Agencies use informal guidance documents in lieu of formal regulation to clarify and interpret uncertainties in existing law and enforcement. Unfortunately, this and other forms of “subregulatory guidance” can also offer a tempting way to extend an agency’s power and authority into new areas, or ban private actions that hadn’t been banned before, all without going through the notice and comment process required by regulation, with its protections for regulated parties. Fair? Lawful? The Department of Justice under Jeff Sessions has lately sought to bring agency use of guidance documents under better control, and in particular end the use of documents that 1) are obsolete, 2) improperly use the process to circumvent the need for formal regulation, or 3) improperly go beyond what is provided for in existing legal authority. I’m interviewed about all this by Caleb Brown for the Cato Daily Podcast.
More: Charlie Savage, New York Times (DoJ revokes batch of guidance documents), Matt Zapotosky/Washington Post; Scott Shackford, Reason (rescission of guidance letter on local fines and fees should be read not as blessing those practices as okay, but as reflecting fact that federal government lacks clear statutory or constitutional mandate to intervene against them); Stephen McConnell, Drug and Device Law (“DOJ Says its Litigators May Not Use Noncompliance with FDA Guidances as Basis for Civil Enforcement Actions”).
One Comment
We need a whole new approach in America to the regulatory state.
Anyone who has dealt with them has stories of bullying, bad behavior etc. Here’s a hypo—examiner is abusive to regulated entity–regulated entity tells examiner’s supervisor that examiner is no longer welcome due to the abusive behavior–what result if push comes to shove? I think injunctive relief from court to bar the abusive examiner from regulated entity’s presence.
Regulators can generally do what they want, and there are no repercussions. That has to end.