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We’re Happy to Comply — But How?
What to expect when the FDA begins enforcing the FSMA
by Shawn K. Stevens
Anyone involved in the food industry has now heard about the recent passage of the FDA Food Safety Modernization Act, or FSMA. Although the FSMA imposes many new and, some might argue, exotic requirements on industry, the one that likely will have the greatest impact on food companies is the mandate that they “develop and implement written food safety plans.” Many companies are asking, what does this really mean? Although none of us can be certain until the U.S. Food and Drug Administration (FDA) begins enforcing the new laws starting in June 2012, we can give you a pretty good sense of what to expect.
Following the passage of the FSMA, the FDA announced in its promotional materials that, moving forward, food companies will simply be required to adopt food safety plans. Not surprisingly, things are not always as simple as they sound. In regulatory and legal terms, this means that regulated food companies will soon be required to develop and then closely follow the Hazard Analysis and Critical Control Point (HACCP) methodology.
So, what is HACCP? Well, at its most basic level, it’s a system designed to address the food safety hazards we fear most. The HACCP concept was first developed by Pillsbury in the 1960s as a quality control program designed to govern the production of food for the United States space program. Under the HACCP methodology, a food processor would first identify the hazards reasonably likely to affect the safety of its food, including the introduction of chemical, physical, and microbiological contamination, and then establish various critical control points where interventions could be used to prevent, reduce, or control those hazards. Ultimately, HACCP was critically important for NASA, because it worked to ensure that the meals its astronauts were taking into space would be as safe and as free from unwanted contamination as possible.
In the early 1980s, Foster Farms of Livingston, Calif., was one of the first meat processors to introduce HACCP into its operations. In 1985, HACCP received more attention when the National Academy of Sciences recommended the system as a means to modernize the United States Department of Agriculture’s (USDA) meat inspection system. Eventually, in the 1990s, the USDA mandated HACCP for all meat and poultry production in the United States. At about the same time, the FDA mandated HACCP for all seafood production, and then, in 2001, extended those requirements to the domestic juice industry in response to numerous outbreaks involving unpasteurized juices. And, more recently, recognizing how HACCP has improved the overall safety of these products, the FDA successfully petitioned to have the new FSMA extend HACCP to all other segments of the food industry. Thus, with only a few exceptions, the FDA will soon require all food companies regulated by the agency to develop and closely follow their own HACCP plans.
According to the FDA, the underlying goal of HACCP is to prevent problems from occurring in the first place. Although describing the HACCP methodology can be somewhat difficult given its complexity, food companies will generally be required to formally consider and identify all reasonably foreseeable food safety hazards; develop written plans addressing each of those hazards; and closely follow those plans to reduce or eliminate such hazards to the greatest extent possible. More specifically, the underlying principles of HACCP will require regulated food companies to do the following:
- Assess hazards: Conduct a hazard analysis to identify reasonably foreseeable food safety hazards and develop reasonably appropriate control measures for each;
- Determine critical control points: Identify appropriate critical control points (CCPs) where a control measure can be applied to prevent or reduce an identified hazard;
- Establish critical limits: Define acceptable and unacceptable science-based limits for all CCPs and use those limits to ensure the production of a consistently safe product;
- Establish monitoring procedures: Monitor each CCP continuously in order to identify and immediately address any deviations from the critical limits that may occur;
- Establish corrective actions: Develop procedures to be followed in the event of a deviation, which should include an assessment of the root cause, the disposition of affected product, and a written record of any corrective actions;
- Establish verification procedures: Test and critique the HACCP plan once designed (and periodically thereafter) to verify that the plan is working correctly; and
- Establish a record-keeping system: Develop a system to maintain and catalog all HACCP documentation for at least two years, in such a form that any records can be made available to the FDA promptly if requested by the agency for inspection.
This may be a lot to swallow, but there are plenty of resources available to help companies develop their own HACCP plans. As a starting point—although they should never be used as a substitute for a well-designed program that will withstand agency scrutiny in your specific facility—the FDA and numerous industry associations have published basic guidance materials online and will likely be publishing additional materials in the months to come (you can view the FDA’s material on FSMA at http://www.fda.gov/Food/FoodSafety/FSMA/default.htm).
In addition to these background materials, numerous industry consultants and lawyers are available to help you develop, refine, and critique your HACCP plan. All companies should strongly consider obtaining advice from a qualified expert in the field as they work to ensure compliance. This is because a company’s HACCP plan will not only need to be scientifically and legally sound, but will also, for all practical purposes, become a direct extension of in-plant federal FDA regulation. Put simply, the FDA’s new regulations will require not only that your HACCP plan be adequate, but also that it is followed precisely.
So, what is a food safety plan? Technically speaking, it is a comprehensive science-based HACCP plan. In lay terms, however, it’s a proven system designed to address the food safety hazards we fear most.