FSIS could step up aggressive enforcement approach
As it has in the past, the USDA’s Food Safety and Inspection Service (FSIS) continues to march aggressively toward its goal of a safer food supply. In addition to tightening existing policy and creating new regulation, the agency will employ new tools in its fight for food safety. Some of these new tools will have an immediate and substantial impact on the industry, while the effect of others will be somewhat more subtle and long-lasting.
Emboldened by its success in reducing the numbers of outbreaks and recalls caused by E. coli O157:H7 (and non-O157:H7 STECs) over the last decade, the agency is now turning its attention aggressively toward Salmonella and Campylobacter. According to FSIS, “Salmonella and Campylobacter bacteria are among the most frequent causes of human foodborne illness in the United States.”
It is estimated Salmonella causes approximately 1.3 million illnesses and 500 deaths annually. Campylobacter, meanwhile, is estimated to make approximately 900,000 people sick each year. In response to the public-health concerns caused by these pathogens, the agency has established new standards in an attempt to significantly reduce the prevalence of Salmonella and Campylocbacter in raw chicken and turkey products, and in turn reduce human illness by 30 percent.
Although Salmonella and Campylobacter are not considered by FSIS to be adulterants in raw poultry and turkey products, FSIS’ new policy is designed to place significant regulatory pressure on processors who fail to achieve substantial reductions in these pathogens. In 2016, FSIS will begin routinely testing each processor’s products and publish the results of those tests on the agency’s Web site. Processors will be categorized based upon their performance and may even be given a failing score.
In addition to publishing the results of its testing for public dissemination, FSIS will use the test results to influence decisions regarding targeted Food Safety Assessments (FSAs). If a processor has difficulty meeting the FSIS performance standards, it could face an extremely uncomfortable, thorough critique of its operational programs and, based upon the results of that assessment, a Notice of Intended Enforcement (NOIE) threatening to shut the company down.
Under the new FSIS policy, it’s not only failing processors who have to worry. It is generally understood in the industry all processors will have some level of Salmonella and Campylobacter in their products. In turn, the agency has announced it will take the positive samples it receives from all processors and compare those samples to the CDC’s PulseNet database to determine whether they can be matched to any foodborne illness. Thus, even processors that are fully compliant with the new performance standards may find that their products nevertheless are causing an outbreak. If so, the agency may take additional regulatory action against those companies.
Finally, consistent with the FDA’s recent announcement to use criminal sanctions as a tool to compel regulatory compliance under the Food Safety Modernization Act (FSMA), FSIS is now employing more aggressive strategies as well. Under the FDA’s approach, the new agency policy is to look for a justification to bring criminal charges any time a food product is linked to a human illness. In the event people get sick from an FSIS-regulated product, the agency has announced that it immediately send an Incident Investigation Team to conduct an investigation. The team will scrutinize the facility’s operations, interview employees and may even subpoena records. Based upon the findings of this review, the agency could take additional regulatory action and, possibly, follow the FDA’s lead by bringing even more severe sanctions.
In addition to its targeted efforts against Salmonella and Campylobacter, the agency will continue to scrutinize processors for their ability to control E. coli O157:H7, non-O157:H7 STECs and Listeria monocytogenes. Together, these pathogens cause thousands of illnesses and hundreds of deaths each year. FSIS will continue to aggressively critique dressing procedures during harvest and environmental control. In response to these efforts, all processors should consider investing in additional pathogen-reduction technologies to control pathogens in the environment. Emerging active air and surface purification technologies offered by some companies offer good additional protections.
In addition to its efforts focused on controlling pathogens, FSIS has also strengthened its ability to find the original source of contamination when foodborne illness outbreaks occur. FSIS now requires all ground-beef processors and retail establishments to maintain grinding records. These records significantly enhance the agency’s ability to trace the source of contaminated product.
Also, under the previous FSIS investigative policy, the agency would in most cases simply record the names of any suppliers whose trim was used to process a positive batch, and then only conduct follow-up inquiries under limited circumstances. Now, if ground beef tests positive, FSIS will launch an investigation to find the original source of the contamination. These investigations will be directed at the supplier (or suppliers) of any trim used to process the contaminated batch of ground beef. Based on the findings of the investigation, the agency may strongly encourage a broad recall of all potentially affected products, including any trim or intact products that were fabricated during any questionable periods.
I predict the agency will be quite aggressive this year with its enforcement activities. Through its aggressive enforcement under FSMA, FDA is sending a very clear message to the industry that it has zero tolerance for human illness. I would predict FSIS, in many ways, will follow suit.
So, keep leaning far forward in the fight for food safety, protecting your products, your company and your brand. NP