For each of the last several years, we’ve compiled a listing of the Top 10 TAG Insights articles as ranked by number of readers … and this year is no different: we’ve compiled the 2019 Top 10 list. Yet, an assessment of this year’s list shows that it is a little different. In past years, a popular topic trend or two was generally evident, but this year’s list covers an array of topics – from the personal impacts of outbreaks to USDA guidance on customer complaints to FSMA rules to allergens – and even last year’s predictions for this year. (Keep an eye out for the 2020 version next week!) So what were you most interested in 2019? The Top 10 TAG Insights articles of 2019 were: 1. Personal Costs of Outbreaks Now Extend to Boards of Directors. Ever since the PCA convictions of executives, we’ve seen the potential personal costs of outbreaks for businesspeople, but 2019 brought with it a whole new area: With litigation still ongoing from the 2015 Blue Bell Creameries Listeria outbreak, not only did it impact a group we’ve not previously seen involved: the Board of Directors, the latest lawsuit was brought not by an impacted consumer, but by a stockholder who sued two key executives and the Board for breach of fiduciary duties, that is, “their duties of care and loyalty by knowingly disregarding contamination risks and failing to oversee the safety of Blue Bell’s food-making operations.” It may be time to take a fresh look at how food safety is being communicated at all levels of the business – including to the Board of Directors. Read the full article. 2. Lessons to be Learned from an Anything-But-Typical Recall. Recalls have, unfortunately, become very commonplace, but this one was out of the norm because of its unorthodox method of communication, which caused a public posting delay. The company sent FDA “a letter in reference to the recall,” but did not issue a public recall notice. Because FDA’s standard procedure is that it only releases recall information upon receipt of such a notice, the recall wasn’t publicly posted for consumer information for four days. While this may seem insignificant compared with the agency’s six-week delay in the October romaine contamination (See #8), it does provide some lessons on industry preparation and understanding of what is required by whom and when. Read the full article. 3. USDA Foreign Object Contamination Focus Prompts Customer Complaint Guidance. With the incidence of foreign object recalls increasing in USDA-regulated foods, the agency took an interesting step of issuing guidance on Industry Response to Customer Complaints. While it may not seem to be a standard area of regulation, the agency put emphasis on response and reporting of complaints because Notification (9 CFR 418.2) requires the reporting of incidents to USDA within 24 hours of determining that the product is adulterated. Read the full article. 4. The Food Industry in 2019: Donning Our Soothsayer Hats. As we’ve also enjoyed doing for the last several years, in January, we “donned our soothsayer hats” and made our predictions for the year. How did we do? Overall, pretty good! While meal kits and restaurant delivery hasn’t elicited much new in the way of innovation or implications that we expected, the “clean meat” and plant-based alternatives are definitely moving forward in a big way. Similarly blockchain continues to be advocated, as we suggested, though the advocacy isn’t turning into much, nor did traceability or digitization bring much we hadn’t seen before. How do you think we did? – Read the full article. 5. Is Your Food “Reasonably Foreseeably” Ready to Eat?. If it is “reasonably foreseeable” that a consumer will eat your food product without further processing, it is to be considered ready-to-eat – and you are responsible for all the FSMA requirements that go along with that – including those of environmental monitoring and control. TAG sees the topic as so critical, we hosted the 2019 IAFP roundtable panel Today’s RTE Redefined – Managing Environmental Controls and the Risk of the “Reasonably Foreseeable”. How do you know if your non-RTE product is being consumed as RTE, making it advisable to implement controls? Read the full article. 6. The Impact of Hemp Legalization on Food. Cannabis, hemp, edibles, oils … whatever the ingredient or formulation, there are vast sums of money being invested in this industry with much of it focused on the use of cannabis in food and beverages. But, there are also extensive and varied regulation depending on the state in which you have your production and, again, the formulation with which you are working. In this article, we break down some of the basics of this continually evolving industry segment (with even more detail and assistance through our hashtag.global website and team). Read the full article. 7. FDA Issues First FSVP Warning Letter, Increases Import Regulation. With FSMA, FDA gained new import oversight authorities which it enforced for the first time in 2019 with the issuance of a warning letter for noncompliance with the Foreign Supplier Verification Program (FSVP). FSVP places the burden of ensuring Imported foods are held to the same high standards required of domestic food on the U.S. importer, and includes FDA inspection and enforcement authority of foreign facilities. The letter emphasized how important it is that foreign and global businesses wishing to export foods to the U.S. – and their importers – understand all that is expected by FDA and how to be prepared. Read the full article. 8. Was FDA’s Outbreak Announcement Delay Inexcusable or Sensible? On October 31, FDA announced a romaine lettuce E. coli O157:H7 outbreak for which the active investigation had ended and the outbreak appeared to be over. There was some pretty critical coverage of FDA’s “inexcusable” delay, but having been an FDA official myself involved in outbreak investigations, is that the delay was practical and sensible. Want to know why? … Read the full article. 9. FDA Defines Requirements for IA Rule; First Compliance Dates Come Up in July. Despite the fact that it was passed nearly a decade ago, rules and compliance dates for FSMA are still pending. With the first compliance date due for the Intentional Adulteration (IA), or Food Defense, Rule due in July, FDA (finally) published the second of an intended three installments of its draft guidance. (No, the third installment has not yet been released. Keep an eye on TAG Insights, we’ll cover it when it is!) Read the full article. 10. Are You Focused on Allergens? Regulators Are. With at least three recent food allergy-related deaths in the U.K., the government has increased its focus on allergens, requesting public comment on “amending allergen information provisions contained within domestic food information legislation for food prepacked for direct sale (PPDS foods).” It is an area on which U.S. food facilities should keep a close eye. If the U.K. initiates new regulation, the U.S. may consider following suit. Read the full article. It’s always interesting for us at TAG to see where our readers’ interests lie, and to know that with more than 14,000 articles having been read over the year, we are providing you with information you want to or need. We sincerely appreciate each and every one of you, wish you the best of the holidays however you may celebrate, and look forward to continuing to share our Insights with you in 2020. -The TAG team
