Coalition Sues HHS Over Dangerous Sunset Rule That Would Automatically Scrap Thousands of Health and Food Safety Protections

Trump-Era Rule Scheduled to Go Into Effect March 22, Setting ‘Ticking Time Bomb’ on Elimination of 18k Regs Unless HHS Works at Unprecedented Pace to Keep Them on the Books

Today, the County of Santa Clara, the California Tribal Families Coalition (CTFC), the National Association of Pediatric Nurse Practitioners (NAPNAP), the American Lung Association, the Center for Science in the Public Interest (CSPI), and NRDC (Natural Resources Defense Council) filed legal action against the Department of Health and Human Services (HHS) over its unlawful 2021 “Sunset Rule.” 

The Sunset Rule — proposed by the outgoing Trump administration the day after the November election and finalized the day before President Biden’s inauguration in the midst of the pandemic — adds automatic expiration dates to more than 18,000 regulations issued by HHS and its sub-agencies, including the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA). The unlawful rule will eliminate nearly all HHS regulations, starting in five years, unless the agency diverts attention away from the ongoing pandemic and other crucial activities to conduct an unprecedented, time- and resource-intensive review of nearly every agency and sub-agency regulation. Without review, roughly 17,200 regulations will automatically be eliminated in 2026, with additional regulations terminating afterward. 

The lawsuit seeks to vacate the unlawful Sunset Rule and prevent the substantial harm it will cause Plaintiffs, healthcare providers, business and nonprofit organizations, individuals, and public health. Democracy Forward is litigating the case as counsel for all Plaintiffs, alongside legal teams from the County of Santa Clara, NRDC, and CSPI. 

“The Sunset Rule sets off a ‘ticking time bomb’ that will eliminate thousands of existing regulations that govern our healthcare system, food safety protocols, public health measures, social services, and so much more,” the Plaintiffs said upon filing suit. “Yet, despite the rule’s sweeping effects, it was jammed through in the eleventh hour of a lame-duck administration with scarce opportunity for the public to voice concerns and no attempt to consult with America’s tribal communities. Simply put: HHS’s Sunset Rule is ill-conceived, impractical, and unlawful. Unless it is immediately halted, millions of Americans, including more than 36 million children, will be hurt by the resulting regulatory chaos, uncertainty, and elimination of key protections.”

“In challenging this rule, the American Lung Association is championing healthcare protections and the lung health of youth at risk from a lifetime of tobacco addiction,” said American Lung Association President and CEO Harold Wimmer. “Keeping the Department of Health and Human Services focused on the COVID-19 pandemic to safeguard the lung health of everyone in the U.S., including the more than 36.6 million living with a chronic lung disease such as asthma or COPD must be a priority. It is critical that the rule is removed.” 

The Sunset Rule will trigger automatic rescission of critical regulations and protections affecting the Plaintiffs’ operations, like:

  • Thousands of HHS regulations the County of Santa Clara relies on to operate its hospitals and clinics, Public Health Department, Behavioral Health Services Department, Emergency Medical Services Agency, and more;
  • Thousands of regulations affecting tribal governments’ programs related to child welfare, healthcare, and public health;
  • Regulations that ensure access to vaccines, ensure safe and effective pediatric medicines and therapies, and allow children to access high-quality, affordable healthcare;
  • Regulations to protect the public from tobacco products, including regulations that protect youth from being targeted with flavored e-cigarettes and other tobacco products;
  • Thousands of critical FDA regulations, including food safety regulations that give consumers confidence that they can purchase food without contracting a deadly foodborne disease, regulations to guard against antibiotic resistance, and regulations limiting the presence of arsenic in bottled water.

The Sunset Rule is — in HHS’s own words — “unprecedented.” To avoid the mass elimination of 17,200 existing health regulations in 2026, HHS estimates it will need to perform over 3,400 reviews over the next five years — a feat the agency has never come close to achieving. HHS will need to increase its pace of review 20-fold simply to keep its existing rules on the books in 2026. But achieving that pace would come at a significant cost to society, as HHS and its sub-agencies redirect resources away from other efforts, including its vital work to combat the COVID-19 pandemic. Parties affected by HHS regulations will likewise be forced to redirect vast resources to try to understand which regulations will be scrapped and to respond in real-time.

The lawsuit states that the Sunset Rule violates both the Administrative Procedure Act and the Regulatory Flexibility Act. Among other things, the agency failed to name which regulations will expire under the Sunset Rule, provided an insufficient 30-day notice-and-comment period, and unlawfully refused to consult with Indian tribes. 

HHS finalized the Sunset Rule despite broad opposition voiced by diverse stakeholders during the unreasonably short comment period. Advocacy organizations and trade associations of all stripes opposed the rule, as did consumer safety advocates, tribes, states, local governments, and representatives of the food and beverage, livestock and veterinary, insurance and healthcare, manufacturing, and agricultural industries. While HHS often receives tens of thousands of comments on a single rulemaking, the unjustifiably short comment period resulted in only 530 comments on the Sunset Rule’s plan to amend 18,000 regulations. Over 98% of the comments submitted — all but eight — opposed the Sunset Rule or advised HHS to withdraw it.

The lawsuit was filed on March 9 in the U.S. District Court for the Northern District of California. Read the complaint in full here.

For more information, contact:

Allison MacMunn
[email protected]

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