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U.S. Department of Health and Human Services

Food

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Voluntary National Retail Food Regulatory Program Standards - January 2011 - Standard 6

Compliance and Enforcement

This standard applies to all compliance and enforcement activities used by a jurisdiction to achieve compliance with regulations.

Requirement Summary

Compliance and enforcement activities result in follow-up actions for out-of-control risk factors and timely correction of code violations.

Description of Requirement

Compliance and enforcement encompasses all voluntary and regulatory actions taken to achieve compliance with regulations. Voluntary corrective action includes, but is not limited to, such activities as on-site corrections at time of inspection, voluntary destruction of product, risk control plans and remedial training. Enforcement action includes, but is not limited to, such activities as warning letters, re-inspection, citations, administrative fines, permit suspension and hearings. Compliance and enforcement options may vary depending on state and local law.

The program must demonstrate credible follow-up for each violation noted during an inspection, with particular emphasis being placed on risk factors that most often contribute to foodborne illness and Food Code interventions intended to prevent foodborne illness. The resolution of out-of-compliance risk factors and/or Food Code interventions must be documented in each establishment record. The essential program elements required to meet this standard are:

  1. A written step-by-step procedure that describes how compliance and enforcement tools are to be used to achieve compliance.
  2. Inspection report form(s) that records and quantifies the compliance status of risk factors and interventions (i.e., IN compliance, OUT of compliance, Not Observed, or Not Applicable).
  3. Documentation on the establishment inspection report form or in the establishment file using the statistical method for file selection in the Supplement to Standard 6, Appendix F, where at least 80 percent of sampled establishments meet the following conditions:
    1. The inspection and enforcement staff takes compliance and enforcement action according to the procedure (i.e. the staff follow the step-by-step compliance and enforcement procedures when violations occur), and
    2. Resolution was successfully achieved for all out-of-control risk factors or interventions that were recorded on the selected routine inspection.

(Note: On this CD, Appendix F has been replaced by the "Standard 6: Establishment File Worksheet" and the "Self-Assessment Summary Worksheet" for the purposes of self-assessment and the "Verification Audit Worksheet" for the purposes of verification audits - and their corresponding guidance documents)

Outcome

The desired outcome of this standard is an effective compliance and enforcement program that is implemented consistently to achieve compliance with regulatory requirements.

Documentation

The quality records needed for this standard include:

  1. A copy of the written step-by-step enforcement procedures.
  2. Inspection form that meets the criteria.
  3. Documentation that compliance and enforcement action was taken correctly for at least 80 percent of the sampled establishments using the worksheet and procedures in Supplement to Standard 6, Appendix F when out-of-control risk factors or code interventions are recorded on routine inspections.  (See NOTE above regarding replacement of Appendix F)
  4. A reference “Key” which identifies the major risk factors and Food Code interventions on the jurisdiction's inspection report form.  [Note: A jurisdiction will not be penalized under Standard No. 6 for sections of the Food Code which have not yet been adopted.