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.
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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).