An effectiveness check is a procedure designed to verify that all notified consignees have received notification about the recall and have taken appropriate action; procedures to conduct effectiveness checks would be consistent with FDA's guidance on a recall strategy in SEC 7.42(c)(3). Procedures to conduct an effectiveness check could expand on the procedures used to directly contact consignees about the recall, e.g., to include forms for consignees to provide information about the amount of recalled product on hand, to include information on follow up contacts via phone or email, or to include personal visits to consignees by sales representatives. FDA has provided guidance to industry on conducting effectiveness checks (Ref. 73). This guidance includes a model effectiveness check letter, a model effectiveness check response form that could be sent to a consignee, and a model questionnaire to be used during effectiveness checks conducted by telephone or by personal visit.
A facility that receives recalled product from its customers must appropriately dispose of the product, e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or by destroying the product. These types of disposition actions are similar to the disposition actions that a facility would consider as a corrective action as a result of a problem that is discovered before the product leaves the facility (see, e.g., the discussion of corrective actions in the final rule to establish FDA's HACCP regulation for seafood; 60 FR 65095 at 65127). Procedures for disposition of a product can help the facility ensure that disposition of recalled product will be appropriate and will not present a risk to animals. Implementation of such procedures is part of determining whether a recall can be considered terminated. Thus, having procedures in place can result in more efficient completion of a recall. Under SEC 7.55, appropriate disposition of recalled product is a consideration in determining whether a recall is terminated.
FDA requests comment on whether the procedures to be included in the recall plan (i.e., to directly notify consignees, to notify the public, to conduct effectiveness checks, and to appropriately dispose of recalled product) are appropriate for all types of facilities or if they should be modified for certain facilities.
FDA requests comment on whether the Agency should require a recall plan to include procedures and assignments of responsibility for notifying FDA of recalls subject to the plan. Notifying FDA could enhance the effectiveness of a recall by allowing FDA to take appropriate steps to minimize the risk of illness or injury related to recalled products. As discussed in section II.E of this document, notifying FDA of a reportable food (including animal food) is required by section 417 of the FD&C Act. Reportable food reports include information about whether a reportable food is being recalled. Thus, in some cases, reporting a recall to FDA could be accomplished by submitting a reportable food report required under section 417. In other cases, facilities could notify the local FDA district office of the recall.
E. Proposed SEC 507.39--Monitoring
1. Requirements of Section 418 of the FD&C Act
Section 418(a) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall monitor the performance of the preventive controls. Section 418(d) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under section 418(c) of the FD&C Act to provide assurances that the outcomes described in section 418(c) shall be achieved. The outcomes relevant to this proposal are those that provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and that food manufactured, processed, packed or held by a facility will not be adulterated under section 402 of the FD&C Act.
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