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.

The internet of things can extend to the food safety world.  First, the internet of things (IoT) is network of computer devises that connect together to transfer data.  The data transfer can occur without human intervention.  How can that help retail-foodservice food safety?  Let’s recap the five major risk factors for foodborne illness as described by FDA in the Food Code.

  • Improper hot/cold holding temperatures of potentially hazardous food
  • Improper cooking temperatures of food
  • Dirty and/or contaminated utensils and equipment
  • Poor employee health and hygiene
  • Food from unsafe sources
There are two types of IoT devises.  The first is the temperature datalogger.  This devise will monitor temperature 24/7.  The most effective types automatically sync their data to a computer.  These devises are most effective for cold holding and can be used for hot holding as well.  The second temperature devise is the bluetooth thermometer.  This IoT devise is most suited to taking the temperature of a food and transmitting the data to a software program.
Clean and sanitary equipment is a little harder to monitor using IoT. One example would be monitoring the temperature of a hot water automatic dish machine.  Sensors could also be used to notify management when detergent or rinse-aid chemicals are depleted.
Handwashing has long been a target for IoT.  There are many different technologies, but most are only partly effective.  One example is using a vibration sensor on a water pipe of a hand sink.  This sensor can record vibration events and if they are assumed to equate to handwash events, they can be counted and related to time of day. Another example is to monitor soap dispenser use.  Each use is equated to one handwash.
Currently there is a new effort at using enhanced UPC label codes called GS1.  This system would allow an operator to scan their food items (shipments, pallets, boxes, item) labels. Working with a software database, the operator can determine if that food was purchased from an approved supplier. In a similar manner, recalls can be flagged for removal.

Gingerbug: A mixture of sugar, shaved ginger, and water is allowed to naturally ferment via wild yeasts and usually lactic acid bacteria.

Shrubs: not the green vegetation things, but actually vinegar based beverage.  It is a high-acid beverage and quite safe.

Trotters: Pigs Feet

Shiokara: Japanese traditional fermented fish viscera – requires ≥ 10% salt for safety.  The result is VERY pungent.

Casu Marzu: maggot infested cheese from Italy.

Molecular gastronomy combines artistic culinary experiences and passion with the scientific and technical foundations of food science.  Freeze-drying various foods is one of the methods currently being explored by these cutting edge chefs.  Another is the rotary evaporation (concentration) of food essences.

The rotovap can be used for two purposes: 1) concentrate non-volatile components in a mixture (e.g, concentrating flavors from a blood orange by removing the water), and 2) to extract the volatile aroma and flavor molecules from mixtures gently (e.g., extracting the desired flavors from a blend of alcohol, herbs, and fruit without heating the mixture up).  The key to understanding any distillation is to remember that it is a separation. Sugars, acids, colors, and most bitter compounds are separated from aromas, alcohols, water, and small flavor molecules, etc.

Is this a “Special Process”?  Are there food safety concerns?


Is this a “Special Process”? This question would hinge on the evaporation process itself.  Are PHFs subjected to conditions that could permit growth of pathogens?  If yes.  Then, yes, its a special process.  What food safety concerns are there?  Basically it is a temperature danger zone question.  If 42-134F for more than 2 hours, an operator would need to demonstrate why their specific process is safe.  Any legal concerns?  Yes.  It is not permitted in the USA to distill alcohol.  The government fears it will not gets its taxes.  It is permitted to have a small rotovap.  Some Chefs feel that if they use alcohol that has been purchased (tax paid), then they are meeting the spirit of the law.

Is this a “special process” under the Food Code?  Yes.  A PHF (TCS) food is being freeze dried to be non-PHF (non-TCS).

The technology and equipment for freeze drying has improved to the point that small operators and even some home preservers can join in.  Pictured is a line of freeze dryers from Harvest-Right (look them up on your own).  From a food safety standpoint, this “special process” is low risk.  Foods MUST be frozen first.  Then the water is removed by sublimation (solid direct to a gas) inside the machine.  The machine also maintains the freezing temperature, so time to dry is not important.  The loss of flexibility or pliability indicates food dryness.  A dry, crunchy, food item is likely to have a water activity close to 0.3, well below the 0.85 pathogen cut off level.

Molecular gastronomy combines artistic culinary experiences and passion with the scientific and technical foundations of food science.  Freeze-drying various foods is one of the methods currently being explored by these cutting edge chefs.

Day 1 Large size notes (pdf)

Day 2 large size notes (pdf)

Last March 2018 ROP Notes (pdf)

Special Process Meats

Bringing the farm to the fork (microgreens, etc)

Molecular Gastronomy

The digital revolution !!

Online courses available NOW

What the heck are

  • shrubs? gingerbug(s)? trotters? shiokara?

Retail-foodservice processes of concern

  • Cold Brew Coffee and Tea
  • Insects as food – crickets
  • Inclusions – PHF layered or inside a non-PHF
  • Appalachian salt-rising bread (aka perfringens bread)
  • Farmer’s markets (where everyone becomes a retailer)

Special Processes (non-meat)

Special Process Auditing

  • Record (desk) inspection
  • Live (in-person) inspection

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The concepts of verification and validation leave most beginner food safety professionals confused.  On top of that there are two different aspects to verification and validation.  The first is related to specific food safety procedures (CCPs, GMPs, SOPs, etc) and the second is a global view.  Is the entire food safety system working?


•    Monitoring: Are the operations being done as intended? (present)
•    Verification: Was the work done according to the food safety plan? (past)
•    Validation: Are the plan criteria (e.g. critical limits) based on science?


•    Monitoring: Is the entire operation being observed and assessed? (present)
•    Verification: Is all of the work done according to the food safety plan? (past)
•    Validation: Is the plan as a whole effective? (past and future)

FSMA Preventive Controls requires that Process Control CCP critical limits be validated by referencing the science or safe harbor (federal performance standard).  No other Preventive Control programs REQUIRE validation.  This includes allergens.  The FDA has not set threshold levels of allergen residuals.  On the global level, FSMA PC requires an effectiveness check (a) at the documentation stage, (b) just after the roll-out stage, and then (c) every three years.

Opposite to FSMA PC, most GFSI schema based on ISO 22000 and PAS 220 standards require formal validation of CCPs and operational prerequisite programs (oPRPs). In addition, cleaning and sanitizing programs must also be validated. Organizations must properly design, document, implement and maintain prerequisite programs, even if the standard does not specify a validation requirement for this part of the food safety system.

Process Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether control measures are capable of achieving their specified purpose (outcome or target) in terms of hazard control. Global Validation involves measuring an entire system’s performance against a desired food safety outcome.