; (vi) a purely internal agency policy; (vii) a guidance document that relates to the use, operation, or control of a government facility; (viii) an internal guidance document directed solely to other agencies; or (ix) any other category of guidance documents exempted by the head of an agency, in consultation with the Administrator. (4) Regulation The term regulation means an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency. (5) Regulatory action The term regulatory action means any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final regulation, including notices of inquiry, advance notices of inquiry and notices of proposed rule making. (b) Approval procedures (1) In general Except as provided in paragraph (2), not later than 210 days after the date of enactment of this Act, the head of each agency shall develop or have written procedures for the approval of guidance documents, which shall ensure that the issuance of guidance documents is approved by each appropriate senior agency official. (2) Exception An employee of an agency may not deviate from the requirements of the procedures developed pursuant to paragraph (1) unless— (A) the employee has submitted an appropriate justification to a supervisor who is an appropriate senior agency official described paragraph (1) or the head of the agency