Food Allergen Controls under FSMA and the FDA Preventive Controls Rule

The new FDA Preventive Control (PC) rule (Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food) requires each food manufacturing facility to implement Good Manufacturing Practices (GMP) to control allergen cross-contact, to assess food allergen hazards during development of the Food Safety Plan, and to develop allergen control plans as needed to prevent or minimize both cross-contact and mislabeling. This includes the need to consider the potential for allergen cross-contact and mislabeling when developing supply chain controls. These requirements apply to facilities in the U.S. and to those that export foods and ingredients to the U.S.  This combination of GMPs, PCs, and supply chain controls represents a significant increase in the level of concern for food allergen safety and the documentation needed to demonstrate control.  Careful planning will be needed to adapt existing HACCP-based allergen control systems to meet the requirements of the PC rule; and extended efforts will be needed by facilities that have previously considered allergen control as a prerequisite program.