U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Retail Food Safety Branch
DRAFT: February 6, 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This document has been superceded by a more recent version.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. 1

This standard applies to the regulatory foundation used by a retail food program. Regulatory foundation includes any statute, regulation, rule, ordinance, or other prevailing set of regulatory requirements that governs the operation of a retail food establishment.

Requirement Summary

The regulatory foundation includes provisions for:

1. The public health interventions contained in the Food Code;
2. Control measures for the risk factors known to contribute to foodborne illness;
3. Good Retail Practices (GRP's) at least as stringent as the Food Code; and
4. Compliance and enforcement at least as stringent as the selected provisions from Food Code and Annex 1 of the Food Code.

Description of Requirement

1. Food Code Interventions and Risk Factor Control Measures

The regulatory foundation contains provisions that are at least as stringent as the public health interventions and the provisions that control risk factors known to contribute to foodborne illness contained in the Food Code. To meet this element of the Standard, regulations must have a corresponding requirement for the Food Code sections as listed in Appendix A, Table A-1 and summarized in Table A-2, from #1 "Demonstration of Knowledge" through #11 "Highly Susceptible Populations." For initial listing, the regulatory foundation must contain at least 9 of the 11 interventions and risk factor controls. In order to meet fully the requirements of the Standard, the regulatory foundation must meet all 11 of the interventions and risk factor controls by the second audit.

2. Good Retail Practices

The regulations contain provisions that address Good Retail Practices that are at least as stringent as those described in the Food Code. To meet this element of the Standard, regulations must have a corresponding requirement for 95 percent of the Food Code sections as listed in Appendix A, Table A-3 and summarized in Table A-4, from #12 "Personnel" through #37 "Variance for Smoking."

3. Compliance and Enforcement

The regulations contain provisions that address Compliance and Enforcement requirements that are at least as stringent as those contained in the Food Code. To meet this element of the Standard, regulations must have a corresponding requirement for each of the Food Code sections as listed in Appendix A, Table A-5, items 1 through 15.

Outcome

The desired outcome of this standard is the adoption of a sound, science-based regulatory foundation for the public health program and the uniform regulation of industry.

Documentation

The quality records needed for this standard are:

1. The statute, regulation, rule, ordinance or other prevailing set of regulatory requirements that govern the operation of a retail food establishment; and
2. The completed Appendix A and its accompanying tables.

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