When we started putting this program together, it was my impression we needed a person to kind of listen, not come in here with a bias, not with an agenda, but to kind of wrap up what has been said. I shared Harley's name with several colleagues I respect and it was unanimous that he would be the person we'd like to get here.

Well, Harley has, in addition to being a Minnesotan and knows (inaudible) companion intimately and likes, graduated with his DVM from Minnesota. He also got a PhD in pathology. He has done tremendous amount of works in gut physiology. He knows diarrhea when he sees it. He also went on to have an initial career at National Animal Disease Center in Ames, Iowa. Then, according to his own life plan, left to go into academia and got involved with a lot of administration and quickly realized science was what he wanted to do. He went back to NADC. It seems to me he actually spent a little time--he's one of the few people that can also say I've been to Saskatoon or lived there for a period of time. Most people like to say they've been to Saskatoon or passed through Saskatoon. Anyway, Harley went on to become the director of the National Animal Disease Center which I think is a fairly prestigious scientific establishment and was there for six years, and just last month, completed a one year tenure as the director of the Plum Island Research Station which is, of course, the foreign animal disease research area. Those kind of credentials are pretty awesome, and he's now gone back to Iowa State University to a chairmanship in the research area there that is an endowed chair which also is a very prestigious honor.

And so, I think you should appreciate--this guy knows science and probably even knows experimental design. Mr. Moon probably knows about controls. And, as such, with no further delay, Harley, would you kind of wrap up what you've heard today?

DR. HARLEY MOON: Thanks, LaRue. I'll be glad to. I suspect my sitting there all day and taking notes indicates that over my career I've lost my ability to listen. So, I had to write.

I don't come here with any preconceived notions or ideas. I am intensely interested in the area of intestinal infections of animals and their transmissibility and what it means to us in agriculture and in human health and the health of wildlife populations. I won't attempt to distill some sort of an essence that could be a conclusion. I will try to encapsulate the things that I heard relative to the question that I understand has us all here. Should llamas--should or should not llamas be allowed in public lands/national parks because of a potential risk that they would disseminate Johne's Disease into wildlife.

Early-on in those position statements, I was impressed, as I listened to the several representatives here of agencies who have the responsibility for looking after public lands and public resources for the good of the nation as a whole, that to a person what they indicated that there is not now or not about to be or not a high priority issue to make a decision on as to whether or not there ought to be a policy relative to this question. That it is a matter of interest that has arisen in the relationship between agriculture and the park industry and they are interested in being here in an open-minded way to listen and to learn and collectively to debate about this question or this hypothetical concern. It was triggered, as I learned today, this question, this meeting, by the decision of a single individual who has a responsibility for a single park and that decision has been reviewed in terms of the charter and the authority of that individual, and the decision was well-founded, well-made within the authority that guides that individual.

Later on today, very late, just before we broke, I learned that there had, in fact, been a second similar decision made again in another park in this region by another independent park superintendent acting with that independent authority. I learned, in contrast to what I had understood or expected before I came here, that these decisions are, in fact, extensively delegated, if you will, to the supervisors of individual parks because of the unique nature of each individual park or area of public property, the unique use that it's designated, the unique cultural and wildlife and biological factors that are there.

On the other hand, in the opening position statements from the people who represent agriculture, who represent llamas and the users of llamas, I learned that they feel that the decision that has been made in this one instance, in the Canyon Land instance, is made with insufficient evidence; insufficient evidence that there is any realistic potential for a transmission in nature of a pack animal moving through to disseminate this disease. Because of the well-known characteristic in other species for transmission to occur animal to animal or across species for very high dose exposures to establish infection and at the high dose be prolonged, repeated over time, kind of like the old lesson of leprosy. Occasional contact, people don't spread leprosy, but high dose constant contact, they do. That reminder kept coming through my mind as I listened to that emphasis.

I learned about what to me is explosive growth in this llama industry; a ten-fold increase in population in the last 10 years, not knowing what lies ahead for the next 10. But, an industry that is clearly rapidly expanding. I learned of the high--or had reinforced, I guess, the high human contact, human observation, human interaction per animal that goes on with this agricultural species as compared to others. And, we have about 10,000 owners with 100,000 animals. On an average then, I guess we've got each of these llamas--for every 10 of them, there's an owner and probably several other people associated with that owner that are observing these animals. They're high value. Their health is of intense concern. In comparison to other agricultural animals, they're more like a companion animals in terms of the sort of health observation and health care that they get.

Then, following that, we moved off and we started talking about the disease in llamas. And, we learned, as I guess as well knew when we came here, that the disease has occurred in llamas. We know that it's occurred in four, three different herds, three different states, that they have been in adult animals, and that the clinical expression was of emaciation with diarrhea terminally; an expression rather like some of the other small ruminants that we see in terms of clinical disease. We learned or I learned that in finding out about this or uncovering these cases and bringing them to our attention at the clinical stage, the people or the owners and the veterinarians and the people dealing with this were able to recognize the disease and diagnose it by rather conventional techniques. Johne's Disease in llamas is, insofar as we know, with this small number of cases that have occurred not significantly different than it is in many other species where the disease occurred. It differs somewhat in its pathologic manifestation from the disease in cervids, but it fits from what we know about it within the spectrum of the disease as we recognize it to occur naturally in other species.

Back to the position statement, I guess, I didn't quite know what was the emphasis from the people that represent animal health and the livestock industry and the Llama Association. Given that sort of human/animal contact and observation and the fact that there doesn't appear to be anything terribly unique, unusual, abscopal (phonetic), surprising about the manifestation of Johne's Disease when it occurs in llamas, the fact then that only four cases, four clinical cases, have been presented would suggest, although not prove, that the prevalence of this disease amongst our 100,000 llamas in this country is probably quite low. But, it is--we don't know and we can't be sure of that conclusion. I'm reminded again later in the day when we saw the Iceberg concept coming in that clearly whatever that prevalence is, it's certainly higher than four animals. We must accept that, but it probably is much lower than in other species, than in other livestock species where we know the disease has occurred spontaneously.

Aside from the clinical and pathologic manifestations, also the laboratory tests and the few limited circumstances where they've been applied to date, those which had worked in other species worked in llamas. We have every reason to think that the limitations, particularly of the serologic tests and the blood tests that we recognize when we apply them to other species, probably apply in llamas, as well, but we don't know that. We don't have a database.

Repeatedly through the day in various ways came in the issue of how little we really know about Johne's Disease in llamas. We have every reason to assume that we can comparatively argue from what we know about the disease in cattle and sheep and in other species, but when we get right down to very hard rock facts specifically about the disease in llama, we don't know a lot and we're probably going to have to go ahead with our public policy for a good long time in the future without knowing a whole lot about the specifics of this disease as it applies to llamas, the shedding levels, the infectious dose levels, et cetera. I see no realistic hope that we're going to have the kind of resources brought to this problem in the next few years to answer those questions given the difficulty and the expense associated with answering it. So, public policy will have to go forward with imperfect information and, therefore, some level of contention will obviously have to continue.

I learned that there is more of this disease in free-ranging wildlife than I had realized. We had presented three examples where the disease has established endemic infections in free-ranging wildlife; not in three areas, two of them overlap; the goat and the Big Horn Sheep in an overlapping area, but the elk in a completely separate area. So, we don't know anything about--nothing was presented and the question was asked repeatedly in several different ways; what's the history, what's the nature of the strains that are in these free-living, free-ranging animals, what was the origin of these infections? And, the answers are we don't know. We know nothing about that, in essence. We have no reason to assume that, in fact, it was introduced from agricultural animals. We also have no evidence to argue that it wasn't. We just don't know.

It was interesting, however, when we looked at those areas where the disease became endemic in free-living animals that the conditions could be identified which are similar to those that we know in cattle, for example, where the disease is best understood, have a high incidence of risk factor, a high likelihood of establishing and sustaining the disease in a herd, for example. We saw the evidence of moisture, of congregation and aggregation of dense population of animals, in manure exposure, filth, if you will, and a continuing pattern of re-exposure and reintroduction into those areas. And, at least, in the sheep instance, as I understand the discussion of these three, clearly throughout the years that the endemic disease has been there, clinically infected animals with very high numbers of organisms in their intestinal tract are naturally occurring in that population, and presumably, recontaminating that environment just like we

think of on the farm circumstance.

So, on the one hand, it answers the question that I had in mind. Would it be possible for something like this to be sustained in wildlife? The answer is yes. It also tells me that our wildlife population is not pristine in terms of being free, completely free of Johne's Disease. And, I learned that the concerns--this was brand new information to me. The concerns that we need to have for the welfare of the wild free-living population that's Johne's Disease infected is not that it decimates the population. Those populations, as I understand, are robust. It sounds like the elk one, at least, is probably more robust than can really be handled. It's, we might say, overproducing. That as an infectious disease, it affects the health and the well-being and the reproduction and the longevity of those populations. There's no evidence of that. The concerns are that once we know that such a free-ranging herd is infected, it then becomes not useful, not acceptable as a source of animals for transplant to other areas as we need to manage our national herds. So, the concerns are management concerns about protecting that germ stock resource so we can transplant.

And then, later in the day, we got back to that concept again when we started thinking about the Canyonlands herd of Big Horns. This herd has traditionally, for what reasons I didn't quite understand, but it has been a very successful source of transplant animals to move into other areas around the nation and that might be another, we assumed or we heard it paraphrased for the person that is absent, probably was another issue that was important in the superintendent's decision to take an extraordinary level of protection for that herd.

As we talked about what we know about the pathogenesis of this disease, repeatedly emphasized were the chronic nature of the infectious process itself in almost all circumstances taking many months, at least, and in most cases, years in order for the disease to develop full-blown and to initiate it. Either if you look at circumstances where it has been initiated naturally on a farm or when you try to initiate in domestic animal species with experimental inoculations, it takes very high doses, it takes repeated exposures over time, it takes a long time after that for the disease to be manifest, and then superimposed upon that, things that happen in the life of the individual that we might refer to as stress, be that nutritional or climatic or population or behavioral interactions with a population, to trigger that disease.

Constantly, the focus for transmission was on the fecal/oral route because that seems to be the dominant way that the disease establishes, spreads, and maintains itself, but we recognize that there are other ways, as well. Fetal infection and shedding at least of the organism in milk were emphasized. And, constantly was emphasized that for any practical matter in the species where we know about it, the time of susceptibility is early. It's the young. It's the animal in the first few weeks or perhaps few months of life that is susceptible.

In terms of trying to manage, as one starts to think about either testing wildlife or testing llamas, based on what we know for the screening tests, the blood tests, the low cost, high population approaches that you would like to take to deal with something like this, it's there that our tests are most unreliable on an individual animal basis. There are only useful in large populations to give you a general indices of infection level and prevalence. They're aren't reliable at the level we would like for individual animal testing. So, again, we're not likely to quickly come to a better level of understanding than we have now.

I'd like to move to a different area in my notes here and talk about risks and risk management, and mostly there, we heard about what we know in cattle. This is a disease of filth, a manure spread, disseminated disease, and the livestock industry--well, the cattle industry where we see the problem are mostly in these intensely managed areas. Contrast beef and dairy, for example, for one example. Contrast the western plains with the east for another example. The examples we saw are cattle in environments heavily infested with manure, solid wet streams of manure running into ponds and pools that are not only walked in, but are (inaudible). The emphasis on dissemination by dirty, filthy manure scoops, by splashing manure directly onto young animals, susceptible animals. Although we recognize in the cattle industry the importance once the disease is established in an individual animal and clinical of the potential spread through milk and directly to the fetus, that the risk factors for the industry or for the herd as a whole, in fact, all reside around this matter of constant exposure to the filth of adult manure where you have a repeated occasional proportion of the population shedding high numbers of organisms.

We learned also about the environmental persistence of this organism in soil for months. The figure of around a year was mentioned more than once in some soils. Evidence that alkaline soils are less likely to attain that survivability than are acid soils and that urine mixed with feces also tends to reduce the survivability of this organism in the environment, as does a lot of exposure to heat, high ambient temperatures, dry soils, and a lot of exposure to UV light. It was emphasized by someone during the course of the day that llamas have a tendency to dung and urinate in the same spot and, although hypothetically that would seem like that would be an advantageous pattern for this case, we in fact didn't hear any data relative to the impact of llama urine on Johne's Disease organisms in llama dung.

Several times during the day the question came up as to is the llama strain unique? The concept of strain variability that this organism tending to adapt to different host species; sheep and cattle strains being discretely different, although it's possible at least to get the cattle strain into sheep. The strains are discretely different in terms of their host survivability, their adaptability. Some of their cultural phenotypes and genetic differences amongst

these strains exist. We don't know, getting back to the llama situation, whether the llama strains are one of several, whether they're most like cattle or sheep, or identical to one and another or different. We do know that the llama strains have been cultured; so, therefore, it would seem like they're probably not the typical sheep strain.

Relative to control, what we know about it when it's there, again what we heard comes largely from the experience with people who have been successful in managing, in either living with or controlling or getting rid of the disease or reducing it's prevalence and it's economic impact in cattle, and the concept there targets around first identifying that high level shedding animal, that clinically affected animal, and getting it out of the environment. And then, insofar as possible, separating that young animal from adult manure. In a species where it's appropriate to wean them early, do it and keep them quite removed and separated with separate utensils, et cetera. From adults in other species where it's not practical to separate the young animal from the newborn (sic) in grazing situations, then make sure you graze extensively and protect the pastures from manure. Don't spread manure on the pastures that you're going to be grazing the animals on. Think about manure dissemination by spreaders, by boots, by feeders, by machinery, by equipment. Keep the manure out of the hay and out of the feedbox.

Later, as we tried to look at scenarios of the potential for--if we make some assumptions which seemed reasonable, I think there was probably consensus on that that it's reasonable to assume that the issue of transmission between wildlife and llamas would probably be similar to transmission between animals in a domestic setting in a cattle or sheep setting. There was some disagreements. I did not--we had two different scenarios as to the environment, the soil type, and the situation that would occur, for example, in Canyonlands. One projected it as an open arid area with a lot of rocks, a lot of sunlight, a lot of drought, extensive dispersal of Big Horn Sheep, for example. Another one pointed out that there are microclimates apparently in place and also in time of the year when, in fact, it is wet and shaded and the animals are congregated. What we didn't--and so, it would seem like if that latter scenario is correct that there would be the environmental opportunity for brief periods of time anyway; however long the dry spells are when they all congregate around similar water holes and where the graze is restricted and how long those last. But, there might be the opportunity if there were high dose exposure continually put into that material for transmission from llama to the Big Horn. We got back then to arguing about the issue and again there seemed to be consensus on the concept that the animals that are--in order to get to that sort of an environment, this would be an athletic llama, this would be a llama that the people are interested in traveling with and being with and that can pack and get into the environment, and that is not going to be an animal that can deliver that sort of load of organisms. The animals that are shedding high enough levels of this agent to be infectious are clinically affected with disease. They're emaciated. They've lost condition. They're not going to be acceptable pack animals. So, it's extremely unlikely that they could get there. And, certainly, the number of "ifs" that we kept going through in terms of getting there repeatedly and getting there heavy enough to--those concepts were, it seemed to me, accepted by all.

I heard no argument or disagreement with the concept that whatever the risk is, it is very small. The risk is low. I heard no one say that we can't say that there is no risk. Back to the early position statements, people pointed out that no risks are not realistic. That zero tolerance is not an issue that one can practically live in a society with.

So, we got down to discussing the issues of the unique roles and responsibilities and expectations that the public has for use of public lands and the fact that the park lands authority, the agencies that are involved in public lands, have the unique responsibility to protect what was there originally and keep it there in perpetuity and--and I hadn't heard this before--without limit. This sounds to me like it drives us very close to, this without limit, to something like zero tolerance. It looks to me like there's a philosophical gap here that is going to be--that will persist because you have two different sides of an issue, two different value sets, two different sets of responsibilities, and the challenge then is to negotiate between these two sides and come up with an acceptable to the public-at-large long-term policy.

And, I think, with that, I'd like to sit down. Thank you.