On March 9, several health groups including the American Lung Association and the Center for Science in the Public Interest joined Santa Clara County, California and other advocacy groups in a lawsuit against the Department of Health and Human Services (HHS) over the Trump administration’s “sunset rule” in the U.S. District Court for the Northern District of California. In their complaint, the plaintiffs asked the court to declare that the Sunset Rule is arbitrary, capricious, contrary to law, adopted without observance of required procedure or consultation, and issued in excess of HHS authority. The complaint also asked that they vacate the rule (expected to go into effect on March 22) and set it aside.
The rule, entitled “Securing Updated and Necessary Statutory Evaluations Timely” 86 Fed. Reg. 5694 (Jan. 19, 2021) requires that the regulations of HHS agencies, including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare and Medicaid Services (CMS) automatically sunset and be rescinded unless agencies, subject to certain exceptions, preform retrospective reviews to assess the economic impact of a regulation’s requirements consistent with the Regulatory Flexibility Act (RFA) ten years after each regulation is issued. To avoid sunsetting, HHS would have to determine whether a regulation’s requirements have a significant economic impact on a substantial number of small entities and assess how to minimize any such significant impact by considering the following factors:
- A continued need for such regulation;
- Public comments received;
- Complexity of the requirements;
- Overlap with other regulations; and
- Technology considerations.
The first assessment would be required two years after the rule is finalized.
The plaintiffs took issue with the fast pace HHS took when issuing the rule. The proposed rule was published in the Federal Register on November 4 and received 530 comments during the abnormally short, 30-day comment period. While many stakeholders requested that HHS extend the comment period to solicit more feedback, the agency declined to do so. Only one public hearing on the proposed rule was held, which was on the Monday before Thanksgiving. HHS published the rule in final barely 30 days later, on January 8, 2021.
In their complaint, the plaintiffs contend that the rule should be set aside because it is arbitrary and capricious. The plaintiffs argue that HHS did not consider the degree of regulatory uncertainty the rule creates and underestimated the burdens imposed on them by requiring that they monitor regulations to ensure they do not expire. The plaintiffs also argued that agencies cannot conduct RFA reviews in accordance with the timeframe stipulated in the rule. In the complaint, the plaintiffs also stated that the rule eliminates public health regulations as an incentive for HHS to conduct RFA reviews, does not clearly identify which regulations have been amended, and does not respond to significant comments or alternatives proposed by commenters.
The plaintiffs argued that the sunset rule was issued in excess of HHS’ authority because it modifies and schedules rescission of 18,000 regulations without using the process required by the RFA. The complaint also argues that the rule modifies and adds expiration dates to regulations without providing the same level of process required for the original regulations including analyzing the impact of the change to each regulation being amended, the statutory requirements for each regulation, and the impacts of the uncertainty created by the amendments.
The rule is scheduled to go into effect on March 22, less than five months before it was first proposed. If it goes into effect, it will cause the majority of HHS’ rules to expire in 2026 and would impact a number of programs affecting food safety, nutrition, public health, and social services. You can read the complaint in the case (County of Santa Clara et al. v. U.S. Department of Health and Human Services et al) here.