Rules of Practice 

2/15/18 

RULES OF PRACTICE 

Objectives 

To demonstrate mastery of Rules of Practice, the trainee will 

1) Define the following terms. 

a) Inspection 

b) Enforcement 

c) Compliance 

d) Due process 

e) Rules of Practice (ROP) 

f) Regulatory control action (RCA) 

g) Withholding 

h) Suspension 

i) Notice of Intended Enforcement Action (NOIE) 

j) Abeyance 

k) Verification plan 

2) Identify circumstances where prior notice of enforcement action is not 

required. 

3) Identify circumstances where prior notice of enforcement action is required. 

4) Describe the appeals process. 

References 

FSIS PHIS Directive 5000.1, Chapter VI – Rules of Practice 

FSIS Regulation 9 CFR Part 500 

Appealing Inspection Decisions: 

https://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/getanswers/food-safety-fact-sheets/production-and-inspection/appealinginspection-decisions/appeals 

Directive 13,000.3 Rev. 1 

Overview 

The goal of FSIS is to protect public health by maximizing compliance with laws 

and regulations governing the production of meat and poultry products. The 

food-producing establishment has the responsibility to comply with the 

regulations and to produce a safe and wholesome food product. FSIS has the 

responsibility to verify that the establishment meets regulatory requirements. 

Inspection personnel ensure that establishments adhere to food safety 

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regulations by conducting inspection verification activities and taking 

enforcement action when needed to ensure food safety compliance. 

Let’s clarify the meaning of some of these terms. Compliance means that the 

establishment’s processes are working properly in accordance with the laws and

regulations. Inspection includes all actions the Agency may take to examine the 

establishment and its processes, products, and systems. Enforcement actions 

are those the Agency takes when an inspector determines that the 

establishment’s plans and systems are not in compliance with laws and 

regulations. There is a range of enforcement actions that FSIS uses. Some 

examples of enforcement actions are regulatory control actions such as slowing 

or stopping the slaughter line, rejecting equipment or processing locations, or 

retaining product; withholding actions; or the suspension of inspection. We will 

discuss these actions in more detail later in this module. The Rules of Practice, 

9 CFR 500, are FSIS’s enforcement regulations. 

Establishments have the right to do business and are guaranteed due process of 

law. The Constitution guarantees that the government cannot take away a 

person’s basic rights to ‘life, liberty or property, without due process of law.’ 

“Due process rights” means that a fair “process” or proceeding, must take place 

before the government interferes with an individual’s property or actions. This 

process might include notifications, hearings, or other activities. By following the 

Rules of Practice regulations, 9 CFR 500, FSIS assures that appropriate due 

process takes place. 

As IPP perform their official duties, it is important to balance the 

establishment’s right to do business with FSIS’s obligation to protect the

public’s right to safe food. Establishments have a right to expect that FSIS will 

be fair and consistent, provide details about enforcement concerns, promptly 

respond to appeals, and provide the opportunity for correction. The Rules of 

Practice provide FSIS officials with the tools to ensure compliance by 

establishments producing meat and poultry products, and the processes for FSIS 

to control product or stop production when establishments fail to meet HACCP 

and other food safety requirements. 

The Rules of Practice were published so that establishments will know the types 

of enforcement actions FSIS takes, and the processes FSIS uses to accomplish 

those actions. They notify establishment management of their right to appeal 

enforcement decisions made by inspection program personnel. They also notify 

management that if FSIS suspends inspection the establishment may request a 

hearing. 

It’s important to remember that the Rules of Practice are regulations. Just as the 

establishment has to follow regulations in producing safe product, FSIS has to 

follow rules in the way we take action on violations we find. The Rules of 

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.__________.I· 

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Practice are regulations that USDA has adopted that apply to inspection 

personnel. 

In this training, we will focus on the parts of the Rules of Practice regulations that 

apply to inspection verification activities. The agency expects every inspection 

program employee to follow the Rules of Practice when they take any 

enforcement action as part of their regulatory duties. The rules of practice are 

explained in FSIS PHIS Directive 5000.1, Chapter VI – Rules of Practice. 

Rules of Practice 

Part 500 

Sec. 500.1 

Definitions 

Sec. 500.2 

Regulatory Control Action 

Sec. 500.3 

Withholding/Suspension 

Without Prior Notification 

Sec. 500.4 

Withholding/Suspension 

With Prior Notification 

Sec. 500.5(a) 

Notification 

Sec. 500.5(b) 

Notification 

Sec. 500.6 

Withdrawal of Inspection 

Sec. 500.7 

Refusal to Grant 

Inspection 

Sec. 500.8 

Rescinding or Refusing 

Approval of Labels 

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Rules of Practice Regulation 

Sec. 500.1 Definitions. 

There are three types of enforcement actions defined in the regulation. 

9 CFR 500.1 (a) A ``regulatory control action'' is the retention of product, 

rejection of equipment or facilities, slowing or stopping of lines, or refusal 

to allow the processing of specifically identified product. 

(b) A ``withholding action'' is the refusal to allow the marks of 

inspection to be applied to products. A withholding action may affect all 

product in the establishment or product produced by a particular process. 

(c) A ``suspension'' is an interruption in the assignment of program 

employees to all or part of an establishment. 

Regulatory control action is most commonly used by in-plant inspection 

personnel. This term refers to any action that inspection personnel take to control 

product or processes. Inspection personnel use regulatory control actions to 

identify regulatory noncompliance and prevent the movement of the product or 

use of the equipment or facility until the noncompliance has been corrected. A 

common example is the application of the FSIS reject/retain tag. 

Withholding actions withhold the marks of inspection. Such actions may be 

taken against product produced by a particular process or all products in the 

establishment. Withholding is a more severe enforcement action than a 

regulatory control action, because it can affect a larger part of an establishment 

or establishment processes. The decision to take an immediate withholding 

action can be made by whomever is in charge for FSIS at the establishment (for 

example, the IIC or designee), the frontline supervisor; or the District Office (DO). 

Suspension refers to the interruption in the assignment of inspection personnel 

to the establishment. A suspension of inspection also has a severe impact on an 

establishment. A suspension is usually in effect for a much longer duration of 

time than a withholding action. Because a federally inspected establishment 

cannot legally apply marks of inspection to product without an assigned 

inspector, this action stops all production, or it can be applied to a specific 

production process. For example, FSIS may suspend all inspection at a beef 

slaughter and processing establishment. The decision to suspend inspection is 

made at the District Office, or higher level of authority. 

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Sec. 500.2 Regulatory control action. 

This regulation lists provisions for a regulatory control action. 

9 CFR 500.2 (a) FSIS may take a regulatory control action because of: 

(1) Insanitary conditions or practices; 

(2) Product adulteration or misbranding; 

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

adulterated or misbranded; 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. 

(c) An establishment may appeal a regulatory control action, as 

provided in Secs. 306.5 and 381.35 of this chapter. 

Regulatory control actions are taken when there is danger of adulterated, 

contaminated, misbranded, or hazardous product leaving the establishment. 

Examples of such circumstances include: 

 Insanitary conditions likely to result in contamination of product, such as 

a piece of equipment that contains residue from the previous day’s 

production found during pre-op inspection. 

 Product adulteration, such as condensation dripping directly into a bin of 

meat. 

 Conditions in the establishment that prevent an inspector from 

deciding that product is not adulterated, such as intensity of light being 

not adequate to determine whether product is adulterated. 

Regulatory control actions are taken in situations that require immediate 

correction. It is not necessary to notify the establishment in advance. Once the 

action is taken, however, the Rules of Practice regulations require that the 

inspection personnel taking the action immediately notify establishment 

management. This can be done orally or in writing. The written notification will 

be a noncompliance record (NR). The NR documents the noncompliance, and 

the description should include any FSIS reject/retain tag numbers issued. 

The regulations also specify that the establishment has the right to appeal a 

regulatory control action to the next level of FSIS supervision. 

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Sec. 500.3 Withholding action or suspension without prior notification. 

The Rules of Practice regulation also identifies situations where FSIS may take 

withholding or suspension actions without giving the establishment prior 

notification. Withholding the marks of inspection and suspending inspection 

services are significant enforcement actions and are taken only after careful 

evaluation of the facts and circumstances. 

9 CFR 500.3 (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. 601; 

(2) The establishment does not have a HACCP plan as specified in 

Sec. 417.2 of this chapter; 

(3) The establishment does not have Sanitation Standard Operating 

Procedures as specified in Secs. 416.11-416.12 of this chapter; 

(4) Sanitary conditions are such that products in the establishment are 

or would be rendered adulterated;...

In most cases, in-plant personnel take these enforcement actions because the 

situation involves an imminent threat to public health. FSIS can immediately take 

a withholding action or suspension without giving the establishment prior 

notification in order to protect the public health, but inspection program personnel 

must be able to document the imminent threat to public health. If FSIS takes a 

withholding action or imposes a suspension without providing prior notification, 

the establishment must be notified orally and then, as promptly as the 

circumstances permit, in writing. As stated earlier, the decision to take a 

withholding action can be made by the IIC or designee, the Frontline Supervisor, 

or the DO, whereas the decision to suspend is made only at the DO level or 

higher. 

FSIS may also take enforcement action without prior notification if the 

establishment has violated the terms of a regulatory control action, has 

threatened or intimidated an FSIS employee, did not destroy condemned 

product, or handled animals inhumanely. 

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Sec. 500.4 Withholding action or suspension with prior notification. 

If a withholding or suspension action is based on any reason other than those 

listed in §500.3, FSIS must provide the establishment written notice before taking 

the action. 

9 CFR 500.4 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 Sec. 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 Secs. 416.13 through 

416.16 of this chapter; 

(c) The establishment has not maintained sanitary conditions as 

prescribed in Secs. 416.2-416.6 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 Sec. 

310.25(a) or Sec. 381.94(a) of this chapter;...

The determination to take withholding or suspension actions against the 

establishment requires that the Agency has compiled extensive information and 

analyzed it carefully. It is only reasonable to provide the establishment with this 

information in advance of any action. This gives the establishment an 

opportunity to provide a response to the notification, to point out any factual 

errors made by the Agency, identify scientific or technical disagreements, and 

articulate differing interpretations of regulatory requirements. Often these 

enforcement actions are based on repetitive noncompliance, such as systemic 

problems with the SSOP or HACCP systems. It is critical that inspection 

personnel properly document and, when appropriate, show a pattern of 

noncompliance and the failure of the establishment’s corrective and preventive

actions. 

The purpose of prior notification is to provide the establishment with due process 

rights as required by USDA regulations and the U.S. Constitution. The 

establishment is provided an opportunity to respond and to demonstrate 

compliance before FSIS takes the enforcement action when the circumstances 

do not pose an imminent threat to public health. 

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

9 CFR 500.5 (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 Secs. 306.5 and 381.35 of this chapter. 

(b) The prior notification provided for in Sec. 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. 

(c) An establishment may appeal the withholding action or suspension, 

as provided in Secs. 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 request 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. 

Notice of Intended Enforcement (NOIE) 

If the IIC believes that a withholding or suspension seems to be warranted, he or 

she discusses the noncompliance situation with the Frontline Supervisor and the 

District Office, and requests that an NOIE be issued to the establishment. An 

NOIE is issued for noncompliances that do not pose an imminent threat to public 

health, but, that may warrant a withholding or suspension if not corrected. The 

Notice of Intended Enforcement (NOIE) will be issued to the establishment by the 

District Manager (DM). 

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A NOIE provides notification to an establishment that there is a basis for FSIS to 

withhold the marks of inspection or to suspend inspection. The NOIE must 

contain specific information including the action FSIS intends to take and the 

effective date of the action, the reason for the proposed action, and the 

operations, products, or processes affected. The NOIE provides the 

establishment an opportunity to present immediate corrective action and further 

planned preventive action. The NOIE also notifies the establishment that it has 

three business days to contest the basis for the proposed enforcement action or 

to demonstrate how compliance has been or will be achieved. This means that in 

the absence of a response from the establishment which includes the information 

requested, FSIS will take an enforcement action in three days. 

When the DM receives the establishment’s response to an NOIE, he or she will 

evaluate it and then decide whether inspection should be withheld or suspended. 

The DM determines whether the establishment’s proposed action plan addresses 

the problem and, if effectively implemented, will ensure regulatory requirements 

are met. 

Upon assessing and evaluating the establishment’s response, the DM may

decide to: 

a. accept the establishment’s plan, 

b. implement the appropriate enforcement action, or 

c. defer his or her decision. 

a. Accept the establishment’s response

If the establishment responds within the specified time frame, has 

demonstrated that compliance has already been achieved, or provides a 

description of acceptable corrective and preventive actions from which the 

DM can determine that compliance will be achieved upon implementation, 

the DM can 

 accept the response, 

 notify the establishment of the decision, 

 ensure that the establishment implements the corrective and 

preventive actions in a timely manner, and 

 close the matter with a letter to the establishment. 

b. Implement an enforcement action 

If the establishment does not respond or, based on the evaluation of all 

pertinent information, the DM finds that compliance will not be achieved, 

the DM will implement the enforcement action. In those instances 

involving 

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 withholding actions, the DM instructs the IIC to impose the 

withholding action and notifies the establishment. 

 suspension actions, the DM instructs the IIC to suspend inspection 

and notifies the establishment. The DM’s written notification to the 

establishment will include the basis for his or her decision. 

c. Defer an enforcement decision 

A DM may defer an enforcement decision when he or she has substantial 

reason to believe that the establishment’s proposed corrective and 

preventive action are adequate to eliminate the noncompliance but lacks 

the substantive and supporting evidence that he or she needs to make a 

definite decision. For example, an establishment may submit an 

apparently adequate proposed plan and have a good history of executing 

its HACCP plan, but not include sufficient documentation to determine that 

the proposed plan will prevent recurrence. In this situation, a DM may 

choose to defer the enforcement decision and allow the establishment to 

implement the plan until it can be determined whether the plan is effective. 

The DM will notify the establishment in writing about the reasons that the 

decision has been deferred. 

If, at any time, during a period of deferment, the establishment fails to 

adhere to the proposed action plan, and the DM determines that an 

enforcement action is warranted, the DM will instruct the IIC to either 

impose a withholding action or effect the suspension. The DM will 

immediately notify the establishment management of this decision and the 

basis for it. 

Abeyance 

There are circumstances when the DM has suspended inspection, and then may 

subsequently decide to hold that suspension in abeyance as specified in 9 CFR 

500.5(e). Suspension held in abeyance means that the suspension is 

temporarily lifted, and the establishment is allowed to operate under mutually 

agreed upon conditions. 

When a DM has suspended inspection, he or she may subsequently decide to 

hold that suspension in abeyance if: 

 the establishment presents a plan that demonstrates that the 

establishment has designed corrective and preventive actions that 

meet the appropriate regulatory requirements and appears adequate to 

eliminate the noncompliance; and 

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 it is necessary to allow the establishment to operate after implementing 

these corrective and preventive actions so that FSIS can determine 

whether the establishment is able to adequately execute the plan. The 

DM will not hold a suspension in abeyance until the corrective and 

preventive actions are implemented. 

If the establishment has a history of failing to meet the criteria discussed above, 

the DM may decide not to accept the establishment’s plan.

If the DM decides to put the suspension in abeyance, and the establishment fails 

to either meet regulatory requirements or maintain regulatory compliance, during 

the abeyance period, the DM may lift the abeyance and put the suspension back 

in effect. If this occurs, the DM will instruct the IPP to suspend inspection and 

immediately notify the establishment management. 

Verification Plans 

When the DM decides to defer enforcement following the issuance of a NOIE, or 

to hold a suspension in abeyance, the EIAO will develop a verification plan. The 

verification plan (VP) provides a systematic means for IPP to verify that an 

establishment is effectively implementing the corrective measures that were 

proposed by the establishment. 

The VP will: 

 Describe the verification activities to be performed by inspection personnel 

based on the establishment’s corrective measures,

 List the procedures for each verification activity, and 

 Identify the regulation for each verification activity. 

IPP schedule and perform directed verification activities identified in the VP. On a 

weekly basis, the in-plant team reports, via e-mail to the District Office, the 

results of the activities conducted under the VP. The in-plant inspection team has 

the flexibility to increase the frequency of the verification activities based on its 

findings. Any failure to meet the conditions of the proposed corrective measures 

would support FSIS imposing further enforcement actions. 

Review of Previous History 

When IPP are newly assigned to an establishment they should review the 

establishment’s history, which is reflected in PHIS, and any enforcement action 

that may have been taken against the establishment. The IPP should be 

familiar with: 

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 PHIS records of recent noncompliances at the establishment and the 

corrective and preventive measures taken by the establishment; 

 Results of FSIS verification sampling; 

 Findings and outcomes from the most recent Food Safety Assessment; 

and 

 If an enforcement action has been deferred, or if a suspension has been 

held in abeyance at the establishment, FSIS expectations described in the 

verification plan, and results of FSIS verification tasks. 

If IPP have questions or concerns about the establishment’s history, they should 

contact the supervisor for additional information. 

Appeal Process 

FSIS regulations, 9 CFR 306.5 and 9 CFR 381.35, provide establishments with 

the opportunity to appeal any inspection decision. An appeal is part of an 

establishment’s due process according to the Rules of Practice. If FSIS program 

personnel issue an NR, the establishment can appeal the whole decision or part 

of the decision. Any enforcement action taken in accordance with the Rules of 

Practice, 9 CFR 500, may also be appealed. 

An establishment should file an appeal without fear of retaliation. FSIS 

encourages establishments to appeal decisions they believe are unfair or are not 

consistent with applicable standards. The appeal process is a mechanism for 

ensuring that any disagreements between establishment managers and FSIS 

program personnel are reviewed. 

The appeal process follows the Office of Field Operations (OFO) chain of 

command. The chain of command ensures that program employees most 

familiar with the appeal facts evaluate the appeal first to minimize response time. 

The chain of command also allows a establishment to appeal to the next highest 

level if unsatisfied with an appeal outcome. The OFO chain of command is: 

1. Program employee who made the finding (e.g. CSI, Public Health 

Veterinarian (PHV), Inspector in Charge (IIC)) 

2. PHV, IIC or Mini-Circuit Supervisor 

3. Frontline Supervisor (FLS) 

4. District Manager (DM) 

5. Executive Associate for Regulatory Operations 

6. OFO Assistant Administrator 

7. FSIS Administrator 

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The formal appeal process starts with the immediate supervisor of the employee 

making the enforcement finding or decision. FSIS recommends that the 

establishment request that the employee who made the finding or decision 

reconsider his or her finding or decision before starting the appeal. Although 

§381.35 indicates that the establishment has 48 hours from the time the decision 

was made to appeal, there is no time limit for the establishment to appeal an 

enforcement decision. FSIS recommends that the establishment make the 

appeal in a timely manner. 

Withdrawal of Inspection. 

Withdrawal of the grant of inspection is the most severe enforcement action that 

can be taken against an official establishment. Withdrawal terminates the grant 

of inspection. Once that happens, no portion of the establishment can operate 

as a FSIS federally inspected establishment. Withdrawal actions can be the 

culmination of a lengthy process. Establishments that have been subjected to 

withholding actions and suspensions can eventually be subject to withdrawal if 

operations are not returned to compliance, or if the situation is severe. The final 

decision to withdraw the grant of inspection is made at the Administrator’s level. 

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Rules of Practice Workshop 

Using the module and FSIS PHIS Directive 5000.1, 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 

___Inadequate HACCP plan due to numerous associated noncompliances 

___Imminent threat to public health exists 

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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Appendix 1 – Part 500 Rules of Practice Regulations 

Sec. 500.1 Definitions. 

(a) A ``regulatory control action'' is the retention of product, 

rejection of equipment or facilities, slowing or stopping of lines, or 

refusal to allow the processing of specifically identified product. 

(b) A ``withholding action'' is the refusal to allow the marks of 

inspection to be applied to products. A withholding action may affect 

all product in the establishment or product produced by a particular 

process. 

(c) A ``suspension'' is an interruption in the assignment of 

program employees to all or part of an establishment. 

Sec. 500.2 Regulatory control action. 

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

(1) Insanitary conditions or practices; 

(2) Product adulteration or misbranding; 

(3) Conditions that preclude FSIS from determining that product is 

not adulterated or misbranded; 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. 

(c) An establishment may appeal a regulatory control action, as 

provided in Secs. 306.5 and 381.35 of this chapter. 

Sec. 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 

Sec. 417.2 of this chapter; 

(3) The establishment does not have Sanitation Standard Operating 

Procedures as specified in Secs. 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. 

Sec. 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 Sec. 417.6 of 

this chapter, due to multiple or recurring noncompliances; 

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(b) The Sanitation Standard Operating Procedures have not been 

properly implemented or maintained as specified in Secs. 416.13 through 

416.16 of this chapter; 

(c) The establishment has not maintained sanitary conditions as 

prescribed in Secs. 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 Sec. 

310.25(a) or Sec. 381.94(a) of this chapter; 

(e) The establishment did not meet the Salmonella performance 

standard requirements prescribed in Sec. 310.25(b) or Sec. 381.94(b) of 

this chapter. 

Sec. 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 Secs. 306.5 and 381.35 of this chapter. 

(b) The prior notification provided for in Sec. 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. 

(c) An establishment may appeal the withholding action or 

suspension, as provided in Secs. 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 request 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. 

Sec. 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 417 of this chapter; 

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

Operating Procedures in accordance with part 416 of this chapter; 

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Rules of Practice 

2/15/18 

(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 Sec. 

310.25(a) or Sec. 381.94(a) of this chapter; 

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

standard requirements as prescribed in Secs. 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 recipient of inspection or anyone responsibly connected to 

the recipient is unfit to engage in any business requiring inspection 

as specified in section 401 of the FMIA or section 18(a) of the PPIA. 

Sec. 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 

(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. 

Sec. 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. 

Inspection Methods 3-18