FSIS Notification Rule – One year later

A little over a year ago, the Food Safety and Inspection Service (FSIS) issued a final rule requiring inspected meat and poultry establishments to notify their FSIS District Office within 24 hours of learning or determining that misbranded or adulterated meat or poultry product received by, or originating from the official establishment has entered commerce (hereinafter “Notification Rule”). Although many predicted that the Notification Rule would result in a significant increase in product recalls and enforcement actions as FSIS became aware of issues that were previously kept “in house”, so far the impact of the final rule has not been nearly as dramatic. With the exception of an uptick in recalls due to foreign material contamination, there has been no noticeable increase in recalls overall, or in FSIS enforcement actions.  This is largely because inspected facilities have traditionally kept FSIS inspectors “in the loop” regarding food safety issues, and this has not changed with the promulgation of the Notification Rule.

With that said, it has been our experience that many establishments, especially small and very small plants, are still not as familiar with the Notification Rule as they should be.  For example, many establishments continue to believe that they do not need to notify the agency of mislabeled or contaminated product that has entered commerce if it is unlikely that the mislabeling or contamination issue would arise to a food safety risk.  This is incorrect.  Even if a product poses no food safety risk at all, if product is considered “adulterated” or “misbranded” as a matter of law and has entered commerce, notification would be required.

Some establishments also mistakenly believe that they would not have to notify the agency in situations where misbranded or adulterated product entered commerce, but the official establishment was able to regain control of the product and the product was no longer in commerce.  Again, the key criteria for determining whether notification is required are whether product: (1) has entered commerce, and (2) is legally adulterated or misbranded.  Even if an establishment is able to regain control over the product and take appropriate disposition, notification would still be required in this situation because adulterated or misbranded product had entered commerce.

Finally, establishments should be aware that just because it might be required to notify the agency of adulterated or misbranded product that has entered commerce, it does not necessarily follow that a recall would be warranted.  Although the agency defines a recall as “a firm’s removal of distributed meat or poultry product from commerce when there is a reason to believe such products are adulterated or misbranded,” the agency will consider the facts of each case on its own merits and may decide that a relatively minor issue would warrant a market withdrawal (in which no press release is issued) as opposed to a recall.  For example, in cases involving foreign material contamination, the agency might decide that a market withdrawal is warranted in a case where an establishment can demonstrate that the contamination event was isolated (not systemic), the amount of contaminated product in commerce is small, and there is no food safety risk posed by the contamination.  To that extent, it would be prudent for establishments to provide information to FSIS regarding these factors when notification is made to the agency regarding noncompliant product in commerce.

When the agency issued its final “Notification Rule,” it issued instructions to inspection program personnel regarding the rule and a questions and answers document.  Recently, FSIS updated its instructions to clarify when it considers adulterated or misbranded product to be “in commerce.”  These documents can be found at:

Notice 36-13: http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/36-13.pdf.

Q&As:  http://www.fsis.usda.gov/PDF/Questions_and_Answers_Notice_34-12.pdf

Establishments should review these documents to ensure they are familiar with their responsibilities under the final rule and should consult with legal counsel, or other appropriate resources, if questions remain.

Categories: USDA

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.