New Limitations on Guidance Documents Expected to Have Heavy Effect on Industry

The Trump Administration recently adopted new limits on the use of “guidance documents” issued by federal agencies. Various industries use the applicable guidance documents to better understand the government’s interpretation of laws, and as such, this may have a sweeping effect on industry compliance measures. The revised policy piggybacks off of a previous memo issued by Attorney General Jeff Sessions that prohibited the Agency from issuing guidance documents that effectively bind the public without undergoing the notice-and-comment rulemaking process. This means that the DOJ was unable to issue guidance documents that effectively created rights or obligations that were binding on those outside of the Executive Branch, or to create binding standards by which the DOJ determines compliance with already existing statutory or regulatory requirements. Under the revised policy, issued by Rachel L. Brand at the Department of Justice (DOJ), the Agency will not “use its enforcement authority to effectively convert agency guidance documents into binding rules.” Guidance documents are not permitted to “create binding requirements that do not already exist by statute or regulation.” Additionally, DOJ lawyers representing the government in court “may not use noncompliance with guidance documents as a basis for proving violations of applicable law,” a common tactic previously used. The guidance documents may be used for “proper purposes” in cases, such as by usin...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs