Last week, we gave you TAG’s 17 most read articles of ’17. For this week’s newsletter, we’ve once again looked into our crystal ball to bring you our predictions for the upcoming year. Following are our 8 for ’18 – compiled from TAG team customer interactions, experiences, and expertise. With five of the eight focused directly on FSMA, it’s no surprise that our FSMA articles of 2017 held high rankings in your most-read list of last week. With FDA’s increased environmental swabbing as it began focusing in on its Preventive Controls inspections in 2017, a new term assailed the industry: swab-a-thons – and we don’t see the Agency’s focus decreasing any too soon. Rather, we’d expect an increase in 2018 as FDA’s requirement for inspections increases as well. Additionally, don’t expect to always be notified, rather we started seeing surprise swab-a-thons in 2017 and fully expect those to continue as well. As we have discussed before, any Lm or Salmonella isolates are being sequenced and added to the international data base of genomes. So the risks of implicating a facility with illness just keep going up. Compliance dates arrive in September 2018 for the Preventive Controls rule for human foods for very small establishments, and for animal foods for small (subpart B) and very small (subpart C) establishments, as well as the continued scramble for small businesses to figure out FSMA, So we will likely be seeing a lot of work being done on Food Safety Plans (FSP) in these businesses. Some of it will be working to finalize the initial FSP before the deadline, as many small businesses – which were to be in compliance in September 2017 for human foods – will be having their debut Preventive Controls inspections. At the same time, we expect FSVP inspections to increase dramatically. According to an end-of-year update from FDA, the agency conducted 289 importer inspections in FY 2017, but they expect to conduct nearly seven times that many in FY 2018 – 2,000 inspections are planned. What does that mean to you? It means you need to ensure you have a well-thought out and well-documented Foreign Supplier Verification Program – and you are putting it into practice. While small and very small plants are focused on their FSPs, larger establishments will likely be – and should be – getting their Food Defense plans and practices in line, as the first of those compliance dates takes effect in July 2019. While most facilities do have at least basic food defense activities, ensuring you have a written program that aligns with the FSMA requirements could take some time. So, it is not recommended that companies wait until the year rolls around again to get started. Another FSMA rule for which compliance dates crop up for small businesses in 2018 is the Produce Safety Rule. However, in September 2017, FDA proposed an extension on compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts), with the soonest arriving in January 2022 for large farms. The extension has not yet been published as a final rule, nor has FDA developed new water requirements. So, with key elements still delayed, it could be an interesting year of growers attempting to comply with what they can, while we all wait for the new water requirements – and finalized compliance dates. To veer off FSMA a bit, we expect supply chains to continue to be affected by recalls as they were in 2017. That is, when a supplier of an ingredient has an event, such as a recall of an ingredient, say Salmonella-contaminated ground black pepper, it can affect more than just one client or food group. If the contaminated pepper is found to be distributed across multiple food products and clients, it, as a single ingredient, can cause multiple product recall events. We have seen this in the past with numerous ingredients. It is a chain-reaction of recalls, where one can lead to more, especially if the black pepper is utilized in another process, such as creation of a “spice blend” which can then be used in even more products, and so on and so forth. We expect to see such chain reaction recalls in 2018, and that allergens will be a recurring theme as they are often left off a label or are mislabeled and can widely affect the supply chain. In 2017, we saw the father-and-son DeCoster management team sentenced to prison for the egg-Salmonella outbreak, despite their request for U.S. Supreme Court review of the case. The sentencing holds a great deal of continuing importance as it establishes that corporate officials can be held personally responsible for foodborne illness outbreaks – even those of for which there is no proof that the accused committed the contamination, intended for it to occur or even had knowledge of its happening. TAG’s 2017 article on the Safe Food for Canadians Regulations was among the top read for the year. And that’s a good thing – since the regulations are coming in 2018. The rules will not only affect Canadian importers, processors, brokers and distributors, they will impact all U.S. companies that ship foods to Canada. The regulations implicate both FDA and USDA commodities, with licenses and preventive controls becoming mandatory. TAG recently established TAG Canada to focus on those doing business in or with Canada. So we are ready to jump in and help both US firms and Canadian firms understand and prepare for the new regulations in Canada. 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. www.AchesonGroup.com
