Thursday, May 21, 2009

Administration Takes Preemptive Action

While we were at ALI yesterday, the administration released a presidential memorandum (technically not an Executive Order, if it makes any difference) regarding administrative agency statements regarding preemption. Not that we were expecting to be, but we won't be surprised by agency preemption declarations any time soon. Preemption determinations must be accompanied by codified regulations to that effect.

The memorandum also states that such codified preemption provisions should be limited - to "where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132." According to a summary of EO 13132 issued by the National Conference of State Legislatures that prior order required:
  • All agencies, except independent agencies, must have a process in place through which they consult with state and local government elected officials and their representative national organizations on the development of regulations and legislative proposals that have federalism implications. This consultation must allow for both meaningful and timely input. Independent agencies may be encouraged to develop similar processes.
  • Each agency must have a gatekeeper who is responsible for implementing this order and for sharing with the Office of Management and Budget (OMB) its plan for consulting with state and local government elected officials and their representative national organizations. The designation of the gatekeeper and formulation of the consultation plan must occur by November 2, 1999.
  • The preamble of every rule about to be issued must contain a federalism impact statement. This statement must describe the consultation process, summarize our concerns, state the agency's need to issue the rule and state to what extent our concerns have been addressed and met. Every draft final regulation submitted to OMB must have a certification that the rule was developed in compliance with E.O. 13132. The same certification is mandatory for legislative proposals
That's their language, not ours.

Finally, the new memorandum directs all federal agencies to conduct a search and destroy mission for Bush administration administration preemption rulings. That's not what it says, of course (the new order covers the "last ten years"), but that's essentially what it means:
Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.
While we think this is an unfortunate development, it's not particularly unexpected in these parts. As to drugs and devices - our playground - the preemption rules are pretty much entirely in the hands of the courts, now. The 2006 Preemption Preamble was dealt with in Levine, and we don't use it anymore anyway.

Our concern is whether the directive to review and revise preemption language will become an excuse to change non-preemption-related aspects of regulations - we're thinking primarily of the FDA's 2008 CBE regulation changes, but there are undoubtedly others - where the FDA brought the regulation in line with its stated original (pre-Bush) intent, but also included statements about preemption. We don't think there were any notice-and-comment related problems (both sides thoroughly addressed preemption) with that rule, so we're not even sure it's covered by the new order. But our side will need to be vigilent to make sure that the bounds of the new order are not exceeded.

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