Unfinished Business: Answering Your Questions About Mock Recalls
By Sam Lewis
Last month, Food Online and the Grocery Manufacturers Association (GMA) hosted a live web chat, Mock Recalls: What Are They, Why Are They Important, And How Do I Perform One? In this 45-minute live Q&A, Jennifer McEntire, Ph.D., Vice President of Science Operations at GMA, answered the audience’s questions about best practices in mock recall exercises. While the session was educational and informative, there wasn’t enough time in the session to answer every question. Here, Dr. McEntire addresses some of the unanswered question from the live web chat.
View the entire web chat or check out part one, part two, and part three
Food Online: Shaker asked, “What is the role of the scientific advisor in mock recalls and is there a difference between a recall and a withdrawal?”
Dr. McEntire: One or more scientific advisors should be considered within your recall plan. During a mock recall, depending on the scenario you are working through, you may not have a thorough understanding of the science (e.g., what is the health impact of this contaminant? Would it have survived my process? How long will it persist? Etc.). A scientific advisor may be able to answer these questions.
Recalls are different from withdrawals. Definitions are found here: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129337.htm
Food Online: Ali asked, “True of False — do not contact your customers when executing a mock recall?”
Dr. McEntire: It depends on the relationship with your customers, and their willingness to participate. If you do want to engage them, it would be prudent to let them know that it’s not an actual recall.
Food Online: Mary asked, “What procedure can a company have to assess the risk of a recall situation in order to classify it per the FDA?”
Dr. McEntire: The FDA’s recall guidance helps with this and can be found here. A company can recommend a classification to the FDA, but, ultimately, the FDA assesses the potential health impact and determines the recall classification. A health hazard evaluation often supports the classification recommendation.
Food Online: Gregory asked, “Can you confirm that packing material should also be included and could be the mock recall in itself — we see this missing in many cases?”
Dr. McEntire: Packing material certainly can be included in a mock recall. A firm may want to select scenarios that are most likely to happen. A situation involving packaging material should be assessed from the standpoint of likelihood to occur.
Food Online: Ana asked, “When communicating with customers that received product, is there a minimum requirement in terms of response rate from customers?”
Dr. McEntire: Success and effectiveness are usually measured by the percent of responses in a certain timeframe. Obviously, the higher the response rate in the shortest amount of time is desirable. There is no regulatory requirement, per se, of a response rate. Some people look at 98 to 99 percent response within a couple of hours as adequate.
Food Online: Lee asked, “For an identified recall item, how do you determine the scope? What about clean breaks in the production process, etc.?”
Dr. McEntire: The scope can’t be determined until the root cause is determined. Depending on the issue, a clean break may not matter. For example, if the issue was with an ingredient that was used in several production runs, even though they had clean breaks in between. If an issue stems from post process contamination due to the harborage of a pathogen in the environment, “normal” cleaning may not address the harborage. So, again, a clean break may not be able to be relied upon. It really depends on what caused the problem.
Food Online: Gabriel asked, “When it comes to the products that are prepared on the retail level, is there an opportunity for the food safety/sanitation program vendor to help?”
Dr. McEntire: If the question is about the food safety or sanitation program, vendor helping a retailer with a recall related to food prepared at the retail establishment, that would be up to the retailer.
Food Online: Darien asked, “In a real recall, what happens with unaffected product that was recalled and how would a supplier be able to get this product back into rotation?”
Dr. McEntire: If the manufacturer knows the scope of the issue, unaffected product should not be recalled. Of course, sometimes manufacturers add buffers and do choose to recall product that is unlikely to have the issue. In this case, because it’s a buffer, the manufacturer should dispose of the product in the same manner as the “known” impacted product.
If a retailer pulls product off the shelf that is not within the scope of the manufacturers recall, then the trading partners need to rely on the way that contracts were written to determine what happens to the product (especially from a financial standpoint). From a food safety standpoint, there is nothing that would prevent “good” product from remaining in distribution (assuming there were no opportunities for cross contact or cross contamination).
Food Online: Steven asked, “While not a recall per se, but are there any requirements that foodservice establishments (including restaurants) conduct "mock" contamination events? Is that commonly practiced in the industry?
Dr. McEntire: I’m not sure of the practices at foodservice establishments. At the corporate level, looking at supply-chain issues yes, but at the individual store level, I am not familiar with the kinds of scenarios that might be practiced.
Food Online: Marcy asked, “What is batch code? What is lot code?”
A lot or batch code is used to identify product with a fair degree of granularity. The preamble to the final Preventive Controls rule has substantial discussion of these terms, beginning around comment 100 (IX. Subpart A proposed definitions) (https://www.federalregister.gov/articles/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human#h-73).
Food Online: Juan asked, “Typically how much of a given lot of processed food you can expect to recover in a mock recall?”
Dr. McEntire: It depends on the scenario constructed. If the situation is assumed to be discovered before the product left your distribution, then you should recover 100 percent (and because it’s in your control it’s not technically a recall). If it’s a short shelf life product (say, one month) and the scenario shows that the recall is due to a pretend outbreak and it took six weeks to recognize the outbreak, there would be no product left to recover. Still, in a mock situation (or a real one) you still know the first level consignees and should be able to demonstrate that you can quickly and accurately determine where affected product went, and show that you’d be able to contact your first level customers receiving that product.
About Jennifer McEntire, Ph.D.
Dr. Jennifer Cleveland McEntire is Vice President of Science Operations at the Grocery Manufacturers Association where she oversees the microbiology, chemistry and packaging laboratories, process authority team, and consumer complaint product forensic analyses.
A food microbiologist by training, Jennifer’s areas of expertise include recall and crisis management, traceability, food defense, and food regulations. Jennifer was previously Vice President and Chief Science Officer at The Acheson Group, where she supported food industry clients through recall and crisis situations.
Prior to joining TAG, Jennifer served as the Senior Staff Scientist and Director at the Institute of Food Technologists (IFT). She also held a two-year appointment with the USDA’s National Institute for Food and Agriculture, and served as a visiting scientist at FDA CFSAN.
Jennifer earned a Doctor of Philosophy from Rutgers University as a USDA National Needs Fellow in food safety and received a Bachelor of Science with Distinction, magna cum laude, in food science from the University of Delaware. She was the 2010 recipient of the Rutgers University Food Science Alumni Association Communication Award and in 2012 was honored with the University of Delaware College of Agriculture and Natural Resources Distinguished Young Alumni award. She has also received two awards from the FDA CFSAN Center Director related to her work on food defense as well as food safety collaboration training materials.
She has authored more than 20 peer reviewed publications, six book chapters, and numerous white papers. She is on the Board of Phi Tau Sigma (the food science honorary society) and is a member of the Advisory Council of the Global Food Traceability Center.