USDA – Food Safety and Inspection Service 

Center for Learning 

Import Sanitation 

Student Notes 

Course Number 7103 

August 30-31, 2021 

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Course Agenda

DAY 1 

9:00 Introduction / Registration / Tech Support 

10:00 Statutes and Rules of Practice 

12:00 Sanitation Performance Standards (SPS) 

1:00 Lunch 

2:00 Sanitation Performance Standards (SPS) - continued 

5:00 Review 

6:00 Adjourn 

DAY 2 

9:00 Sign-in / Review / Tech Support 

9:30 Sanitation Standard Operating Procedures (SSOP) 

12:00 Review and Quiz 

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Table of Contents 

Introduction 4 

Statutes 5 

Rules of Practice 9 

--Rules of Practice Workshop 13 

Sanitation Performance Standards (SPS) 15 

Sanitation Standard Operating Procedures 29 

--SSOP Workshop 1 32 

--SSOP Workshop 2 36 

--SSOP Workshop 3 39 

--SSOP Workshop 4 41 

Regulatory Process for Sanitation SOPs 43 

Appendix 49 

--Attachment 1 – Rules of Practice (9 CFR Part 500) 49 

--Attachment 2 – Federal Meat Inspection Act (FMIA)(Excerpted) 53 

--Attachment 3 - Acronyms 61 

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Introduction 

Before you can learn the terminology and methods associated with the inspection of imports, it 

is important that you develop an understanding of where FSIS derives its authority to regulate 

imports into the United States, and how regulations (rules) are created to hold all importers to a 

uniform standard. Along with this regulatory basis, we will familiarize you specifically with the 

regulations addressing sanitation in inspected establishments. 

The Import Sanitation Course will cover the following three areas: 

• Statutes and the Rules of Practice 

• Sanitation Performance Standards (SPS) 

• Sanitation Standard Operating Procedures (SSOP) 

The way Import Inspectors verify sanitation in import establishments (or “I-Houses”) is very 

much like way sanitation is verified in domestic establishments that slaughter and process 

meat, poultry, and egg products. Before you can do that, however, it is important you know 

from where the regulations and performance standards are derived and know what sanitation 

documents you will need to verify. 

Most I-Houses are large, warehouse-type facilities. Meat and poultry products are not taken out 

of their containers and handled the way they are in domestic inspected establishments, 

meaning the facilities are (hopefully!) less messy and relatively easy to maintain in a sanitary 

condition. For certain tasks, you will need to remove product from shipping containers, thaw it, 

and either examine it or submit it for sampling, and for that you will only need a small, 

designated room or compartment to conduct re-inspection and sampling, often referred to as a 

Meat Inspection Department or “MID room.” 

For this course, you should primarily follow along with the instructors’ presentation; however, 

this Student Notebook is intended for your use as a more detailed reference for the materials we 

will cover. It includes a few short workshops which will help gauge your understanding of the 

material as we go. 

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Statutes, Regulations, and Rules of Practice 

Objectives: 

1. Identify where FSIS derives its authority to regulate imported products. 

2. Explain the relationship between regulations, directives, and notices. 

3. Describe the purpose of the Rules of Practice. 

4. List the three most common enforcement actions in order of severity. 

5. Identify the conditions for taking each type of enforcement action. 

Statutory Authority 

Before we can discuss Import Sanitation and Import Inspection, you will need to develop an 

understanding of the regulatory basis for our authority in inspected establishments. FSIS’s 

authority to conduct inspection activities is derived from the “Acts” (or “Statutes”), laws duly 

passed by Congress authorizing the Secretary of Agriculture to make regulations governing 

amenable establishments and products (the word “amenable” simply means “subject to the 

regulations”). 

• The Federal Meat Inspection Act (FMIA) was passed in 1906 in response to public 

outcry about the conditions in meat-packing plants exposed by author Upton Sinclair in 

“The Jungle.” Section 620 of this Act specifically addresses imported product. 

• The Poultry Products Inspection Act (PPIA) was passed in 1957 in response to the rapid 

growth of the poultry industry in this country. It is largely modeled directly after the 

FMIA. Section 466 of this Act specifically addresses imported product. 

• The Egg Products Inspection Act (EPIA) was passed in 1970, directly addressing 

products made from egg (but not whole eggs). Section 1046 of this Act specifically 

addresses imported product. 

For the purposes of this course, we will focus on the provisions of the FMIA, but understand that 

there are corresponding provisions in both the PPIA and EPIA. Section 620 of the FMIA 

specifically grants the Secretary of Agriculture (“the Secretary”) the authority to make rules 

regarding imported product. 

Section 620(a): 

(1) Prohibits “adulteration” and “misbranding” of imported products 

(a) Adulteration is the introduction of contaminants or other deleterious substances to a 

product that would make it unwholesome, injurious to health of the consumer, or 

otherwise just unfit for human consumption 

(b) Misbranding is the improper labeling or marking of product in such a way as to give 

the consumer a false impression of what is contained in the product packaging 

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Note: For all product, imported and domestic, Section 601(m) of the FMIA provides 

universal definitions of “adulteration” and Section 601(n) provides universal definitions of 

“misbranding.” See the attached excerpts from the Federal Meat Inspection Act. 

(2) Requires establishments to adhere to building construction and other provisions of the 

regulations 

(3) Requires imported product be derived from animals that were slaughtered humanely (in 

accordance with standards of the Humane Methods of Slaughter Act of 1958) 

(4) States that once imported, products are subject to and treated by the same standards as 

domestic products 

(5) Prescribe rules and standards for the marking and labeling of products 

(6) Exemption for items imported for personal consumption 

Section 620(b) authorizes the Secretary to establish standards and conditions under which 

imported product may (or shall) be destroyed (except in cases in which the consignee exports 

the product to another country within a certain timeframe, or in cases in which the consignee 

satisfactorily corrects any misbranding errors on the product). 

Section 620(f) states that imported products will be subject to the same regulatory standards as 

domestic product, and that any imported product that does not meet these standards will not be 

afforded entry into the United States. 

Section 608 authorizes the Secretary to make rules (regulations) addressing sanitation for 

import establishments and products, i.e., prescribe sanitation standards (this will be the 

purview of the Import Sanitation Course). 

Section 621 authorizes the Secretary to periodically make new or amended rules on an 

ongoing, as-needed basis. 

Section 624 authorizes the Secretary to prescribe the conditions under which product may be 

stored or handled. 

Regulations 

Inspection activities are governed by the Code of Federal Regulations (CFR), specifically Title 9 

(“Animals and Animal Products”), Parts 300 through 592 (stylized as “9 CFR 300 - 592”). The 

regulations are derived from the authorities granted to the Secretary by the Acts we just 

covered. As an example, the standards for sanitation are addressed in 9 CFR Part 416. 

Obviously, the Secretary does not sit at his or her desk and write the regulations alone. For 

this, FSIS employs an entire Policy Development Staff, and continually seeks input from 

industry, consumers, and field personnel when proposing new or amended rules. 

It is essential for you to understand the regulations, as these are what you will routinely verify, 

and what you will cite when documenting regulatory non-compliance. 

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Directives 

These documents provide specific instruction to IPP on how to implement and enforce the rules, 

and how to verify establishments’ compliance with those rules. Directives have no expiration 

date—they remain in effect until rescinded or until a revision is issued. 

One example of a directive, FSIS Directive 5,000.1, instructs IPP in detail on how to verify 

compliance with virtually all the routine inspection tasks assigned through the Public Health 

Information System (PHIS), i.e., “Inspection Methodology.” However, there are many other 

directives covering topics ranging from finance to laboratory sampling (and of course there are 

directives related to imports and exports). 

Notices 

Notices are issued to inspection personnel to address specific problems or concerns that arise 

in the field. Occasionally, the Policy Development Staff (PDS) will issue notices when they 

receive numerous questions from the field about a particular topic. 

Notices are numbered sequentially based on the year in which they are issued (e.g., Notice 13-

20 was the thirteenth notice issued during the year 2020), and typically expire one year after 

the date of issue (unless otherwise specified). On rare occasions, guidance in notices will 

remain in practice after the notice has officially expired; more commonly, such guidance may be 

later incorporated into a directive. 

Enforcement Authorities 

-Section 671 of the FMIA spells out our authority for administrative enforcement; that is, our 

ability to implement the Rules of Practice and affect the conditions under which establishments 

may operate and ship products in commerce. Most of our enforcement activity is administrative. 

-Sections 672 and 673 of the FMIA spell out our authority for civil enforcement; that is, our 

authority to seize or detain product in commerce. This authority can have a direct economic 

impact on businesses, and thus must be used by FSIS judiciously. 

-Section 676 of the FMIA spells out our authority for criminal enforcement. Fortunately, this 

authority is not often exercised, but is reserved for serious cases of misbranding product or 

endangerment of public health. 

You do not need to memorize these regulations. Just understand that these are the basis for 

the regulatory enforcement actions inspection personnel undertake on a daily basis. We will 

discuss these under “Rules of Practice.” 

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Constitutional Rights 

Companies that slaughter, process, import, export, and distribute meat, poultry and egg 

products have a constitutional right to do business in the United States. The Rules of Practice 

are designed so that FSIS diligently affords companies “due process” in the daily 

implementation of inspection activities. “Due process” can roughly be defined as a fair 

proceeding before the government interferes with an establishment’s right to do business. 

Inspected establishments have the right to appeal all enforcement actions, minutes, hours, or 

even years after they are implemented. This is why your understanding of your authority and 

the intent of the regulations is so important. 

FSIS Obligations 

In accordance with industry’s constitutional rights, establishments have the right to expect that 

FSIS will: 

• Be fair and consistent in the enforcement of regulations 

• Provide details about enforcement concerns 

• Promptly respond to appeals 

• Afford establishments the opportunity to implement corrective actions 

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Rules of Practice 

Purpose 

The Rules of Practice, as written in 9 CFR Part 500, are published to define the following: 

(1) The various types (and levels) of enforcement authorities FSIS maintains 

(2) The conditions under which FSIS may take enforcement actions 

(3) The enforcement process 

(4) The right of industry to appeal enforcement actions without fear of reprisal 

Regulations 

Section 500.1 – Defines “regulatory control action”, “withholding action”, and “suspension” 

• Regulatory control actions (RCA) may be taken by IPP in order to prevent adulterated or 

misbranded product from entering commerce, or to prevent the use of insanitary rooms 

or equipment. 

• Withholding actions refer to FSIS withholding the marks of inspection from being applied 

to specific products or processes (or all products in an establishment). IPP have the 

authority to take withholding actions but are advised to immediately notify their chain-ofcommand (Frontline Supervisor, etc.) when they do so. 

• Suspension literally refers to the “suspension of assignment of inspection program 

personnel to an establishment.” Only the District Manager (DM) or designee may issue 

a suspension. 

Section 500.2 – Lists the conditions under which IPP may take regulatory actions, instructs 

IPP to provide immediate notification, and affords establishments the right to appeal 

• Insanitary conditions or practices 

• Adulterated or misbranded product 

• Conditions that preclude FSIS from determining that product is not misbranded or 

adulterated 

• Inhumane handling of livestock 

IPP may issue a regulatory control action (RCA) without prior notification to the 

establishment but should immediately notify the establishment orally and/or in writing. 

Regulatory control actions mostcommonly take the form of the placement of a beige tag either 

retaining product or rejecting equipment or compartments. Establishments have the right to 

appeal any RCA. 

Section 500.3 – Lists the conditions under which FSIS may issue a withholding action or 

suspension without prior notification to the establishment: 

• Produced or shipped adulterated or misbranded product 

• Establishment does not have a HACCP plan (does not apply to imports!) 

• Establishment does not have Sanitation Standard Operating Procedures (SSOP) 

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• Egregious insanitary conditions 

• Establishment violated the terms of an RCA (e.g., removed a tag placed by IPP) 

• Establishment employee assaulted, threatened, intimidated, or interfered with IPP 

• Establishment did not properly dispose of condemned product within 3 days of 

notification 

For the purposes of this course, we are primarily concerned with insanitary conditions, the 

lack of a written SSOP, and the production or shipping of adulterated or misbranded product. 

Section 500.4 – Lists the conditions under which FSIS may issue a withholding action or 

suspension with prior notification to the establishment 

• Inadequate HACCP system (not applicable to imports!) 

• Improper implementation or maintenance of SSOP 

• Failure to maintain sanitary conditions; usually a trend of non-compliance 

• Failure to perform testing or meet standards for control of certain foodborne 

pathogenic (harmful) bacteria (also, not usually applicable to imports!) 

Again, for the purposes of this course, we will most be concerned with failures related to 

Sanitation Performance Standards (SPS) and Sanitation Standard Operating Procedures 

(SSOP). 

Section 500.5 – Parts (a) and (b) prescribe the notification requirements and processes for 

withholding and suspension actions without or with prior notification, respectively; it also 

reiterates establishments’ right to appeal and a fair hearing, and affords the District Manager the 

authority to hold a suspension in abeyance (i.e., delay implementation of a suspension to allow 

an establishment to implement corrective actions) 

Section 500.5(b) lays out the conditions for what is called a Notice of Intended Enforcement 

(NOIE), issued by the District Manager (see below). It will state the type of enforcement action 

(withholding or suspension), the basis for the action, the products or processes affected, the 

establishment’s right to appeal, and affords the establishment 3 days to respond with proposed 

corrective actions. 

Section 500.6 – Defines the conditions under which FSIS may withdraw a grant of 

inspection from an establishment 

Section 500.7 – Defines the conditions under which FSIS may refuse to issue a grant of 

inspection to an establishment 

Section 500.8 – Includes procedures for FSIS to refuse or rescind approval of marks, 

labels, and containers 

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Notice of Intended Enforcement (NOIE) 

Under conditions in which inspection personnel present the District Manager with justifiable 

grounds for a withholding action or suspension, the DM will issue a Notice of Intended 

Enforcement, or NOIE. The NOIE will include the following: 

• The nature of the enforcement action (withholding or suspension) 

• The regulatory basis for the enforcement action 

• The products or processes affected 

• Reiterates the establishment’s right to appeal or contest the enforcement action 

• Informs the establishment it has 3 days to respond in writing with proposed corrective 

actions; if the DM deems the proposed corrective actions to be inadequate, he or she 

may proceed to issue a Notice of Suspension (NOS), or may issue a Notice of 

Inadequate Response (NOIR), thus allowing the establishment one or more subsequent 

opportunities to propose adequate corrective actions 

Once the District Manager has received the establishment’s written response, one of the 

following may occur: 

(1) The DM may accept the response 

(2) The DM may reject the response and implement either 

(a) The proposed withholding action 

(b) The proposed suspension 

(i) In some cases, the DM may elect to hold the suspension in abeyance, allowing 

the establishment some time to implement its planned corrective actions 

(3) The DM may defer enforcement and monitor implementation of corrective actions 

Verification Plans 

If the District Manager defers a decision on enforcement, or holds a suspension in abeyance, an 

Enforcement, Investigations, and Analysis Officer (EIAO) will be assigned to develop a 

Verification Plan (VP). The Verification Plan is a systematic plan for the in-plant inspector to 

verify the establishment’s implementation of its corrective actions. These plans typically include 

increased frequency of certain relevant inspection tasks, as well as special weekly or bi-weekly 

documentation of findings for review at the District Office. 

Review of Establishment History 

Under any circumstances, upon entering a new assignment, you should be reviewing recent 

documented non-compliances, reviewing the results of any Food Safety Assessments (FSA) 

conducted at the establishment (think of an FSA as a kind of “audit” conducted by an EIAO), 

and review documents associated with any past enforcement actions at the establishment. 

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Appeals Process 

Recall that the regulations (9 CFR Part 500) stipulate that establishments have the right to 

appeal any and all enforcement actions, regardless of extent or severity (this is a fundamental 

part of due process). They may appeal any regulatory decision of any FSIS program employee, 

and there is no time limit for making such appeals. Furthermore, establishments have the right 

to appeal without any fear of reprisal or retaliation from FSIS. 

Establishments are to follow the FSIS chain of command when making appeals: 

(1) Program employee who made the regulatory determination 

(2) Inspector-in-Charge (IIC)* 

(3) Frontline Supervisor (FLS) 

(4) District Manager (DM) – or designee, such as a Deputy District Manager (DDM) 

(5) Executive Associate for Regulatory Operations (EARO) 

(6) Assistant Administrator for Field Operations 

(7) FSIS Administrator 

*Generally, in an import establishment, you—the Import Inspector—are considered the IIC. 

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Rules of Practice Workshop 

Using the module and Rules of Practice Regulations, answer the following questions. (Note that 

not all definitions are used.) 

1. Match the following terms with their definition: 

Compliance A. Retention of product, rejection of equipment 

or facilities, refusal to allow the processing of 

specific product. 

Due process B. DM suspends inspection; subsequently 

allows the establishment to operate after 

implementing corrective action 

Regulatory control action C. Establishment processes are working 

properly in accordance with the laws and 

regulations. 

Withholding D. Provides a systematic means for FSIS to 

verify that an establishment is effectively 

implementing the correctives measures. 

Suspension E. The documentation that FSIS uses to 

provide prior notification of an intended 

enforcement action. 

NOIE F. Refusal to allow the marks of inspection to 

be applied to products; may affect all or part 

of the product produced 

Abeyance G. A fair proceeding must take place before the 

government interferes with an individual’s 

property or actions. 

Verification plan H. Interruption in the assignment of program 

employees to all or part of an establishment 

I. DM postpones an enforcement decision to 

allow establishment to implement proposed 

plan 

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2. a. Who is authorized to take regulatory control action? 

b. Is prior notification of regulatory control action required? 

c. How is the establishment informed of regulatory control action? 

d. How is a regulatory control action documented? 

3. For each of the circumstances below, indicate the most appropriate type of withholding action 

or suspension that should be taken. Use WO for without prior notification and WP for with prior 

notification 

Produced and shipped adulterated product 

Recurring insanitary conditions documented by FSIS 

Egregious insanitary conditions involving food contact surfaces 

Establishment has no HACCP plan 

4. Read the following statements and mark T for true or F for false. 

a. An establishment may appeal any regulatory control action. 

b. There is no time limit to initiate an appeal. 

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Sanitation Performance Standards (SPS) 

Objectives 

1. Define “sanitation” and where FSIS derives its authority to verify sanitation regulations. 

2. List the SPS regulations and describe where they apply in inspected establishments. 

3. List examples of SPS non-compliance. 

4. Apply knowledge of Rules of Practice to enforcement actions related to sanitation. 

Background 

Sanitation is defined by FSIS as “the formulation and application of procedures that establish an 

environmental state that promotes cleanliness and protects public health.” The Acts state 

multiple times that sanitation is vital to product wholesomeness and authorize the Secretary to 

make sanitation rules and standards and appoint inspectors to enforce them. 

The sanitation regulations are all contained in 9 CFR Part 416. Some of these regulations 

address conditions in and around the establishment that may lead to adulteration of product if 

prudent measures are not taken—these are what we call Sanitation Performance Standards, 

or SPS, and are contained in 9 CFR 416.1 through 416.6. SPS regulations set goals or 

standards establishments must meet for sanitation, but they do not prescribe exactly how they 

must meet the standards, and they do not require any written programs or recordkeeping 

system (though there are some forms of documentation that will need to be verified). The 

remaining regulations (9 CFR 416.11 through 416.17) require establishments to develop 

written procedures describing how they will protect product and food-contact surfaces on a 

daily basis. These are what we refer to as Sanitation Standard Operating Procedures 

(SSOP). 

It is important for you to understand how SPS and SSOP interrelate, and that they carry equal 

weight when it comes to regulatory significance. 

The following types of establishments all must meet the sanitation regulatory requirements: 

• Federal or State inspected establishments 

• Import and Export facilities 

• Identification (ID) warehouses 

• Custom exempt slaughter or processing facilities 

As an Import Inspector, there are some subtle differences from domestic inspected 

establishments to keep in mind. Often, you may only have “jurisdiction” over a small staging 

room or area within a large, warehouse-type facility, and in some cases, inspections may be 

conducted at the back of a truck or on a loading dock. While you may only be assessing food 

contact surfaces and possible direct product adulteration situations in that limited area (i.e., 

SSOP), you are still authorized to assess sanitary conditions in and around the area where 

import re-inspection is conducted (i.e., SPS addresses other parts of the building and grounds). 

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SPS Verification Task 

To verify compliance with the Sanitation Performance Standards, you will routinely perform 

direct observation of the establishments’ facilities and equipment for overall sanitary conditions, 

and you will periodically review certain documents associated with the SPS. Results of the SPS 

Verification task—including any non-compliances observed—will be documented under the 

“SPS Verification” task in PHIS. Some of these documents include: 

• Pesticide use information 

• Certification of water potability 

• Certification of private sewer or septic systems by State or local authorities 

• Safety data related to cleaning compounds, sanitizers, and any other chemicals used in 

the establishment 

When performing the SPS Verification task, you will select one or more of the 11 standards to 

verify. They may be selected at random, or they may be selected in response to recent 

problems or trends in non-compliance. 

To determine compliance, you will use what we refer to as the “GAD” process: 

(1) Gather information by asking questions derived from the regulations 

(2) Assess the situation 

(a) What is known for a fact? 

(b) What is reasonable to conclude? 

(3) Determine if the situation creates and insanitary condition or contaminates or 

adulterates product, i.e., non-compliance 

You are always to use sound reasoning and good judgement, and to follow precisely the 

procedures set out in FSIS Directive 5,000.1 for performing verification activities. 

Some “GAD” questions you might ask yourself: 

• Are the conditions you observed creating an insanitary condition? 

• Are the conditions you observed contaminating product and/or food contact surfaces? 

If SPS requirements are not being met, evaluate what is known and determine whether or not 

SSOP requirements are also not being met. This is how SPS and SSOP relate to one another. 

Sometimes, what initially appears to be a non-compliance with one of the SPS standards

actually is determined to be an SSOP non-compliance because product or food contact 

surfaces are affected. 

In all cases, non-compliance with one or more regulations should result in issuance of a noncompliance record (NR) to the establishment. 

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SPS Regulatory Requirements 

Recall that the Sanitation Performance Standards address conditions in and around the official 

premises of an establishment that may result in insanitary conditions which could lead to 

adulteration of product. (The “official premises” of an establishment are usually determined 

during the grant approval process; however, conditions adjacent to or outside those boundaries 

can still affect sanitary conditions on the premises and in the establishment itself). 

SPS non-compliance refers to “insanitary conditions,” not direct product contamination or 

adulteration situations. 

Next, we will go through the SPS regulations individually and define all 11 Sanitation 

Performance Standards. 

§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. 

9 CFR 416.1 is the overall general rule that requires establishments to be operated and 

maintained in a sanitary condition and thereby prevent the adulteration of product. IPP are not 

to cite this regulation routinely when documenting non-compliance. This regulation is reserved 

for situations in which either (a) there is an egregious insanitary condition caused by obvious 

negligence by establishment management to address a sanitary concern or (b) there is a trend 

of repeated, uncorrected non-compliances leading to an egregiously insanitary condition. In 

either case, this regulation is never cited without first compiling sufficient supporting 

documentation (e.g., prior NRs) and correlating with your Frontline Supervisor. 

§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, 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. 

9 CFR 416.2(a) sets the standard that establishments will maintain a pest control program to 

prevent the possible harborage and breeding of pests (e.g., mice, rats, flies, birds, etc.). 

Concerning observations might include tall grass and weeds near the premises, open or 

overflowing dumpsters, or piles of debris near or adjacent to buildings where products are 

handled or manufactured. 

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The pest control program does not need to be a written program, nor are establishments 

required to hire outside pest management contractors. However, they should maintain 

documents (labels or package inserts) for pest control substances describing the terms of their 

safe and effective use. IPP will periodically need to verify that 

• These documents are maintained on premises; 

• Pest control substances are being used safely in accordance with labeled instructions; 

• Substances are not stored or applied in a manner which could adulterate product. 

Also, note that while pest control is the main focus of this standard, it also prescribes that the 

grounds and premises must generally be maintained in a sanitary condition to prevent the 

adulteration of product by nesting pests and vermin. Trash, debris, spilled chemicals, and 

foul odors outside the establishment can have a direct effect on product held within, even if 

pest activity is not observed. 

§416.2 Establishment grounds and facilities. 

(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. 

9 CFR 416.2(b)(1) prescribes standards for the construction, condition, and size of buildings, 

rooms, and compartments. Observations of concern might include 

• Roofs that leak when it rains; 

• Product handling areas not adequately separated by walls from break areas or locker 

rooms; 

• Storage or manufacturing areas so small and cramped that edible and inedible product 

cannot be kept separated, or employee hygiene practices cannot be maintained. 

§416.2 Establishment grounds and facilities. 

(b) Construction. ...... 

(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. 

9 CFR 416.2(b)(2) specifically prescribes the standards for walls, floors, and ceilings. They 

must be of durable materials, i.e. not easily chipped, cracked, or broken, and they must be 

cleaned and sanitized as necessary—or as often as necessary—to prevent the creation of 

insanitary conditions. 

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Observations of concern might include 

• Unsealed wood which might hold and soak in moisture and trapped food particles and 

bacteria 

• Chipped floors where water containing organic material can pool and lie stagnant 

• Flaking paint, rust, or other foreign materials that may fall on exposed product. 

§416.2 Establishment grounds and facilities. 

(b) Construction. ...... 

(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. 

9 CFR 416.2(b)(3) specifically prescribes that walls, floors, ceilings, doors, windows, etc. must 

be constructed and maintained in such a way as to prevent pests from entering the 

establishment. It is not sufficient for establishments to trap mice, rats, flies, or other vermin 

inside the facilities where product is handled or stored—the pest management program must be 

designed to keep them outside. 

Observations of concern might include 

• Broken screens, windows, or curtain-type doors leading to outside docks 

• Large gaps in doors leading outside (or open doors) 

• Open air vents, or unused drain systems 

§416.2 Establishment grounds and facilities. 

(b) Construction. ... 

(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. 

9 CFR 416.2(b)(4) states establishments must adequately separate edible and inedible product 

by constructing rooms and compartments of adequate size and with clear separations. It should 

be noted that establishments may handle edible and inedible materials in the same 

compartments, if those materials are separated by time and space. That means they might 

handle them in the same room at different times of day (with cleaning and sanitation in 

between), or they may space them far enough apart that, in your sound judgement, edible 

product is not at risk of adulteration. 

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§416.2 Establishment grounds and facilities. 

(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. 

9 CFR 416.2(c) prescribes the standard for lighting. Note that it does not prescribe any specific 

color or intensity of light, only that it be sufficient to facilitate visual inspection of all areas of the 

establishment and that employees are not prevented from taking measures to maintain sanitary 

conditions. 

Example observations of concern might include 

• Poor lighting in a staging area, so an Import Inspector cannot clearly see labels or the 

condition of containers or products 

• No light in a lavatory, so employees are compelled to wash their hands in food 

processing sink immediately after using the restroom 

§416.2 Establishment grounds and facilities. 

(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. 

9 CFR 416.2(d) requires that establishments maintain adequate ventilation to prevent 

adulteration of product by foul or noxious odors or vapors, or by dripping condensation from 

overhead structures. Condensation is always a concern when steam or humid air interacts with 

the cool dry air created by air conditioners and refrigeration units. Establishments must have 

measures in place to both prevent the buildup of condensation and control it when it does 

develop. 

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§416.2 Establishment grounds and facilities. 

(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; 

(3) Prevent adulteration of product, water supplies, equipment, and utensils and prevent the 

creation of insanitary conditions throughout the establishment; 

(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* 

(6) Prevent the backup of sewer gases. 

9 CFR 416.2(e) is a six-part regulation addressing plumbing in inspected establishments. The 

wording of each part is fairly self-explanatory, but in summary, the regulation prescribes that the 

plumbing system must do the following: 

• Must provide sufficient quantities of water as needed throughout the establishment; 

• Must properly carry away sewage and liquid disposable waste; 

• Generally prevent adulteration of product, water supply, and equipment (not 

contribute to an insanitary condition in any way); 

• Provide adequate floor drainage; 

• Prevent back-flow conditions and cross-connections between potable water and 

sewage; and 

• Prevent the backup of sewer gases. 

Observations of concern might include 

• Floor drains in the staging area backing up after wash-down, with pallets of product 

sitting in an inch of stagnant water 

• A hose with no valves laying in a pool of water on the floor 

• An interruption in water supply preventing the proper washing of utensils and equipment 

*We will see some examples of cross-connections and backflow in the slide presentation. 

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§416.2 Establishment grounds and facilities. 

(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. 

9 CFR 416.2(f) addresses the matter of sewage disposal. Most import establishments likely are 

connected to municipal sewer authorities; therefore, you will only need to verify that the sewage 

disposal system is working properly (e.g., there is no backup of wastewater or sewage odor). 

However, some inspected establishments in isolated or rural locations may be connected to a 

private sewage system, such as a septic system. In these conditions, IPP should periodically 

verify that the establishment has on hand a current letter of approval from a State or local 

authority responsible for certifying such private sewage disposal systems (usually this is done 

semi-annually, or as needed). 

§416.2 Establishment grounds and facilities. 

(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 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. 

While 9 CFR 416.2(e) requires that establishments have a supply of water sufficient in quantity, 

9 CFR 416.2(g)(1) requires that establishments have a supply of potable water in compliance 

with the National Primary Drinking Water Act. It also specifies that the water must be supplied 

under a suitable temperature and pressure to maintain sanitary conditions. 

If an establishment is connected to a municipal water supply (as is probably more common 

among import establishments), IPP will periodically review water reports or other documents 

issued by a State or local health authority attesting to the potability of the water supply (typically 

at least annually). If an establishment is connected to a well or other private water supply, IPP 

must review documentation certifying the potability of the water at least twice per year. 

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§416.2 Establishment grounds and facilities. 

(g) Water supply and water, ice, and solution reuse. ... 

(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. 

(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. 

(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. 

(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. 

(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. 

9 CFR 416.2(g)(2) through (g)(6) address the conditions under which used water and solutions 

used in food processing may be reconditioned or re-circulated. It is unlikely this will be an 

important consideration in import establishments, so we will not discuss these in great detail. 

However, it is useful to understand that these provisions exist. Custom exempt establishments, 

however, are not permitted to reuse water, ice, and solutions. 

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§416.2 Establishment grounds and facilities. 

(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. 

(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. 

(3) Refuse receptacles must be constructed and maintained in a manner that protects 

against the creation of insanitary conditions and the adulteration of product. 

9 CFR 416.2(h) is a critically important regulation. All inspected facilities—domestic, import, 

custom, or other—must be equipped with functioning lavatories and toilets (in FSIS terms, the 

word “lavatory” refers to a sink used for handwashing and personal hygiene), and dressing 

rooms or locker rooms as needed. As the regulation states, these compartments must meet the 

following standards: 

• Be sufficient in number for the size of the facility and the number of employees working 

therein. There is no specific formula for the number of toilets, sinks, etc. per person, but 

it must be apparent in the judgement of IPP that they are sufficient to maintain sanitary 

conditions. 

• Toilets and lavatories must, of course, be separate from compartments in which product 

is stored or handled. 

• Lavatories must have running hot and cold water with soap and disposable hand towels, 

and they must be placed in or near toilets. 

• 9 CFR 416.2(h)(3) addresses the placement and condition of trash receptacles. 

Examples of observations of concern might include 

• One functioning bathroom for a large facility with over 100 employees with overflowing 

trash cans that cannot be adequately maintained; 

• A bathroom with an overflowing toilet or sink that is being used by employees during 

operations; 

• A lack of running hot water in establishment handwash sinks, or empty soap or towel 

dispensers; or 

• Overflowing trash receptacles in the processing area. 

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§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. 

(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. 

(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. 

You may only need to verify this regulation infrequently in I-houses, as there is minimal 

handling of product by employees, and often very little equipment involved. While the act 

of contaminating or adulterating product with insanitary equipment or utensils would be covered 

under the SSOP regulations, which we will discuss later, 9 CFR 416.3 addresses generally how 

equipment and utensils shall be constructed and maintained and specifies the requirements for 

receptacles for inedible materials (sub-part 416.3(c)). 

“Equipment” refers to items like prep tables, table saws, sinks, pallets, hoses, hand carts or 

totes, or other items upon which product might be placed, or which might touch product 

indirectly. “Utensils” refers to items like knives or hooks, or even handheld thermometers, which 

employees may use to directly handle product. 

In general, establishments must be able to thoroughly clean and sanitize equipment and 

utensils, i.e., they must be impermeable to moisture and they must be able to access all parts of 

the equipment which may conceal scraps of product from previous days’ production. They also 

must allow FSIS access to inspect all parts of such equipment and utensils. 

Example observations of concern might include 

• Knives with unsealed wooden handles that may soak in moisture and bacteria 

• Plastic cutting boards with deep grooves that may harbor bacteria 

• Rusty carts or tables or dirty hoses, which may be touched by employees who then 

proceed to touch product 

• Being unable to inspect the inner housing of a table saw for scraps of meat and fat from 

a previous days’ production 

• Unmarked inedible bins being used to hold edible product 

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§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. 

(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. 

(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. 

(d) Product must be protected from adulteration during processing, handling, storage, 

loading, and unloading at and during transportation from official establishments. 

9 CFR 416.4 is a critical regulation that is frequently cited in situations of SPS non-compliance. 

As you can see above, sub-parts (a) and (b) prescribe that food contact surfaces and non-food 

contact surfaces, respectively, must be cleaned and sanitized as frequently as necessary to 

maintain sanitary conditions. (For example: 416.4(a) might be cited for the discovery of 

insanitary knives, whereas 416.4(b) might be cited for the finding of a rusty or dirty handcart 

used to transport product, or even a dirty wall or overhead pipe). 

While 9 CFR 416.2(a) governs the safe storage, handling, and use of pesticides, 9 CFR 

416.4(c) addresses the safe handling and use of cleaning compounds, processing aids, or any 

other chemicals routinely used. It also requires the maintenance of documentation—which IPP 

should periodically verify—describing the safe handling and use of such chemicals. (A common 

example would be having Safety Data Sheets on file for all chemicals). 

9 CFR 416.4(d) is perhaps one of the most critical of all SPS regulations. It prescribes that 

product must be protected at all times, starting when it is first unloaded at the establishment and 

not ending until product is delivered to its end-consumer or consignee in commerce (i.e., in 

transit to its final place of delivery). This is why IPP have the authority under SPS to inspect the 

conditions of truck trailers and other conveyances at official establishments. This regulation is 

often cited in conjunction with SSOP regulations when it can be demonstrated that an 

establishment failed to protect product from adulteration. 

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§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. 

(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. 

(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. 

There is only limited handling of exposed product by employees in import

establishments; however, 9 CFR 416.5 gives IPP the authority to observe and verify that 

establishment employees involved in the handling of product undertake prudent personal 

hygiene measures toprotect product and food contact surfaces from contamination. 

Sub-part (a) prescribes general cleanliness for all personnel, while sub-part (b) specifically 

addresses the conditions of clothing and outer garments, such as gloves, frocks, aprons, 

hairnets, etc. Sub-part (b) also requires employees to start the day with clean clothing, and to 

wash or change it as frequently as necessary to maintain sanitary conditions. 

Sub-part (c) explicitly states that employees with outward signs of disease or illness, including 

open sores or wounds, shall not be involved in operations. If, for example, an employee has a 

cut or sore on their hand, they would be required to wash their hand, apply a clean bandage, 

and wear clean gloves both to protect the wound and protect the product. Similarly, IPP are to 

verify that supervisors are excusing from operations employees who are exhibiting coughing, 

sneezing, vomiting, diarrhea, fever, or other clinical signs of illness. 

What is unique about the employee hygiene regulations is that they apply equally to FSIS

personnel. IPP are expected to maintain the same standards of personal hygiene and

cleanliness and are not to be in and around establishments and product when they

exhibit signs of illness. 

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§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. 

9 CFR 416.6 addresses the use of the beige “U.S. Rejected” tag to take regulatory control over 

insanitary rooms, compartments, or equipment. Note that in FSIS, we use these tags to 

REJECT rooms and equipment and to RETAIN product (which is only applied when product 

contamination or adulteration has occurred). Because SPS refers to conditions in and around 

the establishment, only the REJECT component applies here. Once a “U.S. Rejected” is 

applied, IPP should always follow the Rules of Practice by informing establishment 

management orally, then issuing a non-compliance record (NR) to document the finding(s) in 

writing. 

The last clause states that only an FSIS employee may remove a “U.S. Rejected” tag. Removal 

of such a tag by establishment personnel without permission of IPP is considered interference 

with inspection activities and could result in withholding actions (or more severe enforcement). 

In summary, the 11 standards of SPS are as follows: 

416.2(a) Grounds and pest control 

416.2(b) Construction 

416.2(c) Lighting 

416.2(d) Ventilation 

416.2(e) Plumbing 

416.2(f) Sewage disposal 

416.2(g) (Potable) water supply and water/ice/solution reuse 

416.2(h) Dressing rooms, lavatories, and toilets 

416.3 Equipment and utensils 

416.4 Sanitary Operations 

416.5 Employee hygiene 

IPP are to select one or more standards to verify when performing the SPS Verification task. 

These may be selected at random, or on a rotating basis, or they may be selected in response 

to specific ongoing concerns or recent trends non-compliance. 

Though we have discussed the Sanitation Performance Standards in great detail, it is first 

essential that you understand what the standards are, and that the SPS only prescribe the 

goals, not how establishments are to achieve them. Establishments may take whatever 

methods they deem prudent to achieve the SPS. 

SPS is primarily focused on observation in and around the establishment—only occasionally is 

there documentation that you may need to review (this is a significant difference from SSOP). 

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Sanitation Standard Operating Procedures (SSOP) 

Objectives 

1. Define SSOPs and understand their relationship to SPS. 

2. List the 4 regulatory requirements of SSOP. 

3. Understand the 4 tasks IPP use to verify compliance with the SSOP regulations. 

4. Describe how IPP verify establishment corrective actions following SSOP noncompliance. 

Background 

SPS defines 11 sanitation standards (goals) for conditions in and around establishments which 

must be met to remain in compliance with FSIS regulations. Sanitation Standard Operating 

Procedures (SSOP) are the basis for specific daily activities establishments will conduct before 

and during operations to ensure that sanitary conditions are maintained, and that product is 

not adulterated. 

Unlike SPS, Sanitation SOPs must be written, and establishments must maintain daily records 

associated with their implementation. SSOPs are addressed by regulations 9 CFR 416.11 

through 416.17. The basic regulatory provision for SSOP is as follows: 

§416.11 General rules. 

Each official establishment shall develop, implement, and maintain written standard 

operating procedures for sanitation (Sanitation SOP's) in accordance with the requirements of 

this part. 

As we hinted at, there are four regulatory requirements related to SSOP, three of which are 

mentioned in the general rules: 

• Implementation 

• Maintenance 

• Corrective Actions 

• Recordkeeping 

Each of the subsequent regulations spells out the requirements in greater detail. 

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Development 

9 CFR 416.12 directs each inspected establishment to develop SSOPs to maintain sanitary 

conditions and prevent the adulteration of product. In fact, Frontline Supervisors are tasked with 

ensuring establishments have developed written SSOPs before even recommending the District 

Manager issue a grant of inspection. Let’s look at each part individually: 

§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). 

9 CFR 416.12(a) states that the Sanitation SOPs will define procedures conducted daily, before 

and during operations to prevent contamination or adulteration of product. The key words here 

are “daily”, “before”, and “during.” 

§416.12 Development of Sanitation SOP's. 

(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. 

9 CFR 416.12(b) specifies that an establishment’s written SSOP will be signed and dated 

(authenticated) by a responsible establishment official, and that that official will be responsible 

for the ongoing maintenance of the SSOPs. Additionally, an establishment official will sign and 

date the SSOP any time it is modified. 

§416.12 Development of Sanitation SOP's. 

(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. 

9 CFR 416.2(c) essentially establishes the basis for what we refer to as Pre-Operational SSOP. 

Establishments must define, in writing, the steps they will take to make food contact surfaces 

sanitary prior to the start of daily operations. 

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§416.12 Development of Sanitation SOP's. 

(d) The Sanitation SOP's shall specify the frequency with which each procedure in the 

Sanitation SOP's is to be conducted and identify the establishment employee(s) responsible for 

the implementation and maintenance of such procedure(s). 

9 CFR 416.2(d) requires that the written SSOP specify the frequency with which each procedure 

or activity is to be conducted daily and must identify which employee(s) will be responsible for 

these procedures. 

In import establishments, there are limited situations in which you will verify SSOPs 

during operations, because there are no ongoing processing operations. Nevertheless, 

you will need to perform the Operation SSOP tasks whenever product is handled and 

when food contact surfaces are used. 

Note: In some instances, establishments may state that some procedures are to be conducted 

less frequently than daily; however, in these cases, they still must demonstrate to IPP that their 

measures are sufficient to maintain sanitary conditions of food contact surfaces before and 

during operations. 

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WORKSHOP #1- Identifying the Basic Elements of the SSOPs 

Objective: Carefully read the sample Sanitation SOP. Evaluate the Sanitation SOP for 

compliance with §416.11 and §416.12. After you have evaluated the Sanitation SOP, answer the 

questions listed in the worksheet. 

GSP Warehouse—Sanitation SOP 

Owner – Mike Adams 

This Sanitation SOP is for GSP Warehouse and became effective on January 28, 2015. 

Pre-operational 

All food contact surfaces of the facility, equipment, and utensils used in the inspection room will 

be cleaned daily after conclusion of all re-inspections by rinsing, soaping, and sanitizing. All 

cleaning will be monitored daily by Diana Popadoupolis before re-inspections begin the next day. 

Records will be kept on Form Pre-Op I by Diana Popadoupolis. 

Operational 

Every day all equipment and surfaces in the inspection room will be kept as sanitary as necessary 

to prevent contamination or adulteration of product. Every day all employees will follow hygienic 

practices to keep themselves from contaminating or adulterating product. 

These actions will be monitored by Diana Popadoupolis once each day. Records of this 

monitoring will be kept on Form Ops I by Diana Popadoupolis. 

Corrective actions taken during pre-operational sanitation inspection or during operations will be 

written on the back of the Form Pre-Op I or Form Ops I as necessary. 

(Signature and date of 1/28/15) Mike Adams 

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WORKSHOP #1- Identifying the Basic Elements of the SSOPs 

Objective: Verification of compliance with the basic development of SSOPs 

For Training Purposes Only 

PHIS Task: preoperational & operational SSOP record review task 

Relevant Regulatory Question Yes No Student’s comments 

Does the establishment have written 

Sanitation SOP’s that describe the 

procedures the establishment conducts 

daily to prevent direct contamination or 

adulteration of product(s)? [§416.12 (a)] 

Do the establishment’s SSOPs identify 

which of the procedures are preoperational procedures? [§416.12 (c)] 

Do the establishment’s pre-operational 

SSOP procedures address (at a minimum) 

the cleaning of food contact surfaces of 

facilities, equipment, and utensils? 

[§416.12 (c)] 

Do the establishment’s SSOPs specify the 

frequency with which the establishment will 

conduct each procedure? [§416.12(d)] 

Do the establishment’s SSOPs identify the 

establishment employee or employees 

responsible for implementing and 

maintaining specified procedures? 

[§416.12 (d)] 

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Does the establishment have records that 

identify the documentation and the 

implementation and monitoring of the 

SSOPs on a daily basis and any corrective 

actions taken? [§416.16 (a)] 

Did the individual with overall authority onsite or a higher-level official of the 

establishment sign and date the Sanitation 

SOP's 

(1) Upon initial implementation, or 

(2) Upon modification [§416.12 (d)] 

Are there any failures to comply? 

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Implementation 

§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. 

(b) Each official establishment shall conduct all other procedures in the Sanitation SOP's at 

the frequencies specified. 

(c) Each official establishment shall monitor daily the implementation of the procedures in 

the Sanitation SOP's. 

The implementation requirement spelled out in 9 CFR 416.13 stipulates when establishments 

will conduct their pre-operational and operational (before and during) SSOPs, and very 

importantly, stipulates that they will monitor the implementation of these procedures on a daily 

basis. This means that responsible designated establishment employee(s) will actually perform 

the SSOP procedures even before IPP are physically present to verify their effectiveness. 

Note that the act of monitoring might include filling out one or more daily records. However, IPP 

will actually verify recordkeeping as a separate regulatory requirement (to be discussed shortly). 

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WORKSHOP #2: Monitoring 

Objective: Given a scenario identify any noncompliance, the relevant regulations, and the 

actions you would take in response to your findings. 

In-plant Scenario 

You are performing a Pre-Operational Sanitation SOP Review and Observation task at GSP 

Warehouse. You have chosen to observe the monitor, Ms. Diana Popadoupolis, during her preoperational sanitation inspection. You accompany Ms. Popadoupolis to the inspection room. A 

member of the cleaning crew also accompanies you. Ms. Popadoupolis inspects the visible 

portion of the band saw blade. You notice that she does not open the door to the band saw 

cabinet. After she releases the room for operation, you perform the review portion of the task by 

going back to the band saw and opening the door to the cabinet. You observe that the rest of 

the saw blade, as well as the inside of the cabinet, has meat and fat particles, and bone dust, 

adhering to the direct and indirect food contact surfaces. 

1.) Based on your in-plant observations, list your concerns. 

2.) List the actions that would you take. 

3.) Is there is a Sanitation SOP noncompliance? If yes, describe the noncompliance(s) and 

the relevant regulation(s). 

4.) Would you issue an NR? 

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Maintenance 

§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. 

The maintenance regulatory requirement directs establishments to treat their SSOP as a “living 

document,” subject to regular review and revision to maintain their effectiveness. Changes may 

occur as a result of new processes or equipment, as a result of non-compliance issues, or may 

be prescribed for the responsible authority to conduct on a routine basis regardless of whether 

or not changes need to be made. Note that establishments are not required to inform FSIS 

when they make changes to their SSOPs—it is your responsibility to review the SSOP 

regularly. 

Corrective Actions 

§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 Sanitation SOP's or the procedures 

specified therein, or the implementation or maintenance of the Sanitation SOP's, may have failed 

to prevent direct contamination or adulteration of product(s). 

9 CFR 416.15(a) is the requirement that establishments plan for the eventuality that some 

aspect of SSOP implementation or monitoring might break down, resulting in potential or actual 

contamination of food contact surfaces or adulteration of product. They must prescribe, in 

writing, the measures employees will take when either establishment monitors or IPP identify 

failures in the SSOP system. 

§416.15 Corrective Actions. 

(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 and the procedures specified therein or appropriate improvements in the 

execution of the Sanitation SOP's or the procedures specified therein. 

37 
 

 

 

 

 

 

 

 

 

 

9 CFR 416.15(b) spells out three things that establishments must accomplish when 

implementingtheir SSOP corrective actions. In FSIS, we like to use the acronym “DRiP” to 

remember the requirements IPP must verify when verifying SSOP corrective actions. 

• Ensure appropriate disposition of product (condemn, trim, wash, etc.) 

• Restore sanitary conditions 

• Prevent the recurrence of direct contamination or adulteration of product (including 

reevaluation or modification of the SSOPs as necessary) 

Whenever IPP observe and document non-compliance in the course of performing any SSOP 

verification task, corrective actions must be verified before the task can be completed. 

**It is important for you, as an Import Inspector, to understand that there are limits to 

your jurisdiction when verifying and enforcing SSOPs. Product that has been exposed 

and/or contaminated in transit to your establishment would be refused entry and would

need to be destroyed. Thus, in a sense, it has not technically “arrived” in the country yet

and is not subject to SSOP verification. On the other hand, product that has been

exposed and/or contaminated in the process of staging by the establishment (such as for

physical examination) would be subject to your jurisdiction, and therefore SSOP 

verification. Additionally, product that has passed your inspection and is allowed entry

into the United States is now considered domestic product. This product would no 

longer be under your jurisdiction—it would be subject to verification by domestic

inspection personnel; however, if you discover “U.S. Inspected & Passed” product that

is contaminated or adulterated, you should contact your Frontline Supervisor. 

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WORKSHOP #3: Corrective Actions 

Objective: Verify & Evaluate Corrective Actions 

PHIS Task: Operational SSOP Review & Observation task 

FSIS finding: In the inspection room, you observed condensate dripping from an overhead 

structure directly into trays of exposed product and on to the surface of the examination table. 

You initiated a regulatory control action on the contaminated product and equipment. You issue 

an NR for a monitoring noncompliance using an Operational Sanitation SOP Review and 

Observation task. 

Company’s corrective action: Removed the condensate from overhead structure and 

removed the affected product. Trained personnel on condensate control procedures. Modified 

SSOP monitoring by adding two additional checks for the next two months to assure that the 

training was effective. 

1) Did the establishment restore sanitary conditions? Please briefly describe what the 

establishment did. 

2) Did the establishment put measures in place to prevent recurrence of direct 

contamination or adulteration of product? If yes, please list. 

3) Did the establishment appropriately disposition product? 

4) Do these corrective actions meet the regulatory requirements? 

If not, what regulation(s) should be cited on the NR? 

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Recordkeeping 

The recordkeeping requirement of the SSOP regulations is one major way SSOP is 

distinguished from SPS. In addition to conducting daily procedures to ensure that food contact 

surfaces are maintained in a sanitary condition, establishments must develop and maintain a 

system for authenticating that such procedures take place. These are spelled out in 9 CFR 

416.16. 

§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. 

As you can see, recordkeeping exists as documentation of the implementation (and monitoring) 

and corrective actions regulatory requirements. The establishment employee(s) the SSOPs 

designate as being responsible for implementation and monitoring are responsible for 

authenticating all SSOP records with their initials and the date. (Note that these designees do 

not need to be same person as the responsible establishment official who developed and 

signed the SSOP). 

§416.16 Recordkeeping requirements. 

(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. 

9 CFR 416.16(b) permits establishments to maintain SSOP records on computer, provided they 

have sufficient controls in place to maintain integrity and security of them. 

§416.16 Recordkeeping requirements. 

(c) Records required by this part shall be maintained for at least 6 months and made 

available to FSIS. All such records shall be maintained at the official establishment for 48 hours 

following completion, after which they may be maintained off-site provided such records can be 

made available to FSIS within 24 hours of request. 

9 CFR 416.16(c) requires that establishments must maintain SSOP records for a minimum of 6 

months, that they must maintain them on-hand at the establishment for 48 hours, and that they 

must make them available to FSIS personnel for review upon request. 

After the 48 hours, if they so choose, establishments may store SSOP records off the official 

premises, provided they can present them to FSIS personnel for review within 24 hours of being 

requested. 

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WORKSHOP # 4: Recordkeeping 

Objective: Verification of Compliance with Recordkeeping 

PHIS Task: Operational SSOP Record Review Task 

In plant-scenario 

You elect to perform Operational Sanitation SOP Record Review task in the Supervisor’s office 

at the beginning of your shift. You ask the Supervisor for the Sanitation SOP records from 

yesterday. The Supervisor tells you that the records are not available. 

1.) What regulation applies to this situation? 

2.) What does this regulation state about records availability? 

3.) What actions should you now take? 

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Agency Verification 

§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. 

9 CFR 416.17 defines for FSIS the methods we will undertake to verify effective of SSOPs. If at 

any time, IPP determine through their observations that an establishment has failed to properly 

develop, implement, or maintain their SSOPs, they should immediately contact their FLS for 

further guidance, as further enforcement actions may result. 

We will discuss the Agency Verification requirements further as part of our discussion of the 

Regulatory Process. 

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Regulatory Process for Sanitation SOPs 

Objectives 

1. Understand FSIS responsibilities in verifying establishment SSOPs. 

2. Describe the regulatory thought process used in performing SSOP verification tasks. 

3. List the four SSOP verification tasks. 

4. List the two components of each SSOP verification task. 

FSIS Responsibilities 

FSIS Directive 5,000.1 Revision 5 is the document that prescribes the universal inspection 

methodology for all IPP. Sanitation SOP inspection verification responsibilities are spelled out 

in Sections II and V of the directive. 

The Regulatory Process 

The model we use for performing regulatory compliance verification is summed up in the 

acronym “I.D.D.E.” which stands for 

• Inspection Methodology – Described in FSIS Directive 5,000.1 

• Decision-making – Regulatory conclusions reached using the “GAD” process 

• Documentation – Includes PHIS tasks, NRs, and MOIs, as needed 

• Enforcement – If necessary, implementation of RCAs, withholding actions, or 

suspension 

IPP perform inspection methodology under four different verification tasks in PHIS. Two fall 

under the Pre-Operational SSOP, and two fall under Operational SSOP. Thus, the tasks are 

organized as follows: 

Inspection Tasks General Description 

Pre-Operational Sanitation SOP

Record Review 

Use the Recordkeeping verification activity to verify that 

the establishment implements the procedures in the 

Sanitation SOP effectively to prevent contamination of 

food contact surfaces or adulteration of products prior to 

operations. 

Pre-Operational Sanitation SOP

Review and Observation 

Use the Review and Observation verification activity 

and the Recordkeeping verification activity to verify 

that the establishment implements the procedures in the 

Sanitation SOP effectively to prevent contamination of 

food contact surfaces or adulteration of products prior to 

operations. In PHIS, IPP should select the “Both” option 

on the Activity tab. 

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Inspection Tasks General Description 

Operational Sanitation SOP 

Record Review 

Use the Recordkeeping verification activity to verify that 

the establishment implements the procedures in the 

Sanitation SOP effectively to prevent contamination of 

food contact surfaces or adulteration of products during 

operations. 

Operational Sanitation SOP 

Review and Observation 

Use the Review and Observation verification activity 

and the Recordkeeping verification activity to verify that 

the establishment implements the procedures in the 

Sanitation SOP effectively to prevent contamination of 

food contact surfaces or adulteration of products during 

operations. In PHIS, IPP should select the “Both” option 

on the Activity tab. 

Note that under each “Pre-Operational SSOP” and “Operational SSOP”, there are both 

recordkeeping and review and observation components. Review refers to actual hands-on 

measurement of certain factors related to SSOPs. It might involve taking actual measurements, 

for example, room or product temperatures, but most commonly it involves organoleptic (senses 

of sight, smell, and touch) inspection on and around product and food contact surfaces. 

Observation refers to situations in which you watch establishment personnel implement and 

monitor their Sanitation SOPs in real time. 

You will learn more about performing inspection verification tasks in PHIS during the Import 

Inspection Course, but it is useful to understand now that they exist and how they are executed 

in your import establishments. 

The Record Review Tasks: Pre-Operational and Operational 

IPP use the recordkeeping verification activity to verify all four Sanitation SOP requirements 

(implementation, maintenance, corrective actions, and recordkeeping) while performing the PreOperational and Operational Sanitation SOP Record Review tasks. 

During the Sanitation SOP record review tasks, IPP perform the following: 

1) Review the written Sanitation SOP to be familiar with the establishment’s current preoperational or operational sanitation procedures. 

2) Verify that the SSOP continues to meet the design requirements of §416.12. 

3) Verify that the establishment has maintained daily records that demonstrate that the 

establishment has implemented the pre-operational and operational procedures as 

written, monitored those procedures at least daily or at the specified frequency, and 

taken immediate or corrective action when necessary. 

-For instance, IPP verify that the records indicate that the establishment conducted 

monitoring daily prior to the start of operations. If the establishment observed a 

contaminated food contact surface (residue from previous day’s product) during preoperational inspection, IPP verify that the establishment documented that the 

contaminated surface was re-cleaned, re-inspected and released before product passed 

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over the surface. Similarly, if the establishment has documented the finding of 

contaminated product or food contact surfaces during operations, IPP verify that the 

documented corrective actions meet regulatory requirements. 

4) Verify all the recordkeeping requirements of §416.16. 

-For instance, IPP verify that the establishment employee responsible for the 

implementation and monitoring of the procedure has authenticated the records with their 

initials and date. 

The Review and Observation Tasks: Pre-Operational and Operational 

IPP use both the review and observation verification activity and the recordkeeping verification 

activity when performing the Pre-Operational and Operational Sanitation SOP Review and 

Observation tasks. IPP are to verify that all four Sanitation SOP requirements (implementation, 

maintenance, corrective actions, and recordkeeping). 

Each time IPP perform the review and observation tasks, they: 

1) Should review the written Sanitation SOP so they are familiar with the establishment’s 

current pre-operational or operational sanitation procedures; 

2) Verify that the SSOP continues to meet the design requirements of §416.12; 

3) Observe the establishment conducting its monitoring activities and implementing 

corrective action when they find that the pre-operational or operational procedures have 

failed to effectively clean and sanitize food contact surfaces; 

4) Inspect one or more areas and perform an organoleptic examination of some of the 

establishment’s facilities, equipment, and utensils to assess sanitary conditions 

(sometimes referred to as “hands-on” inspection); 

5) Compare their findings with the establishment records/findings, (which may not be 

documented until the start of the next production day for that specific shift), and 

6) Verify that the establishment meets the corrective action requirement of 9 CFR 

416.15 when they find that the establishment’s Sanitation SOP has failed to prevent 

product contamination or adulteration. 

To perform the Pre-Op or Operational Sanitation SOP Review and Observation task, IPP 

should have: 

• A pen or pencil. 

• U.S. Rejected/U.S. Retained tags and some means (tape, string, rubber bands) of affixing 

these tags to equipment, departments, product, etc. 

• A notepad to record their pre-operational findings. 

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Pre-Op Sanitation SOP Review and Observation Task 

• IPP not trained in lockout/tagout (FSIS Directive 4791.11) methodology shall not perform 

pre-op sanitation inspection on any piece of equipment requiring lock out. 

(Lockout/tagout is a systematic method of isolating and cutting off power supply to 

equipment with dangerous moving parts so that they can be manually inspected). 

• After establishment management informs IPP that an area is ready for FSIS pre-op 

inspection, IPP perform the review component of Pre-Op Sanitation SOP Review and 

Observation verification task. They are to inspect areas in the establishment, equipment 

and utensils, and places on equipment that, if insanitary, would present the greatest risk 

of transferring pathogens or other contaminants to product (e.g., direct food contact 

surfaces that are difficult to clean or may serve as microbial harborage sites). 

When performing the Pre-Operation SSOP Review and Observation task, IPP are also to 

review FSIS Directive 5,000.4. This directive provides detailed instruction on pre-op 

sanitation; in particular, the thought process on how to select areas or equipment to inspect. 

In short, the thought process requires IPP to focus on the areas and equipment that are at 

highest risk for becoming insanitary and potentially contaminating product during 

operations. 

For example: While IPP should inspect all production areas and equipment over time, they 

should be somewhat more likely to select cutting boards, knives, grinders, or the inner 

machinery of table saws for organoleptic inspection, over such items as walls, storage 

shelves, or infrequently used hand tools. 

IPP should ask themselves the following: 

(1) Which pieces of equipment directly contact exposed product? 

(2) Which pieces of equipment directly contact ready-to-eat (RTE) product after lethality 

treatment (cooking, heating, or other treatment to kill harmful bacteria)? 

(3) Which pieces of equipment are hardest to clean? 

(4) Is there a history of pre-operational non-compliance documented by either FSIS or 

the establishment? 

IPP should review the following: 

(1) The establishment’s SSOP records 

(2) Microbial testing records (if available) 

(a) Establishments are not required to include environmental or product sampling 

into their SSOPs 

(b) If your establishment does include sampling as part of its SSOPs, you should 

- Observe establishment personnel collecting samples 

- Review laboratory results 

- Verify corrective actions are taken in response to positive or abnormal sample 

results 

(3) NRs 

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• When IPP have completed their examination of the selected area(s) and equipment, IPP 

should compare their findings to the establishment’s sanitation findings. If the written 

records are not yet completed, IPP may ask the establishment about its pre-operational 

findings and any actions taken. However, IPP must verify the recordkeeping 

requirements before completing the task. 

• When IPP observe contaminated direct food contact surfaces during the pre-op 

sanitation verification, they are to: 

o Reject the affected equipment by placing a “U.S. Rejected” tag; 

o Notify the establishment, and 

o Document the noncompliance on NR. 

• The establishment has the responsibility to restore sanitary conditions (clean the 

contaminated food contact surface) and document the restoration of sanitary conditions 

under §416.16(a). Preventive measures do not need to be developed and

documented unless product has been contaminated or adulterated by the unclean

surface. IPP should not remove the “U.S. Rejected” tag until the establishment has 

restored sanitary conditions. 

Operational Sanitation SOP Review and Observation Task 

• IPP should select area(s) of the establishment and equipment that presents the highest 

risk for insanitary conditions or product contamination. 

• IPP should observe the equipment, employees, and facilities to verify that product 

contamination is not occurring during operation. 

• If IPP observe contaminated direct food contact surfaces or contaminated product, there 

is Sanitation SOP noncompliance whether there is a procedure written in the 

establishment’s Sanitation SOP to cover that situation or not. 

• IPP should inspect direct food contact surfaces of equipment, facilities, and utensils. 

• IPP should be aware of other potential sources of product contamination such as 

condensation, peeling paint, dead-end pipes and scaling rust from overhead fixtures 

where products are processed, handled, or stored can contaminate products. 

• When possible, IPP should also observe the establishment conducting its monitoring 

activity. 

• When IPP have completed their assessment of the sanitation in one or more areas of 

the establishment, they should compare their findings with the establishment’s sanitation 

findings. If the records are not complete at the time, IPP might ask the establishment if it 

has conducted monitoring and what observations were made. However, IPP must verify 

the recordkeeping requirements prior to completion of the task. 

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• IPP should be aware that there are times the responsible establishment employee might 

not be able to propose permanent preventive measures immediately (i.e., repairs cost 

money!). However, in these situations, the establishment should propose a tentative 

preventative measure until they determine a permanent solution. 

Note: Even if there is only sufficient time on a given day to perform the review and observation 

component of a Pre-Operational or Operational SSOP task, IPP are still to make time to review 

the establishment’s Sanitation SOPs regularly. Establishments are not required to inform FSIS 

when they make modifications to their SSOPs. 

Documentation and Enforcement 

We will further discuss how to perform and document both compliance and non-compliance 

while performing tasks in PHIS during the Import Inspection Course. However, it will be useful 

for you to understand the basic procedures to follow when you observe non-compliance during 

the performance of SSOP verification tasks. 

(1) Take a regulatory control action 

(a) Apply a “U.S. Rejected” tag to any food contact surface that is found to be in an 

insanitary condition, or 

(b) Apply a “U.S. Retained” tag to any product found to be contaminated by employees’ 

failure to follow SSOPs or other sanitary practices 

(2) Verbally inform establishment management of the non-compliance as soon as possible 

(3) Document a non-compliance record (NR) and issue it to the establishment 

(4) Do not relinquish regulatory control over the affected products or equipment until 

sanitary conditions are restored and corrective actions are completed 

Summary 

• The Statutes (or Acts)—FMIA, PPIA, EPIA, etc.—are laws enacted by Congress 

governing the inspection of meat, poultry, and egg products. 

• Regulations are promulgated by the Secretary of Agriculture to meet the requirements of 

the Acts. 

• Directives are issued by FSIS to instruct IPP how to conduct various activities; they 

remain in effect until revised or cancelled. 

• Notices are issued by FSIS in response to issues that arise, or when the Policy Division 

receives numerous questions from the field on a particular topic; they typically expire 

after 1 year, unless renewed. 

• IPP follow the Rules of Practice (9 CFR Part 500) to afford establishments due process. 

• Inspection Methodology for sanitation (and other areas of verification) is addressed in 

FSIS Directive 5,000.1. 

• Sanitation Performance Standards (SPS) are 11 standards establishments must meet, 

by whatever means they deem prudent and effective, to remain in regulatory 

compliance—9 CFR 416.1 through 416.6. 

• Sanitation Standard Operating Procedures (SSOP) are written procedures developed by 

establishments specifically to protect product and food contact surfaces from 

contamination or adulteration—9 CFR 416.11 through 416.17. 

48 
 

of Federal Regulations Page 1 of 4 

Code of Federal Regulations 

Title 9 - Animals and Animal Products 

Volume: 2 

Date: 2011-01-01 

Original Date 2011-01-01 

Title: PART 500 - RULES OF PRACTICE 

Context: Title 9 - Animals and Animal Products. CHAPTER Il l - FOOD SAFETY AN D 

INSPECTION SERVICE, DEPARTME T OF AGRICU LTURE. SUBCHAPTER E -

REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE 

POUL TRY PRODUCTS INSPECTION ACT. 

Pt. 500 

PART 500-RULES OF PRACTICE 

Sec. 

500.1 Definitions. 

500.2 Regu latory control action. 

500.3 Withholding or suspension of inspection without prior notification. 

500.4 Withholding action or suspension of inspection with prior notification. 

500.5 Notification, appeals, and actions held in abeyance. 

500.6 Withdrawal of inspection. 

500.7 Refusal to grant inspection. 

500.8 Procedures for resc inding or refusing approval of marks, labels, sizes, and containers. 

Authority21 US C. 451-470, 601 -695; 7 U.S C. 450, 1901-1906; 7 CFR 

2.18, 2.53. 

Source: 64 FR 66546, Nov. 29, 1999, unless otherwise noted . 

§ 500.1 Definitions. 

(a) A ·regulatory control action" is the rete ntion of produc t, rejec tion of equipment or facilities, 

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

(b) A "withholding action" is the refusal to allow the marks of inspection to l)e applied to produ cts. 

A withholding action may affect all product in the establishment or product produced by a 

particu lar process. 

(c) A ·suspension" is an interruption in the assignment of program employees to all or part of an 

establishment. 

§ 500.2 Regulatory control action. 

(a) FSIS may take a regulatory control action because of: 

(1) Insanitary conditions or practices; 

(2) Prod uct adulteration or misbranding; 

(3) Conditions that preclude FSIS from determining that product is not adulterated or 

misb randed; or 

(4) Inhumane handling or slaughtering of livestock. 

(b) If a regulatory control action is taken, the program employee will immediately notify the 

establishment orally or in writing of the action and the basis for the action. 

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Attachment 1 – Rules of Practice 

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(c) An establishment may appeal a regulatory control action, as provided in §§ 306.5 and 381.35 

of this chapter. 

§ 500.3 Withholding action or suspension without prior notification. 

(a) FSIS may take a withholding action or impose a suspension without providing the 

establishment prior notification because: 

(1) The establishment produced and shipped adulterated or misbranded product as defined in 21 

U.S.C. 453 or 21 U.S.C. 602; 

(2) The establishment does not have a HACCP plan as specified in § 417.2 of this chapter; 

(3) The establishment does not have Sanitation Standard Operating Procedures as specified in 

§§ 416. 11-416.12 of this chapter; 

( 4) Sanitary conditions are such that products in the establishment are or would be rendered 

adulterated; 

(5) The establishment violated the terms of a regulatory control action; 

(6) An establishment operator, officer, employee, or agent assaulted, threatened to assault, 

intimidated, or interfered with an FSIS employee; or 

(7) The establishment did not destroy a condemned meat or poultry carcass, or part or product 

thereof, in accordance with part 314 or part 381, subpart L, of this chapter within three days of 

notification. 

(b) FSIS also may impose a suspension without providing the establishment prior notification 

because the establishment is handling or slaughtering animals inhumanely. 

§ 500.4 Withholding action or suspension with prior notification. 

FSIS may take a withholding action or impose a suspension after an establishment is provided 

prior notification and the opportunity to demonstrate or achieve compliance because: 

(a) The HACCP system is inadequate, as specified in§ 417.6 of this chapter, due to multiple or 

recurring noncompliances; 

(b) The Sanitation Standard Operating Procedures have not been properly implemented or 

maintained as specified in §§ 416.13 through 416.16 of this chapter; 

(c) The establishment has not maintained sanitary conditions as prescribed in§§ 416.2-416.8 of 

this chapter due to multiple or recurring noncompliances; 

(d) The establishment did not collect and analyze samples for Escherichia coli Biotype I and 

record results in accordance with § 310.25(a) or § 381.94(a) of this chapter; 

(e) The establishment did not meet the Salmonella performance standard requirements 

prescribed in § 310.25(b) or § 381 .94(b) of this chapter. 

§ 500.5 Notification, appeals, and actions held in abeyance. 

(a) If FSIS takes a withholding action or imposes a suspension, the establishment will be notified 

orally and, as promptly as circumstances permit, in writing. The written notification will: 

(1) State the effective date of the action(s), 

(2) Describe the reasons for the action(s), 

(3) Identify the products or processes affected by the action(s), 

( 4) Provide the establishment an opportunity to present immediate and corrective action and 

further planned preventive action; and 

(5) Advise the establishment that it may appeal the action as provided in §§ 306.5 and 381 .35 of 

this chapter. 

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(b) The prior notification provided for in § 500.4 of this part will: 

(1 ) State the type of action that FSIS may take; 

(2) Describe the reason for the proposed action; 

(3) Identify the products or processes affected by the proposed action; 

(4) Advise the establishment of its right to contact FSIS to contest the basis for the proposed 

action or to explain how compliance has been or will be achieved; and 

(5) Advise the establishment that it will have three business days from receipt of the written 

notification to respond to FSIS unless the time period is extended by FSIS. 

Page 3 of4 

(c) An establishment may appeal the withholding action or suspension, as provided in§§ 306.5 

and 381 .35 of this chapter. 

(d) If FSIS suspends inspection and does not hold the suspension action in abeyance as 

provided in paragraph (e) of this section, the establishment may request a hearing pursuant to 

the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H. Upon such request, the 

Administrator will file a complaint that will include a req uest for an expedited hearing. 

(e) FSIS may hold a suspension in abeyance and allow the establishment to operate under the 

conditions agreed to by FSIS and the establishment. 

§ 500.6 Withdrawal of inspection. 

The FSIS Administrator may file a complaint to withdraw a grant of Federal inspection in 

accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H because: 

(a) An establishment produced and shipped adulterated product; 

(b) An establishment did not have or maintain a HACCP plan in accordance with part 41 7 of this 

chapter; 

(c) An establishment did not have or maintain Sanitation Standard Operating Procedures in 

accordance with part 416 of this chapter: 

(d) An establishment did not maintain sanitary conditions; 

( e) An establishment did not collect and analyze samples for Escherichia coli Biotype I and 

record results as prescribed in § 310.25(a) or § 381.94(a) of this chapter; 

(f) An establishment did not comply with the Salmonella performance standard requirements as 

prescribed in §§ 310.25(b) and 381.94(b) of this chapter; 

(g) An establishment did not slaughter or handle livestock humanely; 

(h) An establishment operator, officer, employee, or agent assaulted, threatened to assault, 

intimidated, or interfered with an FSIS program employee; or 

(i) A rec ipient of inspection or anyone responsibly connected to the rec ipient is unfit to engage in 

any business requiring inspection as specified in section 401 of the FMIA or section 18(a) of the 

PPIA. 

§ 500.7 Refusal to grant inspection. 

(a) The FSIS Administrator may refuse to grant Federal inspection because an applicant 

(1 ) Does not have a HACCP plan as required by part 417 of this chapter; 

(2) Does not have Sanitation Standard Operating Procedures as required by part 416 of this 

chapter; 

(3) Has not demonstrated that adequate sanitary conditions exist in the establishment as 

required by part 308 or part 381, subpart H, and part 416 of this chapter; 

(4) Has not demonstrated that livestock will be handled and slaughtered humanely; or 

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(5) Is unfit to engage in any business requiring inspection as specified in section 401 of the FMIA 

or section 18(a) of the PPIA. 

(b) If the Administrator refuses to grant inspection, the applicant will be provided the opportunity 

for a hearing in accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart 

H. 

§ 500.8 Procedures for rescinding or refusing approval of marks, labels, and 

containers. 

(a) 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 under section 7 of the FMIA or under 

section 8 of the PPIA. 

(b) FSIS will provide written notification that: 

(1 ) Explains the reason for rescinding or refusing the approval; 

(2) Provides an opportunity for the establishment to modify the marking, labeling, or container so 

that it will no longer be false or misleading; and 

(3) Advises the establishment of its opportunity to submit a written statement to respond to the 

notification and to request a hearing. 

(c) If FSIS rescinds or refuses approval of false or misleading marks, labels, or sizes or forms of 

any container for use with any meat or poultry product, an opportunity for a hearing will be 

provided in accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H. 

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Attachment 2 – Federal Meat Inspection Act (FMIA)(excerpt) 

§620. Imports 

(a) Adulteration or misbranding prohibition; compliance with inspection, building 

construction standards, and other provisions; humane methods of slaughter; treatment as 

domestic articles subject to this chapter and food, drug, and cosmetic provisions; marking 

and labeling; personal consumption exemption 

No carcasses, parts of carcasses, meat or meat food products of cattle, sheep, swine, goats, 

horses, mules, or other equines which are capable of use as human food, shall be imported into 

the United States if such articles are adulterated or misbranded and unless they comply with all 

the inspection, building, construction standards, and all other provisions of this chapter and 

regulations issued thereunder applicable to such articles in commerce within the United States. 

No such carcasses, parts of carcasses, meat or meat food products shall be imported into the 

United States unless the livestock from which they were produced was slaughtered and handled 

in connection with slaughter in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 

U.S.C. 1901–1906). All such imported articles shall, upon entry into the United States, be 

deemed and treated as domestic articles subject to the other provisions of this chapter and the 

Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]: Provided, That they shall be 

marked and labeled as required by such regulations for imported articles: Provided further, That 

nothing in this section shall apply to any individual who purchases meat or meat products outside 

the United States for his own consumption except that the total amount of such meat or meat 

products shall not exceed fifty pounds. 

(b) Terms and conditions for destruction 

The Secretary may prescribe the terms and conditions for the destruction of all such articles 

which are imported contrary to this section, unless (1) they are exported by the consignee within 

the time fixed therefor by the Secretary, or (2) in the case of articles which are not in compliance 

with the chapter solely because of misbranding, such articles are brought into compliance with 

the chapter under supervision of authorized representatives of the Secretary. 

(c) Payment of storage, cartage, and labor charges by owner or consignee; liens 

All charges for storage, cartage, and labor with respect to any article which is imported 

contrary to this section shall be paid by the owner or consignee, and in default of such payment 

shall constitute a lien against such article and any other article thereafter imported under this 

chapter by or for such owner or consignee. 

(d) Prohibition 

The knowing importation of any article contrary to this section is prohibited. 

(e) Omitted 

(f) Inspection and other standards; applicability, enforcement, etc.; certifications 

Notwithstanding any other provision of law, all carcasses, parts of carcasses, meat, and meat 

food products of cattle, sheep, swine, goats, horses, mules, or other equines, capable of use as 

human food, offered for importation into the United States shall be subject to the inspection, 

sanitary, quality, species verification, and residue standards applied to products produced in the 

United States. Any such imported meat articles that do not meet such standards shall not be 

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permitted entry in to the United States. The Secretary shall enforce this provision through (1) the 

imposition of random inspections for such species verification and for residues, and (2) random 

sampling and testing of internal organs and fat of the carcasses for residues at the point of 

slaughter by the exporting country in accordance with methods approved by the Secretary. Each 

foreign country from which such meat articles are offered for importation into the United States 

shall obtain a certification issued by the Secretary stating that the country maintains a program 

using reliable analytical methods to ensure compliance with the United States standards for 

residues in such meat articles. No such meat article shall be permitted entry into the United 

States from a country for which the Secretary has not issued such certification. The Secretary 

shall periodically review such certifications and shall revoke any certification if the Secretary 

determines that the country involved is not maintaining a program that uses reliable analytical 

methods to ensure compliance with United States standards for residues in such meat articles. 

The consideration of any application for a certification under this subsection and the review of 

any such certification, by the Secretary, shall include the inspection of individual establishments 

to ensure that the inspection program of the foreign country involved is meeting such United 

States standards. 

(g) Administration of animal drugs or antibiotics; terms and conditions; entry order 

violations 

The Secretary may prescribe terms and conditions under which amenable species that have 

been administered an animal drug or antibiotic banned for use in the United States may be 

imported for slaughter and human consumption. No person shall enter amenable species into the 

United States in violation of any order issued under this subsection by the Secretary. 

(h) Reciprocal meat inspection requirement 

(1) As used in this subsection: 

(A) The term "meat articles" means carcasses, meat and meat food products of cattle, sheep, 

swine, goats, horses, mules, or other equines, that are capable of use as human food. 

(B) The term "standards" means inspection, building construction, sanitary, quality, species 

verification, residue, and other standards that are applicable to meat articles. 

(2) On request of the Committee on Agriculture or the Committee on Ways and Means of the 

House of Representatives or the Committee on Agriculture, Nutrition, and Forestry or the 

Committee on Finance of the Senate, or at the initiative of the Secretary, the Secretary shall, as 

soon as practicable, determine whether a particular foreign country applies standards for the 

importation of meat articles from the United States that are not related to public health concerns 

about end-product quality that can be substantiated by reliable analytical methods. 

(3) If the Secretary determines that a foreign country applies standards described in paragraph 

(2)— 

(A) the Secretary shall consult with the United States Trade Representative; and 

(B) within 30 days after the determination of the Secretary under paragraph (2), the 

Secretary and the United States Trade Representative shall recommend to the President 

whether action should be taken under paragraph (4). 

(4) Within 30 days after receiving a recommendation for action under paragraph (3), the 

President shall, if and for such time as the President considers appropriate, prohibit imports into 

the United States of any meat articles produced in such foreign country unless it is determined 

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that the meat articles produced in that country meet the standards applicable to meat articles in 

commerce within the United States. 

(5) The action authorized under paragraph (4) may be used instead of, or in addition to, any 

other action taken under any other law. 

§621. Inspectors to make examinations provided for; appointment; duties; 

regulations 

The Secretary shall appoint from time to time inspectors to make examination and inspection 

of all amenable species, inspection of which is hereby provided for and of all carcasses and parts 

thereof, and of all meats and meat food products thereof, and of the sanitary conditions of all 

establishments in which such meat and meat food products hereinbefore described are prepared; 

and said inspectors shall refuse to stamp, mark, tag, or label any carcass or any part thereof, or 

meat food product therefrom, prepared in any establishment hereinbefore mentioned, until the 

same shall have actually been inspected and found to be not adulterated; and shall perform such 

other duties as are provided by this chapter and by the rules and regulations to be prescribed by 

said Secretary; and said Secretary shall, from time to time, make such rules and regulations as 

are necessary for the efficient execution of the provisions of this chapter, and all inspections and 

examinations made under this chapter, shall be such and made in such manner as described in the 

rules and regulations prescribed by said Secretary not inconsistent with provisions of this 

chapter. 

§601. Definitions 

As used in this chapter, except as otherwise specified, the following terms shall have the 

meanings stated below: 

(a) The term "Secretary" means the Secretary of Agriculture of the United States or his 

delegate. 

(b) The term "firm" means any partnership, association, or other unincorporated business 

organization. 

(c) The term "meat broker" means any person, firm, or corporation engaged in the business of 

buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, 

swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases 

or sales of such articles other than for his own account or as an employee of another person, firm, 

or corporation. 

(d) The term "renderer" means any person, firm, or corporation engaged in the business of 

rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, 

mules, or other equines, except rendering conducted under inspection or exemption under this 

subchapter. 

(e) The term "animal food manufacturer" means any person, firm, or corporation engaged in 

the business of manufacturing or processing animal food derived wholly or in part from 

carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or 

other equines. 

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(f) The term "State" means any State of the United States and the Commonwealth of Puerto 

Rico. 

(g) The term "Territory" means Guam, the Virgin Islands of the United States, American 

Samoa, and any other territory or possession of the United States, excluding the Canal Zone. 

(h) The term "commerce" means commerce between any State, any Territory, or the District of 

Columbia, and any place outside thereof; or within any Territory not organized with a legislative 

body, or the District of Columbia. 

(i) The term "United States" means the States, the District of Columbia, and the Territories of 

the United States. 

(j) The term "meat food product" means any product capable of use as human food which is 

made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, 

or goats, excepting products which contain meat or other portions of such carcasses only in a 

relatively small proportion or historically have not been considered by consumers as products of 

the meat food industry, and which are exempted from definition as a meat food product by the 

Secretary under such conditions as he may prescribe to assure that the meat or other portions of 

such carcasses contained in such product are not adulterated and that such products are not 

represented as meat food products. This term as applied to food products of equines shall have a 

meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and 

goats. 

(k) The term "capable of use as human food" shall apply to any carcass, or part or product of a 

carcass, of any animal, unless it is denatured or otherwise identified as required by regulations 

prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans. 

(l) The term "prepared" means slaughtered, canned, salted, rendered, boned, cut up, or 

otherwise manufactured or processed. 

(m) The term "adulterated" shall apply to any carcass, part thereof, meat or meat food product 

under one or more of the following circumstances: 

(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 in or on such 

article does not ordinarily render it injurious to health; 

(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) a color 

additive) which may, in the judgment of the Secretary, make such article unfit for human food; 

(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, 

(C) if it bears or contains any food additive which is unsafe within the meaning of section 

348 of this title, 

(D) if it bears or contains any color additive which is unsafe within the meaning of section 

379e of this title: Provided, That an article which is not adulterated under clause (B), (C), or 

(D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or 

color additive in or on such article is prohibited by regulations of the Secretary in 

establishments at which inspection is maintained under this subchapter; 

(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; 

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(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; 

(5) if it is, in whole or in part, the product of an animal which has died otherwise than by 

slaughter; 

(6) if its container is composed, in whole or in part, of any poisonous or deleterious 

substance which may render the contents injurious to health; 

(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in 

conformity with a regulation or exemption in effect pursuant to section 348 of this title; 

(8) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; 

or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority 

has been concealed in any manner; or if any substance has been added thereto 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; or 

(9) if it is margarine containing animal fat and any of the raw material used therein 

consisted in whole or in part of any filthy, putrid, or decomposed substance. 

(n) The term "misbranded" shall apply to any carcass, part thereof, meat or meat food product 

under one or more of the following circumstances: 

(1) if its labeling is false or misleading in any particular; 

(2) if it is offered for sale under the name of another food; 

(3) if it is an imitation of another food, unless its label bears, in type of uniform size and 

prominence, the word "imitation" and immediately thereafter, the name of the food imitated; 

(4) if its container is so made, formed, or filled as to be misleading; 

(5) if in a package or other container unless it bears a label showing (A) the name and place 

of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the 

quantity of the contents in terms of weight, measure, or numerical count: Provided, That under 

clause (B) of this subparagraph (5), reasonable variations may be permitted, and exemptions 

as to small packages may be established, by regulations prescribed by the Secretary; 

(6) if any word, statement, or other information required by or under authority of this 

chapter to appear on the label or other labeling is not prominently placed thereon with such 

conspicuousness (as compared with other words, statements, designs, or devices, in the 

labeling) and in such terms as to render it likely to be read and understood by the ordinary 

individual under customary conditions of purchase and use; 

(7) if it purports to be or is represented as a food for which a definition and standard of 

identity or composition has been prescribed by regulations of the Secretary under section 607 

of this title unless (A) it conforms to such definition and standard, and (B) its label bears the 

name of the food specified in the definition and standard and, insofar as may be required by 

such regulations, the common names of optional ingredients (other than spices, flavoring, and 

coloring) present in such food; 

(8) if it purports to be or is represented as a food for which a standard or standards of fill of 

container have been prescribed by regulations of the Secretary under section 607 of this title, 

and it falls below the standard of fill of container applicable thereto, unless its label bears, in 

such manner and form as such regulations specify, a statement that it falls below such 

standard; 

(9) if it is not subject to the provisions of subparagraph (7), unless its label bears (A) the 

common or usual name of the food, if any there be, and (B) in case it is fabricated from two or 

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more ingredients, the common or usual name of each such ingredient; except that spices, 

flavorings, and colorings may, when authorized by the Secretary, be designated as spices, 

flavorings, and colorings without naming each: Provided, That to the extent that compliance 

with the requirements of clause (B) of this subparagraph (9) is impracticable, or results in 

deception or unfair competition, exemptions shall be established by regulations promulgated 

by the Secretary; 

(10) if it purports to be or is represented for special dietary uses, unless its label bears such 

information concerning its vitamin, mineral, and other dietary properties as the Secretary, after 

consultation with the Secretary of Health and Human Services, determines to be, and by 

regulations prescribes as, necessary in order fully to inform purchasers as to its value for such 

uses; 

(11) if it bears or contains any artificial flavoring, artificial coloring, or chemical 

preservative, unless it bears labeling stating that fact: Provided, That, to the extent that 

compliance with the requirements of this subparagraph (11) is impracticable, exemptions shall 

be established by regulations promulgated by the Secretary; or 

(12) if it fails to bear, directly thereon or on its container, as the Secretary may by 

regulations prescribe, the inspection legend and, unrestricted by any of the foregoing, such 

other information as the Secretary may require in such regulations to assure that it will not 

have false or misleading labeling and that the public will be informed of the manner of 

handling required to maintain the article in a wholesome condition. 

(o) The term "label" means a display of written, printed, or graphic matter upon the immediate 

container (not including package liners) of any article. 

(p) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon 

any article or any of its containers or wrappers, or (2) accompanying such article. 

(q) The term "Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]" means the Act 

so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or 

supplementary thereto. 

(r) The terms "pesticide chemical," "food additive," "color additive," and "raw agricultural 

commodity" shall have the same meanings for purposes of this chapter as under the Federal 

Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. 

(s) The term "official mark" means the official inspection legend or any other symbol 

prescribed by regulations of the Secretary to identify the status of any article or animal under this 

chapter. 

(t) The term "official inspection legend" means any symbol prescribed by regulations of the 

Secretary showing that an article was inspected and passed in accordance with this chapter. 

(u) The term "official certificate" means any certificate prescribed by regulations of the 

Secretary for issuance by an inspector or other person performing official functions under this 

chapter. 

(v) The term "official device" means any device prescribed or authorized by the Secretary for 

use in applying any official mark. 

(w) The term "amenable species" means— 

(1) those species subject to the provisions of this chapter on the day before November 10, 

2005; 

(2) all fish of the order Siluriformes; and 

(3) any additional species of livestock that the Secretary considers appropriate. 

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§608. Sanitary inspection and regulation of slaughtering and packing 

establishments; rejection of adulterated meat or meat food products 

The Secretary shall cause to be made, by experts in sanitation or by other competent 

inspectors, such inspection of all slaughtering, meat canning, salting, packing, rendering, or 

similar establishments in which amenable species are slaughtered and the meat and meat food 

products thereof are prepared for commerce as may be necessary to inform himself concerning 

the sanitary conditions of the same, and to prescribe the rules and regulations of sanitation under 

which such establishments shall be maintained; and where the sanitary conditions of any such 

establishment are such that the meat or meat food products are rendered adulterated, he shall 

refuse to allow said meat or meat food products to be labeled, marked, stamped or tagged as 

"inspected and passed." 

§624. Storage and handling regulations; violations; exemption of establishments 

subject to non-Federal jurisdiction 

The Secretary may by regulations prescribe conditions under which carcasses, parts of 

carcasses, meat, and meat food products of cattle, sheep, swine, goats, horses, mules, or other 

equines, capable of use as human food, shall be stored or otherwise handled by any person, firm, 

or corporation engaged in the business of buying, selling, freezing, storing, or transporting, in or 

for commerce, or importing, such articles, whenever the Secretary deems such action necessary 

to assure that such articles will not be adulterated or misbranded when delivered to the consumer. 

Violation of any such regulation is prohibited. However, such regulations shall not apply to the 

storage or handling of such articles at any retail store or other establishment in any State or 

organized Territory that would be subject to this section only because of purchases in commerce, 

if the storage and handling of such articles at such establishment is regulated under the laws of 

the State or Territory in which such establishment is located, in a manner which the Secretary, 

after consultation with the appropriate advisory committee provided for in section 661 of this 

title, determines is adequate to effectuate the purposes of this section. 

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Acronyms and Definitions 

USDA United States Department of Agriculture 

FSIS Food Safety and Inspection Service 

APHIS Animal and Plant Health Inspection Service (a sister agency of FSIS under USDA) 

IPP Inspection Program Personnel 

FI Food Inspector 

CSI Consumer Safety Inspector 

SCSI Supervisory Consumer Safety Inspector 

PHV Public Health Veterinarian 

SPHV Supervisory Public Health Veterinarian 

FLS Frontline Supervisor 

EIAO Enforcement, Analysis, and Investigations Officer 

SEIAO Supervisory Enforcement, Analysis, and Investigations Officer 

CI Compliance Investigator 

DVMS District Veterinary Medical Specialist 

DCS District Case Specialist 

DDM Deputy District Manager 

DM District Manager 

EARO Executive Associate for Regulatory Operations 

AA Assistant Administrator 

OFO Office of Field Operations 

FMIA Federal Meat Inspection Act 

PPIA Poultry Products Inspection Act 

EPIA Egg Products Inspection Act 

HMSA Humane Methods of Slaughter Act 

CFR Code of Federal Regulations 

ROP Rules of Practice 

NOIE Notice of Intended Enforcement 

NOIR Notice of Inadequate Response 

NOS Notice of Suspension 

NOD Notice of Deferral 

VP Verification Plan 

FSA Food Safety Assessment 

RCA Regulatory Control Action 

PHIS Public Health Information System 

NR Non-compliance Record 

MOI Memorandum of Interview (documents any non-regulatory concerns or discussions) 

SPS Sanitation Performance Standards 

SSOP Sanitation Standard Operating Procedures 

HACCP Hazard Analysis Critical Control Points 

EPA Environmental Protection Agency 

FDA Food and Drug Administration 

SDS Safety Data Sheet 

FCS Food contact surface 

MID Meat Inspection Department 

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