FDA will consider track records to target FSMA inspectionsWhat’s on your permanent record?

Food and Drug Administration officials say the agency will consider companies’ food safety histories when prioritizing inspections under the Food Safety Modernization Act. They also say the FDA is changing the way it approaches food safety.

The one-size-fits-all approach is literally being written out of policies and procedures as the agency develops commodity-specific and sector-specific guidance, officials said during a July 7 teleconference organized by the Produce Safety Alliance at Cornell University.

Kathy Gombas, the food safety lead at the FDA’s Center for Food Safety and Applied Nutrition, and Samir Assar, director of produce safety at CFSAN, discussed the status of preparations for implementing the FSMA.

Much of the work will be virtually invisible to the public because it involves technical issues such as integrating a patchwork quilt of computer systems and data bases.

But, Gombas and Assar said other changes will be very apparent.

“We will specialize our inspections and compliance functions and staff by creating commodity-based regulatory programs,” Gombas said. “(Previously) it was quite possible that you might have a medical device investigator in the facility and then the next day they might be doing food, but what we’re going to be doing now is focusing that specialization on food.”

FDA will consider track records to target FSMA inspectionsAssar described a “specialized cadre” of regulators who will be taught how to do on-farm assessments. Gombas said there will be “subject matter experts” available for real-time consultation with regulators in the field so questions can be answered when they come up, whether from inspectors or those being inspected.

“We’re going to invest in our regulatory training and the calibration of our investigators and inspectors to ensure the training is resulting in consistent inspections and decision making,” Gombas said.

Assar said the government is now more concerned with ensuring food safety than in seeking punishment for violations.

“To the extent possible we would like to provide the opportunity on the spot for the farmer to take the corrective action and possibly avoid any type of formal documentation as to a violation but instead record that a corrective action was taken on the spot,” Assar said.

Growers and other companies will fare better under the new system if they are already practicing good food safety protocols, they said. Gombas said there will be regulatory incentives for operations that have good records.

“Firms with good compliance history may be inspected less frequently,” she said. “They may have shorter inspections and or inspections may have a different focus. Maybe it will be a component inspection.

“We will assess a firm’s food safety culture by using a different line of questioning. We will factor whether or not a firm has a culture of food safety into our risk prioritization model for inspection purposes. We will apply a wider range of inspection sampling, testing and data collection activities.

“So gone is the one-size-fits-all approach to inspections and industry oversight in general.”