Further, although most consumer complaints will be related to quality issues, recent experience has demonstrated the value that consumer and customer complaints can provide in bringing attention to possible problems within a facility's preventive controls activities. FDA has received a number of animal food submissions to the RFR (Ref. 48) that have suggested that environmental pathogens hazards were not adequately addressed in a supplier's food safety plan. Some of these were identified through customer verification testing and others through complaints from consumers to a facility. A facility may also receive alerts as a result of state surveillance and testing programs.
Although this proposed rule does not include a provision regarding a review of complaints, the Agency estimates that a requirement that facility personnel review consumer, customer, or other complaints could impose an additional annual cost of
The Agency requests comment on whether and how a facility's review of complaints, including complaints from consumers, customers, or other parties, should be required as a component of its activities to verify that its preventive controls are effectively minimizing the occurrence of hazards.
3. Submission of a Facility Profile to FDA
Proposed SEC 507.30 would require that the owner, operator, or agent in charge of a facility prepare, or have prepared, a written food safety plan. The food safety plan would include the hazard analysis, preventive controls, and other records. Currently, information of this type is not reviewed by FDA investigators until they are physically present at a facility and have begun an inspection. In light of the large number of facilities that would be covered by this proposal, FDA recognizes several potential benefits to having a facility's food safety plan in advance of an inspection, if the Agency were to require facilities to do so. Having such plans could aid in the efficient oversight of preventive controls by allowing FDA to better target inspectional activities to facilities that produce animal foods that have an increased potential for contamination (particularly with biological hazards) and to improve on-site inspections by focusing attention on hazards and preventive controls for which the facility appears to have deficiencies. Facilities would benefit from the Agency's advance preparation through interaction with better-informed investigators and potentially reduced inspection time. The Agency could also more quickly identify facilities that had not established preventive controls for specific hazards of concern to the Agency and advise them to fill such gaps to prevent a problem before it occurs. Also, FDA could use the plans in evaluating the need for guidance on specific hazards or controls and prioritizing guidance to areas where it is needed most.
FDA believes that there are significant obstacles to realizing these benefits from submission of food safety plans, however. The agency would expect to receive a very large number of plans. Further, these plans would be expected to vary significantly in content and format. Assimilating the underlying information in a way that would be useful to the Agency would be an immense challenge. Moreover, not all of the information in such plans may be essential to realizing the potential benefits described above. Therefore, to most efficiently realize the potential benefits of having certain information prior to an inspection, the Agency requests comment on whether to require submission to FDA of a subset of the information that would be in a food safety plan. This information, which could be referred to as a "facility profile," could be submitted through an electronic form using a menu selection approach. The use of an electronic form would enhance the Agency's ability to store the information in a searchable form. Ideally, a searchable electronic system could allow FDA to assess information when a problem occurs with certain types of foods or controls, so that the Agency could target inspections to facilities that manufacture, process, or pack, animal food types that are at increased risk for a food safety problem; to facilities that appear to have insufficient controls to prevent a problem; or to facilities using a control the Agency concludes is ineffective at controlling hazards. The data elements for a facility profile could include some or all of the following:
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