releasing the regulatory knot of SUNSET
WASHINGTON The Department of Health and Human Services stated that it “anticipates issuing in the coming months a notice of proposed rulemaking repealing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule” in a court filing dated April 23 in relation to an ongoing lawsuit in which the agency is the defendant.
The SUNSET rule was announced on January 19, the final day of President Donald Trump’s term in office. It mandates that the HHS, under the Biden administration and in subsequent ones, review and evaluate over 17,000 regulations—among them the Food and Drug Administration’s food safety regulations—within five years of their enactment, failing which they will expire. Any regulations would then, according to the rule, sunset or expire ten years after they were released, unless the agency conducted a review to ascertain if It ought to be changed or revoked.
The proposed rule was opposed by numerous business groups, including those from the food and health sectors, on the grounds that it may divert HHS’s focus from more urgent issues, such the COVID-19 pandemic. Concerns were also raised about the possibility that the SUNSET rule’s approach, which includes stringent deadlines for regulation review and sunsetting, would prevent more deliberate and focused regulatory reforms and could have unforeseen consequences like the unintentional repeal of enduring regulations that have improved consumer health and safety and directed industry operations.
However, the SUNSET final rule was published by the HHS in the Federal Register on January 19, 2021, and the clock started running as the regulation was set to go into effect on March 22, 2021.
In an attempt to stop the HHS from implementing the SUNSET rule, the County of Santa Clara, California, the California Tribal Families Coalition, the American Lung Association, the National Association of Pediatric Nurse Practitioners, the Center for Science in the Public Interest, and the Natural Resources Defense Council filed a lawsuit against the agency on March 9 in the US District Court for the Northern District of California.
In their lawsuit filing, the plaintiffs claimed that the SUNSET rule “sets off a ‘ticking time bomb’ that will eliminate thousands of existing regulations that govern our health care system, food safety protocols, public health measures, social services, and so much more.”
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The plaintiffs claimed that by omitting to specify which regulations might expire under the rule and by only offering a short 30-day notice-and-comment period, the SUNSET rule was “arbitrary and capricious” and in violation of both the Regulatory Flexibility Act and the Administrative Procedure Act (APA).
The plaintiffs further claimed that by causing regulatory uncertainty and confusion that would obstruct their continuing operations, budgets, and planning efforts, the SUNSET final rule threatened to cause businesses and the public immediate and irreversible injury.
Following the lawsuit, on March 19, the HHS, under the new administration, announced in the Federal Register that the final rule’s effective date would be postponed to March 22, 2022, a year later. According to the HHS, the APA allows an agency “to postpone the effective date of action taken by it, pending judicial review,” if it determines that doing so is necessary to uphold justice.
In addition, the HHS notice stated, “HHS now believes it is likely some regulations would expire without any additional administrative process (contrary to the conclusions reached in the SUNSET final rule) given the volume of HHS agency regulations that the Department would need to assess and, as applicable, review in a short period of time.”
In the court filing dated April 23, filed jointly by the Department and the plaintiffs, it was made clear that the current HHS leadership intends to pursue repealing the SUNSET rule. The filing requests a stay of the case until July 30, 2021, giving the Department more time “to evaluate the claims and its position before taking further steps in this litigation.”