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Issue Number: Council II 022


Administrative Procedures for Retail Food Program Standards

Issue you would like the Conference to consider

Jurisdictions that use the Voluntary National Retail Food Regulatory Program Standards would benefit from the availability of a document that describes the processes used by FDA to administer the Program Standards and the processes that FDA expects jurisdictions to follow to "enroll in" and "remain" an active participant. As an addendum to the Program Standards that is maintained by FDA, such a document would serve to consolidate items currently described in Program Standard No. 9 and elsewhere in supporting materials and on websites maintained by FDA.

Currently Standard No. 9 of the Voluntary National Retail Food Regulatory Program Standards contains many of the procedures that jurisdictions are expected to follow if they are to be considered "an active participant" in the Program Standards. Among other things, these procedures address the required frequency for completion of self-assessments and verification audits and how jurisdictions are expected to report progress to FDA for inclusion on FDA Listing of Enrolled Jurisdictions. FDA believes these broad "standards implementation" requirements should be moved from Standard No. 9 to the new addendum, so that Standard No. 9 requirements contain only requirements directly related to a jurisdiction's assessment of their own program.

Public Health Significance

Currently Standard No. 9 requires jurisdictions to assess their programs by conducting a Risk Factor Study and analysis of the resulting data to track trends over time related to the occurrence of risk factors. The intent of this Standard is for enrolled jurisdictions to track and assess their program outcomes as demonstrated by the occurrence of foodborne illness risk factors over time and to develop and implement strategies to improve food safety in their jurisdiction.

In addition, Standard No. 9 includes administrative requirements related to the self-assessment and auditing of a program against the full set of Program Standards and establishes what must be reported to FDA in order for an agency to be recognized as an "active participant" in the Program Standards.

FDA believes such administrative requirements do not belong in a specific Program Standard and instead belong in an administrative procedures document that more fully describes the roles and expectations of jurisdictions formally participating in the Program Standards and of FDA in administering the Program Standards. Having a separate procedures document that describes all that is required for active participation and recognition by FDA should make it easier for stakeholders to locate and understand all the procedures related to Program Standards participation. Further, having a separate administrative procedures document should provide FDA more flexibility to improve the ways it implements the Program Standards without changing a recognized Program Standard itself.

Among the items that FDA believes would be best moved to a separate administrative document are those currently in Program Standard No 9. related to:

  • the frequency of self-assessments and audits;
  • procedures for conducting self-assessments and audits;
  • the qualifications of auditors; and
  • the submission of forms to FDA for inclusion on the Listing of Enrolled Jurisdictions.

Also appropriate for inclusion in such a document are administrative procedures that are not contained in Standard No. 9 but that would address:

- Program Standards enrollment eligibility;

- Procedures for maintaining FDA's Listing of Enrolled Jurisdictions and other means of recognizing participating jurisdictions;

- Procedures for obtaining interpretations of Program Standards through FDA Program Standards Clearinghouse;

- Procedures for resolving disputes concerning the results of non-conforming verification audits.

Recommended Solution: The Conference recommends...

that a letter be sent to FDA requesting that:

1. FDA develop and maintain an addendum to the Voluntary National Retail Food Regulatory Program Standards that describes the administrative processes used by FDA to implement the Program Standards and by jurisdictions that choose to be active participants in the Program Standards, and that the addendum address how, and with what frequency, to:

  • Enroll jurisdictions in the Program Standards;
  • Measure and report progress made by jurisdictions in assessing and auditing their programs for conformance with the Voluntary Retail Food Regulatory Program Standards 1 through 9 (including submission of specific forms);
  • Recognize those jurisdictions meeting the Standards, including how jurisdictions are listed on the FDA website;
  • Interpret the Standards and resolve disputes concerning the results of non-conforming audits; and
  • Otherwise successfully implement the Program Standards.

2. Upon availability of an administrative procedures document, FDA will amend Program Standard 9, as shown in Attachments A and B, to remove language that describes the administrative processes used by jurisdictions to demonstrate implementation of the Program Standards but that are not requirements for conformance with Program Standard 9-Program Assessment and to make necessary editorial changes, as needed;

3. During development of the administrative procedures document, FDA consult the CFP Program Standards Committee for input on its content and format and on the placement of such a document as an addendum to the Standards.


Submitter Information

Name Glenda R. Lewis
Organization U.S. Food and Drug Administration
Address 5100 Paint Branch Parkway, HFS-320, Room 3B-002
College Park, MD 20740
Telephone 240-402-2150
Fax 301-436-2672
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