FDA Issues Supplement to the 2022 Food Code - What Has Changed?

The FDA issued a supplement to the 2022 Food Code.  The changes of note by the FDA are listed here:

• Addressing food protection with new provisions that improve awareness of food defense measures;
• Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; 
• Expanding and clarifying how and when containers can be refilled and reused in a food establishment;
• Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces; 
• Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;
• Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

A detailed listing of the changes are found on the FDA website

https://www.fda.gov/media/183271/download?attachment

I provided some detail on each of these changes.
First, some definitions were added.

Definitions Added or modified include:

“Active Managerial Control” means the purposeful incorporation of specific actions or procedures by industry management into the operation of their business to attain control over foodborne illness RISK factors. It embodies a preventive rather than reactive approach to FOOD safety through a continuous system of monitoring and verification.

“Disinfection” means the application of a substance, or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi, and viruses, but not necessarily bacterial spores

“Food Defense” is the effort to protect FOOD from acts of intentional ADULTERATION or tampering

Food Safety Management System

(1) “FOOD SAFETY MANAGEMENT SYSTEM” means a specific set of actions taken by the EMPLOYEE to prevent the occurrence of foodborne illness RISK factors based on the type of operation, type of FOOD preparation, and FOODS prepared within the FOOD ESTABLISHMENT.

(2) “FOOD SAFETY MANAGEMENT SYSTEM” includes written procedures, training plans, and monitoring records to control specific operational steps in a FOOD ESTABLISHMENT that contribute to foodborne illness.

Reduced oxygen packaging” includes:

(d) Cook chill PACKAGING, in which cooked FOOD is hot filled into impermeable PACKAGING (such as a bag or film on trays) that is then sealed or crimped closed. The PACKAGED FOOD is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychotropic pathogens;

Addressing food protection with new provisions that improve awareness of food defense measures;

2-103.11

Persons in Charge adding in component for Food Defense - first there is a focus to have the person in charge maintain active managerial control (see changes in 8.201 below) in their operation and then Food Defense was added to ensure that employees are trained on this topic.

Additional information on Food Defense is providing in Annex 2  4. FOOD DEFENSE GUIDANCE FROM FARM TO TABLE and Annex 3 1-201.10 and 2-103.11 Person in Charge.

Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; 

2-201.13

Changes to exclusions and restriction of employees diagnosed with illness - specifically Shigella, STEC, nontyphoidal Salmonella with more specific conditions on which the person may be reinstated into the operation.

Expanding and clarifying how and when containers can be refilled and reused in a food establishment;

3-304.17

Reusable food containers - Expanding and clarifying how and when containers can be refilled and reused in a food establishment.

Explained in detail in Annex 3.  3-304.17

Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces;

Disinfectants-  Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces;  This is added to take care of situations like a potential norovirus contamination event. 

Disinfectants added into these sections.

4-302.14 Sanitizing and Disinfecting Solutions, Testing Devices. 

4-501.116 Warewashing Equipment, Determining Chemical Sanitizer or Disinfectant Concentration. 

4-1001.11 Food-Contact, nonFood-Contact Surfaces and Utensils EQUIPMENT, FOOD-CONTACT SURFACES, nonFOOD-CONTACT SURFACES, and UTENSILS shall be DISINFECTED when pathogens of concern are not controlled by available SANITIZERS.

4-1002 Frequency

4-1002.11 Disinfectant Use

When pathogens of concern are not controlled by available SANITIZERS, EQUIPMENT, FOOD-CONTACT SURFACES, nonFOOD-CONTACT SURFACES, and UTENSILS shall be DISINFECTED: 

(A) When contaminated with vomitus, fecal matter, blood, or any other bodily fluid that can lead to disease transmission; or 

(B) During a FOODBORNE DISEASE OUTBREAK or IMMINENT HEALTH HAZARD.

4-1003 Methods

4-1003.11 Chemical

(A) FOOD-CONTACT SURFACES and nonFOOD-CONTACT SURFACES shall be DISINFECTED in accordance with the EPA-registered label use directions.

(B) DISINFECTANTS applied to a FOOD-CONTACT SURFACE shall be rinsed with potable water, unless otherwise specified on the EPA-registered label use directions.

7-102.11 to add the term DISINFECTANTS

Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;

8.201

Food Safety Management System - replaces the term standard operating procedure

8-201.12 Contents of the Plans and Specifications. 

The plans and specifications for a FOOD ESTABLISHMENT, including a FOOD  ESTABLISHMENT specified under § 8-201.13, shall include, as required by the  REGULATORY AUTHORITY based on the type of operation, type of FOOD preparation, and FOODS prepared, the following information to demonstrate conformance with Code provisions: 

(E) Evidence that a FOOD SAFETY MANAGEMENT SYSTEM that ensures compliance with the 

requirements of this Code are developed or are being developed; and

8-201.15 When a Food Safety Management System is Required. 

(A) Within 4 years of the REGULATORY AUTHORITY’S adoption of this Code, a written FOOD 

SAFETY MANAGEMENT SYSTEM shall be:

(1) Developed and maintained to ensure compliance with requirements of this Code as specified in 2-103.11.

(2) Implemented in the FOOD ESTABLISHMENT during all hours of operation, and 

(3) Made available to the REGULATORY AUTHORITY upon request.

(B) This section does not apply to certain types of FOOD ESTABLISHMENTS deemed by the 

REGULATORY AUTHORITY to pose minimal RISK of causing, or contributing to, foodborne 

illness based on the nature of the operation and extent of the FOOD preparation.

Additional information on Food Safety Management Systems in Annex 2 - Amend 3 and Annex 3 1-201.10

Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

 Annex 6 - 4 Acidification Sushi Rice

Cooked rice is a Time/temperature control for safety food (TCS) with known hazards  associated with it. For a TCS product to be stored without temperature control, there must be processes in place to assure that the rapid and progressive growth or toxin production of infectious or toxigenic microorganisms cannot occur. This is commonly done by modifying the pH of the cooked rice to a pH of <4.2 or below. Proper acidification and distribution of acid is essential to prevent bacterial growth, especially Bacillus cereus. 

Acidification of TCS foods with the intent of making them non-TCS is considered a special process in the Food Code. In the case of sushi rice, this process takes a TCS food (cooked rice) and adds acid (typically vinegar) to drop the pH and allow the cooked rice to be held without time or temperature controls. This acid addition needs to adjust the equilibrium pH to less than 4.2 to control the identified hazards. Addition of vinegar for flavor only, when pH is not monitored, is not considered a special process and rice must be temperature controlled just like any other TCS food.

https://www.fda.gov/food/hfp-constituent-updates/fda-releases-supplement-2022-food-code
Constituent Update
FDA Releases Supplement to the 2022 Food Code
November 4, 2024

The U.S. Food and Drug Administration (FDA) today has published the Supplement to the 2022 Food Code. The Supplement updates the 2022 Food Code with recommendations made by regulatory officials, industry, academia, and consumers at the 2023 Biennial Meeting of the Conference for Food Protection.

The Food Code and its Supplement provide government and industry with practical, science-based controls for reducing the risk of foodborne illness in retail and foodservice establishments of all types. The Food Code and the Supplement are joint projects by the FDA, the Centers for Disease Control and Prevention, and the United States Department of Agriculture (USDA) – Food Safety and Inspection Service (FSIS).

Some highlights in the Supplement to the 2022 Food Code include:

• Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces;
• Expanding and clarifying how and when containers can be refilled and reused in a food establishment;
• Addressing food protection with new provisions that improve awareness of food defense measures;
• Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;
• Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; and
• Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

The Food Code is the model for retail food regulations in all 50 states, the District of Columbia and other territories. The FDA encourages its state, local, tribal, and territorial partners to adopt the current version of the FDA Food Code, including the Supplement to the 2022 Food Code. The agency’s Office of Retail Food Protection is available to assist regulatory officials, educators, and industry in their efforts to understand, adopt, and implement the FDA Food Code. Inquiries may be sent to: retailfoodprotectionteam@fda.hhs.gov or directly to a Retail Food Specialist.

The next complete revision of the Food Code will be published in 2026.

For additional information, visit Retail Food Protection.