!:!_SDA Food Safety and Inspection Service 

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Background 

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Administrative Procedure Act 

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•Administrative Procedure Act

(5 U.S.C. 551 - 559)

•Law governing federal administrative

agencies

•Openness, fairness, and uniformity

in administrative processes

•Uniformity in rule making

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• Withdrawal, suspension, revocation or

annulment of license

• Written notice of the facts or conduct

which may warrant the action

• Opportunity to demonstrate or achieve

compliance

• Exceptions for willfulness or for public

health, interest or safety

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Due Process 

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FSIS Rules of Practice 

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9 CFR 500.1 Definitions 

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• FSIS must comply with the APA in carrying out its food safety

and administrative enforcement activities in a fair/equitable

and consistent manner

• FSIS must provide details about compliance concerns and

opportunity for correction

• FSIS may take immediate action for an imminent threat to

public health or safety

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• Defines the types of enforcement actions

• Conditions under which FSIS may act

• Procedures FSIS must follow

• Industry appeal and hearing rights

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• 3 Types of Enforcement Actions Defined

• Regulatory Control Action – Retention of product, rejection of

equipment or facilities, slowing or stopping the lines, or refusal

to allow the processing of specifically identified product

• Withholding Action – Refusal to allow the marks of inspection to

be applied to products

• Suspension – Interruption in the assignment of program

employees to all or part of an establishment

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9 CFR 500.2 Regulatorv Control Actions 

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9 CFR 500.3 Withholding or Suspension 

without Prior Notice 

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9 CFR 500.4 Withholding or Suspension 

with Prior Notice 

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• Insanitary conditions or practices

• Product adulteration or misbranding

• Conditions that preclude FSIS from determining that

product is not adulterated

• Inhumane handling or slaughtering

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• Produced and shipped adulterated product

• No SSOP or HACCP plan

• Insanitary conditions

• Violated regulatory control action

• Inhumane slaughter or handling

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• SSOP/HACCP system inadequate (multiple or

recurring noncompliance)

• Sanitary conditions/sanitation performance

standards (multiple or recurring noncompliance

• Did not collect or analyze for E. coli Biotype 1

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9 CFR 500.5(a) Notification 

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• 

Types of Written Notice 

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9 CFR 500.5(a) Contents of 

Enforcement Letters 

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• If FSIS takes a withholding action or imposes a suspension,

the establishment will be notified orally and as promptly as

circumstances permit in writing

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• Notice of Suspension/Withholding (NOS)

• Notice of Intended Enforcement (NOIE)

• Notice of Deferral

• Additional Notification Letters

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• Effective date of action

• Describe the reasons for the action

• Identify the product or processes affected

• Provide establishment opportunity for corrective

actions

• Advise of appeal process

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9 CFR 500.5(b) Notice of Intended 

Enforcement - NOIE 

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Notice of Deferral 

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Additional Notification Letters 

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• Reason for action

• Identify product or processes affected

• Advise of right to contest basis or explain

compliance

• Three days to respond to FSIS

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• Issued to establishment when proposed

corrective actions seem adequate

• Establishment implements corrective

actions

• Verification plan is included

• Close out with Letter of Warning

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• Notice of Suspension Held in Abeyance

• Allows establishment to operate after presenting

corrective actions and preventive measures

• Notice of Reinstatement of Suspension

• Failure of establishment to meet or maintain compliance

• Letter of Warning

• Notification that enforcement action is closed

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9 CFR 500.5(c) Appeal Rights 

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9 CFR 500.5(d) Hearing Rights 

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9 CFR 500.5(e) Abeyance 

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Due Process protections give the right to the

Establishment to:

• Appeal a withholding or suspension action

• 9 CFR 306.5 and 381.35

• Actions are appealed to next higher level of

supervision

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Due Process protections also give the right to the

Establishment to:

- To request a hearing when a suspension is put

into effect

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• Establishment has been suspended

• The District Manager (DM) temporarily “lifts”

the suspension

• Establishment operates under conditions

agreed by FSIS and the establishment

• Notice of Suspension Held in Abeyance*

* Means that the suspension is temporarily lifted

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9 CFR 500.6 Withdrawal of the Grant of 

1nspectron 

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9 CFR 500.7 Refusal to Grant Inspection 

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9 CFR 500.8 Rescinding or Refusing 

La'o'ets7Ivlarks 

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• Produced and shipped adulterated product

• Failure to have or maintain SSOP/HACCP plan

• Insanitary conditions

• Did not collect or analyze for E. coli Biotype 1

• Did not comply with Salmonella PS

• Inhumane handling or slaughter

• Assault, threat, intimidation, or interference

• Unfitness

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• No HACCP plan as required by part 417

• No SSOP as required by part 416

• Establishment has not demonstrated adequate

sanitary conditions

• Establishment has not demonstrated that

livestock will be handled and slaughtered

humanely

• Unfitness of applicant

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• False or misleading marks, labels

• Forms or containers for use with meat or

poultry products

• Decisions made at Administrator level

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Statutory-Regulatory Exercise 

• 

Rules of Practice Workshop 

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• Example – an establishment has several

associated NRs for condensation in exposed

product areas, some included product

contamination.

• What would your thought process be if

enforcement action were being considered?

• Don’t forget to include the Rules of Practice!

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