Compliance, Enforcement and Public Health Protection (Standard 6) Matt Colson Environmental Administrator Florida Department of Agriculture and Consumer Services Thomas Tederington Food Safety Specialist Michigan Department of Agriculture and Rural Development March 10, :00 pm

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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) Define  Compliance  Enforcement  Chronic Violations  Chronic 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 actions  Citing violation on inspection report  Stop Sale/Stop Use  Fail inspection rating  Re-inspection  Follow-up inspection  Warning letter

Contains Written Enforcement Strategies Enforcement- Punitive actions taken when compliance is not achieved Examples of enforcement actions  Administrative fine  Administrative hearing  Permit suspension  Permit revocation  Closure (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 sink  Adulterated 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  HAACP  Scheduled process  Food safety plan  Other required by law  Falsifying records  Transportation 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 Issued Stop Sale/Stop Use Re-inspect w/in 14 days Deficiency Corrected Fail Rating Admin 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 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. AND the 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. PASS Contact 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 release 4. All lab reports must be submitted by the FE’s lab directly to the TLH Lab Liaison 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 A Stop Use Order and/or Stop Sale Order has been issued. Call 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 AND Management must submit, electronically or by other means 1 required HACCP Plan documentation identified during this visit within 14 days 2. Failure to provide required documentation may necessitate the department to make an additional on site visit and/or take additional enforcement action. 3 PASS Contact 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 release 4. All lab reports must be submitted by the FE’s lab directly to the TLH Lab Liaison and 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 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 PASS In the inspection visit comments include this statement: Management must submit, electronically or by other means 1 required HACCP Plan documentation identified during this visit within 14 days 2. 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) ]

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