U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Retail Food Safety Branch
DRAFT: February 28, 1998
DRAFT: April 24, 2001
DRAFT: June 28, 2001

This document has been superceded by a more recent version. Below is an earlier version.

STANDARD NO. 6

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, 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 record and quantify the compliance status of risk factors, interventions and other serious code violations.
3. Documentation on the establishment inspection report form or in the establishment file that compliance and/or enforcement action was taken to achieve compliance at least 80 percent of the time when out-of-control risk factors or interventions are recorded on a routine inspection measured using the procedures in Appendix F.
4. Compliance and enforcement actions that follow the step-by-step procedure.

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. Documentation that compliance and enforcement action was taken 80 percent of the time using the worksheet and procedures in Appendix F when out-of-control risk factors or code interventions are recorded on routine inspections.
3. 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.]

Last updated by dav/ear/cjm 2006-NOV-14