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CFSAN/Retail Food Safety Team
DRAFT: February 28, 1998;
DRAFT: April 24, 2001;
DRAFT: June 28, 2001;
DRAFT: April 2003; DRAFT: January 2005;
DRAFT: December 2007
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Developed and recommended by the U.S. Food and Drug Administration with input from federal, state, and local regulatory officials, industry, trade associations, academia, and consumers.
Introduction | Purpose | Scope | New Developments | Impact on Program Resources | Comments and Inquiries
Achieving national uniformity among regulatory programs responsible for retail food protection in the United States has long been a subject of debate among the industry, regulators and consumers. Adoption of the FDA Food Code at the state, local and tribal level has been a keystone in the effort to promote greater uniformity. However, a missing piece has been a set of widely recognized standards for regulatory programs that administer the Food Code. To meet this need FDA has developed the Draft Voluntary National Retail Food Regulatory Program Standards (Program Standards) through ideas and input from federal, state, and local regulatory officials, industry, trade and professional associations, academia and consumers on what constitutes a highly effective and responsive retail food regulatory program.
In March of 1996, the FDA hosted a meeting to explore ways in which its retail food protection program could be improved. Participants in the meeting included FDA Retail Food Specialists, FDA headquarters personnel, state and local regulatory officials from the six FDA regions, the president of the Association of Food & Drug Officials, and industry representatives. Following that meeting, FDA established a National Retail Food Team comprised of the Regional Retail Food Specialists, CFSAN personnel and other FDA personnel directly involved in retail food protection. A Retail Food Program Steering Committee was established and tasked with leading the team to respond to the direction given by the participants in the meeting, i.e. providing national leadership, being equal partners, being responsive, and providing communication and promoting uniformity.
The Steering Committee was charged with developing a five-year operational plan for FDA's retail food program. The Steering Committee was also charged with ensuring the operational plan was in keeping with the goals and mission of the President's Food Safety Initiative. FDA solicited input from the regulatory community, industry and consumers in developing the plan. The resulting Operational Plan charted the future of the National Retail Food Program and prompted a reassessment of the respective roles of all stakeholders and how best to achieve program uniformity.
From the goals established in the Operational Plan, two basic principles emerged on which to build a new foundation for the retail program:
These principles led to the drafting of standards that encourage voluntary participation by the regulatory agencies at the state, local, and tribal level. The Program Standards were developed with input obtained through a series of meetings over a two-year period including: the 1996 stakeholders meeting, FDA Regional Seminars, meetings with state officials hosted by the Retail Food Specialists, and six Grassroots Meetings held around the country in 1997. Valuable input from industry associations, associations of regulatory officials, and others was also obtained. The Program Standards were provided to the Conference for Food Protection for further input and to achieve broad consensus among all stakeholders.
In developing the Program Standards, FDA recognized that the ultimate goal of all retail food regulatory programs is to reduce or eliminate the occurrence of illnesses and deaths from food produced at the retail level and that there are different approaches toward achieving that goal. Federal, state, local, and tribal agencies continue to employ a variety of mechanisms with differing levels of sophistication in their attempt to ensure food safety at retail.
While the Program Standards represent the food safety program to which we ultimately aspire, they begin by providing a foundation upon which all regulatory programs can build through a continuous improvement process. The Standards encourage regulatory agencies to improve and build upon existing programs. Further, the Standards provide a framework designed to accommodate both traditional and emerging approaches to food safety. The Program Standards are intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulatory agencies and industry to focus on the factors that cause and contribute to foodborne illness.
The Program Standards serve as a guide to regulatory retail food program managers in the design and management of a retail food regulatory program and provide a means of recognition for those programs that meet these standards. Program manager and administrators may establish additional requirements to meet individual program needs.
The Program Standards are designed to help food regulatory programs enhance the services they provide to the public. When applied in the intended manner, the Program Standards should:
Each standard has one or more corresponding appendices that contain forms and worksheets that facilitate the collection of information needed to fully assess a retail program. Regulatory agencies may use existing, available records or may choose to develop and use alternate forms and worksheets that capture the same information.
The Program Standards apply to the operation and management of a retail food regulatory program that is focused on the reduction of risk factors known to cause or contribute to foodborne illness and to the promotion of active managerial control of these risk factors. The results of a self-assessment against the Standards may be used to evaluate the effectiveness of food safety interventions implemented within a jurisdiction. The Standards also provide a procedure for establishing a database on the occurrence of risk factors that may be used to track the results of regulatory and industry efforts over time.
The Program Standards were pilot tested in each of the five FDA regions in 1999. Each regulatory participant reported the results at the 2000 Conference for Food Protection. Improvements to the Standards were incorporated into the January 2001 version based on input from the pilot participants. Further refinements to the Standards were made in subsequent drafts leading up to the endorsement of the March 2002 version of the Program Standards by the 2002 Conference for Food Protection. The April 2003 version contains enhancements to the forms and worksheets in the Appendices to improve their usefulness. The January 2005 version contains revisions to Standard 1, 5, and 9 based on recommendations approved at the 2004 Conference for Food Protection.
In maintaining these standards, FDA intends to allow for and encourage new and innovative approaches to the reduction of factors that are known to cause foodborne illness. Program managers and other health professionals participating in this voluntary program who have demonstrated means or methods other than those described here may submit those to FDA for consideration and inclusion in the Program Standards. Improvements to future versions of the Standards will be made through a process that includes the Conference for Food Protection to allow for constant program enhancement and promotion of national uniformity.
During pilot testing of the Program Standards in 1998, some jurisdictions reported that the self-assessment process was time consuming and could significantly impact an agency's resources. Collection, analysis, and management of information for the database were of special concern. However, participating jurisdictions also indicated that the resource commitment was worthwhile and that the results of the self-assessment were expected to benefit their retail food protection program. Advance planning is recommended before beginning the data collection process in order to use resources efficiently. It is further recommended that jurisdictions not attempt to make program enhancements during the self-assessment process. A better approach is to use the self-assessment to identify program needs and then establish program priorities and plans to address those needs as resources become available.
To promote uniform and reasonable application of these standards, interested persons are invited to submit comments and inquiries to their FDA Regional Retail Food Specialist or to the Retail Food Protection Team in the FDA Center for Food Safety and Applied Nutrition.
