On June 8, FSIS issued Notice 40-16, “Questionnaire on Consumer Complaints Involving Foreign Material.”

The notice comes on the heels of recent recalls pertaining to foreign material and a May 18 conference call with industry to discuss how establishments handle foreign-material complaints from consumers/customers and findings between establishments.

Under the notice, inspection program personnel (IPP) at regulated facilities are to complete a questionnaire between July 11 and Aug. 11 regarding how an establishment responds to foreign-material complaints. Although the questionnaire has not yet been released, the notice indicates establishments will be asked, among other things: 1) whether they have a written process to gather and evaluate all consumer complaints regarding foreign material; 2) whether they have a written description of the actions they take for complaints, including when no action is taken and why; and 3) whether they make these written documents available to IPP. Information gleaned from the questionnaires will be used “to determine the next phase and to inform policy development.”

The agency is considering a new policy regarding when establishments are required to notify the FSIS District Office of foreign-material complaints. During the May 18 conference call, the agency stated that 9 C.F.R. § 418.2 provides the current notification requirements. This regulation requires an establishment to notify the district office within 24 hours when it has reason to believe adulterated or misbranded product is in commerce; however, to meet the obligations of 9 C.F.R. § 418.2, FSIS is concerned establishments do not have a documented process for determining whether consumer complaints are legitimate and, if so, for determining whether adulterated product may be in commerce.

With regard to what elements should be part of a documented process, FSIS has shared the following questions.

  • Does the establishment/company have a written protocol for tracking incoming complaints?
  • Is there written decision criteria for determining:
    • Whether a complaint is legitimate?
    • Whether the foreign material is isolated or systemic; if isolated:
  • Whether the establishment has a process for reviewing any remaining product; and
  • Whether the establishment considers “repeat isolated incidents” from the same source?
    • Whether the foreign material is visible to the consumer or incorporated into the product?
  • Even if visible, FSIS noted that establishments should carefully consider whether product has been shipped to schools, military, hospitals and other institutions.
    • Whether the foreign material renders product “adulterated?” and
    • Whether FSIS will be notified?
  • If corporate headquarters is doing the analysis, does headquarters provide feedback to the producing establishment and provide updates regarding repetitive contamination?
  • Is the process for evaluating complaints regarding foreign material in a form that IPP can review?
  • Does the establishment provide updates to IPP regarding foreign-material complaints?

Another policy issue under consideration is when establishments are required to notify the district office when foreign material is found between official establishments. During the industry conference call, a question was asked whether establishments are required to notify the district office pursuant to 9 C.F.R. § 418.2 each time foreign material is found upon receipt of food (e.g., blue glove, metal hook). The agency reported it does not currently expect notification to the district office provided the following conditions are met:

  • The establishment finds the foreign material;
  • The establishment follows procedures to evaluate the incoming product to ensure the foreign material is an isolated incident and not more prevalent;
  • The establishment notifies its supplier; and
  • The establishment notifies IPP.

If these conditions are met, FSIS would currently allow the foreign-material finding to be handled in accordance with FSIS Directive 8140.1. Although quite old and recognized by the agency as in need of updating, this directive sets forth procedures it will follow when an establishment receives adulterated product from a supplier. Procedures include completing a Form 8140.1 and notifying agency personnel in the district in which the supplier resides.

In the next few months, FSIS will be scrutinizing how establishments are assessing, responding to, and reporting foreign-material complaints and findings and developing policy based on this assessment. If establishments have not already done so, it’s time for them to reassess their procedures to ensure they are meeting agency expectations.  NP