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Legal and Regulatory Compliance

May 22nd, 2018

Recently, I received an email asking for guidance on how to approach the effectiveness of the cleaning procedures in a bakery were conveyor belts made of a cloth-type material are still used. I would like to share the approach I provided in my answer...

Any company in the US, and probably in any country of the world, MUST be in full compliance with all applicable legal and regulatory requirements before thinking in getting involved in following any voluntary scheme like those benchmarked by GFSI. It is just NOT acceptable to be in full compliance with any of these schemes and not being in compliance with the laws and regulations applicable to the activities performed by the company when manufacturing food products.

Since June 30th, 1906, the definition of “adulteration” can be found in Subchapter I of the Federal Food and Drug Act (FFDCA). It “made it unlawful to manufacture adulterated or misbranded foods or drugs in Territories or District of Columbia and provided penalty for violation.”
The last amendment of the definition of adulteration in the Federal Food, Drug and Cosmetic Act of 1938 was made on October 1st, 2005. The definition of adulteration in the Law grew to include other conditions that will render the food products adulterated. As defined in Section 348 of the FFDCA, “A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 342(a) (adulteration) of this title, unless...(3) in the case of a food additive as defined in this chapter that is a food contact substance, there is: (A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used".

Cloth-type food contact surface does not comply with the above requirement, period!. Moreover, 21 CFR 117.40 - Equipment and Utensils, in Subpart B - Good Manufacturing Practices, states: "All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination".

So, whomever designed and sold a cloth-type conveyor equipment was not knowledgeable of the laws and regulations, as well as those companies that purchase that type of equipment. Only those that purchased and used this type of equipment are in violation of the Law.

It doesn't matter if third or second party auditors have seen that type of equipment working for centuries and accepting them. This type of equipment, since 1906, will produce food products that are, by definition of the Law, adulterated.

It is time for everyone in the food industry to start reading, in detail, or looking for help outside the company to understand legal and regulatory requirements as this is what will be used in the very near future by the FDA when performing their investigations. They will NOT look to see if you are in compliance with the requirements of the GFSI scheme the company decided to follow voluntarily! You might have a perfect score in your GFSI based audit and receive a Form 483 and/or a warning letter from the FDA for lack of compliance with all legal and regulatory requirements.

System's Consistency & Continuous Improvement


Consistency and continuous improvement of a system


Whenever a decision is made to implement a system, the expected outcome is to achieve consistency on whatever will be done, the purpose. The system must be able to attain its purpose consistently.

I learned many years ago that, when developing systems, what is critically important is to make sure we comply with the requirements identified, which could be mandatory (legal requirements) or voluntary (like following an ISO Standard). This is what I believe is the most difficult aspect during the development of the system. This is understanding what we are trying to control and how we are going to do it, all in compliance with the requirements.

Understanding what we are trying to control is the first step. No matter what sector of the industry a system will be developed and implemented for, the “hazards” or “not desirable conditions” to the finished product or service must be adequately identified and understood, as well as knowing their sources. This should allow us to develop procedures that will effectively control them.

Now, some of the requirements may not be related with hazards or conditions we are trying to control but with the systems’ management components. As an example, making senior management aware of the overall effectiveness of the system is a common requirement in any system, with the intention to make them aware of the overall operations and potential needs for resources to maintain consistency and/or to improve the system.

In theory, when a system is developed, the intention is to design it to be effective all the time. That’s why it’ll be necessary to make sure that all elements, individually, and the system as a whole will achieve the purpose of the system.

It’s a fact that systems do not operate as intended all the time and deviations will occur. Whenever a system deviates from the requirements being followed it is not effective anymore. Therefore, all systems must include, as one of the its management components, procedures on how to deal with deviations, commonly known as corrective and preventive actions.

These corrective and preventive actions’ procedures have a very particular and unique purpose, to bring the system back into compliance with the requirements, which is the definition of a corrective action and, to do something to prevent the cause of the deviation from happening again, which is the definition of a preventive action. Corrective and preventive actions’ procedures are critically important to be well understood within the purpose of a system as they are the only resource a system has to recover from a deviation, including dealing with the affected product or service and, to prevent the reoccurrence of whatever caused the system to deviate from its purpose.

Corrective and preventive actions’ procedures are not related with the hazards or conditions controlled by the system. They are related with the assurance that the system is achieving the intention of the requirements and its overall purpose. Proper implementation of these procedures will provide the system with continuous improvement.

Feel free to contact us should you want to develop or improve your food safety system at This email address is being protected from spambots. You need JavaScript enabled to view it. .


Preventive Controls & HACCP Integration

 November 2015


Preventive Controls and HACCP Integration

Almost everyone in the food & beverage industry is concerned with the implementation of the new FDA’s “Food Safety Plan” and with the development and implementation of the “Preventive Controls”. From my point of view, the greatest worry is: how to integrate current food safety programs, where HACCP is the main component for the analysis of the risks of food safety hazards, with the FDA’s “Food Safety Plan”?

In my opinion, the core of the integration process greatly relies on the analysis of the risks; the difference between a hazard that requires a critical control point and a hazard that requires a preventive control is their risk.

When reading 21 CFR 117 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, Section 117.3 – Definitions, the definition of a “hazard requiring a preventive control” is: “a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system”.

As the FDA also developed the guidance document for the implementation of the HACCP method for seafood products under 21 CFR 123 – Fish and Fishery Products, I’m going to use this as reference for definitions for HACCP and to compare with the preventive controls rule. A “significant hazard” is a hazard that is “reasonably likely to occur”. The definition of a food safety hazard is: a hazard that is reasonably likely to occur and “one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.”

Similarities. Preventive controls and Seafood HACCP regulations require: 1) To have a person that is knowledgeable about food safety hazards, the products processed and developing control measures. 2) To implement measures to control those hazards with risks based on severity and probability (risk). 3) Those measures will be implemented because, “in the absence of those controls”, the hazards identified will cause illness or injury. 4) Even though it’s not part of the definitions, hazards from incoming goods (raw material, ingredients, processing aids, packaging material, etc.) and hazards from the process must be analyzed in both cases.

Difference. In the preventive control rule, a control measure must be implemented whenever “a known or reasonably foreseeable hazard” is identified. In the Seafood HACCP regulation, a control measure must be implemented whenever there is a hazard that is “reasonably likely to occur”. However, there is no indication on how to measure the risk of “a known or reasonably foreseeable hazard” or the risk of a hazard that is “reasonably likely to occur”.

With this in mind, the tool that will be used to measure the level of risk is what will represent the biggest challenge to all individuals responsible for the analysis of the risks of the food safety hazards in any product/process. This tool should provide a simple but thorough description of the different levels of severity and likelihood of the hazards. I believe there is also a good opportunity to add to this risk analysis tool another variable: detection. Whenever food safety hazards are analyzed, the risk of those should be adequately assessed by determining the severity, likelihood and detection of the hazards.

What is the severity of a food safety hazard? Is the consequence that will produce. It is normally referenced as death, illness or injury. What is the likelihood of a food safety hazard? It’s the chance that the hazard identified may happen during operations. What is the detection of a food safety hazard? Is the ability to detect the hazard.

In the World Health Organization / Food and Agriculture Organization of the United Nations document titled “Risk Characterization of Microbiological Hazards in Food”, there are several methods to determine the level of risk and each method has its own pros and cons, mostly associated with the level and deepness of the knowledge and skills of the individual(s) performing the analysis of the risks to food safety.

Whatever is the method used to determine the level of risk of all hazards in a food safety system, the “qualified individual” must have very good skills on how to apply sound scientific knowledge to be able to comply with the preventive controls rule while maintaining the HACCP program in place.

FSPCA Certificate - Printing or downloading instructions


Procedure to download or print your FSPCA Certificate

Note: The pictures may take some time to load depending on the speed of your connection to the internet. Please, allow some time for them to load.

Step 1 - You’ll be receiving an email from the “International Food Protection Training Institute” ( This email address is being protected from spambots. You need JavaScript enabled to view it. ). Be vigilant as the email may fall in your junk email folder. The email looks like the picture below.


This email has a link ( to the webpage that you'll be accesing to print your certificate. Also, the email contains the username and password that you will be using to sign-in after the webpage opens.

When you click the link in your email, the following webpage will open:


Step 2 - Populate the first field of the “Login” box with the username provided in the email. Populate the second field with the password provided in the email. Be careful as the password is case sensitive.

Properly populating the fields will take you to the following page:


Step 3 - This page has two sections that can be clicked to “Print Transcript”. By clicking any of the two, another page will open with the certificate in PDF. Download it to your computer and/or print it.

If for any reason this does not work, contact your trainer or the training center.


Best regards,

Jose Sabal








The value of a person


My brother recently sent me a link to see a short video. The video was taken during Victor Küppers’ presentation organized by TEDx Andorra La Vella and the topic was "The Value of a Person". I was delighted with the content and I would like to summarize his presentation and use it as an introduction to the attitude towards food safety.

Victor explains that the value of a person can be expressed by a simple formula: V = (K + S) x A, where V is the value of a person, K is the knowledge, S are the skills and, A is the attitude. For anyone with train-the-trainer background, this sounds very familiar.

The objective of the presentation was to highlight the importance of the attitude of a person. Victor explained that the attitude is multiplying the sum of K and S! You make a difference in your environment because of your attitude. You influence people with your attitude. Knowledge and skills are not only necessary but crucial factors. However, we select our friends by their attitudes…we don’t ask our friends for their Curriculum Vitae’s to determine if they will become our friends or not.

So, how does the attitude of a person correlate with food safety? The life of the consumers of food products is in the hands of the companies manufacturing them.

We all need knowledgeable and skillful individuals to work processing or manufacturing the products we consume. The training of these individuals must be effective and there must be a way to measure how knowledgeable and skillful they are.

For the knowledge, a test or a meeting to discuss the content of the training is satisfactory as long as the trainer, who must be knowledgeable on the topic, evaluates the results. Now, tests do not assess the effectiveness of the skills of people, only the knowledge. A solid training program must include an evaluation of the skills required to safely work in a food processing environment.

The last component of Victor’s formula is attitude. How can we determine if a person working in food processing has the right attitude? This may not be easy; however, not impossible.

The Bell curve is mentioned often when anyone wants to assess probability of distribution. Any method used to determine the distribution of the value of a person in the food industry could be plotted in a Bell type curve. The results would be analyzed to determine potential risk from employees to the food manufacturing operations.

Generically, any Bell type curve has three zones. The center is the average, one of the sides is below average and the other side is above average. Employees’ value falling in the average, or above it, represents low risk to food manufacturing or processing operations. However, those employees that fall into the “below average” side of the curve represent a high risk, a significant hazard.

In a HACCP environment, what do we do whenever we have a significant hazard? We have a critical control point for which we identify a critical limit, continuously or frequently monitor the limit to make sure we remain in the acceptable range, we develop corrective actions, verification procedures, and record-keeping.

Senior management of any food facility is responsible to understand the hazards in the process and provide resources to acquire knowledgeable and qualified individuals that will be directing and controlling food processing or manufacturing operations, also known as: human resources. Senior management is also responsible for the effective implementation of the training program in any food facility.

Senior management is responsible to find a way to determine the value of all employees and implement corrective and preventive actions according to the risk the employees present.

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