Rules Of Practice
EIAO Training
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Objectives
Upon completion of this module, the trainee will be able to:
Describe what the Rules of Practice are and why FSIS must
follow them.
List the conditions when FSIS may take a suspension or
withholding action:
without prior notice
with prior notice
Describe the “due process” protections in the Rules of
Practice.
Describe what an “abeyance” is.
Describe how to support an enforcement action using a
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supportable regulatory-statutory rationale.
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Background
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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Administrative Procedure Act
Withdrawal, suspension, revocation or
annulment of a 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
FSIS must comply with the APA in carrying
out its food safety and administrative
enforcement activities
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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FSIS Rules of Practice
Define types of enforcement actions
Conditions under which FSIS may act
Procedures FSIS must follow
Industry appeal and hearing rights
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FSIS Rules of Practice - 9 CFR Part 500
Effective January 25, 2000
500.1 Definitions
500.2 Regulatory Control Action
500.3 Suspension w/out prior notification
500.4 Suspension with prior notification
500.5 Notification and Procedures
500.6 Withdrawal of inspection
500.7 Refusal to grant inspection
500.8 Rescinding or refusing labels
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9 CFR 500.1 Definitions
3 Types of Enforcement Actions Defined
Regulatory Control Action
Withholding Action
Suspension
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Regulatory Control Action
Retention of product
Rejection of equipment or facilities
Slowing or stopping of lines
Refusal to allow the processing of a
specifically identified product
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Withholding
Refusal to allow the marks to be applied to
products
May affect all product or product produced
by a particular process
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Suspension
Interruption in the assignment of program
employees to all or part of an establishment
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9 CFR 500.2 Regulatory Control Actions
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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9 CFR 500.3 Withholding or Suspension
without Prior Notice
Produced and shipped adulterated product
No SSOP or HACCP Plan
Insanitary conditions
Violated regulatory control action
Inhumane slaughter or handling
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9 CFR 500.4 Withholding or Suspension
with Prior Notice
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
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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Types of Written Notice
Notice of Suspension/Withholding
Notice of Intended Enforcement
Notice of Deferral
Additional Notification Letters
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9 CFR 500.5(a)
Contents of Enforcement Letters
Effective date of action
Describe the reasons for the action
Identify the product or process 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
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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Notice of Deferral
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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Additional Notification Letters
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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Due Process Protections
Appeal Rights
Opportunity For an
Administrative Hearing
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9 CFR 500.5 (c) Appeal Rights
Establishment may appeal withholding or
suspension action
9 CFR 306.5 and 381.35
Actions are appealed to next higher level of
supervision
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9 CFR 500.5(d) Hearing Rights
Establishments have a right to request a
hearing when a suspension is put into effect
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9 CFR 500.5(e) Abeyance
Establishment has been suspended
DM temporarily “lifts” suspension
Establishment operates under conditions
agreed by FSIS and establishment
Notice of Suspension Held in Abeyance
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9 CFR 500.6 Withdrawal of Grant
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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9 CFR 500.7 Refusal to Grant Inspection
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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9 CFR 500.8
Rescinding or refusing labels/marks
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
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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Rules of Practice
Workshop
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