FDA/CFSAN Managing Food Safety: A HACCP Principles Guide for Operators of Food Establishments at the Retail Level

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Managing Food Safety:
A HACCP Principles Guide for
Operators of Food
Establishments at the
Retail Level
DRAFT: APRIL 15, 1998

Drafted by FDA with input from federal, state, and local regulators, industry, academia, and consumers via Regional Food Protection Seminars and Food Safety Initiative Regional Grassroots Meetings.
April 15, 1998

NOTICE

Chapter 1 Introduction

Purpose and Scope
Background
- Risks Associated with Foods
- Figure 1: Risk Factors
- Defining Retail
- Using HACCP Principles at Retail to
  - Manage and Enhance Food Safety
Overview of the Process Approach
Summary

Chapter 2 The Process Approach

The Flow of Food
Process 1 - No Cook Step
Process 2 - Same Day Service
Process 3 - Complex Food Preparation

Chapter 3 Developing Your Food Safety System

Getting Started - Using a Team
How to Use This Guide
Procedural Step 1: Group Menu Items
- Chart 1: Process-Specific Lists
Procedural Step 2: Conduct Hazard Analysis
- Food Safety Management Worksheets and
  - Summaries for Operational Steps
    - Operational Step 1: Receiving
    - Operational Step 2: Storage
    - Operational Step 3: Preparation
    - Operational Step 4: Cooking
      - Chart 2: Food Code Temperatures/Times
    - Operational Step 5: Cooling
    - Operational Step 6: Reheating
    - Operational Step 7: Holding
    - Operational Step 8: Set Up and Packing
    - Operational Step 9: Serving
Procedural Step 3: Identify Critical Control Points and
- Critical Limits
Procedural Step 4: Monitor Critical Control Points
Procedural Step 5: Develop Corrective Actions
Procedural Step 6: Conduct On-Going Verification
- Description
- Procedures
- Frequency
- Observations, Documentation - Examples
Procedural Step 7: Keep Records
Procedural Step 8: Conduct Long-Term Verification

Chapter 4 Prerequisite Programs

Food Code Interventions
HACCP Prerequisites
- SOPs
  - Control Contamination of Food
  - Control Microbiological Growth
  - Maintain Equipment

Chapter 5 Glossary

Chapter 6 Resources and References

Fact Sheet - USDA/FDA Foodborne Illness
- Education Information Center

Annex 1 Seafood Reference

Annex 2 Special Considerations Reference

NOTICE:
This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. The Guide will continue to evolve and improve.
It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific hazards will be expanded to further assist operators in developing their HACCP systems.
The Agency fully recognizes the diversity of "retail food establishments" and their varying in-house resources to implement HACCP. That recognition is combined with an understanding that the success of such implementation is dependent upon identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection.

FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to:

Dr. John E. Kvenberg
HACCP Policy Strategic Manager (HFS-10)
Office of Policy, Planning and Strategic Initiatives
Food and Drug Administration
200 C Street, S. W.
Washington, DC 20204

Hypertext updated by dms 1998-APR-23

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