A commissary or “Central Kitchen” is a hybrid food manufacturing operation.  On one hand, because it serves to supply food to its own “satellites” (retail or foodservice stores), it is considered a retail operation.  On the other hand, the new Food Safety Modernization Act – Preventive Controls For Human Foods (FSMA PC) does not consider commissaries as “retail exempt”.  Therefore commissaries are regulated by the FDA as any other food manufacturer.

Are hospital, school or prison commissaries required to register with the FDA under FSMA and be compliant (with Preventive Controls)?

21 CFR Sec. 1.226 Who does not have to register under this subpart?  This subpart does not apply to the following facilities:

(a) A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States. A facility is not exempt under this provision if the further manufacturing/processing (including packaging) conducted by the subsequent facility consists of adding labeling or any similar activity of a de minimis nature;

(b) Farms;

(c) Retail food establishments;

(d) Restaurants;

(e) Non-profit food establishments in which food is prepared for, or served directly to, the consumer;

FDA flow chart for determination of FSMA Compliance.

What if one store makes food for others?  Is it a commissary?  No.  If a store makes food for other stores it is subject to the 50% rule.  If more than 50% of the food is to go to other stores it is a commissary.  If less than 50% it is a retail operation.

To further complicate matters, the USDA may claim oversight for commissary meat production.  There is no clear guidance here from USDA.  The CFR’s do state that any interstate third party shipped meats MUST come from a USDA inspected facility. However, if a commissary truck staffed with a commissary employee delivers the meat, it may not need USDA inspection. If meats are produced for sale to outside retailers, then that product is subject to USDA inspection.

See: 9 CFR 303

c) For purposes of this paragraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares meat or meat food products that are ready to eat when they leave such facility (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to a receiving restaurant by its own employees, without intervening transfer or storage, maintained in a safe, unadulterated condition during transportation, and served in meals or as entrees only to customers at restaurants, or through vending machines, owned or operated by the same person that owns or operates such facility, and which otherwise meets the requirements of this paragraph: Provided, That the requirements of §§320.1 through 320.4 of this subchapter apply to such facility. Provided further, That the exempted facility may be subject to inspection requirements under the Act for as long as the Administrator deems necessary, if the Administrator determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are rendered adulterated. When the Administrator has made such determination and subjected a restaurant central kitchen facility to such inspection requirements, the operator of such facility shall be afforded an opportunity to dispute the Administrator’s determination in a hearing pursuant to rules of practice which will be adopted for this proceeding.

Seafood production in the commissary IS specifically exempted from Seafood HACCP 21 CFR 123.  Although, food safety of commissary seafood must still be controlled under FSMA PC.

Food Safety
In the food safety world, commissaries are often supervised by former foodservice or retail production staff.  These staff members are familiar with the US FDA model Food Code and NOT with FSMA PC. It is very important to bring in education and training for these staff members regarding food safety and sanitation principles on a large scale.  Outside of food safety; staff, supervisors, and administration must understand the economies of scale that manufacturers use.  Reconsider purchasing ingredients in small sizes, eg. No. 10 cans.  It might take 40-50 cans for a batch of food.

In the food safety world, we talk about controlling all of the hazards “under our control”.  That usually means from ingredient receiving to food product sale.  However, the commissary is often its own distributor or transportation company.  In this case the process under control is from ingredient receiving to food product to delivery.  Therefore, all aspects of delivery have to be controlled usually including safe temperatures and prevention of cross contamination.