With new draft guidance for sanitation programs in low-moisture RTE (LMRTE) food facilities issued 15 months ago, FDA is not only holding the LMRTE industry to a higher standard, but has recently increased its enforcement actions. The industry is now being held to a standard comparable to what powdered infant formula (PIF) manufacturers have faced following recent FDA enforcement actions.
Manufacturers who are likely to be most affected are mid-size LMRTE producers running continuous or semi-continuous lines with legacy equipment and dry-cleaning-based sanitation programs (i.e., manufacturers of nut butters, chocolate, snack foods, and powdered products). However, the guidance applies to all in this industry.
One of the most critical aspects of a company’s program, not only for compliance but for limiting the scope and consequences of a recall, are sanitation breaks. Although sanitation break frequency for continuous production is undefined by FDA, it is consequential. Defining sanitation breaks as stopping production to clean and sanitize all food contact surfaces in the production system, the agency recommends breaks frequent enough to “limit the amount of food that could be affected,” but offers no specific benchmarks. Since the scope of affected product ties directly to the last sanitation break, facilities should document their rationale for chosen intervals and be prepared to defend those decisions.
TAG Recommendations for LMRTE Foods
Given that, TAG recommends:
- Non-continuous production systems: Establish and implement a sanitation break at the end of your daily production
- Continuous production systems: Establish and implement a sanitation break at intervals that are frequent enough to help limit the amount of food that could be affected
Following are other areas in which TAG is seeing increased FDA focus and enforcement, and our recommended solutions:
- Material flush is no longer a defensible stand-alone remediation strategy. FDA states that product push, purge, or flush techniques without an accompanying sanitizing treatment are inadequate for remediating pathogen contamination on food-contact surfaces. Facilities built around dry-clean-only sanitation philosophies should evaluate whether their equipment can tolerate chemical or thermal sanitizing treatments.
- The scope of “affected product” just got much larger. FDA recommends that all food produced since the last sanitation break be considered potentially affected following a contamination event, with further expansion when root cause findings warrant it. For many in the LMRTE space, this is a significant departure from the common practice of using intensified finished product testing to narrow the scope of affected lots.
- “Testing your way out” of a contamination event is explicitly rejected. Drawing on the 2022 peanut butter outbreak, in the draft guidance, FDA reiterates that finished product testing alone cannot verify pathogen control (as product testing is not considered a preventive control). Product that caused illness in the peanut butter outbreak had tested negative under the facility’s own sampling program.
- Whole genome sequencing is becoming the expected standard for isolate characterization. FDA positions WGS as the most discriminating method for determining strain relatedness and recommends its use during root cause investigations and, ideally, on routine positive isolates. Facilities relying solely on serotyping or Pulsed-field gel electrophoresis (PFGE) – or simply looking for the presence of Salmonella without any further identification – should be aware that FDA views these methods as insufficient for distinguishing resident from transient strains.
- Environmental monitoring programs must become more sophisticated. FDA expects a “seek and destroy” approach with trend analysis over time, facility mapping of positive findings, and root cause investigation for every FCS-positive (or finished product positive) result. Programs limited to periodic zone swabbing with basic corrective actions will likely fall short.
- Root cause investigations (RCI) are expected to be comprehensive. FDA outlines an extensive RCI framework, including equipment disassembly, pre- and post-cleaning sampling, ingredient testing, maintenance and production record review, personnel interviews, and post-restart verification sampling. For many mid-size facilities, this level of investigation will require significant additional resources. Root cause investigations will be especially important in driving corrective actions in terms of what constitutes an adequate sanitation break following a finished product positive. FDA will expect facilities to have determined the likely root cause and adequately cleaned all of the food contact surfaces downstream from the probable source of contamination.
- Water control in dry environments is held to a high standard. Even small, sporadic amounts of moisture can enable Salmonella growth and movement in the processing environment. Facilities should have documented protocols for condensation, leaking valves, roof infiltration, and fire suppression water events; and older facilities may face significant capital improvement needs.
Although guidances are not regulations, they do indicate what the industry “should” be doing, and FDA does expect industry to meet guidance standards and can – and does – take applicable enforcement action when it determines product to be contaminated or at risk due to lack of effective sanitation or other procedures.
If you are unsure of the efficacy of your sanitation program, sanitation frequency, or other related area, give TAG a call. We work with many companies on this and can assess your programs and help provide solutions.
