DR. HONSTEAD: Thank you very much, Paul, and thanks, Jim. I don't know if you ever thought your work would be used by FDA, but it is, and it's still today very useful, and Jim comes to a lot of animal health meetings, and it's great to have him around.

I'm John Honstead. I'm from FDA. I'm a veterinarian with the Division of Animal Feeds, and that's the reason we're involved in BSE.

I'm going to give you today the briefest summary of the FDA regulation that's ever been given in history. Because it's going to be so brief, I think it's really important that you have our Web site: www.fda.gov/cvm. It's very simple.

On that Web site are a lot of support documents for the regulation that we've prepared for industry and for anybody to help explain this and make it understandable and get it fully implemented.

Okay. Epidemic curve for the British epidemic and slighted a little bit to the -- I just want to point the other way. I just want to point out here that the rate of decline in Britain has slowed down dramatically. They had originally predicted a decline to insignificant levels in Britain by 2001. This is the British government, and their last report no longer says that. It says that the rate of decline is very slow, and we don't know when it's going to end.

So they may have an endemic situation there for quite a while. We don't know.

Next.

The FDA BSE feed regulation went into -- was finalized in June of 1997. It is a mammalian to ruminant ban. Mammalian proteins are prohibited from being fed to ruminants in the United States.

It is a protein ban. It only applies to proteins. It does not apply to fats. It does not apply to mineral supplements where there is no protein in them. It's only mammalian proteins. It does not apply to fish products, fish meal or poultry, feather meal and such from non-mammals.

And there are five exemptions to this regulation. It does not apply to pure swine and pure equine proteins where these come from a renderer who only does pigs and horses. Now, there is no such renderer for horses, but there are several renderers that do nothing but pigs, and so this protein is acceptable for ruminant feed.

Blood, milk, and gelatin and those types of products are exempt, and plate waste, which is food that's been prepared and cooked for human consumption does not get used or it's not eaten that day, and it is reprocessed for usually cattle feed. This material has a very small amount of meat in it. All of the beef in it comes from USDA inspected, healthy, non-CNS animals, and it's reheated in some sort of process for cattle feed, diluted with large amounts of corn to balance the ration.

In general, the regulation requires -- I have to say that in the past before this regulation, everything was rendered together in one big process. There was never any reason to suspect that anything in any of the proteins in meat and bone meal was of danger to any animal, and so in 1997, this sounds like a simple change, but this in effect was a humongous change for the feed and cattle industry to accomplish. It's very difficult.

Renderers and feed mills must separate the prohibited materials from non-prohibited materials if they handle both, and they must have a written plan to describe and follow as to how they'll do this.

They must label everything that has prohibited proteins in it with the statement "do not feed to cattle or other ruminants." They must keep records sufficient to track the incoming materials and their outgoing materials. They must keep these records for one year, and these records have to be made available to FDA or state inspectors upon request in an investigation.

For renderers, and these are the people that take the fresh gunk and cook it into water, fats, oils, and the bottom stuff in the pot is protein, and it makes an excellent animal feed.

If they handle both, they can choose to separate or not separate prohibited and nonprohibited materials. If they separate it, again, they have to have a plan. They must clean their equipment between the two, and they must follow this plan.

Most renderers are not separating it. It's not efficient for them, and they simply specialize. They either handle prohibited or they handle nonprohibited.

They must, again, label it, and this labeling for renderers which generate very large amounts of this protein is usually in the form of statements on the bill of lading, the shipping materials and those sorts of things, as well as placards, possibly on the rail cars themselves, and it would say "do not feed to cattle or other ruminants."

Their records would have to be able to trace the incoming materials and the outgoing materials, and they would have to keep these records for one year.

Protein blenders, in between the renderers in this country and the people on the farms feeding cattle is a huge system of brokers, feed mills, protein blenders, distributors. Some people only handle this stuff over the phone. Others have trucks and haul it, and it's very complex.

Those people involved in that also have the option of separating or not separating it, and many feed mills have simply gone to absolutely no prohibited material in their operation if they're making feeds for a variety of animals including ruminants.

They have to label any feed products containing prohibited material with a statement "do not feel to cattle or other ruminants," and this label has to be prominent. If it's a bag of feed and these bags are printed, then it has to be on the bag itself. Many bags just have a feed tag on it. It must be very prominent on that sewn in feed tag.

Again, they have to keep records to track it, both incoming and outgoing, and keep those records for one year.

People that feel ruminants, and this falls into two large categories, producers that mix feed on their farm and producers that buy a complete feed and don't do any mixing at all.

Again, they have to maintain all incoming feed invoices so that they can have proof or identification of whether they're getting prohibited materials. They have to keep these labels, and certainly they have to obey the label, and the paper work has to be made available to FDA and the state feed inspectors on request. They have to keep these for one year.

Pet food, you won't find this statement on pet food in the grocery store. Retail pet food going to grocery stores is generally not fed to ruminants at all. It goes to cats, and it's in grocery stores, but as soon as pet food is damaged or unacceptable for use in pets and it gets diverted away from the retail pet food market, it then falls under the regulation and must be labeled.

Now all of the other paper work, tracking, and records is maintained for pet food. They do have to keep records. They simply do not have to label the retail package.

In conclusion, the long incubation period that we've heard a lot about the last two days, it could lead to undetected amplification of BSE in the United States if we recycled ruminant mammalian proteins back to ruminants. So its intent is to prevent undetected amplification of BSE in U.S. ruminants.

It identifies prohibited materials with the label, and it bans the feeding of these prohibited materials to ruminants.

There's a tremendous amount of cooperation going on in the United States. Two-thirds of the inspections have been done by state feed inspectors and the data and the results from those have all been sent to our Center for Veterinary Medicine, and this has been a great cooperative effort, and as we've always heard, we need more research in BSE so that we could understand the implications of U.K. BSE and BSE in sheep and all of these things to this country.

So sheep materials and cattle materials cannot be recycled back to cattle and sheep in this country through animal feeds.

Thank you very much.

(Applause.)

CHAIRMAN BROWN: Thank you, John.

We have time for one or two questions. Stan?

DR. PRUSINER: How did you decide on the one year record keeping?

DR. HONSTEAD: That is a requirement so that we can find out as we show up at an operation as to whether they're in compliance with a regulation. It is not intended to help us or USDA trace a case of BSE's feeding history.

There's a Paper Work Reduction Act now in effect for the entire federal government, and it makes it difficult to impose large amounts of paper work to our customers. One year would suffice for us to see if you're doing -- if the farm is doing its job right. We would have to look at whatever paper work was available in case we were trying to follow up on the feeding history of a case of BSE.

DR. PRUSINER: Okay.

CHAIRMAN BROWN: Bob.

DR. ROHWER: John, we're all very pleased with the implementation of the feed ban, but of course, it's only as good as it's being followed, and how are you going about ascertaining the level of compliance and assuring yourself that it is actually being implemented fully?

DR. HONSTEAD: Of course, it's not 100 percent implemented. We would love to see that, but it's such a huge change and many, many, many of the animal producers are very small, and what we're doing, every inspection performed fills out a two page set of data, questionnaire. That is sent to CVM. We put it in a database, and from that we have an understanding, but non-random, of course.

These BSE inspections are generally performed in conjunction with some other reason to visit the feed mill or farm, and so we have collected this data, and the compliance rates are different for renderers, feed mills, and producers, but they're very encouraging. Almost all of the renderers are doing their job right.

And when the rendering material, meat and bone meal is done correct, then it, of course, gives you a chance for maintaining the feed ban throughout the industry, but we have not done randomized sampling. Our inspections are not random. So we don't have nationwide statistical information on compliance.

CHAIRMAN BROWN: Yes, last comment, Jeff. Oh, sorry. After Jeff, Dave, and then we'll move on.

DR. ALMOND: Okay. Just three very quick comments. The first is I was a little surprised that your plate waste recommendation meant that that material could still be used, the point being there will still be sheep material in that plate waste, and it will include catering waste where you may have essentially the whole of the spinal column of a sheep going back into the rendering industry.

If sheep is the source of VSE, then that would allow the possibility of the spark of BSE cases here as it may have done in the U.K.

The other thing, of course, is the amplification and just elaboration on that. The back calculation method of Anderson and colleagues suggest that at the time when Gerald Wells made the diagnosis of the first two cases of BSE in the U.K. in December 1986, that by then we had 60,000 infected animals. So this disease with that incubation time in cattle of five years, you know, really does amplify before you see it.

The final comment I wanted to make was on your indication that the BSE epidemic in the U.K. is not declining. I accept that the latest figures do show a tailing, and it's not absolutely clear why that is, but in the mathematical modeling of Anderson, a tail is expected depending on the relative contribution of the final animals being derived from either maternal transmission or leak, leakiness in the feed ban.

Now, the feed ban no longer leaks because we banned meat and bone meal for any animal products. They should never go near the farms as of April 1996. So what's left, new cases should be only maternal, and we were prepared for a tail if a majority of those cases we're seeing now are indeed maternal.

The point about it though, as Anderson points out, you would not get -- we are pretty confident or very confident that you will not get endemic BSE in cattle because the R zero value is clearly below one. The R zero value is the number of cases from any one case of BSE that you observe, and the transmission has to be one in order for it not to die out.

So even if there is some transmission cow to calf and some transmission animal to animal, it will disappear because the R zero value -- the epidemic we've observed is not -- is not compatible with an R zero value above something like .1. So it really will go away. It may have a long tail, but it will go away. That's our position at the moment.

DR. HONSTEAD: Thank you. I appreciate that.

I said that the rate of decline was decreasing, but I didn't say there was no decline. There is a decline. It's just slow. Thank you. Thank you for that.

CHAIRMAN BROWN: Do you want to respond to the plate waste and then we'll go on?

DR. HONSTEAD: This reg is written for country right now without BSE, and the plate waste is, again, from animals with no CNS diseases, and it's a very small amount, and even though heating won't completely, of course, inactivate this, it is our requirements for reheating for animal feed are associated with pelleting machines, which do get it hot, and it just -- this would present, you know, a very, very small risk in a BSE-free country.

And I agree with what you say about what they felt like in England when they found their first cases, but the longer this ban's in effect and the longer we are BSE negative, then it's pretty difficult to think that this poses a significant risk.

CHAIRMAN BROWN: Dave.

DR. BOLTON: Yes. A question regarding -- a two-part question regarding compliance. Do you have any idea what the cost differential is to the end user of the two types of feed now?

And the second part is: what are the penalties for the end user of being in violation of the use?

DR. HONSTEAD: The cost differential, you mean for something like pure pork protein versus mixed prohibited materials?

DR. BOLTON: Right.

DR. HONSTEAD: I don't have those with me. You can look in the Feedstuffs magazine, and they may have something on line, but they track the prices of this stuff, and it changes a little bit, but it has not been a type of cost that would break an industry or put anybody out of business.

It was much smaller than the renderers predicted it would be.

DR. BOLTON: It's not sufficient then to induce somebody to risk any penalties that they would incur by using that feed as opposed to using the correct feed?

DR. HONSTEAD: I don't think so because there's been a lot of specialization. The hog plants are putting out a very good protein. There are also uses for all prohibited materials. It can be used for hog feed, horse feed, and one of the biggest uses of all these proteins is pet food, and so our reg did not interfere with a great deal of use of these proteins. It just caused them to be separated and identified, and the larger renderers, which is what most rendered product comes from, only a few very large renders; they specialized, and so these markets are being utilized to accomplish the goals of this economically.

And there was a change, but it has not been dramatic, and it is working very well right now.

DR. DETWILER: John, can I just add that -- it might help answer Dave's question, too -- no, usually the differential is not enough to cause somebody. That would be economic incentive.

The other thing, the availability of the soybean protein here in this country, too, gives another big area of a protein source.

CHAIRMAN BROWN: Thank you very much, John.

We now have our last presentation before lunch from Dr. Lisa Ferguson, Animal and Plant Health Inspection Service of the USDA.

Dr. Ferguson.

DR. FERGUSON: And bear with me for a moment here while I get the computer up and going again. It worked for Diane. So we're hoping it still works for me.

(Pause in proceedings.)

DR. DURFOR: Mr. Chairman, could I take this opportunity to ask a question of Dr. Almond?

I would find this R value calculation much more persuasive if the same analysis had been applied to scrapie because I wonder if you'll get an R value of greater than one for scrapie because of the way in which the endonicity manifests itself at very low in herd incidences and very long incubation times.

DR. ALMOND: I haven't done those calculations, the work of Roy Anderson and his colleagues. So I couldn't precisely tell you whether the comparison with scrapie has been made, but what you do have in BSE is a very, very strong evidence of a falling incidence, and if there are no -- above one, you would not have a falling incidence, and since the beginning of 1993, we have fallen from 4.3 thousand cases a month down to 300 cases a month.

So I think there is plenty of evidence there for a negative R value or a less than one R value in the cattle, and I appreciate that we probably don't know what it is in the sheep.

DR. ROHWER: I mean, I understand that. I'm very familiar with the epidemic curve, but I just wonder if the same thing wouldn't be true for sheep. For example, after the vaccine, the loping L vaccine incident, there was apparently a bolus of scrapie which then subsided again back into endemic levels after that incident, and how do we know that this isn't going to happen with BSE as well?

I understand the calculation. What I'm saying is I think in nature we have an opportunity to test the validity of that observation by looking at scrapie itself and seeing how well that number plays out.

DR. ALMOND: I accept, and I'm the wrong person to be answering your question, other than to say Roy has looked at this quite carefully and has concluded that the R value for BSE in cattle really cannot be anything like approaching one, but I do take your point that when you have an epidemic spread around by something else, the decline because of then the removal of that something else may take you back down to a low level which is enough to establish an endemic disease, but I think we just have to wait and see.

CHAIRMAN BROWN: Dr. Ferguson is now ready.