Date: Mar 03, 2015
This article is reprinted with the permission of Food Safety magazine. It first appeared in the Feb./March 2015 issue. To view the article in the magazine, please click here.
During January 2015, USDA’s Food Safety & Inspection Service (FSIS) issued 6 recall notices for meat and poultry food products that importers failed to present to FSIS for reinspection. By way of comparison, FSIS issued only 6 such recall notices in all of 2014, involving just under 22,000 pounds of product. The January 2015 recalls alone involve more than 220,000 pounds of product, and include not just meat cuts and finished product, but also processed ingredients that are then used in downstream products. The financial implications for companies due to these recalls are significant, not only because of recall costs, but also the potential for penalties to be imposed by U.S. Customs & Border Protection (CBP). In addition, recalls for food ingredients present a problem for customer relations and public perception. As discussed more fully below, a recent change to FSIS import requirements appears to have triggered an increase in FSIS surveillance of FSIS-regulated imports. Considering the business costs presented by the failure to present product to FSIS for reinspection, companies should be taking steps to ensure that their import paperwork for meat and poultry food products is in order.
All meat and poultry food products are potentially subject to FSIS jurisdiction upon import into the U.S. Although FSIS has opted to exempt some products from certain requirements because they contain only small amounts of meat or poultry (under a policy known as “amenability”), importers of all other meat and poultry food products must submit prior notification of the import to FSIS and, upon arrival in the U.S., present the product for FSIS reinspection. The failure to present product for reinspection, known in FSIS parlance as "FTP," is a technical violation, not necessarily indicating whether there is any health or safety concern regarding the imported product; nevertheless, FSIS appears to aggressively encourage manufacturers of FTP product to conduct a recall and has, when issuing recall notices, classified all FTP-based recalls as “Class I,” i.e., a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
The increased enforcement appears to relate to FSIS’s continued implementation of its Public Health Information System (PHIS)-Import component, an electronic alternative to the paper-based import inspection application process. Although the transition to this electronic import notification platform has been going on for over two years, FSIS' September 19, 2014 final rule (effective November 18, 2014) imposing a new deadline for prior notification (no later than when the entry is filed with CBP) and requiring electronic submission of a modified FSIS Form 9540-1 appears to have fomented the increased enforcement. Indeed, we understand that FSIS has doubled the number of staff reviewing import paperwork through the PHIS-Import Component before even issuing industry guidance (which was just published on February 12, 2014).
Since FTP product is imported, companies are not only dealing with FSIS, but also with CBP. FSIS works with CBP to obtain redelivery of the recalled, FTP product and ensure appropriate disposition. According to FSIS Notice 69-14, only destruction or export of the product to the country of origin is permitted. The product also is potentially subject to CBP-imposed penalties, which could be as severe as three times the value of the violative product. There are several mechanisms to mitigate CBP penalties, and companies would be well-served to take proactive action where CBP is concerned.
Recall costs, potential penalties, increased scrutiny on future imports, customer relations, and public perception--these factors should all convince any company that the implications of FTP are substantial. Indeed, the increased enforcement already has drawn attention. The non-governmental organization Food and Water Watch sent a letter on January 20, 2015 to USDA Secretary Tom Vilsack, citing concerns regarding the apparent increase in FTP. Given the scrutiny currently being given to meat and poultry food products, we strongly recommend that companies make sure their import paperwork is in order.
If you have any questions or need assistance addressing a USDA import problem, please contact Brian Sylvester at email@example.com or 202 434-4139.
Brian P. Sylvester, Esq. is an associate attorney in Keller and Heckman’s Food and Drug practice. Prior to joining the firm, he was a regulatory lawyer at USDA from 2009 to 2014.