What Does FSMA Mean for You?

By Paul A. Hall, Ph.D., Contributing Editor

Benjamin Franklin is well-known for the aphorism, An ounce of prevention is worth a pound of cure." This sentiment is the stated aim of the Food Safety Modernization Act (FSMA) signed into law by President Obama on Jan. 4, 2011. This law is the first major overhaul of FDAs powers since 1932.

A number of new mandates in the law focus on prevention, prevention, prevention. The FSMA gives FDA broader records access when it is determined that there is a reasonable probability of serious adverse health consequences." It mandates more-frequent inspections of food-production facilities and gives the agency authority to issue mandatory product recalls if it determines a product is adulterated or misbranded, and where there may be a serious threat to the consumer. It also charges FDA with establishing science-based standards for conducting risk-based inspections.

The bill specifically mandates that standards be established for the safe production and harvesting of produce to minimize the risk of serious illness or death. Processors of all FDA-regulated foods will have to develop a food-safety plan" which requires evaluations of all hazards in their operations and implementation of preventive measures to mitigate those hazards. The difference between a traditional HACCP plan and the new food-safety plan is that the latter requires consideration of potential intentional hazards to food. HACCP traditionally does not address the issue of intentional contamination.

This legislation also focuses on the safety of the millions of pounds of imported foods entering the United States every year. Importers will have to verify that imported foods and ingredients are produced in accordance with U.S. laws and regulations through the use of accredited third-party certification. Third parties can be either foreign governments or private auditors who meet accreditation requirements. The law also focuses on product traceability in case of a recall, requiring that, within 18 months, FDA provides a report to Congress on recommendations for establishing more-effective product tracing. The bill also provides for user fees, whistleblower protection and suspension of registration for noncompliance, among other measures.

What does this new law mean for product developers? Companies are well-advised to immediately start reviewing and modifying their policies and procedures where necessary to comply with the new law. This is not just an exercise for the legal department; it will involve  the whole company, including the product-development group. It is imperative that product developers understand the essence of this legislation and how it will directly impact their day-to-day activities.

Product developers are in a position to help their companies facilitate an effective traceability plan across their supply chain. Product developers can choose ingredients that are inherently less risky, and they can utilize processes or preservation technologies, such as high-pressure or ozone technology, to help mitigate risk.

Product developers also can play a pivotal role in helping qualify contract manufacturers, who will have to abide by the new legislation, as well. Choosing the right co-manufacturer to conduct plant trials and ongoing production can make the difference between a seamless product scale-up and fixing headaches after the fact. By working with the procurement, food safety, quality and operations groups, and others within the organization, product development can guide the team to a successful prevention-focused approach to food safety.

The choices you make when formulating a new product can make the difference between the product being considered a high-risk" food versus a lower-risk food. Your choices are more important than ever before when considering the implications of the FSMA.

As ol Ben once said, A little neglect may breed great mischief for want of a nail the shoe was lost; for want of a shoe the horse was lost; and for want of a horse, the rider was lost." Do not neglect your role in guiding your company through the maze of the new food-safety legislation. If you do, you run the peril of losing the rider: You!

Paul A. Hall, Ph.D., is CEO of AIV Microbiology & Food Safety Consultants LLC, Hawthorn Woods, IL, a leading provider of expert and technical guidance and consulting services to a global food industry customer base. An internationally recognized food-safety expert, Hall has more than 35 years of experience in the food and beverage industry with companies such as Kraft Foods, Anheuser-Busch and Ralston Purina. For more information, visit aivfoodsafety.com or contact Hall at [email protected].

Sponsored by ConAgra Mills.