FDA’s New Enforcement Powers

Senior executives of large food distributors, industry consultants and attorneys, and even FDA officials agree it will take more than simply abiding by the Food Safety and Modernization Act (FSMA) to ensure that unsafe food does not enter the marketplace. “At the end of the day, any regulations, any of your food safety programs, any of your SOPs, are all designed to deliver a specific result—food safety,” said Craig W. Henry, PhD, vice president, Decernis LLP.

“The real challenge is fewer foodborne illnesses, higher consumer confidence in the products that are produced and made available to that marketplace, and a higher degree of confidence in those who help govern, manufacture, deliver, distribute, and retail those products,” Henry told attendees of a workshop at this year’s Food Safety Summit in Baltimore on “Doing the Right Thing—Meeting Consumer and FSMA Food Safety Expectations.”

Jorge Hernandez, senior vice president for food safety and quality assurance at US Foods Inc., said safety and quality have to be part and parcel of any business. US Foods has more than 550 private label suppliers from more than 10 countries, and offers more than 300,000 private label and manufactured products. As a result, “the potential for a problem to be exponentially huge [exists] within a matter of days. To me, it’s not about regulation, but about doing the right things,” Hernandez said.

But for those who fail to grasp the importance of inculcating food safety into every aspect of their business, a senior FDA official outlined the new enforcement powers made available through FSMA, and explained how and when the agency intends to use them. Roberta Wagner, deputy director for regulatory affairs, FDA’s Center for Food Safety and Applied Nutrition (CFSAN), told workshop attendees that a key program goal is to develop and swiftly deploy the fastest, most effective methods for identifying, containing, and eliminating food hazards.

Enhanced Records Inspection

The first of the new tools is expanded authority to obtain and inspect food company records. FSMA Section 101 amended Section 414 of the Food Drug & Cosmetics Act, which itself had been added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the BT Act). The BT Act gave FDA access to records relating to food produced by a registered facility that the agency “reasonably believes” to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals (SAHCODHA). FSMA expanded the agency’s reach to records relating to “any other article of food” that it reasonably believes is likely to be similarly affected (not including farms and restaurants).

FSMA also gives FDA access to records when it has a “reasonable belief” that an article of food is adulterated, or that the agency believes there is a “reasonable probability” that use of or exposure to an article of food will cause SAHCODHA. “There’s a lot of the food industry where the FDA goes out and does inspections and we had absolutely no authority to review certain records,” Wagner explained. “We will invoke the use of this authority to gain access to those records.”

Having this authority would have been useful during FDA’s investigation of the Peanut Corp. of America during the massive Salmonella outbreak in 2009. “The firm refused to show us records regarding its testing programs and testing results,” Wagner said. “The way the records access authority was originally put out there, we were limited initially to only records that pertained to one line in that manufacturing facility, and only the one that produced the King Nut peanut butter that was identified initially as producing several illnesses in a nursing home,” Wagner told the workshop. “The authority given to us under the BT Act of 2002 was way too narrow.”