DR. FERGUSON: Thank you for bearing with me. Sometimes I think these machines are smarter than I am. That doesn't make me feel very good.

Anyway, I'm sort of, I guess, the clean-up hitter here this morning, almost this afternoon, and I think my colleagues have covered a lot of good points. I'm just going to cover a few new ones and then recover or rehit some high points especially that were in Dr. Sutton's presentation.

What is on the agenda was for me to talk about measures for consideration in assuring scrapie free sources of sheep and goat derived materials, especially from countries where scrapie is present. However, I thought I would take this opportunity to also share some information on surveillance in those countries where scrapie is absent. I thought that might be useful, and then, as has been identified also earlier, kind of how we at USDA look at other countries, especially in regards to scrapie and the import of sheep and sheep genetics.

So let's start off. Scrapie free sources, boiled down very simply, you kind of have two options with some other considerations. The two options are a free country and/or a free region, a free zone. You can define your geographic area, or you can have free flocks.

So let's start off scrapie free countries. Traditionally, we at USDA have recognized Australia and New Zealand as free of scrapie, actually free of other TSEs also, but for purposes of this presentation, I'm going to focus on scrapie.

Other countries have requested recognition. Specifically, South Africa has sent us quite a bit of information. This is currently under review. We haven't reached a final conclusion yet. So I can just kind of give the high points of what they have submitted.

There probably will be others in the future. Mexico has already been brought up. That is one that has requested it. We haven't gotten very far with that, but I'll go into that in a bit more detail.

So let's start off with our colleagues down under. What are they doing and how have we assured ourselves that they are free of scrapie?

First of all, Australia. To start with, they have a very strong veterinary infrastructure. We have faith in the fact that they do have solid veterinary services both from a federal and a state standpoint, and that they have adequate resources at a diagnostic level and also as a regulatory authority to diagnose scrapie and to control it if it did show up.

They have very stringent import controls not only just for scrapie, but for all other diseases. Since they're an island continent, they've been able to maintain a very high animal health status by virtue of their stringent controls.

They have identified scrapie, and 1952 was the only occurrence. This was in Suffolks that had been imported from the U.K. I believe they were imported in 1950, and they diagnosed the disease in 1952. The animals were still under quarantine. They were not on an offshore quarantine. They were in Victoria, but they were still under APHIS' control.

They slaughtered all of the affected and in contact animals and have not really had a problem since.

Scrapie is a notifiable disease. All nervous system disorders are investigated, brains examined. They are doing surveillance. Since 1990 they have looked at greater than 2,400 brains. I don't have an exact figure, but that at least will give you an idea.

And how does that relate to their population? Australia has a lot of sheep, 120 million sheep, but one significant fact. A vast majority of those are the Merino breed. That's a wool breed, not really high prevalence for scrapie.

Okay. Let's move over there across the Tasman Sea and talk about New Zealand. Again, New Zealand also has a very strong veterinary infrastructure. They also have stringent import controls.

They, however, have had two incidents of scrapie. Similar the first time as in Australia, 1952 and 1954. Again, these were Suffolks that were imported from the U.K. They initially had identified scrapie in 1952 and slaughtered those affected animals. However, in 1954, there were some contact herds, and some of those initial imports had moved around. So they diagnosed the disease again in 1954.

And they slaughtered all of those affected herds and contacts and did not have problems again until in the 1970s. They decided they would again some imports from the U.K., and these animals were still in the offshore quarantine.

Both Australia and New Zealand traditionally are using the offshore quarantines for their live animal imports.

And these were different breeds. In 1976, the first one was an East Friesian sheep, and in 1977 then it was a Finnish Landrace. These both were from the U.K., but different breeds.

All of those imports then were slaughtered and were never released off the quarantine.

Again, scrapie is notifiable in New Zealand. All nervous system disorders are officially investigated. They also are doing fairly active surveillance, greater than 1,100 brains sine 1990, and this figure here, greater than 325 since 1994, that just breaks it down a bit more for you.

How many sheep do they have? They also have quite a few, 50 million sheep, but they have various breeds. It's not the high preponderance of the Merinos as in Australia.

Countries under review. South Africa has requested that we recognize their status in relation to scrapie, and our review has been ongoing for a while. They have diagnosed scrapie, in 1966, and they did a very stringent eradication program and eradicated the disease in 1972.

Since that time, they've had an active -- well, an ongoing both active and passive surveillance program. They have looked at many, many sheep brains. So initially our review is fairly favorable.

We do have some outstanding questions. So that's not completed totally yet.

And this next bullet, "can expect others in the future," let me kind of side track here into some of the questions about our North American partners.

Mexico, as I stated, has requested that we recognize them free of scrapie. We really haven't started that review. We're very unsure of the amount of information that they have provided us.

We're also a little bit leery of the fact that we send hundreds of thousands of culled ewes to Mexico every year for slaughter, but we know some of those animals are diverted into Mexico. So it's a bit hard to at least at face value take the fact that Mexico is claiming they're free of scrapie when we know that we send them large numbers of animals, and we have scrapie here in the U.S.

So that is a concern of ours, but that will be under review in Mexico's status.

Canada's status essentially is similar to ours, and at this point in time, they do have a scrapie control program. I believe people probably have seen some of the press reports. In Quebec they really had a significant scrapie problem in Quebec over the past year or so and have slaughtered quite a few sheep.

They also are in the midst of developing a voluntary certification program similar to ours. I wasn't able to confirm if they've actually finished that and have gotten it started yet, but their industry tends to kind of run along the same lines as ours, and I know that the two industries like to coordinate things just because we do have more truly North American market. There's a lot of movement back and forth.

Let me try and clarify some of our import regs I think at this point would be a good spot for that. Traditionally in relation just to scrapie, we have not accepted sheep and goats from countries other than those countries that we defined free of scrapie, i.e., Australia and New Zealand, or countries that we considered had an equivalent surveillance system, i.e., Canada, just because that's a large volume of trade.

So traditionally that's where most of the live sheep imports have come from, have been those three countries.

Now, there was a brief window of time in the mid-'80s where we decided, okay, let's broaden this out. We had a lot of demand for additional genetics, and we decided, okay, we would allow either genetics, i.e., semen and embryos, or in certain cases some live animals from countries that, again, either were free, and these would be mostly European countries, or countries that could demonstrate to us that they had an adequate surveillance program, and that they could justifiably say, okay, these are certified free flocks.

And we did import quite a few embryos and semen. We also imported some live animals from continental Europe, not in significant numbers though.

So let's get back specifically to Mexico. We have not brought in live animals from Mexico with one exception every year. Annually we allow in about 5,000 kid goats and lambs essentially for certain ethnic purposes, I guess, for lack of a better word, anyway, folks that like the barbecued kid goat, Cabrito. So we allow those animals in. However, they're immediately slaughtered and are not going in for breeding purposes.

Other animals from Mexico traditionally have not been allowed in because we have not recognized them free of scrapie.

So hopefully that has clarified a bit of some of the confusion earlier. Now, let me get into some points about scrapie free flocks. What could we do for flocks in the U.S. to assure that sheep and goat materials would be scrapie free?

Again, we do have the voluntary flock certification program. We administer that program. We believe in that program, and we think that if a flock has achieved certified status, that that could be a very low risk of scrapie. Certified status means they have participated in the program for at least five years and have had no known problems for that period of time.

If we wanted to look at flocks in other countries, you could apply those same standards and say that a scrapie free flock would be one that has achieved an equivalent status in another country.

However, you could also do additional monitoring, and this is where I'm getting into a bit of a repeat of what Dr. Sutton had presented. Additional monitoring for certified free flocks could include that you're required to examine tissues from all dead animals over 18 months. If a ewe over 18 months dies, you have to look at the brain. You have to examine that brain, look at tonsils, lymph nodes, whichever other tissues you so chose.

Another option could also be to include genetically susceptible animals as sentinels. Now, I realize we've already had a detailed discussion about genetics. There's a lot unknown about genetics, but there is some that is known, and I think if you had known susceptible animals and you put those in a flock, they could serve very well as sentinels, and if you had a problem that was not actually showing up in the flock, if you had known genetically susceptible animals, especially those with a known shorter incubation period, if the agent was there, it would be more likely to show up in those animals. So that could give you an additional assurance factor.

Live animal tests. I believe Dr. Sutton adequately covered those. Those might be a future possibility for other options, and also donor animal testing at slaughter. I'm not extremely familiar with the tissues that are used and exactly what we are talking about here, how they are obtained. However, if they were obtained at slaughter and if you could hold those tissues or hold that carcass while you did some testing, this could be another additional option, or you slaughter the animal and you pull out brain, tonsils, lymph nodes, whichever, do the testing for PrP on those tissues, and once you got negative testing on those tissues, then you could release the carcass, release any of the other materials that would be used.

That, however, does lead to some consternation. As discussed, again, earlier in the abattoir surveys, what do you do if you have an animal that is positive on some tests and negative on others? I guess my best recommendation there -- and you all can kick this around further as I'm sure you will -- would be to go for the better safe than sorry school, and if there's any positive, then you would cancel out that animal.

Other considerations. I'll just hit these. We don't need to go into any further detail.

Closed versus open flocks. If you have a closed flock, you've got a more defined population, more control, and that would most likely be a better source.

Genetics. I won't even go into that one again.

History. You need to know have they been exposed to scrapie, possibly exposed to scrapie, even remotely exposed to scrapie.

And again, feeding practices. At this point in time we do have a feed ban in effect, but that's only been in effect for a year or so. What about earlier, prior to that?

Now, I started off with our colleagues down under and mentioned the fact that they had very stringent import controls. They have imported sheep and goats and/or genetics in the past decade or so. However, they've done this under very strict conditions, and this is sort of a summary of those conditions.

I am putting this in because I thought this might be useful as a demonstration. Initially I thought it was a bit hard to wrap my head around this problem, to say, okay, well, this is an import solution to prevent scrapie from coming into a scrapie free country.

However, if you look at it another way, it could be similar to one point actually that Dr. Asher had mentioned initially, that this could be a way to establish from genetics a known free flock from known free progenitors. This is essentially what Australia and New Zealand were doing with these programs, and they called them their scrapie freedom assurance programs.

First of all, it started off with a quarantine isolation. You had a defined population that was going into a very strictly controlled situation. Usually this was off shore, but if you're looking at this in more generic terms, that could be anywhere as long as you have defined isolation.

They introduce sentinel animals in there, both sheep and goats.

New Zealand, especially, never released the actual import animals. They only released the germ plasm from those animals. So they had an embryo transfer barrier essentially, but they collected both embryos and semen. Australia did the same thing, collected embryos and semen from these animals, froze those, and saved them until the end of the release.

And each of these quarantines were -- initially they were at least five years. In Australia's case they've extended that out to seven years in one instance. New Zealand has now backed off of the five years and is going with three years, but it is an extended quarantine time.

Now, significantly they did bioassays, and it varied in each import and also from each country, exactly what they were using. New Zealand traditionally used mesenteric lymph nodes, and they would pull those nodes from the imported animals themselves. They injected them intracerebrally and I believe also intraperitoneally into some of the sentinel sheep and goats.

They have also in Australia -- they also collected placentas, and they did pooled uterine washings. As they were collecting embryos, they would use those flush fluids and, again, would inject those into the sentinel sheep and goats. Then they would examine the sentinel sheep and goats.

There were examinations also of all of the imported animals, any that might have died during the quarantine, and then they usually were never released off of the quarantine, but those animals themselves were also examined, each and every one of them, and all of the sentinels were examined.

So that is a very stringent program, but that is an example of one very tight program that could be used.

Other considerations, final points. In the information that has been sent out, it's been referenced that there are no OIE guidelines for scrapie as there are for BSE. However, I thought it would make the point that this chapter on scrapie is in development and has progressed fairly far in the process. It was up for comment again this year, which means it will at least be another year down the line. The earliest it could be adopted would then be next May. However, it might even be beyond that.

But it is in development. It's looking better, and in this new chapter there will be guidelines for defining free zones, for establishing free flocks, and it also will include minimal requirements for effective surveillance and monitoring. So that will be a tool that we can use in the future.

And I believe that that is all that I had to cover this morning.

(Applause.)

CHAIRMAN BROWN: Thank you, Dr. Ferguson.

Is there a question or two before we break for lunch? Bob?

DR. ROHWER: I really would, with the Chairman's permission, like to badger you to find out exactly how much exposure we have had from imported animals. It sounds to me like we did import live animals from Europe or maybe even the U.K. in the mid-'80s for breeding purposes; is that correct?

DR. FERGUSON: We did not import live sheep from the U.K. in the mid-'80s. We did import cattle in the mid-'80s. All of those animals, I think -- you guys are well aware of that, but we did not import sheep.

Linda will help me out here as I screw up. We have some animals from Belgium. We currently know where those animals are and are dealing with that situation.

We brought in other -- live animals, there were not that many. Semen and embryos was more significant.

DR. ROHWER: So we've also imported animals from Europe since 1989 is what you're saying?

DR. DETWILER: Let me.

DR. FERGUSON: Yes.

DR. DETWILER: I can give you the whole rundown since this is my nemesis for the last two years here.

We imported 65 East Friesian and Textel Charolais from Belgium/Netherlands. They came in under the flock certification program. Then they announced all of the information on the BSE in sheep and goats. In that small window of opportunity after they came in, they actually came into three different flocks in the country. Two were in Vermont. One was in New York.

As soon as we were made aware of this really potential and the possibility of the feeding of the meat and bone meal, the sheep were quarantined. None of the imported animals were entered into the human or the animal food chain.

Since that time we have attempted to buy the animals. We have gotten the ones in New York. We have not gotten the ones in Vermont. Even their progeny and their subsequent progeny are all under quarantine. They've been offered money. Basically nothing can move off the farm, even to slaughter.

If they want to go and cull, go to slaughter, we buy them. Tissues get collected, and the carcasses get incinerated. The same thing happens if something dies.

So we're in this pattern of trying to do something with them.

We've offered something similar with the germ plasm, that they would collect germ plasm. We'd, you know, slaughter all of the imported animals or all of the live animals, run all the tests on them, and if everything was clean, then release the germ plasm. So that's been offered as well.

DR. FERGUSON: But I think let me try and clarify one more time. Probably where the confusion is coming in is initially in '89 our restrictions applied, restrictions on ruminants applied to countries that had identified BSE in native animals. Okay? The U.K., France, blah, blah, blah, that list.

So those other countries that had not identified BSE in native animals at that time, let's say, in 1992, we could have allowed live ruminants in from those countries. Now then you add our scrapie controls kind of on top of that, and until a certain period of time, we were not accepting live sheep except from those countries that I described in here.

Then there was a brief window, like '95-'96, where we changed that policy, and we did allow some of those sheep in, and that's where we allowed the group in from Belgium. At that time Belgium had not diagnosed BSE in native animals. So they were clear on the BSE front, and then we looked at the scrapie issue and said, "Okay. They've got a surveillance certification program." They were clear on that issue.

Does that help?

CHAIRMAN BROWN: It's nice to know that Yankee farmers are so stubborn.

(Laughter.)

CHAIRMAN BROWN: It would be disappointing if you had any other result.

Are there any other questions?

(No response.)

CHAIRMAN BROWN: In that case, we will break for lunch. It is now 12:15. We'll reconvene in one hour, 1:15.

(Whereupon, at 12:16 p.m., the meeting was recessed for lunch, to reconvene at 1:15 p.m., the same day.)

Hellman