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Compliance, Enforcement and Public Health Protection (Standard 6)
Matt ColsonEnvironmental Administrator
Florida Department of Agriculture and Consumer Services
Thomas TederingtonFood Safety Specialist
Michigan Department of Agriculture and Rural Development
March 10, 20152:00 pm
Ground Rules1. Please shut phones off or place in silent mode.2. Please split up tables if you have more than one person from
your jurisdiction participating to leverage your time and to give others equal access.
3. Try to give everyone chance to ask questions or offer comments.4. Stick to the agenda topic.5. All questions are good questions.6. It’s ok to disagree, but do it respectfully.7. Please listen during presentation as well as during Q&A – try to
refrain from side discussions.8. Honor time schedule - when you hear the bell (gong, whistle,
announcement whatever) please move quickly to your next table of choice and settle in.
9. Access Alliance conference portal to find presenter information!
Standard 6 Program Elements
The State program has a compliance program that:• Contains written enforcement strategies• Tracks critical and chronic violations and violators• Determines when a directed investigation, follow-up, or re-
inspection is needed• Establishes a timeline for progressive actions• System to communicate to manager and non-managers
Contains Written Enforcement Strategies
• Review your State Regulatory Authority and adopted regulations (Standard 1)
• DefineComplianceEnforcementChronic ViolationsChronic Violator
• Identify the events that trigger a compliance or enforcement action
Contains Written Enforcement Strategies
• Compliance- Conformance with law• Compliance action- Actions taken to encourage
conformance with law• Typically immediate actions• Can also be preventive
Education and outreach activities (Standard 7) to promote voluntary compliance
Contains Written Enforcement Strategies
• Examples of FDACS compliance actionsCiting violation on inspection report Stop Sale/Stop Use Fail inspection ratingRe-inspection Follow-up inspectionWarning letter
Contains Written Enforcement Strategies
• Enforcement- Punitive actions taken when compliance is not achieved
• Examples of enforcement actionsAdministrative fineAdministrative hearingPermit suspensionPermit revocationClosure (final order)Criminal sanctions
Critical Violations
• Critical violation (MFRPA proposed definition) - are violations which are directly linked to public health risk, food adulteration, and/or known contributors to foodborne illness
• Critical violation (major violation)- (FDACS proposed definition) - Any violation of Chapters 500, 502 or 597, F.S., or this rule chapter that may result in economic or physical harm to a person or may adversely affect the public health, safety, or welfare or creates a significant threat of such harm shall be considered a major violation
Critical Violations• Examples of critical (major) violations include:
Sewage backup Insect/ rodent infestation Severe roof leak Lack of critical equipment such as hand sinkAdulterated products
Lab confirmed Positive sample (Standard 10)Multi-agency investigation or recall (Standard 5)
Critical Violations• More examples of critical (major) violations:
Failure to follow process control HAACPScheduled processFood safety planOther required by law
Falsifying recordsTransportation of foods
Chronic Violations and Violators• Chronic violation (FDACS proposed definition) - the second
and any subsequent notice of non-compliance for a same or similar violation is issued to a food establishment within a three year period
• Chronic violator (FDACS proposed definition) - repeated fail ratings in which the general condition of the firm, when viewed as a whole, is more likely to contribute to food contamination, illnesses, or environmental health hazard; Or a violator with previous violations for the same or a similar offense that resulted in enforcement action
FDACS Development Process
• Used general procedures that provide guidance to field staff
• Wanted to develop a more detailed system of compliance and enforcement strategies Limit subjectivity Promote uniformity Ability to be tracked and reviewed/audited (Standard 4)
FDACS Development Process
• Prepare a flow chart to overview the process• Involve field staff• Think about how to capture the data• Test, Test, Test• Training (Standard 2)• Include these steps in your strategic plan
(Standard 9)
Written Enforcement Strategies with Progressive Timelines
Stop Sale/Stop Use
Follow-up w/in 30 days
Start-Violation Observed
Major(Critical)
Imminent Health
Deficiency Corrected
Stop Sale/Stop Use
Follow-up w/in 30 days
Deficiency Corrected
Fail Rating IssuedStop Sale/Stop Use
Re-inspect w/in 14 days
Deficiency Corrected
Fail RatingAdmin action
Re-inspect w/in 14 days
Deficiency Corrected
Minor 1 Minor 2
Follow-up next routine inspection
Deficiency Corrected
Follow-up w/in 30 days
Deficiency Corrected
Admin action Follow up within 30 days
End
Deficiency Corrected
Yes Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
FDACS Development Process
• Developing a compliance protocol : Describes the compliance/enforcement program Strategies for each inspection type (Standard 3)
• Example: Seafood HACCP Compliance Strategy
Table 4*Scombrotoxin Forming Species of Fish
(histamine prone finfish listed on table 3-2 of the Fish and Fishery Hazard and Control Guidance.)AND
The FE has not developed adequate controls strategies as recommended in the Guide that establish control of the
hazard (see Chapter 7, p. 125).
The FE has a HACCP Plan for control of Scombrotoxin related hazards however the plan is not implemented and/or the FE has inadequate controls to control the hazard.
ANDthe FE does not have temperature monitoring
records that ensures control of the hazard.OR
does not have adequate control to control species and product related hazards.
The FE has No HACCP Plan or the HACCP Plan has missing or improper content issues to control
the Scombrotoxin hazard however FE has established control of the hazard.
PASSContact a supervisor and the HACCP team. Issue a SSH order until evidence of control of the hazard has been established. This will include proper documentation of temperature while in transit and while in storage. The FE may be able to have the product tested by an accredited lab as a means for release4. All lab reports must be submitted by the FE’s lab directly to the TLH Lab Liaison [email protected] 5. Issue a SU order on the equipment if required. The equipment may be released once the FE has established control of the food safety hazard(s) and the proper documentation has been submitted and accepted by TLH or the PSI. In the supplement notes and in the inspection visit comments include this statement:
A Stop Use Order and/or Stop Sale Order has been issued. Call 850-245-5520 when corrections have been made and/or when the required documents have been
obtained to request for a written release of the equipment and/or product.6
ANDManagement must submit, electronically or by other
means1 required HACCP Plan documentation identified during this visit within 14 days2. Failure to provide
required documentation may necessitate the department to make an additional on site visit and/or take additional
enforcement action.3
PASSContact a supervisor and the HACCP team. Issue a SSH order until evidence of control of the hazard has been established. This will include proper documentation of temperature while in transit and while in storage. The FE may be able to have the product tested by an accredited lab as a means for release4. All lab reports must be submitted by the FE’s lab directly to the TLH Lab Liaison and [email protected] 5. Issue a SU order on the equipment if required. The equipment may be released once the FE has established control of the food safety hazard(s) and the proper documentation has been submitted and accepted by TLH or the PSI. In the supplement notes and in the inspection visit comments include this statement:A Stop Use Order and/or Stop Sale Order has been issued. Call 850-245-5520 when corrections have been made and/or when
the required documents have been obtained to request for a written release of the
equipment and/or product.6
PASSIn the inspection visit comments include this statement:Management must submit, electronically or by
other means1 required HACCP Plan documentation identified during this visit
within 14 days2. Failure to provide required documentation may necessitate the department to make an additional on site visit and/or take
additional enforcement action.3
*Final disposition of the affected product or products must be evaluated on a case by case basis depending on the imminent health hazard or threat posed to public health and safety.[Note: Alternately you may use the Miami Dade County regional office telephone number (305) 639-3560.]
Current Status
• Piloting draft seafood HACCP compliance strategy Review/revise/finalize Use as a template for the other inspection types
• Assigning point values to citations Triggers compliance or enforcement action
• Awaiting implementation of Administrative Penalties Rule
Current Status• Tracking Critical and Chronic Violations
and Violators (FIMS)• Developing procedures to:
Improve monitoring Improve inspection uniformity
Compliance and Enforcement Program
• Any questions, comments, or ideas related to this topic?
• What is/was your program’s biggest hurdle developing and implementing standard 6?
Contact Information
Matt Colson
Environmental Administrator
Florida Department of Agriculture and Consumer Services
Email: [email protected]
