Fixing What's Broken at FDA, Part II

Canada's success at streamlining their food safety laws 35 years ago is a model for America. It could have helped prevent what happened with our infant formula crisis.

Part I can be found here.

Books and movies have forever influenced culture. But some have had an outsized influence on public policy and laws. Rachel Carson’s 1962 “Silent Spring” influenced the John F. Kennedy Administration and future regulators to curb or eventually ban the use of chemical insecticides like DDT. The movie “One Flew Over the Cuckoo’s Nest” in the early 1970s helped spur the closure of hundreds of mental hospitals in favor of others forms of treatment.

And in 1906, Upton Sinclair wrote a muckraking novel, “The Jungle,” that would spur the Theodore Roosevelt Administration to sign two landmark laws, The Pure Food and Drugs Act and the Meat Inspection Act. While technically a novel, Sinclair’s tome exposed terrible worker and safety conditions in Chicago’s meat industry. Roosevelt ordered an investigation and found many of the anti-capitalist Sinclair’s assertions to be true. Sinclair would eventually enter politics, narrowly losing a race for California Governor in 1934 based on an interesting collectivist anti-poverty agenda.

Both new food and drug laws were primarily about “truth in labeling” but would result in the creation of the Food, Drug, and Insecticide Administration by the start of the Great Depression. “Insecticide” would be dropped from the name by 1938.

Both laws were expanded a few years later, and new ones, like the Poultry Products Act, were added. The FDA today has grown into a $6.5 billion behemoth with 18,000 employees, regulating everything from condoms to lasers and, most recently, cigarettes. Annual appropriations from Congress cover more than half their budget. Industry user fees generate the rest to expedite drug approvals. The agency and its advocates have long sought to expand user fees, such as approving new food additives - including “contact substances” or food packaging - and even food safety inspections.

Ah, paying for the joy of being regulated. That’s like paying the IRS to conduct your tax audit.

The Center for Food Safety and Applied Nutrition is responsible for activities that fall under the first word in FDA. They employ over 1,200 workers, mostly food safety inspectors, with a budget of $182 million. Those roughly 900 food safety inspectors check some 53,000 facilities or about 1 for every 5-6,000 processing facilities.

Meanwhile, at the USDA’s Food Safety and Inspection Service (FSIS), some 8,000 inspectors oversee 6,000 meat and poultry facilities. We described in Part I what that is - radically divergent food safety inspection regimens. No other country operates its food safety systems quite this way. While FDA stretches its ability to cover 53,000 facilities, USDA has more inspectors than the facilities they oversee.

And by the way, the foodborne illness outbreaks always have and will continue to be with us, despite increased government authority, inspectors, and money.

No one is suggesting that, but instead of adding more FDA inspectors, there’s a better way to fix the problem. And Canada showed the way 35 years ago.

In 1997, Canada created a single food safety inspection agency, the Canadian Food Inspection Agency (CFIA). Meanwhile, public health policy and standard-setting responsibilities were consolidated within Health Canada, roughly their version of our Department of Health and Human Services. Previously, food safety inspections, food policy, and risk assessment responsibilities were shared by three agencies. The consolidation was primarily cheered by food manufacturers.

So, what were Canada’s objectives, and how has consolidation worked out?

“Reducing spending was one of Canada’s objectives in consolidating its food safety system,” reported the Government Accountability Office (GAO) study of Canada’s reforms, along with calls from government and industry to operate more efficiently and effectively. During the CFIA’s first two years, food safety operating expenditures were reduced by 10 percent, mostly from finding “alternative ways of doing business.” The GAO reported that both government and stakeholders cited improved service delivery by providing a single contact for consumer and industry clients; more consistent and timely enforcement of food safety laws and regulations; reduced overlap in inspections; increased coordination among entities involved in food safety activities; and improved accountability and transparency.

While there has been the occasional criticism – much of it stemming from a severe 2008 food safety outbreak involving Listeria in processed meats, resulting in 22 deaths and exposing some gaps in enforcement – there remains high confidence by both industry and government in food safety regulation and management resulting from the 1997 reforms. Food safety hasn’t emerged as a partisan political issue in Canada. And Canada isn’t alone in consolidating food safety agencies.

In fairness, notable differences exist between the U.S. and Canada, starting with a population (360 million versus 36 million) and our government systems. But has Canada provided a roadmap for the United States to reorganize its food safety system in a way that is not disruptive but will result in greater efficiencies and effectiveness, including protecting consumers? The answer is yes, but perhaps not all at once.

Replicating Canada’s success will not be easy in the U.S. for many of the same reasons that previous efforts have not been successful. It will not be easy to craft a unified force of food safety inspectors from one unionized agency (FSIS) and another (FDA) that is not, especially when considering that these two groups operate with very different underlying systems. But the benefits of making inspections more efficient – having a single, risk-based approach versus the current bifurcated system -- could be substantial. It would mean that just one agency, not two, would inspect manufacturing facilities that make products currently under both FDA and FSIS jurisdiction. A food facility operating under dual jurisdiction would mean one agency and one point of contact.

It could eventually result in the designation of another agency, like Health Canada, responsible for standard-setting, labeling, and related policy considerations. Whether it is HHS or USDA, that kind of consolidation of oversight agencies doesn’t have to be accomplished simultaneously by creating a single food inspection agency. Just pick one, eventually, but it can wait until we merge the inspectors under a single room. We can do this incrementally.

The arguments against doing this are predictable. We are disrupting a system that works and putting food safety at risk, some may say (Canada made it work). Congressional turf wars between the committees that oversee HHS, which are different from the Agriculture Committees, will kill it. Maybe, but when they passed a major GMO disclosure law (genetically modified foods) six years ago, the HHS committees gave way to the Agriculture folks. The turf war thing is probably overblown. Others fear a single politicized agency, but it hasn’t worked out that way in Canada. Just require nominees to have expertise in the field and subject the director to Senate confirmation. Everyone else can be career professionals with a few “Schedule C” political appointees as needed.

As for the union versus non-union inspector force, I’ve always agreed with President Franklin Roosevelt that government unions shouldn’t be allowed. But in this case, so long as the employees are deemed “essential” and are not allowed to strike, it’s negotiable.

I’m just guessing, but I suspect such an agency, with the agility to move inspectors as needed regardless of facility types, would have been on top of any issues at the Abbott infant formula plant in Sturgis, Michigan, much faster and faster more effectively.

The last three Presidents, George W. Bush, Barack Obama, and Donald Trump, have endorsed the concept of a single food agency. It’s time for food safety to enter the 21st Century.