Enhancing Your Operations To Stay Ahead Of FSIS Policy Changes

Posted in Regulatory Compliance

Food safety is one of the highest regulatory priorities of FSIS. As a result of recent industry efforts driven by FSIS policy changes, we have witnessed a significant reduction in the numbers of foodborne illness outbreaks and recalls being reported annually. Given its heightened interest in food safety, we expect that FSIS will continue to challenge industry by aggressively regulating additional levels of safety into raw and ready-to-eat animal products.

Driven by our own long history serving the industry as USDA and FSIS lawyers, we will continue to closely follow, and keep you apprised, of new FSIS policy developments as the occur.  The following provides a quick synopsis of the policy initiatives we expect that FSIS will continue to pursue.

E. coli O157:H7 and Non-O157 STECs

Over the last decade, driven in large part by FSIS policy initiatives, there has been a tremendous reduction in the number of reported foodborne illness outbreaks and recalls. In the ten year period spanning 2003 through 2012, the Centers for Disease Control investigated approximately 400 E. coli O157:H7 outbreaks. These foodborne illness outbreaks involved approximately 5,000 illnesses, 1,500 hospitalizations, and 50 deaths. From a financial standpoint, the impact on industry was substantial as well. In 2007 and 2008, for instance, there were nearly 50 recalls involving approximately 50,000,000 pounds of ground beef. Thus, it has been a priority for both industry and FSIS to work toward better control of E. coli O157:H7 and non-O157 STECs, and a reduction in these numbers.

Between 2008 and 2014, there was a steady decline in the numbers of outbreaks and recalls. So far in 2015, there has not been a single outbreak or recall involving E. coli O157:H7 or Non-O157 STECs in raw ground beef. Although there have been two product recalls involving these pathogens in raw beef trim and intact product, only 3,551 pounds of raw product were affected.

In the future, we expect that FSIS will attempt to maintain these trends by placing additional focus in federally regulated harvest establishments on sanitary dressing procedures, and also requiring establishments to create and implement high-event day protocols to contain and (if necessary) divert any potentially contaminated product. FSIS will also require retail grinders to keep formulation records and will conduct aggressive traceback investigations to the harvest level in the event the regulatory or public health system detects a positive. When FSIS conducts these investigations, it may determine that expensive recalls of both non-intact and intact product at the harvest may be warranted.

Listeria Monocytogenes

In addition to controlling E. coli O157:H7 and Non-O157:H7 STECs, FSIS is also committed to eliminating Listeria Monocytogenes (“Listeria”) from Ready-To-Eat (“RTE”) products. Each year, Listeria causes approximately 1,600 foodborne illnesses and 260 deaths. The largest Listeria outbreak occurred in 2011, when cantaloupe contaminated with Listeria caused 1476 illnesses and 33 deaths. The owners of the company were charged criminally for failing to adequately control for Listeria. Notably, nearly 15 percent of case patients who are infected with Listeria will die.

Listeria has also taken a significant financial toll on industry as well. Since 2009, nearly 15 percent of recalls (involving meat products) were triggered by the presence of Listeria in RTE foods. In 2009, the meat industry issued 8 recalls associated with Listeria in approximately 50,000 pounds of products. In 2010, an additional 400,000 pounds of meat products were recalled. Between 2011 and 2010, over 500,000 pounds of meat was recalled and, in 2013, over 1,000,000 pounds of products were recalled.

Although FSIS has always mandated that federally-regulated establishments who produce RTE products develop and implement effective Listeria control programs, we anticipate that, in the coming months and years, FSIS will continue to place an increasing amount of regulatory importance on environmental and finished product Listeracontrol. In particular, FSIS will begin scrutinizing more closely establishment environmental control records and looking for adverse trends or patters that could be indicative of a broader sanitary or food safety issue.

We also anticipate that, as more establishments are successful in controlling Listeria in their finished products, and as future FSIS policy develops, FSIS will begin adopting and enforcing zero-tolerance policies for Listeria in the processing environment. Thus, in the future, when a positive Listeria sample is cultured from the environment (from a floor drain, for example), be prepared to put corrective actions into place and explain to FSIS what you are doing not only to identify, but also complete eliminate, its source.


In addition to a heightened regulatory response aimed at Listeria, we also expect FSIS to take additional steps in a coordinated effort to control the presence of Salmonella in raw animal products. Every year, Salmonella causes approximately 1.3 million illnesses and 500 deaths. Bolstered by its success in decreasing the numbers of outbreaks and recalls associated with E. coli O157:H7, FSIS is now committed on developing policies which will eventually achieve similar results with respect to Salmonella in ground beef and poultry.

In the short term, and to inform the development of these policies, FSIS has announced that it plans to increase the amount of testing it is conducting in raw trim and ground beef, and then to use the data it from the results to develop new Salmonella performance standards. We also anticipate that, moving forward, FSIS will likely continue to urge processors to initiate voluntary recalls of raw products that test positive for antibiotic-resistant strains of Salmonella. Thus, all processors should expect to see the level of Salmonella regulation from the agency steadily increase as FSIS continues to place additional pressure on processors to eliminate Salmonella from their raw beef and poultry products.

Increased Access To Information

Finally, while FSIS is increasing its regulatory control and oversight of pathogens of concern, the agency will also begin changing the way it investigates samples that test positive for pathogens, conducts its traceback investigations, interprets establishment microbiological testing data, determines the appropriate scope of product recalls, and shares establishment-specific information with the public. In this regard, FSIS has announced numerous changes in its information-related policies.

For starters, FSIS has announced that it will expand its regulatory control over raw ground beef formulation records at retail. According to FSIS, grocery stores which process ground beef will be required to maintain formulation (or, batch) records at retail. FSIS believes that having access to this information will allow the agency to more quickly and accurately conduct a traceback investigation and identify the likely original source of an emerging outbreak.

Second, as part of future outbreak investigations, the agency has announced that anytime there it obtains a positive regulatory or public health sample, FSIS will use all available information (including traceback and formulation records) to identify the most likely supplier of the raw beef trim that led to the positive finding. Once the supplier is identified, FSIS will visit the harvest facility (or facilities) at issue and conduct a broad investigation into the fabrication of the raw materials used to process the ground beef at issue. If the suppliers’ internal testing or other records suggest there is a broader contamination issue relating to the production periods in question, the agency will likely require a recall of the raw trim or intact product used to formulate and process the contaminated ground beef that was associated with the positive finding.

In addition to giving itself access to a broader array of information, FSIS also plans to begin sharing the establishment-specific information it collects with the public. The agency intends to create a web portal that will allow the public to access inspection-related information about an establishment and its daily inspection activities. FSIS believes that doing so will encourage regulated establishments to enhance their existing food safety protocols and will, ultimately, lead to a safer product.

FSIS has made considerable policy changes in recent years. We believe that the agency will continue to challenge industry to made additional strides in controlling the presence of all pathogens from raw and RTE food products. Begin reviewing your own internal policies now to make sure that you are anticipating the new regulatory initiatives, and are well positioned to address any related challenges.

With some proactive planning today, you can solidly position your company to better withstand and avoid any unwanted FSIS criticism and scrutiny in the future.