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General store bill format for Animal science

[Music] my title is regulatory perspectives and how composition data are to be interpreted feed all right so uh while uh we talk about other things the emphasis of my talk is on p uh and just to uh cure the a codex does not cover feed all right but it's intertwined with feed so it's very difficult to separate so essentially whatever codex has published applies to feed although the uh codex elementarius publication will say it doesn't P to Pete and the reason for that because there's a human and there's an animal part and the animal part would be what would apply the feed and there's been no uh effort in that to work on uh GMCs I thought it was good to talk about terms which we've been uh talking during the uh Workshop uh genetic engineering the process of transforming recombinate DNA technology uh transformation event transformation event means the introduction of a plant genetic material that has been manipulated in vro U and that comes from the FDA 92 policy a genetically modified or bioengineered means food derived from a plant that is developed using a transformation event uh conventional counterpart a related variety its composition or products for which there is experience of establishing safety based on common use as a food that comes from oacd documents experimental comparator conventional counterpart okay regulatory Mandate of all countries uh is to ensure the safety of all domestic and imported Foods intended for human or animal consumption composition analysis of key components is a part of safety assessments comes from codex and oacd documents food and feed regulatory process for all GM crops uh there are two types of regulatory procedures one is specific product based and that's US and Canada where we're uh most interested in what's being produced that's uh in the new plant variety and then there's the specific process base and that's the EU and I think Australia ing to Publications where they more interested in the process as well as the product both procedures require conf position data intended versus unintended changes intended changes new plant proteins increase or decrease levels of plant components pretty straightforward we've talked about that during the week or during the the workshop unattended changes increased or decreased levels of nutrients antinutrients Andor uh natural toxicants and there's some thing called other compounds that are thrown in uh that uh come up in the oacd documents uh composition is common to all regulatory safety assessments uh for intended effects the new plant proteins or newed altered metabolites or compound for unintended in facts we got nutrients at nutrients intoxicants and then the other which I didn't have listed here okay for the the purpose of this talk I'm not going to talk about the the new plant protein or the older metabolic I think these uh are all on a Case by case basis and dependent on what the the protein is the molecular U uh process and all uh this is common and I think for the purpose of this talk restricting to the unintended effects all right in that respect as Kathleen Jones had told us o CD has published crop specific consensus documents that list the key nutrients anti nutrients secondary metabolites and natural toxicat uh for other crops data on these compounds are extracted from literature because there are other varieties plant varieties other than those that are common those that are covered by OCD those that are covered by ELC database that we have to find composition data and those generally come from the literature uh for that data uh and one one of the problems going to be the methods and Hillary talked about validating methods yesterday but they that has to come from literature with some eye on how good the data is uh the US national research Council has published a scientific report on Nutri requirements of domestic animals which serves as a standard for deriving key nutrients antinutrients and natural toxins and animal feeds so in in the US and I think most how many people are familiar with the NRC a nutrient requirement publication uh those are on their website you can go uh to the NRC website and you can get those and so we use those in determining what are really important ke note unit as defined by oecd we have proximates me acids fatty acids calcium phosphorus uh key antinutrients is defined byd is adversely affect metabolism example tripon Inhibitors and sway beans uh they have those that buy minerals and make them unavailable for the feed phytic acid and corn uh cause adverse effects to the animals uh phytoestrogens and soin cause adverse health effects in animals gossip and cotton seed s genetic acid or yeah CTIC glycosides in Caba hydrogen cyanide makes it simple what are approximates moisture it's the weight loss after drying uh there's a lot of U literature and so forth about this there are General uh procedures for doing that pros and cons of that uh crude protein nitrogen by 625 is generally in the US what's used but 6.25 five is uh a general number uh it's not specific for any particular crop per se uh and it's debatable about this figure we haven't had any discussion on that here but there's other uh figures that are used uh and those you may recall with the uh episode with melanine we had to problem because they're looking at nitrogen not protein so when you mully the nitrogen 625 it give you a crude protein which means it's an estimate which mean it was a bad estimate because it was mostly non protein nitrogen which is not protein crud fats usually ether extractable Ash is remainder after combustion in a furnace at 500° celsus so there's no organic matter left fiber usually with approximate is crude fiber but we'll say that's remainder after acid treatment and drying but uh it's mainly a comparative figure now if we look at crude fiber is not meaningful except for literature comparison all right even though you will find Foods they'll give a fiber crude fiber uh and you'll find feeds they give crude fiber but it seems that it got uh ingrained in the regulatory process and it appears on the label and is not really meaningful nutritionally total dietary fiber is not digested by humans so that in human nutrition is the important thing to look at is to dietary fiber that's a detergent fiber which is cellulose plus lingan and leg is are minus indigestible to animals that's leg is indigestible then you got so acid detergent fiber is generally indigestible neutri detergent fiber has the ADF fraction plus the hemicellulose that is digestible it's supp the animal this is very important in animal nutrition in calculating diets and the energy for the diets what are the amino acids of course they the building blocks are making proteins uh you can use a Lego hat put all those little pieces together and you make a protein if you call each one of those in amino acid uh and you link them all together and you make a protein so you have in animal nutrition you have important amino acids Arginine Hine isoline lysine Lucine Meine procine fenine thine veine and copine uh in my Elementary uh nutrition courses in college you had a hill MPV how many remember that there's a few people that do uh so that's the ared his isol and so forth U they're considered essential uh for non ruminant animals uh and of course there's a difference between the ruminant and the non ruminants and the non ruminants are more like people that have simple stomachs and ruminants have four stomach compartments with uh a Rin which is a big bat for for fermenting uh the nutrient Glycine tyrosine and sirine are also important uh particularly in poultry uh most limiting Amo acids for animals are lysine with iine and thine that means in the diets of animals with the ordinary seed ingredients those are the things most likely to be limied so it limits the full growth of the animal what are fatty acids some fatty acids are essential on the diet for Animals linolic acid linolenic acid others of Interest are M lenic gamma pic and pidal Lake all right uh but if we're looking for swine diets then we're worried about having enough of these too all right so some of the other things can bury other fatty acids and they really don't don't matter a whole lot in the diet what are minerals major minerals include calcium and phosphorus magnesium pottassium and sodium tresh minerals include iron selenium maganese copper and zinc uh other than calcium and phosphorus the key minerals depend on what feed from the unmodified plant is recognized for so if you have one it's more more recognized uh for iron or selenium but there's a problem uh like with selenium the soil where the plant is grown highly influence the selenium content of the plant and that's probably the case for a lot of the minerals in animal nutrition these trace minerals are added as a routine based on the uh geographic location where the feed they're being fed and where the feed generally comes from so it's quite common to add these uh trace minerals to the diet in formulating the diet phosphorus and calcium are always important um then from the standpoint of phosphorus uh the uh anti-nutrient U citas is a very uh important U part of of the equation uh here in Maryland we we're in Virginia but next St over in Maryland on the there's a regulation that the uh swine and ptry Farmers have to add fase to the diet to release the fighting phosphorus that's tied up because of the problem of the phosphorus going into the waterways because the fighting phosphorus is not digested as the excreted by the animals and goes in to in the manure and eventually winds up in the waterways and it's causing a problem so that's why you know phosphor is important in with equation of fight fight fight for vitamins fat solu a d e and K water soluble B1 B2 B6 C poin niin and tantanic acid and again the key vitamins dependent on the feed from the unmodified what the unmodified PL is recognized for but in in animal nutrition uh it's common to add these vitamins uh with uh particularly with the romanet and with the non romanet you concerned about some of the water salable bment and they also added in di so uh in I know in human nutrition we've talked about potassium I mean vitamin K Alon Edwards could tell us more about that but we uh it it becomes important important in certain diets uh and that with the soy diets maybe that okay so putting that aside let's talk about generation of data uh so we start with experimental design as David told us that what's what we should start with is your experimental design to ensure that your study is designed to show what you think so when you line up uh Racers to a starting line you like to have them both equal to start so if there's a difference that you can find that difference and and you don't have several other factors ENT entering into the equation compounding your results we like the word compounding right okay uh the DM PL righty and it's parent now the reason you select a parent is again you only want as few differences in the comparator as you can so you'd like to have the only difference that you really want to look at is the new uh plant protein and in the transformation event so those are the only differences that you would hope would be in there so you can say that would be what the the uh fact the effect comes from in order to do several field locations are selected representing the geographic area where the bi injured plant is expected to be grown so this gives you replication and gives you more confidence in the results within a location plot lands are allocated to experiment uh usually three or more blocks containing two or more plots are formed to ensure that the treated and control plants are grown under the same condition so it's a way of petitioning out the effects uh to ensure that you're only wanting to look at the intended effect here or the effect of the uh new plant protein and the transformation event on the plant so we're narrowing down the differences that could exist as much as he can and you do that by blocking if you expect different parts of a field would have the soil would be different enough to cause a difference in in the plant so that's why you're you're putting them in blocks to narrow that uh differences down that might exist there maybe David tell did Fisher design did he designed these block designs well anyhow it comes from uh good good design okay precautions are taken to ensure no cross fertilization or other outside conditions influence the outcome so if you're GR corn you don't want genes flowing in from uh close relative or the close proximity to influence how that corn is is going to be fertilized and grown so you you eliminate all those that you can so you're only looking at what you think you are Harvest storage and processing and analyses harvest uh in other words you're going to harvest them in a way that you the you retain the Integrity of the sample all right so you want to M that maintain Integrity is very important so it's got to be harvested so you maintain that composition analysis is conducted using validated analytic methods so you got to be sampling to to maintain the Integrity all right you have to store it you have to process it to maintain the integrity and then you have to use the validated analytical methods to measure so we make sure that we take everything out of it from the standpoint of variability that we kep resulting data that is subjected to appropriate St analysis resulting in probability estimate all right now probability estimates that we talked about earlier are are just estimates no more than that uh how they're in Tred is is up to the evaluator um we we'll talk a little bit more about that sponsors commit data and information on the safety and nutritional assessments of the new plant variety this is called the biotech notification PL this is what the US FDA process is uh FDA evaluates all known hazards and for potential unattended effects on plant composition and interal property and this is aside from doing all the uh evaluation uh of the transformation event and insurance of the stability of the uh the new Gene in the plant uh and to make sure that the methods used are recognized are valid and everything else is done so this commission that comes in can be quite thick because it has all that information in it so it is a scientific document this not just a summary now somebody might read the regulations think the summary just says you know it is just an abstract but it's not it has data in it tables in it has raw data uh has fysical analysis has scientific tables and what we say in in the US is that no hanging Chads now some of you may not know what a hanging chat is but we go back to uh a political presidential election several years ago and there were in Florida they had well they were punching cards but they had laid the little hole punch on the card so they called a Chad all right so uh and they were debating whether to count those votes or not all right so we're saying do not leave that Chad hang if you bring up up a question then you have to answer the question scientifically so you just don't bring up a question and leave it hanging you have to answer it in the submission okay data presented data on each component will be assembled in a table form as I said the mean average P or F value and L arrang it you given uh and we talked about the sources of databases yesterday uh we had papers on that what the source of the databases are uh the the open literature is also a source uh and as well as we can find how valid the data in the literature is De be consistent recognized database component those must be given out a percent of dry weight and I asked a question yesterday you cannot compare oranges and apples all right so if you really want to know what's in a plant you get it down so it's on uh an equal basis uh 90% protein in a 30% moisture is not the same as that in a 10% moisture all right so you got to get it on an equal basis if you want to compare it uh you can uh fatty acids are usually given our percent of total fatty acids part of that's because the way that you that you separate out the oil and then you run your chat graphic uh procedure on fatty acid and that's generally what's acceptable to people in in the literature do it on a percent of total fatty acid and there are uh people that will make uh a case that's how uh the fat should be and you know the fat total should come from that but amuno acid they also given out percentage total protein that's given that we know how much protein is in the plant and that goes back to the nitrogen time 625 we could have a whole U seminar on what's the appropriate Factor there uh the express protein is not a critical feed consider Express protein is not a toxin or related to a known toxin or other components are not adversely affected but there is no compounds produced expressed that would require food adity with petition in the US uh say that we do not uh the law doesn't provide for pre-clearance of food and applies Falls for pre-clearance of food adity difference between a food and food ABY food is something you eat of course food ABY is something you add to food all right that's a simplest terms I can give because you go around and round in circles on some of that but if it's uh can cause a safety problem and is not known to be safe then it require a fality petition we've had one such uh petition with the npt2 uh enzy uh but ordinarily uh that's this Congress has given FDA the scientific authority to make this determination and there's been court cases to prove that FDA has this Authority so that is a difference between the US and a lot of uh Regulators is that uh the US has a scientific authority to to make these decision okay the CH nutrients anti-nutrients and natural toxin normally present and the bioengineer plan are not adversely changed so that that's what we're talking about mainly in this talk uh if we're looking at evaluate composition data the first comparison to the experimental compar comparator of significant difference phone compare recognized database range recognized database included but not limited to O USDA LC uh n wh NRC and fairw journals uh difference still exists logical scientific justification must be presented involving safety data or new safety data must be generated weight of evidence conclusion made and Lynn talked about weight of evidence conion made on acceptability of a bio inur plant variety based on all the submitted evidence valid scientific rational is acceptable to bridge data the Cici data there may be significant difference between the bioengineered plant and its comparator for some of the constituents literature Rangers can help give guide whether further assessment is needed for the plant composition is within expected range for the constituents uh results FDA consultations for fade 1995 to 212 I emphasize feed because we've had okay all right so just to wrap up we've done several consultations uh 129 uh transformation events uh with all these different um varieties and the bottom line is no differen has been found I [Applause]