Update to FSIS Directive 8140.1
FSIS clarifies steps establishments must take to address shipment of adulterated and misbranded product from another official establishment.
On July 3, 2017, the Food Safety and Inspection Service (FSIS) issued FSIS Directive 8140.1 (Revision 1), “Notice of Receipt of Adulterated or Misbranded Product.” The directive updates inspection program personnel (IPP) on procedures for handling an inspected establishment’s receipt of adulterated or misbranded product from another official establishment. Among other things, the directive clarifies whether receiving establishments are required to notify the FSIS District Office (DO) pursuant to 9 C.F.R. § 418.2 whenever they receive adulterated or misbranded product from another official establishment.
On its face, 9 C.F.R. § 418.2 requires inspected establishments to notify the DO within 24 hours of learning that adulterated or misbranded meat or poultry product has entered commerce. This applies to both producing and receiving establishments. However, in a May 2016 conference call with industry to discuss foreign-material contamination, the agency stated that foreign material findings in product shipped between establishments could be handled with notification to IPP and the use of FSIS Form 8140-1 instead of notification to the DO. The agency stated that Directive 8140.1 (issued in June 1995) would be updated to reflect this fact.
The directive has now been updated to clarify that although both receiving and producing establishments are required to report adulterated or misbranded that has entered commerce to the agency, receiving establishments do not have to notify the DO if they notify IPP of the adulterated and misbranded product and IPP completes and distributes an FSIS Form 8410-1 (hereinafter “Form”). The establishment can notify the IPP or DO, but is not required to notify both.
If IPP are notified that adulterated or misbranded product has been received by an establishment for further processing, they are to complete the Form to ensure timely notification to all applicable DOs and the producing establishment. On the Form, the IPP will indicate the type of adulteration or misbranded product, the determination of likely cause and the establishment’s disposition of the product. If the establishment’s disposition decision has not been made yet or the likely cause has not been identified by the time the Form is completed, IPP are to indicate how the product is being controlled and update the Form when these decisions are made.
Once completed, IPP are to submit the Form to the receiving establishment’s DO and Frontline Supervisor. The receiving establishment’s DO will then forward the Form to the producing establishment’s DO, who will forward the form to the producing establishment’s Inspector-in-Charge. If the adulterated or misbranded product originated from a non-inspected establishment or became adulterated or misbranded during transportation, the DO will also submit the form to the relevant FSIS Office of Investigations, Enforcement and Audit regional office for investigation. If the adulterated or misbranded product was imported, FSIS Import Operations will be notified.
Once the IPP at the producing establishment receives the Form, they are to notify the establishment management, verify that the establishment has taken corrective actions pursuant to 9 C.F.R. § 417.3, if appropriate, and document the corrective action on the Form. If an NR is issued and the establishment responds to the NR, the response can be used to document the corrective action on the Form. If it is determined that additional adulterated or misbranded product has been distributed into commerce, IPP at the producing establishment are to contact the DO to determine if recall procedures should be initiated.
It should be noted that there are certain situations that are exempt from the above procedures. These include:
- The receiving establishment directly notifies its DO;
- The receiving establishment receives adulterated or misbranded product for further processing under USDA seal and FSIS Form 7350-1, Request and Notice of Shipment of Sealed Meat/Poultry, accompanies the meat and poultry product; or
- The misbranded or adulterated product is received by the establishment under other control measures with the intent to make it not adulterated or misbranded, such as cooking E. coli O157:H7 positive beef product.
The new directive was slated to be implemented on August 3, 2017. NP