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Regulatory Spotlight Shifts to Proposed FSIS Standard

Those of you who read the TAG newsletter on a regular basis know that we tend to have a greater focus on FDA regulation than that of USDA. This is likely due, in part, to FSMA holding the spotlight on food safety for the last decade, my own former commission with FDA, and the abundance of communication put out by FDA vs. USDA. But we’re turning the spotlight in this issue to a USDA-FSIS 2019 proposal on new performance standards for Salmonella in raw ground beef and beef manufacturing trimmings. While the proposed standard was published in late October, there was very little mention of it outside the Federal Register. In fact, it was an FSN article of Jan. 9 that brought the standards and their potential 2020 impact to our attention. So to ensure our raw ground beef and beef manufacturing trimming readers understand the expected standard and get their year started out right, following is an overview of the proposed standard, why FSIS proposed it, and what it all means. What it is: The FSIS proposed standard would update how the agency assesses the efficacy of Salmonella controls in establishments producing raw ground beef and/or beef manufacturing trimmings. Following the poultry performance assessment standards begun in 2016 (81 FR 7285), FSIS is proposing the use of a similar 52-week “moving window” of FSIS sampling results and other related verification activities. As explained by FSN, for the moving window, FSIS evaluates samples taken within an initial 52-week period (not necessarily a calendar year). Then, every week, the 52-week period “moves up” one week, adding a new week’s testing result and removing the oldest week’s results. A test is considered positive when any Salmonella organisms are found. Through this method, FSIS would be increasing Salmonella sampling from the current frequency of a maximum of four times per month to once per week. This would ensure that a sufficient number of Salmonella samples (i.e., 48) are collected to assess the establishments’ performance. For both raw ground beef and beef manufacturing trimmings, FSIS is proposing a pathogen reduction performance standard for Salmonella of two allowable positives out of 48 samples in the 52-week period. Approximately one year (52 weeks) after the new standards are made final, the agency would post individual establishment performance as either “meeting” or “not meeting” the pathogen reduction performance standard on the FSIS website, based on the most recent 48 Salmonella sample results. (If fewer than 48 samples are collected or analyzed, the establishment’s status would be reported as “N/A,” provided the establishment has two or fewer Salmonella positives in that window.) The standards would be applicable to establishments that produce more than 50,000 pounds of these products per day). FSIS notes this as accounting for approximately 91 percent of the total raw ground beef and 96 percent of the total beef manufacturing trimmings production volume annually. FSIS has opted not to propose pathogen reduction performance standards for those producing 50,000 pounds or less per day, but it will continue co-analyzing for Salmonella in all samples it collects for STEC analysis from these establishments to monitor ongoing pathogen prevalence. Why it was proposed: According to FSIS, Salmonella bacteria are among the most frequent causes of foodborne illness. These bacteria reside in the gastrointestinal tract and other organs of food animals. While contamination of the meat can be minimized, there is not currently a way to completely eliminate it from commercial slaughter, fabrication, or further processing operations. Because of continued outbreaks of Salmonella illness associated with the consumption of ground beef products, FSIS is proposing updated and new performance standards to address the market failure from information asymmetry between producers and buyers. What it means (Why we’re telling you about it now): With the comment period closing on January 27, 2020, and poultry already being held to a similar 52-week sampling program, this proposed standard is likely to become final this year impacting all high-production producers of raw ground beef and/or beef manufacturing trimmings. As a comment from me, there is no doubt that the introduction of performance standards in past years have had a positive impact on risk control in the meat and poultry industry. The tough part for industry that I have seen is that once you are below the standard, it can be difficult to get back into the standard due to the time it takes for some “bad results” to fall off the 52-week window. There seems to be no mechanisms for FSIS to recognize that short-term failures are not indicative of long-term problems, and I encourage FSIS to look at ways for industry to accelerate regaining the appropriate status more quickly. After all, performance standards should reflect current performance and not be a punitive tool for a past failure. About The Acheson Group (TAG): Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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