Ensuring the Safety of Business to Consumer E-Commerce of Human and Animal Foods - Day 1

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>>> Good morning. And welcome to the new era of smarter food safety on e-commerce. I am Mike Kaminski and I will be helping moderating today's activities. Micah moderator,

Carrie ferret. This is a 3 day event. So, please sit back and enjoy the ride. We have a lot of great information to cover, a lot of great speakers. But first, let me give you a few little notes. That you can interact with us throughout the

day. So, first off, you will see a link on your screen right now. That link is also located in the description on the YouTube page. This is for our public comments. If you want to submit written public comments. We really encourage you to submit with, written comments to the docket. For more information you will

see the federal notice to the sling. It is located in the food, in the description. We also have hashtag for this event which is hashtag smarter food safety. We do encourage you to use as half, this hashtag when you post on social media so we can help spread the word regarding this event. >> Next, I want to talk about Q&A. We talk about Q&A sessions throughout each day. So, how the Q&A will work. For those of you watching

on YouTube. 1, there is a link on the screen right now which is our email address, smarter food safety at FDA at HHS.gov. When we get to those Q&A sessions. And again, only when we are in the Q&A sessions, then you can submit questions to that mailbox. And then, we will cover them during, there is a

live Q&A. Again, hold off on your questions until we get to that section of the event and they will be marked off so, you will know and the link will come back on your screen for that portion. Finally, let's talk about how this event has really gone worldwide. The different industries and that participating. We are amazed that,

you know, the level of people who are participating today from around the world and the different industries. You know, from government to tech to media, consumer products, food industry, it was just a great response. Even more so, I wanted to share this with you. We literally have 44 countries participating in today's event. So, because of you, this event and those who registered, this is a worldwide kind of event. And

we can't thank you enough for participating. So, with that being said, throughout the day, I will be also monitoring and have to possibly jump in if we do have any issues. This is a live event. Keep that in mind. Anything can and will sometimes go wrong but that also

adds to the fun of all of you who have been in virtual meetings the last two years. So, that being said, if something does happen, don't worry, we may have an unscheduled back to a great address it. But we will do our best to keep the show rolling. >> Now at this time, I would love to hand this over to Michael moderator, Carrie Barrett. Carrie Barrett will kick off today's event. So, carry. While I transition, are you there. >> I am here. Can you

hear me? >> Yes I can. Why don't you take it away? >> All right. I would love to. Thank you so much, Michael. And really, welcome, everyone to the new era of smarter food safety Summit on e-commerce. Ensuring

the safety of food ordered online and delivered directly to consumers. As Michael noted, my name is Carrie Barrett and I will also be one of your co-moderators during this three-day event. Are as Michael is typically behind the scenes ensuring the smooth operation, I will be working with our Summit panelists and speakers to keep us on track so we can cover all the great content that we do have ahead of us over the next three days. And again, the purpose of this summit is to help FDA and interested stakeholders improve our collective understanding of food safety considerations, as -- to business to consumer e-commerce models across the U.S. and globally. This summit is meant to be the start of the continuing FDA foods program conversation on e-commerce. And

we hope that you will find the somewhat useful in evaluating the current state of affairs in relation to e-commerce and food safety. And that is, the discussions and presentations will help you in the public process that we have set up. A few quick notes. I just want to remind folks that the summit agenda, the background document, as well as all of the speaker biographies are posted on our FDA website on the -- page. We also are transcribing and report, recording our three-day event. And the recording and presentations of our speakers should be available relatively soon. Typically within about

a week of the transcription can take a few weeks. I just want you to be aware of that if you are looking for it. >> Now at this point, I would like to turn the program over to our Summit host, Andre S Keller. He is the director of multi-commodity foods and the office of food safety. And the FDA Center for Food safety and applied nutrition. Address will

join us each day as we join start off our Summit and he will join again at the end of the day to close. Today, you also see Adreas And his crew moderator role during our industry perspective panel. With that, Adreas, Let me handed over to you. >> Thank you, Kay. And it is my pleasure to be hosting this three-day summit focused on business to consumer e-commerce and food safety. Is an area that I have been immersed in for a number of years and it is exciting to see all of the thought leaders that the summit has brought together. First-day

future leaders -- government, industry, consumer organizations, give you a sense of how -- our collaboration on this food safety issue will be as we unite behind our shared goal of keeping consumers safe. -- Collaboration between government, industry, public health is a building block of FDA's new era of smarter food safety initiative. And the summit demonstrates that commitment. Leaders included the next two speakers it is my pleasure to introduce to begin our Summit and greet all of our participants. We have Dr. Janet Woodcock am acting Commissioner

of Food and drugs. Dr. Woodcock began long and distinguished FDA career. In 1986, -- for Biologics evaluation and research. And a 1994, Dr. Woodcock was named director of the FDA's Center for food, drug evaluation and research. -- It is the world's gold standard for drug approval and safety. And a further step of very

distinguished public health career, this past January -- named acting Commissioner of Food and drugs. Following Dr. Woodcock's greetings, we have Mr. Frank Yunus, FDA deputy commissioner for food policy in response. Will provide -- Mr. Yunus. Renowned a food safety expert

and likely known by many of you. Is a principal advisor to the FDA commission on food safety issues. And is a fact the agent's chief ambassador to reduce food safety risks -- high rates of compliance with FDA food safety standards while being committed to working in innovative collaboration with external partners and stakeholders. Our morning lineup will close with our future speaker, Phil Lampert, who Frank Yunus will introduce after his remarks. I will now turn the program over to Dr. Woodcock with Mr. Yunus to follow.

>> >>> Take it away, Carrie. >> Thank you, Michael. Welcome back, everyone. First with our panel session is industry perspectives on e-commerce and food safety, procedures and standards of care from production to delivery to consumer. We have two moderators for this panel. We have Andreas Keller, director multicommodity foods, opposite food safety, FDA -- and we have Natalie a Dan. Food

Georgia Department of Agriculture. At this time, Andreas and Natalie, take it away. >> Hello, everybody again. Welcome to the panel discussion on industry perspectives on e-commerce and food safety. Perceivers and centers of care food production from delivery to consumer.

Natalie Adan, Department of agriculture, and I, Andreas Keller, will be muttering to this panel. Natalie serves as a food safety division director with the Georgia Department of Agriculture. -- Provide support to the retail food, manufactured food, -- produce safety programs. I currently serve as a director multicommodity foods at the FDA Center for Food safety and nutrition. I managed crosscutting food policy

and food science issues and I am the co-lead with my FDA colleague, Brenda Lewis, director of retail of the new era of smarter food safety Summit on e-commerce. For those watching, I would like to mention that your participation is essential to ensuring the success of the summit and that FDA has the input necessary to determine just what, if anything, it might need to do to ensure the safety of foods produced, manufactured, sold, and being delivered via commerce, business models. What we sometimes refer to B to C. You have two options for providing your input. You can submit questions live to the panelists to answer, or you can provide your input to us in writing. We will let you know when it is time to send us the live questions. >> Of choosing the second option, we have open, adopted to solicit a wider range of views from all stakeholders. And I

encourage all of you to submit comments to that, and address any topics we will be discussing during the summit, as well as any other issues discussed at the Federal Register notice and background materials for the summit. Natalie? >> It is my pleasure to introduce today's first panel on e-commerce and food safety. We are honored to have with us today a diverse, distinguished and accomplished panel, which will cover the manufacture, retail, delivery and sales of foods via e-commerce. The purpose of the summit is to engage with all stakeholders.

And obtain your input throughout this meeting. As well as through comments submitted to the FDA docket mentioned by Adreas. FDA intends to use all of the information obtained in this public meeting and comments submitted to the docket to determine what actions, if any, should be taken to help ensure the safe production and delivery of foods pulled through e-commerce business model. A panel of 7 will be presenting the perspective on foods sold through business to consumer e-commerce. Their bios can be found on the FDA website.

Distinguished panelists are, Dominic, Joe set a. He is the head of microbiology, SNR, R&D for Unilever >> Ashley Asmus is the director of federal affair for Grub Hub. Charlene them under is the chief operating officer for blue apron.

Jorge Hernandez is the vice president of call quality insurance for the Wendy's company. Her letter Brujan is the vice president for product assurance, risk insecurities for Amazon. Howard but pula is the vice president of corporate food technology and regulatory compliance for Kroger Company. Toshiko -- is director of food safety and regulatory compliance for Insta cart. As just mentioned, our

panel will focus on how several industry sectors represented here today, manage food safety and e-commerce arena. We will focus on new technologies, food safety issues, standards of care, and a compliance challenges which might exist. Labeling, consumer education on safety and handling of food sold via e-commerce, as well as transportation and delivery. Given the what the manufacturing retail delivery experience and e-commerce possessed by our panel, as well as the data sharing experiences and the fact that they are innovators in the e-commerce arena, today, discussion will promises to be both interesting and informative for us all. With that being said, please allow me to introduce you to our first speaker, our first speaker is Dominic Cara Vetter with Unilever North America.

>> Hello, everyone. Thank you, Andreas, Natalie, for this opportunity to share some of the approaches to this new era of smarter food safety for e-commerce. I do want to take you back a little bit to the origins of the new era in food safety. Specifically, the origin of -- and its evolution and its transformation to his mama. These are what we call systematic approaches,

which focus on prevention. For food safety issues. Systematic means of accomplishing food safety by design. So, I have continued to be a very strong proponent of these principles, whether you call them ASP principles or fist are FISMA principles. And how they may be applied to e-commerce. These principles were always meant to be applied comprehensively.

Terms that you have heard such as from farm to fork, or some of you may have also heard, from soil to soul in a more spiritual sense. For e-commerce, the extra attention is given in the distribution aspect of it. And, reviewing the risk assessments, and preventative controls needed. By these very same

principles apply. As we see, going back to the 1960s, these principles were developed to actually make food for space travel. And it was quite a rigorous program that was developed. Pillsbury working in conjunction with FDA. The first

program was developed by Howard Bowman at the Pillsbury Company. I had the privilege to do my first program with him in the mid-1980s. When they taught this course in 1972, it was a 21 day course. Immensely rigorous. 11 days in the classroom. 10 days were spent in the canned foods factory. Using these principle, the FDA actually

developed our -- food regulations a few years later using this HACCP mind-set. And, continued to service very well. In fact, with my international experience over the years, I can very confidently say, that the United States is probably the most rigorous and best canned food regulations in the world. >> During the 1980s, and mid-1980s, several emerging pathogens were coming about, specifically E. coli 157 and Mysterio monocyte Todd Jenny.

And it was at that time that FDA began potential tool for the industry to deliver food safety by design. >> We start reposition it for industry to apply. We start to see industry beginning to embrace it, and as that began to happen in the late 80s, early 90s, mid-90s, we start to see HACCP beginning to deteriorate, in terms of how it was being applied. And I use this HACCP iceberg as an example, where we see things being superficial . Where, in fact, the bulk of what is really required to conduct a proper food safety plan was often missing. I think some of the efforts were being made

at that time to avoid calling critical control points CCP's, calling them SOP's. I call it washed up HACCP or HACCP --. And it began to deteriorate and very symptomatic of the culture at the time, trying to limit CCP's. We had a lot more HACCP gurus at the time then there were actually HACCP plans , if I remember correctly back then. So, the system was really not doing what it was intended for. I will share from an example of what was going on in the late 1990s and throughout the early 2000's.

These are not so much about HACCP -- but really talking about why a new era of food safety was really needed and required and how that came about. And the slides that I am going to share really exemplifies very large visibility, these incidents took national attention and brought enormous cost to the food industry as well. So, this was a bag of spinach 0157 salmonella in peppers, which at the beginning are thought to have been tomatoes as the root cause, causing millions and millions of dollars of destruction. Peanut butter Salmonella incident in 2008, causing some tragedy. And, Listeria and cantaloupe 2011. I remember this one clearly. I was actually at the time, based, spending a 5 your

assignment in China, and I was really looking at how listeria had been evolving from food category to food category. And to this one to me was immensely surprising. E. coli 104 in sprouts, -- sprouts. This was mostly European, but it actually affected 16 countries. 51 deaths. So, we see the

opportunity to really look for modernization food safety modernization system. A new era in food safety. And, for me, a lot of FISMA is very similar to the HACCP principles, and the term CCP was then replaced of preventative controls. But there was one important difference. To FISMA, is that there is a

mandatory aspect to FISMA, which I believe , in many cases, was missing with HACCP, with the exception of maybe, in some cases, with USDA. But I believe those to be an immensely meaningful aspect, in terms of FISMA , and the principles and tools. >> Of course, there is still a lot of work to do, and you can see incidences still arising from some of these conditions you are facing in the food industry. I wanted to share, in

terms of how I apply a lot of the same principles in building food safety by design within e-commerce. Beginning from end to end hazard analysis, for me, the e-commerce presents the opportunity to focus significantly on the distribution risks, and doing a very solid HACCP analysis there. Of course, there are certain qualifications and expertise that are needed here as well. And, it is important that there is a lot of experience in doing proper conduct did hazard analysis and looking at preventative control. >> One of the principal things I like is to understand the predictive fate of pathogens, of public health significance. So, within the -- of those pathogens in the product, and potentially, what kind of, what kind of hurdle technologies can be applied to either create lag in the growth of microorganisms, or even eliminate growth completely? I am a very strong proponent of inoculated challenge studies. And this is

an area that I feel needs to be done in many cases. Not always in every case, but in many cases, it needs to be properly considered. And actually -- the worst-case conditions, whether they be in distribution, temperature, time related. But really, simulating worst-case conditions with inoculated challenges.

Not just exposing products to those conditions. And what I refer to as reasonable worst-case conditions. Of course, with FISMA, validation verification of controls is one of the essence of FISMA. To me,

consumer communications is probably the biggest opportunity, I feel in this area. How to recognize, safe and acceptable product upon receipt of your packages. Educating the consumer to understand what is a potential reject of that. So, whether there are time stamped records that are accompanying the package, just ways of communicating and educating the consumer. More other technologies such as time-temperature indicators, and other tools that can help the consumer in the end, really understand that this product has arrived safe and ready for consumption. >> A final slide here showing the comprehensiveness from farm to fork. And for some of you, from soil to soil. To soul. Thank

you. >> Thank you so much, Domenic Caravetta. That historical perspective is very helpful. Our next speaker is Ashley -- with Grub Hub. Ashley. >> Great. Thanks, Natalie. Hey, everyone. I am so happy to be here today. I am Ashley Disma. This is your office of federal

affairs for Grub Hub . Unlike a lot of what we were just talking about, which is -- Grub Hub is an on-demand delivery company that facilitates the delivery of product that is often very freshly prepared by restaurants, directly to the consumer. And really what we are is an intermediary between the restaurant and the consumer, which makes our individuals that are carrying out our deliveries are really package carriers more than anything else. So, a little bit of background on Grub Hub, who we are and what we do. Grub Hub is a leading Grub Hub online delivery marketplace. Super

exciting that we are privileged to serve 33 million diners. But just in the U.S. Grub Hub features more than 300,000 restaurant partners and over 4000 U.S. cities. >> Deliveries and restaurants to consumers -- I feel like delivery network companies, which is really nerdy legal terms for who we are and what we do. You know, there is a lot of -- the role we play during of course, Covid-19 and it grows in popularity. Just go back and use it, delivery has been around for a really, really long time. And actually started -- when Queen Margarita demanded

that the people -- eventually named after had Margarita pizza was brought to her and the king. From there, took a while, particularly to grab hold in the U.S. But in the 1920s, the Los Angeles and New York City, -- takes a pride for fomenting the role of delivery and -- from restaurants to consumers in the United States. There has been up and down swings along the way. During the Great Depression and certainly due to World War II.

But in the 1950s, with the advent and really, the process of having TVs in the home, people wanting to hang out with the family and catch the favorite show. You see a huge upside in home deliveries. Really just continued through their. >> Covid-19 pandemic of course as I said before, has -- brought convenience into a lot of the spotlight for our role in helping individuals during Covid-19, particularly individuals who are immunocompromised. And other individuals during the pandemic

and during the ongoing pandemic, were not so comfortable leaving their homes to go grab food or necessarily dine in restaurants. >> So, the individual who is carrying out the delivery, Grub Hub is very concerned at the onset of the pandemic of how to get these individual space and what we could do as there partner. The vast majority of delivery drivers on our platform are independent contractors and therefore, we have to really work with governments on every level. Local jurisdictions, cities, counties, states and then up to the federal level, to really help devise guidance that would keep them safe. But also, allow them a choice to work, you know, when they wanted to and how they wanted to. So, one of the first things that Grub Hub came up with was the concept of contactless delivery. That means

when you go on the app and put in your order, you have this option of the driver leaving the delivery out the door. You can see the delivery driver, you know, walk away or drive away. And all of a sudden, you could open the door and grab that delivery. This was really critical in making sure that individuals, when they did not feel comfortable -- have that at their disposal. >> The second is certainly providing protection for drivers in the form of PPE. And other --. So, when possible, and

fairly frequently, Grub Hub shares safety guidelines and guidance, particularly that put out by governments to at least drivers and -- the form of emails and notifications through the app. >> So, restaurants, certainly brought Grub Hub together products from point A to point B and consumers trust us. But the package that was sealed by the restaurant arrived directly to them in the fashion that the restaurant intended. So, this is

highly specific. Like I said, the restaurant that -- the package. Has everything contained in it and our drivers, to the extent, do not even put in, you know, plastic or ketchup packets or anything of that sort. That is directly for the restaurant to finish the product and then for our individuals that are carrying out the deliveries to Carrie the package from point a to point B. >> This is just a fun little shot. I don't know you guys know

the social media icon.. -- Delivery apps better than dating apps. Which really shows how we are continuing to go into the mainstream. And the fact that the Covid-19 pandemic certainly drove this idea of on-demand delivery from maybe what was considered a luxury, or certainly something that was a choice, into a function of an important aspect of just getting through your day. >> So,

what is -- delivery? I'm very excited to share this advancement with you. Earlier this year, Grub Hub launched a robot. We call them rovers. For all intents and purposes, I was a robot twice. And, these are essentially self

driving rovers that Carrie out deliveries. We launched this program at Ohio State University, the campus. And we actually launched 50 rovers on that campus, which is rumored to be -- the potentially one of the largest deployments of delivery robots are rovers in the country. Which is really exciting. So, a little bit about this program and how it works, just because I know everyone will have some questions. Essentially what happens is that Grub Hub working with Ohio State University and their food program on campus, to create resources for students who were maybe were missing mealtimes, right? We all remember back in the day, if you, on your meal card, if you miss a meal time, you are really kind of, you know, in the words -- until the next time. So, -- want to make sure of course that students had access to nutritious meals when they want them and need them.

So, essentially, working with the on-campus food providers, we created this system through the Grub Hub app where the student could actually order food directly from the food service providers on campus and have it delivered to them by one of these rovers. >> We are all -- a huge, huge advancement in certain countries and states. That have favorable laws toward --. For example, this photo was taken in Norway. Where the pizza company that is featured as test piloting delivering their pizzas. And what is really fascinating about this, is that, you know, we really do see that certain governments are embracing types of innovations. And letting companies figure it out and sort

it out with consumers. And then coming in and working with the individual companies -- help understand, you know, what may need regulation, what may be tweaked. But certainly, what does not. A lot of the in between, and relation to what -- does which is restaurant deliveries directly to consumer, you have a time, regulation and check on the restaurant side. Whether it is you know, health and safety codes for the local jurisdiction, whether it is products that are getting to the distributor are coming to a supply chain and -- it is really for the restaurants to then prep the food and make sure that consumers are getting the product that they want at the end of the delivery process. >> We do find again, for example, there is like Ohio State jurisdiction, like different places in the U.S. that are helping different AI

cars learn and certainly drive on the road. It is really help to create new ways for technology to help the consumer. And certainly help the business. But, without that type of guidance and certainly

without that type of encouragement, it is very complicated for businesses to be able to test with -- technology. >> Now. -- Talked about before -- innovation and regulation. So, in the same way, that delivery driver on the Grub Hub platform, where they are picking up in order. -- Put it in the car and drive it to the consumer, through the app the consumer can see, hey. What pathway is the driver taking? Or are they en route?

And, this has created a ton of situations where, instead of, you know, may, for example, going and picking up a delivery for my family and maybe I realize that I have not picked up my dry cleaning along the way and maybe I need to go do something else, we have less stops, right? So, it is just individual who is facilitating and carrying out the delivery from the restaurants directly from point A to point B. It is this, extremely efficient and it is much faster. And therefore, much less of a risk for any sort of -- sitting long periods of time. This is all the same the more traditional models we have all seen a 1980 movies where there is like the pizza guy that has 15 pizzas in the trunk of his car. And you are maybe getting your pizza two hours later. And like I said, a delivery network

companies certainly through the app and transparency that they provide, customers can understand that their food is going really from point A to point B in a very safe, effective and efficient fashion. So, we -- innovation a regulation can have a better place in this, right? I think additional guidance directly to restaurants and packaging, right, is always helpful. During Covid-19, we worked really carefully with restaurants including -- fee help them figure out how to seal packages so that consumers felt safe, but nothing, you know, had been exposed. Especially in days of Covid-19 where there were still a lot of questions about how it was running. >> And then the other thing, -- consumer safety. -- If we could

continue to have some communication that could be sent to consumers about deliveries and -- about different types of items and temperatures related with those items. So, thank you so much for your time and I look forward to the question-and-answer. >> Thank you so much, Ashley-tran07. This is interesting a great information.

A great look at what the near future looks like in this arena as well as the struggle. Our next speaker is Charlene come under with blue apron. >> Thanks, Natalie. Hello, everyone. And thank you again for joining us

to day. My name is Charlene come under and I am blue apron's chief operating officer. At blue apron, we provide direct to consumer meal kits from chef inspired recipes. That empower our customers to embrace their

culinary curiosity. Our vision is better living through better food. And we believe that it is our response of Liti to show our customers the amazing benefits of a home cooked meal, and how I can complement their daily lives. Every week, our customers can choose from to the menu options, to fill a box that features quality and seasonally inspired ingredients. These recipes are created by our culinary team,

who have trained in the best kitchens in the country, as well as in-house nutritionists and registered dietitians. So, each box is then shipped to thousands of customers and it includes pre-portioned, fresh ingredients and step-by-step instructions. We do all of this while minimizing our environmental impact by using a direct sourcing supply-chain. Maintaining high ingredients standards with established animal welfare requirements, deploying an extensive food waste reduction program, and pursuing a deep commitment to recyclable packaging. >> Blue apron was actually founded in 2012. And we are one of the planners

in the -- in the U.S. Every week, our customers choose different recipes through our website and mobile app. From easy prep and cleanup to premium recipes to meal prep options. We have a fully integrated ecosystem. This allows us to

deliver the best for our customers. From ingredients we are seeing to how we develop Recip these, to ensuring there is a simple way for them to select, cook, and share feedback on their experience. This it in turn allows us to make our recipes and experiences better. We actually serve the contiguous U.S. from our two FDA regulated and -- certified fulfillment centers. We have one based in Linden, New Jersey and another in Richmond, California. >> We are committed to sourcing fresh, quality and seasonal ingredients year-round from our supplier network that includes farmers, ranchers, and fisheries. Our recipes change every week, and often feature

specialty ingredients that promote culinary exploration. Through our carefully crafted recipes, we are able to introduce our customers to ingredients that they may have never experienced before. We have close streamlined supplier relationships. Was 70% of our ingredients directly from suppliers, we are able to provide several benefits to our customers.

We can work with suppliers on demand planning and specifications to optimize inventories and minimize waste. Throughout our process, we leverage data and analytical tools to help us identify -- demands and make sure we make purchasing decisions accordingly. With our suppliers, we also co-create ingredients specifically for our recipes. Such as custom sauces, unique spice blends, or, for example, Ramen noodles from a third-generation noodle maker. We can use our economies of scale to make

quality, high standard ingredients available to our customers at value, such as meats produced without added growth motors or subtherapeutic antibiotics, pasture raised -- certified humane pasture raised eggs, or even personal side spaghetti squash. >> Lastly, these relationships help us ensure supply-chain transparency. As we move forward against our responsible sourcing and sustainability goals. >> Blue apron is committed to providing safe, high quality ingredients every time, everywhere. We approach our ingredient selection process

for our meal kits with strict ingredient specifications. And we can do so in part because of our close supplier partnerships. Our approach to sourcing insurance at each supplier upholds the same standards we do. Our vendor qualification process includes an in-depth assessment of sourcing practices to ensure they uphold our strict ingredient standards, including alignment our commitment to the humane treatment of animals, raised for meat and poultry. Once our culinary team has identified an ingredient to use, they worked closely with our product category leads, our food safety and quality assurance teams, and suppliers to start the qualification and on boarding process for that item. We require all of our suppliers to enroll in -- vendor management system, where we collect a rope last industry-standard set of documentation related to food safety, quality assurance and labor welfare among other things. This enables our team to perform an in-depth risk

assessment and determined that the supplier is able to meet our stringent, stringent standards. If so, it helps us determine the appropriate schedule for on-site food safety audits. After product passes are intense qualification process, we start to introduce them into our fulfillment center and the production process. >> Tradition Mac [ Captioners Transitioning ] >> Once codes are assigned they can be moved to storage or ingredient preparation. Prepped or prepackaged ingredients are stamped with an internal date. Food safety regimens are

embedded throughout the facility and we follow a very strong and cold chain management program which helps maximize ingredient shelflife and eliminate food waste. Our fulfillment centers are set up with five fillers so that we can score other ingredients at the optimal temperatures. We have freezers where we store all proteins, we use coolers at about 50 degrees Fahrenheit. A temperature around 36 degrees Fahrenheit. We also use a warehouse managing system which allows us to keep track of inspections history. Incorporate unique temperature range as well

as restrict scanning and ingredients outside of the acceptable range. We can deliver our product to our customer safety without the right packaging. Packaging plays a very important role in meal kits. It protects the safety and shelflife that has different storage requirements as they travel to our customers homes. That is also an important part of the customer experience. To manage this, we take a holistic approach to address the critical design aspect. We designate unique packaging based on

we make sure the packaging is right sized we do all of this with a goal of improving the sustainability of the packaging by using recyclable content. All while never compromising the safety. Or ingredient quality or shelflife to reduce waste. We use over 250 record combinations. Each has its own

temperature requirement. We use proprietary tools to help us figure out the right packaging, nations and based on temperature forecast and benchmark testing standards. In our operations we have a dedicated functional team and packaging lab to drive our progress. We have built a proprietary specification system that helps us right size each customers and packaging material so that we are sending the necessary packaging to keep ingredients safe and maintain quality.

We are also always finding and testing new innovations and materials in our laps to enhance sustainability with partnership from our FS QA team and often from our packaging suppliers. With the right packaging identified , which can change depending on the configuration of a box, our boxes are packed by my colleagues on the packing line. Finally, we work with shipping providers with refrigerated trucks that allow us to ship our boxes safely to our customers. >> Once the boxes arrive in our customers homes, we have clear direction on our box, recipe cards and as well as our website and blogs to show different ways to safely store the food. We

also offer information on how to recycle the content of their box. As an e-commerce company, social media is one of the many ways we communicate with our customers. Either proactively to get them excited about new initiatives were as a way for them to reach out to share experiences. As it directs to a consumer company it is important for our customer service team and our rations team to state in locked steps. We believe that both are extensions of each other with

both functions reporting directly to me, it allows us to make sure the teams are connected and supportive of each other. We believe this allows us to stay ahead. They avoid any confusion about the product and delivery.

We want to ensure accurate information is being shared. Thank you for your time today. I am proud of blue aprons work and the industry leadership in food safety and I truly believe that we are at the forefront of food safety standards. I look forward to your questions later in the session. >> Thank you so much, Charlene.

That was a very interesting presentation. Our next speaker is Jorge Hernandez. >> Thank you, Natalie. Thank you for this opportunity. Thank you to the FDA for sharing our thoughts on this new business model that we see growing.

It is very key to food safety. Armada is food safety is our first ingredient. My name is Jorge Hernandez and I'm in charge of food safety and quality assurance for the Wendy's company. A little bit about our company, we are countries. We have over 6700 restaurants. We call traditional and nontraditional formats. Including the delivery awning and delivery and pick up only restaurants. We also

about 10 languages spoken in a restaurant. That makes it very interesting. Today we are going to be talking about nontraditional facilities. I am going to have my comments mostly to virtual Christians kitchens.

to the customer. I will divide my conversation a few different ways. We will talk about the food safety and some of the things we learned in some of the things we have questions on. Perhaps there are opportunities in this mode and I will talk a little bit about the regulations in the U.S. and how they help or

not of enabling these kinds of businesses. One of the things I'm going to mention is that this business model has grown significantly . It was there before the pandemic but has grown significantly since the pandemic and continues to grow. There is not one single model with different ways to do the work.

One facility with one concept in a specific location, others number of different concepts in one location that makes it have more abilities at the same time. What is important here, this business model will continue to be for a period of time. They will try to get the best quality food to customers very fast and continue to meet that customer demand for convenience. With customer safety, one thing we have learned is it's been very important to develop safety management for the location. And for the business model. The different models, summer in preparation for a location. Some

are in location and transfer to another location. They put together to deliberate and pick up for a customer or for a service that delivers the product to the customer. That is critically important to understand how that is going to happen so you can make sure that you find the right control points and use that as part of the system to manage the operation and ensure safety and quality and consistency so it's in compliance all the way across. Your space is for

A lot of times for the models, especially if you share the space with other businesses, you have to share the space, sure equipment, share people in cases, sometimes some of the food can go into different things. It is very critical to understand all of that to ensure that you have the right processes and procedures so that the food safety management is appropriate for that location. That can present a challenge when a business exits and another comes in. That is very often the case in a number

markets. After all, we are all committed to ensure there is no foodborne illness and to ensure all the food is prepared correctly. It is important to ensure that those systems are not static. They continue to change. Somethings can be difficult to manage especially in you share space, equipment, people or food is allergens. It's important because you communicate to the customer it needs to be the truth and accurate and sometimes some of the other customers have allergies you aren't aware of. Having the management systems to

keep that appropriately segregated, clean, etc. is going to be important to this type of operations. If we move to the bigger part from the restaurant businesses, we don't always a lot of control on the people who pick up the food. Sometimes we do have relationships with those organizations but sometimes we don't. It's very difficult for the person who is preparing the food to know if the person who is picking up the food at the location is indeed the customer itself business who is going to deliver to another customer later on. I think the issues of packaging are very important for these concepts. That we you are insured that you minimize at all

possible eliminate tampering of the food. With the possibility of any contamination. Of course you are mindful of the temperature until that product makes it to the ultimate customer. That is a key area for operations to keep track and make sure they have the right controls. And then we have the actual delivery. Depending on the market, that can be done for all kinds. They could be a bicycle, a car, motorcycle,

again, we don't always have control of that. We don't always know the people who have taken position of that product. product needs to be maintained safe, protected, the right time and temperature throughout the delivery process. can happen here and we have seen sometimes, the containers in the conditions in the delivery vehicle. need to be clean and sanitize. Allergens

Those are the things that are important to delivery and that they understand and that companies understand to be able to maintain that. They have control to ensure there is no tampering and another one that would be important to ensure that there was increase ability to ensure that product went to that process for the customer. The customer is looking at the purchase which they think they got from the restaurant. They don't realize they went to another business for that. That is an important

key part of the entire process that needs to be watched out for . That takes me to the next step on the regulatory environment. In this area where we see there is a little bit of a gray area in rotation from jurisdiction to jurisdiction. In my opinion, the commission and FDA does establish part relinquishing of positions to a delivery service, part of that requirement that is the same as the requirements for all restaurants to ensure the safety of the product throughout. That is not always the case. Jurisdictions can see that is a gray area. Some don't regulate

and some may be different for what we have seen in the regulatory environment. That can be a concern. The other one is of course, during the preparation area there are meeting regulations with controls in the right area depending on the location of the process and procedures in place. What we see sometimes is locations are mobile. The product is ready to be assembled and there is going to be a certain part of time with a will assemble it and get it together. All of those things are variable and continue an influx. They are very important for safety and quality of product.

In the preparation we see an uptick on the requirement. We consider tamper-resistant. Some is very restrictive and some of them are actually not very effective. And then of course, the delivery of the people and eventually be part of the training. Have to bring them equipment that a safe and sanitary. It takes a lot of time for the company.

themselves as a software company in my perspective, I think the regulation needs to be clarified the foods are protected all the way through the consumer , with that is mind I'm really looking forward to your questions and I will take it back to Natalie. Thank you >> Excellent information and great perspective around the importance of developing those relationships. Thank you so much, Jorge. Our next speaker is Carletta with Amazon. >> Hello everyone. My name is Carletta and I am with with Amazon, brisket security. It is great to be here for this virtual summer. I also want to expect I gratitude for to the

FDA for can this meeting. I want to talk about how we talk about the safety of food through investments we have made in technology and investment in innovations. I want to talk about how we lead with technology to the first approach with the big challenges we have. Let's go ahead and dig in. I'm hoping that some of you have heard of Amazon and I'm hoping a bit more that some of you are valued customers. I want to start with context with Amazon because it's important for the rest of the presentation. I do want to share in Amazon vision that is the earth's most concentric company where customers can find and discover anything they may want to buy. This vision has led

to a variety of business models. They speak to the sheer size and scale of how we operate at Amazon. We like to start by saying we are in innovation company. We were originally one

of the first online bookstores and we are a store where you can find and buy almost anything you could ever need or want. This the constant for us is the notion of customer obsession which is one of our leadership principles at Amazon. At Amazon we provide high quality food at great prices with free delivery available in almost every area.

We are constantly looking to expand and enhance our vast selection of consumable product offerings. We use a two-term consumable to describe everyday food and essential items that you might need. Things that are used every day in your home and everyday life. Amazon gives customers access to a wide selection of shelf staples, groceries, pet foods, personal care products, things that are in everyday sizes with delivery across every ZIP Code in the U.S. including

Alaska and Hawaii through our Amazon.com site. Hopefully that is the one our customers are most familiar with. We also have Amazon fresh which launched a decade ago. Amazon fresh offers free delivery for most areas where they are available and we have a complete selection of full-service grocery kinds of products. Fresh, frozen, produce, seafood, dairy, all of those kinds of things. We also have electronics, toys and gifts

and other things that customers might need. Today, our physical stores that carry consumable include 520 whole foods markets, 15 Amazon ghost stores and 19 Amazon fresh stores. Amazon has thousands of people virtually every region around the world focused on product integrity and customer safety every single day. At every hour of every day, all your long, there are people at Amazon working on food safety. Our strategy remains heavily intellect technology. We do this in order to ensure

product integrity and regulatory compliance. We choose this approach because it is part of our corporate DNA to embrace in a bit of a solution. Also at the scale we do business, and because technology advances so quickly, we know it is smart and adaptable and forward-looking. It is a way to promote

compliance and safety in our stores and catalog. I want to dive into a few of the tools that we have used to leverage food safety in the scale of which we do business. Broadly speaking, we use a combination proactive and reactive processes that mere human experience and expertise with artificial intelligence to create safety mechanisms at scale. Amazon has a predicted controls that can be illustrated

by the use of our machine learning technology that captures customers feedback data in a private to the machine learning model to inform new insights into all of the related products. They use predictive control to move our actions upstream. From reacting to preventing. We think that is a critical component of our safety controls. As an example, select a product from our website, we have actually calculated the relative distance between it and any product that has ever received a safety related concern. It is close enough that we also predict the severity of a potential issue as well as the likelihood that an issue could occur in it is something above our confidence partial. We each treat prediction signal the exact same as we would a customer conflict.

Our investigation project is identical. We request documenting for safety compliance and in order to close the investigation, we either receive proof and are able to reinstate the item or we use our recalls tools to allow us to keep the product from being unsuppressed were lifted. We look for signals of abuse , notices of copyright infringement, customer complaint and those types of things. We were able to combine those factors and others to inform a comprehensive risk evaluation approach. With predictive modeling we are able to calculate most risk predictions for our selection and items in our stores before they have ever shipped. It is worth noting here , this is very much an iterative process. Our algorithm and

personnel are fixed on the team with experience, feedback to the system. It keeps improving over time. She learning is critical for staying ahead and is our team of engineers, scientists and investigators that need it the information it needs so they can continuously improve. Even if we continue to invest heavily in our proactive technology that I just covered, we also have expansive reactive controls. We have tools that monitoring to help us control our catalog. We perform something that we call customer feedback monitoring on all listing identifying issues and potential safety concerns. Last year we consumed about 67 million pieces

of customer interactions per week. Each of those data points is incredibly important. It is relevant because it helps to inform our product safety and our compliance strategies and approach. Our systems scan and scrape our

stores every single second looking for concerning items were concerning sellers. We inject and sort through the hundreds of millions of data points in real time. When a concern arises we move quickly to protect customers and work directly with sellers, brands, government agencies.

When we find a potential problematic listing we can suppress it or basically remove the detail page so that the customer can't purchase the item. We can evaluate the potential issue and then take the appropriate action. Globally, we have tens of thousands of policies or rules which govern the sale. That includes the restriction or being in of certain items. Those who violate our policy including

a potential removal of their account. Another tool we are leveraging is something that we call product risk evaluation tool. It was developed in order to achieve a synchronized objective databased risk output. That is generated regulatory and internal data for each supplier and product. It is an algorithm that helps determine overall supply risk based on inherent product risk. Manufacturing audit performance,

consumer feedback, food safety withdrawals and recalls, audits in on-site assessments. It helps us understand the industry specific issues including product risk, recall incident hike, food fraud, country concerns, it helps inform and prepare auditors areas of focus and raise our internal standards. Is important to understand that while it helps us optimize our resources for high risk products and categories, we pay close attention to our low risk categories as well. What we don't want is to see a low product become a high-risk product. Last, I want to share an example of how we use technology to drive compliance for our employees. In our day-to-day grocery operations. We believe our employees are our latest

asset and they deserve best in class training, resources and a delivery of training through innovative media. As such, we have moved to provide real-time compliance driven automated prompts that remind our employees of critical steps to take during the operational workflow. In this example I want to share, it is a training solution for Amazon employees that uses prompts to prevent cross contamination in a shopping back. If you think about York brick-and-mortar

store, customers have the option to back produce or separate items to make sure that chemicals stay away from the food they are purchasing. Even at checkout, the customer has that option to request items are handled and separately backed. In an online shopping model we are maximizing the customer experience and require bagging of all proteins and chemicals. In order to automate that, we have established task driven prompts. They told employees to back this item or align this back to control temperature. This mechanism has driven 39.4% increase in employee bagging compliance across a very large sample size.

We continue to add more prompt to the tool, when packaging or baked goods. Or temperatures for pretty selection. It is showing us that real-time food safety compliance and quality coaching tools are effective at both training and effective in enforcing safety and quality requirements. With

that, I want to thank you so much for your time today and listening to a little bit about what we are doing at Amazon. I hope this presentation was helpful. I hope that you understand that food safety is a core element of our everyday operation and that we make these investments in technology and innovation in order to accelerate our approach to food safety. Thank you. >> Thank you Carletta. That's a very interesting information about machine learning technology. >> Our next speaker is Howard with Kroger Company. >> Good morning and good afternoon and good evening wherever you may be. I would

like to thank the FDA for inviting me to share a little bit about our models where the challenges we face from a student food food safety standpoint. Better still, how we can share our own learning for the food industry. My name is Howard and I have the overall strategic responsibility for Kroger's food safety and regulatory compliance efforts. That is over 2800 retail stores in 33 manufacturing facilities and several and third-party delivery relationships. Kroger models includes but is not limited to what you are seeing on the board. First, a Kroger fulfillment operation is an exclusive association.

software platforms that powers and utilizes bots in groceries. The first three are up to 30 locations. You can see to the left of that slide. We also have ghost

kitchen operations. This is the relationship between third-party kitchens. One that has been obviously -- in past presentations. There is the traditional Kroger pickup. Formally known as click list. This model is well known throughout all retailers. It involves ordering groceries online and picking them up from the store.

Another well-known model where you order product online and is shipped directly to their homes. Sometimes, it is native to Kroger and this is a model that we would utilize for delivering groceries to one central location, usually in a place that is regarded as desert, not a lot of retail scores stores. >> We utilize the Insta cart and delivery model . And of course, autonomous delivery which you have had the opportunity of hearing about today. For the purpose of my presentation today, I will be focusing on those solutions where. Along with

mention of the ghost kitchen operation which I suspect you are curious to hear about. Let us examine how the fellow will model differs from the traditional grocery stores. Our customers will shop online at our website using our app there is all categories of groceries. The fulfillment

consider use allies is an automated process. are refrigerated at 34 degrees and our freezers are at -11 degrees . A proprietary software program will generate a delivery group for our drivers who are 100% company employees and utilizing our company owned delivery. Third-party delivery services are utilized. These facilities are referred to as hubs and also utilized as a model which is maintained at 34 degrees. They bring in products from the hub to cross dock. In all, our delivery the last mile of delivery to the consumer's homes.

Like every new introduction or concept there are challenges to the process. It's an entirely new process without precedent. It is not your traditional grocery store.

It is not a distribution center. Our business will seek to maximize efficiencies. With new product entries and how to better serve our customers. We have been challenged by the lack of work, is the consistencies and how these models have been regulated.

Market to market, cities the city, state to state, we have found different guidelines and enforcement on the same issues. One glaring opportunity is in shelflife management. obvious that different retailers at different go to market strategies and therefore must take into account how product shelflife is managed within the model. Training challenge. Associates often do this model as a box out operation. We continue to train our associates in the area of safety and customer focus.

What has been helpful to us in this journey, being largely unregulated, we have taken it apart ourselves . We ensure the safety of our customers. My team and I are indebted in the process leading up to the design, build and operation in the center. This makes the case to build food our operations by operating an old refrigerator to sell it. It ensures the products have been received, stored, picked and transported at the appropriate temperature.

Our training group along with the food safety team developed in all fulfillment centers, they begin their We have also had an external safety protocol audit conducted on a periodical basis in order to -- >> Let's talk a bit about the kitchen differs from the traditional groceries. Kroger has been in the news very often to to the third-party ghost kitchens. I have a few things to say about the concept. As you may already know, those Kipper and kitchen operations differ in its own model. Customers may choose

and order from local restaurants served by a single vendor who has been contracted by the local restaurants. This may be done inside of a Kroger store or externally there is also a bottle where a restaurant converges under a single roof consisting of a kitchen, operated by a party to fill customer's orders. Regardless of the model, it is generally utilized to the consumers who went to a Kroger store location to be picked up by the customer. What are some of the food safety risks that we see? The first safety risk, I have talked about and well-documented this.

a Kroger, managing the risk in our whole chain and diverse operating conditions, takes the most of our attention and does not include the models that I talked about earlier on. Managing deliveries and sorting that food is left you have the be sensitive to customer complaints with a lasting corrective action. The safety and security of our system is also top of mind. How do we manage food safety in transit and delivery? We do this through the use of our own delivery dependences. The use of insulated coats, dry ice as well. We also

outbound temperature logs on the delivery vans. Along with a radio to serve that ensures safety in general quality. These processes are part of our internal and external audits. They also undergo vetting process.

This is for accountability purposes. I would like to end my presentation on the operations with approaching this grown area with different regulations of the U.S. Some of the challenges I will ask our regulators to examine and include storage practices in this automated warehouse and how it influences cross-contamination. As one of the presenters, software companies are not necessarily food companies , how do we establish an accountability for all players. And finally I ask that we work together to begin standards for these operations and in particular food in transit for delivery. Autonomous delivery that includes

drones , however you want to call it. Most important thing, foods are delivered and sold are considered. Thank you for listening. I will kick it back to Natalie. >> Thank you so much, Howard. >> Our last speaker is with

Insta cart. >> Thank you. >> I want to thank the FDA for giving me this opportunity to join this discussion. I don't know much -- if you about Insta cart, there are over 600 retells in the marketplace where there are over 600,000 food choppers . We have over 87% of the U.S. household. I will discuss how Insta cart things of e-commerce and food safety and the steps we are taking to ensure food safety. We have integrated electronic controls to mitigate food safety risks. Waste on the shopping location, the customer app will

show what is available in the area. The customer will select their favorite store to shop in. Once store selected, they can shop but I'll, category or by typing the name in the product. Customers can get more information such as ingredients, allergen information and nutrition information.

This gives the customer lots of information. The customer will select the product and deliver and pay for it. At this time the customer can follow along in pick each product. The customer can discuss any changes or assessment . Once the shopper has completed the shopping portion, the food is picked up and delivered to the customer.

When adding products to the customers order, it has tied the product to the shopper. Once the shopping is complete, the shopper will suggest directions to the customer and the most sufficient route to reduce travel time. The customer contract the route taken by the shopper similar to how you track .

Shopping at a grocery store and taking those groceries is not a hard concept and millions of consumers eat safely every day. The 600,000+ shoppers are also consumers that shop for their families and they know how to do it safely. When you think of food safety and grocery delivery, you think of ways to make it relatable to the shoppers that they constantly understand. We aim to provide them with and materials to make it even safer.

It's important to not

2021-10-24

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