Protect Your Products Against Allergen Contamination

Simple, practical controls can avoid costly food allergen contamination losses.

Food allergy trends over the past 20 years have become a serious issue for the food processing industry. From peanut sensitivity to gluten intolerance, such issues have spawned both a growing liability and market opportunity for food and beverage processors.

It’s important how you manage the FDA's “major allergens” in formulations (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans) and to consider replacing such items (if feasible), processing controls and appropriate labeling. Fully disclose all recognized allergens – including certain dyes, colorings, flavorings, and/or preservatives – and conduct periodic reviews of product labels to ensure updates reflect formulation changes.

Preventing allergen cross-contamination in your supply and processing chain can be a tough proposition. Managing food allergen risks extends beyond your own plant – including ingredient suppliers, vendor packaging, storage services and transport carriers. You need to research and test new ingredients. By not actively researching (and managing) potential allergens, you risk incurring direct costs associated with product alerts, recapturing products you’ve already distributed, a full recall, disposing of product, regulatory citations, elevated insurance coverage and potential lawsuits – that may cause profound damage to your public image and reputation.

The 2004 Food Allergen and Consumer Protection (FACP) Act and 2011 Food Safety Modernization Act (FSMA) have shifted industry focus from responding to contamination toward processing safety and labeling practices. Control practices such as separating workflow/processing areas, sanitation procedures, documenting procedures and training employees can elevate product quality, consumer awareness and industry image.

Of course, the safest solution when processing potential allergen-containing materials is a separate plant or isolated site, which could include outsourcing to a manufacturer (you still hold responsibility for effective cross-contamination controls). Ensure suppliers are committed to preventing allergen contamination. It’s always a great idea to evaluate written control practices and test results and to inspect suppliers' plant(s). Remember, allergens contaminate at “parts-per-billion” levels, so conduct a thorough analysis of facility, machinery, utensils and clothing.

Along with process controls, your company should consider indemnification agreements and “additional insured” clauses. Indemnification agreements outline a supplier’s responsibility to reimburse for losses resulting from products or services they provide their customers. Many processors rely on such an agreement to clarify responsibility for product contamination costs should an incident occur. A knowledgeable attorney can help a processor understand their rights and responsibilities under the agreement – as well as the roles of other parties.

Additionally, food processors and suppliers need to be aware of the laws that apply to how indemnity agreements are enforced, as all states do not necessarily recognize such agreements uniformly. The same is true for international laws and jurisdictions that can affect relationships with international suppliers. Last, processors should understand that enforcing an indemnity agreement may rely heavily on a supplier having adequate insurance coverage for a reported loss.

Food processors may also incorporate an “additional insured” endorsement with suppliers to add another entity under their own product's liability insurance policy. Protections may vary broadly based on language of the applicable insurance policies and applicable local, state, federal or international laws. As with indemnification agreements, an “additional insured” endorsement may be limited if international suppliers are involved.

This is potentially complicated as narrow insurance policies offer coverage for distinct loss causes. For example, general liability, errors and omissions, or directors and officer policies may cover bodily injury and professional liability claims arising from contamination. Provided policy coverage(s) may be limited by stated terms and applicable laws. Accordingly, processors should not only negotiate with allergens in mind, but also consider costs for product recovery, recall, and other foreseeable liabilities that could occur. To effectively manage your allergen risks:

  • Thoroughly understand allergens in your process
  • Fully assess new ingredients before adding to formulations
  • Isolate potential allergens from “free-from” processing
  • Evaluate labeling and packaging for allergen risks
  • Review and test recall procedures for your products

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