The Intersection of Government and Industry Standards

The Intersection of Government and Industry Standards

The food & beverage industry must merge new FDA rules with existing processes, which may mean creating their own interoperability protocols and best practices for safety.

“When I sit down for a daily meal it never occurs to me that the food I’m about to ingest may be contaminated. Which is why I winced when the Centers for Disease Control and Prevention (CDC) reported that each year foodborne diseases get 48 million Americans (1 in 6) sick, 128,000 people are hospitalized and 3,000 die.”

 

It’s a serious issue, and one that is now under the control of the Food and Drug Administration (FDA), which is hammering out the final details of the Food and Safety Modernization Act (FSMA) of 2011—the most extensive overhaul of food safety laws in over 70 years.

The new regulations, which are still under review, are designed to prevent microbial pathogen contamination at every stage of food processing. That means farmers and manufacturers and everyone in the supply chain will soon be under the FDA microscope to prove they comply with new quality, safety and traceability standards.

Once the rules are finalized and implementation and enforcement begins in 2016 and beyond, companies that have a food safety incident and that are found not to be in compliance could have the suspect product put on hold, or worse, a facility could be shut down. That doesn’t bode well for the many brands populating the FDA website which includes a daily showcase of safety warnings and product recalls.

So what does this really mean for manufacturers? Money. An investment, that is, in modern traceability systems. According to the 2014 Food Safety and Traceability Report from PMMI (PMMI is the parent company of Automation World), four technologies could greatly increase traceability capabilities. These technologies include bar codes, 2D matrix codes, RFID tags, and integrated unit tracing options to automate applying lot labels and recording corresponding database entries.

A great example of why food manufacturers need to have fine-tuned traceability processes and technologies comes from a pistachio processor, which, in 2008 had a salmonella outbreak traced back to the company. It was found that the pistachios were contaminated when the roasted product mingled with the raw product. The company couldn’t determine where the lines ran together and which lots were the problem, and therefore had to recall its entire 2008 crop, according to David Acheson, a former FDA official and current president and CEO at The Acheson Group, who shared this case during his 2012 Automation Conference keynote.

Despite the fact it could have been a very small percentage of the product that was contaminated, they were penalized for not keeping good records.

Ultimately, control is best left in the hands of the manufacturer, not the FDA. But that means making a commitment as an industry to drive innovation rather than respond to regulations.

“It’s about knowing what goes where in your system,” Acheson says. “And using automation to do it. We need systems in place that look after themselves.”

Perhaps more importantly, the food and beverage industry needs to band together on this one to help make the rules. The FDA hosts meetings open to the public to go over proposed standards—the next one being on February 10, 2015 focused on FSMA’s Environmental Impact Statement (EIS) for growing, harvesting, packing, and holding of produce for human consumption. Attending such a meeting is a great opportunity to help define the rules.

In addition, the PMMI report suggests the food industry devise its own interoperability data standards and protocols for uniformity, as the FDA is not likely to design or dictate such protocols. Although industry-wide protocols might not yet exist, some large companies do currently operate their own traceability databases, which could conceivably form the beginnings of an industry-wide protocol. Manufacturers are also looking to automation and equipment suppliers to build features into existing and future products that address FSMA requirements.

Acheson, too, urged vendors to design hardware, software and control technology that will help their customers with FSMA compliance because food processors, he says, are under a lot of pressure right now. “They are going to be tasked with identifying where risks are in their systems and controlling it.”

Ultimately, control is best left in the hands of the manufacturer, not the FDA, don’t you think? But that means making a commitment as an industry to drive innovation rather than respond to regulations.