In the year-end FSMA Friday webinar, TAG President and CEO David Acheson provided a regulatory recap of 2019 and expectations for 2020. 2019. Throughout 2019, FDA filled in some of the gaps outside the seven major rules of FSMA – one of which was lab accreditation (section 202). In the past, unless a firm was on an import alert, FDA had not required use of an accredited lab for testing. But in early November, the agency issued a proposed rule to establish a lab accreditation program. What most hit me about this was a “sleeper,” FDA’s proposal to establish a new regulatory tool – the Food Testing Order. Though not much was stated about this, the order would, in certain conditions, require food companies to embark on testing using accredited labs. For example, FDA finds a problem (e.g., Listeria) during a swabathon and issues 483. The facility responds that it will do more testing of finished product and zone 1. I’m thinking that, with this new order, FDA will now say okay – but you have to use an accredited lab, then send us the data as you get it – which could bring up all nature of challenges for food companies. As far as produce, FDA is more aggressively focusing on enforcing the Produce Safety Rule and has ramped up its produce testing – which will to continue to be a major focus. Although testing is not a robust public health prevention tool in my opinion, this does send a strong message to industry. The challenge is that there are so many random acts of bird behavior, etc., that can’t be controlled. But I think we need to take money from testing produce and plow it into better product tracking. The industry is economically challenged, margins are tight; we have to be smarter about where we spend our dollars. The industry does a lot of testing because retailers and restaurants require it, but it doesn’t incrementally reduce risk. FDA also has been ramping up FSMA inspections, some of which are very focused on a particular area, e.g., GMPs, recall plans – and FSVP. FDA has issued a number of 483s on lack of FSVP compliance. So, if you’re an importer, be sure your FSVP is robust and complete. They are being aggressive with that. We also are hearing that FDA is looking closely at firms’ supply chain control programs. Because facilities with a Class 1 risk are required to have third-party audits, many are referencing their GFSI audits for compliance. But FDA inspectors are saying this is not adequate. I would expect it is because it is a standard GFSI audit, but you actually need it to specifically address the Class I risk. You need to do risk analysis, and if you identify a risk that relies on a supplier for control, the audit needs to show that. If you don’t connect those dots in the audit, it won’t be acceptable. 2020s. FDA has placed a great deal of emphasis on its “New Era in Smarter Food Safety” approach. What will this mean? Given the background of FDA’s Deputy Commissioner for Food Policy and Response Frank Yiannas, with his role at Walmart, and long-time focus on traceability, artificial intelligence, using data, and food safety culture. But we also can get some clues as to FDA’s anticipated direction from the “Food for Thought” document it published, in which it provided its ideas on how to begin the New Era. From that, we can expect FDA to focus on data handling, traceability, prevention, improving response times, data analytics, and food safety culture. There is a section in the document titled: Enhance Traditional Retail Food Safety, in which one idea is listed as “Expand the food code to require industry food safety management system for retail establishments. Note the word “require” – Will the food code, which is the current guidance with regulation set at the state level – become mandatory at the federal level. And would that make a difference? This doesn’t mean FDA will go this way soon, but it is indicator of that. Another area I see expanding in 2020, and likely becoming a focus of regulation, is that of e-commerce, home delivery, meal kits. It is an area we didn’t think about 10 years ago but is now part of life. Home delivery is growing, but it is a somewhat unregulated area; it is kind of the Wild Wild West once the food is loaded into someone’s vehicle. New Product Tracking Regulations And the focus on traceability isn’t going away, rather it will continue to grow. Interestingly, however, the final provisions of FSMA dealing with traceability were significantly less demanding than that which the House drafted when FSMA was originally discussed – back in about 2008, when I was FDA Associate Commissioner of Foods. One of the suggested provisions was a requirement for food companies to have full-pedigree traceability within two days. So, if FDA were to go into a retail store – the retailer would need to be able to provide documentation tracing the product back to the field within two days. It was shot down because it was not economically and technically feasible – then. Since then, we have learned that it is technically feasible – if there is interest in driving it economically. That request morphed into section 204 of FSMA, giving FDA authority to “enhance” traceability programs – which doesn’t give it much more authority than the one up/one back it already has – and it doesn’t apply to farms, retail or foodservice. And it explicitly prohibits FDA from requiring full-pedigree traceability. So not only does FDA not have legal authority for full pedigree product tracking, they’ve been told don’t do it. In “Food for Thought” document to which I previously referred, the very first section is titled: Facilitate End-to-End Traceability Throughout the Food Safety System. That’s where I see FDA going; since it cannot legally require end-to-end traceability, it will “develop foundational components needed to make full traceability standards operational,” then “encourage industry/company adoption of new technologies.” We desperately need better systems when we have outbreaks and retail and foodservice have very little information or records to track back. The discussions on traceability are always focused on produce, as package goods have lots of information. It’s the produce industry where it continues to be a major hurdle, and FDA lacks authority to change it. FSMA only enables FDA to require high-risk foods to have more information about where those handling the food received it from and where it went. Will FDA publish the high-risk food list as it been pushed to do? I expect it will. But, personally, I don’t want to see a high-risk food list, because it will damage those on it and provide false sense of security for those not on it. It is a dangerous precedent – we’ve seen low-risk become high-risk overnight. But we definitely need to do better; to find ways to reduce risk but also provide logistics benefits to the industry. Because of all this, I think we’ll see tracking innovation next year. We have to. A few other interesting areas to watch are The cannabis and hemp industry, particularly where it goes in relation to edibles and beverages. There is a desperate need for federal oversight; they can’t ban or outlaw it, so will need to manage it. Whole Genome Sequencing (WGS) is very much alive and well. The public health systems are adding about 8,000 new sequences/month, and I expect that to climb. In meat and poultry, we are likely to see increased standards set for campylobacter, but that’s a challenge because there is no sense of how to control it. Plant-based proteins … QMS … data … preventive analytics – there is no shortage of interesting things coming in this decade – both FSMA and non-FSMA.