USDA-FDA Joint Public Meeting, Day 1, Afternoon



okay let's go ahead and get started with session three today strategies to address potential hazards and provide appropriate regulatory oversight frameworks for cell culture technology products drive from livestock and poultry our first speaker today is dr. Phil Bronstein executive associate of regulatory operations in the office of field operations at FSIS dr. Bronstein all right thank you everybody so your I have a few slides here let's make sure I can use this that you've already seen before in my talk earlier if you were here this morning but I'm going to use them kind of just some touch points to talk on some other things about hasip so as as I as I told you briefly before there are two major steps for FSIS at regulated establishments the first one is to get a grant of inspection and during that grant of inspection we were looking for sanitation performance standards we're looking for sanitary s SOP our sanitary SOPs and we're also looking for a written asset plan and all of those things need to be in place for us to be comfortable to even give you a grant of inspection so that you can start your production the house of principles actually we had a draft of the hasit principles well actually first of all at least according to the Lord that I know of Hasek came from NASA and it was used in the space program so it was to make to make sure that that the the shuttle and the Rockets were actually able to perform their mission to the highest level of possible and get people astronauts back to from space as safely as possible and then in 1994 we published our drafts hasip a rule which which basically took the house of principles and applied them to food safety and and and we accept the public comment we made some changes final rule was in 1996 and we implemented has it more or less than our establishments by 1998 and and I will have to say that that now it's been about 20 years and I think by and large the basic hasit principles for FSIS haven't changed all that all that much we have made tweaks especially during for on some rules with a couple of extra rules that we have since developed guidance materials and other directives and notices we have kind of interpreted the hasip rules a little bit differently from time to time but I think overall I would say that the tacit principle has has done well by FSIS and I think that one of the key tenants to it is is that it takes why we do need to understand the hazards as regulatory agencies we need to be as proactive as we can that's why meetings like this are so very important is for us to try to get his head around as many hazards as possible but it puts the onus squarely on the industry to look at their own process look at any unique hazards that may be necessary and that may prop up in their own process and and then develop critical control points and critical limits so they can they can manage the hazards in their own process and so and then with with the government agency coming in to verify that those things make sense and then a validation of your has a plan I think it's a really robust system so I really think that these sorts of meetings are great because we can get what are the what are the what are the hazards out there in in this space but we don't have to be we're always going to miss something and we don't have to try to get everything on the first pass because of the openness of hasip and FISMA for that matter there the principles are the same and FISMA is that the onus really is on the industry to identify the the the issues in their own establishment so that we can mitigate them so as I said before before the grant of inspection you know we're looking for the general condition of the of the facility whether that's a slaughter facility or a processing facility we're looking for things like potable water rodent control acceptable sewage we're looking at their sanitary operations what chemicals they're using how they're using them and how are they using them safely and how are they monitoring their usage and monitoring their effectiveness in the process and that's a part of the SSO piece so that's a what's actually happening in the written SOPs and as I told you before what our inspectors are doing on a daily basis is verifying that the establishment is executing their s SOPs on a daily basis so what is pre-op look like are they conducting all their their controls at the frequencies specified and whether daily and what are the daily implementation records out there looking for any deviations looking for corrective actions when there are deviations from the establishments and then I will just quickly you know went over these before I'll quickly go over the seven main tenants of hasit the first one is conducting the hazard analysis microbiological chemical and physical hazards it's the onus on the establishments on the the owners to think about their process and understand what hazards there are and then think about what they can do where they can control these hazards and what are the appropriate parameters they need to put in place to make sure that they're at their critical control points they are looking for hazard or they are controlling these hazards and then establishing monitoring procedures because we need to make sure they're meeting those have those critical limits and then also have corrective actions like I said if there are deviations what are you gonna do now so if if you have a heating and cooling deviation which may allow for the outgrowth of bacteria or you have a the wrong formulation of a product so that you have higher levels of one chemical or one food additive is that safe and if so how are we going to mitigate any of that any of the ill effects we might see from that and then finally once again because we can't be everywhere at one point it's key to all to both FISMA and to hasip to have record-keeping and documentation procedures so we need to be able to the the regulatory agency needs to look back over through time and come back and say hey what how was this yesterday when I wasn't able to get to this process what happened over here and verify with that and then as I said the the one of the key pieces is the validation of the hasip system so we do allow establishments whether that is through a developer asset plant or an addition of a new technology process or intervention we allow them to implement in the in their establishment and then look collect data and then show us that that the that that their processed there either their new process or procedure or their hasip system in general is performing as they think it should in their written in the end they're written systems so those are the major points of hasip and that's that's basically what i was wanted to kind of reiterate to everybody and tell you prior to us discussing this further thank you and I'd like to introduce Jenny Scott she's a senior advisor in the office of food safety at SIF San and FDA Jenny thank you so this morning we've actually already covered some of the strategies to address potential hazards and the appropriate regulatory oversight framework so Phil and I are just setting the stage for the comments that we expect people to make about preventative controls and the inspection process now Phil talked about hasip and sanitation standard operating procedures as they apply to meat and poultry FDA actually has some passive and SSP regulations as well these apply specifically to juice and to seafood products but I'm going to focus more on this key regulatory framework component which we got from our FISMA the legislation that was promulgated that gave us the hazard analysis and preventative controls requirements and as indicated this morning we wrapped the preventive controls requirements into an update of our current good manufacturing practice requirements so we have this part 117 regulation with a very long title of current good manufacturing practice hazard analysis and risk based preventive controls for human foods first some of the key Good Manufacturing Practice requirements that could be applicable in this situation of sell cultured products first are GMP s require appropriate quality control operations to be employed to ensure that food is suitable for human consumption raw materials and other ingredients must be clean and suitable for processing into food and all food manufacturing processing packing and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms for allergen cross contact for contamination of food and deterioration of food and then finally individuals engaged in the manufacturing processing packing or holding a food must receive training in the principles of food hygiene and food safety now this is a very brief synthesis of something that takes up several pages in the Code of Federal Regulations turning to the hazard analysis and risk based preventive controls facilities that manufacture process pack or hold human food have to conduct a hazard analysis for known or reasonably foreseeable biological chemical and physical hazards this hazard analysis applies to the raw materials and other ingredients as well as the process so they have to determine whether or not there any hazards that are associated with anything they're using in making the food as well as in the processes that are applied to making the food and this includes determining whether or not contamination of foods with environmental pathogens is a hazard that warrants a preventive control the hazard analysis leads to the identification of those hazards that are significant enough that they have to have a preventive control applied and the firm has to implement those preventive controls which would include process controls that would be controls that they take during the processing of the food food allergen controls sanitation controls and any other needed controls as well as having a recall plan these preventive controls are applied at critical control points just as in hasip but it goes a bit beyond hasip in that there are also other controls that may be applied at places other than critical control points and those are very important for food safety and those are part of the preventive controls requirements facilities have to monitor and verify the preventive controls and take corrective actions when necessary the verification activities could include sampling and testing the food or in processed food and it could include environmental monitoring to make sure that contamination of foods with environmental pathogens is not likely to occur the preventative controls rule also requires a facility to conduct supplier verification when preventive controls are applied to raw materials or other ingredients before they're received in the facility that means the facility is not going to control those hazards they are expecting them to have been controlled in that raw material ingredient before they receive it and everything has to be documented in records that are available for FDA review and keep in mind that the hazard analysis and preventive controls requirement provisions may apply to multiple facilities along the chain so someone that manufactures a raw material or of ingredient may send it to another company that does and further manufacturing and processing and then ultimately it comes to the facility that is making the finished product using those raw materials ingredients so all along the way hazard analysis and preventive controls have been put into place FDA's regulatory framework provides the flexibility to address a broad array of food facilities and manufacturing processes keep in mind that processes that we know today were new at some time in the past for example at one time aseptic processing was new high pressure processing was new food irradiation was new the existing regulatory framework has provided for oversight to ensure the safe use of these processes and the foods that they are applied to the FDA's inspection system is also designed to be adaptable to inspect the broad array of manufacturing processing packing and holding facilities under FDA's jurisdiction thank you [Applause] Thank You Jenny so now we're gonna move into another open comment period just like we did before lunch so on this open public comment period is on addressing potential hazards and providing appropriate regulatory oversight that said we welcome any comments so um we do have a series of questions on the slide and these are a few of the questions that you'll find in the agenda as well there are a number of questions so we do have the two microphones up front here we have Usher's to guide you and as you'll see in the agenda we've designed a number of opportunities for you to make public comment so if you're giving public comment later this afternoon or tomorrow as well don't let that stop you please go up now if you have additional information to offer so with that we'll get started please come forward you'll have three minutes to make your comments and when you do come up please state your name and affiliation hi this is Sarah saucier again with Center for Science in the Public Interest I'm when we're reading off the screen here but I'll also be giving public comments this afternoon and I just wanted to focus mainly in this section on the pre-market approval aspects of this question although certainly there is a need for a hasip plan and process control and frequent inspections with these products and you know as we think about the system with what pre-market approval should look like it's really important to recognize that the final system has to be good enough not just to satisfy regulators in industry that these products are safe but also consumers and sometimes that's a different question and we see a strong analog here with genetic engineering where you had a new technology that didn't fit well into exist doing regulatory framework and consumers didn't fully understand it or trust it and what we saw with GE is that industry can believe that technology is safe and regulators can agree that the technology is safe and that doesn't necessarily translate into consumers also believing it and in order to you know that consumers have pretty roundly rejected the idea that GE technology is safe and in order to you know win them over you have to look back at where we were twenty or thirty years ago and think about what we could have done differently to win over consumers and I think a key component of that is knowing that regulators are there providing the review that consumers can trust so what what does that review look like well for one thing it should be comprehensive and mandatory we shouldn't have a sense that companies are opting in voluntarily to a process they should be required to undergo review before they market a product it should be independent the final decision about whether products can be marketed should be made by a regulator who's charged with serving the public interest and it should be transparent meaning that evidence that's used to make the approval decision is publicly available and the existing regulatory structure we have for approving new food ingredients doesn't doesn't isn't great at accomplishing this it was designed for foods that for food additives really which is distinct chemicals added to foods and it wasn't designed to Evette into our new processes and this is led to difficulty with GE difficulty with nanotechnology and that's why CSPI has long advocated for an act of Congress to create a new process that would be tailored to new technologies for approving them and one of the most problematic parts of the current system is that it allows for FDA approval actually epi a does not have to approve a new ingredient if it's generally recognized as it's safe and in fact manufacturers can make this determination internally and they only need consult with FDA on a voluntary basis this is not appropriate for a new technology because you can't have something as generally recognized as safe if it doesn't have a history of safe used or well documented published literature showing it safe and it's particularly inappropriate for cultured meat because as so this morning and I guess yesterday science board meeting there is not a scientific community that's out there that really understands these products were all scratching your heads at what they are and what their safety could be so we think the grasp process would be inappropriate and I've run out of time so I'll save the rest of my comments for this afternoon thank you for your comments our next speaker hello I'm Jessica almy I'm the director of policy for the good food Institute and as my colleague told you earlier we're a think-tank that's dedicated to a better future of food and as such we're very enthusiastic about this technology and I would respectfully disagree with some of the comments that Sarah just made despite our common background I came to GFI from the Center for Science in the Public Interest I wanted to share with you that we have a team of scientists who are closely looking at this technology and there's a wealth of information available my colleagues and I have copies of this article which was published in food technology magazine we've delighted to share with you just come up in CS kind of goes through the process for creating cultured meat the message I would share with USDA and FDA today is that no new regulations are needed as we saw this morning FDA has adequate precedents to address safety pre-market and as dr. Browns Bronstein and miss Scott just elucidated both agencies have approaches to hazard analysis and preventive controls that include record-keeping and inspection I'd like to echo Lou Cooper House's comments this morning that the existing systems for preventative control could be applied to cultured meat and I think I raised this for two reasons the first is that I want to encourage FDA and USDA to continue the dialogue with each other and with stakeholders to develop a clear regulatory path to market i've been heartened by the comments of both secretary Perdue and commissioner Gottlieb that we need a bright lines for the industry so that they know how to go through this regulatory process I would say that the first characteristic of a bright-line regulatory process is a single point of entry and I think we're starting to hear that FDA may be an appropriate single point of entry for the companies to work with as they're going through the regulatory process the other reason I raise it is that right now in Congress there's a spending bill which includes a provision that would require USDA to promulgate regulations for this industry and it's really important given the important work that's happening today and yesterday and will continue tomorrow and into the future that Congress know that no new regulations are needed the two agencies are working productively together and with stakeholders and groups that represent consumers and I would encourage FDA and USDA to let Congress know about the progress that they're making so that this unnecessary provision in the spending bill can be cut thanks for the opportunity to address FDA and USDA and the folks who are in the room on this really important issue I'm excited about the better future of food and thank you all for the part that you're playing in bringing about about thank you for your comments our next commenter hi Thomas crema and Consumer Federation of America I'd like to build on what Sarah saucier from from CSPI said in a lot of respects that as I said before I think the inspection system for for these products should be informed by a pre-market approval and a pre market safety assessment and and that assessment should be made by government regulators in a transparent process that is free of conflict of interest one candidate for for a pre-market approval programs the food added a petition prep process that we learned about earlier this this this morning dr. Fasano talked about that I also talked about the food contact surface approval process that doesn't involve rulemaking and maybe that would that would be an avenue to explore something that that could be maybe more efficient more more expeditious but not involve industry self-regulation which which is it's kind of what we have with the grass process in that that the slides there was the statement that the quantity and quality of the data supporting a grass determination and an approval by by FDA is is similar and we just don't agree with that there's a few reasons we think grass is inappropriate for cultured meat and and the first I think it's just worth reflecting on how your typical consumer might respond to the question is meat produced by in vitro cultivation of animal cells generally recognized as safe and from I don't think we can generally recognize anything about these products right now it sounds like we there really hasn't been a lot of study of any of these the products that have been the prototypes that have been made second grass the grass process kind of guarantees uncertainty because it doesn't require the companies to notify FDA and so it makes a cumulative assessment of exposure to say residues of you know growth hormones that might be in one of these products very difficult to assess and finally I'd say to grass you know it sets up an inherent conflict of interest you have the companies hiring the scientists to issue report doesn't need to be published in a peer-reviewed journal it just needs to be publicly available this analysis that says the product is safe and if you know there's data analysis that suggests the product isn't safe maybe we don't hear about that so I think my time ending and you know I just want to say reiterate what Sarah said about you know having an approval process that gives consumers confidence in these products thank you thank you if anyone else would like to come forward we have all of the staff and the scientists from FDA and USDA in the room today so we'd really like to hear what you have to say this is your opportunity to make comment and it's open to anybody right now so you didn't have to pre-register for this so please feel free to come forward and let us know what you're thinking hi I actually have a formal comment so I'll do it now my name is Michael Hanson I'm a senior scientist at consumers Union the advocacy Division of Consumer Reports there are two basic ways to produce lab-grown me one by proliferating existing muscle tissue in vitro or via a scaffold based system which involves growing cells around a specific structure that cells attach to the former system using skeletal muscle explants is not currently economically viable for a number of technical reasons such as a lack of blood / nutrients circulation in the EX plants the ladder or scalpel based system is more technologically feasible and often involves culturing suitable stem cells from various tissues so that they proliferate attached to a scalpel to then grow and differentiate into muscle cells when / fused with a culture medium in a bioreactor this method appears to be the one that is moving toward commercialization today the source of cells may pose a safety problem the primary cells stem cells satellite cells can be derived from repeated biopsies of select animals which means that a collection of animals will be needed these primary cells can also be derived from cell lines particularly ones that are immortal and can proliferate indefinitely as a team of UK scientists pointed out in a paper published this year research is needed on quote the safety of ingesting genetically modified cell lines as these lines exhibit the characteristics of a cancerous cell which includes overgrowth of cells not attribute to the original characteristics of a population of cultured primary cells and quote Visayas doesn't does not allow cancerous lesions or tumors to enter Commerce or the food chain regulators should request data on whether lab meat will contain oncogenes that are expressed and if so make a determination as to the appropriateness of consumption in order to assure the safety of lab-grown meat three things must be assured first the safety of all the chemicals and other ingredients needed to get the animal cells to grow and differentiate nutrients growth factors hormones differentiation factors off including fetal calf serum anti anti microbials and also on materials to make the bio scaffold etc should be evaluated and their use regulated perhaps as food additives or processing aids second since there is a huge potential problem from contamination of cell lines and our growth culture medium with pathogenic bacteria viruses fungi and a micro plasma cell cultures unlike living animals do not have a functioning immune system therefore there needs to be continuous monitoring of the cell lines and growth media bioreactor for these contaminants and some sort of standards established to assure safety our position is that bacteria fungi and mycoplasma that are human pathogens should be considered adulterants third there should be close oversight continuous inspection of production facilities to ensure they're operating in a safe manner how regulatory responsibility should be divvied up between FDA and USDA as an open question safety the production inputs may best be handled by FDA however for the reasons Sara and Tom have said we don't think grass is appropriate for that as as for the safety of the operation of the production facilities this may be an appropriate role for USDA FSIS who has inspectors in all the slaughter facilities during our production production of our facilities will require continuous inspection in some consumers union appreciates the opportunity to comment cultured meat products should be required to go through a pre market safety assessment and the grass process should not be used cultured cell lines and growth culture mediums should be continuously monitored for contaminants and standards set to assure safety there should be continuous inspection of production facilities to ensure that they are operating the safe manner thank you for the opportunity to comment we will submit detailed written comments to the docket thank you thank you for your comments [Applause] we have anyone else that would like to come forward today the session is open to anyone we have a number of questions in the agenda talking about if you know do you have comments on preventive controls tools what are the ways to assess these hazards we'd really welcome your your insight today no pressure if you're also making a formal public comment later this afternoon and you'd like to do that now you're welcome to come forward at any time we really set up that formal comment period and had folks pre-register so that we would we could make sure that everyone that wanted to speak had the full opportunity to do so so that's really what today and tomorrow are about we've got a number of open sessions to hear from you whether you'd like to wait for the formal comment period or come down now please come down now I'm dr. Rhonda Miller with American Meat Science Association and these will be my formal comments I was in 1b and as the American Meat Science Association is the organization that represents scientists that generate disseminate scientific information about meat science for producers consumers and regulatory agencies MSA recognized efforts in the commercialization of cultured animal tissue from cells in a liquid medium with the goal of producing meat without harvesting animals the MSA meat science lexicon which is a scientifically peer-reviewed published Journal article states that to be considered me cultured animal tissue must result in a product that is comparable and composition functionality and sensory characteristics to meat naturally derived from animals to date there's no public information or product for independent scientific evaluation to determine if cultured almal tissue project is similar in composition functionality and sensory characteristics to meat it's imperative that labeling and safety assurance systems are the same and have the same rigor regulation and oversight as for conventionally produced meat consumers need full disclosure and transparency on labeling it would be misleading and confusing to consumers if the labeling requirements were not the same safety oversight through hasip inspection food security and labeling regulations should be the same substances used in production of cultured animal tissue need to the same rigorous evaluation of approval process to become grass scaffolding materials that are food grade need to be monitored for purity and lack of hazards remaining scaffolding should be labeled cultured animal tissue should be held at safe refrigerated temperatures or frozen after the culture phase is completed there are many meat science unanswered questions concerning cultured animal tissue as production of product to date has been limited meet scientists have not been able to answer these questions but are willing to cooperate with the cultured animal tissue industry to obtain answers major questions such as how the conversion of muscle to meat when animal cultured animal tissues removed from its life supporting environment questions about color chemistry nutrient content amino acid content micronutrients protein functionality product performance microbial growth pH and variability and pH protein and water chemistry made to be answered to make sure that the resultant product performs like meat because cultured animal tissues have not been fully characterized MSA is determined that there is not enough scientific information to conclude that Coulter Tamil tissue should be called meat appropriate categorization should be determined with these food products become available for rigorous independent scientific evaluation to determine if cultured animal tissue should be called meat research by scientists is urgently needed to characterize cultured animal tissue for human consumption as this technology is commercialized there is a willingness for this cooperation between cultured animal tissue companies and AMSA members but product availability is limited MSA strongly supports the production and marketing of safe healthy and accurately labeled meat for human consumption as required by current regulations thank you for the opportunity to comment thank you for your comments our next commenter hi my name is Eric Meyer and I am the executive director of compassion over killing we are a National farm animal protection organization and we represent thousands of consumers who are extremely concerned about the welfare of billions of animals used for food every year our mission is squarely focused on the negative consequences both for people and animals of our current system of animal agriculture which is ethically economically and environmentally unsustainable and it externalizes heavy costs to be borne by all of us I want to thank the agency is for hosting this meeting and allowing me to share my comments regarding the use of cell culture technology to develop products derived from animals which is commonly referred to as clean meat compassion over killing conducts undercover investigations to give consumers a glimpse of what happens to animals on industrial factory farms and inside slaughterhouses in the past year one of our investigators worked inside a Tyson food chicken supplier in Virginia we found birds who spent their short lives crammed by the thousands into large windowless sheds we saw workers violently kicking slamming and throwing live Birds chickens were run over and crushed to death by forklifts as employees worked to round the birds up for slaughter and on top of these awful conditions many birds suffered from painful leg injuries and other deformities because they have been bred to grow rapidly large in an abnormally short period of time to yield the most meat as quickly as possible upon their arrival at the slaughter plant these animals face a gruesome death in 20 2015 we conducted an investigation inside a North Carolina chicken slaughterhouse where our investigator documented Birds being violently thrown around the facility workers forcefully slamming birds into shackles punching the birds shoving them and pushing them while they're still upside down in their shackles this is the plight of nine billion chickens every year in the United States that's nine bill living breathing suffering animals and these are not isolated incidents investigation after investigation shows similar mistreatment of animals including inside a pig slaughterhouse in Minnesota that we investigated that is participating in the USDA's high-speed slaughter pilot program that the agency is now hoping to expand nationwide we need real alternatives to the suffering we need real alternatives to the cruel and inhumane conditions forced upon billions of animals we need alternatives to artificial insemination overcrowding genetic manipulation long transport and slaughter we need an alternative to abuse endured by these animals who feel pain and fear and we need an alternative to the foodborne illnesses and the proliferation of antibiotic resistant bacteria that's common today we agree with Secretary produced sentiment that we need to embrace these new techniques and not put up the unnecessary burdens that would shut down or push offshore new technologies that we provide these alternatives to suffering whatever hurdles are between where we are now and a future that can provide a safer more sustainable and ethical alternative to the meat industry as it is now should be aided rather than hindered by regulation and I also know that the agencies are looking for comments on the labeling of clean meat this new product is made from the from real animal cells to label this product regarding anything other than what it is meat would be insincere I want to I want to urge the agencies not to subject this new industry to unnecessary regulation clean meat offers real positive alternatives to eliminate this needless suffering of animals and to provide safe food thank you thank you for your comments anyone else would you like to come forward and make comment during this open comment period we really want to hear from you today that's really what this meeting is about this is your opportunity to let us know your thoughts please go ahead good afternoon Amanda Starbuck food and water watch and these are our formal public comments thank you head work for food and water watch a national nonprofit advocacy organization we are concerned that the federal government's current regulatory framework is insufficient for overseeing the novel technologies and risks associated with cell cultured meat we urge agencies like FDA and USDA to update their existing frameworks for regulating biotechnology and other novel technologies before allowing any cell cultured products to come to market the current regulatory framework for new technologies relies on outdated tools predating the first wave of genetically engineered products this means that the vast majority of genetically engineered products in market today have been largely treated like conventionally produced foods they have not been sufficiently evaluated for safety and are not continually monitored for health and environmental impacts we are concerned that products creating created through new technologies like cell culture techniques will be treated similarly and end up on consumers dinner plates with virtually no federal oversight instead FDA should conduct its own risk assessments of each and every novel ingredient and product created using cell culture technology and continue to monitor these products once they've come to market to screen for possible adverse health effects instead of a warden grad status cell culture products should be regulated under the processes for food additives and potentially even new animal drugs which would initiate a more rigorous regulatory process similarly the USDA needs to have a system in place for inspecting the factories or sell cultured meat is being processed to ensure the safety of the products and help prevent outbreaks of foodborne illnesses the risks of cell cultured meat are not hypothetical academics that pointed out that inducing cells to proliferate makes them similar to cancer cells and we don't know whether they are safe to consume additionally the technologies require a sterile laboratory environment but often relies on antibiotic use the amount of antibiotics consumed and the question of where they end up whether as residue and end products or released into the environment deserves greater scrutiny finally these highly processed products contain novel ingredients that may pose alert allergic risks to sensitive populations the regulatory process should also incorporate reviews from other federal agencies including EPA which should investigate the risks of environmental contamination that may occur from the production and use of these new technologies we urge USDA FDA and other federal agencies like EPA to first update their existing frameworks for addressing biotechnology and other novel technologies before assessing cell cultured meat independent risk assessments transparency and engagement of the public and every step are essential components of a rigorous regulatory framework thank you for the opportunity to comment today thank you for your comments would anyone else like to come forward and make public comment today we certainly would love to hear from you even if it's a brief thirty seconds you don't have to speak for the full three minutes I know sometimes three minutes seems really hard to fill we do have some other questions in the session three agenda so if you're interested in talking about inspection types or frequency or oversight activities we'd really love to hear from you good afternoon Paul Shapiro again I know I offered a comment this morning but I offer one more which is that if we think about the some of the comments that we've heard about these sale culture products being so novel I think it is helpful to recall that there are lots of cell culture products including cell culture animal products that are already on the market if you think for example about hard cheese right now nearly all of the hard cheese that we have contains rennet that comes from genetically engineered microorganisms that produce this climb ascent the enzyme that is functional in rennet it used to be that we got all of our rennet from calf intestinal linings now about technology has allowed us to replace that in cheese with synthetic rennet and nobody seems to be that concerned about it I don't see the alarm bells going off when we think about eating cheese that has that type of cell culture biotechnology in it and I think similarly when we use a cellular agriculture to produce the very types of products like that we know that that process has been used for a long time it's also used for producing insulin for human medicine rather than using calf and pig pancreases now we synthetically produce via a cellular agriculture human and so on so I don't think it's as novel I think there are some novel aspects to it but I don't think it's as novel as we might be led to believe by by some of the commentary that we're hearing thank you thank you for your comments has anyone else interested in coming forward this afternoon and making a public comment the floor is open well I'm not going to pressure you but I'm pressuring you and I'm not seeing any takers so here's what I'm going to suggest because we are moving next into our formal public comment period and I think we should just take our break a few minutes early maybe lunch was a little too heavy for you and I hope you enjoyed the USDA Metiria so let's reconvene in 15 minutes so about five six minutes after two and we'll just bump the uh agenda up a little bit and then this afternoon we'll go into our formal public comment period okay thank you yeah folks we're gonna get started again in just another minute or two all right if we can go ahead and take seeds welcome back we are at that point now where we will begin the official formal comment period so this is a session that folks have signed up for in advance to offer their formal public comment they are limited to three minutes and again there there is a timer up front if you can be respectful of that I know you know if you're if you've just gone over three and you're wrapping up that's fine we appreciate that but but do just keep the time in mind we will run through the the categories my understanding is that people have an understanding if they're and say for example category 1a and some expectation of when where they are in the order and I also have tried to mark off some folks who have already spoken but we will begin and so what we'll ask is those individuals who are in category one a if they would like to come up and we have the two microphones so we'll just begin the process who's ever in 1a would like to kick us off and again if you'll say your name and affiliation as you begin your comments that would be great good afternoon and thank you to both USDA and FDA for the opportunity to provide comments on such an important issue my name is Bob Noble and I'm here today to speak on behalf of the Iowa Cattlemen's Association an organization that serves as the voice for Iowa's 30,000 cattle producers my wife Jane and I operate a cattle operation in Northeast Iowa where my family has raised cattle for 122 years I also have a background in meat science and beef processing which provides an important perspective for the topic we are discussing today cattle producers in Iowa across the country take their role in producing safe and nutritious beef for consumers very seriously from the past year to the processor to the plate our industry has made investments and improvements at every stage of production to ensure the highest level of integrity of the beef that we produce we want to ensure that reasonable science-based standards are the basis for the regulatory system of all meat food products regardless of how they're produced the Iowa's Cattlemen's Association stands behind the National Cattlemen's Beef Association and other groups call for USDA oversight for cell culture alternative protein products with the top priority of food safety all meat food products regardless of how they're produced should be subject to the same set of stringent physical biological and chemical standards processors of all meat food products and all establishments should be subject to continuous daily inspection current FSIS oversight already requires that meat and meat food products undergo daily continuous expense inspection and that processing plants incorporate interventions at critical control points to control any hazards that exist usda regulation accomplishes this through the concept of hazard analysis and critical control points or Hasek though the risks inhabits hazards may differ between methods of production hasip and USDA's regular regi reasonably account for these differences the Iowa Cattlemen's Association supports exclusive jurisdiction of animal cell stell cultured meat food products by USDA's Food Safety Inspection Service however we do recognize a lineal role of the Food and Drug Administration delegated in the federal Meat Inspection Act that act references the Federal Food Drug and Cosmetic Act which FDA is charged with implementing and enforcing this reference specifically comes with the definition of adulteration which describes the presence of chemicals that could constitute adulteration though the various chemicals used in production of cell cultured meat will require review determine their safety and maximum tolerances under the Federal Food Drug and Cosmetic Act the production and processing of the cell cultured meat food products will be subject to the continuous inspection Mandate of the federal Meat Inspection Act to put simply FDA's role in the regulation of these products should be limited to the review of chemicals used but the production and processing falls under the purview of USDA's FSIS to conclude we appreciate that USDA is taking a lead on this important issue as prescribed by federal law and thank you for your time an opportunity to provide comments today thank you very much for your comment do we have an additional organization one a category one a thank you on a raised mic that's a little bit again if you'll say your name and affiliation good afternoon everybody my name's Eric Scholes II and I'm the vice president of product and regulation at Memphis meets Memphis meets as a research stage cell-based meat company based in Berkeley California we hope to commercialize our cell-based meat poultry and seafood products here in the United States in the near future so base meat products are familiar meat poultry and seafood products produced ex-vivo meaning cells that would normally grow to form edible tissues in an animal are instead grown matured and harvested in a controlled production environment outside of the animal as has been discussed over the course of the day we will need to find new and more efficient ways to feed an exponentially growing global population cell based meats represent a promising way to meet those challenges as noted in our joint letter with the meat institute highlighted by secretary Purdue this morning under existing law policy and long-standing precedent both FDA and USDA have roles to play in regulating cell based meat and poultry products we look forward to continuing to work with both agencies and other stakeholders in implementing a clear predictable and risk-based regulatory framework for these products that fosters innovation while continuing to assure a safe and reliable food system without a clear predictable and timely framework this industry cannot succeed any delays in moving forward would jeopardize the u.s. standing in the world as the leader in protein production and responsible science-based food innovation we're encouraged by the joint effort between USDA and FDA and clarifying how both agencies would be involved in regulating cell based meat as has been noted by both Purdue and Commissioner Gottlieb in others today and we appreciate the opportunity to comment on these important issues the risk associated with celibate cell based meat products are well understood and can be effectively managed using existing regulatory paradigms and established controls as is the case for many foods the primary hazards involve the introduction of potential contaminants at certain process steps are due to failures in control measures these types of hazards are well endures have been already addressed in FDA in guidance and other context as the FDA speakers noted today we're confident any potential risk can be adequately controlled through material inputs aseptic and closed containment processes manufacturing controls well-established methods and include characterization and qualification of cell lines and those raw material inputs and monitoring and verification in terms of pre market safety FDA has well-established authority and expertise to evaluate the ingredients used in cell based Mead consistent with long-standing policy to this end FDA has a history of the valley new or novel foods including those made from and used in meat and poultry products and USDA has historically provided input to FDA as a part of this process given USDA's experience we believe that role should continue after pre market safety has been established the US state should regulate cell based meat products as it does all other meat and poultry products applying relevant findings from FDA's safety evaluation we recognize that the agencies will have to establish an appropriate inspection process but we have confidence that they can forge a sensible approach based on their respective areas of expertise our primary hope is that the type and frequency of inspections will be tied to the specific nature of the products themselves and that they're not be duplicative or inefficient regulation we look forward to providing more details regarding these important issues in our written comment and think the agencies again for their joint effort and clarifying the regulatory system for this important industry thank you okay thank you very much okay we'll now move on to the next category which is 1b so we have a commenter from 1b you'd like to come up great come on up all right last time was a bit too short hi thinks Jeremy back Mike Selden co-founder and CEO of finless foods company that's per days producing cell based fish I already spoke a little bit earlier and so now I'm going to attempt to say things that add more to the conversation rather than repeating myself and others one issue that was brought up today was the question of using serum an example of which is FBS fetal bovine serum fetal calf serum these are all in the same realm of things and using that in the production process I want to reaffirm as I did yesterday that finless foods will not be bringing products to market that use serum in their production only in the initial R&D process when we'll be setting up our cell lines this Muse there is a point where rnd ends for each cell line or use of serum ends entirely for that cell line and potential risks such as prions that are introduced by the use of serum can be tested for using methods already explained in existing literature after that point we will not be reintroducing serum to our process so past that point any potential vector for contamination due to agents such as prions that can be present in serum will be eliminated and there is no need to do continuous testing for them because there is a total lack of vectors for introduction serum usage in production goes against the mission of our company because using serum is both not sustainable and involves extreme animal cruelty it is also different difficult to work with due to hits high price its fluctuations in quality batch to batch and inherent properties that cause stir tank bio reactors to foam on top of that the supply is quite limited one wouldn't be able to create any sort of mass-market product that uses serum as an input because there just isn't that much serum produced on earth with Earth's current supply chain environmental issues aside in terms of labeling I'd like to again assert that we sell based food producers do need to use the terms fish and meat to reiterate if one is allergic to animal based seafood that person has a high probability I would say almost a 100% certainty that they will be allergic to the seafood produced using our technology labeling it in any other way has a large potential of creating a public health hazard for millions of people earlier was brought up that plant-based sausages sold online shouldn't be able to use the word sausage although no apparently consider on the stage for ours even though they've been removed we believe this argument totally beside the point as plant-based sausages are created using an entirely different set of ingredients and so our compositionally quite different whereas the animal cell based products we hope to produce are grown from actual animal cells we're striving to create on a cellular level the exact same fish meat that people currently eat it's simply a shift in the way by which we produce it the comment earlier comparing this to a shift in ice production from being harvested via lakes to being Harvard produced in freezers which are also a man-made invention a technology is apt and accurate this freezer based ice is slightly different in that it contains less debris than its lake based ice equivalent but both in the end used the term ice because they are effectively the same product despite being produced using a different methodology thank you so much for listening and thank you to the USDA and FDA both for convening this meeting thank you for your comments other folks who registered who are on 1b who would like to give comment okay I'm looking around we're gonna move on to one see if you are listed for the 1c timeslot and would like to give your comment does everybody know what category they're in I do have some names here let's see one see okay let me call out a few organizations and it may be that they did give comment earlier in the day and have met met that need to give comments but I had Perdue farms and I know they did speak earlier Perdue farms wanted to give additional comment okay great and again if you'll say your name thank you this is Eric Christensen I'm the chief marketing officer at Perdue farms if I was gonna get away with my colleague dr. Bruce Stewart Brown and his remarks earlier but I guess I will lodge a a formal comment so first off thank you again as everyone has stated for hosting this session it's been awesome learned a lot and very excited about it Perdue farms is a company that is about consumer choice and labeling that empowers and informs consumers and obviously today we know that consumers have two primary choices in protein that raised from a food or I'm sorry that raised from animals for food and that raised from plants that mimic some of the qualities and properties nutritional properties of the animal-based protein but contain no animal cells so this this third choices is obviously very exciting I'm excited about it but unlike the plant-based products these new cell based products might be for all intents purposes and I say might because I'm not sure bio chemically equivalent if someone can interpret what that means to meet harvested from livestock so I think that is a big body of work that has to define what does bio quit biochemically equivalent mean to the average consumer so anyway however if we are able to achieve this biochemical equivalents in the mind of consumers does it really translate to equivalent and there are plenty of studies and whatnot that suggest that consumers are needing and asking for labeling that distinguishes between what they know to be a conventionally grown food and that which is not a different alternative so we agree with that there's a report Consumer Reports is a well trusted source of information and they did a survey in June of this year that that stated that so I think at Perdue farms we're asking to support consumer choice in a couple of ways two ways particularly one that we clearly differentiate sell cultured and our meat from conventionally produced meat with language that communicates the process we also believe that we should not encroach or attempt to equivalents these artificial or cell cultured meat especially against well-known and established animal types such as chicken turkey pork beef and fish I would say artificially made chicken is not chicken those those names should probably reserved for the Creator sell cultured food from chickens I think is an interesting idea for a label that would that would be clear as to what that is or sell cultured food from fish might work too we believe these criteria are essential to giving consumers the type of information that they need to make their choices we also think that claims need to be very carefully substantiated and evaluated avoid ambiguous claims like clean that's very ambiguous and we should certainly not label these as natural given they are not naturally made against the USDA definition and I think what consumers would expect natural to be one of which is not minimally processed these clearly are are highly processed safety has been talked about extensively today and we also believe as Memphis meats that the USDA should be the primary regulatory agent and excited that FDA will lend their their expertise to help with that and that FSIS should be the inspecting body as as animal meat after all the USDA has ensured safe I like the safe wholesome and accurately labeled agriculture for decades or maybe a century whether it's growing on a farm or a ranch in a chicken house or even in a lab and additionally USDA is probably more appropriately equipped to ensure equivalency as these technologies are advanced outside of the US so in closing one comment for my friend Paul Shapiro who is a good friend water is an inanimate lifeless thing turning into ice animals are not and so we need to you know work on that analogy and in closing I am personally very excited about the future my children will be as well they are part of that and I can't wait to eat my first cell cultured product made from chicken thank you great thank you for your remarks we also had in this time category someone from Morgan State University that individuals still here I'd like to give comment go on of food resource LLC okay we'll go on to category one C so if there is anyone signed up for one C have I done this before okay nany do we have a Naomi representative who would still like to speak you've given your remarks thank you okay Texas Tech University higher stakes okay one I know is still here CSPI would you like to come up and give your formal comment so thank you thank you for this opportunity to comment and my name is Sarah Sora I'm with some represent given the formal comments for Center for Science in the Public Interest we're a food safety and nutrition consumer group located in Washington DC with 45 over 45 years of experience educating consumers about nutrition and food safety and also advocating for a healthier food system we don't take any funding from industry or grants from the federal government and we don't have a financial stake in the outcomes of outcome of today's proceedings from the consumer perspective we're facing a brave new world with a technology that was once the stuff of science fiction now becoming a reality and this new technology is arriving at a time when consumers care increasingly about where our food comes from and its impact on the environment on Public Health and on animal welfare cell based meat offers a new alternative to traditional agriculture and whether or not Americans will be interested in buying it depends in large part on the work being done by the people in this room today we appreciate all the care and thought that USDA FDA and Industry are putting into this public process it's important for the two agencies and industry to figure out what steps are needed to assure the safety of these products before they are commercially marketed but as I said earlier this process has to be sufficient not just to assure regulators and industry of the safety of these products but also consumers and we've seen with genetically engineered foods that a lack of mandatory approval combined with lack of transparency and labeling has led to a world where consumers many consumers seek to avoid GE crops in spite of a wealth of scientific evidence that they're safe to eat this has a real impact we've talked to developers who are now reverting to traditional breeding methods taking over a decade to develop products that could have been completed in one or two years with GE technology out of concerns with a negative consumer response and we think the solution is for Congress to create a new pathway for all new technology and not just cultured me but apps in this we would support FDA's use of the food additive petition process to ensure that every component that makes its way into the final product has been into vetted well FDA has authority over the pre-market approval of cell-based meet this does not preclude the USDA from carrying out ongoing inspection of cell base meat at least for the meat that's derived from animals that it already regulates and as I've noted the end product should be pathogen free because this is both feasible and it will meet consumer expectations for these products and finally while we don't think it's necessary to prohibit the use of terms like meat or fish on these products it's important that the labeling be clearly differentiate between sell cultured meat and traditional meat poultry and fish so that consumers aren't misled by what they're buying consumers have demonstrated time and again that we care what goes into our food with the right action from regulators and industry that impulse will benefit these new products and sell base meat we'll have no trouble gaining a foothold in the marketplace but if you disregard that impulse and ask us to trust an industry and not look too deeply into what we're eating you'll get a very different response from consumers so thank you for this opportunity to come in thank you very much ok well now go on to comment category 1d ok and again if you'll say your name and affiliation come on up yep and feel free to lower it if you need you can also come over to this one too hi there Halligan I'm the director of federal affairs with animal wellness action animal wellness action supports the development of cell cultured meat known as clean meat as a way to reduce animal suffering and address concerns about how to safely feed the world as the population grows we recognize that it will take time for these products to become broadly available in the marketplace and we continue to support humane sustainable agriculture currently 815 million people around the globe are malnourished as has been discussed a few times today hunger has been on the rise for the last three years and this number is expected to drastically increase as the world's population grows we must rethink the globe global food production system sell cultured meat is a logical way to address this issue it eliminates many of the negative impacts of conventional animal agriculture it circumvents the basic problem involved in raising animals for food specifically the intensive resources required such as water in space that are required to produce the food to feed the animals it also helps eliminate the negative environmental impacts of animal waste and contamination from runoff the increasing problems with antibiotic resistance which currently threatens global health and the public health risks associated with bacterial contamination and meat furthermore it eliminates the animal suffering involved in conventional factory farmed animal production the public is beginning to reject conventional agriculture as they become more aware of the cruel practices used in raising and slaughtering animals for food such as intensive confinement where mother pigs are kept in spaces that are so small they don't even have space to move around in fact voters in Arizona California Florida and Massachusetts have all voted overwhelmingly to abolish extreme confinement of farm animals the US has an opportunity to be a leader by facilitating innovation in cell culture meat there may be some industries concerned about this meat taking market share but that's the history of innovation in a free marketplace and fortunately we did not stop cell phone companies from cameras in cell phones even though traditional camera manufacturers probably weren't happy about it and as for labeling while these industries don't want to call it me we certainly should call it meat because that's exactly what it is so we would encourage USDA and FDA to favorite competition and not maintain the status quo thank you for your comments additional comments from one day CAD or yes and again please say your name and affiliation hi again my name is Asha dattara I'm executive director of new harvests new harvest is a 501c3 that supports public academic research and cellular agriculture all of our research is funded by individuals and foundations ten years ago my poultry science professor introduced me to the idea that we could grow meat from animal cell cultures and I've been intrigued and excited by this idea ever since as we've moved over generations from extensive to intensive agricultural production systems to create more food from less land it seemed obvious to me that the next step for food technology would be farming cells instead of whole animals and because this particular type of intensification removes the need for whole complex organisms I suspect that producing meat from animal cell culture rather than whole animals could result in fewer viral epidemics fewer threats to food security and fewer externalized costs to environment public health and animal welfare potential benefits aside there are clearly many unknowns about producing meat from animal cell culture technology and it is of utmost importance that the oversight hazards and controls of this technology are well understood to ensure consumer safety I've dedicated my career to this work because I believe this transformative technology is inevitable however I want to ensure that it enters society in the most responsible way possible so it's very exciting to be here today overall I believe there are already frameworks in place from food and drug manufacturing that could assess and manage many of the risks associated with this technology however these existing frameworks come from both food and drug manufacturing and there may be differences in the intended use and the route of exposure of the products evaluated by these existing frameworks and the intended use and route of exposure for a sell cultured meat further while the frameworks may cult rates are further but while the frameworks may cover several processes for cell based meat production I'm not sure they can cover all future processes given that there are so many opportunities for novel innovation in the development of cell based meat production processes the bringing together of the USDA and FDA for this conversation is thematic of what this field needs it is inherently interdisciplinary we need to bring together animal scientists and cell biologists who derive the initial cell lines we had material scientists developed scaffolds we need biochemists to develop the serum free media and we need bioprocess engineers to develop the bioreactor systems we also need meat scientists to understand how this engineered muscle tissue becomes meat one theme from yesterday's science board meeting was noting the lack of specific experience and concrete data in this space as well as a need for learning by doing the basis of good governance and good regulation is informed by evidence in peer-reviewed research federally funded research is an important part of this equation perhaps because of their novelty of this work or perhaps because it pulls from areas of science that have not crossed paths before theirs this research has not received meaningful federal support the majority for research in the production of cell based meats has come from venture capital funded companies or philanthropy funded research organizations like new harvests these funding streams have definitely brought the field to this point however for this technology to be fully safely realized not just as a product but as a new paradigm for food production we will need to see more support for academic peer-reviewed research perhaps the identification and support of research initiatives that would both equip regulators and minimize burden on innovators could be an important first step for the FDA USDA and perhaps the NIH and NSF to work together with the cell-based meat industry my organization new harvests as the primary funder of academic research in this space to date with much experience designing interdisciplinary research efforts would be a keen collaborator and resource in moving this forward thank you hey thank you good afternoon my name is Jennifer Houston I serve as president elect of the National Cattlemen's Beef Association on behalf of NCBA and our members we thank you all for hosting this very important meeting to all of our cattle producers I've been a cattleman all my life in addition my husband and I own and operate each senousy livestock center in Sweetwater Tennessee in CBA members are committed every day to producing safe healthy nutritious and affordable cattle and beef for this reason it's imperative that the Food Safety Inspection Service assert primary jurisdiction over sale cutter culture products while the chemical physical and microbial risk and hazards associated with these products will likely differ from the conventional products any product derived from livestock sales will surely be subject so similar vulnerabilities that can be effectively addressed through the FSA is oversight developing and adopting science-based control standards like hasip plans and s SOPs prevents problems before they occur simply put the FS is regulatory system is effective because food manufacturing facilities are held accountable through daily continuous inspection anti IRA culture activists sometimes argued that there isn't a slaughter process and other differences in production methods mean that FSIS lacks the authority and competency to regulate sell cultured meat products this is simply not true these assertions exhibit not only an ignorance of the law but more important on how FSIS does its job and its abilities approximately two-thirds of the FSIS plants are further processing plants and cell based plants will be treated no differently show FS is your abiding by hasit plants s SOPs and other food safety requirements necessary to ensure a safe product if s is is perfectly capable of applying its existing expertise to the production of SEL cultured meat products and is far better suited to ensure the safety of these products throughout the lab – for continuum having said that the Food and Drug Administration and USDA have a long history of collaboration and partnership in determining the appropriate boundaries of their respective regulatory authorities the pebbled Food Drug and Cosmetic Act authorizes FDA to utilize existing review processes as a template to build upon and then the case of cell based meat FDA should review the various manufacturing processes and the novel substances used in production to ensure the safety of these processes beef producers are more than willing to compete on a fair level playing field remember in this case however a level playing field is as much about safety assurance systems as it is about nomenclature insuring FSIS has jurisdiction over sell cultured products is the only rational path forward to ensure that result again thank you for allowing me to provide my comments today thank you for your comments additional folks you signed up for 1d hi Thomas crema and Consumer Federation of America Consumer Federation of America is a an association of nearly 300 consumer groups established in 1968 to advance consumer interest through research education and advocacy I have already said a lot of what I wanted to say in these formal comments today and and we'll be submitting written comments for the record but I just want to hit on a couple things that we did that weren't part of the program earlier today first I'd like to say that you know American consumers deserve safe nutritious food that is produced and in a manner that's consistent with their values whatever those values are and and I think these technologies are really exciting and respond to some really legitimate concerns out there but they also raised a lot of new concerns about safety and and how we're going to regulate them with respect to labeling we submitted comments with the Center for Science in the Public Interest on the National Cattlemen's Cattlemen's Beef Association petition to USDA which requested restrictions on on use of the terms meat and beef and in these products and in vegetable based products and the point we made in those comments that I think are worth reiterating here is that labeling like the gentleman for Purdue said it really well you know labeling should empower and inform consumers and so it should be based in evidence of what consumers understand and and what consumer confusion is out there and I have yet to see evidence of consumers going to the grocery store and mistakenly purchasing veggie burgers one day when they want to by hamburger so I think that's something to keep in mind as we as we talk about you know what how are we going to call these things and and you know I think there's some other issues that need to be clearly labeled if these products actually have some animal serum or products in them that needs to be labeled if they make a claim to be cleaner or safer that needs to be maybe defined by the regulatory agencies and and clearly labeled in a clear way so that's that's a that's it for me today thank you for for this opportunity to comment and thanks to all audience for listening to me three times today I just wanted to add I knew it's he had mentioned the Cattlemen's position petition I just wanted to clarify for everyone in the audience that that was the US Cattlemen's petition not the National Cattlemen's petition thank you at this point and if there is someone else who expected to give comment this afternoon if you'd like to come on up thank you and again your name and affiliation of course good afternoon just an old field with the California Cattlemen's Association in Sacramento California here on behalf of our member producers that produce responsible cattle and beef in the state's largest agricultural economy and the fifth largest economy in the world so certainly appreciate USDA and FDA for hosting this meeting today I'm going to be brief much of what I can say has already been said certainly want to echo the comments made by my former former presenters colleagues of mine in the livestock industry particularly those of the National Cattlemen's Beef Association food safety is an extremely important component of our business is is probably the pillar that we rest on in terms of ensuring consumer confidence the industry has invested millions to implement the proper technology to ensure fast safe and wholesome beef supply and although collaboration between USDA and FDA is absolutely necessary we firmly believe that FSIS must have the primary jurisdiction over the production of sell cultured products the use of tainted inputs production practices can ultimately lead to contaminated end products and can disrupt supply chains for not only cell culture products but for the entire beef supply as well FSIS must have a day-to-day inspection role in the future production of self cultured products and certainly our producers don't fear competition but emerging cell culture products must adhere to the same food safety standards that we do thank you very much thank you for your comments I do have three organizations that are remaining for this afternoon to get public comment to I called out before but I just want to call them out again Texas Tech University do we have a representative higher stakes and the Minnesota State Cattlemen's Association okay we are going to wrap up a little early this afternoon but before we do that two things one is if there's anyone who wanted to give any last informal comment on hazards or controls you are we could take a couple additional comments if again if it relates to hazards or controls for today as we close out today's session okay with that then I'd like to call up USDA to give closing remarks thanks Carrie and now let's give a big round of applause to my moderators today I think they did a fantastic job so thank you to Carrie and Selena and thank you to all the presenters who presented for the really robust dialogue that we had today very informative remarks and so we really appreciate all that you've done – perfect prepare for this so a couple of just quick notes before we adjourn today wing 5 will open at 7:30 a.m. tomorrow morning and we're going to start promptly at 8:30 so please be here if you're planning to attend tomorrow session and then if you need anything this evening we have a full staff out at the registration desk that can assist you with anything on your way out so thank you again have a good night [Applause]

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