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Are Your Environmental Controls Protecting Your Low-Moisture Foods?

While the news continues to be dominated by the virus-that-shall-not- be-named, there are many important food safety studies and developments taking place but eliciting only secondary or in-industry headlines. One of these that TAG has recently been noticing and following is that of minimizing the all-too-frequent occurrence of Salmonella contamination and recalls of low-moisture foods.

As discussed in a study funded by USDA NFIA, while various processing interventions and technologies exist, “they have achieved very limited market penetration, and none will provide a universally acceptable solution.” Additionally, FSMA’s Preventive Controls Rule has made validation of “legacy" technologies not designed as “kill steps" (e.g., drying or baking) necessary. While the five-year study is not set to end until 2022, NFIA recently published an update stating that the team has generated new scientific evidence that is aiding FDA’s work in validating pathogen control processes and developing regulatory policies that are framing guidance documents currently under development.

While FDA continues to develop its guidance, the industry can look to other studies and developments in the continuing quest to minimize contamination of low-moisture foods. One of these is last week’s publication of “Processing Environment Monitoring in Low Moisture Food Production Facilities.” Among the key points of the study:

  • Finished product testing is of limited interest in case of low prevalence contamination.
  • Environmental monitoring is a proactive approach for anticipating product contamination.
  • Sampling should consider product proximity and priority, hygienic conditions, and place in the process (before or after heat treatment).
  • Genetic characterization of isolates, such as whole genome sequencing (WGS), can help differentiate between resident and sporadic strains.

What does this mean to you?

While none of the above are surprising, it speaks to the continued focus on this area of risk.  Finished product testing is particularly limited for low-moisture foods where the identification of low prevalence of contamination is a key aspect of food safety. But implementing controls throughout the process rather than just testing finished product is certainly not a new concept; in fact, it goes back to the 1950s with the first uses of HACCP in the food industry.

Since that time, the concept has continually evolved with environmental monitoring and controls not only an important aspect of a food safety program, but also a regulatory requirement for many. While the sampling used in environmental monitoring is key to identifying harborage niches and critical points for routine sampling and maintaining seek-and-destroy programs, its real aim should be that of verification that your environmental control program is working.  In my view, the environmental monitoring program should not be the only tool you are using to manage the risks in your high risk or ready-to-eat areas.

An environmental control program outlines practices that prevent pathogens in the environment from entering the product zone and contaminating finished product. A successful environmental control program incorporates Good Manufacturing Practices (GMPs), hygiene area controls, sanitary facility and equipment design, product separation (e.g., raw, allergens, RTE, etc.), cleaning/sanitation programs and other such practices which work together to prevent product contamination from environmental pathogens.

With these programs in place, your environmental monitoring sampling can then be used to verify their effectiveness and that your control program is working. While no single sampling scheme, target organism, method, frequency or corrective action will be applicable to all, as the best practice is dependent on the specific product hazard and facility environment, low-moisture product sampling should always consider product proximity and priority, hygienic conditions, and place in the process (i.e., before or after heat treatment) for validation.

Additionally, as noted in the study, whole genome sequencing (WGS) can help differ between resident and sporadic pathogens. While it is essential to control any pathogen, a sporadic (or transient) pathogen that is brought into the facility can generally be eliminated through cleaning and sanitation. However, a resident strain – that which becomes established in your facility, multiplies and persists – will require more in-depth controls. Not only is it more likely to contaminate more product, but if a resident strain is detected by FDA and not corrected, a Form 483 and then a warning letter is likely to follow. This is because of the persistent contamination risk for foods processed in that facility.

While recommendations for environmental monitoring and controls are applicable in some form to all food facilities, they can be particularly critical for low-moisture foods for which low-prevalence contamination is a primary concern. Implementing controls and monitoring for validation will help keep your product – and consumers – safe.

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