CHAPTER V - SPECIAL CONSIDERATIONS FOR LARGE VOLUME RECALLS

    A. There may be situations involving recalls that include large volumes of product and numerous product labels, dates, and establishment numbers due to the inclusion of the recalled product in other FSIS-regulated products. If the FSIS establishment or FDA-regulated firm that produced the adulterated source materials has already recalled the affected product and receiving establishments have used the affected product as source materials to produce additional new FSIS-regulated products, FSIS will consider the new products subject to the original recall and will not ordinarily announce multiple separate recalls for the same issue. However, FSIS would expect any receiving establishment that has used the affected product to produce a new product to follow the instructions received from their supplier (e.g., recover or dispose) unless, as determined by the Agency, the process under which the new product was produced is sufficient to have mitigated the specific hazar d (e.g., raw ground beef recalled for STEC was previously utilized by a downstream establishment to produce fully cooked sausage).

    B. FSIS personnel are to verify that the establishment or FDA-regulated firm that produced the adulterated source materials or ingredients has recalled the affected product, including product incorporated into new products. If any receiving establishment refuses to recover new products containing adulterated source materials or ingredients implicated in the recall, FSIS personnel are to detain and seize those new products.

    C. If new products are produced using affected product or if the scope of a recall or details about recalled product change, FSIS will publish a notification to the public that this has occurred. This may or may not necessitate convening an Event Assessment Committee, as determined by RMTAD.