The FDA Food Safety Modernization Act Preventive Controls for Human Food identifies four types of preventive controls. The first type of preventive controls, Process Preventive Controls, was discussed in my October, 2016 column. The second type of preventive controls is Food Allergen Preventive Controls.

The Preventive Controls for Human Food regulation requires documented food allergen preventive controls. The need for specific food allergen controls is determined through the hazard analysis process.

The following food allergens contribute to about 90% of the food allergic reactions in the U. S.; milk, egg, peanut, tree nuts, fish, crustacean shellfish, wheat and soy. The Food Allergen Labeling and Consumer Protection Act (FALCPA) mandates labeling for these food allergen groups if they are present in a food product.

Allergen Preventive Controls procedures must address; 1. Preventing allergen cross-contact and 2. Accurate labeling of finished goods.

To prevent allergen cross-contact you must; clean shared equipment, properly manage rework and avoid in-process or post-process allergen cross-contact. Allergen cross-contact is defined as the unintentional incorporation of a food allergen into a food. In determining your allergen cross-contact preventive controls you should also consider; equipment cleaning and sanitary design, scheduling, manufacturing and engineering controls, allergenic ingredient control, personnel practices and employee training relevant to the above. Whether or not these are preventive controls or prerequisite programs depends on how the facility manages their operations and the complexity of their allergen concerns.

Allergen labeling considerations includes both label accuracy and the supply chain program. Label accuracy includes both accurate printing of allergen ingredients on the label and the right label on the package. Supply chain programs must ensure that food ingredient suppliers accurately identify allergens in the products that they supply and that packaging suppliers accurately print ingredient information on labels. Product labeling MUST be accurate. Allergen labeling errors are a primary cause of food product recalls.

In future columns the other two types of preventive controls will be addressed; Sanitation Preventive Controls (December, 2016) and Supply Chain Preventive Controls (January, 2016).

For additional information on FDA’s Food Allergen Preventive Controls go to the Food Safety Preventive Controls Alliance (FSPCA) website,