outgoing shipments documented on the shipping

documents?

Are tanker trucks and/or rail cars inspected to detect the presence of any

material, solid or liquid, in tanks prior to loading liquid products?

Do you keep records of the above-referenced inspections of tanker trucks

and/or rail cars?

Are chain-of-custody records maintained for tanker trucks and/or rail cars?
USDA/Food Safety and Inspection Service

December 2007

657

15. Which of the following food defense procedures does your facility have in place for

handling incoming shipments?

Yes No N/A

Is access to loading docks controlled to avoid unverified or unauthorized

deliveries?

Is advance notification from suppliers (by phone, e-mail, or fax) required for

all incoming deliveries?

Are suspicious alterations in the shipping documents immediately

investigated?

Are all deliveries checked against the roster of scheduled deliveries?

Are unscheduled deliveries held outside facility premises pending verification?

Are off-hour deliveries accepted?

If off-hour deliveries are accepted, is prior notice of the delivery required?

If off-hour deliveries are accepted, is the presence of an authorized individual

to verify and receive the delivery required?

Are less-than-truckload (LTL) or partial load shipments vehicles checked?

Are incoming shipments of raw product, ingredients, and finished products

required to be sealed with tamper-evident or numbered seals (and documented

in the shipping documents)? Are these seals verified prior to entry?

Do you check incoming shipments of raw product, ingredients, and finished

products at the receiving dock for evidence of tampering?

Is the FSIS Public Health Veterinarian notified immediately when animals

with unusual behavior and/or symptoms are received?

Are the feed and drinking water supplies for live animals protected from

possible intentional contamination?

Are transportation companies selected with consideration of the company’s

ability to safeguard the security of product/animals being shipped?

Do the transportation companies perform background checks on drivers and

other employees who have access to product/animals?

Have your ingredient suppliers taken steps to strengthen food defense in their

facilities and during transport?

When choosing your compressed gas vendor do you consider whether or not

they have implemented food defense measures?

When choosing your packaging materials and labels vendor do you consider

whether or not they have implemented food defense measures?

16. Does this facility allow returned goods, including returns of U.S. exported products,

to enter the plant?

Yes

No [GO Question 18 under Water and Ice Security]
USDA/Food Safety and Inspection Service

December 2007

658

17. Which of the following food defense procedures does this facility have in place for

returned goods?

Yes No N/A

Are all returned goods examined at a separate designated location in the plant

for evidence of possible tampering before salvage or use in rework?

Are records maintained of returned goods used in rework?

Does the plant follow the procedures outlined in FSIS Directive 9010.1 for

return of U.S. exported products? (Helpful information is provided at the

following website:

http://www.fsis.usda.gov/opped/rdad/fsisdirectives/9010-1.pdf)

Water and Ice Security

18. Which of the following food defense procedures does your facility have in place for

its water and ice supply? (Helpful information is provided at the following website:

http://www.epa.gov/region1/eco/drinkwater/pdfs/drinkingH2Ofactsheet.pdf)

Yes No N/A

Is access to water wells restricted? (e.g., by locked door/gate or limiting

access to designated employees)

Is access to ice-making equipment restricted?

Is access to ice storage facilities restricted?

Is access to storage tanks for potable water restricted?

Is access to water reuse systems restricted?

Are potable water lines periodically inspected for possible tampering?

(i.e., visual inspection for physical integrity of infrastructure etc.)?

Are non-potable water lines inspected for possible tampering (i.e., visual

inspection for physical integrity of infrastructure, connection to potable lines,

etc.)?

Have arrangements been made with local health officials to ensure immediate

notification of the plant if the potability of the public water supply is

compromised?

Mail Handling Security

19. Which of the following food defense procedures does this facility have in place to

ensure mail handling security?

Yes No N/A

Is mail handling activity conducted in a separate room or facility away from

in-plant food production/processing operations?

Are mail-handlers trained to recognize and handle suspicious pieces of mail

using U.S. Postal Service guidelines? (Helpful information is provided at the

following website: http://www.usps.com/news/2001/press/serviceupdates.htm)
USDA/Food Safety and Inspection Service

December 2007

659

Personnel Security

20. Which of the following food defense procedures does your facility have in place for

ensuring that personnel adhere to the security requirements?

Yes No N/A

Are background checks conducted on all employees and contractors (both

permanent and seasonal) who will be working in sensitive operations?

Do all plant employees receive training on security procedures as part of their

orientation training?

Are employees, visitors, and contractors (including construction workers,

cleaning crews, and truck drivers) identified in some manner at all times while

on the premises?

Does your plant control access by employees and contractors entering the

plant during working hours (e.g. coded doors, receptionist on duty, swipe card,

etc.)?

Does your plant control entry of employees and contractors into the plant

during non-working hours (e.g. access limited by key card or code number)?

Does your plant have a way to restrict temporary employees and contractors

(including construction workers, cleaning crews, and truck drivers) to areas of

the plant relevant to their work?

Is there some manner to identify personnel with their specific

functions/assignments/departments (e.g., corresponding colored uniforms)?

Is an updated shift roster (i.e., who is absent, who the replacements are, and

when new employees are being integrated into the workforce) kept by

management for each shift?

Does your plant allow personal items within production areas?

Do you inspect employee lockers?

Are employees and/or visitors restricted as to what they can bring (cameras,

etc.) into the plant?

Are employees prohibited from removing company-provided clothing or

protective gear from the premises?
660

Food Safety Education

OBJECTIVE

At the end of this module, you will be able to:

1. explain the goal of the FSIS food safety education program.

2. identify the highest risk populations for foodborne illnesses

INTRODUCTION

This module will introduce you to the FSIS food safety education program.

FSIS public educational programs have considerable science-based planning strategies

to:

• reach the “general public;”

• utilize marketing principles to “sell” food safety behaviors; and

• target those most at-risk for foodborne illness.

The success of food safety education has been recently documented in studies. For

example, consumer’s knowledge and use of food safety practices is increasing.

Consumers are demonstrating a greater awareness of foodborne pathogens and risks.

Recent consumer research has proven that consumers report making changes in how

they handle and prepare food. These behavior changes have been attributed to food

safety education information provided by the media

Consumers are confident in themselves and the food supply. However, many do not

follow some recommended safe handling practices. Because of the last point, FSIS has

partnered with many organizations and agencies to improve safe handling practices.

FOOD SAFETY EDUCATION PROGRAMS

FSIS has 5 key education programs to reach the general public. They include the

following:

1. The USDA Food Safety Mobile

2. The Meat and Poultry Hotline

3. The Fight BAC!TM Campaign

4. Cooking for Groups

5. Science and Food Supply Program for High School

The USDA Food Safety Mobile:

This is the newest addition to the successful FSIS consumer educational campaign.
661

The USDA Food Safety Mobile, a bus, travels all over the country. FSIS personnel who

are staffing the bus attend a variety of local events and use those events as

opportunities to educate the public about the practices for safe food handling. The

schedule of the Food Safety Mobile is posted in an Outlook public folder, and on the

FSIS website. If the bus is in your area, work with your supervisor to make sure those at

work; and, in your community are aware of it. You can also let the Food Safety

Education staff know of an event planned in your area and it may be possible to have

the bus there if planned well enough in advance.

The Meat and Poultry Hotline:

The Meat and Poultry Hotline is one of the most important public service outreach

activities. It is staffed by food safety experts who can answer a variety of questions from

all types of callers. The Hotline receives over 100,000 calls annually. Most callers want

to know basic food safety information. Any Information that callers share about food

safety complaints is entered into the FSIS Consumer Complaint Monitoring System so

that emerging or on-going problems can be investigated.

The Fight BAC!TM Campaign:

The Fight BAC! TM Campaign is an example of FSIS partnership In action. This has

been a successful public service campaign for several years now with all aspects of the

food industry including retail stores, restaurants, consumer groups, states and other

government agencies. All of these groups distribute the brochures of the campaign.

You may have seen the public service announcements on television or heard them on

the radio. Your children may have brought some of the campaign materials home from

school.

The Fight BAC message is simple:

• Clean off BAC.

• Separate - don’t cross contaminate and spread BAC.

• Cook to the right temperature to kill BAC.

• Chill foods properly- don’t let BAC grow!

This is a simplified version of basic food safety principles. The Fight BAC caricature is

very popular with kids!

Cooking for Groups:

Cooking for Groups has been another key public service campaign. FSIS has produced

a Volunteer’s Guide to food safety. Currently over 370,000 brochures have been

Distributed in English and 70,000 have been distributed in Spanish. This guide reached

over 60 million people when it was released through newspaper articles.

Science and Food Supply Program for High School:

FSIS has joined a national coalition with the CDC to deliver science-based food safety

information to schools. This coalition information is being provided throughout the US

educational system.
662

Go to the website www.FoodSafeSchool.org for more information on the latest materials

and activities.

One of the most successful Food Safety in Schools program is the supplementary

curriculum for Middle Level and High School Classrooms called “Science and Our Food

Supply”, including food safety from A to Z - or everything from acidification to

zoonoses/zoonosis. This curriculum was co-funded by the Food and Drug

Administration and the National Science Teachers Association. The video “Dr. X and

the Quest for Food Safety,” received an Emmy award from the National Academy of

Television Arts and Sciences, Mid Atlantic Region for its creative and entertaining

approach to teaching food safety.

The modules are:

1. Understanding bacteria

2. Farm

3. Processing and Transportation

4. Retail and Home

5. Outbreak and Future Technology

To keep up with the latest information on Science and Our Food Supply, you can log

onto to FDA’s website: FoodSafety.gov.

FSIS has partnered with Health Schools, Healthy People Program SNAP – School

Network for Absenteeism Prevention, a hands-on initiative for middle schools that's

designed to help keep students in school and learning by improving overall health

through promoting clean hands. The Centers for Disease Control and Prevention reports

that hand washing is the most important thing you can do to keep from getting sick (CDC

- Handwashing: Clean Hands Save Lives). Schools can use the SNAP program to

increase student and staff hand cleaning and help them stay healthy.

SNAP offers a free educational poster-toolkit that makes it easy to incorporate clean

hands education into middle school curricula. The SNAP Toolkit has been piloted in

schools in more than 40 states and Canada. You can get a school in your local area

involved too - by downloading the SNAP Toolkit from the FSIS web site.

FOOD SAFETY EDUCATION MESSAGES

The following are some key food safety facts shared with the public in the public

awareness campaigns:

THERMY

Cooking studies have shown that color is not a reliable indicator of food safety. Since E.

coli O157:H7 is a major pathogen of concern for products FSIS regulates, the Agency

worked closely with USDA Agriculture Research Service (ARS) to determine if

consumers could really tell if a hamburger was cooked to a safe level by using the

traditional method of looking at the color of the meat and juices. The study showed that

cooking for food safety by color can be misleading. One out of 4 hamburgers turns

brown before it reaches a safe temperature. The ARS concluded that using a food
663

thermometer is the only reliable way to determine if food is safely cooked. In 1994

Hotline survey, less than 50% of the callers reported that they owned a food

thermometer. Most of those who had a thermometer used it only for the Thanksgiving

turkey, if at all. Very few reported that they used it for all types of meat and poultry

products.

Consumer attitudes about using a food thermometer included:

• Inconvenience -- “It’s a hassle.”

• Added expense to purchase a thermometer.

• Experience – they feel it is not necessary to use a thermometer – “they know when

food is done”.

• They have been cooking for years without experiencing any ill effects.

After receiving the results of this study, FSIS conducted scientific focus group studies to

see what would cause people to change their behaviors to begin using thermometers to

help them determine when food had been cooked to a safe temperature. The key

finding of these studies was that behavior change is possible under the following

circumstances.

Parents of young children are most likely to change behavior -but for their children only.

Upscale cooks interested in quality foods might consider use of a thermometer to avoid

overcooking.

After much development, FSIS launched the national campaign character “THERMY”

who teaches: It’s safe to bite when the temperature is right!

The Multi-Faceted Campaign included life-sized Thermy’s visiting public relations and

education events, brochures in several languages with specific temperature guidelines

for all meat and poultry products, promotions using the T-stick in hamburgers and food

thermometers for all cooked meat and poultry products.

Question: What temperature should ground hamburger reach to kill all pathogens?

Answer: 160 degrees F (71 degrees C) internal middle temperature, or when the T Stick

turns black after 5 seconds inside the hamburger. If ground beef is still pink inside, don’t

eat it. This is critically important especially for the young, elderly or immunocompromised.
664

FSIS believes the Thermy campaign has been successful. A 2001 national survey

shows:

1. 60% own a food thermometer, up from 46% in 1998;

2. 6% use a thermometer when cooking hamburgers; up from 3% in 1998;

3. Industry sales data show an increase in sales of thermometers.

Listeria

Another key educational campaign concerns Listeria. It targets persons who are most at

risk from the effects of listeriosis. Listeriosis primarily affects pregnant women (the

fetus) and infants, senior citizens, and persons with weakened immune systems and

chronic illnesses.

FSIS conducted focus groups with pregnant women. We found that they were confident

in their ability to handle food safely, but did not always follow safe practices. They were

also unfamiliar with Listeria monocytogenes and the dangers of listeriosis; and, they

were not aware that they are at risk. The study also found that these women did not get

any type of food safety information from their doctors. They did not know to cook hot

dogs and luncheon meats and did not know to avoid certain cheeses and other foods

that have been implicated in outbreaks of listeriosis. They had not made any food

handling changes since becoming pregnant. However, they were very willing to change

when provided the information.

The focus group analysis findings were that:

• The best way to educate pregnant women on steps they must take to prevent

listeriosis is through their doctor or caregiver.

• Obstetricians, nurses and other care providers must be made aware to inform

patients.

• Information should be widely disseminated through books, magazines, and web

sites.

The Agency also published Listeria Facts with the CDC and distributed them throughout

the public health and medical communities. Currently a low-literacy brochure is also

under development.

Education package for senior citizens

Another key public service educational campaign for high risk consumers is the

educational package for senior citizens entitled, “To your health! Food Safety for

Seniors.” It includes a video and a brochure. It is distributed to senior centers and

educators.

FSIS is working on reaching immuno-compromised audiences. There is research

underway at Ohio State University through a CSREES grant on the following:

• HIV/AIDS populations
665

• Bone marrow transplant patients

• Solid organ transplant patients

• Senior citizens

• Solid organ cancer patients

One of the most successful public service partnerships is the one that produced the

Physicians Primer. The American Medical Association, CDC, FDA Center for Food

Safety and Applied Nutrition and FSIS partnered to produce, “Diagnosis and

Management of Foodborne Illnesses: A Primer for Physicians”.

In summary, our public health educational, and regulatory goal, is to eliminate BAC.

DIRECTIVES

There are two Directives related to communicating and interacting with groups outside of

FSIS that you should be familiar with. One is Directive 1050.1. It covers the guidance

on requesting participation at meetings and events, such as the ones we have been

talking about, like fairs or other public events where we can promote the food safety

message, including recruiting events. The other is Directive 1240.1. It covers

communicating with external entities, such as the media, Congressional staff, and

others. Please review both of these directives and be aware that you are responsible for

following this guidance.

Additionally, the new web-based Meetings Attendance System was added to the

meeting request references on April 26, 2005. This system allows FSIS staff to enter

information about outside meetings into the automated system, where that information is

available for immediate review by the Assistant Administrators and the Administrator.

Once you have entered your information in the system, you will receive an email

message acknowledging that your request has been entered. Once reviewed, you will

receive another email once your request has been acted on. This system does not

replace the other steps as discussed in the Directives, but does help with the

coordination of speaking engagements.

It’s important that the message we deliver is accurate and consistent with Agency policy.