Under SEC 16.1(b), the procedures in part 16 apply when a regulation provides a person with an opportunity for a hearing on a regulatory action under part 16. Section 418 of the FD&C Act does not expressly provide for a hearing if circumstances lead FDA to determine that an exemption provided to a qualified facility under proposed SEC 507.5(c) should be withdrawn. However, the Agency tentatively concludes as a matter of agency discretion that providing an opportunity for a hearing by regulation in this subpart of the proposed rule would provide appropriate process to the owner, operator, or agent in charge of a qualified facility subject to withdrawal of the facility's exemption. The Agency also tentatively concludes that the modified part 16 procedures contained in this proposed rule would provide the owner, operator, or agent in charge of a qualified facility subject to a withdrawal order sufficient fairness and due process while enabling FDA to expeditiously adjudicate an appeal of a withdrawal order for which an informal hearing has been granted.
Section 16.119 provides that, after any final administrative action that is the subject of a hearing under part 16, any party may petition the Commissioner for reconsideration of any part or all of the decision or action under SEC 10.33 or may petition for a stay of the decision or action under SEC 10.35. Proposed SEC 507.73(c)(6) would specify that these procedures for reconsideration and stay would not apply to the process of withdrawing an exemption provided under proposed SEC 507.5(c). The circumstances that may lead FDA to withdraw an exemption include an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility, or the Agency's determination that it is necessary to protect animal or human health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility. Such circumstances require prompt action. Under SEC 16.120, a qualified facility that disagrees with FDA's decision to withdraw an exemption provided under SEC 507.5(c) has an opportunity for judicial review in accordance with SEC 10.45.
I. Proposed SEC 507.75--Presiding Officer for an Appeal and for an Informal Hearing
Proposed SEC 507.75 would require that the presiding officer for an appeal, and for an informal hearing, must be an
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