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.”
Thurston said integrated data flow is an important tool for organizations as they prepare for FSMA, reinforcing their existing hazard plans. Storing all sample data electronically in a centralized database available to management at any critical point enables decision makers to stop production quickly if needed and to keep out-of-spec products out of the marketplace.
Even though much of the act has yet to be implemented, the FSMA has been a tipping point for the industry, according to Scott Scdoris, director of food and beverage for Celsis.
“The days of keeping paper records and not being able to readily access information from testing that you’ve completed are done,” he said, noting that just a few years ago, companies still kept records in notebooks. “Now and then the USDA or FDA would come in and look to see if we were keeping them, but not much more than that. If anyone asked us to go back six months and look at this lot of products run on this machine, it would have been almost impossible.”
Despite the FSMA’s setbacks, Scdoris said, most companies have already put in place formal policies and plans related to the law. “They’re focusing on the questions of how the data is maintained and how it is accessed if they are using electronic records.”
FSMA’s Little Siblings
Apart from the FSMA, a number of other food safety regulations were enacted in 2012, including the final phase of the FDA’s egg safety rule. The mandate, which first went into effect in 2010, required shell egg producers with more than 50,000 laying hens to implement Salmonella prevention measures. This year saw the FDA impose the same requirements on all producers with more than 3,000 hens; those with fewer are exempt.