Lawsuit Argues 'Ticking Time Bomb' Could Invalidate Thousands Of Health Rules

If you go to the grocery store and pick up something wondering what's in it, that nutrition label is there because of rules from the Department of Health and Human Services.

If you show up at an emergency room needing medical care, you have to get treated because of these rules. You're also able to drink bottled water knowing it doesn't contain arsenic because of rules, too.

All of those rules — and thousands of others — could disappear without warning because of the Trump administration's Securing Updated and Necessary Statutory Evaluations Timely or SUNSET rule, finalized the day before President Biden's inauguration. A lawsuit filed Tuesday in federal court argues that that rule is a "ticking time bomb" designed to tie up the current administration in bureaucratic knots.

In short, the rule requires the Department of Health and Human Services — which includes the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health — to review all 18,000 existing agency regulations, within several years.

If a review of a rule isn't completed in the required time frame, it will automatically expire. The SUNSET rule states that its aim is to "ensure the Department's regulations are having appropriate impacts and have not become outdated."

The SUNSET rule reflects the Trump administration's "overarching view that regulations do no good — that they're generally harmful," explains Erin Fuse Brown, health law professor at Georgia State University.

"This SUNSET rule does go way beyond the idea that it is good for agencies to periodically review their regulations and make sure that they're keeping up with the times," Fuse Brown says. "This creates this presumption that all regulations should disappear unless they're subject to that periodic review."

To be clear, Fuse Brown explains, rules are law. When Congress passes a bill, it's not getting into the details.

"[Congress] provides the materials, it provides some direction — 'Build a skyscraper that generally will be about this tall and have this many floors.' But it's really up to the agency to design that and implement it and make sure it actually becomes a building," she says. "You take the building away if you take the rules away."

As an example, Congress passed HIPAA, the Health Insurance Portability and Accountability Act, with the goal of protecting people's health information. But what actually spells out those health information protections in detail, Fuse Brown explains, "is a regulation that the agency [HHS] came up with, because Congress doesn't have the expertise to come up with the details."

The initial notice of the proposed SUNSET rule came on Nov. 4, the day after the 2020 election, with a public comment period of 30 days. The complaint filed Tuesday alleges that the Trump administration rushed the rule through and didn't follow legal requirements for the public to be able to weigh in.

That window to provide public comment, in December 2020, was right at the time "we had the biggest COVID surge in the entire country — and that was definitely true here," says James Williams, county counsel for Santa Clara County in California, a plaintiff in the suit.

"Our hospitals were filling up." Williams said. "We were focused on ICU capacity. We were focused on doing what we needed to do to run our hospital system. And so we couldn't take our eyes off of that crisis to try to figure out which of the 18,000 regulations [that affect us] would automatically expire under this rule."

The suit also alleges the rule exceeds the agency's authority and is arbitrary and capricious.

"The promise made in the SUNSET rule is that the [Health and Human Services] department will go through and, one at a time, review all of those regulations," says Samara Spence, senior counsel at the Democracy Forward Foundation, which is representing the plaintiffs in this case. The five-year review window for most regulations would require staffers to do this work many times faster than has been done previously, she says, and if they miss the deadline, "then the time bomb goes off and everything they did not get to just poofs out of existence."

In addition to Santa Clara County, plaintiffs include the California Tribal Families Coalition, the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, and the Natural Resources Defense Council.

"This is the first time that the National Association of Pediatric Nurse Practitioners has joined a lawsuit like this, and so I think it's indicative of how strongly we feel about it and how concerned we are about it," says association president Jessica Peck. "These regulations ensure access to vaccines for children and critical preventative services like well child care and milestone screenings to help each child begin a healthy start in life."

The SUNSET rule does have its defenders. "Whether the goal is boosting growth, reducing risks to health and safety, or generally promoting societal well-being, the rule will likely be a force for good," James Broughel of the Mercatus Center at George Mason University wrote in an opinion piece for STAT.

Douglas Holtz-Eakin, president of the conservative think tank American Action Forum, thinks that systematic, retrospective review of federal regulations is a good thing. The SUNSET rule "seems interesting and has the right principle, but it seemed to occur at a weird time — as [the Trump administration was] walking out the door — and in a very narrow place — one agency," he says.

"If you're going to do something like this, I think it should be done across the government on a uniform basis, everyone should be subject to the same set of rules," Holtz-Eakin says. "And I would prefer that these things be done as part of legislation — that the Congress thinks hard about what it wants the executive branch to do in executing its desires and put it into law."

What happens next depends on how the Biden administration responds to the lawsuit, and whether Congress decides to weigh in. Because the rule was filed so late in the Trump administration, Congress could eliminate the rule through the Congressional Review Act, explains Fuse Brown of Georgia State. HHS could also decide "to stay the rule and suspend its implementation and its effective date indefinitely while the litigation is pending," she says.

HHS did not respond to a request for comment on its plans for the SUNSET rule.

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