– Opinion –
Editor’s Note: It was written in response to comments from FDA Commissioner Dr. Robert Califf. Exclusive interview With Food Safety News publisher Bill Mahler, posted on Feb. 27.
Dear Dr. Caliph,
The FDA Food Program is different. The food system and food safety are complex, but the core of FDA’s food safety role and Congress’ mandate is simple. FDA establishes standards and guidance for industry and works with industry and regulatory partners in a variety of ways to ensure compliance with those standards. The Foods Program’s mission is fundamentally different from Google and hospitals.
Matrix management may sound logical, but it is the FDA’s prescription for failing to meet its Food Safety Modernization Act (FSMA) vision and obligations.
As representatives of the food industry and consumers, and as state food regulators who have worked directly at all levels of food programs for many years and share our unwavering commitment to food safety success, we offer: increase.
- Cultural change requires central leadershipFDA’s food safety success depends on the seamless functioning of headquarters and field inspections, laboratories and import departments with a shared vision, mission and priorities. The required changes cannot be achieved simply by defining decision rights in a matrix management system. It is about changing culture, moving field units from a culture of fixed response and enforcement to a culture of public health prevention and cooperation to achieve food safety, supported by enforcement when needed. It is about leadership that can be transformed into
- Previous attempts at matrix management have failedBeginning with the program coordination of the partially empowered Deputy Commissioner for Food and Veterinary Medicine and Commissioner Hamburg from 2010 to 2018, matrix management for FSMA implementation has been attempted in multiple formulations for over a decade. but apparently failed. There is no reason to believe it will succeed at this time.
- The need for a single empowered leader is well documentedMatrix management failures in food programs have been thoroughly documented by an independent panel of experts at the Reagan Udall Foundation. In addition, the Commission should consolidate all elements of the food program under a single leader with all-bank administrative authority to guide its essential cultural change and modernization of the programme. recommended. So far, there are no convincing explanations to refute this recommendation.
- Food safety requires an integrated food programFor the FDA to be successful in food safety, a large frontline workforce must see themselves as an integral part of the food program and become an integral part of the food program. There is no need to continue to be a separate organization protecting the FDA’s independence and antiquated closed culture and food safety response. problem.
- Integrated field force does not compromise efficiencyRather than clinging to a fragmented ORA food program structure that hinders food safety progress, it is possible to achieve the desired logistical and administrative efficiencies for the food program’s field activities through shared services with the medical products program. can.
We encourage you to rethink plans that rely on a failed matrix management approach to lead and transform your Foods Program. We recognize that large-scale organizational change is often met with internal questions and resistance. These need to be considered, but the stakes are high if bureaucratic issues are so important to American health and so important to public confidence in the FDA’s oversight of food safety that it prevents progress. Too much.
Successful food safety needs and deserves better.
stop food poisoning
consumer report
consumer brand association
Association of the Food and Drug Administration
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