During his presentation, “FSMA, How to Prepare: A Practical Approach,” Mr. Stratford pointed out that FDA is now required to inspect every food US processing facility that deals in interstate commerce at least every 5 years. The agency is not required to announce audits, but it has been known to give notice of a visit. The law further mandates that higher risk facilities be inspected a minimum of every 3 years.
Although currently FDA doesn’t have the necessary manpower to carry out this obligation, Mr. Stratford said he believes that will change. Someone in attendance of Mr. Stratford’s presentation suggested that they were aware FDA is hiring additional inspectors. Mr. Stratford also stated later during his presentation that FDA is authorized to reach out to third-party firms to perform audits in the future.
Another major change required by the law is companies have to register with FDA every two years, beginning next year. Companies should currently be registered with FDA because of the Bioterrorism Act of 2002, but will be required to reregister biannually.
Further, the new law basically requires companies to complete a Hazard Analysis and Preventive Controls plan. ”This is similar to HACCP used internationally for food safety, although there are several unique differences,” he said.
One new aspect is that hazard analysis now includes radiological, along with biological, chemical and physical. Common preventive controls include regular sanitation, metal detectors, sifters, x-ray machines and vision systems; however, plants must be able to verify that its methods are capable and have documentation to show it’s in control, he said.
Even companies with HACCP will most likely have to update their plans, and the new law requires companies keep records for two years. However, if a company keeps records for more than this period, FDA auditors can review them during inspections, Mr. Stratford noted.
Companies need to re-address their hazard analysis program at least every 3 years, he added.
Traceability programs required by the new law are virtually the same as previously required. It’s basically a one up, one down program. This means companies need to be able to trace their ingredients to their supplier, and finished product to the first point of shipment. Additionally, facilities must have a program to recall product from the market if necessary.
While recalling a product is a major issue for any company, having to recall a product yet not knowing what to do would make the situation much worse. “Hopefully you are doing traceability and recall exercises at least twice a year,” Mr. Stratford said. “It will test the efficiency of your program. You don’t want to learn to do this when you have an actual recall.”
As one last piece of advice, Mr. Stratford said, “Don’t let [requirements of the new law] slip past you.” He also suggested registering at www.fda.gov to receive information and updates on FSMA.