While the basic focus of this article is food safety in the United States, the principles of a hazard analysis and critical control points (HACCP) system are global. Pairing HACCP with the Food Safety Modernization Act places these initiatives at the forefront of the battle against foodborne illness.
The 2011 passage of Food Safety Modernization Act (FSMA) ushered in a new era of regulation and oversight designed to further improve the safety of food from farm to fork, emphasizing prevention rather than response. Provisions of the new law, as well as the defining rules, still leave some terms open to further definition. Among the provisions of the law and the rules is the description of a “qualified” person who has responsibility for developing and applying a food safety system.
As FSMA worked its way through Congress from 2009 through 2010, it became apparent that the identification of a qualified individual as required under the new rules could be left to interpretation. Training alone may not be enough to meet either the spirit or the letter of the law or rules. As many in the food industry know, it is not until the point of inspection or audit that a company may learn it is not in compliance—which is, of course, too late.
The History of HACCP
The genesis of HACCP can be traced back to a control system the Pillsbury Company (part of General Mills, Inc.) created for the National Aeronautics and Space Administration (NASA) in the 1960s to ensure a safe food supply for the first manned space missions. Engineers applied critical control points to test system reliability, and the same concept was applied to the food safety systems for spaceflights. The effectiveness of the process led Pillsbury to adopt what would become a formal food safety HACCP system.
The HACCP system and its guidelines were ultimately defined by the Codex Alimentarius Commission, an intergovernmental body established by the United Nations and later joined by the World Health Organization.
Developed with a global approach, HACCP has become the accepted and recognized system for ensuring food safety worldwide. These principles also formed the basis for International Organization of Standardization (ISO) system standards specifically designed for the food industry, like ISO 22000, which provides a framework for global trade in food and food products.
The Evolution of Food Safety Principles
While many companies throughout the food chain have developed a series of safety programs, FSMA now requires all food companies regulated by the U.S. Food and Drug Administration (FDA) to develop and implement written food safety or HACCP plans. This requirement applies to all facilities that manufacture, process, pack, or hold human food.
With only a handful of exemptions as we now understand them, the new preventive control provisions would apply to facilities that are required to register with the FDA under the agency’s current food facility registration regulations.
Under the new FSMA requirements, written food safety plans should include six elements: (1) a hazard analysis; (2) risk-based preventive controls; (3) monitoring procedures; (4) corrective actions; (5) verification procedures; and (6) record keeping. In addition to creating plans that will pass FDA scrutiny, food companies must also demonstrate the plans have been designed by a ‘qualified’ individual.
