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TAG April 21, 2017 0 Comments

Having been given, essentially, a nine-month grace period with a six-month education period, retailers are now being held accountable for recordkeeping requirements established by USDA’s December 2015 Final Rule, Records To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products. The rule became effective June 20, 2016; then from Oct. 1, 2016, to March 31, 2017, USDA FSIS investigators reviewed grinding logs at retail stores and educated retailers on the Federal Register Notice. But, as of April 1, 2017, investigators are now verifying compliance. While this rule impacts only retail stores and official establishments that grind raw beef, its implications and significance extend across the entire food industry. Intended to expedite traceback and trace-forward procedures that enhance the agency’s ability to investigate outbreaks and identify source materials, it is simply, one more example of the importance that the federal food safety agencies are placing on recordkeeping. It is an importance of which any food facility subject to the Food Safety Modernization Act (FSMA) is well aware (or certainly should be!). And it is a requirement that extends well beyond U.S. regulation into standards, such as the Global Food Safety Initiative (GFSI); foreign government decrees; and customer supply chain programs. But good recordkeeping holds value well beyond that of simply ensuring regulatory compliance. As any food company that has been involved in any aspect of an outbreak – or even internal positive pathogen test – knows very well, good records are invaluable in limiting the scope of a recall. The recordkeeping requirements of the new FSIS rule mandate that those who grind raw beef products maintain records on: Establishment numbers of suppliers for each lot of raw ground beef product. All supplier lot numbers and production dates. Names of all supplied materials, including those carried over from a prior production lot. Date and time each lot is produced. Date and time when equipment and related food-contact surfaces are cleaned and sanitized. It is a fairly simple list, particularly for food manufacturers who have had to follow one-forward/one-back traceability since the implementation of the Bioterrorism Act of 2002. But it becomes rapidly complex with the mixing of ingredients from multiple sources into a single product – whether that be cuts of beef from various sources or the various ingredients required for a product such as pizza or soup. It’s no accident that each of the regulations … Bioterrorism, FSMA, Beef Grinding … was originated because of an incident or incidents which the federal government was seeking to prevent in the future, at least in part through recordkeeping. In its announcement of the beef-grinding recordkeeping rule, FSIS specifically mentions the “2011 Salmonella outbreak in Maine and parts of the northeastern region of the United States [which] resulted in illnesses that could have been prevented if establishments had kept records of suppliers on file.” And, similar to the increased records access rules of FSMA, the intention of the rule is to ensure that “public health officials have the ability to quickly search records to identify the exact source of the raw beef products during outbreak investigations.” While the ultimate goal of all these, and other traceability rules, is to protect the consumer, good recordkeeping provides just as much protection for a food company and the food industry as a whole in limiting the scope of a recall for the industry – thereby limiting the amount of product needing to be recalled and, potentially, the number of food manufacturers and suppliers involved in a recall; the cost of the recall and related wasted production and finished product requiring disposal; the impact on the brand of every company implicated in the recall, as well as on every other food producer in the segment should consumers avoid a food product altogether out of “an abundance of caution.” One need only look back the 2008 Salmonella outbreak for which tomatoes were initially implicated, but jalapeno and serrano peppers grown in Mexico were later cited as the likely cause. By the end of the outbreak, the U.S. tomato industry “had lost a reported $250 million and blamed the government for being singled out on the basis of ‘flimsy evidence’.” While better recordkeeping would not have prevented the outbreak, as a whole, it is certainly likely that the source would have been found much more quickly, not only significantly reducing the impact on the tomato industry, but reducing the number of consumers sickened. 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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