CHICAGO — On a keynote panel mostly about the angst being felt around food safety, Costco’s Craig Wilson was the calmest guy in the house. And why not?
When Wilson, Costco Wholesale Corporation’s vice president for food safety, asked those in the 1,000-seat theater if any of them had Costco cards, half to two-thirds raised their hands. And when he circled back a few minutes later to ask how many were Costco suppliers and how many were Costco consumers, he learned the split was fairly even.
The 2017 Food Safety Summit, moving into its second day, featured five speakers for its keynote presentation. They discussed how food safety professionals are coping with new Food Safety Modernization Act (FSMA) rules taking effect and the increased likelihood that company actions will be subjected to legal review.
Wilson called it “the elephant in the room,” noting how much has changed in the past five years. He said the regulatory environment is in a “state of flux.” For those who needed reassurance, he added: “If you are buying ingredients from us, let us know and we will figure it out.”
The FSMA was signed into law by President Barack Obama on Jan. 4, 2011, and required about five years of rule making processes before it could be fully implemented. Kathy Gombas, former FDA senior advisor for food safety, said some small- to medium-sized processors are only now scrambling to get the training they need to comply.
She said processors need to find out what they need to do to comply and then share the burden of doing it among more than one person in their company. Gombas said training, guidance documents, tools like model plans and templates, and technical assistance through states, academia and trade associations are among the resources readily available.
Gombas also said she had permission to announce that FDA is close to rolling out a web-based food safety plan builder on its website.
The United Fresh Produce Association’s recently retired senior vice president for food safety and technology, Dave Gombas, said there is still confusion among businesses that don’t know if they belong under the produce rule or preventative controls. “They don’t know where to start,” he said.
The FSMA produce rule marks the first time that farms are falling under FDA regulation, although the smaller operations remain exempt. “I think there are a lot of small processors that do not know the rules that apply to them,” he said.
Kathy Gombas suggested people seek out human sources of help, rather than relying entirely on the internet. She said state departments of agriculture are often serving as the best “FSMA ambassadors.”
Food industry attorney Shawn Stevens said it’s important that people in the industry understand that with the FSMA “FDA was commanded by Congress to stop foodborne illness.” Stevens advice is for food companies to lean into FSMA and be aggressive about it.
Stevens said the goal now is to avoid making the operational mistakes that could result in criminal exposure. When FDA inspectors “come into our facilities, they are looking for evidence of contamination,” he said.
Jeffrey Steger, assistant director of the U.S. Department of Justice’s consumer division, said no one should expect any lessening of DOJ’s backstopping FDA’s enforcement actions. DOJ has several high profile food industry prosecutions under its belt and Steger expects the trend will continue.
DOJ gets involved in cases where there is significant harm to consumers, where food company executives had prior knowledge, and where legal action will protect the integrity of the regulatory system and prevent future harm.
Steger said the U.S. Supreme Court may again rule on the so-called Park Doctrine used by FDA to prosecute “responsible corporate officials” for violations they are not expressly aware, but that fall under their overall responsibilities. He said DOJ favors preservation of the Park Doctrine.
The keynote panel was moderated by Dane Bernard, managing director of Bold Bear Food Safety.
The event at the Donald E. Stephens Convention Center in Rosemont, IL, wraps up today with more educational sessions and workshops. A morning “Town Hall” will feature the top officials from the U.S. Department of Agriculture’s Food Safety and Inspection Service, Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.
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