Proposed SEC 507.62(c) would require that FDA issue an order to withdraw the exemption to the owner, operator, or agent in charge of the qualified facility. The requirements of section 418 of the FD&C Act are directed to the owner, operator, or agent in charge of a facility. The Agency tentatively concludes that the statutory language of section 418 enables FDA to issue an exemption withdrawal order to any of these persons.
Proposed SEC 507.62(d) would require that FDA issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order.
D. Proposed 507.65--Contents of an Order To Withdraw an Exemption Applicable to a Qualified Facility
Proposed SEC 507.65(a) through (i) would require that an order to withdraw an exemption applicable to a qualified facility under SEC 507.5(c) include the following information:
* The date of the order (proposed SEC 507.65(a));
* The name, address, and location of the qualified facility (proposed SEC 507.65(b));
* A brief, general statement of the reasons for the order, including information relevant to:
. An active investigation of a foodborne illness outbreak that is directly linked to the facility; or
. 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 (proposed SEC 507.65(c)).
* A statement that the facility must comply with subpart C of this part on the date that is 60 calendar days after the date of the order (proposed SEC 507.65(d));
* The text of section 418(l) of the FD&C Act and of this subpart D (proposed SEC 507.65(e));
* A statement that any informal hearing on an appeal of the order must be conducted as a regulatory hearing under part 16 of this chapter (21 CFR part 16), with certain exceptions described in proposed SEC 507.73 (proposed SEC 507.65(f));
* The mailing address, telephone number, email address, and facsimile number of the FDA district office and the name of the
* The name and the title of the FDA representative who approved the order (proposed SEC 507.65(h)).
FDA tentatively concludes that the requirements that it proposes in SEC 507.65 would provide the owner, operator, or agent in charge of a qualified facility subject to a withdrawal with adequate notice of the basis for the Agency's determination to withdraw the exemption and of their opportunity to appeal the Agency's determination and to request an informal hearing. The proposed notification procedures are similar to and consistent with the notification requirements in other regulations involving administrative action, such as administrative detention of food under SEC 1.393 orders for diversion or destruction of shell eggs under the PHS Act under SEC 118.12(a)(i), and with procedures for an informal hearing in part 16.
E. Proposed SEC 507.67--Compliance With, or Appeal of, an Order To Withdraw an Exemption Applicable to a Qualified Facility
Proposed SEC 507.67(a) would require that the owner, operator, or agent in charge of a qualified facility that receives an order to withdraw an exemption applicable to that facility under SEC 507.5(c) either comply with applicable requirements of this part within 60 calendar days of the date of the order; or appeal the order within 10 calendar days of the date of the order in accordance with the requirements of SEC 507.69. The Agency tentatively concludes that either of the two circumstances that could result in the determination that an exemption should be withdrawn (as described in proposed SEC 507.60) warrant prompt compliance with the rule in the interest of animal or human health. The Agency tentatively concludes that 10 calendar days for the submission of an appeal from the date of the receipt of a withdrawal order is appropriate for purposes of the efficient adjudication of the appeal of a withdrawal order and would provide reasonable due process that comes to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if the Agency denies the appeal.
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