Comments to HHS Sunset Rule

The US Department of Health and Human Services (HHS) recently published a proposed rule, entitled “Secure Updated and Necessary Statutory Evaluations Timely” (SUNSET). The stated intent of the proposed rule is to enhance the Department’s implementation of the Regulatory Flexibility Act (RFA), which requires federal agencies to publish in the Federal Register “a plan for the periodic review of the rules issued by the agency which have or will have a significant economic impact upon a substantial number of small entities.” The proposed rule would therefore require HHS to conduct a retrospective review to determine whether each rule should be continued without change or should be amended or rescinded.

The proposal also sets an expiration date for all regulations in CFR Title 21 at the end of either (1) 2 calendar years after the year that the SUNSET proposal becomes effective, (2) 10 calendar years after the year of the regulation’s promulgation, or (3) 10 calendar years after the last year HHS assessed the regulation. If finalized as proposed, this broad action is likely to have vast impacts for the color industry which operates under a number existing food standards and regulations.

IACM continues to evaluate the proposal and has submitted comments requesting a comment period extension.