The year started out with so much promise. President Obama had signed the Food Safety Modernization Act into law a year earlier, setting up rules for the FSMA’s foreign supplier verification program and safety requirements for high-risk produce, to be implemented the following January. The FDA was slated to roll out regulations for preventive controls shortly after.
But a year later, those rules have yet to be released. Although some industry observers predicted that action will finally be taken following the presidential election, others noted that additional barriers may hamper implementation. For example, with a government divided over federal spending, finding the funds to implement the new rules may be difficult. In other words, for many food safety experts, the biggest story about food safety in 2012 was what didn’t happen.
“FSMA has turned out to be yet another unfunded mandate to the FDA,” said Will Hueston, DVM, PhD, executive director of the Global Initiative for Food Systems Leadership at the University of Minnesota in St. Paul. “It passed with broad bipartisan support, but implementation has been slowed by lack of action on regulations and will continue to be slowed by simple lack of funding. It’s unfortunate, and there’s widespread frustration because we thought this was going to be the big year for compliance.”
Still Preparing for FSMA
The good news for manufacturers and distributors is that the delays and frustration haven’t stopped vendors who will help industry comply with the FSMA when it’s fully enacted. Colin Thurston, director of product strategy for process industries at Thermo Fisher Scientific, said his company has been developing laboratory information management systems focused on sample and data control and compliance based on the EU’s requirement for food safety labs. Those rules require adhering to the International Organization for Standardization’s 17025 standard for calibration and testing laboratories as a comparison point.
“Our LIMS for the food industry is focused, in addition to laboratory workflow and data management, on ISO 17025 requirements such as training records for users, calibration, and maintenance records for instrumentation in the lab; authorization of results before they are issued, even HACCP requirements; and all of those kinds of control aspects on top of the normal lab record-keeping,” Thurston said. “The goal is integrating lab data not just within its own process but throughout the manufacturing space, with connectivity tools like our CONNECTS platform, so that management has a view to risk management processes and is prepared with data in the event of any out-of-spec production, thus preventing contaminated product from reaching the consumer.”