Hazard Analysis And Risk-Based Preventive Controls — Required As Of July 3, 2012, For Most FDA-Regulated Facilities

As of July 3, 2012, companies that manufacture, process, package or hold food products regulated by the U.S. Food and Drug Administration (FDA) are required to identify potential hazards, implement preventive controls to minimize each of the hazards, monitor the performance of the controls and maintain records substantiating the monitoring and compliance with each control. Although such risk-based preventive controls have been required in USDA-regulated facilities since 1996, the Food Safety Modernization Act (FSMA), enacted January 4, 2011, imposes this requirement for the first time in most FDA-regulated facilities.

Section 103 of the FSMA amends the Food, Drug and Cosmetic Act by imposing for the first time a requirement for risk-based preventive controls to address hazards to which the company's food products or processes may be vulnerable. As with much of the FSMA, Section 103 focuses on the means of preventing production and distribution of adulterated and mislabeled food products rather than detection of contaminated food products in commerce and corrective actions.

The FSMA's newly implemented requirement of risk-based preventive controls is not merely limited to enactment of a Hazard Analysis and Critical Control Points (HACCP) program, but rather will likely necessitate a combination of a HACCP program with Current Good Manufacturing Practices, Sanitation Standard Operating Procedures, hygiene training, environmental sampling and controls, supplier verification, recall plans, and allergen controls and labeling. This is simply not a one-policy-fits-all requirement. A company's Food Safety Plan should be composed of multiple policies and procedures that are specifically tailored to address the unique risks associated with a specific food product and the associated processes that may vary by plant, or even by line.

The first step to implementing the required Food Safety Plan is to conduct a hazard analysis identifying the potential hazards specific to the food product and processes, taking into account the facility and product history. Potential hazards can range from biological contaminants; to physical contaminants (e.g., foreign objects); to radiological pathogens and natural toxins (e.g., aflatoxins); to allergens; to natural hazards; to unintentional hazards; to labeling concerns; to intentional hazards (food defense). The Food Safety Plan should encompass not only a HACCP program but also a Food Defense Plan. Food Defense...