Environmental Testing and the F&F Industry: Mitigating Contamination Risks

Luke Grocholl Ph.D., Head of Regulatory
Sarah Powell Price, Regulatory Affairs Expert

Introduction

Any facility that handles food products, including flavors and fragrance (F&F) ingredients, must establish a robust hazard assessment and mitigation program such as a Hazard Analysis and Critical Control Point (HACCP) to help safeguard consumer safety and protect the general food supply.

Environmental testing is often a key element of these programs and helps ensure food and safety throughout the supply chain. While qualitative considerations such as temperature, humidity, packaging conditions, and shelf life are important in determining risks and conducting hazard assessments, they may not always be sufficient.

Certain commodities or ingredients may necessitate additional testing and verification to meet safety and regulatory requirements. For example, variations in oil, water, sugar, and starch content within some food products can affect risk and should be evaluated.

Hazard Assessment and Environmental Testing Considerations

Effective hazard assessment and environmental testing must consider chemical, biological, and physical risks of contamination. Although pathogens, molds, heavy metals, and other contaminants can infiltrate food at any stage of the production process, specific points of vulnerability may require further analysis of individual constituents and additives.

Environmental testing and monitoring for verification should also align with existing recall and traceability plans, sanitation standard operating procedures (SSOPs), preventive maintenance, staff training, and pest control plans.

Comprehensive environmental testing may include air, surfaces (direct and indirect), personnel, and process water as part of verification sampling programs. Targets for testing may also include drains, floors, doorways, and other relevant areas within a facility where contaminants could conceivably transfer from and infiltrate food components. Active air monitoring with any range of fit-for-purpose technologies using settle plates, agar strips, or cassettes is a recommended method to assess microbial risk in a facility. Sanitation verification tests, including ATP testing, serve to validate current microbial sampling and are among the most efficient ways to rule out pathogen contamination.

When using media for total colony counts, it is essential to use compliant, validated, and fit-for-purpose media to reduce opportunities for false positives and false negatives. Additional factors may also influence the selection of media in certain facilities; for example, some halal facilities may wish to restrict materials that are used for environmental testing to those that are halal certified.

Additionally, it is important to note that verification of environmental testing activities is typically stipulated by statutory requirements, for example, within the US Code of Federal Regulations (21 CFR 117.165)

Regulatory Perspective

Some of the most costly and high-profile recalls in the US have been traced to poor environmental monitoring and controls. Recent overhauls to the existing regulatory framework at the US Food and Drug Administration (FDA) for food oversight are already changing the enforcement landscape.

In their fiscal year 2024 (FY24) budget request, the US FDA recently sought expanded authority to mandate manufacturers to implement more frequent and systematic environmental monitoring. This requires that positive test results for relevant pathogens in final goods be reported, even in cases where the products have not yet left the manufacturer's control. This added authority enables the FDA to collaborate with firms in real-time to address positive findings and enhance the safety of products entering the market.

The FDA Investigations Operations Manual Subchapter 4, "Environmental Sampling," outlines the plan that FDA investigators use when they visit a site to take environmental samples and can be a useful guide for flavor and fragrance facilities planning to establish or improve their current environmental monitoring programs.

Applications for Flavors and Fragrances

Many flavors and fragrances have low water content and are not highly susceptible to microbial growth, however, facilities involved in the production of these ingredients must maintain a hygienic environment and incorporate appropriate hazard assessment and monitoring procedures. Microbial contamination of equipment, utilities, or work areas involved in handling flavors could serve as a source of contamination for food. For example, microbial contamination could be transferred to packaging or surfaces. Even if contamination is confined to the exterior packaging, it could be conveyed to transport systems and to food processors that use the flavors. Cosmetic customers have similar concerns regarding fragrances as a potential route for contamination.

Conducting environmental testing at flavor and fragrance facilities serves to ensure the cleanliness of processing areas and helps mitigate the risk of secondary contamination from surfaces and containers. By verifying the cleanliness of their facilities, F&F firms contribute to ensuring their products align with the stringent hygienic requirements of the global food supply network.