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Trump Administration Issues Regulatory Freeze Memo; FCNs Not Affected

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The Trump administration issued a directive to manage the Federal regulatory process in the weeks immediately following the inauguration to ensure that presidential appointees or designees have the opportunity to review any new or pending regulations. A January 20, 2017 memorandum from White House Chief of Staff Reince Priebus to the heads of executive departments and agencies titled, “Regulatory Freeze Pending Review,” states that new regulations must be reviewed by someone appointed or designated by the President and that regulations that have been published in the Federal Register but that have not taken effect  must be postponed 60 days from the date of the Freeze Memo, unless subject to statutory or judicial deadlines. The memorandum also directed Agency heads to immediately withdraw from the Office of the Federal Register (OFR) any regulations that have been submitted to OFR but not yet published in the Federal Register.  Any exceptions to allow for emergency situations or other urgent circumstances must be approved by the Director or Acting Director of the Office of Management and Budget.  

The Environmental Protection Agency published a notice in the January 26, 2017 Federal Register listing 30 EPA regulations affected by the freeze. The Food and Drug Administration has not yet announced which regulations are impacted. However, the freeze should not affect the Food Contact Notification (FCN) process since no final regulatory action by FDA is required for an FCN to become effective. The Freeze memo explains that “regulation” refers to regulatory action and includes guidance documents, notices of inquiry, advance notices of proposed rulemaking, or agency statements “that set forth a policy on a statutory, regulatory, or technical issues or an interpretation of a statutory or regulatory issue.”