Managing Temperature as a Preventive Control

Several regulations required to implement sections of the Food Safety Modernization Act (FSMA) will begin to take effect this year and the first half of 2016. The final rule for Section 103: Hazard Analysis and Risk-Based Preventive Controls (HARPC), is due to be published in the Federal Register on August 30. Most FDA-registered food manufacturing installations will have 12 months to come into compliance.

A proper application of HARPC will lead to the conclusion that if a hazard analysis identifies a significant hazard, say in an ingredient, an appropriate risk-based preventive control needs to be developed, implemented, and managed to control the hazard. Control options include process steps with the capacity of eliminating or reducing to an acceptable level the identified hazard and/or operational and non-operational programs and activities capable of preventing the hazard from occurring and/or being introduced into the manufacturing process and the product.

Why does HARPC appear to be so much broader than HACCP? In other words, why would HARPC assert the need for preventive controls (PCs) in general and not just for process steps capable of eliminating or reducing to an acceptable level an identified significant hazard? Understanding the answer to this is essential to developing and implementing an effective food safety program to control unintentional adulteration under HARPC.

A review of food safety failures and recalls during the last 20 to 30 years will show that the root causes of such disappointments were not associated with CCP failures, that is process-step preventive-control failures, but rather due to insufficient rigor in the application and management of operational and non-operational support programs and activities capable of preventing such failures in the first place. The food industry paid attention to process steps capable of eliminating or reducing to acceptable levels an identified hazard, but not enough attention has been given to preventive activities or controls implemented as part of operational and non-operational programs.

This is exactly what HARPC is designed to address. By allowing more flexibility, but at the same time demanding more focused and rigorous management of identified preventive controls “as appropriate to the nature of the preventive control” (read: beyond CCPs), food safety failures and recalls should diminish considerably in years to come.
 

PC Identification and Management.

Let’s explore this flexible, but more rigorous, identification and management requirement of a preventive control, using temperature control at receiving as an example. Assuming that:

• A biological hazard is known to be associated with, or is reasonably foreseeable to occur in a given raw material or ingredient (e.g., a pathogenic or toxin-forming bacteria).
• The risk analysis determines that it is a significant hazard, based on probability of occurrence and severity on human health.
• The HARPC team will have to review, discuss, and define the appropriate preventive control or controls. The control could be a process step with the capacity to eliminate the hazard or reduce it to an acceptable level, a preventive operational activity (such as measuring a temperature), a non-operational activity (such as an allergen changeover cleaning), or a basic preventive prerequisite program (such as sanitation). The appropriate preventive control, or combination of controls, will depend on the nature and characteristics of the ingredient, the supplier’s manufacturing process, and the receiving facility’s manufacturing process and finished-product profile containing the ingredient. Thus, there may be one or more preventive controls available to assure food safety in the finished product.
   

Given the above criteria, the HARPC team would select the appropriate preventive controls(s) and develop and implement a management scheme “as appropriate to the nature of the preventive control” selected.

Since the identified hazard is biological, temperature control at receiving would be essential to prevent a lot of ingredient from entering the facility with a temperature above a scientifically established limit for bacterial growth. In general terms, this would be at or below 41°F, though for some products the limit would be lower.

While this temperature preventive control (TPC) at receiving cannot assure that an incoming lot is free of the presence of the identified pathogen, if well established and managed, the TPC would inhibit potential pathogen growth from the time it was loaded at the shipping point to its arrival at the receiving facility.

What this implies is that, in order for the TPC to be managed “as appropriate to the nature of the preventive control,” the management scheme will have to include temperature controls at the shipping point, in transportation, and at receiving.

As a side note, depending on the receiving facility’s manufacturing process and finished-product profile, further temperature control, an eliminating process step, or some other controls such as pH or water activity may be available for food safety purposes during the manufacturing process of the finished product containing this ingredient.
 

Developing Requirements.

Next, the HARPC team would develop clear and easy-to-understand staging/loading, transport, and receiving/unloading temperature conditions, procedures, and documentation requirements for the TPC.

Similar to a CCP master plan, the TPC plan, in order to demonstrate management “as appropriate to the nature of the preventive control,” should contain:

• The name of the ingredient.
• The identified biological hazard associated with the ingredient.
• The temperature or time/temperature parameters essential for food safety at the origin, in transport, and at receiving. These parameters must be science-based and relevant to the nature and characteristics of the ingredient and the identified hazard. The temperature parameter for the product at the receiving facility should be no more than, and preferably somewhat below, 40°F, or it could be a total time/temperature combination, depending on the shipping and transport conditions, or in case the cold chain is interrupted during transport.
  • The monitoring activities of the temperature requirements at receiving. These are known as the what, when, how, and who. The “what” would be the temperature or time/temperature conditions of the ingredient when the product arrives at the receiving facility. The “who” would be educated and trained personnel in charge of receiving activities. The “when” and the “how” need more thought to assure compliance with the coded requirement of “as appropriate to the nature of the preventive control.” Questions the HARPC team may consider while defining the when and how components of the PC include:
    • What temperature-measuring device should be used to monitor the temperature at the shipping point during staging and loading, in transport, and at the receiving facility when the ingredient in question is delivered in a refrigerated transport mode?
    • What temperature will be monitored during transportation? The internal temperature of the product, the surface temperature, or the ambient temperature of the truck?
    • Will a sampling procedure be used? If so, how representative is it?
    • How will the temperature requirements be monitored if the product is delivered in ice or with gel packs, or shipped refrigerated in an insulated truck, but with a delivery time of less than four hours?
    • With what frequency should temperatures be taken at origin, in transport, and at delivery?
    • What is the appropriate relationship between the temperature of the cold rooms, the refrigerated transport mode, and the product?
    • With what frequency will the temperature-measuring devices be verified for accuracy?
    • Do the temperature-measuring devices need to be cleaned and sanitized?
       
• Corrective actions to address any TPC failures need to be developed as well, both short- and long-term corrective action. Unlike the predetermined corrective actions under HACCP, HARPC provides flexibility regarding the short-term corrective action decisions that need to be implemented and documented when a deviation of the preventive control occurs.
  These decisions can be predetermined, such as rejecting a lot if the receiving temperature is not met, or they can be made case by case, based on verifiable and measureable time/temperature parameters, the capacity of the manufacturing process of the receiving facility to eliminate the hazard, a diversion of the ingredient to a use where the receiving temperature is not an issue, or the rejection of the lot.
• The verification activities such as records review, observation of monitoring activities, and calibration of temperature-recording devices will need to be planned, carried out, and documented. Among these, the observation of monitoring activities being carried out by receiving personnel is the most challenging. In order for such observation to be valid, it must be done without the person doing the monitoring being aware that he is being observed, since otherwise, the person will “always” do it right.
• Records reflecting the real temperature conditions and results of monitoring activities covering shipping point, transport, receiving, as well as corrective actions, verification, calibration, and deviations will be key to demonstrate that the TPC was managed “as appropriate to the nature of the preventive control.
   

The success of the TPC at receiving will depend to a great extent on providing clear, written communication to the supplier of the ingredient and the transport provider, regarding temperature requirements, monitoring, and required record systems. This written information, as part of the purchase and transport contract, has also been codified under Section 111, Sanitary Transport of FSMA.

Under FSMA, FDA now has the legal right, under situational conditions that could result in serious health consequences or death to humans and animals (SAHCODHA), to request all records associated with the manufacturing of a given product. It is therefore imperative that all records be audit proof. In non-legalese language, this means that the records of the TPC must capture the real temperature conditions under which the ingredient was shipped, transported, received, accepted or rejected—every time.

These, like all records subject to an FDA audit, cannot have incomplete temperature data, be ambiguous, have errors that were not corrected, lack signatures of those who do the monitoring and the verification, or worse.

Finally, relevant education and training activities of transport and receiving facility employees need to be developed, implemented, and documented. This education and training element also is required to be part of the written transportation contract or arrangements.
 

Summary.

While HACCP has and continues to be a very effective hazard control scheme, the over reliance on CCPs as elimination steps to the detriment of preventive supportive operational and non-operational programs and activities has led to unacceptable numbers of food safety failures and recalls. Many of these failures could have been prevented with a more proactive food safety management of preventive operational and non-operational programs and activities. So, while HARPC may appear to be more encompassing than HACCP, in reality it is not. However, it correctly points out the necessity for paying more attention to preventive, rather than solely corrective, control measures.

Some readers of this article are likely to conclude that “there is nothing new, we are already doing this.” Congratulations, you are ahead of FSMA/HARPC and should be able, with proper records, to demonstrate with confidence that you are doing the right thing. Others may reflect on the phrase “as appropriate to the nature of the preventive control” and decide that the scope and management of the TPC activities could stand improvement to assure effective hazard control.

It is vital to remember that the preventive controls have been codified into law. Therefore, in order to demonstrate that a PC is being implemented and managed as written, it is essential to demonstrate that it is the right PC and that the records prove that you are doing what you say you do. In other words, the TPC records must reflect the true conditions under which such ingredient has been received, accepted, or rejected, and long-term corrective actions taken to eliminate or reduce deviations. The same holds true for all PCs.

The author is Global Manager, Food Safety Services Innovation, AIB International.