Many food processors ask how long can they leave RTE foods out of cold holding to perform further preparations or packaging?

Here is the answer from FDA.  Note that column 2 says “internal temperature” and not ambient (processing room) temperature.

I made what I think is a correction to the FDA data on Raw > 50F (2nd row).  The original FDA reference lists > 70F.  That seems to be an error to me.  I sent a FDA TAN request to see what FDA thinks.

Here is the standard validation support for a USDA food (and HACCP plan).  Be sure and cite this Tomkin paper and place a copy in your HACCP validation file (required by USDA FSIS).

Download (PDF, 137KB)

Issue 1: Cook-Chill or Sous Vide 3-502.12 (D)(2)

(f) Held in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily, with a verifiable electronic monitoring device to ensure that times and temperatures are monitored Pf

(g) If transported off-site to a satellite location of the same business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation, Pf and

Cook chill (sous vide) stored at 34F (30 days) transferred to 41F (7 days). Note this option was inadvertently left out of the 2013-2017 food codes. A 2018 Issue was submitted, approved, and the FDA will make these changes to the 2017 (update) Food Code.

Generally, if a commissary is stand-alone and functions as a manufacturer and supplier of foods to its satellites, then it must comply with FSMA PC (assuming gross sales > 1 million/yr). If a commissary is part of a restaurant or grocery store and makes less than 50% of the foods sold, then it may be exempt from FSMA PC. See FDA flow chart guide below or get a copy directly from the FDA.

Note concerning USDA oversight of Restaurant commissaries creating meat products.  This is 9 CFR 303.1.  Note the requirement that the commissary staff must deliver the foods to satellites.  A third party shipper cannot be used.  If third party delivery is used the operation must be under USDA inspection.

§ 303.1 Exemptions.  (iv)(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.

  1. Special processes 3-502.11
    1. No mention of drying
    2. No mention of fermentation
    3. Question on canning foods in hermetically sealed containers (acid and low acid?)
  2. Fish ROP 48h rule.  Move to 3-502.11 that requires a variance (no HACCP?) so that RA can make sure safe process, or ?
  3. Did the option to remove ROP 30 d 34F to 7 day 41F get into code?
  4. ROP requirement for a manual 2X daily check of a frig with datalogger.

The FDA food code is a strong proponent for “Active Managerial Control (AMC)”.  AMC is essentially that the person-charge actively manages food safety controls in his or her operation.

AMC consists of three parts:

  1. Policies: Lay out a clear instructions for your employees to follow.
  2. Training: Ensure that your employees are trained to your policies so that they know them and can follow them.
  3. Monitoring and Verification:  A way to ensure on a regular basis that the policies are being followed (including recording important food safety measurements (e.g. temperatures).

Chances are if you observe a restaurant, grocery store, manufacturer or foodservice operator using AMC, you’ll see staff using paper checklists or logs to monitor the food safety of their operations.

One solution to this is a digital or electronic food safety management (eFS) system or eAMC (electronic Active Managerial Control). The goal of an electronic (or computerized) food safety system is to get food safety data into an electronic form.  At the very minimal end, the data is captured as static data or simply a PDF or photo of a paper form.  At the opposite end, the data is captured into a database that permits data analysis and reporting.

For example, temperature sensors can be placed in all of an operator’s cold holding equipment.  The sensors report the cold holding temperature 24/7/365 in real time.  The eAMC system is programed only to notify management IF and WHEN a temperature deviation occurs.  If the system is working effectively, there is no time and effort expended by management until a deviation occurs.

The eAMC system is often a computer based software program that can be programmed to perform many different tasks.  Policies can be stored for retrieval in a few “clicks”.  Corrective actions can be attached for access only when needed.

Another AMC requirement is training of staff.  With constant turn-over, and other staff issues, this can become a paperwork nightmare.  An eAMS system can provide on-demand training videos and assessments.  Training videos can be linked to processes, ingredients, and equipment.   Imagine that each standard operating procedure (SOP) had both a written text form and a video demonstration.