Women in Agriculture 

Tape #302 - Food Safety and Farm Production

 

This is the Food Safety Farm Production Workshop.  I hope you are in the right place.  Okay.  Great.  We're going to have approximately 90 minutes to devote to this workshop.  We have two speakers who will be speaking approximately 30 minutes each.  Let me introduce myself first.  My name is Gerry Howell and I am a Nutritionist with U.S. Department of Agriculture in the Women, Infants and Children Program which really doesn't have too much to do with farming but we are helping out, moderating various sessions.  As I said, this session will run for approximately 90 minutes.  We will have time for questions and answers and discussion at the end of the session.  However, we would like to have a rather informal workshop this morning.  So feel free to have your questions answered the presenters are a minimal? to that.  We do ask that you use the microphone right in the center of the room if you have a question because all of the workshops are being taped and people will be able to purchase them, I think, near the registration desk later on in the conference.  So, we want to make sure that we get your question registered via the microphone. 

 

Okay, I think we are about ready to start.  Like I said, we do have two speakers this morning and I'll introduce both of them and they'll go ahead and give their presentation.  First, we have Dr. Bonnie Fontaine, she's the Director of Animal Production Food Safety at the Food, Safety and Inspection Service at the U.S. Department of Agriculture and this is the agency that regulates meat and poultry slaughter and egg processing plants.  Her topic is animal production food safety in the United States.  Our next presenter is Dr. Linda Tollefson and she's with the U.S. Department of Health and Human Services Food and Drug Administration and she works at the Center for Veterinary Medicine.  She will address antibiotic resistance from agriculture and the use of antibiotics.  So, we'll go ahead with our two speakers.  Thank you.

 



Thank you.  I hear you're a lively group so I would like to extend the invitation again if you have questions during the talk to please use the microphone and ask them.  We are going to be fairly informal today and hopefully that Dr. Tollefson's and my presentation will stimulate some thoughts and we also would like to hear from you.  How many people here are from a foreign country other than the United States?  Great.  I really, really encourage you to build on what we've said and share how you might be doing things back home and help us to learn about your production systems and how you address food safety.  Today, I'm going to focus my talk on livestock production and how there are certain U.S. Federal changes in our regulations of meat and poultry slaughter plants and processing plants which are going to  impact food animal producers in this country and I think throughout the world and also, then I'm going to focus on salmonella and ecoli 0157 in livestock and give those as two key examples of some of the food born pathogens that we are concerned about, and then, I'm going to discuss how women in agriculture can impact food safety positively by working with their livestock on the farm.  I do have a few hands up.  I have about 30 hand-outs and Kristen Tondra here is helping me.  So, see her afterwards if you'd like a copy of all my slides, and also, I have a hand-out on the impact of our regulations on pork producers.  So, if you are interested in pork production, the national pork producers have given us a very good brochure on the importance of quality assurance programs.  Anyway.  Okay, Kristen let's put the next slide on.  In the United States, we have many agencies that have a part and responsibility in regulating and in encouraging the voluntary adoption of food safety handling and practices and production practices.  This is a list of some of the agencies that have the key roles at the Federal level.  The Food and Drug Administration which Dr. Tollefson represents is responsible for ensuring that domestic and imported food products are safe and wholesome and are properly labeled.  They deal a lot with the veterinarian aspect of drugs and she'll go into her aspects of the Center for Veterinary Medicine.  The Food Safety and Inspection Service as I mentioned earlier, has regulatory authority over meat and poultry slaughter and processing plants and egg processing.  However, we do share with FDA the farm-to-table strategy of trying to promote good food safety practices from farm-to-table.  In the Animal Plant Health Inspection Service, they have primary responsibility over controlling animal and plant diseases and where that issue of plant and animal diseases impacts food safety, we have a nice cross-over there.  They are also encouraging producers on their quality and producing a good quality product.  The Greater Inspection Packers and Stockyards Administration ensures the quality of marketing of grains and where food safety comes in is they control aflatoxin  and have inspected corn and sorghum and rice for aflatoxin.  The Agriculture Marketing Service within the USDA has a part of the grading process.  It takes the responsibility for grading dairy, egg, fruit, meat, poultry, seafood and vegetable products, and then also, where that issue of quality and safety as far as sanitation comes into play.  They do play some role in assuring sanitary conditions.  Our Agriculture Research Service does all kinds of wonderful research in the basic sciences for food safety and quality and the Environmental Protection Agency has primary responsibility for pesticides and chemicals and helps us to keep the waters from being contaminated from feed lots.  They have the clean water responsibilities and the Centers for Disease Control and Protection which you are all familiar with has tremendous responsibility in taking a look at the impact on human health and monitoring and surveillance.  Linda, did I cover those pretty well?  Yeah.  Just a quick overview.  The importance of these last couple of years is you see all these agencies.  You wonder how in the heck do we do food safety with so many different agencies?  Well, we work together in partnerships and we really try hard to coordinate our efforts and particularly, the President's National Food Safety Initiative which you've  probably heard of is one of the most important initiatives which has enhanced the networks of communication and collaboration among all these agencies to focus on how can we reduce food-born illnesses and protect the safety of our food supply from farm-to-table.  So, there is a great effort for all of these agencies to work together through the President's Food Safety Initiative.  Ok, Kristen, next slide.

 



In ensuring meat U.S. milk and meat safety, I'd just like to go through a little history here.  Throughout the country we've had many many years of eradication of _____________ from cattle and particularly, brucellosis and microbacteria and I spelled it wrong there, but I do have it right on your hand-outs, tuberculosis.  So, for many many years we've been focusing our efforts on the control of these pathogens.  __________ pathogens.  And then of course, we've had the pasteurization and the quality milk program, particularly, for any products that are shipped interstate and the role that these Federal agencies play when products are shipped interstate.  The Federal agencies have a significant role to play in enhancing that so pasteurization has improved the safety.  So, we've had 100 years of a meat inspection system which has really focused on removing animal diseases from the supply.  So, with this focus over the years, we realize that we have to have new meat and poultry inspection regulations and they are called the Pathogen Reduction and Hassup Systems, to really address the microbial food born pathogens which are causing the food born illnesses today.  So, um, this new regulation institutes microbial control systems, as well as,  the removing of diseased animals to control the food born diseases.  And the next slide.  I'll go into a little bit about what these new regulations are in case you haven't heard of them.  This regulation was passed in 1966 and it applies to meat and poultry slaughter plants and processing plants and the part of this regulation that directly has an impact on food animal producers is the section which says that slaughter and processing plants must conduct a hazard analysis to determine chemical, physical, and microbial hazards reasonably likely to occur before, which means the live animals, during and after entry into the establishment.  So, with this new regulation to try to address microbial food born disease organisms there in residues and chemical residues, as well as, physical hazards such as needles and buckshot and other metal objects that could come into the plant with these animals.  These plants have to develop a plan of how they are going to control or eliminate or reduce these hazards from entering the food supply as they slaughter and process products from animal proteins.  So, first of all, I'm going to have the next slide and we're going to talk about residue control because that's something that you all should be familiar with on the farm as to your responsibilities to avoid illegal or what we call violative residues.  Um, these meat and poultry slaughtering plants are now responsible to assure the Federal Government and the consumers that there are no violative residues.  It's no longer a game of the Federal Government catching them.  They are according to this rule, responsible for developing systems to make sure that the incoming animals do not have these illegal residues.  So, what they need to do with their suppliers is some of them will and have already developed certain contracts with suppliers which specify what they would like to know about these animals, maybe about their treatment history perhaps, if their, what kind of things that they've been exposed to so that the plants can then determine the type of plan that they need to assure that there are no illegal residues in the products when they process those animals.  They could also say that they only want to purchase from producers who are in certified quality assurance programs and residue avoidance programs and in the United States, industry has worked very closely with government to develop guidelines, industry standards that educated their producers.  There's the National Cattleman's and Beef Association Quality Assurance Program, there's Support Quality Assurance Program, there's sheep and veal, every single major commodity has a quality assurance program.  Some of these packing plants may say that they understand that people who are educated in these quality assurance programs are more likely to sell them a safer animal.  So, they may say we are only in fact, in January of 1999, Hormel who buys for pork is only going to buy from producers who are on the pork level three quality assurance program and if you don't have your little card saying that you participate in this program, they are not going to buy your animals.  And this is all part industry taking responsibility.  People who are in these programs have records of their treated animals so we can see the plant would be able to perhaps take a look at those records or the producers at least have those records on hand to see that the animals that had been medicated.  They also encourage that these animals be identified if they've been medicated and also, all these programs encourage that the producer work with a veterinarian.  Plants may also request letters of guarantee from the suppliers and that has the impact of some very strict Federal laws when you do sign a letter of guarantee.  So, these are ... next slide.  These are some of the ways that this new regulation and to try to avoid residues um, would impact your producers if you were supplying directly to a slaughter plant.  Now, there are certain classes of animals that have had a history of residue problems and these particularly are young animals, bob veal calves which are usually a hundred to two-three hundred pounds, roaster pigs, older animals, cold dairy cows, diseased, disabled, and dying animals and those of unknown sources.  The reason I wanted to point this out is that women are so often the ones who take care of the calves and of the sick animals, so you must be very aware of the issues of food safety as far as residues and the drugs that you use and the potential as Dr. Tollefson will talk about.  Improperly using drugs that could lead to antibiotic resistance or to residue problems.  So, these are important classes of animals which may pose more of a risk and which we know, you as women, very often have a very important role working with them.  As we move onto the next slide, I'll go over some of the impacts of these food born diseases on how we do business on the farm.  There's the new USDA rule that I talked about and plus the President's Food Safety Initiative have developed important strategies to reduce food born diseases and these are the key priority pathogens.  Salmonella species is being used as a marker organism in the meat and poultry slaughter plants and processing plants.  The USDA has published for the large plants this year.  This is a level of salmonella that you must have below your product.  So, salmonella is the first species that we have used as a performance standard, as a measure of pathogen control, and in particular, there is an interest in a new organism called salmonella ______________type dt104 which also has some important antibiotic resistance issues.  And then in salmonella___________ in eggs has been very prominent in many food born outbreaks.  Ecoli 0157, ____________, lysteriamonocytogeny?, stapharia?, _____toxoplasmigondei?.  Those are the ones that um, we are really looking at as priorities to figure out ways to control from farm-to-table.  Next slide.

 


So, what about food born pathogens and animal production practices?  Well, this is a very complex problem because there are multiple sources of microbial contamination from farm-to-slaughter.  As you are aware, many of your animals don't go directly from farm to the slaughter plant.  Here in the United States, we have millions of small producers and ranchers.  There are extensive marketing systems in which an animal may sometimes be sold in California a dairy-called cow and end up being slaughtered 1,500 - 2,000 miles away and has gone through four and five markets during that time.  So, it would be kind of frustrating for you to bare a lot of responsibility on the farms for controlling pathogens and as soon as it leaves, it's gone, you know, 5,000, you know, different hands it's passed.  So, it is a very complex system, but the role of production management to the pathogen interactions really holds one of the greatest potentials that we have for reducing pathogen shedding.  There is a tremendous, a lot research going on in our country and I'm sure throughout the world on what kind of practical interventions.  Is there an oral competitive exclusion product like they've developed in poultry that the animals could consume and it could compete with the bad organisms?  Is there a way that we could develop a vaccine?  Are there different feeding?  So, a lot of basic research is going on.  But, what I'm going to focus on in the next few slides is a little bit of what we know about the characteristics of these organisms that may give us some hints as to what we could do practically, right now, to try to prevent their contamination and spread.

 

In U.S. livestock operations, I'd like to talk a little bit about salmonella.  And this data comes primarily from the U.S. Department of Agriculture, Animal and Plant Health Inspection Services surveys, national surveys that they've conducted over the, uh, since 1995.  To take a look at populations of animals and their shedding, we know that approximately five to six percent of cows are shedding and that fecal shedding is higher in dairy cows that are designated for culling.  And cows, when they're in the market system have about fifteen percent.  So, cold dairy cows, where they're ready to go, have about eighteen percent shedding overall and then when they go into the markets, they maintain at about fifteen percent.  You can find at least one cow shedding salmonella in twenty-eight percent of dairy farms.  And at least one cow shedding in sixty-seven percent of the dairy cows at markets.  So, you have, you know, individual chances on two-thirds of the farms to find or of the markets to find at least one animal shedding.  And salmonella______________ was not common; it was only about three percent, and in dairy calves of this salmonella that was cultured, about twenty-seven percent of those salmonella's cultured were of the typha_______ strain.  So, we are beginning to look at the antibiotic resistance patterns of salmonella more and more.  In cold dairy, we did a national survey.  The Food Safety Inspection Service in partnership with the universities, did 5,000 cold dairy cows at slaughter.  We sampled these across the country at winter and summer months and we looked at the good versus poor body condition scores and took cecal and colon samples.  It was a real simple hypotheses we asked.  We said, are good conditioned dairy cows that go to slaughter less likely to shed salmonella than those in poor conditions?  Because if you could sort the animals before slaughter that were potentially shedding more, you could possible reduce in-plant contamination.  Well, what we found that sorting of dairy cows at slaughter by body condition score was not a good predictor of salmonella shedding.  So, unfortunately, there wasn't a real easy tool with this study which I feel is very extensive that you could just put your hand on it at slaughter and say, okay, these are skinny cows, we'll do them at the end of the day and our plant will be cleaner.  Next slide.

 





An organism as I mentioned earlier that's growing in more and more importance throughout the world and your countries might have come into working on this one, is salmonella_______________ type dt104.  It's important because of antimicrobial resistance patterns and it's resistance to ampicillin, _________________, streptomycin, sulphur, and tetracycline, and also, there are some additional ones I'm sure.  Dr. Tollefson will you be talking a little bit about dt104?  No, not specifically.  Okay.  We have found it present in all cattle, cattle in all areas of the United States but it's a complex organism because it has this antimicrobial resistance and it's uncultured from humans, cattle, horses, goats, emus, dogs, cats, elk, mouse, coyotes, squirrel, raccoon, chipmunk and birds.  So, you know, you just can't point your finger at dairy cattle here and then all of you who live on farms think about how many times you've seen these animals,  perhaps even have emus on your farm.  But we have had human and cattle outbreaks in this country, as well as others and the direct contacts between humans and animals is very important in this as a risk factor.  And what's really bad is that because of this antibiotic resistance when you do get sick, there's not a whole lot of treatments available antibiotic-wise.  So, it can have some serious implications.  Okay.  I just gave you a little bit of overview of salmonella and what we know about it and it's presence in this country and I'd like to talk a little bit about ecoli 0157H7 in U.S. livestock.  What do we know about it?  Again, these are from the national surveys that our sister agency has conducted on farms throughout the country.  And other researchers have kind of combined some information here.  We know that the shedding of the _______ toxic form in dairy milk cows is approximately one percent.  If you were to put a number on it that's what you would put.  You could find at least one culture- positive cow in twenty-four percent of dairies.  If you went out to the dairies throughout the country, at least one would be shedding ecoli 0157 twenty-four percent of the time.  And in feed lots, and in cases, some of the people from other countries are to where we congregate young cattle in these huge feed lot areas to finish them, and you can find at least one positive in sixty-three percent of the feed lots throughout the country.  There  seems to be a higher shedding in summer months and it is also an increase in human illness during this period.  And there seems to be higher shedding in herds that are larger, greater than a hundred cattle, about forty percent, you can find at least one positive than in the smaller herds.  It seems like only about one in nine percent of the herds with the shedding.  To continue on with 0157H7, it seems that feed lot cattle on feed, when they're just there their first hundred days, they seem to shed more 0157 than those that have been on feed longer indicating that there may be a period of adjustment so that the transport, maybe being off feed or the change in feed causes an initial shedding of 0157 and we're very clear that this organism exists intermittently on a majority of U.S. cattle farms.  The word ubiquitous has been used and the frustrating part is that you can follow one cow and it can be shedding and then it won't shed and there's this intermittent, unknown why they have not, why this organism can be shedding that way.  There does not seem to be, at least we don't know of them, and if you do know, please let me know.  Any long-term reservoirs and we haven't been able to identify long-term carriers.  We have cultured this from deer, sheep, dogs, horses, flies and birds.  So, again, you have that.  Lots of potential cross-contamination.  That doesn't seem to cause irrecognizable disease in cattle although they have been able to make young calves experimentally, very sick with 0157 when they've given them huge doses of this organism and growing cattle seem to have a higher prevalence, so the younger the animal it seems the more possibility of shedding 0157.  Now the important thing that I would like to talk about is that they've cultured it from water troughs and also in waste feeds, feed that has gotten wet, as well as silage.  In a beef safety workshop in _______ recently for our Canadian friends, Jan Sargent, an Assistant Professor from Kansas State University's Food Animal Health and Management Center reported that she found ecoli 0157 in bulls, cows, calves and feral deer near pastures.  In other words, almost everywhere in the cattle-raising system, even free-flowing water, in nearby streams and creeks, ecoli 0157H7 could be found.  The simple advice to farmers to prevent spreading the bacteria was to wash off the loader bucket between cleaning and barnyard and move feed with it after it's been thoroughly cleaned.  Again, we are talking here some common sanitation practices.  Another researcher is very famous and well known in this is Dr. Dale Hancock from Washington State University.  He said that he found two places where the bacteria can multiply in feed lots in the water troughs and in wet feed such as silage.  Based on his findings, he recommended regular cleaning of the water trough to eliminate ecoli 0157 from the sludge that collects at the bottom and to feed rations containing high amounts of propionic and acidic? acids, both of which appear to inhibit the bacterial's growth.  The simple sanitation techniques described are not likely to eliminate ecoli 0157H7 completely but we believe that every little bit counts in addressing food safety.  Okay.  So that brings us into what can you do?  What can women in agriculture do to enhance food safety thinking about all the things that I've just covered?  In the area of residue prevention, remember to keep medicated animal records.  Very often the woman is the one who treats the animals and it's important to write it down, to keep a record of what you treated, how much you treated, when you treated, and it's going to be very very important for what Dr. Tollefson's going to talk about, as well as, to prevent illegal residues because you'll know how long you must have to keep that animal before it's safe to eat.  Whether you slaughtered on the farm or you send it off to a market.  Separate and identify sick and treated animals.  That's always important and its even more important with the potential of food born contamination pathogens.  Consult with a veterinarian before medicating food animals and I know many people don't have a veterinarian or access to a veterinarian.   There may be some other experts.  But try to get expert medical help in your decisions about medicating and treating animals.  Practice good hygiene.  Washing hands.  Washing your feed buckets, the food loader.  It's all very very important.  And when you have sick animals, try to keep children away.  These organisms can be very very dangerous to the young and the very old and very often they're the ones that end up treating the sick animals.  So, do try to be careful with the children's contact, and as you know as I mentioned earlier, with salmonella type____________ dt104, um, if children get that in particular, there's no antibiotics that can treat it very well.  And again, basic sanitation, prevent fecal oral transmission from human and animals, and of course, visa versa from animals to humans.  Animals can get infected from humans, as well as, humans from animals.  And we, one case of that where human sewage at times overflows and you can infest and contaminate animal pastures and water with that.  And the last slide.  What can women in agriculture do?  We want to also try ways to minimize wildlife and cat defecation in feed troughs and feeds.  Cats are really important for toxoplasmagondei? and if you do have your pet cat and you think that having cats around your barn is fun.  Really think about that.  Um, they are very important in the transmission of the toxoplasma, as well as, with rodents and other wildlife defecating.  So, I know that's a real tough one.  Preventing defecation and preventing wildlife but wherever you can, try to think about bio-security.  And as Dr. Hancock said, clean green scum from water troughs.  He found out in a study that water troughs on the average were not cleaned in over a year when he went to speak to producers.  They just literally leave the water trough there and in that ecocosm in the water, your ecoli 0157 can exist.  Prevent environmental water contamination and, in particular, in dairy farms and other farms, avoid standing water.  Salmonella and many of these pathogens love wetness.  So, where you can try to make and grade your farms in a way that water does not collect and animals constantly going in and out with fecal contamination.  Avoid consuming unpasteurized milk.  Practice good animal culling and I also added calf-rearing methods.  It's important that when you raise the calves that they get the appropriate __________.  It will mean less antibiotic treatment, it'll be healthy animals and less opportunity for these pathogens.  And for culling, make sure that you check your records for treatments, that you are very, you don't keep the animals longer than you need to.  We have found that disabled animals at slaughter, particularly, disabled dairy cows, are more likely to shed 0157.  And cattle that have been down for a period of time may also shed more 0157.  So, cull them as early as possible.  And most importantly, for those producers here in the United States, I will say make sure you're on the certified program for quality assurance.  Go through the educational program, follow what's in it and be a certified producer and encourage your family to practice all of those important standards.  If you have any questions, I'll be glad to answer them.  The microphone's back there.

 

Question:  I'm Sally Williams from Florida.  I was wondering if you had a program in place for assisting farmers with identifying areas on their farm that would cause contamination similar to the study that Dr. Hancock did?

 

Answer:  Yes.  The U.S. Department of Agriculture's Extension Service works in very close partnerships with state extension and county extension agents.  They and your veterinarians, practicing veterinarians, are expert in taking a look at where potential diseases can be spread and if you take it from the approach that you want to reduce animal disease.  I mean if you go to an extension person and say I want to reduce ecoli 0157H7 on my farm, they may look at you a little, you know, with surprise.  But if you say, I want to look at ways that I can improve my bio-security and sanitation and hygiene and I want to practice the best methods possible to reduce contamination and spread of disease, they'll be able to work with you very closely on a farm plan.  Dr. Tollefson, do you want to add anything to that?  Um, yes, I was going to say that you could also or those county and state extension service agents will be in contact with the universities.  In Florida, it's Florida State University in Gainesville, University of Florida.  Is it?  Is that correct?  Yeah, it has a college of veterinary medicine and I'm sure there are researchers there that could help you.  But generally, the extension service is the best way to go and they'll have those additional contacts.  Sometimes, if you're interested, there are surveys that are asking producers to participate.  If you have an opportunity, you or yourself were to convince your family that it would be important to have people come on your farm and do samples.  You may want to contact a university and say, I'd be willing to volunteer my farm for this.

 

Question:  Would that be confidential?

 


Answer:  Yes, it very much is and that's very important because people are so afraid if they volunteer on some of these studies that somebody's going to come tromping back on their farm with some, you know, regulatory.  First of all, the Federal Government agencies don't have direct regulatory authority unless there's a very severe animal disease that AFIS needed to control, like tuberculosis or if you are a residue violator.  The Federal agencies would be very interested in knowing.  But for these general studies that we can get data, they sanitize it so you may be Farm M or X or either some number and nobody would really know what farm you are.  However, you can work it out with that researcher to give the information back to you so that you can work to make improvements.

 

Thank you very much.  Thank you Dr. Fontaine.  Now,

Dr. Tollefson.

 

Good morning.  Kristin, if you would just put up the first one and I want to introduce the subject.  I'm with the Food and Drug Administration Center for Veterinary Medicine and like Bonnie, I am also a Veterinarian involved in food safety issues primarily with food-producing animals.  I'm going to be talking about a subset of the microbial pathogen problem that Bonnie went into in detail.  Um, and this is antibiotic resistance.  Now you may have heard about it, Kristen, not yet, thanks.  Um, you may have heard about it from the point of view of human health.  There is a crisis occurring throughout the world according to the U.S. Institute of Medicine, the International World Health Organization and other eminent health authorities in that many of the antibiotics are no longer useful in human medicine.  This is a result of many causes.  [Cannot hear?  You have to speak right into it.  Okay.  Dr. Bunton's clue saying you were right on top of it.  Okay, um.]  The crisis that's occurring in human medicine with antibiotic resistance is a result of many causes.  This is due to some of the hospital problems where infections are rapidly transmitted among patients.  Also, there are community acquired infections that are similar.  However, there is one area and that is food born disease where resistance in animal pathogens is a concern.  What I'm talking about here is primarily salmonella, camplavactor?, ecoli, which Dr. Bunton had gone through and explained a little bit of the epidemiology behind those.  In these situations, there is a little person-to-person spread, salmonella being a very hallmark of an example.  Food born disease is unique in that we're talking about enteric pathogens that are in the animal rarely cause disease in the animal but their organisms live in the intestinal tract of the animal and this can be contaminated at slaughter on the carcass and then those pathogens resistant or otherwise are transmitted to humans through the food supply.  Okay, go ahead.

 


What I wanted to talk about in antibiotic resistance is really a very general sense.  This problem has been with us a long long time and the issue of what's it due to, how much is due to human misuse of antibiotics versus animal or agriculture use of antibiotics.  So, I wanted to go through historically.  Um, it actually started with the United Kingdom, with Britain in 1960, a _________ Committee was formed to consider passable human health implications from the use of subtherapeutic antibiotics in livestock.  Now, a little definition of terms here.  Subtherapeutics is a misnomer.  What they're referring to are antibiotics that are used at low levels and for long periods of time to enhance growth and production in animals, not that are used therapeutically to treat diseases.  That was followed in 1969 by a committee called the Swan Committee to look at what are we going to do about it?  Um, this was also in the United Kingdom and that committee reported that they could find no hazard to humans or animals from the use of antibiotics in poultry or swine.  However, the committee linked an outbreak of salmonellosis in humans to therapeutic use of antibiotics in sick calves and the committee members felt that this was a harbinger of possible potential human health problems.  So, they recommended that antibiotics used in animals to be divided into a feed or a subtherapeutic or a therapeutic class.  The feed antibiotics class should not include drugs that are used therapeutically in humans or animals.  And also, that therapeutic antibiotics should be available only on prescription.  Now, um, that committee actually had a lot of foresight and those recommendations were taken to heart by most of the European countries, all of the European Union countries plus the Scandinavian countries that weren't part of the European Union and also, Australia and New Zealand.  They were not taken to heart by the U.S. or Canada, unfortunately.  Although we had the problem in North America, so we were quite aware of it.  In 1970, the Food and Drug Administration looked at the issue, and again, um, this is a selection of antibiotic resistant pathogens from use of antibiotics in food animals.  What they concluded was that the use of low level amounts of antimicrobials did favor the selection and development of resistant bacteria.  This is really an issue of selection pressure on the microbes.  They are going to survive and um, become resistant to the external object, the antibiotic in this case.  Also, animals antimicrobial treatment may serve as a re [end of side 1]  [beginning of side 2]  on an increase in the prevalence of antibiotic resistance bacteria in humans, um, based on the Center for Veterinary Medicine began requiring some studies for petitioners or sponsors of antimicrobial drugs to get approval.  Okay, next slide Kristen, please? 

 








In 1977, Center for Veterinary Medicine followed-up by recommending the withdrawal of these feed or subtherapeutic uses of penicillin and tetracycline from animal feeds either when used alone or in combination.  However, these two drugs were chosen by the way, because of their importance in human medicine.  There are many other subtherapeutic or low level antibiotics that are approved for use in animal feed, Congress, however, intervened.  Food and Drug Administration was criticized by the animal agricultural industry because they didn't have alternatives.  They felt that this would be a great hindrance to their production efficiency and be an economic problem.  So, Congress blocked that action and also required that we look into it further.  As a result of that, Congress required the Food and Drug Administration to spend 1.5 million dollars of it's appropriated funds on a study in 1978 by the National Academy of Sciences.  Thanks, Kristen.  That study was finally finished in 1980 and it's results were inconclusive.  Basically, it concluded that the existing data neither proved nor disproved that use of antibiotics in animals lead to a human health concern and they called for additional studies.  In 1984, the issue doesn't seem to go away.  The National Resources Defense Council petitioned the Department of Health and Human Services to immediately suspend approval of these penicillin and tetracycline antibiotics.  They claim that it represented these drugs used in feed represented an imminent health hazard.  We did not find that that was the case.  The National Resources Defense Council had cited some very recent studies done by Centers for Disease Control where they, for the first time, established the length where use of antimicrobials in animals lead to disease and the resistant pathogen in humans.  However, FDA did agree that it required more study.  There was new information and at that time.  We went forward in a King County Seattle Department of Public Health to review specifically, the possibility of the movement of bacteria from chickens to humans.  This study was useful in that it found for the first time that camplovactor? organism was more common on poultry than salmonella.  Although salmonella was also common and that camplovactor?, in particular, does appear to flow from chickens to man via consumption of poultry products.  The report stated that the icelets from human cases and those from retail poultry has similar antibiotic susceptibility patterns including prevalence of thirty percent in the humans and thirty-three percent in poultry for tetracycline resistance which was found to be plasma-mediated.  This study then found several things of importance that camplovactor? was common on poultry.  It did move from poultry to humans.  It was resistant to tetracycline which was being fed to poultry in feed.  And also, an added piece of information that the tetracycline was mobilizable.  It wasn't on the chromosome or the bacteria, it was an R factor or plasma-mediated which means it can go from bacteria to bacteria.  This is important because once present, you no longer need to have a presence of tetracycline in order to confer tetracycline resistance.  We now know that it's linked for example, to ampicillin and many penicillin and other drugs, sulphur.  In 1987, next slide, please, as FDA issued a report on antibiotics and animal feeds and assessment of scientific data concerning their safety took the 1984 King County study into account but concluded that the therapeutic use of antibiotics.  Now we're moving to a different subject that yes, the use of antimicrobials in animal feed may be a problem but we could still continue to approve therapeutic uses in antibiotics in animals and that animals certainly need these drugs available to treat disease.  We decided to do nothing on the subtherapeutic issue because Congress had made it clear to us that they weren't going to allow us to do this.  The economic problem in other words, still remained with removing the subtherapeutic antimicrobials.  Interestingly, Europe and New Zealand and Australia had moved past this point and were using other non-antimicrobial products as growth enhancers which I'll speak to you on it a little bit later.  In 1988, the Institute of Medicine which is part of the National Academy of Sciences took it upon themselves to review all the information available about the issue and they concluded that they did find a link between subtherapeutic drug use and antimicrobial resistance, particularly again, penicillin and tetracycline, fed to animals for growth promotion, feed efficiency and disease prevention claims.  In other words, preventing a disease before it occurs.  However, it said that they couldn't quantify this.  They didn't know how much of the problem in humans was due to the subtherapeutic use in animals and that became the problem in general.  It's very difficult to find concrete evidence that resulted in, you know, human health concerns.  Now, we know from misuse of antimicrobials in human medicine that it does lead to increased morbidity, mortality and increased health care costs.  But we couldn't find that link between the use in this animal population and the human health affect.  However, things have changed since 1988 and what has changed is what I mentioned in the beginning, that if you concentrate on food born disease, those enteric pathogens that commonly contaminate the carcass at slaughter, that subset there is a problem with using antimicrobials in animals that can become a problem in humans.  Again, it's similar to Dr. Bunton's statements on the residues and food safety issues in general.  There are many players along this continuum from farm-to-table  so it's not just the fact that the animals are getting treated with antimicrobials, there are many other intervention points that need to be looked at and mitigating factors that can be taken into account.  In 1995, American Society of Microbiology raised the issue to kind of a higher level by issuing the report that stated they were gravely concerned about the national and global increase in antibiotic resistance and the complex issues surrounding this public health threat.  The food supply since 1988, at current times, has become quite global.  You are eating food from many countries.  We are exporting food to many countries.  It's no longer the problems associated with food safety are no longer relegated to individual countries but it's truly a global problem.  They call for a number of prevention measures to be undertaken including looking for antimicrobial resistance.  One of the issues has always been well, who knows how resistant bacteria from animals are and people generally don't test outside of clinical microbiological diagnostic-type labs that are usually state agricultural land grant colleges.  These are used by Veterinarians for treatment purposes.  So, they recommended that more monitoring be done and a number of recommendations.  Then, in more recent times, World Health Organization in October 1997, had an expert consultation on antimicrobial use in food producing animals specifically, to review the question of whether the use of antimicrobials in animals leads to antimicrobial resistance in humans.  The goal of the meeting was to gain an international consensus on the priority of the potential medical problems that could come from use of antimicrobials on livestock and to recommend actions that the World Health Organization should take.  Um, at that meeting, the representatives which Food and Drug Administration took part in, I was there along with another person from the Center for Veterinary Medicine.  They reinforced in affect, earlier recommendations that antimicrobial agents should not be used for growth promotion, if the drug is used in human therapeutics.  This was a restatement of the 1969 Swan Committee, fairly old.  Or if it is known to select for cross-resistance to antimicrobials used in human medicine.  At this time, also in the 1995 American Society for Microbiology study, subtherapeutic are  this low level growth feeding that is no longer the only concern.  Science in microbiology had progressed to the extent that it really doesn't matter if you are directly treating the pathogen or if you're feeding in the low levels.  It's more a matter of extent.  You are more likely to cause resistance if you feed at suboptimal doses.  But therapeutic use also does cause antimicrobial uses.  The WHO went a little bit further than some of these other studies in that they finally did some recommendations.  One was for more research to find alternatives to antimicrobial agents.  Again, they, like American Society for Microbiology called for monitoring a resistance.  With the idea here is that if you have surveillance systems in place looking for resistance, you can detect it as it emerges and take action to prevent it's further increase and dissemination.  And then, they also recommended managing risks through prudent use.  Now, the U.S. Food and Drug Administration, the U.S. Department of Agriculture, go ahead, Kristen, has taken many of these recommendations to heart.  One specifically, on prudent use is this is FDA believes that prudent use of antimicrobials should be emphasized to not only look at residue problems but also to minimize a development of antimicrobials resistance and to assure the continued efficacy and safety of these antimicrobials that we do have approved for food producing animals.  Antimicrobials that are used in food producing animals go through pretty rigorous pre-approval process.  I don't have a slide on that, Kristen.  You don't only have to show that the drug is effective and safe and the whole stand along, you have to show that there's no threat of harm in the products that humans will consume from those animals.  So, we had not considered antimicrobial resistance or the transfer of resistant pathogens prior to very recently.  We only considered residues.  So, this was kind of a wake up call to look at the issue more specifically.  At the same time that we started to become concerned about this, we started a national antimicrobial resistance monitoring system in conjunction with U.S. Department of Agriculture, several of the agencies, Dr. Bunton's Food Safety and Inspection Service Agency but also Agricultural Research Service and the Animal Plant Health Inspection Service, plus the Centers for Disease Control and Prevention.  And what we're doing with this, which began in January 1, 1996, is to look at animals going into slaughter taking icelets from them.  As of 1998, we're using the salmonella icelets that are required under the hazard analysis critical control point program that Dr. Bunton referred to.  And also, ecoli, in general, that we're specifically looking for 0157.  And then also, animal clinical samples, these are from state diagnostic labs and in those situations we are looking at salmonella, ecoli, and camplovactor? and then there's and identical system in humans from Centers for Disease Control.  They are taking clinical samples from humans from state public health departments, from humans that are ill with salmonella, camplovactor?, and ecoli and we're looking at the susceptibility patterns to seventeen antimicrobial agents that are used in both veterinary and human medicine.  These are all gram negative bacteria so that antibiotics that we're looking at have that spectrum or a broad spectrum where they cover both gram positive and gram negative.  What we're hoping that the system will do for us is as American Society for Microbiology called for, kind of a sentinel or a wake-up call to say you can now track the resistance through time and see if there are changes.  We are looking at increases in resistance, changes and patterns of resistance, detection of multiple resistance, and use that information to go back to human physicians, veterinarians, animal producers, to let them know where it's occurring on a national scale rather than working directly through their veterinarian for sick animals and you know, with a diagnostic lab.  This is really more healthy animals and possibly then to change your use of antimicrobials on a particular farm.  This is directly tied in then with prudent use.  What we're finding in the monitoring system can be fed into prudent use programs to direct recommendations coming from these programs.  Now, that also leads into, let me have the next slide, there needs to be a definition of prudent use so that everybody knows what we are speaking to and this is use that maximizes the therapeutic effect while minimizing the development of resistance.  It's somewhat of a technical term but it's something that was agreed upon by many of the stakeholders in the process, veterinarians, physicians, American Veterinary Medical Association, the American Society for Microbiology, and the Infectious Disease Society of America.  So, that's a starting point that we all agreed that's what prudent use should aim for.  Next slide, please.  And as I said before, it is a global problem.  There was a follow-up meeting specifically on flor____________.  This took place in the first week of June in Geneva.  World Health Organization sponsored it.  This was specifically on the medical impact of using flor________ in animal agriculture on human health.  Flor__________ are the newest class, in general, a large antibiotic class that are quite useful in human medicine and particularly used for occasions when salmonellosis is treated and for salmonella___________ type dt104 are multiple-resistant organisms.  Flor____________ appear to best the last choice drug.  Flor____________ are approved for use in food producing animals in many countries of the world including the United States for poultry.  They are not approved for use in Australia and New Zealand and I think that's about all.  This meeting was to sort of step back and say what do we say about specific antimicrobials and we are planning subsequent meetings on certain classes.  The meeting agreed that antimicrobial agents including these _____________ classes are very important to treat sick animals but they shouldn't be used for preventing illness and they should come under prudent use guidelines.  Ok, so that in other words, they should be used with caution.  The World Health Organization also called for more information to find out exactly what uses will stop the increase in resistance from occurring or prevent an increase in resistance and then also more information on possible affects of human illness directly from the use of the drug.  Ok, next slide, please.  What Europe is doing is um, they've gone back to the use, they all have flor___________ approved for therapeutic uses.  They pretty much follow the recommendations of the Swan Committee and some more recent um, activities are shown in this slide.  Switzerland, for example, very recently prohibited virginiamyacin? that is a growth promotant.  It's approved in this country for poultry, swine and cattle.  It's used as a growth promotant, a feed efficiency enhancer, but unfortunately it's cross-resistant with              coxi? with vancomycin which is a drug used to treat ______________ infections in humans.  Denmark, Norway, and Sweden, also have voluntarily stopped using it.  The European Union agricultural commissioner has stated that he is willing to take action on feed uses due to concerns over resistant bacteria.  Also, their scientific committee on animal nutrition concluded that tylecin? and spiromicin? should continue on market but that there were human health concerns and more control should be instituted.  We have tylecin? approved in those countries.  And then Sweden's Ministry of Agriculture Food and Fisheries recently campaigned to discourage antimicrobial use in animal feed, in general and they have a pretty good producer organizations that are also um, promoting this now you need to realize that there's a trade issue here too is what they're trying to do.  In other words, if they can claim that their country has more prudent use than another country there is some international trade implications and we're involved in that and um, World Trade Organization also.  Okay, next slide.  Some recent data um, that has come out since 1995 and American Society for Microbiology  called for some studies, is Denmark has traced vancomycin resistant ____________coxi to the use of avaparceen? on poultry and swine farms.  Denmark producers have voluntarily stopped using that drug as a growth promoter.  It's not approved in this country.  We were concerned about the resistance for a long time.  Subsequently to that, the European Union has put a ban on use of that drug for two years while they gather more information.  Very recently the Minnesota Department of Health has completed a camplovactor? study which is about to be published in the New England Journal of Medicine, where they've found that eight-eight percent of retail poultry sample were camplovactor? positive.  Twenty percent of those poultry were positive for            oxicyn? resistant camplovactor?.  ___________oxycycn is a flora___________ and this has implications for human use of flora___________, um, so that's a relatively new finding.  Next slide, please.  Then, under the National Food Safety Initiative, many studies are now being funded to look at the issue in detail.  One of these is a vast surveillance program called Foodnut that has many state and local public health departments looking at both the incidents of food born disease in humans, uh, camplovactor?, salmonella, ______gella, ecoli, and then also looking at resistant pathogens.  Ten of these sites are in the National Antimicrobial Resistance Monitoring Program, I'm sorry, all the Foodnut sites are in there, plus additional sites and they are following back cases of illness and in this case, this is camplovactor?, they found that patients with _______oxicyn resistant camplovactor? had more severe disease as measured by bloody diarrhea and more likely to visit an emergency room and hospitalization.  So that thirty-one percent of humans with resistant camplovactor? were hospitalized versus three percent of humans with camplobacteriosis? that were not resistant.  This is the first study the so what question on antimicrobial resistance in food born disease.  So, it's considered to be a landmark study.  It's a small number of cases and they are going to continue the study.  And I think that's the end of my slide.  No, go ahead.  So, just a wrap-up, we are in the process through the National Food Safety Initiative to look at not only microbial pathogens and how they get transmitted to humans, what are some of the research issues on how they become prevalent within the food animals, what sort of mitigating factors can we do to stop, you know, their use in or their spread among food animals but also looking at resistant pathogens.  We now know that most salmonella, ecoli 0157 and camplovactor? infections in humans in the U.S. originate from food in animal origin.  There is little person-to-person spread because of the high infectious doses for salmonella and camplovactor?.  That actually isn't true for ecoli 0157.  You might be aware of the recent swimming pool incidents of transmission among children.  That pathogen is particularly viral into humans and it only takes of the order of ten to a hundred microorganisms.  It's not true of salmonellas and camplovactor? that are quite high.  And also the potential exists that resistant food born microbes will be transferred to humans through the food supply.  Are there any questions?  Yes.  Could you go to the microphone and identify myself.  It's being recorded.  That's not going to actually work.  Dr. Tollefson could you repeat the question then?  Okay, sure. 

 

Question:  The question was that animal vaccines often contain, the vaccines are grown in a antibacterial mix to prevent bacterial contamination of the vaccine and the question was is that a concern about antimicrobial resistance?

 

Answer:  It isn't.  Usually those are inactivated in terms of once a vaccine is grown in a culture, the antibiotic is really no longer there and active.  So, it doesn't elicit a response in the host.  But it does bring up a point that vaccines are now being re-looked at as an alternative to antimicrobial therapy for ill animals and to prevent disease, as well as to treat or other immune modulating agents.  And in addition, Dr. Bunton had mentioned briefly, competitive exclusion products that has been approved by the Food and Drug Administration but that was developed in Department of Agriculture that is fed to baby chicks, is actually sprayed on their feathers at one day of age and then they preen themselves and will eat the product that will line their intestinal tract with good bacteria if you can think of it that way, it will colonize their intestinal tract and prevent colonization from occurring with salmonella and camplovactor? and it shows a great deal of promise.  Any other questions?  Anyone from outside the U.S.?  Are you currently using antimicrobials in feed for food-producing animals or are you aware of this at all?  [someone talking in back]  ..that's not an antimicrobial?  Is that what you.... [someone talking]  yeah, that's our understanding too.  Yeah, Australia's been pretty out in the forefront on that.  Australia is a big exporting nation and I think they learned early on I think, um, particularly to Japan who are quite picky about what they buy.  Um, so early on Australia and New Zealand has been fortunate in not getting used to using these products.  Anything else?  Okay, if there are no other questions, that concludes our workshop.  Please give some appreciation to our two speakers.