Presidential candidate Donald Trump ignited controversy in mid-September when his campaign website suggested eliminating “the FDA Food Police” and advocated rescinding several food safety regulations. The Trump campaign called into question the FDA’s oversight of farm soil, food hygiene, and safe food temperature recommendations.
In an odd stroke of poetic irony, the term “overkill” was actually invoked to argue against the public health role the FDA plays in the inspection of food manufacturing facilities. Fortunately for American gastrointestinal tracts, and after a public outcry, the campaign backed off of its anti-FDA proposals.
Any move to reduce the number of food safety inspectors—or, for that matter, any other action that would hamper FDA enforcement powers—would leave unrealized the legislative achievements of one of the most important and future-minded public health laws in America: the 2011 Food Safety Modernization Act (FSMA).
Hamstringing the FDA (the federal agency tasked with enforcing FSMA) would make FSMA an unrealized “dead letter.”
Such a term was used over a century ago by another food-regulation commentator. In October 1890, Robert Wallace, a professor of agriculture in Scotland, delivered a lecture to British students interested in the American beef export trade to Great Britain. Wallace’s lecture covered many aspects of the then-growing transatlantic livestock and meat trade, animal disease controls, and related economic policies.
And his wise words on the importance of regulatory enforcement are worth heeding in today’s political environment. In his remarks, Wallace stressed that a law on-the-books but unenforced “remains to all intents and purposes a dead letter.”
One wonders what Wallace and Trump might talk about if they were living in the same era. While Trump might lament regulatory “overkill,” Wallace would likely caution against laws that are merely “dead letters.” Perhaps the two would discuss a common dilemma historically faced by all governments: How is one to achieve a sensible and effective regulatory “balance?” That is, what is the level of enforcement required to give a law or regulation metaphorical teeth (i.e., avoiding a “dead letter”) without going overboard and creating a pseudo nanny-state that unnecessarily, ineffectively, or counterproductively interferes with the free market (i.e., “overkill”)?
Wallace might try to convince Trump that handicapping FDA inspection personnel and programs would turn FSMA, a much-longed-for effort to bring American food safety into 21st century, into a “dead letter.”
FSMA, like all laws, needs two key components: 1) sufficiently objective and prescriptive details (not merely vague aspirational statements) about what ought to be accomplished through the law and 2) a means for practical enforcement of those details by a regulatory body. FDA scientists have worked hard to elaborate the details of FSMA, whose objectives are both grand and specific. FSMA is the largest expansion of FDA authority since the 1930s. And although it only amends the 1938 Federal Food, Drug, and Cosmetic Act, the 89 pages of amendments have generated thousands of pages of notices, scientific commentaries, stakeholder feedback, and rules.
Some, like the campaign operatives who reluctantly pulled their proposal from the Trump campaign website, might point to so many pages as overkill. But let’s remember that, with the passage of time and the evolution of policies in different sectors of ever-increasing complexity (e.g., information technology and cybersecurity, health care, and the food system, just to name a few), it is only normal for laws to accumulate (and, to be sure, law libraries grow). The admittedly daunting size of government regulatory documents can make a large organization like the FDA an easy target (particularly for food safety novices seeking to score political points amongst cynics who question the effectiveness of government). But the enormity of regulatory texts isn’t a recent product of, say, the Obama administration; rather, these documents have consistently grown over time (in America’s case, since the founding of our government, and in the case of U.S. food safety law, since the passage of such laws as the 1906 Federal Meat Inspection Act).
The late David Landes put it well in his book, The Wealth and Poverty of Nations: simply put, “government rests on paper.”
Some might argue that FSMA was birthed by a rogue group of special interests or lobbying. Not true. Neither was it a spontaneously generated law invented by bored politicians. From its genesis, FSMA was a true group effort if there ever was one (involving both Republicans and Democrats); many thought leaders came together to help the U.S. government better respond to the latest category of food-related public health crises.
As food scientists studying the safety, security, and ongoing operation of the food system, we have seen the sources of foodborne illness outbreaks shift from primarily animal protein-based products to other troublesome food vehicles like spinach, frozen foods, cantaloupe, peanut butter, and others. Other new threats include the intentional adulteration of food abroad, and the ever-present specter of terroristic attacks on the food supply. These developments got the attention of politicians (who, in our republic, are to represent the people and make decisions in their interests) who rightly perceived a need to update—“modernize,” as the law’s title hints—food safety regulation in the U.S.
FSMA was the outcome of their efforts.
In light of that, let’s not allow FSMA to fall into “dead-letter” repute through an irresponsible dismantling of the FDA.
Enforcing laws involves a balance between doing nothing on the one hand, and taking unduly wide-ranging all-inclusive action on the other; somewhere in the middle the right balance can be struck. If Trump and Wallace were to discuss the pros and cons of funding and continuing the FDA’s implementation of FSMA, Wallace would (hopefully) convince Trump that moving FSMA forward is wise for public health, economic, and even political reasons. Here’s why.
First, undoing a law is costly. Hours of research and political jockeying were required to write FSMA, and even more time and energy has gone into the rulemaking and enforcement processes. Turning our backs on FSMA now would be a tremendous waste of already spent American taxpayer dollars.
Second, history has demonstrated that an unregulated, open market won’t automatically deliver on safe food practices. While many good actors participate in the food industry, America’s food safety laws and regulations were birthed in response to bad actors (see Upton Sinclair’s The Jungle and the resultant Federal Meat Inspection Act), unintentional acts of contamination (as we have seen in fresh produce in recent years), as well as outright malevolent threats (hence the 2002 Bioterrorism Act).
Third, the American food safety system was and still is far from perfect, and shortcomings can have significant public health and economic ramifications. Chipotle, for example, is still reeling after numerous food safety lapses in 2015 and 2016 (norovirus, Salmonella, and Escherichia coli outbreaks) that betrayed consumer trust and saw shares fall 45 percent. The CDC estimates 1 in 6 Americans will fall ill this year from contaminated food. Of that number, 3,000 will die and many more will be left with life-altering, debilitating aftereffects. It is the duty of food safety public servants to continue enforcing laws to prevent illnesses from happening and to keep up with scientific breakthroughs to keep Americans safe.
Fourth, it takes years for a society to trust its food supply, and that trust can be quickly lost. One might say that is precisely why nations have regulatory institutions—to safeguard the public’s trust. America’s food safety regulations have survived Republican and Democratic-dominated Congresses (and liberal as well as conservative Presidents) because they are enforced by politically insulated agencies. For every supposedly incompetent bureaucrat, there are scores of competent, politically neutral public servants working for the FDA. Oh, and by the way, microbes don’t care if you vote Democrat or Republican.
Wallace warned of the dangers of ineffectual laws over a century ago. Regardless of one’s political leaning, let’s all heed Wallace’s warning of “dead letters” and, in the case of our food supply, see the implementation of FSMA to the end.
Dr. Gragg is an assistant professor at Kansas State University and works at the K-State Olathe campus. Her research interests include pre-harvest and post-harvest food safety (in produce, meat, and poultry). Dr. Kastner is an associate professor at Kansas State and author of Food and Agriculture Security: An Historical, Multidisciplinary Approach. He has served as PI for over $1M in federal (e.g., U.S. Department of Homeland Security) career development grants. Unruh is a graduate research assistant and PhD student at Kansas State. His research is a hybrid program focused on food safety in the laboratory and policy ramifications of food safety regulations. Reach him email@example.com.