Proposed SEC 507.38(b) would require that the written recall plan include procedures to perform the following actions:
* Directly notify the direct consignees of the product being recalled and how to return or dispose of the affected product (proposed SEC 507.38(b)(1));
* Notify the public about any hazard presented by the animal food when appropriate to protect animal or human health (proposed SEC 507.38(b)(2));
* Conduct effectiveness checks to verify that the recall is carried out (proposed SEC 507.38(b)(3)); and
* Appropriately dispose of recalled product, e.g., through destroying the product, reprocessing, or diverting to a use that does not present a safety concern (proposed SEC 507.38(b)(4)).
Procedures that describe the action to be taken would enable a facility to act promptly by following its plan when the facility determines that a recall is warranted rather than developing a plan of action after the need for a recall is identified. Procedures that assign responsibility for taking those steps would save the time needed to make such determinations during a recall and enable the owner, operator, or agent in charge of a facility to clearly communicate such responsibilities to applicable managers or staff so that such managers or staff can take action as soon as the decision to conduct a recall is made.
Directly notifying direct consignees about the recall (proposed SEC 507.38(b)(1)) is the most effective mechanism to ensure direct consignees know that the product is being recalled and is consistent with FDA's general guidance on recall communications in SEC 7.49(a). Further, instructing direct consignees how to return or dispose of an affected product minimizes the chance the affected product will be disposed of improperly and allows direct consignees to act quickly. Further, it is consistent with FDA's guidance on the content of recall communications in SEC 7.49(c)(4). FDA has provided guidance to industry on a model recall letter (Ref. 73). This guidance may be useful in developing procedures for directly notifying direct consignees about the recall and on how to return or dispose of an affected product.
ication procedures could identify a variety of communication means, including email, telephone, fax, text messaging, and urgent mail delivery. Notification procedures that would establish only a general notification to the public (e.g., through a press release or through information posted on a facility's Web site), without procedures for concurrent contact directly with direct consignees about how to access the general notification, would not satisfy proposed SEC 507.38(b)(1); a general notification to the public would rely on the chance that the direct consignees would see the information and may not be effective.
Notifying the public about any hazard presented by the animal food when appropriate to protect human or animal health is a common practice (e.g., see FDA's Web site that provides information gathered from press releases and other public notices about recalls of animal food, Animal & Veterinary Recalls & Withdrawals) (Ref. 74). Notifying the public in such circumstances is consistent with the Agency's guidance on a recall strategy that the purpose of a public warning is to alert the public that a product being recalled presents a hazard to human or animal health ( SEC 7.42(b)). Notifying the public, in addition to direct consignees, may not be necessary to protect the public if, for example, the animal food being recalled was all distributed to animal feeding operations (who were notified as a direct consignee) and not distributed for retail sale. Procedures in the recall plan for notifying the public could include model press releases and procedures for disseminating information to the public though press releases or other means, such as by information posted on the facility's Web site or provided to end users of the animal food using social media. FDA has provided guidance to industry with a model press release for the presence of Salmonella in pet food and pet treats (Ref. 75).
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