FDA and USDA Under Pressure to Improve Food Safety Approach
A preview of this year’s food safety agenda
Each year, an estimated 46 million Americans are sickened by foodborne illness. Lost productivity and medical costs associated with food safety outbreaks are estimated to be as high as $90 billion annually. Although Congress last advanced comprehensive food safety legislation over a decade ago, with both federal food safety regulators — the Food and Drug Administration (FDA) and the Department of Agriculture’s Food Safety and Inspection Service — plotting significant moves and Congress chomping at the bit for oversight, we could see more action this year.
FDA shakeup
Last week, FDA Commissioner Robert Califf announced a proposed restructuring of the agency’s food oversight responsibilities, including naming a new Deputy Commissioner for Human Foods. The move, which Califf characterized as a “new transformative vision for the FDA Human Foods Program,” comes in response to an infant formula crisis, months of congressional scrutiny, and an independent third-party review of the FDA foods program.
How did we get here?
Agency observers know well that the food side of the Food and Drug Administration often fails to operate with the same sense of urgency and efficiency found in the human health and drug side. As detailed in a timely and comprehensive Politico piece written by Helena Bottemiller Evich last year, FDA routinely fails to advance important food and nutrition policies promptly, and dysfunction persists at every level within the agency.
These warning signs came to a head last spring when several babies died from cronobacter infections — suspected by public health officials to be caused by tainted infant formula. An investigation led to the shuttering of the Abbott Nutrition facility in Michigan and a subsequent nationwide infant formula shortage. As images of bare supermarket shelves graced the nightly news, FDA officials were summoned to the Hill to be questioned by furious lawmakers.
Amid this uproar, Commissioner Califf asked the Reagan-Udall Foundation to conduct an operational evaluation of the structure, function, funding, and leadership of the Human Foods Program. The shared frustration of industry, consumer groups, and state regulators, along with the significance of the Reagan-Udall evaluation, was discussed at an Invariant-hosted webinar last December.
Released in December, the Reagan-Udall evaluation found the “lack of a clear overarching leader of the Human Foods Program contributed to a culture of indecisiveness and inaction and created disincentives for collaboration.” The need for a singular food leader was a constant theme throughout.
Hill and Stakeholder Reaction
Under Califf’s proposed plan, the new Deputy Commissioner for Human Foods would be responsible for significant portions of the agency’s food safety work. However, the field staff responsible for ensuring that manufacturing facilities are safe would remain under separate leadership. The concept that the Human Foods Program would essentially remain fragmented was not lost on industry and consumer groups, and Capitol Hill noticed. Commissioner Califf promised additional details on the restructuring later this month, just in time for his annual appearances before the appropriations committees.
USDA and Salmonella
While much of the recent attention is focused on the FDA, we cannot forget about the US Department of Agriculture (USDA) Food Safety and Inspection Service’s (FSIS) role in keeping the public safe. FSIS recently put out for public comment a new Proposed Framework for Reducing Salmonella Illnesses Attributable to Poultry, which almost immediately drew harsh criticism from some in the industry who say it lacks a basis in science and data and is overly costly and complicated. Although the House and Senate Agriculture Committees have a packed farm bill agenda, USDA’s moves here are likely to be the focus of an oversight hearing, and numerous food safety topics appear on the House committee’s just released oversight agenda.
The infant formula crisis and other repeated missteps by the FDA continue to drive bipartisan interest in reform in ways complex food safety regulations and guidance documents often fail to do. In fact, the Energy and Commerce Committee’s recently released oversight plan for the 118th Congress includes examining “whether FDA’s reorganization efforts are improving the effectiveness of FDA regulation, or worsening delays and inefficiency in decision-making.”
For years the FDA’s foods division avoided scrutiny from Congress through a perfect storm of competing priorities and muted public interest. However, after the infant formula debacle, there is no longer anywhere for the agency to hide.
