Later this week, most of us in the United States will gather together for the simple but meaningful act of sharing a meal as a way to celebrate and reflect upon the relationships and blessings that enrich our lives. The menus will differ from table to table, and family to family, of course. But very few of us will give much thought to whether the food is safe to eat whether it’s been tainted with bacteria or other pathogens.
All things considered, the United States has a strong food safety system—among the best in the world—something to add to our list of things to be thankful for. But distressingly, the system relies on a series of programs that are designed to respond to food illness outbreaks after they’ve already started with the objective of limiting their scope and impact as much as possible. It’s far less adept at preventing such outbreaks in the first place, a lesson we’ve been reminded of over the last several years as outbreaks have popped up again and again.
This decades-old “reactive” approach can and should be improved. The Centers for Disease Control (CDC)—the main and best source of information, given its role in tracking and investigating major outbreaks—estimate that foodborne disease causes 48 million illnesses each year in the United States. Recent outbreaks include the Listeria-tainted cantaloupe from Jensen Farms in Colorado, which killed at least 33 people and sickened 147 more across 28 different states, and the peanut paste products infected with Salmonella, which killed at least nine people and sickened 714 more across 48 states.
Congress and President Obama recognized the shortcomings of the existing food safety system in 2011 when they enacted the Food Safety Modernization Act (FSMA), which sought to overhaul the country’s approach to food safety by instituting programs designed to prevent foodborne illness before it occurs. Two of the laws’ programs—one aimed at “Preventive Controls” for processed foods and the other aimed at “Produce Safety”—will likely have the biggest impact on averting foodborne illness outbreaks.
To get the preventive controls program in place, the Food and Drug Administration (FDA), which Congress has charged with implementing the FSMA’s provisions, is working on separate rulemakings for processed human foods and processed animal foods. These rules will apply to non-farm activities such as turning carrots into “baby carrots” or the manufacture and preparation of food items ranging from frozen meals and spices to nut butters and cheeses. In contrast, the Produce Safety rule identifies key farming practices (irrigation, fertilization using manure and biosolids, equipment choice, worker training) that are vulnerable to pathogenic contamination if not carried out properly.
These two sets of rules are among the 13 “essential” regulatory actions featured in CPR’s recent Issue Alert on safeguards that the Obama Administration can and should implement before the completion of its term in office. As these rulemakings illustrate, completing these actions will deliver enormous public health benefits to the American public, and they can be accomplished even in the face of the gridlock that is sure to characterize the relationship between the Executive and Legislative branches for the remaining years in the Obama presidency. To be sure, these rulemakings will involve a lot of complex and technical work, but the only real barrier to their completion is the Obama Administration itself. It already has the legal authority to complete them. The question is: Does President Obama have the political will to do so?
To this point, progress on these two regulatory actions has been much too slow a slog. The FDA issued new “re-proposals” for the two Preventive Controls rules and the Produce Safety rule in September 2014, which puts these rulemakings well behind the FSMA’s mandated timeline. (The Preventive Controls for animal food was supposed to be proposed by no later than October 2011 while the Produce Safety rule was supposed to be proposed by no later than January 2012; the Preventive Controls for human food was supposed to be completed by no later than July 2012.) The FDA is now under a court order to complete the Preventive Controls rules by August 2015 and the Produce Safety rule by October 2015.
If it is to meet these new judicial deadlines, the Obama Administration cannot allow any further delays. The first test of the Administration’s commitment to completing these rules in a timely fashion will come next month, when the comment period on the re-proposals is scheduled to end. The FDA should demonstrate its commitment to protecting the public against foodborne illness by resist any calls to extend the comment period further. That way, the agency will be able to begin working toward drafting the final rules as quickly as possible.