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‘Chaos’ Would Come From HHS Review of All Rules, Lawsuit Says

March 9, 2021, 11:13 PM

A late Trump administration rule causing health regulations to expire if they aren’t reviewed every 10 years is being challenged in California’s Northern District by an array of health and public interest groups.

The Department of Health and Human Services under former President Donald Trump finalized the Sunset Rule rule in January. It didn’t publish in the Federal Register until Jan. 19, one day before President Joe Biden took office. The HHS now also is likely reviewing the rule because it was released in the final 60 days of the Trump administration.

The plaintiffs in the case—which include Santa Clara County, Calif.; the Center for Science in the Public Interest; and the American Lung Association—say the rule’s impact is “vast and unprecedented” and would terminate more than 17,000 health regulations by 2026. It creates “incalculable costs and chaos” by placing highly technical rules on a rescission list. Those rules structure the groups’ operations and regulatory obligations, delineate their and their members’ rights, and protect the populations they serve.

“The Sunset Rule was proposed and finalized entirely during the outgoing administration’s lame-duck period, amends nearly all HHS regulations to add self-executing expiration dates,” the complaint, filed Tuesday in U.S. District Court for the Northern District of California, said.

The final rule (RIN 0991-AC24) exempts certain Food and Drug Administration regulations and annual Affordable Care Act rules, in addition to procedural rules, regulations issued jointly with other agencies, and regulations around internal management.

Under the rule, the HHS will have five years to assess regulations that are more than 10 years old, and the department can extend that deadline one time per regulation, for up to a year.

The case is County of Santa Clara et al v. HHS, N.D. Cal., No. 5:21-cv-01655, 3/9/21.

To contact the reporters on this story: Fawn Johnson in Washington at; Shira Stein in Washington at

To contact the editors responsible for this story: Jo-el J. Meyer at; Brent Bierman at; Karl Hardy at