Representatives from the Consumer Brands Association, the Safe Food Coalition, and the Association for Food and Drug Officials have written to Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA), to express their support for FDA's compliance with the Food Safety Modernization Act's (FSMA) inspection frequency mandates. The letter also proposed a collaborative approach to addressing the inspection challenges and opportunities outlined in the recent FDA report entitled “Resiliency Roadmap for FDA Inspectional Oversight" (hereafter "Inspection Roadmap").
The letter specifically requested that FDA build on its Inspection Roadmap and New Era initiatives by leading a stakeholder engagement process to explore ways to meet the domestic inspection frequency mandates in FSMA and better protect public health through modernizing inspections. The letter also requested that FDA provide the organizations that authored the letter with a seat at the table to discuss inspection modernization with FDA and how to most effectively leverage technology and state regulatory resources. The groups also communicated that they are looking forward to further engagement with FDA on inspection modernization.
On the topic of FSMA, the organizations noted that:
"This year marks the 10th anniversary of FSMA’s enactment. The regulatory framework is largely in place, but [your] Inspection Roadmap report is a reminder that much work remains to achieve a modernized inspection program—one that makes the best use of all available resources and fulfills the law’s vision of risk-based prevention, comprehensive accountability, and consumer confidence in the safety of the food supply. We propose that FDA build on its Inspection Roadmap and New Era initiatives by leading a stakeholder engagement process to explore ways to meet the domestic inspection frequency mandates in FSMA and better protect public health through modernizing inspections. The undersigned stakeholders specifically request a seat at the table to discuss inspection modernization with FDA and how to most effectively leverage technology and state regulatory resources."
They also expressed some concerns with the Inspection Roadmap:
"We are concerned, however, by FDA’s suggestion in the Inspection Roadmap document that Congress should revisit and possibly modify or repeal the FSMA inspection frequency mandate for domestic food facilities. We support having a risk-based inspection strategy, but we see no conflict between such a strategy and the FSMA domestic inspection mandate, which establishes a baseline frequency of domestic facility inspection and gives FDA broad discretion to tier inspections based on the agency’s assessment of risk. Indeed, we see the inspection mandate as a critical component of managing foodborne illness risk, and for that reason, oppose weakening this important provision of FSMA."
As a first step toward a collaborative approach to food inspection modernization, the organizations urged FDA to engage in dialogue with them and other stakeholders to improve understanding of the data and analysis underlying the Inspection Roadmap report.