Salmonella Controls That Prevent FDA Spice Recalls

When a Wisconsin seasoning manufacturer voluntarily recalled topical spice products in 2026 due to potential Salmonella contamination — citing risk to young children, elderly individuals, and those with weakened immune systems — it joined a troubling but well-documented pattern in the low-moisture food industry. The FDA recall notice is publicly available. The recall itself isn't the story worth studying. What's worth studying is what a functioning quality system would have stopped cold before product ever left the facility.

Why Dry Seasonings Are a High-Risk Category

There's a counterintuitive assumption embedded in a lot of small and mid-size food manufacturing operations: dry products are inherently safer than wet ones. The logic goes — Salmonella needs moisture to grow, so dry spices should be fine. That reasoning is dead wrong, and it has cost companies their businesses.

Salmonella doesn't need to grow in your product to contaminate it. It only needs to survive. In low-moisture environments — spices, seasonings, dried herbs, powdered blends — Salmonella can persist for months to years. The organism is remarkably adaptive at surviving desiccation, and once it colonizes a facility's environment, it can be extraordinarily difficult to eradicate without systematic intervention.

FDA's Spice Safety Initiative found Salmonella in approximately 12% of spice samples collected from domestic and import sources — a rate that reflects a structural pathogen risk in this category that FSMA's preventive controls framework was specifically designed to address. That's not a fringe statistic. It's a baseline condition that every dry seasoning manufacturer should be planning around.

CDC estimates that Salmonella causes approximately 1.35 million infections annually in the United States, with an estimated 420 deaths. Low-moisture foods, including spices and seasonings, have been implicated in roughly 10% of U.S. Salmonella outbreaks traced since 2000 — a disproportionate share given the category's size.

The Regulatory Framework: What 21 CFR Part 117 Actually Requires

The Food Safety Modernization Act (FSMA) established a paradigm shift in food safety: move from reactive response to proactive prevention. The operative regulation is 21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, which became effective for most manufacturers on September 19, 2016.

Under 21 CFR Part 117 Subpart C, any food facility subject to the rule must:

• Conduct a written hazard analysis identifying known or reasonably foreseeable biological hazards — Salmonella in a spice facility is unambiguously in this category
• Implement preventive controls for hazards requiring them
• Monitor those controls at appropriate frequency
• Establish corrective action procedures
• Verify the system is working as intended
• Maintain records sufficient to demonstrate compliance for a minimum of two years (21 CFR 117.310)

For a dry seasoning manufacturer, Salmonella is a biological hazard that almost certainly requires a preventive control — whether a process control (kill step), a sanitation control, or a supplier control, depending on where in the process the hazard is most effectively managed. The regulation doesn't prescribe which control to use. It requires the manufacturer to identify the hazard honestly, assess it with rigor, and control it effectively.

That last part — "effectively" — is where a lot of companies fall short. A written plan that looks good on paper is not the same as a system that actually works.

The Environmental Monitoring Program: Where Most Recalls Actually Begin

In my experience working with food manufacturers across multiple categories, the single most common gap I find in dry product facilities is an inadequate Environmental Monitoring Program (EMP). This is also where Salmonella recalls in the spice category most often trace back.

An EMP is not optional for facilities where environmental Salmonella is a reasonably foreseeable hazard. FDA's guidance is explicit: facilities producing ready-to-eat products or products receiving no further kill step before consumption must have a systematic program for detecting and eradicating environmental pathogens.

A functioning EMP for a spice or seasoning facility operates across four defined zones:

Zone 1 — Direct product contact surfaces: blending equipment, conveyors, filling systems. A positive finding here is a critical event requiring immediate product hold and root cause investigation.

Zone 2 — Adjacent non-product contact surfaces within the production area: equipment frames, legs, floors immediately surrounding Zone 1 equipment. Positive findings here indicate migration risk into Zone 1.

Zone 3 — Areas more removed from production but within the facility: drains, walls, floor-wall junctions. These sites often serve as Salmonella harborage points — cracks, gaps, and rough surfaces where the organism establishes itself for extended periods.

Zone 4 — External areas: entryways, break rooms, receiving docks. Findings here help identify introduction vectors.

The problem I consistently find in smaller operations is EMPs that exist on paper but collect samples too infrequently, at too few sites, or focus exclusively on Zone 1 while ignoring the harborage zones where Salmonella actually lives. A positive Zone 1 finding at the moment of sampling is already a failure. The point of an EMP is to find Salmonella in Zones 2, 3, and 4 before it reaches Zone 1.

Supplier Controls: The Hazard You're Importing

In a topical seasoning operation, raw ingredients are typically dried herbs, spices, or blended powders — many of them sourced internationally. Salmonella in incoming raw material is one of the primary introduction vectors, and supplier verification is the regulatory mechanism designed to stop it at the door.

Under 21 CFR Part 117.410, if a hazard requiring a preventive control is addressed at the supplier level — meaning your process doesn't include a validated kill step downstream — you must implement supply-chain-applied controls. These include:

• Conducting a written hazard analysis for the supplier
• Verifying that the supplier actually controls the hazard
• Obtaining documentation: certificates of analysis, third-party audit results, or incoming material testing

A Certificate of Analysis alone is generally not sufficient. If your supplier provides a CoA claiming Salmonella testing but you have no visibility into their testing methodology, sample frequency, or lab qualifications, that CoA is providing false assurance. I push clients toward incoming material testing as a verification activity — not as the primary control, but as a check on supplier performance. Testing every lot, or a statistically representative sample, of incoming spice materials is a reasonable and defensible verification step for this hazard.

Under 21 CFR Part 117, failure to verify supplier controls when a facility lacks a downstream kill step is a regulatory violation — not a documentation gap, but a structural failure of the preventive controls system.

Kill Step Validation: The Control That Eliminates the Hazard

The most robust approach to Salmonella in a spice or seasoning operation is a validated kill step — a process intervention achieving a specified log reduction of the pathogen. This is the same logic that makes pasteurization so reliable in dairy. You control the hazard by eliminating it, not merely monitoring around it.

For dry seasonings, validated kill step options include:

• Steam treatment — Low-moisture steam or pressurized steam can achieve a 5-log reduction in Salmonella when properly validated. Equipment manufacturers offer validated time-temperature profiles that facilities can adopt as a foundation.
• Convective heat or infrared heat — Applied at sufficient temperature and dwell time, with documented validation data.
• Irradiation — FDA-approved for spices under 21 CFR Part 179.26. Reliable and effective, though some marketing programs avoid it.

The critical word is validated. A kill step that hasn't been validated through a properly designed challenge study is not a preventive control under 21 CFR Part 117 — it's an assumption. Validation requires demonstrating that the process consistently achieves the target log reduction across the range of conditions expected in production, and it requires documentation a process authority can stand behind.

Industry guidance and FDA risk assessments generally point to a 5-log reduction as the target for Salmonella in spice applications. Your process authority should be involved in establishing that target and designing the study.

What a Functional Quality System Looks Like in Practice

Let me put the difference in concrete terms. A facility that doesn't experience Salmonella recalls typically has the following in place:

That table reflects the actual difference between facilities that pass their FDA inspections and those that generate recall activity.

The CAPA System: What Separates Proactive Facilities from Reactive Ones

Most small food manufacturers can handle the corrective part of CAPA — when something goes wrong, they fix it. The preventive part is where the majority fall short, and where FDA investigators often find the most telling systemic weaknesses.

A mature CAPA system in a spice facility includes a formal process for capturing quality events (positive environmental findings, customer complaints, supplier deviations, audit observations), a root cause analysis requirement that goes beyond "operator error" to identify systemic failures, a preventive action element that asks what structural change will prevent the next occurrence, and an effectiveness verification step confirming the CAPA actually worked.

In my view, a recurring Salmonella finding in Zone 2 or Zone 3 that receives a corrective action of "re-clean and re-test" without deeper root cause analysis is a CAPA system that isn't functioning. The question isn't just "did we clean it" — it's why is Salmonella establishing itself in this area, and what structural change will prevent recurrence?

A Practical Gap Assessment Starting Point

If you're running a dry seasoning operation and haven't conducted a formal gap assessment against 21 CFR Part 117 in the last two years, here's where to start:

Review your hazard analysis for Salmonella. Is it specific to your facility, your raw materials, and your process — or is it a generic template you've adopted without modification? The hazard analysis drives everything downstream. A weak hazard analysis produces a weak preventive controls plan.

Audit your EMP. How many sites are you swabbing, and at what frequency? What are your positive-finding criteria and escalation procedures? When did you last find a positive, and what happened as a result?

Validate your kill step — or implement one. If your process doesn't include a validated Salmonella intervention, you're relying on your raw materials being Salmonella-free and your facility being Salmonella-free. That's not a preventive control. That's an assumption.

Review your supplier verification program. For each spice or herb you're purchasing, can you articulate what you know about your supplier's food safety controls and what verification activities you're performing? "They've never had an issue" is not supplier verification.

Test your records. FDA investigators ask to see records for specific production dates and lots. Can your team produce those records — organized and complete — within a reasonable time? Recordkeeping gaps are as damaging as control gaps during an inspection.

The Voluntary Recall as a Quality System Indicator

Here's something worth saying plainly: a voluntary recall is, in one sense, the system working. A company that identifies potential contamination and removes product from commerce is behaving responsibly. That's better than an FDA-initiated mandatory recall triggered by illness reports.

But a voluntary recall almost always means the detection system found the problem after product had already left the facility. The preventive system failed to stop it upstream. The goal of a well-designed quality system is to never arrive at the recall decision — to find the contamination, or eliminate it entirely, before finished product is packaged and shipped.

The FDA recall database is a useful signal for the industry. When Salmonella appears in a facility's finished product or environmental monitoring at a frequency that drives recalls, the preventive controls aren't working — regardless of what the food safety plan says on paper.

At Certify Consulting, I've helped more than 200 food and regulated product manufacturers build quality systems that hold up under FDA inspection and, more importantly, actually prevent the failures that drive recalls. Our track record includes a 100% first-time audit pass rate across our client base — not because we teach clients to look good on paper, but because we help them build systems that genuinely work.

If you're in the dry spice, seasoning, or low-moisture food category and you're not confident in your preventive controls program, a gap assessment is the right first step. Explore our FDA food safety compliance services at certify.consulting.

For manufacturers navigating FSMA implementation and FDA inspection readiness, you may also find value in our consulting services overview at certify.consulting.

Last updated: 2026-06-04