It all started with an exploratory meeting held by the FDA in 1996. Regulatory officials from around the country and FDA specialists put their heads together to improve the food protection regulatory process on a national scale.

In one respect, what came out of it was a series of suggestions for— roughly speaking—“inspecting” the inspectors. More precisely, a set of new recommended standards tells regulatory agencies what they can do to create the best possible foodservice sanitation inspection systems to support public health.

An FDA-sponsored Retail Food Program Steering Committee developed a five-year plan, emphasizing two basic principles as a foundation for retail (and foodservice) food safety. They suggested that we need to focus on the risk factors most commonly associated with foodborne illness, and establish a recommended framework for retail food regulatory programs that helps to address these risks.

Even though the FDA provides the Food Code as a model for regulations at state and local levels, the FDA says that we lack standards for how to build effective food regulatory programs based on the Code. The answer is FDA’s Draft Voluntary National Retail Food Regulatory Program Standards, designed to:

Encourage regulatory agencies to improve and build upon existing programs
Accommodate both traditional and emerging approaches to food safety
Reinforce proper sanitation practices (standard operating procedures)
Address factors that cause and contribute to foodborne illness.

Managing Risks

Built into the recommendations are some core ideas, such as risk intervention, and placing resources where they can have the greatest impact. For a dietary manager, the FDA-recommended approach is called active managerial control—which means managing the hazards that can cause foodborne illness (e.g., through a HACCP program). Active managerial control requires supervision and managerial follow-through by the person in charge. It flows from a risk management strategy that says: Target the factors most likely to cause problems—and focus controls on them to prevent foodborne illness.

Standards—An Overview

The standards as drafted contain nine sections. Here are some highlights:

1. Regulatory foundation: Regulations should closely correlate with Food Code topics, and provide a means of controlling risk factors for foodborne illness. A detailed checklist tells local regulatory agencies how to inventory their own regulations against the Food Code.

2. Trained regulatory staff: Inspectors need to have the knowledge, skills, and ability to perform their required duties. Recommendations cover training and ongoing education.

3. Inspection program based on HACCP principles: These standards recommend inspection programs built around risk factors. They suggest ways to determine and document compliance, and address immediate and long-term correction for out-of-control risk factors.

4. Uniform inspection program: The FDA suggests that health departments use a quality assurance program to ensure uniformity among regulatory staff in the interpretation and application of regulations and procedures.

5. Foodborne illness and food security: There should be a system to detect, collect, investigate, and respond to complaints and emergencies that involve foodborne illness, injury, and intentional or unintentional food contamination.

6. Compliance and enforcement: Compliance and enforcement activities, with standard follow-up protocols for violations, are essential for success.

7. Industry and community relations: A jurisdiction should foster communication and information exchange among regulators, industry, and consumer representatives. This includes outreach activities that provide educational information on food safety.

8. Foodborne illness and food security: There should be a system to detect, collect, investigate, and respond to complaints and emergencies that involve foodborne illness, injury, and intentional food contamination.

9. Compliance and enforcement: Compliance and enforcement activities, with standard follow-up protocols for violations, are essential for success.

The draft standards provide forms and checklists for regulatory agencies. For example, one addressing food security suggests trace-back procedures as follows: “Program management has an established procedure to address the recall of foods implicated in an illness, outbreak, or intentional food contamination. The trace-back procedure provides for the coordinated involvement of all appropriate agencies and identifies a coordinator to guide the investigation. Trace-back reports are shared with all agencies involved and with the CDC.”

Background for uniform inspections provides agencies with a statistical method to ensure that inspectors are applying standards consistently. (For the dietary manager, this consistency should translate into a reliable, predictable health inspection experience.)

Beyond day-to-day management, tackling risks with a long-term perspective is characteristic of HACCP. Long-term control, according to the FDA draft, may include items like risk control plans, standard operating procedures, buyer specifications, menu modification, and equipment or facility modification.

The FDA draft program standards, just like the Food Code, are voluntary guidelines only. Just as health departments around the country gradually adapt and adopt the Food Code over time, the same departments may, in time, re-structure how they go about regulating food safety.

By Sue Grossbauer