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

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

 Massive Deregulatory Effort Jeopardizes All HHS Regulations Affecting Everything from Healthcare and Vaccination Programs to Baby Formula and Drug Safety

 Lawsuit Filed by the County of Santa Clara and a Coalition of Tribes, Food Safety, Public Health, and Healthcare Organizations and Professionals

March, 9, 2021, San José, C.A. — 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.”

For quotes from all of the Plaintiffs, click here.

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.

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Democracy Forward is a nonprofit legal organization that represents organizations, individuals, and municipalities in impact litigation to keep corruption out of policymaking.

The County of Santa Clara government serves a diverse, multi-cultural population of 1.9 million residents, more populous than 14 states. The County provides essential services to its residents, including public health protection, environmental stewardship, medical services through the County of Santa Clara Health System, child and adult protection services, homelessness prevention and solutions, roads, park services, libraries, emergency response to disasters, protection of minority communities and those under threat, access to a fair criminal justice system, and many other public benefits.  The Office of the County Counsel serves as legal counsel to the County of Santa Clara and is responsible for all civil litigation involving the County and its officers.  Through its Social Justice and Impact Litigation Section, the Office litigates high-impact cases, drafts innovative local ordinances, and develops policies and programs to advance social and economic justice. For more information, visit counsel.sccgov.org.

Comprised of more than 40 tribes and tribal organizations from across the state, the California Tribal Families Coalition’s mission is to promote and protect the health, safety and welfare of tribal children and families, which are inherent tribal governmental functions and are at the core of tribal sovereignty and tribal governance.

The National Association of Pediatric Nurse Practitioners (NAPNAP) is the nation’s only professional association for pediatric-focused advanced practice registered nurses (APRNs) dedicated to improving the quality of health care for infants, children, adolescents and young adults. Representing more than 8,000 health care practitioners with 18 specialty practice issues groups and 53 chapters, NAPNAP has been advocating for children’s health since 1973 and was the first APRN society in the U.S. Our mission is to empower pediatric-focused advanced practice registered nurses and key partners to optimize child and family health.

The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy and research. The work of the American Lung Association is focused on four strategic imperatives: to defeat lung cancer; to champion clean air for all; to improve the quality of life for those with lung disease and their families; and to create a tobacco-free future. For more information about the American Lung Association, a holder of the coveted 4-star rating from Charity Navigator and a Gold-Level GuideStar Member, or to support the work it does, call 1-800-LUNGUSA (1-800-586-4872) or visit: Lung.org.

The Center for Science in the Public Interest (CSPI) is America’s Food and Health Watchdog, a non-profit consumer education and advocacy organization that has worked since 1971 to improve the public’s health through better nutrition and safer food. CSPI does not accept government or corporate donations and is supported by donations from individuals and foundations and subscribers to its Nutrition Action Healthletter. For more information, visit us at cspinet.org.

NRDC (Natural Resources Defense Council) is an international nonprofit environmental organization with more than 3 million members and online activists. Since 1970, our lawyers, scientists, and other environmental specialists have worked to protect the world’s natural resources, public health, and the environment. NRDC has offices in New York City, Washington, D.C., Los Angeles, San Francisco, Chicago, Bozeman, MT, and Beijing. Visit us at www.nrdc.org and follow us on Twitter @NRDC.​

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