“ Each agency shall identify in writing the specific market failure (such as externalities, market power, lack of information) or other specific problem that it intends to address (including, where applicable, the failures of public institutions) that warrant new agency action, as well as assess the significance of that problem, to enable assessment of whether any new regulation is warranted." (b) by inserting in section 1 (b) (7) after "regulation" the words "or guidance document". (c) by inserting in section 1 (b) (10) in both places after "regulations" the words "and guidance documents". ”

“ Means a guidance document disseminated to regulated entities or the general public that, for purposes of this order, may reasonably be anticipated to: " (A) Lead to an annual effect of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; " (B) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency ”

“ Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights or obligations of recipients thereof; or " (D) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order ”