USDA-FDA Joint Public Meeting, Day 1, Morning

Just another WordPress site

USDA-FDA Joint Public Meeting, Day 1, Morning

Good morning I’m Carmen Rotenberg I’m the acting deputy undersecretary for Food Safety and on behalf of USDA I want to welcome you here to our building and also the joint public meeting on the use of animal cell culture technology to develop food products from livestock and poultry we’re very pleased to see such a diverse group of stakeholders that I’ve registered for the event we have approximately 600 people who are expecting to be here between today and tomorrow either in person or through the webcast and today to open the two-day public meeting were honored to have secretary Perdue and Commissioner Gottlieb here to deliver some opening remarks we have a very full two-day agenda so with that it’s my pleasure to introduce the 31st secretary of agriculture the Honorable sonny Perdue now go ahead a coffee yet good morning kind of week there earlier so good to see all of us we appreciate you coming out so early to talk about an important topic this may be one of the more robust meetings we’ve had here at USDA and we want to welcome our guests on stage our Commissioner of FDA dr. Scott Gottlieb and his team and all of you in the audience and people who are viewing from around the world who are interested we’ve got a lot of international interests as well so we’re happy that you’re here and we hope that we’ll have a great informed panel over the next day or so so I want to thank frankly everyone in both agencies who come together work together to pull this meeting together and actually these things just don’t happen takes long hours and very dedicated to detail work to put together so essentially what we’re trying to accomplish here today is basically a stakeholder meeting as we begin to frame how the new technology of cell cultured meat is regulated by the federal government I’m glad to see the excitement over new technology and it’s always important to have good informed interested stakeholders as we begin to talk about this and listen to your comments as it informs our decisions on public policy going forward so that’s why we’re here today I think dr. Gottlieb will also comment in a spirit of collaboration with various government officials our scientists our consumers and members of our industry making a decisions together as we move along obviously here in this room today it’s filled with individuals who have an interest in ensuring that the food on America’s tables remain safe wholesome and accurately labeled and these are challenges as new technologies that never have been thought about in the past come to fruition it’s very important that we have a framework that encourages innovation and encourages new technology while we provide the responsibility of a public safe wholesome and nutritious food supply so industry innovators and consumers alike can help determine the roles of USDA and FDA simply put we’re here to talk about kind of how do we how do we decide who does what in this arena and how do we come together as one federal government to make the best decisions for the public at large and how do we how do we make those kind of regulatory framework and protocols that are clear and concise and easily be complied with so there needs to be a clear understanding of the roles and responsibilities of both the Federal Drug Administration as well as the USDA in the production and commercialization of this new technology I think it’s also interesting note that the industry as many times is already ahead of us I note that the American North American Meat Institute along with one of our innovators in this area of Memphis meets agreed in a letter to President Trump a few weeks ago they envision a role for both agencies in this new technology both the industry as I said and the consumers the public have a right to know and expect clear concise regulations and bright lines it’s important to keep in mind that right now also as the United States is leading in this area to see how we looking and see how we handle this issue from a regulatory standpoint and we want to be true world leaders on this topic as we have a challenge to feed the world our new motto at USDA you may have heard is to do right in feed everyone that’s pretty profound do right as a lot of connotations but feeding everyone is a little bit like our energy independence I like to think about the approach all of the above and while it sounds like a very lofty goal to do right in feed

everyone it has real world meaning and we know demographically they’re projected to be nine billion people on this planet by the year 2050 and that means they’re going to be nine billion hungry souls and that means we have to feed them wherever they are by whatever means are available and necessary so as I said we here are talking about a whatever it takes and all of the above technology including new technology like cell cultured meat new proteins should being treated in the same fashion as we believe past products there must be safe processing and safe production for consumers as well as safe innovation making sure that these things have no unsafe or unhealthy aspects to them it’s my review that both of our agencies need to be open innovation and welcoming of innovation that will help to feed people the projected population of our planet demands it so we’ll need to produce the same amount of food this is startling over the next 50 years as we have in the history of civilization that’s the exponential result of demographic change to do that I believe in our motto we must do right and feed everyone and now in order to continue that conversation of collegiality cooperation collaboration I want to welcome my friend and colleague dr. Scott Gottlieb Commissioner of the Food and Drug Administration thanks a lot and thanks for hosting us here too I want to thank the secretary for his his collegiality and and the work that he’s done in collaboration with FDA we’ve worked on a lot of important issues together to advance the public health and advance the interest of growers all over the country and were grateful for that that collaboration with the secretary with his team I’d like to thank all the participants for joining us here in this room and also those who are tuning online today it also like to thank the secretary and his team for hosting this where we’re here over the next two days to discuss cell culture technology in the food industry adoption of this technology has advanced rapidly over the past few years and numerous companies are currently working to harness this technology to develop new products in recent years FDA has been contacted by firms interested in developing foods using cultured animal cells from various species and we’ve had several stakeholder engagements on this topic it’s clear to us from these meetings that cell culture products will take many forms products derived from livestock and poultry will be the focus of this meeting but cell cultured seafood is also on the horizon and at FDA we foresee that this technology could be used for a variety of multi-component foods and in development of innovative food products that can only be a managed imagined right now in the present moment and it won’t be long before these products reach wide scale and wide marketplace reports indicate that the cost of using cell culture technology to develop food products derived from livestock is one fiftieth of what was just a few years ago and while I don’t have a crystal ball to see the future I wouldn’t be surprised to see cell culture burgers on restaurant menus in the coming years this today meeting presents an opportunity for the FDA for USDA to hear from stakeholders about the potential hazards oversight considerations and labeling of cell cultured food products and we fully anticipate that both FDA and USDA will have active roles in the regulatory oversight of cell culture products and the feedback we hear you today will help us to advance this interagency cooperation and these discussions as they go forward our two agencies take very seriously our shared mission of protecting the public health and while there are many considerations regarding proper oversight of the use of cell culture technology to produce food consumer safety will always be at the forefront of our work one of my priorities as commissioner is enabling innovation and consumer choice while supporting Public Health and Safety and for the FDA these products stands at an interesting intersection of medical technology and food technology as many of you know the field of animal derived cell culture technology began in the medical product space today animal cell culture technology along with human cell culture technology is used to create products such as recombinant proteins cell therapies gene therapies for human and both veterinary use and in the near future we expect this technology will also be expanded to produce products such as regenerative medicine products derived from stem cells it will also be used for tissue engineering products such as tissue grafts and solid organs created from the living cells of ex vivo culturing techniques FDA has already

approved many novel medical products that use different cell culture technologies and these novel products manufactured using various cell culture technologies emerged as they emerged our scientists recognized unique risks introduced by these technologies we require proper controls needed to prevent the introduction of hazards into these products while helping these tools these innovative tools advanced and as a result we’ve issued a number of guidance documents for the production of these products and I believe that our technical and our scientific work has assured the safety of these products and provided life-changing novel therapies to patients and our consistent regulatory approach provides certainty to companies currently making these medical products or considering entering the market in the future that’s our medical product experience but now we’re grappling with the challenge of determining how to ensure that food products derived from these same technologies are also safely produced cell culture drive tissues that are inserted into the human body and become part of living tissues of very different applications than cell culture products that are ingested and we want to define the aspects of our medical products experience that are pertinent to food products and identify those pieces that are different we also need to examine whether existing food safety oversight tools is sufficient for these products or whether more is needed and these are the questions that we’re all actively discussing in collaboration and I hope we will have a robust discussion on all of these issues here today we also have a long history of ensuring the safety of the country’s food supply and this encompasses our oversight of food additives added added substances and dietary supplements and you’ll hear more about FDA’s broad regulatory authorities for foods later today so here I’d like to just say a few words about the work we’re doing to implement the Food Safety Modernization Act or FISMA FISMA is a transformation for transformative because of the tools it gives FDA to help prevent foodborne outbreaks before they occur the law requires facilities that manufacture processed pack or hold human food to create and maintain food safety plans among other components this plan must include a hazard analysis of known or reasonably foreseeable hazards controls to prevent allergen or Sennett sanitation issues and plans in the event of a recall FISMA also provides the FDA with new enforcement authorities and it gives us important new tools to hold imported food to the same standards as domestic foods the risk-based prevention oriented food safety framework that the FDA is working hard to strengthen lends itself well to evaluating and ensuring the continued safety of new food technologies such as cell culturing the USDA of course has their own safety framework for foods under their jurisdiction and there’s no question that our two agencies working together have the right regulatory tools in our tool boxes to ensure the safety of new food products and this includes cell cultured food but deciding whether and how to use available tools is the art of regulation and I know that our success will depend on and help secure consumer and stakeholder support and confidence and buy-in of these new products yesterday after science board walkthroughs walked through some of the basics of animal cell culture our board provided their input to a series of questions aimed at understanding potential hazards in the source materials and the culture media and the structural materials they also provided us with valuable insight into questions of the nutritional properties of the future state finished products this public meeting today helps build on those discussions first and it gives FDA and USDA a chance to walk you through our current safety and labeling frameworks but more importantly FDA and USDA will learn from you about the potential hazards you anticipate as well as hear your suggestions on possible wasters and strategies to address them we also look forward to hearing from you on the labeling of these products both in terms of naming and what claims can be appropriate to some of these new products sell cultured food sits at the Nexus of many constituencies and includes tech startups consumer advocates producers of traditional food products everyone in this room might have a different view on the regulatory considerations for these products depending on a profession or their personal conviction and that’s one of the reasons sell cultured foods are so exciting but also very challenging for us we don’t pretend to have all the answers yet you’ll help us identify the best path forward and the FDA and our partners at USDA know the value of this sort of stakeholder input whether you provide your opinion or expertise or just raise related issues we may not have thought of we welcome your continued engagement and today’s meeting and also in the future throughout this process FDA is committed to working with USDA and with you to determine the most efficient and most effective regulatory oversight framework for these novel products we want to advance these promising technologies but to be clear regulatory efficiencies won’t come at the expense of consumer safety and that’s why USDA and FDA are holding the

meeting together today partnership and coordination between our two agencies will be critical as we work together leverage our respective expertise and considering these novel technologies and so I look forward to hearing your thoughts and concerns today in the coming months and I look forward to continuing work with USDA and with the secretary on these challenging questions and issues and I want to thank you for join say and for your interests and your participation thanks a lot okay thank you very much secretary Purdy with Commissioner Gottlieb I have a few housekeeping announcements before we get started here today as a reminder the meeting is being webcast live today and tomorrow and will be available for viewing after the meeting today and tomorrow so it will be immediately available for those that want to watch after it’s been recorded as a result of it being a public meeting and being webcast and recorded to video if your publicly speaking or in the auditorium you may be part of those recordings and there’s no expectation of privacy I would say to our friends in the media who it looks like our exiting stage left over there that out of courtesy and out of respect for our speakers we’d ask that media members remain seated while speakers are presenting and can have an opportunity to ask speakers questions during the breaks the meeting format is designed to create a number of opportunities for the public to make comment and throughout the two-day meeting USDA and FDA will be giving presentations on each of the topics as commissioner Gottlieb outlined oversight considerations potential hazards and labeling after each topic we have several open public comment sessions as well as formal comment sessions so you’ll have opportunities to comment in either of those spaces either in response to the questions in each segment or at the end of the day for open formal comment well the way this will work is if you wish to make a comment you’ll come to the front of the stage where we have two microphones here to give your comments and you’ll have be limited to three minutes we have a timer up here that you all can’t see from back there but the speakers can see from the front and then as I mentioned the final session of each day will have a formal comments public comment session and we would just ask so that we can move people along that folks come up to the microphones and sort of be staged up while the other person is speaking the formal sessions have been scheduled advanced and pre-registered comments commenters have received notification of their group number to come forward and give that public comment and we want to give anyone who’s interested and here in person a chance to speak so again you’ll be limited to three minutes we also would encourage you to submit your written comments to us on regs gov regulations gov or you can mail your comments to the docket clerk the comment period is open until November 26 and then we would encourage those who are watching on the webcast to submit their comments in writing by mail or electronically we have a great team of USDA staff here to assist many of whom you met on your way in so please feel free to ask them if you need anything and with that I would like to start the formal section of our segment of our program and introduce dr. David Goldman chief medical officer here at FSIS dr Goldman well good morning and as Carmen said I’m the chief medical officer here at FSIS as Secretary Purdue and commissioner Gottlieb have both said today and previously both USDA and FDA expect to have a role in the oversight of food products cultured from the cells of livestock and poultry that’s what this meeting is about I attended yesterday’s FDA Science Board meeting that that dr. Gottlieb referred to where this was a prominent focus of discussion this topic you’ll hear more about the Science Board meeting a bit later this morning during the meeting today but that meeting reflected the considerable complexity of cell culture technology and so to inform the agency’s presentations later today and tomorrow we thought it would be important to provide you at the beginning of this meeting a broad foundational overview of cell culture technology this has been presented before was presented yesterday and I think it will be informative for those of you who may not have heard this presentation at the FDA’s public meeting in the summer or were president yesterday so to do this I’d like to introduce layest it’s an FDA public affairs specialists in the food and cosmetic information center at Sif’s Ann who will be providing you a brief overview of this technology based in

large part on FDA’s experience with biologic projects products Lea snips Thank You dr. Goldman and thank you for everyone in the audience who has chosen to participate today I am going to give you a brief overview this won’t take a lot of your time I’m going to provide this to you first with a schematic or a definition of animal cell culture food technology it has referred to in the Federal Register notice for this meeting as the controlled growth of animal cells from livestock poultry fish and other animals their subsequent differentiation into various cell types in their collection and processing into food next I have an overview a schematic of the entire process from the cell procurement and qualification through to final post harvest processing using traditional food processing techniques animal cell culture begins with tissue collection you go to the live animal you take a biopsy you place the collected muscle ur tissue in some type of solutions such as Hanks balance salts to maintain physiological osmotic pressure and pH next you liberate the cells from the tissue in muscle which is what I’m going to focus on for this presentation you have to digest away the extracellular matrix to liberate the cells to do so enzyme treatment is typically used the enzyme could be classically derived or recombinant Lee produced if one desires to avoid the use of enzymes there are other ways to liberate the cells from these liberated cells you’re now selecting for the cells that are known as satellite cells or myoblast these are you know nucleic cells that are capable of proliferating now you have a seed cell sample this seed sample can be possibly used for the establishment of master cell banks qualifying a master sylvain usually 10 to 200 vials involves quality control testing for the presence of viruses bacteria yeast and mycoplasma as well as cell line authentication there are not many established master cell banks and cell lines for the animal species humans typically use for meat and poultry so we may only have a qualified vial of cells to begin now we begin the proliferation phase where we multiply the cells cells require growth factors such as cytokines hormones and signaling molecules nutrients such as sugars fats minerals amino acids and vitamins gases oxygen and carbon dioxide to grow cell culture media is a solution that contains nutrients growth factors pH buffers and other components necessary to grow cellular structure currently the primary cell culture media used contains fetal bovine serum serum free formulas do exist for cell culture but they are very expensive we have read that firms working in this space have a heavy focus on research to eliminate the use of animal serum and create economical serum free media currently sourcing sterilizing and certification requirements for cell culture media are established for biomedicine use it is hoped by the firms in the industry that the requirements for cell culture media use for food production will be focused on food safety requirements rather than on biomedical requirements at this time the technologies used for creation of food products from animal cell technology are on a laboratory scale with cells being cultured in flasks or in small bio reactors to optimize cell attachment plasticware for cell culture is generally coded by the manufacturer or if not often by the end user choices include collagen fiber nekton laminin gelatin or other extra cellular components bio reactors for

proliferation do not require cell attachment necessarily and will likely be stirred tank reactor reactors which are already developed and in use for things such as vaccine production removal of cellular waste products is also an additional requirement during this phase next we move to the different ation phase the Coco differentiation phase the cultured cells are now manually seated onto scaffolds and allowed to grow differentiate and mature firms that are working to commercialize these products are currently working on scale-up and automation of this phase so that it will be viable on an industrial level as in the proliferation phase the cells still need trance they still need gases and they need growth factors now the growth factors are specifically selected for their role in helping the cells to differentiate for most structured food product applications scaffolding is required in order to grow the cells and have them adhere to each other in any sort of 3d manner scaffolding and structural elements are additional areas of research and innovation and going forward we may see both animal and plant derived scaffolding used for these products we anticipate that scaffolding may be developed through 3d cell printing recombinant microbes hydrogels or yet undiscovered structural elements because the scaffolding may be consumed as part of the product depending on its function as a perhaps a bone which likely would be or connective tissue which could be eaten the scaffolding material should be edible low cost and its components must be readily available to achieve a product that’s comparable to conventional meat cells also could be Co cultured and differentiated into a 3d scaffolding structure the scaffolding must allow nutrient media to profuse the structure such that all cells continue to receive the nutrient media mechanical differentiation factors are important to consider as well exercising the cells in some fashion may be required in order to impart the appropriate texture and protein content for the eventual food products industrial scale maturation bioreactor systems have not yet been developed and will require perfusion capability and mechanical differentiation capability these bio reactors will have to be able to feed the cells exercise the cells remove waste products and maintain pH and other critical factors to maintain a healthy and quality product with real-time quality control systems for scalability development and implementation of this set of bioreactors is critical another option is the creation of tissue type products with multiple cell types such as muscle fat and connective tissue cells through 3d printing of the cells into a tissue like biological material next we move to the harvest phase the biological material whether it be clumps of cells tissues or tissue like materials will be harvested once the material is harvested and is no longer supported by its life-sustaining Culture Media the cells will soon become non viable following harvest the material then enters the traditional food manufacturing packaging and labeling processes this concludes my presentation it’s been a pleasure to share this material with you and I look forward to the rest of the meeting today and tomorrow Thank You Leah can we have our next few speakers come forward so we’re gonna go ahead and start with session one if you’re following along in the agenda it’s the current regulatory safety frameworks for foods and products of cell culture technology our first speaker this morning is dr. Phil Bronstein he’s an executive associate of regulatory operations in the office of field operations and FSIS although everybody so as Selena said my name is Phil Bronstein I work for FSIS in the office of field operations I’m a

microbiologist by training and today I’ll be talking to you a lot about what the current regulatory framework is for FSI is and what FS is does on a day-to-day basis okay okay so first of all who are we or a public health agency and in the u.s DEA is responsible for ensuring that all meat poultry and processed egg products are safe wholesome and properly labeled for us and the US consumers we have several different acts that give us our authorities the three ones that I want to focus on today are the federal Meat Inspection Act which was passed in 1906 the poultry products Inspection Act which was passed in 1957 and the eggs product Inspection Act which was passed in 1970 these are the three major acts that give us all of the authorities to regulate products at FSI as regulated establishments so what do we actually do so for meat poultry and egg products we provided an inspection of domestic manufacturing we also conduct multiple laboratory analysis both chemical and microbiological and pathology for all of the products that we produce we carry out in commerce surveillance through 150,000 commerce facilities we conduct outbreak investigations and manage product recalls if something has gone wrong we also determine equivalency of foreign food safety systems andrey inspect all products at the point of entry that come into the United States overall we have about 9600 employees and around 7,000 of those are actually feel out in the field so there’s about 6,400 establishments throughout the United States in the Pacific Islands in Puerto Rico we have inspectors that are in each one of these domestic establishments we also have 133 import inspection houses that are on the borders of the of our country we’re all product that is exported to the United States that is meat poultry and processed egg product goes through these I houses to get a tree inspection and as I said before we also have 150,000 in commerce facilities nationwide so I’ll focus on those very quickly so we actually have a whole office a hoffa the office of investigation enforcement and audit and we have about 150 employees in this office in addition to responding to outbreaks natural disasters and intentional contamination events they actually carry our authorities to all where where FSIS products are stored transported and available for in commerce along with FDA in the states to make sure that after the product leaves emphasized regulated establishments that it continues to be self safe health wholesome and properly labeled so for the rest of talk I’m going to go ahead and talk mostly about the FSI as a regulated establishment and what we do there so at our regulated establishments we have continuous inspection at slaughter and this is what most people think of when they think of a food safety inspection service at USDA is our carcass by carcass inspection of all animals that are slaughtered in the United States whether they are livestock or poultry but we also do inspection on once per shift in every establishment that processed meat poultry and processed egg products and we for meat and poultry and then we have continuous inspection for egg products and then once again we have a hundred percent Riaan spec ssin for imported products so what does that inspection actually look like in terms of numbers well for ante-mortem inspection so the animals that are outside of our slaughter facilities before they enter we inspect about nine point six billion head of livestock and poultry a year and we’re may sleep mostly looking for animal health and and humane handling at this point we want to make sure that all the animals that are going to be destined for the American table are are healthy and wholesome and suitable for for food products and at post mortem so after the animals have been slaughtered and they’re inside the facilities at slaughter inspection we do about a million food safety related tasks a year and once as I said before it’s a hundred percent carcass by carcass inspection in livestock and poultry so what what are those food safety tasks and we’ll talk more about this in detail later but slaughter hasip hasip stands for hazard analysis and critical control point livestock zero tolerance poultry zero tolerance verification good command commercial manufacturing practices and for our new poultry inspection systems we’re also doing our zero tolerance food safety verification checks so who are these people that are

doing all of this inspection as I said there’s about seven thousand people and FSIS that we have nationwide duties and inspections the first group I’ll talk about there’s about 2,400 and food inspectors and these are the folks that are actually what we consider online at slaughter facilities they’re the ones that are checking carcass by carcass they’re our first line of defense so they also are involved in looking at product handling general sanitation of the facilities and doing the anti mourning a post-mortem inspection we also have about 3800 consumer safety inspectors and so these are these folks have a little bit more advanced training and they go in in both slaughter facilities and processing facilities and they are verifying establishment programs having to do with sanitation performance standards sanitation standard operating procedures which for short is s SOPs and hazard analysis and critical control point plans which I will go into more in detail on top of that we also have approximately 750 public health vegetarians throughout the nation and these are the and these folks actually mostly focus on disposition of animals but they also do analyses of the facilities and equipment we use their their scientific training to not only look at the facilities in the equipment but also to communicate with with the establishment personnel and finally we have an enforcement investigation and analysis officers we have about a hundred and thirty of these throughout the field so these are our folks that are the most highly trained for food safety and in the field and they go from from establishment to establishment and look at their comprehensive food safety programs making sure that they’re working as intended making sure that there’s no process deviations making sure that overall their food safety system of every establishment is working as intended and they do this both on a routine basis and for any for cause if we have any potential issues then we will actually have an EIU go out to an establishment and put of food safety assessment and then they also go to do other consumer protection activities and very recently we’ve also been highlighting their outreach so they actually go into the establishments without an enforcement hat on and try to explain FSIS tenets of food safety and making sure that the the establishments understand what are the what FS eyes expectations are and how they can comply with those so just to reiterate we coordinating on only inspection activities but all of these people I just talked about in the field are also doing enforcement activities so if they do see a problem if they do have an issue with the establishment they talk to the establishment they can put they can start an enforcement actions to correct anything that is happening that is that is wrong out there in the field and then overall they ensure that the products and FSI that FSS regulates are safe wholesome and properly labeled I wanted to make that point here because I won’t be talking about labeling in my talk today but you will have two talks tomorrow about Osias labeling requirements and as I told you the e iOS and and others perform in-depth evaluations and analyses of the establishments house of systems and sanitation and perhaps one of the most important other parts that they’re doing is they’re actually collecting data our our our food safety system is far from static we’re always looking for ways to improve we’re always looking for additional data so that we can modify and improve our inspection practices and our regulatory framework so we use our infield inspectors to gather data which they input into the public health information system which is a centralized database for FSIS and we use that data not only to look for trends in industry but to identify potential issues in establishments and go and throughout the nation and also we use the data to develop new policies and regulations so what are the steps in becoming an FSS regulated establishment well the first thing you have to do is is is get a grant of inspection so there are several things that you have to do before you can get a grant of inspection one of the first things is is we have to you have to have demonstrate that you have sanitation performance standards so we want to make sure that the environment that you’re going to be producing FS is regulated products is going to make sure that the product does not become adulterated so we focus on conditions that may result in the adulteration of the products such as making sure that they have a reliable source of potable water and make sure that that water is not contaminated have an acceptable sewage system so that all the waste that’s being produced at these establishments is carried away and doesn’t result in in incidental contamination looking at their sanitary operations we want our process or our plants to be free and Santara clean and sanitary so to do that we’re going to be using a lot of chemicals that they will be losing a lot of chemicals we need to demonstrate not only that they know how to clean the environment but also that these chemical use is safe for their employees and our employees and also the establishment has must have minimum four walls and a and a roof and sufficient light and receptacle for identified for

inedible and edible product cuz the last thing we want someone to do is combine the two of those the next thing that they have to demonstrate is that they have sanitation SOP standard operating procedures or s SOPs so the first thing before the plant starts they need to make sure that these are written we want to see the plan they have to have a plan that has written procedures that that outline what what’s going to be performed daily before and after operations to make sure that we keep their establishments clean and sanitary we also want to see them to see that they have identified procedures to verify the sanitation on the food contact surface and any utensils that may come in contact with the food and also specify the frequency and identify the personnel that are responsible once the establishment has started and I’ll jump around a little bit but what our people are doing are actually verifying that the s SOPs are being performed by the establishment so they’re going to be conducting pre operational procedures for a standard s SOPs so our folks will be around looking before production starts at the beginning of the day if they see any sanitation problems and that any deviations from the establishments written procedures that can stop production until those corrective actions are taken they’re going to make sure that the the the procedures that the establishment laid out are done at the proper frequency and are implemented properly and if there are any issues as I said before they’re going to make sure that the establishments are taking the appropriate corrective actions to to make sure that doesn’t happen again and to ensure a safe and wholesome product so the the last part of the of our food safety system for FSIS is the hasit plan so the hazard analysis and critical control point plan so these requirements are laid out in 9 CFR 417 and you have to have several components one is a hazard analysis one is the plan itself and then the other requirement and 9 for 17 is that these records must be written and available to inspection personnel upon upon request and this is really important because you can’t be everywhere in an establishment at all times so we want to make sure they have proper records so that we can actually check and see what they’re what they’ve been doing on all the in all the areas we can’t be at and then perhaps the most important part of all this the hassle system must be validated it’s great to have a system in theory we want to see how it how it actually works out in practice at the a specific establishment so what are the seven designing principles of FSIS hasit plans the first one is to conduct a hazard analysis so this can be biological chemical physical hazards so it may include pathogens or other bacteria that are associated with the products it could be chemical residues from hormones or pesticides we need to understand how the establishment if the establishment thinks that that is a hazard reasonably likely to occur and also physical hazards there are many times when there are physical hazards either through the process itself or pieces of metal or plastic can be introduced we need to have the establishment consider all of those things and and tell us where they think the hazards are reasonably likely to occur and after for every hazard that they have found is reasonably likely to occur they need to determine how they’re going to mitigate that hazard so where are their critical control points and at those critical control points what are the actual critical limits that they need to meet to make sure that critical control point at that kurtal trol point they are effectively managing that hazard and after that we also want to see monitoring procedures so it doesn’t good do any any good set a set of limit and never check to see if you’re hitting that limit so we need to see how often and how are you going to be monitoring your critical limits what happens if there is a deviation if your spray cabinet stops working or your x-ray machine goes down or you do get a deviation in the process what are you going to do to that product that is subject to that deviation and how are you going to implement something new to make sure it doesn’t happen again and finally for the first of the seven is the establishment of record-keeping and documentation procedures which is key to the house of principle and our inspection system on the next one the very last one is to establish a verification procedure so we have we give our establishments 90 days validation to validate their hazard plans once they start operating so the idea is is that we have a wonderful passive system which has technical and scientific support for every critical control point and critical limit that we’ve set and we need to make sure that the establishment can actually achieve that on a day to day basis when they’re operating so what we ask the establishments to do is run 90 days collect data look at their production

data which can include their house of documents their critical decision-making documents for the CCP’s the critical operation procedure our parameter logs in the initial equipment set setup and calibration documents and also any sampling results for their product or the process of interest and what we expect them to do is to put that together and demonstrate to FSIS that they do they can’t execute their hasip system as designed and written in their in their written documents and FSIS personnel also will Vala will verify that those those procedures had our validation is appropriate so we haven’t just done this for decades in products such as meat and poultry we also have recently implemented the same FSIS regulation to Solera form a system salera for maize establishments or as we say in the Unites it’s a typically catfish but so far our seller for maize we’ve just implemented it fully implemented this about a year ago after an 18-month transition from FDA to FSIS where we have put all domestic establishments that produce catfish or solar for maize and and importing countries are countries that export to us Solera form is products such as basa and try and swipe into the United States we’ve integrated about a hundred and ten domestic establishments and at this point we still have three countries that export Solera for maize into the United States so building on that point we actually have in addition to those three countries there are 30 36 other countries that export about 4.1 billion pounds of product into the United States a year that is regulated by FSIS and as I said previously FSIS inspects a hundred percent inspection of all of that product at the point of entry so there are many points of entry into the United States over 300 that CD CD yes CBP has identified and all of that product needs to be funneled into 133 I houses our inspection import houses that FSIS has personnel at and we do 100% reinfection of all the product that comes in that includes looking at their certificate the health certificate for that product looking at the condition of container and and other frequency we will actually do laboratory testing to look for speciation chemical residues microbiological hazards or any other thing and this is an important part of our equivalence process so what is our equivalence process FSIS has a relatively unique equivalence process it has three different steps to it and FSIS equivalence is a country to country equivalence process so what we’re doing what we’re asked countries that want to export products the United States to do is to demonstrate that they have a food safety system that that offers equivalent level of protection to the US consumer that FS is SS food safety system offers for meat poultry and processed egg products so the first step of this is a document review we ask the central competent authority and the foreign government to send us all the regular training documents guidance documents all the written pieces of information that we can review that show that they have a food safety system that is robust as a as SF FS ISS is if after looking at these documents we determined that that on paper they look equivalent then we will send on we will send out on-site audits to the foreign countries and look at their food safety system in practice once again it’s great to have something on a piece of paper we really want to see it in action so we’re going to go out there to the establishments we go to their lab we’ll go to the foreign countries labs we’ll go to there the central competent authorities government offices we will do a records review we will walk around with their inspectors and we’ll see are they actually implementing their food safety system the way they told us they implement their food safety systems through the document review for products that are being exported to the United States not necessarily all the products but definitely the ones that are being exported to the United States and so if if the on-site audit gives us confidence that they are performing at the they’re performing as they have written and they have an equivalence level of protection for the products that are being exported to the US then we will grant them equivalency and but the process doesn’t end there just like we do in our establishments we actually are going to be verifying continually verifying that establishments and foreign countries are meeting the marks that they have laid out so we do as I said before the port of entry re-inspection for all the product comes down as a final step and a final check in the equivalence process in addition to that we also do export certification so we have about 15 billion pounds of meat poultry and processed egg products that are shipped out of the United States to the to the to the rest of the world and we actually

provide health certificates for all of that product to ensure anyone who is receiving that product throughout the world that is safe wholesome and properly labeled and up to FSIS standards so we have a lot of a lot of folks as I said before think of FS is at a slaughter facility and actually a majority of our work is not at a slaughter facility we have around 6400 establishments 4000 and 200 or 4,000 300 of them are processing only meaning that they are taking the products that are derived from the carcasses and then further processing them and actually of these about 1200 of them are actually dual jurisdiction with F SR with FDA so we actually already work very closely with FDA in the inspections space so these further processors are actually very complex foods food processing systems which include canning irradiation high pressure processing fermenting enzyme based processing and advanced meat recovery as a matter of fact the technology in these establishments is always evolving at a very high pace I’ve seen establishments that have lasers that graph out the size of the piece of meat and then air saws or water saws that will actually cut to the designated size and shape of those process as they pass through a completely automated line it’s very impressive and FSIS is has had to develop special processes to keep up with these process innovations so we actually in our office of policy program development we actually have a whole new technology review process so we actually take a multidisciplinary approach with teams of microbiologist and toxicologists chemists biologists meet scientists etc and we have a team here at F at F sis that looks at every new submission so if an establishment wants to use a new machine a new process or a new intervention to control a hazard they first must submit a package to FSIS we take that package if it’s a chemical or has other process it usually goes through FDA prior and then FDA will pass the passed the information on to us that ethic if it’s a chemical it’s generally regarded as safe and then we’re looking for suitability in that case but in any case we look at every all the submissions from our industry we make sure that it is going to be a safe and effective for our personnel and their personnel and the consumer any of their processes we do a technical review and if it meets our standards than for suitability and an establishment will produce a no object which means that I can now implement with specific parameters any of these new technologies into the process into a processing establishment and and once again we are we that becomes part of their hasit plan we expect if it’s going to be a large deviation from what’s normally done that they’re going to have critical new critical control points and critical limits that they’re going to need to look at and that we will verify so I’ve actually kind of outlined overall are very robust inspection and enforcement process but mistakes do happen we are always looking and are in our regulated establishments and in commerce for for any things that may have gone wrong we if we do identify a problem we’ll initiate an investigation and if we do find that product that may have been adulterated has entered into commerce we will take action the first thing we do if we decided there’s the products adulterated we ask the firm to do voluntary recall the product if the firm does refuse to do that we can actually move to a seasoned detain in commerce to make sure that no adulterated product is available for human consumption out there so we’re always looking for investigation as you can see from this slide there’s about 572 recalls of approximately 133 million pounds over the last five years or so that emphasis is recalled a majority these are from undeclared allergens and this is actually a direct result of our inspection force going in there looking at records production records ingredient lists sanitation records a lot of times what actually happens is there’s not great sanitation between products that are being produced with an allergen followed by production of products that are declared allergen free so we are constantly looking and making sure that all the product that comes out of our establishments are safe and wholesome so I just in closing I just wanted to let you know that we know we are a science-based data-driven organization and we’re always looking for ways to improve and integrate new technologies and looking for ways to ensure that the over 127 billion pounds of meat poultry and processed egg products that pass through the FS is regulated system are safe wholesome and properly labeled not only the united states consumer but the consumer of u.s. products throughout the world thank you thank you Phil I’m gonna

go ahead and introduce our next three speakers they’re from the FDA’s Center for Food Safety and applied nutrition dr. William Jones he’s the acting director of the Office of Food Safety dr. Jeremiah Fasano consumer Safety Officer in the division of biotechnology and grass notice review in the office of food additive safety and mr. Douglas Stern deputy director for regulatory affairs dr. Jones Thank You dr. Kramer good morning I’m going to spend a few minutes introducing the overall regulatory framework for food safety at FDA and providing a brief overview of some significant aspects of the Food Safety Modernization Act first let’s define our terms food is defined as anything used for food or drink as well as anything that is a component of something used for food or drink chewing gum which gets its own list entry is also included in that definition you’ll notice that the food and drink can be consumed by humans or by animals today we’re going to be focusing on human consumption the Federal Food Drug and Cosmetic Act sets out requirements for the safety of food there are a number of conditions that could make of food unsafe or adulterated and therefore unlawful first and foremost if food contains a poisonous or deleterious substance which could be harmful that food is adulterated the Act differentiates between poisonous and deleterious substances that are added to food and those that happen to be present in food for those that happen to be present which are not common in food the requirement not uncommon in food the requirement is that the level be low enough that it wouldn’t ordinarily be harmful plants are a good example of this many plants naturally make toxic substances which protect them from being attacked by insects mold or other pests at some level those substances would be harmful to humans however in agricultural crop varieties while these substances may still be present and detectable their concentrations are far too low to raise any food safety concerns two other key conditions relate to food additives and in sanitary conditions first if you add an unsafe food additive to food you would alter ate that food and render it unsafe we’ll talk more about food additives later but essentially this means anything you add to food must either be approved by FDA as safe for that use or must meet certain criteria that exempt it from the FDA approval requirements finally if a food is being made packaged or stored under conditions that would lead to contamination such as microbial contamination or would otherwise lead to that food becoming harmful for consumption in some way then the food is adulterated unsafe and unlawful there are other adulteration provisions but this gives a sense of the overall framework the recent Food Safety Modernization Act increases FDA’s focus on preventing food safety problems rather than reacting to them the law also provides FDA with new enforcement authorities that are designed to reinforce compliance with prevention based and risk-based safety standards in addition the law gives FDA important new tools to hold imported foods to the same standards as domestic foods one key component of FISMA focuses on hazard analysis and risk based controls as section 118 of the Act says this is about preventive controls which are cornerstone the cornerstone of the modernized approach under FISMA the elective effective controls of this type are informed by hazard analysis of each facilities manufacturing processes and matched to the risks identified during that analysis each food is required to develop a food safety plan each facility is required to develop a food safety plan incorporating these elements the implementation regular regulation is found in title 21 part 117 of the Code of Federal Regulations which also updates the current good manufacturing practices or CG MPs this requires a written food safety plan with several required elements first there’s the hazard analysis which should include known or reasonably foreseeable hazards of all types including biological chemical and

physical hazards second appropriate preventive controls of various types should address hazards identified during the analysis based on the level of risk associated with each of them the plan should also include steps to oversee and manage the controls including how to monitor them correct any issues that arise and verify the effectiveness of the corrections records must also be kept and for manufacturers and processors the plan must also address the facility’s supply chain if relevant hazards are identified there during the hazard analysis finally the plan also needs to include recall procedures that could be used effectively in the event a recall should ever become necessary finally I’d like to identify a few questions that are a good starting place when considering a new food production process for implementation in a manufacturing facility first what hazards are identified during the analysis phase of developing the food safety plan second what preventative controls are defined by the plan do they cover all hazards associated with applicable risk and are they sufficient to control the identified risks also what substances are being used in production are all substances safe and lawful for their intended use this is just a brief and quite broad overview of FDA’s regulatory framework for food safety as you can see there there’s a lot to think about but these basic questions may be a good place to start so thank you and I will now turn the podium over to Jeremiah Fasano thank you so now I’d like to spend a little time talking about food ingredients it’s sort of inescapable when you’re considering food safety next slide please so the definition of food ingredients is actually fairly broad if you look at this as any substance the intended use of which results into becoming a component of food reasonably be expected to become a component of food or otherwise affecting the properties of food it’s a very expansive inclusive definition you’ll see in the last part of the slide there’s a even things that come into contact during a packaging processing handling those are all technically included in the food ingredient definition so it’s true that many of these things may not have much practical impact on the properties of the food but as a starting point for analysis it’s always worth considering the expansiveness of this definition makes it so you’ve already heard from Bill about the standard of safety for substances that are constituents of food and not ordinary at levels not ordinarily injurious the standard of safety for substances that you deliberately add to food is reasonable certainty of no harm in the minds of competent scientists that the intended use is safe so that is a not an absolute safety definition it is a definition based and reasonable certainty by qualified scientists how is that actually get put into practice of identity and exposure or critical factor in considering this both exposure to the substance itself as well as to metabolites that might be produced after consumption came out of exposure to this and related substances in the diet relevant properties of the substance are also very important we have a lot of tools now that can actually allow us to infer information about the properties of the substance before we even begin to do studies whether it’s from quantitative structure-activity relationships other kinds of read across tools various kinds of pharmacokinetic modeling information we have about interactions with ligands especially those that are in the body so that’s all very important information in figuring out what is the appropriate data in order to reach reasonable certainty of no harm and this is going to depend a great deal on both the intended use of the substance and on the properties of the substance in terms of how this works out in practice at sifts and there’s three broad categories of substances that we think about and from a regulatory perspective first there’s food and color additives so these are substances which require approval by FDA before you can use them in food and it’s done by a row making process and all the rules are published in the Federal Register another kind of substance that we would consider a food additive but that is exempt from this requirement it’s authorized in a different way through a notification process these are food contact substances or substances from packaging or other materials that might migrate into food we have an inventory of those that we maintain companies can notify us and we assess those as well and then finally there’s grass ingredient uses so this is another exemption from the food additive approval requirement and the way that you get this exemption is to demonstrate that not only is there evidence showing that your intended use is safe and it’s appropriate data that evidence also has to be publicly available and you have to show that there is an expert consensus that that data shows the safety of the

intended use so in that case you don’t need authorization from FDA because you’ve essentially already shown that the scientific community is on board with the view that that intended use of that substance is safe but in all cases although there’s a lot of variation in the kinds of data that you end up needing depending on the properties of the substance and the intended use this quantity and quality of data is the same regardless of which of these regulatory boxes you’re in it’s just sort of the context and which is presented that can differ so another thing to think about and when you’re when you’re thinking about ingredient safety is changes in the manufacturing process it’s often easy to focus on the process for producing a food or food ingredient but in terms of the lens we look at for ingredient safety assessment we’re really thinking about the properties of the food and the process is important to the extent that it affects those properties that’s what’s really going to matter for the safety assessment so it’s important to understand the potential impact on the properties that are relevant for safety this is also another important point is that when you change a production process you can change many Bertie’s of the food the first part of the analysis is to identify those differences but the next part is to think about which ones are actually going to be relevant for safety assessment and then if you have identified changes what information is needed to sort of rebuild the safety case depending on those change properties so next I’m going to put this in more concrete terms and talk about a few examples from past experience these are for various kinds of ingredients that are produced to biological production platforms so these are sort of an interesting variety of methods of manufacture for these there’s often a lot of variability in the process and so I thought it might be interesting to hear a little bit about how we had dealt with some of these the three broad classes of substances are substances produced by cultured cells the cultured cells themselves and then also new plant variety is produced by modern biotechnology substances produced by cultured cells have a fairly long history as food ingredients the the canonical original example is the discovery that fungi actually secrete enzymes into the culture medium and you can recover those and use them for various purposes including in food technology this was all been later expanded to recovery of many other kinds of substances that were secreted from cells and culture but enzymes are the starting one we also have looked at a number of oils produced by cultured algal cells so they recover the oil that is produced by the cells whether by its processing of the cells or in some cases secretion and then finally and this is a technique that’s very common in the therapeutic space and industrial settings but it’s also common in food production as well is the use of cultured cells as a production platform for transgenic proteins you can design your protein of interest you can put it in a production platform such as a micro brewery used and then recover that protein for use as a food ingredient so these are all examples of substances we’ve looked at it produced by cultured cells in general you know you’re looking to make sure that there’s no unwanted metabolites that are produced by the production platform and also that there’s no microbial contamination of any kind in addition to looking at cultured cells as a production platform we’ve also looked at the cells themselves as direct ingredients and we’ve looked at a variety of different kinds of types including bacterial algal and fungal cells the bacterial cells I mean yogurt is the most obvious example of this but there are many other instances in which people have generated bacterial cells and culture and then use them as direct ingredients in food we’ve seen a number of those through our grass notification program we’ve also seen some algal cells grown up in culture and sort of suspension culture in a tank and then harvested and used as a direct food ingredient and then finally fungal cells these yeast is again the most obvious example but we’ve also seen other kinds of fungi grown up in culture and then collected and used as a protein source and in these cases the selection of the cell is an important consideration you want to make sure you have the appropriate cell that will grow well that it won’t produce any metabolites of concern and again of course microbial contamination is an issue and then finally this is a slightly different case but it’s an interesting illustration of thinking about again using biological processes as a production platform for food so we’ve been looking at plants produced through modern biotechnology new varieties for over 20 years and it’s raised a number of interesting challenges that I feel like we’ve been successfully able to address the underlying technologies used to generate these new plant varieties have evolved over time new technologies have been introduced but the lens that we use to look at this is essentially to ask what substances are being added to the food what changes in the properties of the food itself have resulted and to what extent are those changes material for safety or nutritional concerns and so using that sort of framework to think about this we’ve been able to deal with new plant varieties from a wide variety of underlying techniques for for

developing each variety and this has served us pretty well over the over that time and you know some of the things that we encounter which perhaps we’ll return to a little bit later are this question of what are some of the fundamental characteristics of food from a plant what can you expect in terms of you know key nutrients and other compositional properties and if you have introduced something new does that raise any concerns from a regulatory perspective as a food ingredient so in general I mean these are complex systems and reasonable to ask to what extent when you’re using these as ways of producing food how consistent can you be how much control can you have over the process and our observation has been that you know there are often questions to ask when you’re looking at a new production process but that it is possible to adequately characterize the food product with respect to key properties that would matter for safety or other material concerns and to consistently produce these products in a way that all issues can be addressed before market entry so I’ll just close by reiterating something from our 2014 guidance on new manufacturing processes for ingredients and just say that again it’s easy to have your focus drawn closely to a new production technology and the alternatives very interesting and there’s a lot of interesting issues to consider but but fundamentally it really comes back to the properties of the substance any predictable impacts on the properties of the substance that may come from the production process and again when you change those properties what relevance do they have for safety or other material concerns thank you so with that I’ll turn it over to our deputy director for regulatory affairs Tuck Stern good morning my name is Douglas Stern and I’m going to speak a little bit about FDA’s approaches related to this these areas that have been addressed and how we seek to do do our job FDA has a number of different responsibilities we’ll get to in a minute but we try to focus always on prevention as our goal has oriented by our mission that is to prevent food safety hazards and other hazards before they arise and we have various ways of doing that there’s a focus on inspection which I’m going to get to inspection and compliance which we do and we have certain actions that are outputs that are very visible those include some traditional enforcement actions which include seizing product in joining firms that is ordering firms to follow a certain protocol or do certain things prosecution which is my first calling and also there’s other actions the agency takes that may be administrative that may stop a company from doing particular actions so those are things that people focus on but I think it’s I’d like to step back a little bit and talk about our overall responsibilities and how they fit within their FDA has huge responsibilities we have more than 88,000 FDA registered domestic food facilities more than 200,000 foreign foods facilities that’s the the vast majority of the food supply is something that falls within FDA’s responsibilities we also have responsibilities as dr Gottlieb mentioned for all medical products including all drugs medical devices and biologics all of which have a dizzying array of products many of which are constantly innovating especially today we’re really on the cusp of an environment where things are changing incredibly quickly and a lot of that is being driven by technology personalized medicine and so we’re seeing a lot of change all those areas and we’re starting to see more change in the food areas well and this is one example of that we also have a very large import program FDA has more than 40 million different product lines entering the country that it’s responsible for and so the question is how do we do that it’s a very challenging mission and what we do is we really focus on a systemic approach that is risk-based and founded in science and so it’s very important to think about these things we believe systemically and focus on where the risk is we believe in a lot of the traditional measures which I came back to earlier they are measures that check that system so inspections and testing check that system and our inspections and testing our risk-based meaning that we adjust them up or down based on the risk and as you met as dr

Jones and dr. Fasano mentioned there’s particular ways in which we sort of flagged that risk based on how we analyze what the product is and what the what what the issues may be so we have different inspection frequencies within surveillance we also will direct inspections where there’s more of an issue for whatever reason and the depth may vary based on that as well and our product sampling also is adjusted by risk which we do both import and domestic this systems based approach is really embodied within the preventive controls rule which would be the rule that would be applicable here and this is similar to a lot of the thinking that’s gone on broadly within quality thinking over over a long period of time so preventive controls focuses on a number of things you have to have a sanitation control program that avoids cross contamination that assures that you’re sanitizing and cleaning your equipment that you have an appropriate environmental monitoring program where warranted and that you have an allergen control program that cleans the sanitizers equipment avoids cross contact has controls for labeling you have to control your process in terms of temperature controls pH and formulation and we also have a lot of emphasis and this is trooper as dr. persona mentioned four ingredient control a lot of products we regulate have ingredients that go through multiple steps so it’s important to have supplier approval receipt of incoming raw materials and to verify so this is key to verify that whatever is coming into the plant had the same level of control that you would expect within the plan itself so we want to make sure that that there is an appropriate safety approach to ingredients as well as what’s done at the finished product step and all that should be in your food safety plan which dr. Jones mentioned so really it’s part but part of that is to have a system to assure you’ve analyzed your hazards and you have a system and that you and under our approach you also should have procedures that are in line with a good manufacturing practice that’s that acronym GMP and these are modernized to make them flexible so I’m gonna come back a little bit to that so I want to mention just a little bit about this systems based approach and what does it mean and why did we get here inspections and testing are really good things to have they’re very appropriate they check the system and we rely upon them and we believe in relying upon them there’s also some limits to them one is if you know depending on the hazard we have to make sure that we are looking at the right thing so there’s tests tests for a particular thing and if you’re doing an inspection your folks you may be focused on a particular thing so it’s important that within whatever whatever approach that you have it’s focused at the right at the right step it’s also important to try to fix and prevent this goes back to the principle of prevention to prevent issues before they arise and that’s why it’s important to have a at hazard analysis design a system that checks execute monitors and remediates issues throughout so we really want to put a focus on that these inspection and testing really sort of her ways to check that it’s a they also can be imperfect contamination is not uniform so sometimes contamination is in one place it’s not in another sometimes there’s a practice that is problematic it’s in one place but it’s not in another so sometimes when we look we can miss and that is something that’s one of the reasons that we want to try to make sure that we put more resources where there’s a greater risk and that there’s an analysis that advises us in terms of that checking as to where it goes in terms of that generally sometimes that’s talked about talking about building quality in you may have heard that concept or continuous improvement so the idea is that we want to encourage companies to self monitor and then we check and oversee what they’re doing within the medical approach something this is usually referred to as a quality system so we have had some experience with that and it poses some special issues related to product innovation because you know as products change and sometimes they change very frequently in certain areas it poses some certain challenges does the does the firm really understand what the risks are does

whatever component that is checking whether that be a quality control unit within a facility or whether that be in outside agencies such as ourselves or or anyone else do they understand what the issues are and can focus on it sometimes if something is new the risk can be underappreciated or over appreciate it meaning that you know we’ve seen some products where the there’s an if there are products that emerge over time that we see as issues that we did that are not fully understood initially and so one of the that’s one of the reasons that we think it’s important to sort of focus on that design approach and that was and having a scientific understanding about what the plan is and then have a plan to to monitor that and remediate that and that was that was mentioned to some degree in dr. vasanas comments so we do want to try to have an approach that accounts for that and also we also want to be able to allow for changes in process as if things are in an area where they’re innovating quickly sometimes there are ways that can be adjusted so that the product maybe the product manufacturing may be more efficient or may be made even safer and if there are rules that stand in the way we have to be cognizant of that possibility and to try to use our authority and make sure that we are doing things in a way that makes them safer and as efficient as possible so our approach really is to try to construct a systems based oversight and so we come in and if we have the plan you can look at that plan we also want to look at your procedures that and look at those procedures in line with what current good manufacturing practices as well as outside indicators so outside indicators may be do we know if something is happening outside of that facility that might inform where we think a risk might be that might be based on science it might be based on outside sampling results it might be based on something else but we try to do that so that when we go into a facility and we’re looking at that we can determine is this plan functioning it’s in the way that it’s intended to and then our approach really is adjusted as I mentioned by risk in terms of how deep that look is going to be how frequent so we have different levels of frequency depending on the issue and then also by specialty so we have certain product experts in our field inspection that would come into a particular facility depending on what the issue is FDA has a large laboratory capacity we have 13 field laboratories in the United States in Puerto Rico eight of those focus on food issue human and animal food all of those are ISO certified so among the types of testing we do our detection of foodborne pathogens veterinary drugs pesticide nutritional composition and environmental contamination including heavy metals and we also have facilities that work on method development and other issues that are trying to sort of improve our laboratory capacity and understanding in order to do the appropriate types of testing within imports as I mentioned we have a wide import portfolio we have a general principle that food must from abroad must be as safe as domestic food under the foreign supplier verification program importers are responsible for ensuring that their foreign suppliers have adequate preventative controls in place it’s also true for ingredients under the preventative controls rule FDA does really thousands of foreign inspections so we do have a considerable foreign inspection program while at the same time we rely on coordination with other regulatory body yet bodies we have certain powers within FISMA that are important in terms of mandating certification for high-risk foods we have an expedited review system that we are building for certain importers that meet certain standards and have third party audits that have been accredited by FDA and we can deny F entry if in access for inspection is denied we do have a hundred percent electronic verification so part of our system is to check all of the different that that a product coming in has been has met all of the requirements it has it should require given its type and also it has triggers or flags within our system whether it’s an apparent risk so we are going to look wherever there’s cause to believe or or in many cases to suspect that there might be an issue so we have a risk-based approach there as well as I

mentioned you know those are those are the approaches that we do for trying to make sure that there’s a surveillance approach and that that surveillance approach and those outward actions that I mentioned are key back to the overall goal of prevention that’s our core goal on our mission to make sure that we we do the best for the American people to make sure that all food is safe with that I’m finished thank you Thank You mr. stern and I’d also like to thank all of our speakers this morning it’s been great hearing from everyone and I hope you’ve already started to glean a lot of important information we’re gonna go ahead and we’re gonna take a break right now we’re gonna meet again in here at 10:20 sharp and get started there are restrooms in wing 4 and wing 5 and make sure you have your passes with you so you can move freely about those wings you also can find the the USDA cafeteria in wing 3-3 but please note that food and drink are not allowed here in the Jefferson auditorium so let’s let’s meet again at 10:20 yeah if everyone could go ahead and take their seats we’ll go ahead and get

started momentarily

it’s a monster

he’s dancing

alright let’s go ahead and get started with our next session if everyone could please take their seats so thanks for coming back so we’re gonna go ahead and get started with Session two we’re going to talk about potential hazards for cell culture technology products derived from livestock and poultry our first speaker today is dr Emilio Esteban chief scientist in the office of public health science here at FSIS Emilio well good morning again hopefully you had a lot of coffee and hopefully you went to the restroom because I’m not stopping alright well thank you for coming this morning I’m just gonna spend a few minutes giving you a big picture of what we do in the last in the way of hazards and how to identify them how we deal with them so that’s a beautiful slide it’s not mine alright so if you walk away with anything today I would like for you to walk away with this five concepts of how we deal with hazards in emphasis first point and you heard this before from Phil Bronstein we have continuous on-site inspection there may be six thousand establishments but we are there every single day the food is not produced on this there’s a presence from Ephesus in that place it’s continuous inspection point want to remember point to everything we do in the agency with drafting policy taking enforcement action monitoring something everything we do is always science-based and the objective is to protect public health so science-based there’s three labs and I will control that we can work on what those three labs do in the next few slides so I’m moving on to the third bullet which is flexible we may be addressing a series of hazards but we have the flexibility and and the throughput in our labs to adjust depending of the hazards that are identified and we do those things both in the mic and micro in chemistry world and physical things so as hazards come a right as something happens in the environment where they defy something different something new we can adjust on the fly and keep going the fourth point everything we do is with full transparency and by that I mean when we’re gonna use some method we publish it online 30 days before we start using it so you know what we’re gonna test for how we’re gonna test for in case you want to do something ahead of time that works also on the other side when we actually collect the data that is also be made public as soon as possible

so it’s transparency on the inputs and on the outputs and the last point is that we have ongoing monitoring programs both for measuring trend in the environment as well as for a break response or for emergency emergency situations so these five bullets continuous inspection science let the decision-making flexible full transparency and ongoing monitoring those five things I think even you keep in mind when you’re working with hazards in Ephesus so how will preventable illness we we have this four modules if you will the first one is the we perform inspection at every plant nationwide and this includes every as you heard this morning as well includes import and domestic product the second module is taking box to the left we maximize everything that’s to do with the Mexican interests and comply with food safety policies by looking at the labeling everything has to be properly labeled and documented before we actually let it go into commerce the next one we feel that this is a team thing it’s by achieving food safety in public health because it’s a team effort we have a significant outreach effort through public education consumers so that we cover the basis not only of who’s producing it we also considered who is consuming it and and finally we collaborate with internal and external stakeholders we’re not going to do this alone our process is based on trust but we verify so we work with industry work with consumer groups we cover the whole gamut front from the farm to the fork and from the front from the people that produce the food to have people that consume the food as I said before we have on-site inspection every single day are three Laboratories and we have one in Athens Georgia one in San Luis Missouri one in Albany California we receive about a hundred thousand samples in those three labs about ninety thousand of those are microbiology the other 10,000 are for residue chemistry we actually do everything in real time so when you get into one of our labs in the morning and in the afternoon you get a FedEx truck and the whole FedEx truck is boxes of our samples coming in and so everything is barcode labeled all three labs are ISO 17025 accredit so everything is it based on high-throughput lab we monitor current and emerging foodborne trends and we have at leadership of matters that have to do with science – so can graduate proper policies again this is just a with locations of the labs the one thing I wanted to highlight from this this slide is the last bullet which is when we have a nice odor coming into one of our labs an isolate it could be a nice little could be a sample if it’s a sample we isolate something from that sample we take it all the way to the end we characterize that organism to its fullest and I will go into details as to what this means in the next few slides all right so we have six groups of potential targets that we look at like a biological chemical physical we have some emergent issues things that come up in the environment allergies and identity so we have capability and capacity in our labs to this for these six groups of potential hazards for micro like I said before about eighty thousand samples last year we have eighty-nine thousand samples came in for microbiological work we have three types of plants large small very small on the average some large plants or sample once a week the small plants a sample every other week this very small plants at least four times a year or one during production the point about that is that we actually collect samples at every plant but we’re doing our samples and this is a key concept we do samples to verify that the plants hasip is under control our samples are verification that they have subsample the hasip system is operational so their verification samples when we get an isolate from it for example that comes to one of our plants due to one of our labs we do the screening with the screen for all the pathogens that we’re looking for if we get any any pathogen out of those samples we actually do stereotype at the microbial resistance whole genome sequencing past fill electrophoresis everything is done in real time and everything is is publicly available through foyer and except for the whole genome sequencing which goes directly into NCBI and a public database like I said before is real-time and it’s full transparency on those hundred thousand samples or 89 thousand samples last year in 1718 was about the same we got about a close two hundred fifty thousand different tests a sample when it comes to the lab we don’t only test it for one target we tested for multiple targets so

example that may come in for example of ground beef can be tested for multiple things on Manila ecoli Aztecs for example we look at these four major pathogens a coli o157 and the other top six istex Campylobacter Salmonella and Listeria monocytogenes and of course we cover raw and cooked beef pork poultry egg and celery forms with Scottish this lie dedicated to just for Listeria because for the studium we consider this one of the environment environmental contaminant that we may be relevant when you look in a silly agriculture for the stereo we have sampling programs that include not only sampling the product for contamination but it includes surface sampling and environmental sampling of those establishments and we have ongoing programs that right now that we have historical data back going back for at least eight years that we know if we ever have one of those theory I so listen that plant we can trace it back to up to eight years if it’s still present in that plant so for harborage purposes i think there’s gonna be really relevant when i look at going forward to this type of production that we’re discussing here today where there may be environmental contamination this is the only life that i have to have sexual data it’s just to show you that in the graph to the away to your left the orange one you look a slightly downward trend in circum for coming near a chicken so ground ground chicken and the left both for Campylobacter and for salmonella the venus load downward and the one on the right the same thing but but for beef and beef trim for ground for for Salmonella one point that is not present but I would like to highlight is this as we go through the years 14 15 16 and you can see that that one trend consider the fact that not only is it trend going down but the fact is that we’re doing getting better at finding these organisms so even though they would be a much better finding them it’s still going down which is a good thing for industry and for us to know is actually being protective of Public Health lower contamination rates even is even even though we’re looking at it with more detail alright so the second group of hair sort of what we’re looking at is chemical hazards and so we emphasize does not set standards we enforce the standards that are set by FDA for veterinary drugs every sample that comes into the lab again we have a scheduled sampling program for 6,000 7,000 samples gets tested for up to 200 different compounds 90 of which come from a single method that’s called the mounted multi multi residue method it tells for antibiotics antifungals until mentok synthetic drugs beta agonist and inflammatory and tranquilizer drugs so a single sample could be tested for all those targets at the same time we have 6,000 of those and I can said before everything is done in real time we don’t store them or accumulate them when they come in there the test started that same day our labs operate seven days a week four cups of pesticides again we don’t set the standards we just enforce the standards and the tolerance that are set by EPA and again for this one we have a single method that in this case I have as I stated there it takes about 108 pesticides the current version is going to be detecting a lot more than that and the pesticides can include everything from the classical persistent organic pollutants like DDT to the ones that are more commonly used today like chlorpyrifos the beauty of both methods that I described the mrm and in this PST method the pesticide method is that they’re very flexible we can add or pull compounds every year earth needed and we have a very tight ongoing collaboration with FDA and EPA for we discuss we meet once a year and discuss what are the compounds are relevant that we should be monitoring for the following year so again flexibility and transparency two other features that we have an assistant we work with our partners to decide what are the things that are really relevant for the environment and for the substrate worth testing and then test only for those things when it comes to pathology or inspectors that every plant do an ante mortem a post-mortem inspection of the animals so when there is so I’ve classified these potential pathology issues as both food safety conditions and non food safety conditions so the animal itself the whole carcass will be condemned if it’s unfit to be presented for first a lot of simply we do not let its law and condemn the whole carcass on occasion for some type of illnesses based on pathology results we can only condemn parts of it so some of the meat is not if it’s not a food safety issue it can be passed for consumption in parts of it that they’re

not appropriate or condemned and of course the other thing that we can find in pathology is foreign objects you know there’s a whole I could tell you stories about the things that we could find sometimes in food that is weird mostly it like little pieces of plastic or metal that that I pass through that our pathology team is really good at finding all those foreign objects and and again are simply our sampling is for verification purposes so another strong component that we have in addition to those three major groups we actually have a whole testing program that has to do with the quality of the wholesomeness of the of the of the food and this is include speciation which has been very useful in case for example solar reform to make sure that if they say there is selling at catfish there is in fact catfish but it also very commonly useful for the for example when somebody’s claiming that you have a pork sausage you want to make sure that it is actually pork and not not pork blended with chicken or something else so we have a set of systems and methods that allows for speciation for differentiation of two to assure people that the label claim is correct in addition to that we have some components of nutritional components that we look for to put include the water content the protein sodium fat and most recently we’ve developing a method that was transferred to us by FDA to address the top eight allergens so we will probably start using this in the near future just three quick bullet points here on special focus that could be addressed with the cellular agriculture we’re looking at today so culture method usually use antibiotics and growth modulators so we probably have to flex it flex our systems to address those things some contaminants of mycoplasma the weight ratios don’t look for we may have to adjust to create methods to look for those things and someone differentiate itself is could resemble cancer and could cut this is an immune compromise people so as we move forward to with cellular agriculture what I’m trying to say here is that we will adjust to whatever the hazards that are identified and finally I just want to close with this one slide by saying that nobody can do this alone and if this is in my 20 whatever many years career here I’ve noticed we work very good with federal partners with states with with tribal authorities with all the stakeholders we have meetings here with the stakeholders pretty much every every month and we don’t do this on a vacuum we work OCC FDA Department of Defense whoever it’s appropriate that we need to build with we work with so it’s a team effort in order to accomplish our mission we cannot try to do it by ourselves and we’re much stronger by doing it with everybody else so with that I’ll close thank you I’d like to welcome again dr Jeremiah Fasano to talk to us about the overview of potential cell culture technology hazards including summary of hazards discussed at the FDA Science Board meeting yesterday dr. Cesana thank you so dr. Esteban has just walked you some of the hazards associated with traditional meat and poultry production for which FSIS has decades of experience in thinking about how to manage these risks control them appropriately I’m going to talk to you a little bit today about something that we all know a lot less about which is the potential hazards associated with this new method of food production and also summarize some some things that we heard yesterday at the FDA science board meeting which might be of interest so the science Advisory Board is an is an interesting body they contains folks with expertise a broad variety of areas that are relevant to to FDA’s mission from nutritionists and surgeons to pharmacologists epidemiologists there there’s a lot of different kinds of expertise and I want to take a moment to just express my appreciation on behalf of everybody who was involved yesterday for the the board’s interest and engagement with this topic we heard a lot of interesting stuff from them that I’ll cover in a minute so in thinking about potential hazards associated with this production process we tried to cast a very broad net we developed six questions in consultation with USDA that were meant to be useful as sort of starting points for analysis for anybody thinking about cell cultured food from any any source right so any species going through this process what are some things that might be useful to consider as a sort of points of analysis or departure and so first I’m going to walk you through those questions that we shared with the board and then I’m going to cover a few key themes that after

some reflection last night seemed to me to emerge from that from that discussion there’s certainly many things that the board covered and I’m not going to mention all of them today okay my slides don’t seem to be up here so I’ll just cover from memory what I can recall the questions that we presented to the board so the first question first group of questions is really about adventitious agents we were interested both in the potential for contamination in the seed materials and the raw materials going into the culture process so whether it’s the sort of animal cells themselves or other materials that go into the culture medium as you know right now many of those are derived from from animal sources like fetal calf serum so those as potential sources of contamination and then we are also interested in the potential for contamination during the culture process as in the in the earlier talk where you saw some of these sort of mechanics of how this process works we expect there to be potentially multiple passages from one culture vessel to another you know there could be contamination as sort of the start of the culture process or during one of those passages and so we’re interested in hearing from the board their thoughts on the significance of those risks and what may be sort of appropriate ways to frame those risks the next sort of group of two questions is really about substances that are added during the culturing process so first there’s the culture medium the leads all these sort of materials and signaling molecules the cells need to grow and then differentiate into appropriate cell types those are all things that need to be added and then in addition to that you also need structural elements from any of you cells in order for them to to sort of remain viable and differentiate properly and so that’s something else that’s introduced both potentially into the culture medium but then also possibly into the biological material that’s harvested particularly if you have complex structures you’re going to need some kind of scaffolding material and so we’re interested in the board’s thoughts on what sort of safety assessment considerations you might need for those materials and then the final sort of group of two Spence was about cellular properties and there’s two aspects to this we certainly know from our experience in culturing other kinds of cells that if cells are stressed or if the culture process is not optimal they can produce undesirable secondary metabolites or other substances that you don’t really want in the food and certainly their methods to control that but we’re interested in the board’s perspective on whether that was a concern for animal cell culture and if so what kinds of cells might there be or what kind of substances might they be and then finally we were interested in other cellular properties these cells they’re obviously you know being used to generate a food what are the nutritional characteristics of food we might expect from that how would they compare to traditionally produced food products are there any other properties and non nutritional ones that might be material are worth considering so those were the six questions that we put to the board and they had a very broad and far ranging discussion as I said I think we didn’t get a lot of answers from this discussion but honestly I don’t think that we were expecting to these products really aren’t on the market yet there’s not a lot of specific experience with implementation there’s not a lot of concrete data that we had to offer the board and so this was really more in the nature of sort of a theoretical analysis or a preliminary analysis of the kinds of things that might be worth considering and so I feel that we did come away with a lot of interesting avenues to pursue and I’m just going to cover a few broad themes now the four that really jumped out to me were challenges of scale the appropriate reference or comparators for risk assessment for these products the role of exposure assessment in thinking about safety considerations for these products and the challenges of designing effective preventive controls for this production process so I’ll cover each of those in a little more detail I think the single word that we heard more than any other yesterday was scale people were very focused on the challenges of bringing this technology from the bench top to clinical settings to industrial settings where you are looking at potentially multiple orders of magnitude in terms of scale for the production process and while there’s a lot of experience with managing biologic production process in the therapeutic side production scale is going to be a lot bigger than that it’s going to have to be for these things to be a meaningful part of the food supply so there may need to be some learning-by-doing you may need to actually start ramping the stuff up at scale to learn some of the things you need to learn and you know you may need some new technologies to manage things at scale if the problem you know sir challenges or technical

issues may emerge at a that are not present in sort of a benchtop or a sort of a bench side reactor that are going to be a problem when you get up to industrial scales and because there is going to probably be some learning-by-doing there may be need for strategic use of post market surveillance in order to understand as this learning is going on that were properly capturing that and integrating that back into the sort of assessment process so that’s scale as a theme and I was again it was a very prominent one another one which i think was a really key theme that jumped out at me was what are the appropriate comparators for assessment of risk safety other properties of these food products there are many that you could potentially choose in a lot of different areas and selection of the appropriate one is really going to be essential for informing a safety assessment process so there’s a number of kind of areas to think about here one is the risks of microbial er viral contamination potential references or comparators could be traditional meat poultry and seafood products and thinking about how those risks compare cultured cells and clinical applications we heard a little bit about contaminate contamination events that occur there they’re very rare but they are obviously of significance when they do occur is that an appropriate comparator what can we learn from that what’s useful and not useful and then also broadly distributed food pathogens that are present in a wide variety of food products things like Listeria what to what extent is that useful as sort of a touchstone for comparison or thinking about microbial sort of risk assessment in these products so that’s one area another one is nutritional characteristics you could you could think of a couple of different ways and a couple of different sort of perspectives were discussed here as well if you’re sort of looking at a target food that you’re trying to match that is one sort of analytical framework for thinking about the nutritional properties of a food there could be certain kind of essential characteristic properties of a food that any sort of cell cultured food might be expected to have and in order to sort of be appropriate for that food category you could also think of it as sort of a design nutritional properties without reference to a particular food so those are all potential points of reference when you’re thinking about nutrition and that was another area that the board discussed with respect to the safety of media and and structural components there was a number of potential reference considered there as well the the point was brought up that many of these substances are things to which we have already had exposure a number of the structural materials that were discussed were common biological materials like cellulose structure material in plants collagen which is a structural material animals chitin things like that that you know are already we’re already exposed to it through food consumption for a lot of the media components I mean if you’re thinking about this essentially you’re trying to recapitulate the environment of the interior of an animal so many animal products that we already eat you have some history of exposure to many substances are going to be similar to those in culture medium whether it is derived from an animal or as it’s likely to be the case in a sort of commercial production of these foods from from an animal free medium and then finally there was sort of this idea about considering the components whether they be in the media and the structural elements in isolation as opposed to in the context of an actual oral exposure and I think I’ll just remind you at this point of something I brought up a little bit earlier we think about safety assessment for food ingredients we’re always thinking about an intended use we don’t consider the substance in a vacuum but we think instead about what is the intended use what is the estimated exposure that all informed safety assessment that was something that kind of was brought up here as well and then the final area is thinking about sort of risk assessment with respect to cell properties what again are essential sort of touchstones thinking about is cultured cells that are used in therapeutic applications where there you get exposure via a non oral route whether it’s systemic or parenteral exposure versus sort of oral exposure of the cooked cells is that a good way to think about it can you think about sort of the characteristics of cell exposure from traditionally produced meat poultry and seafood those are all potential points of reference when you’re thinking about the properties of these cells I’m almost done I promise the – two more themes I’ll quickly cover the first one was just exposure as a sort of a theme thinking about on the one hand the exposure to sort of a biologic or therapeutic product versus the exposure to things that are in food where people eat multiple times a day consumption is is enormous ly broad and so even rare food safety events have a large significance and really the emphasis on the importance of making sure that those events are as rare as possible given how widely we consume food there was this idea of exposure when you’re considering an acute contamination process microbial one versus sort of chronic exposure to the

ingredients that are used in making these foods which lead sort of into a discussion of how the food ingredients safety process food ingredient safety assessment process addresses these kinds of issues of chronic exposure which is something that you know we routinely consider and then finally another theme in terms of exposure was the importance of using that as sort of an opening step in in sort of thinking about food safety assessment for substance again the consumption doesn’t occur in a vacuum that you you have you have tools to actually think about what kind of exposure people actually getting and then do your safety analysis from there and then the final theme was just the challenge of designing effective preventive controls given how new this area is I was discussion about our extending of microbial understanding of microbial contamination in therapeutic context and what hazards are reasonably foreseeable based on that experience some discussion about the value and effectiveness of testing at different points during the production process you’ve already heard here from multiple speakers about you know what testing is useful for and what other things need to be in place to make that effective and then different kinds of contamination failures in clinical experience I mean many it it appears that many of the contamination failures that you see in clinical experience because the culture medium is so effective at growing microorganisms the cultures fail before you can even complete the production process and so there’s the sort of visible contamination failures versus sort of silent contamination failures and the essential importance of making sure that your system is capable of catching particularly the second kind and then the final thing that came up in this idea of preventive controls and sort of effective risk management programs was the idea that there is a lot of existing guidance at there and best practices from the biologics world when thinking about cell culture and it might be useful to take that as a point of departure and then as we gather more information gradually modify or adopt practices based on the actual risks that were gaining insight into from our experience so that’s just a quick overview of some of the stuff that was covered again I’d like to express my appreciation to the board for all of their they spent five hours listening to presentations from us from the public and really grappling with these questions and it was extremely interesting and I think useful exercise thank you thank you dr. Fasano so I just wanted to take a moment to introduce myself and Kari Barrett to you my name is Selena Kramer I’m the team lead and congressional in public affairs at FS is Kari Barrett she is the advisor for strategic communications and public engagement in the office of foods and veterinary medicine and we’re moderators today so Carrie’s gonna go ahead and take over this next session on open public comment on potential hazards and if we could have our Usher’s come forward thank you all right well thank you Selina and so we’ve come to the point in our agenda where we’re really turning the mics over to you essentially and I’m glad I see these maybe folks helping in the process but what we’ve done with this agenda is we have built in and designed into the format multiple opportunities for the audience to provide comments on different subject areas and so we’re starting now with the session that’s focused on potential hazards I believe the questions are behind me what our hope is is that you’ll consider the session to be somewhat like a breakout session or an open mic where you can come up to either microphone and offer some of your comment perspective or line of inquiry thought on this topic and it’s to benefit really everybody in the room as well as the agencies we there is a transcript of this meeting so we’ll be looking carefully at everyone’s comments but hopefully all of you will also be submitting public comment so this may be an opportunity to hear some new ideas and offer food for thought so with that the process is if you would like to make a comment and I want to pause on that because there are the the term comment comes up quite a bit in the agenda this is really meant to be a pretty open opportunity you don’t have to have a script you can come up and just make a remark you don’t have to speak for three minutes but that is the maximum time that we have per speaker so that we can hear a lot of perspectives but if you would like if you have come today with prepared

statement that you were going to offer later in the formal public comment and you want to use this time to talk about the potential hazards you can do that if you want to elaborate a little bit more in this area where you may not have time to do that this afternoon please feel free to do that okay so it’s really an opportunity to share some some good thinking and I want to encourage everybody to participate in this process we do have folks up front who can help just direct you to the microphone so please let’s go ahead and begin if there’s anyone who would like to offer some comment you’re welcome to come up and we just ask that you come to the microphone you gave and you give your name and affiliation so come on down okay yep come on up again if you’ll say your name and organization hi my name is Tomas crema and I’m the director of the Food Policy Institute a Consumer Federation of America I think there’s a great questions I want to thank FDA and USDA for having this meeting I briefly wanted to remark that that asking these questions now seems like a very good idea to both to help consumers protect consumers from from dangers that might be associated with these products but hopefully to move the food inspection system to a more risk-based approach that something we heard a lot this morning and as I was thinking about these questions when the agenda came out we we work a lot with FSIS and trying to improve meat and poultry inspection for for consumers and microbial contamination seems to be the big the big factor there you know I’ve got some statistics CDC estimates that mean poultry cost 22 percent of foodborne illness and 29 percent of the deaths from foodborne illness and the sources of that of that microbial contamination can fall into two categories you know in a way you can probably categories it different ways but things that in fact that the animals on the farm and transport one not and things that infect the meat and the slaughterhouse and the factories and and I wanted to underscore like a risk-based system really should be doing more on the farm and that’s you know I know that’s a little bit for our field of what we’re talking about today but but we could really be protecting a lot more consumers going to the farm making sure there’s not Salmonella in the feed or getting transmitted from the breeders with with cultured meat it seems like like the hazards may be very different and I think it’s it’s still very ambiguous what what the big threats are going to be and I think a pre market approval process is going to be very important to kind of inform the inspection system and and later you know we’ll talk more about that and and we’ll have a lot more to say about the grass system and some of what’s been said today and that’s that’s for now I think that’s great well thanks for starting us off additional comments perspectives again I feel just say your name and organization I gotta say I’m surprised there’s not more of a line in this room it’s a packed house so my name is Sarah saucier I’m from Center for Science in the Public Interest we’re also a consumer group and I got to say I think one of the reasons there might not be so comments is that it’s been a very wonderful and thorough set of presentations talking about the risks in particular I appreciated that the agencies are considering that you know compounds that we may have and traditionally in the food supply you know when they’re considered for a new use like this one they have to you have to look at that safety assessment again you have to look at exposure you have to look at whether the conditions change the safety so I appreciated that I’d say that thing I wanted to add was it’s really maybe not so much a risk of this product but a potential benefit which is

that as Thomas was nicely pointed out with traditional meat we don’t have a zero tolerance standard for pathogens and that product can be sold with contamination with Salmonella and other foodborne illness you know this product these could be sold cooked ready-to-eat they could be sold raw and I think we should consider that consumers may have a different understanding of these products I’m in part because of the potential that they have and they’re already being touted as clean meat as pathogen free and that could mean that they end up being consumed raw more frequently than traditional meat people are always pretty grossed out when I introduced this idea but we do have meat that’s consumer we have steak tartare we have sushi and you know consumers may decide to use these products in novel ways or not keep them separated when they’re preparing salads and so it’s really important that the product live up to that expectation and have a zero tolerance standard which ever regulatory structure is put in place for it great thank you Sarah some more comments perspective I think our earlier speakers to do a very good job and laying a lot of the Sabbat you may have some additional comments to add to that thank you and again if you’ll say your name and organization Barbara kowalczyk the Ohio State University I think I wanted to just add to the aspects of the safety of these products that should be considered I think as was discussed and presented earlier a lot of the microbiological pathogens that are found traditionally in meat and poultry plant radition meat and poultry products are likely to be found in these products because of the way they’re grown but when it comes to traditional and I don’t know the answer to this so this is something that the agencies need to consider in traditional meat and poultry products intact cuts of meat the pathogens sit on the surface and so the it’s well recognized that an intact cut of meat needs to be handled differently than a non intact cut of meat and so in producing these products which should they be would they be considered an intact or non intact and how do we communicate that to follow up on Sarah’s point how do we communicate that risk to consumers because non intact cuts of meat need our pieces of meat and poultry products need to be cooked thoroughly in order to fully kill all pathogens whereas intact meat and poultry products they can be cooked because most pathogens sit on the surface so that’s an aspect that I haven’t heard come up yet but I think should be considered great thank you another comment thank said if you’ll say your name and organization hi my name is shir Isaiah from the UK Louisville University and so I’ve got interests in cell therapy and represent the International Society for cell therapy so there’s two topics I think will be covered perhaps later on which I’m quite interested by hearing about so one is raw materials that’s obviously a huge factor in traditional cell therapeutics where the suppliers aren’t really aware of the GMP regulations and some of the products that would produce perhaps two cell therapy locations weren’t particularly adir into those regulations or qualifications so some issues around know fps and the gqm qualification and the second thing is around facilities so where would these poets be produced and again that’s been quite an interesting thing I’ve looked at during my PhD which is been around how those facilities were built within hospitals produce cell therapy how would they be produced it posed for the food application whether it be where would they be produced and also what talent will be required to actually produce these materials what training will they need and sort of the capacity required for them great thank you thanks for coming up some more perspectives again if you yes thank you and if you have again if this was something you’re gonna speak to in your prepared remarks and there’s you want to go ahead and cover that ground and in this session and shorten her remarks for later you’re welcome to to have that kind of an approach as well rosemary verse Tegan International serum Industry Association just like to pick up on a couple of things that have been said I think there’s a tremendous amount that we can learn in this area from the biotherapeutics world I think there are major advances that have been made in terms of control in terms of management of systems in that area cell therapy is very new and is still happening very

much on the research side and I think it will obviously develop and is developing into a more mature science but there’s an awful lot that’s out there already to learn so I would strongly encourage that continuation of discussion thank you additional comments if you’ll repeat your name and organization léa léa Stitz Center for Food Safety and applied nutrition FDA one comment that I meant to make in my presentation today but failed to do so which I was just reminded of by someone else’s comment is this that these processes these phases as I discuss them this morning could all be endpoints for another you know so the procurement and qualification of cells could be an endpoint and then that product be sold to someone else the process can go all the way through by one manufacturer or it could be done in segments and one of the key hazards areas for hazards that needs to be considered is the transportation of these end products from a supplier to to the buyer thank you great thanks Lea for coming up okay I’m gonna offer I’m gonna make it another deal with you since not everybody’s warmed up yet if you are offering public comment later this afternoon at the end of the day when you may not have as much energy and you’d like to take some time now to give that public formal comment to read your statement if you’re in the first categories I have to look and make sure I say that 1a or 1b if you’d like to take this time to go ahead and do that you are welcome to come up you’re also the mics remain completely open for anyone else to make a comment just as well I’m Danny beer with the US Cattlemen’s Association I have a question about the end end product or by-product is there anything at the end of this process with these products that we end up with and and who regulates that thank you and on those kinds of questions really this is a open public comment process and so we hope that folks will provide us with their thoughts on that very important question when they submit their written comments to the docket I am giving a comment later but this is not that comment okay my name is Isha I’m with new harvest which is a non profit organization that has been funding research in this space for since 2004 actually and I think the hazards that are the same between traditional meat products and those from cell culture technology are quite to me it’s quite obvious that they’re questions of contamination whether viral bacterial or fungal but we already have quite a bit of expertise when it comes to understanding contamination and controlling for it I think something that’s missing from this conversation are the hazards of traditional meat production that are externalized and actually don’t come from the product directly and those are things like viral epidemics and antibiotic resistance which do not generally come into the discussion of regulation but I think should be factored into understanding how important it is to advance these new technologies I think one of the reasons why there are so few comments is because of something that came up in the science board meeting yesterday which is that there are pockets of expertise related to this field right now so there are people coming from cell based Theory cell based therapies people coming from large-scale production of cells for biomedical biologic purposes and then there are people from the meat and science of meat poultry and meat science world and we have not seen a lot of crossover between those two worlds so far and I think that’s absolutely necessary to best move these conversations forward thank you thank you so much for your comment I’m dr. Rhonda Miller I’m a professor at Texas A&M University and I represent the

American Meat Science Association and I’m going to use some of this time to wil make my comments later shorter okay so that I think is meat scientists we know that the chemical physical and microbial hazards associated with production of cultured animal tissues likely will differ due to the differences in the production system and I want to commend the speakers for doing a very good job I really liked the discussion from the FDA meeting from yesterday I think we’re all aware that there are differences in the production systems and that there’s the potential for the cross contamination during production and anybody’s worked with cell tissue culture know that even in a very sterile environment the cross contamination issues can be a real problem be very problematic and as we upscale this technology I think there’s a lot of things that we still don’t know about how to control some of those I appreciate the comment from my colleague that at harvest muscle from healthy animals are basically free of bacteria and it is through cross contamination on the exterior surface of the meat that we obtain mainly microbial hazards also we can get physical and chemical hazards but as we know most of those are microbial and the potential for cross-contamination in cell cultured tissue especially we’re growing that at in layers of cells most likely provide opportunities for the interior of the cell not to be sterile and that one of the things that I think is a huge question a lot of meat scientists minds is that we use interventions to control critical control points and to reduce hazards and meat production systems but will those interventions that are conventionally used be the same will we be able to utilize that technology what interventions do we need to to develop and as we know there’s not a lot of meat available this is all evolving we know that and we’re willing to work on that thank you great thank you very much again if you’ll say your name and affiliation sure my name is Mike Selden co-founder and CEO of pinless Foods I’m also hoping to make my comments later a little bit shorter I’m gonna try and talk on some topics that others are a bit less likely to bring up so finless foods is a company that’s developing sustainable seafood using animal cell culture technology we call this cell based fish we take a sample of cells from real fish and grow them out in order to create healthy and sustainable seafood without the presence of substances such as mercury and plastic which I believe ties into the topic that we’re on large doses of mercury have the potential to impair the development and functioning of the brain and nervous system based on current evidence carnivorous fish at the top of the food chain have the highest mercury levels because mercury is bio accumulated this means that it can rise up the food chain and it becomes concentrated at the top because of this the FDA and EPA have advised that many large fish species be consumed in limited quantities by at-risk groups such as women of childbearing age with our technology we have the potential to remove mercury as a concern entirely since mercury travels through a pathway that doesn’t play a part in our means of production the effects of plastic found in wild caught fish on the human physiology is less well studied but we believe it is still a cause for concern studies that have been done on how plastic consumed by fish can affect their physiology have been conducted with some pointing to signs of liver toxicity and pathology reduced feeding and shoaling behavior and altered metabolisms our process has no ties to the ocean other than the tiny starter culture and so the recent studies indicating that there will be more plastic than fish by weight in the ocean by 2050 aren’t of concern to people’s health through the fish they if they are eating fish produced using animal cell culture technology current wild caught fish productions tied to nature make for a less than stable supply chain time and time again it has been shown that a sizable chunk of the fish that we eat in America is mislabeled this is often because of supply chain instability using the process we are developing we hope to have a much higher level of certainty of how much fish can be produced providing increased stability and making the miss labeling of fish a thing of the past something that we feel very strongly about in the main thrust of what I’m trying to get out here is that we must in some way or form potentially with qualifiers use the correct terminology and label these cell based fish that we produce as fish tuna is tuna salmon as salmon etc an estimated seven million Americans are allergic to seafood which is about 2.3 percent of the population

if one is allergic to animal based seafood that person has a high probability I’d say almost a 100% certainty of being allergic to the seafood produced using our technology so labeling it in any other way has a large potential of creating a public health hazard for these millions of people I hope this perspective proves itself informative and look forward to continuing the conversation with all of you in forms open and beyond that thank you very much great thanks for coming up they’re folks who have built some commentary about the hazards and their formal comments you may want to provide that perspective at this time except you’ll say your name an organization thank you my name is Alex Rossi I’m with SPC met CMS we host events and facilitate investment in the cell based technology space one question I had or one thing that I was thinking in response to what mike from finland food said was that i cell culture technology allows us to have a more more control over the process which is better for contamination from consumer perspective but one concern that I have as a consumer is that if we are consuming large amounts of meat or the product from one source or one cell line is there are there any hazards with that thanks for for raising that up again something to to submit comments on as well yes another speaker hi my name is Larissa rudenko I’m a visiting scholar at the Massachusetts Institute of Technology where I’m looking at emerging technologies and their governance one of the things I think that we’ve learned from many emerging technologies used for either medicine or food is that some of the hazard and risk questions that come on early in the technologies are generally applicable across the technology as opposed to to specific processes although there is specificity of hazard and risk to a particular process and I know that yesterday Ms dotar talked a little bit about funding for some of these basic research questions and I would like to just simply raise the issue of whether or not either FDA or USDA is thinking of providing a grant or funding program for the regulatory science that goes into the across-the-board hazard or risk kinds of characterizations that would apply to this technology thank you another speaker hello my name is Paul Shapiro author of the book clean meat and I want to echo the sentiments of the previous speaker because we know that the governments of Japan and Israel are investing in this type of research and helping the startups in this space because they want to be providing the protein of the future and I think it’s incumbent on us DEA perhaps through Agricultural Research Service or maybe through other avenues who also see about fostering some of this innovation here in the United States so that we in the US can be a leader not a follower when it comes to the cellular agriculture field and to the point that mr. Selden made earlier from finless Foods I do think that it’s important to emphasize that we do call this what it is because as he noted people of allergies to various meats will also be allergic to this and it brings to mind a little bit of the ice shipping industry of old and you think about how 150 years ago we had huge blocks of ice being harvested out of lakes and shipped all over the world and when you enter the advent of industrial refrigeration you all of a sudden had a much more efficient way to produce ice just by cooling the water down right in front of you and the ice barons were livid over this technological innovation railing against what they called artificial ice saying it might not be safe that the ammonia in the coolant might leak out and harm you you fast forward to today and virtually all of us have artificial ice makers in our homes we call them freezers and we don’t think there’s anything unnatural about them at all and we call it ice even though it is not made by Nature it’s made by a human invention a very sophisticated technology that we call refrigeration we don’t think there’s anything unnatural and we call it just ice because that’s exactly what it is and I think similarly with cellular agriculture we have a chance now to produce what for millennia was only produced in nature and now we can produce through a very efficient and safe way of growing meat from animal cells ourselves I personally have eaten this kind of meat about half a dozen times now I felt great after doing it I still feel great today and I think that it should be one of the points of discussion as this very admirable public meeting goes by which

I’m very grateful to both USDA and FDA for holding that the naming of this product is something that we ought to consider because we see that debate happening elsewhere whether it’s in plant-based milks and cheeses and other types of debates that FDA is considering right now as we speak and so why not get that discussion started as well on cellular agriculture produced meats thank you great thank you for your your comments and we will be talking tomorrow quite a bit about labeling and and claims with these products yes if you’ll say your name on our conversation sure my name is Jack Bobo I’m with in tracks on and I want to pick up a little bit on what Paul just said about what’s going on globally and the opportunity for the United States to be a leader but I also think that it requires countries to come together and determine what the appropriate comparator is for this and that could be work done through oacd or some other body and the the question I think is not necessarily obvious because is the comparator this exact breed of animal from which the cells are taken or is it the comparator all of beef for a beep product and so I think deciding how that’s going to work and I think there are some examples of how maize and other products are used in the OEC database to determine the comparator for genetically engineered crops and other things just finally on the point of naming I think that it’s a really important point I also think though that how the information is communicated to the public is separate from the question of whether or not it’s meat because some consumers may be interested in knowing about this if there are differences whether those are benefits or risks I think that needs to be communicated so that the public is aware of it now that could be done through government engagement or it could be something that industry itself comes together to to figure out but I think that both what it’s called but also how you communicate the fact that it may be produced in a different way is also important Thanks yes thank you for coming up more comments perspectives around potential hazards we’ll also open it up more broadly if there is someone again who is giving a formal public comment this afternoon and you’re in a category one a 1 B 1 C or one D and you want to go ahead and offer that comment you are welcome to do that at this time as well I can up that ante and anyone who is giving formal public comment today it was scheduled to give it at the end of the day we would really you know welcome your you’re welcome to do that just please let us know if that is your intention and again I feel to say your name and organization hello Melania Brawl from the good food Institute um this was gonna be our public comment later it’s for the afternoon so I’ll go ahead and give it now the good food Institute is a non-profit think tank with 50 staff members across science and technology innovation corporate engagement and policy we’re grateful to the USDA and FDA for engaging stakeholders in robust and open dialogue about cultured meat sometimes called clean meat or cell-based me we appreciate your commitment to enabling innovation and technological advances in the food sector and ensuring the safety of the resulting food products the United States has a robust regulatory regime that is more than capable of ensuring that cultured meat is safe and truthfully labeled the regulatory path to market must assure consumer safety and confidence without imposing unnecessary or duplicative regulatory barriers to producers as the National Academy of Sciences has recommended there should be a single point of entry into the regulatory framework for the products of biotechnology to streamline the approval process for products like cultured meat it is abundantly clear that the FDA has the pre-market authority and expertise to be that point of entry a position echoed by the vast majority of companies and organizations that submitted written comments to the FDA’s docket regarding foods produced using animal cell culture technology irrespective of any other positions they held on cultured meat the FDA currently evaluates microbial algal and fungal cells generated generated by large scale culture that are used as food ingredients as well as ingredients in meat and poultry and it also manages safety issues associated with cell culture technologies in therapeutic settings as dr. David Welch and other speakers dr. day as dr. David Welch GFI’s director of science and technology and other speakers explained to the FDA Science Board yesterday the potential hazards associated with the production of foods using animal cell culture technology are not significantly different than those associated with the other forms of food production and processing that the FDA already

regulates and as was discussed yesterday there are well-established controls to effectively mitigate against these hazards once pre-market safety has been established inspection and labeling requirements should ensure a truly fair and even playing field for all meat poultry and seafood producers in particular if you da exercises regulatory authority over cultured meat and poultry products it should apply basic principles of fairness equally to cultured and conventional meat producers cultured meat is expected to be identical to conventionally produce meat in its basic nature composition and all other essential characteristics and producers should be able to use meat and poultry related terms on their labels any additional labeling requirements including statements of identity information about production methods and species origins of meat should apply equally to both conventional and cultured meat produce products to ensure consumer confidence and to avoid present prejudicial requirements that could disadvantaged producers as Secretary Purdue astutely observed to reporters earlier this month quote we don’t want this new technology to feel like they’ve got to go offshore outside the United States to get a fair regulatory protocol and quote GFI agrees wholeheartedly some foreign governments have already begun investing in cultured meat companies as a means of addressing food security food safety antibiotic resistance and climate change the u.s. is currently home to some of the leading cultured meat companies and the US can and should play a leading role in bringing clean meat to the global market in a way that is safe efficient and fair that’s why it’s critically important to guarantee all producers are playing on a level playing field we’re very grateful for this opportunity to comment on the regulation of this extremely promising new technology and we look forward to continuing this dialogue thank you thank you so much for your comment and again if you are giving um what you would give us your formal comment later today so just note that I guess I was scheduled speak on one a this afternoon okay hi everybody my name is Luke Cooper house and I’m co-founder president CEO Blu Nalu a San Diego based company that is a pioneer in the emerging field of cell based seafood which we call cellular aquaculture during my 35-year career in the food industry I’ve led teams of say food safety our deregulatory policy an Operations personnel a number of food companies had been under FDA and USDA inspection I’m also certified as a trainer in hasip and a preventive controls for human foods have been educated in both food science or microbiology as a result are very familiar with the regulatory processes and inspection requirements for both the FDA and USDA published these two agencies operate quite differently both are quite consistent with their risk based methodology for assuring safety to our nation’s food supply via hasip the principles of hasip originated over fifty years ago and have been enhanced several times since then resulted in continued improvements to the food safety in our nation a dramatic reduction in illnesses and deaths as a result as the principles are mandated by USDA for facilities that produce meat and poultry and similarly mandated by FDA for facilities that produce seafood products hasit methodology has recently evolved as a result in afisma regulations and now harp see a system of hazard analysis and risk based preventive controls is in place harp C includes a list ik assessment of any food safety hazard may occur in our food supply including biological physical chemical hazards that we all know about and also those that may be naturally occurring or unintentionally or intentionally introduced into a food product these categories of potential hazards that exist in cell based meat poultry and seafood are entirely consistent with those that exists in many other food industries including meat and poultry products that are conventionally produced and these existing hacivat harp C methodologies are absolutely appropriate for cell based products our cell based food companies will produce a large stainless tanks with agitation and process controls to provide proper growing conditions in an environment that is free of environmental contaminants in fact this process is far more sanitary than what occurred from the harvesting of animals which today originated in the ocean seas farms fields in slaughterhouses the FDA USDA already had the tools and expertise in hand to effectively regulate products produced using Seiler agriculture aquaculture and these are consistent with all other products that regulate but also be quite consistent and logical for FDA to continue to serve as a sole agency with regulatory agency with regulatory authority force all based seafood products this discussion today is extraordinarily significant a slightly ler agriculture and aquaculture companies have the potential to transform the food supply of our planet a secretary produced said this morning the USDA and also the FDA are all about feeding the world the timing is critical as our planet is facing a crisis due to climate change and a host of environmental factors our supply for seafood cannot keep up a global demand we are unable to feed the world in the decades ahead in addition consumers are increasingly

concerned about the health effects of what they eat a seafood products may contain mercury toxins and other poisons pathogens viruses and parasites micro particles of plastics and a variety of other environmental contaminants consumers are also very concerned about animal welfare and the way in which fish to raised and how they are killed for human consumption yes we all need to change our ways and restore our planet we also need to create another solution and to do so quickly a production of Saul Bass seafoods meats and poultry is that solution this enormous opportunity for all of us work together thank you very much for inviting stakeholder comment as you consider the best path forward thank you for your comment good morning my name is mark top I’m with the North American Meat Institute and I have some remarks to make because you invited us up to talk about other topics I’ll feel free to do that if that’s all right first of all let me say that the Meat Institute appreciates the opportunity and the willingness of both FDA and USDA does this public meeting in my view this issue isn’t really that complex so let me be clear it’s incredibly important that USDA and FDA work collaboratively to ensure the safety of these products but primary jurisdiction regarding the regulation of cell-based meat products rests with USDA I’m an attorney I could bore you with the details citing the statutory authority support in that conclusion but I’m not going to do that today because I’ve got limited time none of it is a law say that but it’s a conclusion also based on common sense and it’s a conclusion that benefits and not only traditional meat processors cell based meat processors and most importantly consumers the meeting agenda as we’ve seen asks a series of questions and we will meet Institute we will respond to all of those questions in our written comments in detail but I have some additional questions that I think need to be asked and I think they need to be answered in a public fashion that the inspection system FSIS administers is more rigorous than one – administered by FDA is undeniable administrations have administration’s officials have said as much to me but I’m baffled frankly baffled why those who advocate that FDA should have primary jurisdiction over cell based meat products who want to deny the companies that manufacture those products the benefits of FSIS inspection and yes I’m talking about the benefits and for example why deny a cell based companies an opportunity to have their products bear the mark of inspection a mark that matters very much to consumers likewise why deny a cell based companies the benefits of explicit preemption protection provided in the meat poultry statutes that preemption protection protects companies from arguably ill-considered state requirements that are out there that recover not only labeling but how a plant operates it’s packaging its facility design amongst a variety of other considerations that same preemption provision is not found in the Food Drug and Cosmetic Act and why are we going to deny cell based not companies the benefits associated with prior label approval I know we’ll talk about labeling tomorrow but prior label approval it’s important that approval effectively precludes the frivolous plaintiffs bar litigation lawsuits that we see running rampant through our legal system the process can be cumbersome and we complain about that sometimes that’s the downside but it also benefits consumers and it benefits the regulated industry because it helps ensure product is accurately labeled and is not represented to be something that it is not FDA in contrast has no such a label assistance they will approve a program show and tell time about these products just a couple days ago on the Internet one says original sausage beer brats the other one says artisan sausage andouille they both represent themselves to be sausage and our standards of identity that FSIS has for both of these products guess what there’s no meat in either one of them I’m gonna ask by the way that these be admitted into the administrative record thank you we are a must at time here finally at a recent good food Institute conference dr. Marc Marc Marc post excuse me co-founder and Co Steve science officer Atmos a meeting said consumers top concern was so-called quote unquote clean meat is food safety and for that reason the industry should embrace regulation so why do those who oppose emphasize inspection wish to deny consumers the confidence that comes from knowing cell-based meat products a product category in its infancy are subject to deal the inspection rather than inspection once every three to five years I look forward to the answers to my questions thank you thank you for your comments besides you say your name

and organization and Bruce Stewart Brown I’m a veterinarian with Perdue farms responsible for food safety quality and live operations and you know my as I hear the part about hazards this but the hazard piece I’m wondering how big a batch is of cell culture product how big the batch can be and how many things cross over from one batch to the other and in the end I wonder how big a recall would be on a cell culture based product and to me from what I hear and how it sounds it could be huge it could be really big I would think it and and or but at the very least my only comment would be we do this process you might not know it that that every company that has a meat product typically does a huge amount of mock recalls in a given year where they take product and suggest that what if this part of it came under question how big would the recall be associated with products that might be implicated and you have a number for our kind of everything and you judge yourself how fast you could do it and the implication to the marketplace all that at the at the very least it would be fantastically interesting and perhaps important to do mock recalls on on a cell culture based product okay thank you for raising that up a good morning I am Dan Kovac staff veterinarian and director of science and technology with the National Pork Producers Council I will go ahead and give my comments I was going to make this afternoon now as they are focused primarily on one particular hazard that we America’s poor producers feel is not receiving due attention this matter and that is the source material for the cells you would like to produce these products as as mentioned this morning currently any animal presented for slaughter the United States is subject to an sand board of inspection by the food safety inspection service this is very important to ensure that the animals fit for human consumption it is also a core component of our general animal health surveillance system in the United States we’ve also heard this morning that the cell lines utilized to produce culture products have their origin either from a biopsy from a live animal or from cells that were harvested at slaughter we believe it’s essential that the same mechanisms that are currently in place for live animals be utilized to ensure that the animals that serve as the source of these products are both hit with fit excuse me fit for human consumption and do not suffer from another animal disease malady I think this is particularly important if we look at situations in terms of cell cultures particularly if they’re moving internationally that we taken a consideration animal health risks things that may not be a food safety risk and therefore subject to a food safety procedure but may again have a value animal health risk now currently the USDA is the only agency that has the expertise both to do antemortem inspection of animals and service source materials and to ensure that any product moving either interstate or internationally does not pose an animal health threat to this country therefore we feel that it’s absolutely essential that the US see I have the primary role in ensuring the safety of these products both in terms of food produced but as well as as a general component of our agricultural system thank you thank you for your comments other comments perspectives these are all some of my comments for this afternoon okay great good to say your name and organization and you’re much taller than me clearly my name is Ashley Peterson and I’m the senior vice president of scientific and regulatory affairs with the National chicken Council let me start by thanking both agencies for hosting this critically important and timely public meeting regardless of your views on the regulatory oversight of cell culture and meat products I think we can all agree that it is important that all food products whether derived from plants our animals are safe wholesome and properly labeled taken with the efficiency of traditionally derived meat and poultry production reached the recent growth of cell cultured meat products is evident that the u.s. food production companies are as secretary sonny Perdue stated continuing to feed people efficiently and effectively as these two new

technologies are being explored it is critical that they receive fair and proper regulatory oversight to ensure that consumers maintain the same level of confidence in the safety and labeling of these products of that as they have since 1906 under the feet federal Meat Inspection Act and for traditionally raised were traditionally derived red meat products and since 1957 under the poultry products expansion expection Inspection Act for traditionally derived poultry products to that end the National chicken Council believes that the following principles are essential for ensuring that cell cultured meat products are safe and are safe and properly labeled the USDA FSIS should regulate the labeling and safety of these products it is not appropriate to determine to refer to these products using terms such as clean meat nor should these products be named or described in a way that disparages conventional animal proteins these products should be named or labor labeled in a manner that clearly discloses the process by which they were made and finally claims that these products are superior to conventional animal proteins should be prohibited unless these claims can be substantiated by scientific evidence to reiterate NCC believes that is to ensure customer confidence and all meat and poultry products whether traditionally derived or cell culture NCC believes that both of these products should receive the same regulatory oversight a framework that will rely on FSIS expertise but may also draw on FDA’s experiences as well FSIS has the statutory authority relevant experience and robust regulatory framework to perform continuous oversight of daily production practices additionally FSIS has detailed process to oversee the labeling of such products in a manner that clearly discloses the process by which they were made and otherwise ensure that they are labeled in a manner that is not false or misleading likewise FDA may have additional expertise to fill a role in regulating these products FDA has long ensured that ingredients used in meat and poultry products are safe for use in food through FDA’s authority over food additives additionally FDA has experience with similar food production technologies such as microbial algal and fungal cells generated by large-scale culture and used in direct food ingredients this may lend itself for FDA to address the technical safety of the cell culturing technology used to create such products and determine whether these results whether the results of these technologies are or are not approved food additives we look forward to working with both agencies moving forward as the regulatory framework for these products is developed thank you thank you for your comments do we have others who want to give some perspective or your comments I was originally gonna make these statements section 1d but I’ll make them now okay and your name and organize my name is Alex Rossi I’m with SV CMS we host events and facilitate investment in the space and regarding labeling is a precursor to tomorrow’s agenda and for the sake of efficiency I think it’s important that we make sure that the naming does not deter consumers from these products and what these products may be really call it what you want but don’t stunt the growth growth of this technology and the many benefits that will come to both people and industry as consumers I have great faith and great trust in the American food system thanks to the USDA FDA and also the state authorities advancements in cell AG technology can really improve the food system but I think it’s important that moving forward in the industry we work with the USDA we work with the FDA we work with organizations like NCBA and North American Meat Institute and and also the companies in industry and when agencies like USDA and FDA get involved I think that’s a good thing and I think when parties in the traditional meat industry can get involved that’s a great thing great thank you for your comments are there comments okay I think looking at the time it’s 11:45 I think we could go ahead and break for lunch and please be back in the room at one a with one or 115 115 I’ll turn it over to Celina thank you yeah and just a reminder for folks to take your personal belongings with you when you head to the cafeteria the cafeteria can be found in wing three and then if you have any questions please

stop at the registration desk our staff is happy to help thank you when I got to you we’ll see you back here at 105 thank you