As the global food chain becomes more intertwined and as pressures to enhance food safety grow, government regulators in such diverse countries as the U.S., China, Canada, and Mexico are seeking to strengthen and streamline their inspection activities by leveraging private-sector audit and certification activities.
The presumption is that private certification schemes, such as those recognized by the Global Food Safety Initiative (GFSI) or developed by the International Standards Organization (ISO) can help food facilities meet or exceed national food safety laws. Thus, food companies that have been audited and certified by organizations such as the SQF Institute, BRC Global Standards, or FSSC 22000 are highly likely to be in compliance with government food safety requirements. This would allow regulators to focus their limited inspection resources on unaudited companies, considered more likely to have food safety problems than audited and certified firms.
Canada is in the process of implementing a new certification policy that would tailor inspection and oversight activities to private audits. “Where companies are certified to be in good standing to a scheme that we’ve assessed, we will give them credit,” said Mark Burgham, senior director for program policy integration at the Canadian Food Inspection Agency (CFIA).
The audit credit would be entered into an algorithm that CFIA created, which also includes the firm’s compliance history, its inherent product and process safety risks, international intelligence, and other factors. Outputs from the algorithm “will influence the level of inspection, the frequency of inspection, or how we target specific direction to our inspectors,” Burgham told a GFSI-convened briefing in Washington, D.C. in November 2016.
In a pilot project, GFSI benchmarked schemes “met or exceeded” Canadian food safety standards for preventive controls, Burgham said. While CFIA will neither endorse nor recognize any specific private certification scheme, “there is recognition of great things going in industry that we need to understand better and ensure that we leverage,” he added. “So we will be looking at matching the highest risks with how we respond to them.”
Convergence with FSMA
“If you have a GFSI-benchmarked certification, you are very close to being compliant with FSMA [Food Safety Modernization Act],” said Mike Robach, chairman of GFSI’s board of directors and vice president for corporate food safety and regulatory affairs at Cargill Inc. “That’s the way we’ve prepared for it both with Cargill in the U.S. and in our facilities outside of the U.S. that export to the U.S.,” he told conference attendees.
In July 2016, Robach and other GFSI officials met with Stephen Ostroff, MD, FDA deputy commissioner for foods and veterinary medicine, to discuss a pilot project that would compare GFSI’s benchmarking requirements against FSMA regulations. As part of this effort, GFSI commissioned The Acheson Group, founded by David Acheson, MD, former FDA associate commissioner for foods, to conduct a side-by-side comparison of FSMA’s final preventive controls rule with GFSI’s new Version 7, due to be issued in January 2017. GFSI had planned to discuss the results of that analysis with the FDA in early 2017, Robach said.
“We hope and believe that given the alignment between GFSI and FSMA that there is a role for GFSI to play in demonstrating compliance with the new law as one of several risk-based criteria in compliance, just as we’ve seen with Canada,” Karil L. Kochenderfer, GFSI’s North American representative, tells Food Quality & Safety magazine.
The preventive controls rule (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food ) requires U.S. and foreign firms that manufacture, process, pack, or hold human food to have written plans that identify hazards, specify steps to minimize or prevent those hazards, identify monitoring and recording procedures, and specify actions that will be taken to correct problems that arise. FDA has the authority to evaluate these plans and inspect facilities to ensure the plans are being followed.
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