FSIS Foreign Matter Recalls Increase In 2016
Foreign Matter Recalls Since 2012
A review of FSIS recall data from the past five years indicates that recalls of meat and poultry products due to the presence of foreign matter contamination have grown in number, particularly over the past year. Indeed, as noted on the unofficial chart below, there have already been 23 FSIS foreign matter related recalls in 2016, which is significantly more recalls of this type than conducted during the previous four years.
Recent FSIS Activity Related to Foreign Matter in Food
The recent increase in recalls due to foreign matter appears to be related to FSIS (1) increasing its focus on food safety issues involving intentional adulteration; and (2) on FSIS’s recent review of the consumer complaint handling system establishments currently have in place for foreign matter related complaints. Back on May 18, 2016, FSIS conducted a conference call with members of industry to discuss how establishments handle foreign material complaints and respond to related regulatory findings between different establishments. Then on June 8, 2016, FSIS sent its inspection program personnel FSIS Notice 40-16, Questionnaire on Consumer Complaints Regarding Foreign Material (June 18, 2016). The Notice instructed IPP staff at FSIS regulated facilities to complete an online questionnaire addressing whether the facility has a written program in place to capture, evaluate, and respond to consumer complaints regarding foreign matter. IPP staff were further instructed to complete the questionnaire by August 11, 2016 so the questionnaire data could be reviewed by FSIS Headquarters Staff to determine any next steps in evaluating facility compliance in this complaint area.
FSIS Foreign Material Directive
As background, FSIS Directive 7310.5, Presence of Foreign Material in Meat or Poultry Products, which has been in force since 2003, provides guidance to IPP Staff to help verify that establishments are properly addressing the possibility that foreign material is present in products, in a way that is consistent with Hazard Analysis and Critical Control Point (HACCP) requirements pursuant to 9 CFR 417.2. IPP Staff are also responsible under the Directive for verifying that HACCP critical control points for foreign material have been established and validated. Thus, FSIS has existing regulatory controls in place to regulate foreign material contamination issues at regulated establishments.
FSIS Classification of Foreign Matter Recalls
Based on a review of FSIS foreign-material related recalls, FSIS generally treats recalls due to the presence of foreign material very seriously relative to the anticipated hazard often posed by this type of adulteration. For example, FSIS classifies many foreign matter-related recalls as “Class I,” which means there is a reasonable possibility that use of the product will cause serious adverse health consequences or death. In some cases, however, industry recalls due to foreign material appear to involve the presence of very little foreign material (i.e., just a few small pieces) and involve “no reported injuries.” So classifying such recalls as Class I could arguably be a “heavy-handed” approach by FSIS. From industry’s perspective, FSIS foreign matter recall classification should correspond closely with an establishments hazard analysis addressing the contamination issue. In cases where the extent of the foreign material contamination appears to be well-contained and no injuries have been reported, FSIS should be more amenable to classifying the recall at a lower level (i.e., Class II/III) when reasonably warranted.
In summary, FSIS is now placing greater focus on foreign material contamination involving regulated products and on related facility complaint handling systems. Accordingly, we recommend that regulated establishments review and update their HACCP procedures related to foreign materials and also review their compliant handling procedures where appropriate.
Arent Fox will continue to follow and report on developments involving food safety issues and FSIS requirements for regulated establishments. Please contact Georgia C. Ravitz, James R. Ravitz, Wayne H. Matelski, Naomi J.L. Halpern, or Robert G. Edwards for further assistance.