With the passage of the Food Safety Modernization Act (FSMA) on Jan. 4, the nation's food manufacturers may have to rethink the way they operate. Len Heflich, chair of the American Bakers Association (ABA) Food Technical Regulatory Affairs Committee, offered some advice forBaking & Snack'sOperations Update readers.

"Perform a comprehensive food safety risk assessment of all production and food storage facilities and implement actions to minimize the identified food safety risks," Mr. Heflich said. "FDA has 18 months to fully define what is required, but the legislation gives us a hint: Existing seafood and juice HACCP programs meet the requirement. We can look at these programs to identify the key steps. Even though some of the details will be different the main structure will be applicable to our business. Start now."

Another facet of the FSMA is its documentation requirements. The act allows FDA greater access to records concerning any food products it believes might be adulterated and present a risk of serious adverse health consequences or death. "Are your forms legible?" Mr. Heflich asked. "Is documentation complete, or are there gaps? Do operators understand the importance of accurate, complete documentation? When an out-of-compliance event occurs, are people taking urgent, corrective actions to assess the event and take appropriate actions? Are the actions and decisions documented? Test your system; play devil’s advocate and look for inconsistencies in your system. Better you find them now and correct them before FDA asks the tough questions."

Baking and snack companies also must review their supply chains to make sure vendors are complying with the new requirements. "Imported ingredients are a potential gap in our current food safety programs," Mr. Heflich said. "We don’t know the vendor, their operation or how well they comply with food safety requirements. The industry desperately needs a good third-party audit and auditing partner to go to food manufacturers globally and provide the assurance we need that these producers are safe and in compliance."

Finally, Mr. Heflich recommended developing a testing program to ensure pathogens are not present in production facilities. "This is tricky and can put you at risk of a product recall if you do it wrong," he cautioned. "The basic guidelines include: Do not test finished product for pathogens; test for indicator organisms; [and] test non-food contact surfaces, especially drains and under equipment. When you find a hot spot, modify your cleaning procedures and frequency until the hot spot is eliminated."

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