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September 23, 2005
The 2005 FDA Food Code is a model food safety guideline for retail food operations and institutions. It assists food protection jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules to be consistent with national food regulatory policy, and to promote uniformity across the country.
The following Questions and Answers were developed to highlight the significant changes made to the 2005 Food Code. For more detailed information on the individual changes, see the Summary of Changes in the FDA Food Code.
FDA now updates the Food Code every four years to provide best practices for the retail and food service industries (restaurants, grocery stores, vending, and institutions such as nursing homes) on how to prevent foodborne illness. The last full edition update was published in 2001. A Supplement to the 2001 Food Code was issued in 2003.
Some of the changes made in the 2005 Food Code are minor and include editorial changes made for consistency and clarity. More significant changes include added and changed definitions of terms, information about major food allergens consistent with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), and amended date marking practices for consistency with recommendations in the Listeria monocytogenes Risk Assessment which are addressed in the Questions and Answers below.
FDA collaborates with the Conference for Food Protection, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA) to update the Food Code with respect to current science, emerging food safety issues, and imminent health hazards related to food safety. In addition to new Federal rules or initiatives, the Food Code may be revised due to suggestions from regulators, industry, consumers, academia, and professional organizations.
Although it is neither Federal law nor regulation, the Food Code is used by state and local regulatory agencies across the country to achieve consistency among these various regulatory jurisdictions (48 of 56 States and territories representing 79% of the U.S. population have adopted some version of the Food Code since the 1993 edition). For information on the number of states and territories that have adopted the Food Code, see Real Progress in Food Code Adoptions.
Some of the changes to definitions in the 2005 Food Code include amending the definition of potentially hazardous food; and adding a definition for major food allergens. Below is a brief description of the changes:
Potentially hazardous food: two pH and aw interaction tables were added to the definition of food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.
See Chapter 1-201.10 for more details.
Major food allergen: means milk, egg, fish (such as bass, flounder, cod), crustacean shellfish (such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or a food ingredient that contains protein derived from one of these foods (consistent with the FALCPA).
See Chapter 2-102.11 for more details about how this definition is applied through the Code.
Yes. Part 2, Employee Health of Chapter 2 of the Food Code is revamped to better address ways to protect public health, based on new science regarding the agents that are most likely to be transmitted from an infected food worker through food. More targeted criteria for reporting, restriction, exclusion, and returning to work are included. Handwashing procedures are amended to update the proper sequence for handwashing procedure and avoiding recontamination of the hands after handwashing and to be more consistent with the recommended handwashing procedure in CDC's Hygienic Practice Guidelines for Health Care Workers.
See Chapter 2-201.11, 2-201.12, 2-201.13, and 2-301.14 for more details.
Yes. The 2005 Food Code not only amends the procedures for reduced oxygen packaging (ROP), but adds Listeria monocytogenes as a pathogen of concern that needs to be controlled in addition to Clostridium botulinum. The 2005 Food Code amends the procedures to require specific temperature controls for cook-chill and sous vide packages. These procedures require that bagged products must be cooled to 34 degrees F within 48 hours and held for no more than 30 days.
Further, if foods are packaged using a cook-chill or sous vide process, other food safety measures must be taken including: a HACCP plan; records retention for 6 months, and no sale of the ROP bagged product to another business or consumer who may not have adequate temperature control.
The 2005 Food Code also allows reduced oxygen packaging for cheeses - hard cheeses, semi-soft cheeses, and pasteurized process cheeses, because of certain intrinsic factors that add protection.
See Chapter 3-501.12 for more details.
Date marking is the practice of indicating the date or day by which a ready-to-eat, potentially hazardous food (TCS food) should be consumed, sold, or discarded - a practice that helps prevent growth of Listeria monocytogenes.
Based on the results of FDA's Listeria risk assessment and the recommendations from the 2004 Conference for Food Protection, FDA reevaluated date marking provisions in the Food Code and focused its recommendations for date marking on high-risk foods rather than foods that present a low risk of Listeria contamination.
The 2005 Food Code now exempts deli salads (e.g., ham, chicken, egg, seafood, pasta, potato, and macaroni) prepared and packaged in a food processing plant. Scientific data support the exemption of these products because deli salads prepared and packaged by a food processing plant contain sufficient acidity and preservatives to prevent the growth of Listeria monocytogenes.
In addition, the 2005 Food Code exempts cultured dairy products and certain types of hard and semi-soft cheeses because as processed, these products contain organic acids, preservatives, competing microorganisms, pH, water activity, or salt concentration that control the growth of Listeria monocytogenes.
See Chapter 3-501.17 for more details.
Annex 2 of the 2005 Food Code, "Food Defense Guidance from Farm to Table," provides a summary of available resources on food defense and links to useful publications from FDA, CDC, and USDA as well as industry groups. One of the resources, USDA's "A Biosecurity Checklist for School Foodservice: Developing a Biosecurity Management Plan," provides information for school food service managers. Food security measures continue to be only recommendations in the Food Code.
See Annex 2: References for more details.
In the 2005 Food Code, Annex 5 (formerly Annex 4) is rewritten and renamed "Conducting Risk-Based Inspections." Annex 5 now focuses on high-risk practices.
See Annex 5 for more details.
It should be noted that Annex 4 is now "Management of Food Safety Practices - Achieving Active Managerial Control of Foodborne Illness Risk Factors."
See Annex 4 for more details.
Two significant highlights include amending the definition of juice and the impact of that amendment for food operations at the retail level; and changes that better address the issue of managing potentially infected food employees and food employee applicants (Conditional Employees).
The definition for juice was amended to say that purees of fruits or vegetables, often prepared in health care facilities, that are not used as beverages or ingredients in beverages are not required to comply with HACCP requirements.
See Chapter 1-201.10 for more details.
Chapter 2 better describes the fact that a Conditional Employee may not become a Food Employee unless the applicant is in compliance with the employee health provisions of the Code. Annex 2 now includes a description and link to a U.S. Equal Employment Opportunity Commission (EEOC) Guide, "How to Comply with the Americans with Disabilities Act: A Guide for Restaurants and Other Food Service Employers." This Guide clarifies many situations in food establishments related to the Americans with Disabilities Act (ADA) that may occur during the hiring process.
See Chapter 2-201.11 and Annex 2 for more details.
