The COVID-19 pandemic has revealed regulatory obstacles that could inhibit the private sector's often-heroic responses. Regulations such as trade barriers and "Buy American" provisions boost prices, limit choices, and can keep critical products out of the country.
There have been some timely adjustments. Just this month, the Food and Drug Administration (FDA) liberalized its standards for blood donations and authorized the use of a blood purification system to treat patients admitted to intensive care units (ICUs) in respiratory distress. It also issued Emergency Use Authorizations for sterilizing and reusing N-95 masks. And, as my colleague Sally Pipes has enumerated, there are many recent examples of easing overly stringent, arbitrary, or irrational standards for healthcare professionals: "Within the last few weeks, almost every state has conditionally eased out-of-state licensing restrictions on physicians, physician assistants, and nurse practitioners to help meet demand for care," she writes.
As far as coronavirus relief efforts are concerned, it's all hands on deck for American regulators.
The Environmental Protection Agency (EPA) has also responded to the pandemic: they recently issued guidelines about when cleanups of waste sites across the nation should be shut down. "EPA remains committed to protecting human health and the environment as we continue to adjust to the evolving COVID-19 pandemic," said EPA Administrator Andrew Wheeler. "This guidance will allow us to keep workers and the residents in these communities safe while also being able to respond to any emergency that may present an imminent danger to the public health or welfare." Work should be suspended, advises the EPA, if workers get sick with COVID-19, can't maintain proper social distancing, or face other coronavirus-related hazards.
The guidance encompasses, among other programs, the EPA's "Superfund" program, which is the agency's primary instrument for the cleanup of toxic sites. Created decades ago to clean up the nation's most hazardous toxic-waste sites, the program has been plagued with problems almost since its inception.
Originally intended to clean up and reduce the risk of toxic-waste sites such as factories, chemical dumps, abandoned mines, and military bases, it was first conceived, in 1980, as a short-term project: $1.6 billion over five years, to clean up some 400 sites (by law, at least one per state and, not coincidentally, about one per congressional district).
It has since grown, however, into one of the nation's largest public-works projects: more than $30 billion spent on about 1,300 sites. And as the pandemic forces us to consider which federal and state regulations might be revised or dispensed with permanently, the EPA's Superfund program should be near the top of the list.
INEFFICIENCY FROM A FLAWED RISK PARADIGM
The Superfund program has long been considered inefficient and ineffective. As the Wall Street Journal editorialized a few years ago, "Superfund has too often become a sinecure for the bureaucracy and a cash cow for lawyers." The editorial goes on to describe the bureaucrats' inefficiency: "EPA staff offices can wait years or decades to assess a Superfund site, figure out who's liable for what, consult with the community, decide on a remedy and assign the actual work."
The editorial describes egregious, but not atypical, examples of the program's ineffectiveness:
Take the West Lake Landfill Superfund site in Bridgeton, Missouri, which was used for quarrying in the 1930s and later as a landfill. In 1973, 8,700 tons of leached barium sulfate from the Manhattan Project was dumped there, along with soil and waste. The EPA listed the 200-acre facility as a Superfund site in 1990 ... Yet it took 18 years for EPA to decide how to clean up West Lake, finally settling in 2008 on a multi-layered engineered cover and a system of new monitoring wells. In 2009 the Obama EPA ditched that solution and re-opened the file. In 2010 an underground chemical reaction ignited a fire that is still smoldering.
In another instance, the Bunker Hill Mining and Metallurgical Complex in Idaho and Washington state, emitted air and soil pollutants contaminated with heavy metals such as lead. To this day, that case remains open—even though the EPA was alerted to the activity back in 1983.
The pyramids were built faster than that.
Various studies have attempted to evaluate the impacts of Superfund's massive and costly cleanups, but the results are equivocal. Putting that another way, after the expenditure of tens of billions of dollars, no beneficial results have been demonstrated.
On the other hand, some Superfund projects have definitely caused harm. University of California Davis economics professor J. Paul Leigh analyzed the occupational hazards of environmental cleanup projects. Leigh concluded that the risk of fatality to the average cleanup worker—a dump-truck driver involved in a collision, say, or a laborer run over by a bulldozer—is considerably larger than the cancer risks to individual residents that might result from exposure to untreated sites.
It seems the regulators do not fully understand the nuances of their job. Although it might seem counter-intuitive, EPA's insistence on too extensive a cleanup is a significant problem with Superfund remediation.
In his excellent book, "Breaking the Vicious Circle," Supreme Court Justice Stephen Breyer (then, a lower-court judge) addressed the EPA's counterproductive efforts to eliminate "the last 10 percent" of risk from a substance or activity. Breyer noted how the EPA's strategy involves "high cost, devotion of considerable agency resources, large legal fees, and endless argument," with only limited, incremental benefit. He quotes an EPA official as observing that "about 95 percent of the toxic material could be removed from [Superfund] waste sites in a few months, but years are spent trying to remove the last little bit."
In other words, regulators don't know when to stop, and Professor Leigh's findings indicate that their zeal can actually create more safety hazards than it eliminates. The cure should not be worse than the disease.
Even former EPA Administrator William Reilly admitted that Superfund's risk-assessment paradigms are flawed. In a 2016 speech at Stanford University, while a visiting lecturer, he discussed the excessive costs of basing cleanups on exaggerated worst-case scenarios:
The risks [Superfund] addresses are worst-case, hypothetical present and future risks to the maximum exposed individual, i.e., one who each day consumes two liters of water contaminated by hazardous waste. The program at one time aimed to achieve a risk range in its cleanups adequate to protect the child who regularly ate liters of dirt...
One such example was a cleanup target level set so low that a child could eat a pound of dirt a day for years without ill effects. But here's the rub: the site was a swamp, so it is highly unlikely that any child would eat any dirt there, ever.
These sorts of bad judgments and incorrect assumptions have led to astronomical costs and abandoned sites that could have been suitable for commercial development.
The bottom line is that Superfund has not only been a dismal failure at cleanups, it is a net killer of Americans. As the poster-child for what (then) OMB Director Mick Mulvaney once called "federal programs that sound good but don't work," Superfund needs radical reform and diligent oversight.
The dire public health, economic and psychological consequences of the COVID-19 crisis bring to mind Samuel Johnson's observation, "Depend upon it, sir, when a man knows he is to be hanged in a fortnight, it concentrates his mind wonderfully."
Let's not let this crisis go to waste. Let's trim or eliminate the Superfund program.
Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the FDA's Office of Biotechnology. You can find him online or on Twitter at @henryimiller.