During the first three quarters of 2019, allergens were the cause of 40 percent and 30 percent of FDA’s and USDA’s recalls, respectively, making 2019 a record year for undeclared allergens, according to Stericycle’s Product Recalls Index.
“According to FDA data, mislabeling is the leading cause for allergen recalls, but even if we’re seeing fewer Class I recalls for cross-contamination, it doesn’t mean that sanitation and allergy control is generally good or that the risk is low,” says Charlie Kalish, a food safety consultant and trainer who works with businesses on compliance and audit readiness. “There are all kinds of cross traffic and risk for cross-contact in many facilities, and that’s a sort of ticking time bomb.”
Effective allergen cross-contact prevention is based on different procedures, such as supply chain control, cleaning and sanitation, personnel hygiene practices, and the use of color-coded tools. Hygienic design, however, is what creates the ideal environment for those procedures to be more effective.
Ideal Facility Design
Hygienic design is often mentioned in relation to equipment and tools. A less talked about aspect is its application to plant layouts. The ideal facility design for allergen management is conceived with the purpose of separating traffic patterns of allergens and non-allergens at every processing step: storing, handling, processing, and packaging. “If you can minimize the footprint in a plant where you have allergens, then you can do a better job at controlling them. If they’re all over your facility, then it’s much more difficult,” says Mark Morgan, PhD, head of the food science department at the University of Tennessee in Knoxville, and U.S. liaison for the European Hygienic Engineering & Design Group (EHEDG).
In the Food Safety Modernization Act (FSMA) the principle of separation is included in the cGMPs in Title 21 Sec. 117.20, and states that allergen cross-contact may be reduced by (among the other things) separating “location, time, partition, air flow systems, dust control systems, enclosed systems, or other effective means.” It’s up to food businesses to determine what these effective means are.
To what extent allergens should be segregated from non-allergens will depend first on the type of product and its ingredients. “If your product contains powdery allergens that can become airborne and travel around, like, for example, wheat flour, then you want to design a facility with an enclosed area for that,” says Vicky Waskiewicz, CEO of Safe Food Resources, a food safety training and consulting organization based in Milwaukee, Wisc.
Another factor is how these ingredients enter the facility. “If I’m just bringing products that are enclosed in a metal drum into my warehouse, they’re going to need fewer controls than products that come in a paper bag, which may drop and break, spreading flour all over the facility, or be pierced by a fork truck,” says Elise Forward, president of food safety consultant firm Forward Food Solutions, based in River Falls, Wisc.
Once you know the risk of cross-contamination associated with your products, you can then decide on the ideal traffic patterns inside the facility. In practical terms, that might mean assigning separate delivery areas, warehouses, and processing lines to allergen-free products and to those containing allergens.
For plants that are still in the design phase, businesses can work directly with their building contractors to incorporate these principles. The project manager within the company “should be somebody with a keen understanding of how their food is being made, because hygienic design is going to revolve a lot around efficiency,” says Kalish.
Hygienic Design for Existing Facilities
For existing facilities, the process is more complex. Many plants offer little or no segregation or unidirectional traffic flow, or have separated production lines that share the same area, or even allergen and non-allergen products being processed using the same equipment.