FDA's Recommended National Retail Food Regulatory Program Standards
03.may.06 - INTRODUCTION
The aspect of national uniformity has long been a point of contention among the industry, regulators and consumers. Adoption of the Food Code has historically been the keystone in achieving that uniformity. However, a missing piece has been an agreed upon national standard or foundation for regulatory programs that administer the Food Code. The attached DRAFT Voluntary National Retail Food Regulatory Program Standards were formulated by FDA from ideas and input from federal, state, and local regulatory officials, industry, trade and professional associations, academia and consumers.
In March of 1996, the FDA met to explore ways in which the retail food program could be improved. Included in that meeting were the FDA Retail Food Specialists, FDA headquarters personnel, and state/local regulatory officials from the six FDA regions, the Association of Food & Drug Official's president, and representatives of industry. As a result of that meeting, FDA established a National Retail Food Specialist Team comprised of all the Regional Retail Food Specialists and set up an agency Retail Food Program Steering Committee representing all agency components involved with retail food. The Steering Committee was tasked with responding to the direction from 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 the FDA's retail food program. As the President's Food Safety Initiative began to form, the committee was recharged with formulating an operational plan in keeping with the Food Safety Initiative's goals and mission. The Operational Plan involved soliciting input from the regulatory community, industry and consumers. The resultant Operational Plan describes the future of the National Retail Food Program and involves reassessing the respective roles of all stakeholders and how best to achieve program uniformity.
The broad goals of the plan involve two basic principles to build a new foundation for the retail program:
1. Active managerial control of the CDC identified risk factors that are known to cause foodborne illness, and
2. Establishment of a recommended retail food program framework within which the active managerial control of the risk factors can be realized.
The broad goals led to the drafting of program standards that would involve voluntary participation by the regulatory agencies. The draft standards were developed after significant input from all the stakeholders at the 1996 meeting, FDA Regional Seminars, subsequent meeting held with the states by the Retail Food Specialists, and six Grassroots Meetings held around the country in 1997. Also included were the written comments provided by industry associations, associations of regulatory officials, and others. The draft document is the result of that two-year process. As promised at the Grassroots Meetings, the draft document is being provided to the Conference for Food Protection for further input, defining, and consensus from all the stakeholders.
One of the challenges in developing and agreeing on program "standards" lies in the recognition that the overarching goal of instituting them is ultimately reducing illnesses and deaths from food produced at the retail level and that there are likely several ways to get to that point. Currently, federal, state, local, and tribal agencies have various mechanisms with varying levels of sophistication trying to achieve that goal.
The challenge in this draft document is not to capture the level of food safety to which we may ultimately aspire, but to begin to construct a standard from which is the foundation for all regulatory programs. Standards that reinforce sanitation (good retail practices), operational and environmental prerequisite programs; standards that provide direction and focus to regulatory agencies and industry on the causative factors of foodborne illness and the contributing factors; and to improve and build upon existing mechanisms and programs.
These standards constitute a framework designed to accommodate both traditional and emerging approaches and a process for continuous improvement via future standards revisions through the Conference for Food Protection process that will allow for constant program enhancement and promote uniformity.
PURPOSE AND INTENT
The purposes of these standards are to serve as a guide to regulatory retail food program managers in the design and management of a retail food program as described below in "SCOPE" and to provide a means of recognition for those programs that meet these standards.
The intent in the development of these standards is to establish a basic foundation in design and management of a retail food program. Program management may add additional requirements to meet individual program needs.
The appendices are intended to assist in the collection of information necessary for an assessment of a retail program. Alternative forms that capture the same information may be used, including those developed by a regulatory agency or jurisdiction.
The standards apply to the operation and management of a regulatory retail food program focused on the reduction of risk factors known to cause foodborne illness as well as other factors that may contribute to foodborne illness and on the promotion of active managerial control of all factors that may cause foodborne illness. The results of a self-assessment based on these Standards may be used to evaluate the effectiveness of food safety interventions imposed by government and implemented by industry. The Standards provide a procedure for establishing a database against which to measure regulatory and industry efforts by measuring trends in the occurrence of risk factors over time.
In developing 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 this program.
In fact, the draft Program Standards were pilot tested in each of the five FDA regions during 1999, and each regulatory participant reported the results at the April 2000 Conference for Food Protection. Comments from the pilot participants were reviewed and incorporated into the document dated January 2001.
IMPACT ON PROGRAM RESOURCES
Jurisdictions that pilot tested the 2/6/98-draft document reported that the initial use of the self-assessment was time consuming and could significantly impact an agency's resources. Collection, analysis and management of information for the database were of special concern. Advance planning is recommended before beginning the process. However, they also commented that the resource commitment was worthwhile, and that the results of the self-assessment were or were expected to be beneficial to the retail food protection program.
To provide a uniform and reasonable application of these standards, interested persons are invited to submit comments and inquiries to the FDA Regional Retail Food Specialists or Retail Food and Interstate Travel Team (RFITT), Center for Food Safety and Applied Nutrition.