Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.
Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), either by withdrawing or delaying the implementation of the actions.
The memo, issued by White House Chief of Staff Ronald Klain, calls on the heads of executive departments and agencies to “propose or issue no rule in any manner – including by sending a rule to the Office of the Federal Register [OFR] – until a department or agency head appointed or designated by the president after noon on January 20, 2021, reviews and approves the rule.” Previous administrations, including those of Trump and Barack Obama, issued similar memos to stop last-minute actions by the outgoing administration.
The memo also calls on agencies to immediately withdraw any last-minute rules that have been sent to the OFR but have not yet been published in the Federal Register and postpones the implementation of rules that have been published but have not yet taken effect for 60 days, “For the purpose of reviewing any questions of fact, law, and policy the rules may raise.” The memo leaves the door open for extending the 60-day period and encourages agencies to open a 30-day comment period for any postponed rules.
Rules subject to statutory or judicial deadlines are excluded from regulatory freeze, as are rules that “affect critical health, safety, environmental, financial, or national security matters.” In either circumstance, the memo calls for agency heads to notify the Office of Management and Budget (OMB) director of any rules that they feel should be excluded.
The memo also explains that it does not strictly apply to “rules” but also to “any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and any agency statement of general applicability and future effect that sets for a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.”
In a separate executive order revoking six of Trump’s executive orders, including the notorious “two out, one in” order that required government agencies to repeal two regulations for each new regulation they instituted, the new administration says it is clearing the way for its departments and agencies to effectively address the public health, economic, racial justice and climate challenges of the day.
“This order revokes harmful policies and directives that threaten to frustrate the Federal Government’s ability to confront these problems, and empowers agencies to use appropriate regulatory tools to achieve these goals,” the order states.
Among the other orders revoked are an order that required agencies to institute a regulatory reform task force to review its regulations and make recommendations to repeal, replace or modify ones that meet certain criteria and two orders that sought to rein in guidance from federal agencies.
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