BSE Open Forum -- February 13, 1997
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE AND
THE OFFICE OF CONSUMER AFFAIRS
PUBLIC MEETING FOR CONSUMERS REGARDING
FEDERAL REGISTER 21 CFR PART 589
SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD
OR FEED; ANIMAL PROTEINS PROHIBITED
IN RUMINANT FEED; PROPOSED RULE
Thursday, February 13, 1997
9:06 a.m.
Holiday Inn - Capitol
550 C Street, S.W.
Washington, D.C.
CONTENTS
Introduction
Michael Blackwell, D.V.M., M.P.H., Deputy
Director, Center for Veterinary
Medicine, FDA
Overview of the Proposed Rule
George "Bert" Mitchell, D.V.M., Associate
Director for Policy and Regulations,
Center for Veterinary Medicine, FDA
Environmental Assessment
John Matheson, Senior Environmental
Specialist, Center for Veterinary
Medicine, FDA
Questions and Answers
Open Comment Period
Dr. Michael Hansen, Consumers Union
Caroline Smith DeWaal, Center for Science
in the Public Interest
Bob Hahn, Public Voice
Linda Golodner, National Consumers League
Richard Wood, Food Animal Concerns Trust
Mary Finnelly, Human Society of the
United States
Felicia Nestor, Government Accountability
Project
Richard Beckwith, Hilltown Pork, Inc.
David Bossman, American Feed Industry
Association
Dennis Griffin, National Renderers
Association
Dr. Don Franco, Animal Protein Producers
Industry
David Evans, National Renderer
Association
Barry Talley, National Renderers
Association
Dr. Gary G. Pearl, Fats and Proteins
Research Foundation, Inc.
Dr. Jerry Breiter, American Meat
Institute
Mike Langenhorst, National Renderers
Association
Bruce Blanton, National Renderers
Association
Dr. Fred Bisplinghoff, National Renderers
Association
Douglas Anderson, Darling International,
Inc.
Dr. Beth Lautner, National Pork Producers
Council
Questions and Answers
Adjournment
MR. GAYLORD: Good morning. We will be starting our meeting in just a few minutes. We are trying to give some more people a chance to come in, so we will start very soon.
[Pause.]
MR. GAYLORD: We are going to go ahead and get started for this morning. I would like to introduce myself. My name is Charles Gaylord and I am the Acting Associate Commissioner for the Office of Consumer Affairs. On behalf of the Food and Drug Administration, I would like to welcome each of you to FDA's public meeting on the proposed rule, substances prohibited from use in animal food or feed, animal proteins prohibited in ruminant feed.
As you remember, in the January 3 Federal Register, it stated that there were going to be meetings both for industry and for consumers. The industry meeting was held in St. Louis recently, and I understand as of today, the transcript of that meeting is on CVM's, the Center for Veterinary Medicine's home page. That meeting was very successful, and today, in tandem with that meeting, we have its counterpart for consumers. So we welcome all of you today for today's meeting to discuss this proposed rule.
Now, I know that looking at the list of presenters for today, that some of you from that industry meeting are also here to participate in that forum, and that is good. The more dialogue that we have, the more comments, the more FDA will be better able to respond and to address your concerns.
When we look at the Office of Consumer Affairs in the Food and Drug Administration, we see that the mission is to bring about an exchange of information between the agency and the public. We do this by talking about the policies and programs that the agency participates in and how they impact on the public's health. In addition, we are responsible for facilitating a dialogue between the agency and the public. In this way, the public gets involved in the decision making processes of the agency itself.
So how can this be done? Well, it requires that the agency learn consumer views, learn about their attitudes and their feelings on specific topics, and so discussing the proposed rule today will allow different points of view to be put on the table for consideration in the final rule.
When we think of the past results of public participation, we see there has been very fruitful collaboration between consumers and the agency. We might think of the food labeling, and now the food labeling has taken hold of the public. People are using it to make decisions affecting their health. We also might think of the recent med guide deliberations with the Keystone Center, and basically, now there will be a plan where consumers will have more information on the prescription drugs that they use. This is the collaboration at its finest, where there is a dialogue between the agency and the public.
Therefore, in considering the proposed rule banning ruminant-to-ruminant feeding, your comments will be evaluated and considered as part of the record and deliberation before the final rule is actually promulgated.
By looking at FDA as a whole, we know that it is the oldest consumer protection agency in the country and it has the vast range of products that it regulates. It regulates the safety and effectiveness of over $1 trillion worth of goods. When we think about that figure, we cannot really comprehend that, $1 trillion. But fully 25 percent of all expenditures from consumers are spent on items that the Food and Drug Administration regulates.
This agency has been protecting consumers against public health risks for over 100 years and we haven't done this in a vacuum. Each day, there are new challenges, there are new concerns, and we do our best to find the answers and are committed to seeking the answers to these challenges. Our responsibilities encompass drugs for people and food, the food supply, medical devices, human biologics, animal feed, and all of these things, when you look at all of these products that affect the American public, are part of our everyday lives. We think of the vital role, again, that the agency plays.
So each one of these product areas has been looked at and considered with respect to the potential for transmissible spongiform encephalopathies, or TSEs, in humans or animals. We looked at what happened in Europe and we know that there is great concern in this country that there not be a repeat of that. So as Dr. David Kessler said, this proposal will, and I quote, "build a protective barrier against the spread of BSE."
We need meetings such as these to empower you to question the agency and to keep the focus on science. We know that there is no end of speculation. There is, everywhere we look, a vast amount of information on the topic of TSEs and, most notably, BSE being the most prominent of those in the news.
If you were to go in the Internet, you would see several "mad cow" home pages, and if you look at those particular Web sites, all of them are very popular. Looking at one last night, they had a head of a burning cow with flames all around it. I don't know what the symbolism of that was, but again, this is something that's on the public's mind.
Now, looking at Time magazine of two weeks ago, they published an article and it asked, U.S. beef, could mad cow disease strike here, and it reported on the science journal Nature that tried to project the number of Europeans that could potentially become ill due to their exposure to BSE. And in looking at that situation, they used a complex epidemiological model to project a range anywhere from 75 up to tens of thousands of people getting sick, and the concern was that scenario could play out in this country.
The irony is that because Britain has taken concrete steps to reduce the threat of BSE in their own country. The paper didn't have much of an effect there, but the opposite was true here. It hit a responsive chord. So each new article, each new bit of information that comes out leads to the concern that consumers have.
So, therefore, meetings such as these are necessary to help dispel those concerns, help alleviate concerns and answer questions that people have.
Now, the European Community in the wake of the beef crisis that they had are calling for the creation of an independent body to monitor food safety and, I quote, "dispel the climate of fear among people." It has been suggested that the United States Food and Drug Administration be the model for that independent body. So whether we talk about things on the domestic front or internationally, we see that this issue must be addressed and rational measures need to be taken both here and abroad.
So FDA's mission is simply this. It is to protect the public health, and today, we are here to further that mission.
Before I turn the microphone over to our next speaker, I want to let you know that as the meeting progresses, if you have any concerns or needs, please feel free to ask any of the FDA personnel that you see here with the name tags. We have the distinctive teal and blue name tags and we will be more than happy to address any concerns or questions you may have or direct you to the person that can answer your questions.
Our next speaker is Dr. Michael Blackwell and he is the Deputy Director for the Center for Veterinary Medicine. Dr. Blackwell is responsible for developing and implementing veterinary medical policy for FDA and for providing scientific and regulatory expertise for surveillance and compliance in the veterinary area.
In addition to his duties for CVM, he also holds the position of Chief Veterinarian of the United States Public Health Service, representing the Surgeon General in contacts with public and professional groups associated with veterinary medicine. Please welcome Dr. Blackwell.
[Applause.]
INTRODUCTION
DR. BLACKWELL: Thank you, Mr. Gaylord.
I am honored to welcome you here today to participate in this second public forum regarding our proposed rule, substances prohibited from use in animal food and feed, animal proteins prohibited in ruminant feed. The first forum, held last week in St. Louis, involved about 100 participants and is regarded as being successful in achieving dialogue. That meeting emphasized the economic assessment of the proposed rule. Today's meeting is organized to focus more closely on consumer interests.
In order for FDA to carry out our mission, it is very important that we provide a forum for you, the consumer, as well as other stakeholders, such as the regulated industry, to provide us feedback and share concerns. Meetings such as this afford you the opportunity to influence our decisions, but these meetings also give you an opportunity to hear from us directly. Face-to-face dialogue helps to advance public health and we are committed to continuing to seek your input on major initiatives being pursued by the Food and Drug Administration.
The Center for Veterinary Medicine's mission is to help man and animals by ensuring the availability of safe and effective animal products. We are very pleased to be joining in partnership with the Office of Consumer Affairs to provide you this opportunity to dialogue with us.
The proposed rule published January 3 of this year provides that animal protein derived from mink and ruminants, such as cows, sheep, and goats, is not generally recognized as safe for use in ruminant feed. The effect of such a rule under the Food, Drug, and Cosmetic Act is that animal protein from these sources cannot be legally added to ruminant feed without a food additive regulation or an exemption.
The proposed rule is the latest in a series of preventive measures that FDA, other Federal agencies, and industry have taken to protect animals from transmissible degenerative neurological diseases, including bovine spongiform encephalopathies, or BSE, and to minimize any potential risk that such diseases could be transmitted from animals to humans.
The agency has two objectives for these public forums. First, to provide information and answer questions about the proposal and related issues, policy issues. Secondly, to provide an opportunity for feedback and comment from consumers and industry.
It is my hope that as a result of these public forums, consumers will have a better understanding of the proposed rule and that all parties will have an opportunity to voice their perspectives and concerns.
The recorder is here today to make a formal transcription of the proceedings. Copies of the transcripts from the two public meetings will be made part of the docket for the proposed rule. Individuals who were unable to attend these two forums or individuals who would like to expand on comments voiced today may submit their comments in writing to the public docket, and that docket number is 96N0135--96N0135.
We also encourage you to submit in writing to the docket any comments voiced verbally today. Of course, the closing date for the comments is February 18 of this year.
The entire docket, including the transcripts, will be available on the FDA home page. As you just heard, we already have that available from last week's meeting. Our Web address would be www.fda.gov. In addition, copies of the transcript will be available by filing a Freedom of Information request with the FDA.
To write the final rule in the coming weeks, the agency will be carefully reviewing the transcripts of the public forums and all of the submitted written comments to the docket. Again, we thank you for attending and look forward to your comments, and again, I want to thank the Office of Consumer Affairs for facilitating this meeting, coordinating the many things that go into making this sort of thing happen.
I have been asked to serve as the facilitator, and I hope I will use that power appropriately. One thing I know I am going to have to do is serve as something of a traffic cop. We have a number of people who have indicated a desire to make comments. Our time, although it is not limited in the extreme sense, certainly has to be attended to and appreciated, and so we are going to ask that if I give you the nod, to bring closure to your comments, if you would please cooperate with me on that.
The panel today represents each of the centers in FDA as well as APHIS and FSIS in the Department of USDA. We will be asking each of our panelists to introduce themselves to you so that you will get to know a little bit more about where they are located. Someone characterized the group as a brain trust, and I think that is an appropriate descriptor for this group. But we also have a number of members from both agencies--all three agencies in the audience as resource people, and as the panel members see appropriate, we will call on them.
Because the meeting is intended to obtain feedback from consumers, the consumer groups desiring to present will be allotted a little bit more time for comments than the associations and industry groups making comments. After all, they had their chance last week in St. Louis and we want to make sure that our consumer groups are, in fact, able to have sufficient time today.
However, if additional time is needed for comments, we will consider lengthening this meeting in order to make sure that all are heard. So hopefully, no one will leave feeling they did not have an opportunity to express their comments.
During the open comment period, then, we are going to ask the presenters to use the mike in the center aisle and for the consumer groups, if you would limit your comments to no more than ten minutes. We are not asking you to try to fill ten minutes. If you can get it done in three, that is great. We could use the extra minutes.
For all others, we will ask that your questions and comments also be presented from the same mike but that you would try to limit yours to no more than five minutes. Again, we will do our best to make sure everyone is given the opportunity to share what you came here today to share.
A little bit on the housekeeping side. The restrooms are located not very far from here. If you go out the doors and make your way in that direction, you will come upon a guard's station on your left. You just turn right there and the restrooms are on the left as you proceed down that corridor. Anyone in that area will probably be able to assist you if you have some difficulty.
The telephones are a little bit further in the same direction. And, of course, drinking fountains are located there, but we do have water in the room and some other refreshments.
Sometime during the morning, we are going to work a break in. I don't know exactly where that will occur. We are going to try and time it so that if people are starting to squirm a bit, look a little anxious, we will figure that's time to take a break. If I haven't picked up on that fact, you might give me a signal and let me know that that time has come. We will try to be very sensitive to the need.
For the most part, we will follow our agenda as printed, this very nice, colorful agenda here, and I will actually reorder the commentors who are listed at the end of this agenda. We will get to that when that time comes.
With this bit of oversight, I am going to ask if our next speaker will come to the podium. Many of you, or most of you probably know Dr. Mitchell. We will ask if he will come on up and give his comments. Thank you so much.
[Applause.]
OVERVIEW OF THE PROPOSED RULE
DR. MITCHELL: I have a few slides to show, but before I do that, we would like to go across the head table here on the podium and have the individuals seated here introduce themselves. I am Bert Mitchell of the Center for Veterinary Medicine, Associate Director, Policy and Regulations.
MR. MATHESON: I am John Matheson. I am the Senior Environmental Scientist at the Center for Veterinary Medicine.
DR. VANDERVEEN: I am John Vanderveen. I am Director of the Office of Plant and Dairy Foods and Beverages at the Center for Food Safety and Applied Nutrition.
MS. HELLMAN: I am Kiki Hellman, Senior Scientist, Office of Science and Technology, Center for Devices and Radiological Health.
DR. ASHAR: I am David Ashar, Chief of Method Development at the Center for Biologics Evaluation and Research.
MS. VINCENT: Carol Vincent, Microbiologist, Center for Drug Evaluation and Research.
DR. DETWILER: Linda Detwiler. I'm a veterinarian with USDA's Animal and Plant Health Inspection Service veterinary services.
DR. BREWER: Robert Brewer. I'm a veterinarian with USDA, the Office of Public Health and Science.
DR. MITCHELL: We have some other technical resource persons throughout the audience here. I see some of them. Dr. Graber is sitting over here in the front row, Division of Animal Feeds, John Lynesh [ph.], Economic Assessment, and Elaine Power, also from that staff, who has been involved in writing the economic assessment. I see Tim Lyna [ph.] and others back through there. We have John Bailey here in the front row from CFSAN, Cosmetics. John Hunstead [ph.], you know.
Susan Duran [ph.], who is our consumer representative to the Veterinary Medicine Advisory Committee is in the audience. Would you stand so that people can see you? Thank you, Sue. Dan McChestney [ph.] is there. Dick Guyer [ph.] is seated in the back corner there, trying to be unobtrusive but he will not be able to manage that entirely.
What we want to do is show a few slides to give an overview of this regulation. Many of you know it very, very well, but I'd like just to take a few moments to go through some of the points, and thanks for the light.
Helping man and animals by ensuring the availability of safe and effective animal health products. The first overhead here is transmissible spongiform encephalopathies and this outlines the encephalopathies of major concern to us with this rule, scrapie, chronic wasting disease, and TME have been diagnosed in animals in the U.S. and the rule is designed to protect against bovine spongiform encephalopathies.
This week, as a matter of interest, in the Journal of Wildlife Diseases, there appears an article on 49 servids, mostly from Colorado, 46 mule deer, two elk, and one white-tailed deer that have been diagnosed with chronic wasting disease. These are animals that are in the wild.
Elsewhere, outside the United States, TSEs have been diagnosed in zoo animals and felines. These are the diseases in people that we are most interested in addressing here.
In sum and in general, the transmissible spongiform encephalopathies are poorly understood diseases. We are very early in the process of learning their etiology, specific etiology, pathogenesis, transmission, and methods of controlling these diseases. They have a long incubation period. Experimentally in the U.K., BSE in cattle, this is artificially induced disease, starting in calves, it is described as a disease of 200 days' incubation followed by eight days of clinical signs followed by death. That is a characteristic of an experimental disease and is rather typical. The times are different with other manifestations of TSE.
The causes of TSE are still being widely debated. One prevalently held theory is that they are an abnormal protein called prion protein. The second theory is that it is a virus and the third, a bacteria. The dots positioned here beside each of these terms is a pictorial way of describing, trying to illustrate that there is a wide variation in the size of these agents, the prion being the smallest and the bacteria being comparatively very large.
Now, going back through 1986 in the handouts and these slides, and you can strain your eyes to see the slides, you will see some of the major events that have occurred in the following of BSE, with the first diagnosis in the U.K. about 1986. Since then, more than 160 head of cattle have died of BSE. These originated from around 33,000 herds, primarily dairy herds but some beef herds were involved in this, as well.
Since 1989, there have been no cattle or cattle products imported from BSE countries into the United States. The FDA, and you have represented here in this panel in front of you the centers who have been involved in these activities, have issued a number of bulletins, import alerts, and letters to manufacturers beginning in 1992 through the latest was in May of 1996, advising manufacturers that they should avoid the use of ingredients from animals, bovine animals that were raised in BSE countries.
To date, USDA has examined something more than 5,100 brains of animals showing CNS symptoms, the most highly suspect animals in the country, and at this point, there has been no finding of BSE in the U.S.
So potential sources of BSE that we consider this rule needs to protect against is scrapie or some other TSE infecting cattle, spontaneous mutation, and while the introductions through imports have been very well controlled, we think, we do not believe that that can be expected to be 100 percent, considering all the travel that is going on these days.
So the January 3 proposal declares that rendered animal protein from ruminant and mink is not generally recognized as safe for use in ruminant feed. This is the legal premise on which this proposed rule is built.
In order to achieve protection of the animal and public health, we proposed a flexible system of controls to ensure that ruminant feed does not contain rendered protein from ruminants or mink, and this is designed to allow innovation in the industry, to achieve the highest level of control at the least cost.
The alternatives to the ruminant-to-ruminant prohibition are also outlined, at least, some of them are, in the proposed rule as published on January 3. The mammalian-to-ruminant prohibition is described, along with advantages and disadvantages. The ruminant-to-mink-to-ruminant prohibition is the target. The code is actually written on this proposal.
The partial ruminant-to-ruminant prohibition would be the prohibition of feeding of tissues from ruminants that have been shown to cause infectivity in susceptible strains of mice, possibly the most science-based approach.
Prohibition to ruminants of all rendered materials from species which have been diagnosed with TSEs in the United States, and these are sheep, goats, mink, deer, and elk. The adult sheep and goat prohibition is an alternative discussed there, as is a no-action option, and lastly, any other actions which would meet the regulatory objective. So the comments to the proposed rule can, therefore, be wide.
Now, we mentioned the information that is on the CVM FDA home page and Dr. Blackwell mentioned the address. If you want to write it down, that's it. It is getting a lot of attention. We have, as of a week ago last Monday, 1,200 what's called hits, accesses to this information and a lot of other related information, like it's most active at mid-day and Friday is the busiest day.
The last slide is other information that is on the home page. The rule, proposed rule, is there. The economic assessment is there. The environmental assessment is there, along with information on the public meetings. This is the docket. The St. Louis public meeting information is there now and we expect to post the information from this meeting as soon as we can. Based on the St. Louis meeting, that will take about ten days or two weeks.
Those conclude my formal remarks. The next speaker is John Matheson who will talk about the environmental assessment.
ENVIRONMENTAL ASSESSMENT
MR. MATHESON: Thank you. I'm John Matheson again, and I'm one of the authors of the environmental assessment for this action. I've been at the Center for Veterinary Medicine since 1978 doing environmental assessment work, but this is really one of the more unusual kinds of actions that we've had to look at and is one of the least quantitative, and I'll show you what I mean as we do the overview.
This overview is not a substitute for reading the environmental assessment. This is what it looks like in paper. It's on the home page and I'd encourage you to pull it down.
If I could have the first slide, please. This is one of the tables from the environmental assessment. It's a summary table that compares all the actions that Dr. Mitchell was just talking about. We've tried to, instead of do a quantitative review, do a qualitative review that compares the effectiveness of the action or the environmental impacts of the action based on their intended effects.
So you can see there is watchful waiting--that is the euphemism for no action. That is really more hoping for a technological fix to come along that will solve our problem for us. It's a possibility.
Adult sheep and goat controls, which is the 1994 proposal from the Center for Veterinary Medicine, to control the crossover of scrapie to cattle. This is the controls on all animals, all species known to have TSEs in the United States.
This is the proposed action, ruminant-to-ruminant ban, basically. Designated tissues is also an alternative that we very seriously looked at, and the mammalian protein to a ruminant ban. That's essentially what is in the U.K. right now.
These options seem to separate into proactive and reactive kinds of groupings, in general. These are essentially reactive, basically waiting to do something when BSE occurs or if it occurs. These two, well, actually these five all prevent crossovers of scrapie to cattle. These three are looking more at amplification of BSE among the cattle population and trying to prevent the spread of that during the incubation period, when it would be undiagnosed in the United States.
So these groups break into pay later or start paying now kinds of options in terms of environmental impacts. You can see that there's no much payment at the very beginning here on these first three, since they're reactive. There'll be no changes in the watchful waiting kind of procedure or on-farm disposal, landfilling, incineration, or industry waste reduced. The effects from sheep or goats controls or the other species are not really very much in the big scheme of things in terms of just the total quantity of these wastes that are generated, so they really don't make much of an impact in terms of changes at these sites.
These other three start to make more of an impact immediately in terms of disrupting the situation right now in terms of how these wastes are handled. I have some other overheads that I'll show you about those.
Go to Table 2, the second part of Table 1. If you look at these actions, they really do not, in the final analysis, prevent BSE. In spite of our best efforts, it somehow gets into the country because there are things about BSE we do not know. There are vectors we may not know. It may be undiagnosed in other countries and may be imported from there.
Then the situation changes entirely in terms of the long-term, if BSE occurs. The maximum losses are in these three reactive proposals or reactive actions and the minimum losses are in the three that start with the proposed action and move to the right. That's because they prevented the amplification of BSE in the herds in the United States during the time that it's here undiagnosed. That's really how we tried to assess the potential impacts of these various alternatives.
I'd like to go to the next overhead. This is also a figure from the environmental assessment. We tried to look basically at the food chain and what the various different actions are doing, starting with no action. Ruminants and minks of all ages come in, are grown. They either show up as 4-D animals, they're mortalities or they're downer cows or they're losses, roadkill in the case of deer, or they go through the slaughter procedures, through edible products, human food products, that would be--and as plate waste or as grocery returns show up at the rendering facilities.
Some of these also show up at the landfill. Then at some slaughter, there's also the inedible products that's inedible to humans because those are also going into rendering. But also, some proportion go into incineration, burial, or landfill. We know how many animals are slaughtered, but we really don't know how the proportions go, the numbers from all these different arrows and we would appreciate information about that. We are really--that is why this is a qualitative kind of environmental assessment rather than a quantitative one.
The 4-D animals are even less known. Some proportion of them are left where they drop, particularly in the range kinds of situations or large pastures, and are lost to predators or scavengers. Many probably go to rendering. Some are buried. Some may go to landfill or incineration. Again, the relative proportions here, we do not know. In the current situation, with no change, no action, we really don't know how these numbers break out.
From rendering, the products are separated into fats and oils or protein and bone, and right now, there's no restrictions on any of the uses of ruminant feeds or non-ruminant feeds or industrial uses. Voluntary actions are being laid onto this in terms of the proposed prevention of sheep and goats going into ruminant feed and then there's also some discussion about cattle, but this is basically the situation right now.
The next overhead shows the effect, on basically the same chart, of the proposed action. Really, it is identical except for a partial blocking of the protein and bone materials going to ruminant feeds. The reason I say partial is there is no stoppage on blood, milk, or gelatin products and those are all protein products. There is no restriction on fats or oils or how hides are used. So even for cattle, a large proportion of each cow going through this process is still marketable in the same way it was in the past.
So we really don't know the effect of the alternatives or the proposed action on the relative proportions where 4-D animals go or where slaughter products go. This is where we are really looking for information.
I think that's all I've got for now. We can follow up with questions.
QUESTIONS AND ANSWERS
MR. GAYLORD: Okay. We would like to thank both Bert Mitchell and John Matheson for these presentations.
We are going to enter a period here of questions from the audience, especially in regards to what you've just heard and trying to understand what the rule is saying. For those who would rather not go to the mike and pose your question, we do have some index cards which will be distributed to either write your question down and it will be somehow redistributed back this way and then we'll read your question to the audience.
But we're going to ask our panelists here to try and take any of your questions, and let's get started.
MR. LANGENHORST: Good morning. I'm Michael Langenhorst with Anamex Corporation from Green Bay, Wisconsin, also here with the National Renderers. I have a couple of questions, John. Could you define slight, moderate, and some?
MR. MATHESON: Those are not quantitative values. They're qualitative, so they are all relative to one another. We do not know the overall magnitude of any of this action.
MR. LANGENHORST: Then maybe I'll try and help define it a little bit.
MR. MATHESON: Please.
MR. LANGENHORST: As I said, I'm from Wisconsin and I hope everyone here realizes that we all support the initiative of this, which is trying to find and keep a safe feed. However, I don't really agree with the assessment. In a three-week period in our State of Wisconsin, there are about seven million pounds of deer product and mink product that are collected and this is in the end of November and early December, so everything is frozen. That's about 350 truckloads in a three-week period in one State.
The cost of landfilling that seven million pounds, using the FDA's assessment in the economic impact at $65 a ton comes out to $227,000. So if that's considered some or slight, I'd hate to see what it is throughout the country.
You said you didn't know the effect of the dead stock or fallen animals on the farm. That's 32 million pounds a week, so about four times the amount that I just described there, or almost $1 million a week for disposal of that.
And the other question I have is in doing your environmental impact, have you contacted the Department of Natural Resources of all the appropriate states that would be affected and see what plans they have in place where they do not allow landfilling of carcasses at this time.
MR. MATHESON: The answer is could I. I have no doubt that we could, but they are certainly welcome to contact us and I would encourage you to have them do that, or someone that has that information to provide to us. It is a public procedure and we are hoping to hear from them, but we have not heard from any of the States, really, in terms of this issue.
MR. EVANS: My name is David Evans. I'm with CBT Resources in Greensboro, North Carolina.
It's a little frightening to me to write a regulation and using terminology like maximum and minimum and moderate and enlarge this. Our industry supports building a firewall or protective measure to protect the consumer and the American food supply, but without an environmental impact statement to determine quantitatively what the repercussions might be, we might create a bigger problem than the problem that we are trying to prevent, which actually doesn't exist in this country.
I would implore the Food and Drug Administration to consider an environmental impact statement using real numbers so we can develop a relative assessment of both the pros and cons of a final regulation. Thank you.
MS. SMITH DEWAAL: I hope you don't mind if I actually have some questions. Caroline Smith DeWaal, Center for Science in the Public Interest.
On the section of the regulation dealing with renderers who have both ruminant and non-ruminant products that they're rendering, the record keeping provision or the record requirement of that section, will those records be publicly available, as well, or just available to the agency?
DR. MITCHELL: Well, I don't know if any other resource person wants to weigh in on this.
MR. BISPLINGHOFF: [Spoke from audience--inaudible.]
MS. SMITH DEWAAL: But the agency will have access to sales invoices and other records that come out of that.
DR. MITCHELL: That's my interpretation, is that this is accessible to agency or state officials who would be appropriately authorized under FDA law.
MS. SMITH DEWAAL: Okay. And then it wouldn't be publicly available unless it was part of the agency's record, is that--
DR. MITCHELL: That's right.
MS. SMITH DEWAAL: In the warning section, that product would require some kind of warning indicating that it may or may not contain ruminant feed, or, excuse me, ruminant products that could not be used in ruminant feed. You need to consider the issue of how that warning label should best be placed on the product, and specifically, you need to indicate on that warning the reason why people need to be particularly cautious with that material.
In looking at warning labels, how warning labels can be effective, they often require both the word "warning" or "caution" and also a why statement as to the importance of heeding the warning, and that didn't appear to be in the regulation, those elements of making sure that's an effective warning.
I also have a question about--you set forth some elements that would make the regulation more flexible, that if these things occurred, that the regulation wouldn't be effective or it would be modified instantly or in some manner. And one of them is that if a test method is developed that detects the presence of the agent that causes TSE, products that contain the agent shall be labeled "not for use in animal feed". Well, goodness. I think if there's a test that shows us that the infective agent of TSE is in a product, that product should probably be destroyed and shouldn't be used in any manner. Thank you.
MR. GAYLORD: Thank you.
MR. LEVENSON: Bruce Levenson with Federal Focus. I had a couple of questions today, one of which was I was wondering who the key Federal officials are on this issue and I think you've been kind enough to answer that with your presence.
My other question would be if you could discuss who some of the leading scientific experts on this issue are and also their affiliation.
MR. GAYLORD: Anyone like to start that?
DR. MITCHELL: I think we'll ask Dr. Detwiler to comment from the standpoint of the research into the etiology of the disease and transmission and the studies that are going on around the world in that respect, and if that doesn't answer all of your question, feel free for a follow-up.
DR. DETWILER: Ready? Okay. In the animal transmissible spongiform encephalopathies in the United States, you have the Ag Research Service, part of the USDA, and some of the primary researchers are Janice Miller and Randall Cutlip at AMSILA [ph.]; Katherine O'Rourke at Pullman Washington and Don Knolls at Pullman Washington [ph.]; and the Institute for Basic Research, Rich Rubenstein--they're also working on the etiology, as well--Rich Rubenstein, Dave Bolton, Ann Wisniewski [ph.]; Dick Marsh at the University of Wisconsin and associates--that's primarily TME and also some etiology; Rick Race and Bruce Cheesborough [ph.] at Rocky Mount Lab in Montana--they're part of the NIH system and they work with both the animal and the etiology.
NIH is working with etiology and tests. They do both diagnostic tests as well as basic research and that's Joe Gibbs and Paul Brown and Carlton Gajdusek; and then Stan Prusiner, who probably everybody's heard his name out in the University of California-San Francisco.
MR. LEVENSON: I didn't get that last one.
DR. DETWILER: Sure. Stanley Prusiner. That's prion theory.
That's some of your basic main ones in the United States, and in Europe, as part of the Ministry of Ag, Foods, and Fisheries with BSE and epidemiology is John Wilesmith [ph.]; Ray Bradley, who is retired but still does consulting; Richard Kimberland [ph.], who is retired but does a lot of consulting that did a lot of work with scrapie and scrapie pathogenesis--I forgot to mention in the United States Bill Hadlow, who's retired, who's Mr. Pathology with all the diseases. He's out in Montana, as well.
In England, Nora Hunter's lab at Edinburgh. They do a lot of genetics, Mora Bruce, Michael Dawson [ph.]. That's some of the groups in England. There's a number of people at--I'm sorry, in the human, Bob Will at the Edinburgh neuropathegenesis unit; John Collinge in London.
Going on to the continent, Brahm Schroeder [ph.] in the Netherlands; Heino Derringer [ph.] in Germany; Pukieri [ph.] in Italy does a lot with the agent and inactivation as well as with the human diseases.
MR. ASHAR: Domenick Dormante [ph.].
DR. DETWILER: Thank you. Dormante in France. In CWD, Beth Williams and Mike Miller. They're helping me out. That's in Colorado and Wyoming. Can you guys think of anybody else? That'll give you a start.
[Laughter.]
DR. DETWILER: There's also the Japanese, Akita Group doing scrapie, as well.
DR. MITCHELL: We should add to that some people in ARS, I think, and particularly with methodology development.
DR. DETWILER: Did I miss--
MR. ASHAR: You mentioned them.
DR. DETWILER: Okay. I did mention them in the beginning.
MR. GAYLORD: Thank you so much, Linda.
DR. DETWILER: Oh, and we do practical--APHIS does some practical research. It supplies a lot of tissues to a lot of the people I mentioned.
MR. GAYLORD: Yes, John? You have to go to the microphone, John.
MR. HONSTEAD: Most of those people and their work are in the reference section of the proposal, and I think that's a pretty complete list, too.
MR. GAYLORD: Thanks.
DR. DETWILER: Another accessible--OIE, the Office of International Epizootics, had a meeting to coordinate some research efforts back in October and I think you can access some of that information and they have a Web page, as well.
MR. GAYLORD: Yes, sir?
MR. HIGGINS: Yes. My name is Tom Higgins from Viscase Corporation in Chicago. We are a manufacturer of packing films, including cellulosic sausage casings.
My question is with regard to the environmental evaluation, do you plan to expand the scope of this environmental evaluation to cover some of the perhaps unintended environmental effects that may have surfaced in the St. Louis forum and perhaps here today?
I'm speaking specifically with the question that concerns our industry, that is the recycling of spent cellulosic sausage casings. These are materials in which our customers manufacture hot dogs and other processed meats and these products are currently, once the hot dog is made, are waste and are landfilled but it is possible to recycle these into cattle feed. There is, however, a small presence of ruminant protein in these casings and meat protein and this protein is non-infective muscle tissue.
It is internationally recognized as not containing the BSE infective agent. It is USDA inspected both before and after slaughter. It is approved for human consumption and it's safe and wholesome, but yet this small amount of protein in there would prevent the recycling of a much larger quantity of cellulosic sausage casing.
I would just like to add that, currently, we are in full production of hot dog casings. The meat industry is exporting poultry hot dogs to China and to Eastern Europe and we can barely keep up with the demand. Thank you.
MR. GAYLORD: John, did you have a follow-up on that?
MR. MATHESON: I did read your testimony from St. Louis. We'd be interested in knowing what the numbers are, what are the quantities and just submit them to the docket so that we can work with that.
MR. HIGGINS: All right. Just briefly, 50 to 150 million pounds of these spent cellulosic casings are--
MR. GAYLORD: You need to use the microphone.
MR. HIGGINS: Fifty to 150 million pounds of spent cellulosic sausage casings are currently generated, is our estimate, per year.
MR. GAYLORD: Thank you.
I have a question that's been sent to the front here. I believe it may be for Bob Brewer. The question is, what is the total number of bovine brains which have been examined for BSE, parenthetically stated here, those with CNS disorders equal about 5,000/100, but have there been others in addition to that number, the total number and the time period, if known. Linda?
DR. DETWILER: I'll answer that. Our agency is responsible for surveillance and coordination and surveillance efforts in the United States. As of January 23, we had examined or been examined in veterinary diagnostic labs throughout the United States 5,342 bovine brains.
These consist of sources of adult cattle exhibiting neurologic disease found on antemortem condemnation at slaughter by FSIS. They are from field cases of CNS diseases reported to us by private practitioners or producers. We have foreign animal disease diagnosticians trained in the diagnosis. They are from rabies-negative suspects at public health laboratories. They come from veterinary diagnostic laboratories throughout the country or from veterinary schools. Then we do some surveillance of downer cows at the higher volume plants. Our diagnosis methods consist of immunohistochemistry and histopathology.
MR. GAYLORD: Thank you.
Yes, sir?
MR. BECKWITH: Richard Beckwith, a small packer/processor, upstate New York.
I have a question in regards to meat imports. Will we be importing meat from countries that aren't practicing the proposed ban? In other words, if we domestically go to this ban, will we be importing product from countries that are basically doing the status quo now?
MR. GAYLORD: Linda, I believe?
DR. DETWILER: At that point in time, then we can look at the same as. That's how we would look at the equal equivalent or higher than status.
MR. RAGANSTEIN: Joe Raganstein from Senator D'Amato's office.
The question of what database do we have on the actual transmission of BSE or BSE-like substances by ruminant feeds following processing. In other words, what do we really know about the actual time-temperature that is necessary to produce a safe feed, given an intentional attempt to transmit. I mean, what is the database really like there and what do we really know?
MR. GAYLORD: Bert, would you like to take a stab at that?
DR. MITCHELL: John, can you comment on the temperatures from the U.K. study? I think there are individuals here in the audience, actually, who are able to address this question as well as we can.
MR. HONSTEAD: There are definitely some experts on this in the audience. Taylor in Britain did a very well-done study using pilot plants for rendering. Fifteen scale pilot plants were tested and four of them allowed survival of BSE agent. The missing piece here is we don't know what the minimum dose of BSE it takes to make an animal sick, because another trial with BSE in England, they exposed young calves to BSE brains in various amounts and one gram of brain from BSE cow one time caused BSE in the calves.
So the two--that study needs to be repeated and done with even smaller doses of BSE brain to see what that minimum dose is. So until we know the minimum dose, we don't know the impact of the rendering studies.
MS. NESTOR: Felicia Nestor, Government Accountability Project.
I have a question. Given that British scientists succeeded in creating a TSE in swine through inoculation in Britain and that the USDA has some evidence of a spongiform encephalopathy in swine here, although it's not conclusively a TSE--in fact, USDA said that it probably is not--has there been any consideration of extending the ban so that ruminants would not be fed to swine, as well?
MR. GAYLORD: Bert, would you like to take that?
DR. MITCHELL: I think we need to have a comment made on the premise of the statement. I'm wondering, Linda, if you would be prepared to make a statement about the assertion of a TSE in swine and I'll follow up.
DR. DETWILER: Sure. The work that was done in the United Kingdom involving swine, there was transmission by the intracerebral route. They also are conducting, in the process of conducting another project where they fed swine the oral route brain tissue, infected brain tissue. Those animals are now between five-and-a-half and six years old and they have no evidence of a TSE or spongiform encephalopathy in the swine.
They are also doing the same project with chickens and both intracerebrally and the peripheral routes. There is no evidence so far in poultry, and those are six-year-old chickens.
MR. GAYLORD: Thank you.
DR. MITCHELL: As far as, in general, the response to comments, we are going to be considering all of the comments that come into this docket, including one made in this response.
MR. HANSEN: Yes. My name is Michael Hansen from Consumers Union for you, Linda. I'd like to ask of those 5,000-plus brains that were checked, the two questions are, how many downer cow brains were checked and did you use molecular probes for that? I guess the second question is was the pathology that you were looking for classic British-style BSE?
DR. DETWILER: Let me answer it in two ways. I am sorry. I didn't bring the breakdown of downers. They are up in the couple hundred per year. I can submit that to the record, and I'm sorry I left the house today without it.
The two methods, it would be the classical histopathology that the brains are examined, that's all the brains, and then we use immunohistochemistry, all right, which would detect the evidence of the abnormal form of the prion protein, which would, in case there were not the classic lesions on there. Now, I don't know when you say molecular probe--
MR. HANSEN: That's basically it. What's the level of sensitivity here, since Dr. Gibbs at the hearing a couple weeks ago mentioned that those probes don't work until you get to thousands of infectious doses per gram.
DR. DETWILER: To my knowledge, what you'd have to do is some kind of systematic study starting with animals that you knew were infected and take tissue along the way to see at what level that that test, and to my knowledge, no one has done that in the United Kingdom with the immunohistochemistry to know how much in advance, or at least pre-clinically. We're going to try and do some work in that in the United States with scrapie, where we can follow animals from an early age and look at not only brain but peripheral tissues, as well.
MR. HANSEN: Thank you.
MR. HAHN: Bob Hahn, Public Voice.
Can you give us a sense of how frequently FDA inspects renderers and feed mills and other affected parties?
DR. MITCHELL: Feed mills--the question is, FDA inspections? I presume it's okay to use state-authorized inspections under the Food, Drug and Cosmetic Act. The largest and most complex milling sites in the country, those who handle certain types of drug products which are used in feed, are subject to a biannual inspection requirement.
Beyond that population of mills, inspections do take place from time to time in other feed mills and in rendering facilities, usually for cause, when we have a reason to--a need to be there.
MR. GAYLORD: Could you go to the microphone, please? Thank you.
MR. HAHN: Could you explain what would constitute for cause?
DR. MITCHELL: Typically, it would be some report of a product being ineffective or causing harm to an animal, typically to an animal, some report that would come to us, first of all, as intelligence information, a report, and then we follow up and get evidence.
MR. HAHN: And lastly, could you separate the state and the Federal for the inspection, the biannual inspection of the feed mills?
DR. MITCHELL: Right now, that's running about three to one, with 75 percent carried out by states, 25 percent by the FDA.
MR. HAHN: Thank you.
MS. NESTOR: Felicia Nestor, Government Accountability Project. I'm assuming from the answer that you will consider these comments that you have not yet considered the swine in the ban.
I think you mentioned that there were something like 5,200 brains looked at for CNS, and if I'm not mistaken, that period is from 1990 to the present and some of them were downers, a few hundred were downers. As I understand, there were some that were also brains sent in by private vets and they were not done by the government. So I'm wondering, how many were cattle that were found with CNS and I'd like to make a comment about them.
My concern is that a study done in a packing plant in the United States suggests that animals being caught with CNS by FSIS are a very small fraction of the number of animals that actually have CNS in the country, to the tune of in one year, FSIS condemned 79 pigs with CNS and if this plant was representative of the existence of CNS in swine in the country, 13,500 swine should have been condemned for CNS, and I think that's because the antemortem procedures are that only five to ten percent of the animals are inspected in motion and that's when the inspector would normally detect the CNS.
So when you're talking about the studies that are being done, I think that it seems that there's some unanswered--or there's an inference that we've looked at 5,200 brains and that that's all of the brains or--I mean, do we know what percentage of the brains that actually is of cows that had CNS?
As I understand it, this is a very expensive--some of these tests are very expensive and so it's not practical to actually look at all of the CNS brains or all of the downer brains and we'll never do that. I'm wondering what percentage of the number of animals that actually have CNS, not the ones that are just condemned by FSIS, will be looked at.
And in reference to the study in England, I spoke to one of the scientists over there and I heard from him that once BSE hit, basically, all resources were transferred to studying BSE. So I'm wondering--now, as far as I know, the study hasn't been published on the feed, transmission through feed in swine, so I'm wondering, how conclusive is that study? Has anything happened? Have they modified it at all because of the new--as new research shows us different--as we gain more knowledge, and--I've forgotten the third part. That's enough for now.
MR. GAYLORD: Thank you for that question. I believe--well, either Linda or Bob.
DR. DETWILER: And then I'll pass it over to Dr. Brewer.
Let me try and address a little bit more on the surveillance with the neurologic cases. I had said that I'd forgotten the numbers of breakdown of downers versus actual CNS cases, but I think it's important to keep in mind that some people say, well, 5,300 brains over a total cattle population of about 103 million, you know, that's not saying much, but that's not a fair assessment to take, because if you look at animals less than two years of age, you wouldn't expect to find lesions in the brain, so that's not a fair denominator.
When we look at the amount of adult animals in the country and then take it out and then extrapolate, we had found in a National Animal Health Monitoring Survey and a dairy study that about one-tenth of a percent of adult animals are reported to have neurologic signs. When you look at that as a denominator across the adult cattle population, at the rate of surveillance per year, what we figure is that we will be able to detect the disease in adult cattle if it occurred at three per million, using that denominator, three per million at the rate we're doing now.
The downer cattle, and I want to go into that, or the non-ambulatory cow, that is a theory, and not to be confused with that non-ambulatory cow or downer cows are a certain disease entity and I think we do that sometimes with our foreign trading partners that think we have some disease called downer cow syndrome, which is not.
A downer cow or non-ambulatory cow is any cow that cannot rise. It can be a broken leg, it could be some kind of metabolic disease, milk fever, calcium deficiency, magnesium deficiency, et cetera. But Dr. Richard Marsh at the University of Wisconsin with the last case of transmissible mink encephalopathy in 1985 in Wisconsin, that the owner had said that he fed downer cows, so Dr. Marsh said that perhaps there was a sporadic occurring disease that manifested--was similar or transmissible spongiform encephalopathy in cattle.
Hence, with this theory, in 1993, we started to look at downer cows in the United States, and then there was a theory that perhaps that the lesion pattern would not be the same as found in BSE in England. Hence, we started to institute using immunohistochemistry at looking at the brain samples.
So we have two methods, so looking for the abnormal form, the partially protease resistant form and the prion protein as well as regular histopathology. I would say that we are the only country in the world that is systematically doing both methods of diagnosis and routinely doing so-called non-ambulatory cattle at slaughter.
I would say that, looking throughout the world, that we are probably the most aggressive, with the exception of probably the U.K. that has BSE or right up there, by using immunohistochemistry as far as surveillance, and to date, we have no evidence of BSE in our cattle and no evidence of another form of a transmissible spongiform encephalopathy in cattle in the United States.
In answer to the pig study, they are six years old and no evidence of clinical signs. It's basically once you inoculate them, I mean, it changes a protocol with new science. Once you inoculate them, basically, you wait for an extended period of time with these and then where you decide, eight years or so you're going to fall them out, then you get the knives and look at the tissue. So they're just in the waiting process, and I'll let Dr. Brewer answer some of the FSIS.
DR. BREWER: I would like to reiterate what Linda said about the so-called downer or non-ambulatory cows. They are not all CNS by any stretch of the imagination. They do not have CNS problems necessarily. As a matter of fact, it's been interesting that over the last ten years or so, the number of animals that are condemned for CNS problems on antemortem have run approximately 290 to about 325 head per year, and that has not changed.
Now, when this whole issue started approximately a year ago, we did send a letter to all of our veterinarians that are in bovine plants. We sent them the video that was done in England about the BSE situation in England, so they've had that video to review. They've had messages to alert them to try to make them more sensitive to the problems of potential BSE, and so I think we have had more surveillance by the veterinarians in these cow plants for potential animals with BSE and the rate of animals condemned for CNS has not increased significantly this year.
MR. GAYLORD: Yes, sir?
DR. PEARL: Yes. I'm Gary Pearl, a veterinarian from Bloomington, Illinois.
Dr. Detwiler and Dr. Brewer, I think it should also be noted, the diagnostic laboratory system developed and in place in the United States for diagnosing all animal diseases and the value that that has in relationship to monitoring TSE. We referenced the 5,100 brains. In a recent survey of diagnostic laboratories, it indicated that there's approximately ten-to-one of animals submitted to diagnostic laboratories that may have been exhibiting CNS symptoms that were diagnosed in the laboratory as having some other definite disease, like rabies, like listeriosis, like polio, a number of other non-ambulatory CNS conditions that did not appear to have any indications of BSE at all. These animals, then, that were not diagnosed were then sent to the USDA laboratory and made up a large number of those 5,100.
So I think it would be fair to say that the surveillance really at the diagnostic laboratory could be expanded by approximately 10X, that the USDA aims group has identified.
DR. DETWILER: I'd like to just comment. I think Dr. Pearl has a very good point. We had, back probably in 1990-91, had come up with--we sent two pathologists of our own over to U.K. to study and learn about the diagnosis and then they came over and prepared slide sets, et cetera, training tools for these system of veterinary diagnostic laboratories, and I know the renderers went out and conducted a survey and had more submissions or at least the labs it looked at.
We are trying to work with the laboratories now and ascertain on what can be counted in our numbers, and I think it's really important for us. When we give you numbers, we want those to be valid. We don't want to have, if they didn't look at that section of the brain that's characteristic to be included. If they looked at animals under two years old, it's really not fair.
So what we're trying to do is work with the laboratories to get the numbers that are valid so we have good, solid data that we can present to the American public, the research community, as well as our world trading partners.
MR. GAYLORD: We're going to have to have these two questions be our last for this section of our meeting because time is moving right on.
MR. SHUBERT: Can I make it three?
MR. GAYLORD: Okay, but no more. We really have to prepare for the next section.
MR. BOSSMAN: I'm David Bossman with the American Feed Industry Association. I've got two short questions. The first one is a follow-up to Ms. Smith DeWaal's question, when she talked about the records. Would the records be an acceptable means of compliance or proof of compliance?
MR. GAYLORD: Bert, do you want to take that?
DR. MITCHELL: Yes. That's the strategy behind record keeping.
MR. BOSSMAN: And the second question, this is all predicated on the presumption that we may or will get BSE in this country. How does the agency think we will get BSE?
DR. MITCHELL: It's based on three theories. Those are outlined in the proposed rule, that it's epidemiologically transferred or transferrable somehow from scrapie or one of the other TSEs that already exists here, that it's a spontaneous mutation, and the third is that it is imported somehow through the border.
MR. GAYLORD: Thank you. Yes, sir?
MR. WOOD: This is a follow-up question, I guess, to the one that was just asked. Beyond the inspection of records in the rule, does the rule provide for any further inspection of facilities, and then also if you could also tell me, are there other existent inspections that are currently in place of feed mills, beyond the biannual of feed mills and rendering facilities. I'm Richard Wood with Food Animal Concerns Trust.
MR. GAYLORD: Bert, would you take that one, as well?
DR. MITCHELL: Part of the process of developing writings, the final rule, involves addressing compliance aspects of the rule under the Regulatory Flexibility Act. We will need to prepare a compliance plan and make a summary of that available at some point, and I can't tell you exactly when that has to be made available at this moment. But yes, there will be a compliance component to the final rule.
MR. GAYLORD: Thank you.
MR. SHUBERT: Yes. Dave Shubert from Autoimmune. My question is, has the FDA performed an economic impact assessment on the effect on the food industry, cosmetic industry, the rendering industry, the feed industry, and, specifically, the pharmaceutical industry, and I break that down into human and veterinary products, that would, if there were a case of BSE in the United States, how this would impact all those industries financially?
MR. LIENESCH: John Lienesch with the Economic Staff at FDA.
Our economic consultant, Eastern Research Group, was not specifically tasked with studying anything more than the effect on the renderers and the slaughterers and the animal drug industry, but, I mean, we will take those thoughts into consideration if and when we go forward with this. We will definitely take those considerations--we will take all that in consideration.
MR. GAYLORD: Thank you.
I do have one question. I believe it may have been answered earlier, but just to be certain, this individual is asking, does heating or cooking of meat destroy BSE, scrapie, CWD, and TME? A real short answer on that one.
MR. HONSTEAD: What was the answer?
MR. GAYLORD: No.
Okay. At this point, we are going to need to transition into our open comment period. Are we anxious for a break or should we get into a couple of those before we take a break? Break? Okay. It seems to be unanimous. Let's be back in ten minutes, no more than ten minutes. We really need to keep moving.
[Recess.]
MR. GAYLORD: We are going to ask everyone to please take their seats. We are going to need to get started, if you will make your way to your seats, please.
[Pause.]
MR. GAYLORD: I appreciate everyone promptly returning to your seats so that we can get started. However, before we have the first commentor, we wanted to revisit two points mentioned earlier.
There was a question I raised at the end of that first session that had to do with meat and whether the agent is destroyed in meat and we're going to ask if Linda would respond to that a little bit further. There was an important point that needed to be stressed.
DR. DETWILER: I feel like I'm hogging the show. This was supposed to be FDA's deal. Sorry about that.
MR. GAYLORD: That's all right.
DR. DETWILER: The thing about meat muscle tissue, I think it is important to clarify that the agent in any of the animal TSEs, human TSEs in naturally occurring disease has not been found in muscle tissue.
And the second point, that the agent is not--if you say it can't be killed by, like, regular cooking temperatures, that's correct, but it's not totally indestructible. There are conditions that will reduce infectivity or detectable infectivity. Autoclave conditions are more effective, wet heat, and some of the rendering studies with BSE were effective in removing detectable infectivity, and with the scrapie study, 133 degrees Centigrade, three bars of pressure, 20 minutes was successful at removing detectable infectivity.
MR. GAYLORD: Thank you, Linda.
We also have some more feedback on the swine TSE question, and I believe Bob wanted to make some comments.
DR. BREWER: I would like to comment and amplify a bit on the swine TSE issue. Those tissues were sent in from one relatively small swine plant. They were reviewed and then subsequently with a FOIA request recently, those records were located, they were reviewed again. The slides were sent to Great Britain where they were tested with the immunohistochemistry methods and the English concluded that they were not transmissible spongiform encephalopathies in those swine.
Now, I want to inject a personal note here. I practiced for 32 years before I went to work for FSIS and I thought I did it rather successfully, and there are a lot of veterinarians out there--I'd like to amplify what Dr. Pearl said--that a lot of veterinarians, both in private practice, industry groups, state veterinarians, and they're not exactly asleep at the switch. If there's a widespread or any kind of a consistent outbreak of something like a BSE or a TSE in any species, it's going to be found. These people would have quite a feather in their cap.
Also, you've got these individuals that are farming in this day and age have a great deal of investment, and if they start losing any animal species routinely, they're going to find out what's causing that. They, too, spend thousands of dollars a year in diagnostic purposes, and so I don't think that we're hiding anything or that these BSEs or TSEs are going undetected in this country.
MR. GAYLORD: Thank you, Bob.
Okay. Our first commentor is Dr. Michael Hansen with Consumers Union. I'm going to sit down, but when I stand up, it's time to move on to our next commentor. He'll be followed by Caroline Smith DeWaal.
OPEN COMMENT PERIOD
DR. HANSEN: Thank you very much. The Consumers Union commends the FDA for considering steps to prevent the possible occurrence and spread of the TSEs in ruminants. However, we feel that the current proposed action, which is prohibiting the use of ruminant or mink proteins in ruminant feed, is not sufficiently protective of the public health. In fact, we don't feel that any of the six options are currently protective of public health.
Because TSEs may occur in pigs and chickens as well as ruminants and because TSEs are believed to be transmissible to humans and because of the severity of the risk, FDA should take a more prudent approach. To fully protect public health, we are urging the FDA to basically do what was done in Britain and that is to prohibit the use of any mammalian animal protein in food for any food animal, so any farm animal.
That's what they're doing in Britain and our basic concerns are, leading us to think why we should be banning all mammalian protein in use of animal feed, first, as has been pointed out, TSEs have been experimentally induced in pigs. Yes, it was an intracerebral inoculation, but it showed that they can, indeed, become infected when done that way.
There's also enough that is not known about this disease at all and how the TSEs work that cause there to be concern here. I would just like to point out that others have made similar points. Dr. Paul Brown, who is a renowned expert on CJD, in the British medical journal just last year said, and I quote, "It must also be emphasized that the link to cattle products is itself only a presumption. How ironic, for example, if 11 million British cattle should be slaughtered in a preemptive strike to eliminate the risk of zoonotic Creutzfeldt-Jakob Disease only to belatedly find that the true villains were pigs or chickens which were also fed contaminated nutritional supplements but were brought to market at such a young age that the disease had not had time to become manifest."
We also had Dr. Clarence Gibbs just a couple of weeks ago at the Congressional hearing. He's the Acting Chief of the Laboratory of Central Nervous System Studies at the National Institute of Health. He again made a similar point. He said, and I quote, "Pigs held for eight years after intracerebral inoculation with BSE develop a spongiform encephalopathy. Meat and other tissue of the pig might harbor low-level infectivity at the time of slaughter at an early age.
"We also do not know whether the agent replicates in chickens or other poultry. BSE-contaminated bone meal was fed to chickens. Poultry would be expected to shed massive quantities of infectious amyloid in their feces. Chicken manure is widely used as fertilizer on vegetable crops. This means that vegetarians might be at risk. It is best"--and I emphasize this--"it is best to admit our ignorance rather than to imply that we have information about this."
So, the point being that it can occur in pigs. We should also point out that the biology of these diseases, when you look at the prion genes, they occur in all mammals. They occur in birds, too.
In fact, ones that are most widely understood, which I think are the human forms of the disease, that in Creutzfeldt-Jakob Disease, 85 percent of that is what's called spontaneous. That means it appears for, they're not sure why. The explanation has been proposed for that by Dr. Prusiner and others is that there is a spontaneous mutation rate that happens to the prion gene which makes it more susceptible to flipping over to the confirmation that is the infectious confirmation.
So if you, indeed, buy that theory, then since that's how it works in humans and the TSEs appear to all be similar, that's what we should expect to happen in virtually all mammals, that it's going to be there, there'll be spontaneous mutations in the prion gene which ultimately lead to disease and that could occur at such a rare rate that we're not picking them up.
Again, at a meeting in December, Clarence Gibbs, when there was a panel and talking about whether BSE is endemic or whether it's here, he basically said, of course, we should expect it to be here, since this is how the biology of the diseases work, that you expect that there is some form of something here but albeit at a very low level.
Now, it should be pointed out also that if you look in Britain, they banned--the actions that they took, in July of 1988, they banned the feeding of ruminant protein to ruminants, and two years later, in September of 1990, they said no specified bovine offal could go into any animal feed, and yet they've had over 30,000 cows have been born since that ban went into effect, so it shows that the ruminant-to-ruminant doesn't necessarily work.
We know that these TSEs can cross species barriers. If you look in Britain, the wild ungulates and the felines, they think that where they got that stuff was from the diet, and, in fact, if they've done sort of strain typing with the feline cases, if you look on a Western Blot, they come up very similar to BSE, whether it's been in macaques, whether it's been in cows, whether you put it into mice. It looks very similar to the felines and to this new v-CJD that has been found in humans. So that's a little bit disconcerting.
Finally, we should point out that the assays that are out there are, in fact, very, very crude assays. There was a work a couple weeks ago in Science magazine that purported to show that the prions perhaps might not be the infectious agent because there were mouse studies which showed that you couldn't detect it in the brain and yet these brains were infectious.
Again, with Clarence Gibbs, he made a similar point that the animals that have disease can be infectious for quite a while before you can even detect it, and again, this is what Clarence Gibbs said a couple weeks ago, and I quote, "The assay for the PRP," the prion, "is not sufficiently sensitive to detect it before infectious titers, that is, levels in the brain, reach many thousands of infectious doses per gram.
"In the mid-1960s, we demonstrated with our French and English collaborators that during the early incubation of the TSEs, when the virus titer in the brain was very low, there were already marked functional changes even though no pathology was yet detectable. Thus, it is clear that early replication to only low-level infectivity titer far below that necessary to detect PRP biochemically or immunologically can already lead to disease."
So the fact that the brains have not tested positive, while reassuring in one sense, since the method that you're using is very crude, that's not, in our mind, sufficiently protective.
Since there are all these unanswered questions, I think the CIAC [ph.] did the proper thing. They said, since we don't know actually what the infectious agent is or the level of infectivity that's below what they can detect, that's why they proposed, and, in fact, are implementing in Britain, a complete, as I said, mammal-to-food animal ban, and that's what Consumers Union will be supporting. We'll also be submitting comments to the agency on this regard. Thank you.
MR. GAYLORD: Thank you.
Caroline Smith DeWaal, Center for Science in the Public Interest, and she will be followed by Bob Hahn.
MS. SMITH DEWAAL: Thank you. First of all, I do want to thank the agency for having a consumer meeting. I'm reminded of times in the spring when, right after the findings in Great Britain were announced and publicized widely in our media, when our phone at CSPI was ringing off the hook with reporters' questions on the public health effects in this country. I was surprised at that time to learn there was a series of meetings going on between FDA and the industries involved, meetings to which the consumer community was not invited. So I am glad that the agency at this time has decided to include consumers in these discussions.
Make no mistake about it. American consumers expect that you will protect them from the risk of BSE. I am reminded of an episode that I'm very familiar with dealing with another government agency that had a call to action in the form of a major foodborne illness outbreak associated widely with the Jack-in-the-Box restaurant chain and the story of a little boy, Alex Donnelly, who six months after that outbreak occurred was fed a hamburger in Chicago, Illinois, by his mother and died.
His mother, Nancy Donnelly, has since become very, very active on the issue dealing with E. coli 015787 in meat because she thought the government had addressed the problem. She'd heard about the outbreak. It happened on the West Coast and it had been six months. She thought they had addressed the problem. She thought ground beef was safe to serve her son. She learned the hard way, and American consumers don't want to learn the hard way again that the U.S. Government isn't acting proactively to protect them from risk from the food supply.
When the first case of BSE is documented in this country, the failure to act by this agency, by USDA, and any other agency with involvement here will be catastrophic. It'll be catastrophic to the cattle industry. It'll be catastrophic to American consumers. We saw the impact in Great Britain. We can learn from that example.
Cost-benefit analysis should not be used to weaken the public's health protections which are needed to address this problem. The benefit to consumers of avoiding a fatal brain disease is not quantifiable and they are willing to take whatever steps, to see the agencies take whatever steps so they can avoid that risk.
The risk here, we're lucky because we're dealing with a situation where we think it hasn't been found yet in this country. We can almost entirely avoid the risk if we take the proper prophylactic steps right now, and it's up to the government agencies involved to take those steps.
We believe the risks to American consumers have not been adequately assessed. We've heard numbers, 5,100 brains have been examined, 5,300 brains have been examined since 1990 or maybe 1989, who knows. The bottom line is, that's not really enough to give us tremendous confidence that it doesn't exist.
In addition, we do know that CJD, the TSE most commonly found or associated with humans, does arise spontaneously and so it is likely that it does exist in low levels in this country.
Therefore, we urge the agency to take prophylactic protection and we support nothing less protective than the ruminant-to-ruminant feed ban which you have proposed. In addition, we think that Consumers Union's proposal for a mammal-to-all-farm animal ban should be carefully considered by the agency and should be adopted if it is, in fact, more protective of public health.
I also have to note that the absence of inspection of feed mills is troubling. I don't see how you can enforce this rule without inspections, and simply having a paperwork inspection system, as we know because of the work on HACCP, isn't going to be enough to satisfy American consumers that enforcement is really occurring.
So I think you need to look at the issue of whether you have adequate inspection frequency of these plants and how you plan to enforce it. That really isn't adequately addressed in the rule. Thank you.
MR. GAYLORD: Thank you. Just one question or clarification. We are trying to engage in a very open process for addressing what is, in fact, a very challenging question for this country and for the world at large, and we do want very much to include all interested people and we think that would be essentially everyone.
But could you clarify the statement regarding the meetings where we left out consumers? That would be something we need to understand.
MS. SMITH DEWAAL: There were a series of meetings, and actually, Bob Hahn can also respond to this because he actually managed to get entry to one of them, but we understood there were a series of meetings occurring in the spring shortly after the new scientific findings in Great Britain were announced and they involved industry groups.
When I started trying to call to get meetings with the agency, we finally had to go through the Constituent Affairs Office at the Food Safety and Inspection Service and they organized meetings with APHIS and I believe FDA may have been represented. But it took several months and it took us going in a very circuitous route to finally get entre to the same scientists and people who were speaking to the industry groups and who were apparently working with the industry groups to come up with a response to this.
In my book, that's not acceptable. We need to be at those tables. I don't mind having joint consumer-industry meetings, but we need to be invited and I don't feel like--in the spring, I felt like there was a huge gap. We weren't invited and those meetings were being conducted and I just have to raise that in dealing with the agency at this point.
MR. GAYLORD: Any comments from our panel on that feedback?
DR. MITCHELL: Well, from the FDA perspective, I would say that we have tried to be just as open as we possibly can throughout this rulemaking process, with the advanced notice of proposed rulemaking coming out in the spring, the opportunity for the public to be involved in that, and the publication of the proposed rule, the open forums that we've been holding since then is exemplary, I believe, example of due process in trying to develop a rule here that is--that we hope will ultimately be satisfying to society.
MR. GAYLORD: Thank you, Bert.
Bob Hahn, Public Voice, and he will be followed by Linda Golodner.
MR. HAHN: FDA has concluded, based on the best scientific information available, that it is possible that BSE could occur in some small number of U.S. cattle, despite our best efforts, and from that small foothold, ruminant-to-ruminant feeding could spread or amplify it to create a silent epidemic, silent because of the disease's long incubation period.
Because the consequences of such an epidemic would be so devastating in terms of animal health, economic cost, and probably human health, as well, FDA has proposed preventive action.
The only way that we know at this time to ensure that a BSE epidemic never happens in this country is to put in place the ruminant-to-ruminant ban, the full ban and not a partial one, according to FDA, and we think that FDA is right.
If it's not too much of a stretch, I think an analogy might be made here to the recent FAA proposal on airport security. In both cases, we're vulnerable. We know we're vulnerable, and even if the dreaded event has not happened here yet, we ought to take preventive action to reduce our vulnerability.
Although I'm still considering some of the specific aspects of the proposal, I think as a preliminary matter that the scope of the proposal is appropriate, though I don't have enough information at this time to comment on some of the specific exclusions, such as tallow, and while I haven't gone over the enforcement provisions thoroughly either yet, as a preliminary matter, I do see a couple of areas where we would like to see them strengthened, and particularly the area of inspections of feed mills and rendering sites.
That's really all I have to say at this time. Thank you.
MR. GAYLORD: Thank you.
Linda Golodner, National Consumers League, and she will be followed by Richard Wood.
MS. GOLODNER: Thank you. The National Consumers League supports the Food and Drug Administration proposal to prohibit using tissues from ruminants, from cows, sheep, goats, and other animals in the manufacture of ruminant feed, and we would urge you to seriously consider the comments of Consumers Union to expand precautionary measures to assure safety.
The American public depends on its government regulatory agencies to take all reasonable precautions to prevent BSE from arriving on our shores. Our nation has a history of taking measures to protect its citizens from questionable foods, animal and plant diseases, and viruses. Consumers traveling across the borders and sometimes from state to state recognize and accept the strict rules that are meant to protect us from human infection and infections of our animal and plant life. This is why we applaud the actions of the FDA and we recognize the safeguard to ensure that the spread of BSE is highly restricted.
While the FDA is protecting our animal population with a potential of protecting the public from the possibility of CJD, the United States Department of Agriculture has not yet acted to assure the American public that meat does not contain spinal cord and other nerve tissues. I recognize that the FDA called this public meeting, but the American public considers the government the government and that the FDA and the USDA work together.
There is evidence that there is spinal cord tissue and brain stem tissue in product derived from advanced meat recovery systems used by major processors in the United States. This so-called meat has been analyzed by experts at the University of Nebraska in 1995 and they found spinal cord presence. The FSIS veterinary pathologists in Athens, Georgia, the regional laboratory of the Agricultural Research Service, found spinal cord and brain stem tissue in AMR samples.
And while the FDA is taking precautionary measures to assure that animals are safe, the USDA has not responded to this evidence of spinal cord in our meat supply. There is also evidence of marrow in the AMR product, and I will in my written comments, I will give very specific references to this.
The industry is also concerned. The Food Marketing Institute has written to FSIS and said that it's our belief that consumers do not want or expect spinal cord or bone marrow in their ground beef or pork. Spinal cord should be prohibited from the meat supply.
We urge the FDA to work with the USDA to assure that all these products are safe. It is irresponsible and dangerous to delay action and the FSIS should ban the use of neck and backbones in the AMR system. We applaud the FDA for its proposed regulation to protect animals and we urge you to get the USDA to follow your lead.
In listening to the discussion today, there's been mention of the cost to industry in this regulation, and if the cost is passed on to consumers, we're sure that they would pay, willingly pay, an additional amount of money to purchase safe meat. Thank you.
MR. GAYLORD: Thank you.
Our final presenter is Richard Wood, Food Animal Concerns Trust.
MR. WOOD: I thank you for the opportunity to comment on this rule. I'm Richard Wood, Executive Director of Food Animal Concerns Trust, or FACT.
FACT is a nonprofit organization that advocates better farming practices to improve the safety of meat, milk, and eggs. We have participated in the FDA and USDA steps responding to concerns about BSE and TSE to the best of our ability, as has already been pointed out, steps that have led to this meeting and to the proposed rule.
While we may be classed as a consumer group, actually, we could have gone to the Kansas City meeting, as well, I guess, because in 1984, FACT launched its Nest Eggs Program, which is a model egg farming program or system in which our Pennsylvania farms include controls for salmonella enteritidis.
We support the implementation of the proposed rule prohibiting the use of ruminant-derived protein in feed for ruminants. We believe this rule addresses the well-being of both the public and the well-being of the food animal industry.
Without this prohibition, the public is at risk to a disease that is fatal if contracted. Without this prohibition, the industry is vulnerable, as we have seen, to the same devastating consequences experienced in England. And since we are dealing with a disease that has an extremely long incubation period and currently there is no adequate diagnostic test to determine its presence in animals, furthermore, it appears to be linked to a fatal human illness, in this circumstance, both the public and the industry should welcome new regulations. We would expect that any opposition to the regulation will be short-lived.
Nothing less than a prohibition on using ruminant-derived protein to feed ruminants is acceptable to us. The alternative proposals offered in the rule allow for too great a risk regarding undetected TSE in tissues or in other animals in the herd or flock. On the other hand, FACT is not opposed to a more stringent ban than what has been proposed, such as a mammal-to-ruminant prohibition, particularly if it simplifies the regulation's enforcement and compliance.
The proposed regulatory requirements need to be strengthened, though, where both ruminant and non-ruminant materials are handled by a firm. The rule requires that firms establish separate equipment and facilities or clean-up procedures to prevent cross-contamination. The only verification regarding the integrity of this process in our records are written procedures to be maintained the firm.
FACT wants on-site inspection by the FDA to visually determine that ruminant and non-ruminant materials can be handled separately throughout the processing and shipping. This inspection could be facilitated if there were tests to determine the presence of BSE or tests to distinguish between ruminant and non-ruminant proteins, and, of course, these tests do not exist. FACT calls on the FDA to encourage the development of such tests.
As an aside, we hope that this rule will also lead to a more comprehensive strategy on the part of the FDA regarding pathogens in animal feed. It makes no sense to feed pathogens to food animals. Several years ago, the FDA was ready to address the presence of salmonella in feed, but then dropped this initiative. We would support the renewal of steps to avoid feeding salmonella to the animals we eat.
Regarding this rule, FACT welcomes and supports the proposed rule on ruminant-to-ruminant feeding. We encourage its implementation without delay. Thank you.
MR. GAYLORD: Thank you.
I'm going to ask if Dr. Mitchell would just respond to one point made regarding FDA's initiative in the area of salmonella and animal feed.
DR. MITCHELL: I'd like to state for the record that the agency has not abandoned the need for there to be better controls in place to control pathogenic bacteria in animal feed. There are several very explicit steps underway, including those involving the industry voluntarily, at this point, adopting HACCP to control the likes of salmonella species in feed.
There is a forum for the annual discussion of new research and enforcement mechanisms involving industry, academia, and states as well as the regulatory agencies. That occurs at the U.S. Animal Health Association each year in a committee designed specifically for this purpose. There really is a lot of activity going on to reduce and hopefully, ultimately eliminate these pathogens.
MR. GAYLORD: Thank you.
Before we go to others who would like to make comments, there was another question which made its way to the front and I think this might be a good time to ask someone to answer it. The question is, how can BSE spontaneously mutate? David Ashar?
DR. ASHAR: Yes. I'm glad that came up, because the hypothesis is that there might be a mutation in spontaneous somatic mutation--wrong microphone.
The hypothesis is--
MR. GAYLORD: Dave, could you just restate your name so everyone will know?
DR. ASHAR: Yes. David Ashar, Center for Biological Evaluation and Research.
The hypothesis is that there might be spontaneous mutations in somatic cells, that is, non-germ line cells, producing encoding variants of the prion protein that are more prone to spontaneous folding changes into the relatively protease-resistant form that is purported to be the infectious agent.
If so, the prediction would be that such mutation should occur at some basic rate in normal populations. That's asserted to explain why there's one case of Creutzfeldt-Jakob Disease per million population overall per year.
That is an entirely hypothetical assertion, and an alternative explanation for the cases is that they're transmitted just as cases have been transmitted by known contaminated products of human origin, only in the known contaminated products, we are able to figure out how it was that they were transmitted, whereas in the sporadic cases, we don't know how they were transmitted.
There is some evidence, I think, could be marshalled in support of either hypothesis. The reason why I am concerned about the spontaneous mutation hypothesis is it doesn't explain how populations of animals like sheep in Australia can go for so many years without the disease being recognized, although I suppose one can say that it didn't get recycled, it didn't amplify, but the point is that this is not a universally accepted fact. This remains hypothetical.
Whether the disease is always transmitted from subject to subject or occasionally occurs by spontaneous transmission doesn't affect the fact that it would amplify in either case and amplification should be prevented and that's what a feed ban is designed to do.
MR. GAYLORD: Thank you.
We're going to move, then, to the rest of our commentors, and again, we're going to ask if you will confine your comments to five minutes or less.
Yes. We have a hand.
MS. SMITH DEWAAL: Were you going to ask for participation from other consumer groups?
MR. GAYLORD: Are there others who would like to comment? We have a couple. Why don't you just go to the microphone and introduce yourself.
MS. FINNELLY: Actually, at this point, I basically have two questions. My name is Mary Finnelly [ph.]. I'm with the Humane Society of the United States.
I was wondering if, supposedly, blood and other such tissues are considered safe, then why are we banning them from BSE countries? That's one question.
Another is, is it theoretically possible if BSE material is fed to swine and poultry that even if they don't develop the disease necessarily, that they might recycle it back to cattle if they are rendered back into cattle feed?
MR. GAYLORD: Linda, is that your question?
DR. DETWILER: You notice how they always look down this end of the table, right? Yes. I could probably speak to both of the questions.
When we talk about the products that were prohibited, you're right that we prohibit the entry of blood, et cetera, into the United States. APHIS, we looked at these prohibitions back in 1989. Little was known about the disease. Our charge was to protect the animal health of the country and, in turn, protect the human health of the country.
We looked at it that in some of those products, they would be going same species to same species, and even though evidence at that time with scrapie and some of the other animal TSEs that there was no evidence in blood in certain products, that so much was unknown, like the tallow and the gelatin at that time, that we said, let's go with a, like a no-risk type of approach and that's how we had the prohibitions, because again, we were going to go same species to same species, and that's important to realize. There is a species barrier. So infectivity from, like, one cow to another, you'd need less than if you're going across species. That's why that was taken.
The second question about swine and chickens, let me repeat it to make sure I got it. You said, is it possible--
MR. GAYLORD: Theoretically.
DR. DETWILER: --theoretically possible that they do not show signs of the disease but harbor the agent. That's theoretically possible and I think the work that's being conducted in England, that after they decide to end the work, if the animals never develop clinical signs would be then to do some examination of tissues to see if the animals actually cleared the disease or--I mean, the agent, I'm sorry, or if they harbored it.
MS. FINNELLY: Just one more point I would like to make while I'm here. Bob Brewer had said that there has been no increase in central nervous system disorders this year, but according to an APHIS Veterinary Service document, there has been a significant number increase in CNS disorders since 1983 in cattle, so I think that is an important point to consider.
DR. BREWER: I'm not sure what you're referencing. You say an APHIS report?
MS. FINNELLY: Yes, regarding BSE. I don't remember the exact title. It was a blue document, one of the BSE reports, implications for BSE in the United States.
DR. DETWILER: I think Dr. Brewer was referring to his agency condemns at slaughter, CNS antemortems, and our document, I'm not familiar with the wording of our document as far as the increase and what it was referring to, because sometimes you have an increase just in reporting, et cetera, or when you're asking for the data to be gathered, since it comes from so many different sources.
MS. FINNELLY: It doesn't know what the cause is but there has actually been a significant increase.
MR. GAYLORD: Thank you.
I believe I saw one other hand, and while she makes her way to the mike, we have reordered the list that you see on the second page of the agenda and we're going to ask if Richard Beckwith will start to prepare, because he will be our first commentor, followed by Dave Bossman.
Yes?
MS. NESTOR: Felicia Nestor, Government Accountability Project.
In response to that last question and comment, I just wanted to reiterate that we do have a study which suggests that 79 over 13,500 is the ratio of CNS cases that are discovered to CNS cases that exist, so whether there's been an increase or not, that's only significant if we adopt the premise that the screening is effective, and I think that we can call that into question with some evidence.
I just had two other comments. In relation to consumer confidence, on the swine study that I'm talking about, Mr. Brewer or Dr. Brewer, I'm not sure which it is, said that the slide was sent to England, that the information was gathered in response to a FOIA request. I drafted the original FOIA request and was told that there were no records. Then I was given some records. Then I had to ask again to have the report of the scientist, Dr. Hadlow in Montana, given to me, and then I had to ask again to obtain the film, which I was told didn't exist.
Now, if it's true, if you're right that there is a scientific report from England, I guess I'm going to have to go back to this agency which is trying to be open and get that report from England as far as the two scientific experts that did pass on this slide, and I'm not arguing this to say that, yes, we have a problem with BSE. I'm trying to make a point about the openness of the agencies and how consumer confidence is tied to that.
The slide went to Dr. Hadlow, who's a scrapie expert, if I'm not mistaken. So far, there are no experts in a possible TSE in swine because we don't know of it yet except through the inoculation. So it went to a scrapie expert in this country and it also went to Dr. Miller. Now, I'm not sure what her qualifications are, but I am fairly certain that she does not hold herself out to be an expert on TSE and that is the segue to my next comment. If she does, I'm sorry that she's not here and that we can't speak to her, Dr. Hadlow, and other people that are more directly involved with this information.
I work for the Government Accountability Project. Our primary responsibility is to defend whistleblowers, people in the government that have noted some wrongdoings and then are retaliated against because of that. I wish I could say that we lose most of our cases. Unfortunately, we don't. We've represented people in USDA. We've represented people in FSIS.
At this point, without being too specific because there is the danger--you know, you were mentioning that the agency wants to be open and up front--as a person who gets calls from people who won't tell me their names, as a person who speaks to people and then has people stop speaking to them after a certain period of time because they say they can't speak but they will get in touch with me after another certain period of time, and I'm not going to go into the specifics, and I'm talking about issues that are related to what we are talking about in this room right now.
I am already making files for possible cases of people whose jobs are threatened who are directly involved with these things.
MR. GAYLORD: May I just interrupt a second and ask you to try to focus a little bit more on this rule so that we can move forward.
MS. NESTOR: That's all my comments.
MR. GAYLORD: Okay.
MS. NESTOR: I was focusing on the comments, saying that the agencies with whom we are dealing here are interested in being open, and I really certainly welcome the sense that we are really getting to the critical information and that we can get at the critical information. I think all consumer groups would be happy about that.
MR. GAYLORD: Thank you.
Did anyone care to respond?
DR. BREWER: I think I'll refrain from a comment because I certainly couldn't add anything that would advance the topic of the discussion here at the moment.
MR. GAYLORD: Thank you.
DR. DETWILER: Can I just speak on the credibility? This was FSIS that referred that, but I'll speak on the credibility of the people that screen that because I'm familiar that they sent it to these, to Bill Hadlow and to Janice Miller. Bill Hadlow, I referred to earlier as Mr. Pathology. He's who the U.K. went to when they first diagnosed the spongiform encephalopathy in cattle. He's who referred to Carlton Gajdusek with Kuru. He called up Carlton and said, hey, those lesions look like--so I think if you go world, maybe Dave Ashar would say, would you say pathology?
DR. ASHAR: I would say Bill Hadlow opened up the field of spongiform encephalopathies in human beings. It was his observation that Kuru in New Guinea resembled in important features scrapie in sheep. It was that observation that opened up a whole new field of infectious diseases. I don't know anybody who has a greater experience in the pathology of the spongiform encephalopathies or anybody whose judgment I would trust more.
DR. DETWILER: Yes. And I think to say in swine, but even in new emerging things, that's who the world turns to, and, I mean, we're lucky to have him.
As far as Janice Miller, Janice Miller has worked with--she's with USDA ARS. She is a pathologist. She has worked with our laboratory that does the practical diagnosis to develop the techniques that we're using now to screen for BSE.
MR. GAYLORD: Thank you.
Okay. We are going to move quickly here into our other comments. Richard Beckwith, Hilltown Pork, Incorporated. You should try to be finished within five minutes, sir.
MR. BECKWITH: Okay. I'm listed underneath with my friends in industry and so on, but yet I think really we all should be listed together because we all are consumers. We have kids, and I'm a soccer dad and all that business, so we're all here--the ultimate goal of everybody is, of course, product safety, and we're just a little small little meat packer in upstate New York, and I'm not here for any industry group or anything like that, but what I want to kind of focus this decision on is how this affects a little small meat packer and small farmers right down the row.
Again, product safety is the issue. Along with this, there are several concerns that I have and a lot of my associates have as small packers. The first concern that we have is the removal of these byproducts. At our facility, we probably slaughter, oh, 100 to 200 goats and sheep a week. Well, back in July, the rendering companies came around and said that we're not going to take goat and sheep offal anymore. Well, when you hit 90 degrees in July, that's a real problem for us. You have all this byproduct outside and it creates a real nuisance and a potential hazard.
Now, small meat packers are kind of in a unique situation because we have to rely on the shadow industry of the renderers for us to be in business. In other words, without the renderers, we're out of business. Large meat packers render their own products, so they have an outlet.
So when we were faced with this situation of not being able to dispose of this, well, what do you do? First of all, you call the state. We called the State of New York Department of Agriculture Markets. We called the Department of Environmental Conservation in the State of New York, various landfills and so on, and had limited, limited success in securing an outlet for these products.
So since you don't have an outlet to get rid of this, well, what do you do? You might want to change your business philosophy and maybe do something else. Well, instead of maybe slaughtering so many goats and sheep, you might start slaughtering hogs or something else. So what we ended up doing is buying in more imported goats and sheep from Australia and New Zealand, so this, in effect, had a decrease in the amount of product that was domestically produced.
So the viable alternatives to the small--I mean, when we talk about we could landfill it and we can incinerate and so on, I think we as small packers, we're not asking for any kind of handout. Maybe what we're asking for is possibly a helping hand. If this rule does come down, we're going to need some time and some assistance, and I'm glad to see Senator D'Amato's office is here, to help us to get rid of this stuff.
I mean, the renderers were great. I mean, it was gone, it was clean, we were using it for food, and it was really great.
Also, we have to consider, by taking this product off the market--and again, product safety is the utmost. I mean, we have to--if the customer is not satisfied or doesn't feel safe about eating meat, well, then we're all out of business.
So by taking the dry rendered tankage off the market for animal protein, that's going to force higher grain prices, which, in effect, has a vertical integration from the farmer to the packer to the consumer, so higher prices all the way through.
With the USDA, I just want to allude to this quickly because we are--
MR. GAYLORD: You have one minute, sir.
MR. BECKWITH: One minute, okay. The Agriculture Secretary is promoting the sheep and goat industry, so this would dramatically affect this, this rendering ban.
Also, we as a federally-inspected plant can harvest and save--now, this is very important--we can harvest and save sheep and goat heads for human consumption, but yet, under this ban, they cannot be rendered for animal food, so this dichotomy is going to have to be addressed. We can eat it directly but yet it can't go through the food chain that way.
So basically, that's--so there's three basic assumptions, a scientific, an ecological, and an economic consideration that should be addressed. Thank you.
MR. GAYLORD: Thank you.
Dave Bossman, and he will be followed by Dennis Griffin.
MR. BOSSMAN: Good morning, and thank you for the opportunity to speak. I'm David Bossman, President of the American Feed Industry Association, or AFIA. We are the national trade association for the livestock, pet, and poultry feed industry with over 700 member companies. I am speaking not only as President of AFIA today but also as a concerned citizen who has been in the livestock feed business for over 30 years.
This whole BSE issue is getting as far from science or reality as any issue we've seen in a long time. I'm concerned that we may be on some of the same flawed paths that our British friends took when they have BSE and we don't even have it.
The first problem is that nobody knows about BSE but everybody knows about mad cow. When I mention BSE to friends or strangers, they all ask, "What's that?" When I say mad cow, everybody knows or thinks they know what I'm talking about, when in reality they really don't.
Why is that a concern? In the past year, we have had several meetings in both academia and government settings but the level of understanding does not seem to have gone up. I thank the agency for having these meetings because it's important not only to the affected industries but to the American public's understanding of the real issues at stake and the implications of this rulemaking.
The primary option in the proposal calls for a ruminant-to-ruminant feeding ban. This sounds simple and doable, but it's not. By FDA's own preamble, there is no known scientific way to enforce such a ban. The simple reason that it is unenforceable is that there is no way to test the difference between ruminant and non-ruminant rendered product.
The Elisit test, which some have touted as an effective or accurate test to develop, or was developed to determine the amount of raw kangaroo meet in raw beef hamburger. While that test may be accurate to make that determination, it is not at all accurate to test ruminant meat and bone meal from non-ruminant meat and bone meal.
If we in this great country start down the slippery slope of writing unenforceable regulations just to address a problem which has no easy solution or to satisfy a public relations concern, we will forever leave the public wondering if our safe, wholesome, and abundant food supply is, indeed, really safe.
The feed industry in the United States by FDA's own record and acknowledgement has an outstanding compliance record. I am convinced that having regulations that are feasible and enforceable is the primary reason for that enviable record.
I think we all agree that this issue has no easy or scientific answers. Protecting the supply of meat, milk, and eggs is everyone's concern. We in the feed industry are also consumers and we rely on safe food as our livelihood.
We are asking that FDA not rush to regulate but instead give all parties time to work together to develop a plan to ensure that the beef supply remains safe and BSE-free. Adding a few days to the current comment period would certainly help.
We have offered FDA the following alternatives to the ruminant-to-ruminant ban and will give more details in our written comments. Prohibit the feeding of rendered proteins from all known TSE species to all food-producing animals. Write good manufacturing practices or HACCP regulations for rendering facilities. Implement strong import restrictions on known TSE material.
MR. GAYLORD: You have one minute, sir.
MR. BOSSMAN: And begin an effective education and surveillance program with veterinarians, producers, and processors.
I'd like to close by expressing a concern I have about this whole BSE issue. Many of the people involved who are trying to solve this food safety concern do not understand what ruminant-to-ruminant feeding means. From the conversations and the questions I've heard in the past months, it's obvious that they think ruminant-to-ruminant is actually feeding your cows bone.
This may sound silly for those of us in the feed and rendering industry, but the consumer at the grocery store who buys meat has never been told that there is a meat and bone meal product, a product that has gone through a sophisticated rendering process, changing the bone to a safe, nutritious ingredient. They have never been told that the rendering process turns the bone from our plate that we will throw to our dog to play with and enjoy into a palatable, digestible meal full of necessary protein and minerals.
Normally, the public doesn't need to care about the rendering process, how it protects the food supply and the environment, but this time, with consumer confidence is critical to finding the proper solutions, they need to know. Everyone involved in this rule needs for the public to know. We need to explain to everyone who thinks they know about mad cow that ruminant-to-ruminant feeding is not like feeding and throwing your cow a bone. Thank you.
MR. GAYLORD: Thank you.
Our next commentor will be Dennis Griffin and he is representing Griffin Industries.
MR. GRIFFIN: That's correct. I'm Dennis Griffin with a family rendering business located in Kentucky, out in the midland where all of these actions will eventually have effect.
I come here today to ask the FDA to thoroughly review the proposed actions and only make a decision as based on science. Your past decision making speaks well on your ability to take an official position as based on science and do what is right. Sometimes when we see the influences that are inside the Washington beltway, it makes that position very difficult. But in the past, you've demonstrated that you will make your decisions based on science.
Your actions presently proposed do not totally reflect the possible damages to our society and to our environment. If other user markets do not use these proteins if a ruminant-to-ruminant ban takes place, it is undeterminable at this time by our industry and by the people that have worked on this project to determine what the real damage is to small business, and that's our main customer in the midlands is the small business.
Your action of making a protein product be considered non-safe is probably one of the biggest problems we have with all that has been said in the past few months. You are sending the wrong message, not only to users of protein in the United States but worldwide, that by the United States being the only country that truly has a grass and non-grass classification, we're sending the wrong message, that suddenly, by a single stroke of a pen, our products have been deemed unsafe.
I'm not a scientist or a veterinarian but I'm a very interested party of the agribusiness community. I have studied data, I have traveled to the U.K., throughout the E.U, trying to determine what happened in the U.K., if there was a chance of this happening here. Believe me, there are many different conditions in the U.K. than what exists in the United States.
Everyone in this room is here today because they are concerned about food safety, and I somewhat take exception that we're not considered consumers. We are consumers. We have families, we have grandbabies, and we certainly are concerned about food safety.
We join in the efforts of FDA, trying to build a firewall or a safety net around our beef industry, but please, base your decisions on science, not perception, not misguided information or political pressures. The FDA deals in risk assessment for all agency problems, and please keep your discussion based on science. Thank you.
MR. GAYLORD: Thank you, sir.
Our next presenter will be Dr. Don Franco, and he will be followed by Barry Talley.
DR. FRANCO: The Animal Protein Producers Industry supports FDA proposed rule on the regulatory initiatives with recommendations and they write in the regulations, government agencies must conform to the highest level of authenticity, regardless of the complexity of the subject. You cannot write a rule based on the theory that if the act is good in itself, it is good in spite of scientific affirmation or its ultimate practical success.
I also recognize quite well that you cannot construct a maxim that would function for everyone, a form of categorical imperative that satisfies all. An absolutist policy like a specific ban, be it ruminant, mink-to-ruminant, or mammalian-to-ruminant, or a mixture of any of the alternatives that may satisfy your regulatory objectives, would still create serious compliance challenges to the agency.
As the biosecurity arm of the rendering industry, my organization has worked with your agency, and I thank you for your technical support, to introduce throughout my industry a system of preventive controls that will assure safety both of the finished product and the resulting prevention of disease transmission through HACCP principles.
HACCP in itself has already been validated by the industrialized societies of the world as a proactive, logical answer to feed safety assurance. It is the country's formal regulatory initiative. Let us apply it to feed safety.
The proposal infers also the possibility of spontaneous occurrence of BSE in this country without supporting scientific postulates. The initial hypothesis of the spontaneous theory in the United States evolved during a philosophical discussion by the BSE national consultant task force in Beltsville, Maryland, in which an ARS scientist speculated on relative risks and suggested, what if BSE could occur in the cattle population in a similar incidence as classic CJD in humans, approximately one in a million globally?
The remark was made as a thought-provoking analogy, not an absolute, by any means. The same speaker also theorized, what if it occurred one in five million or one in 50 million--nothing more than an inference for risk assessment. The only other reference to spontaneous was a statement made by a well-respected neuroscientist at the USDA's Riverdale campus who alluded to a case of BSE occurring in a cow in this country about 100 years ago. My reaction to the comment was that science has serious barriers of communication, a distressing challenge, indeed.
I sincerely plead with the agency, also, to sequester the transmissible mink encephalopathy, downer cow complex, into the non-reference category. The substantiation for the request is the fact that we have had only one outbreak of TME in this country in the last 39 years. Mink are fed every conceivable type of material. Elementary statistics would be pressed to affirm an associative link. They also have that theory speculated by asking only, what if, and it was not a confirmed postulate.
Our regulatory action in this country was instigated and heightened by a hitherto unreported cluster of ten cases, currently now called NV-CJD, alleged to a possible although unproved link to BSE in the U.K. This association of BSE to NV-CJD should not be taken lightly. There is reason for concern. However, great importance was given to the age range of NV-CJD, defining how unusual it was to discover these neuropathologic changes within the effective age group.
MR. GAYLORD: You have one minute, sir.
DR. FRANCO: Yes, sir. Yet, Creutzfeldt's initial case, after whom the disease was co-named, first described the condition in one of three mentally institutionalized sisters in Germany characterized by incoordination and progressive mental deterioration. He first saw it at age 16. There's a bit of irony here. Additionally, you have references by Martens and Quinlan who describe CJD in the age ranges of 14 and 18.
Mr. Chairman, the complicated confounding variables of epidemiology plus the complexity of these diseases will continue to challenge and mark our collective ingenuity. To FDA, I say, pursue the science but be advised, no ready or easy answers await you. You have both my respect and empathy.
MR. GAYLORD: Thank you.
Before our next commentor, I think we have just a response here from Dr. Mitchell.
DR. MITCHELL: I just wanted to say for the record that in the proposed rule, the reference to spontaneous mutation and emergence of BSE is based on personal communication. I recognize that that's not yet published in a peer reviewed journal, but it originates from observations that will be published from Ireland and from Switzerland, where BSE has been diagnosed in animals in which there is no BSE in the siblings or parentage and for which there is absolutely no record of these animals having been fed rendered products from ruminants. They're entirely grass or hay-fed animals. So that is the basis for that short paragraph that's in the proposed rule.
MR. GAYLORD: Thank you, Dr. Mitchell.
Barry Talley, please, and he will be--
MR. TALLEY: Mr. Chairman, if I could request that Mr. Evans would like to switch positions.
MR. GAYLORD: Sure.
MR. TALLEY: He has a flight to catch this morning.
MR. EVANS: Thank you, Mr. Chairman. My name is David Evans. I'm with CBP Resources in Greensboro, North Carolina. I'm also Chairman of the North American Rendering Industry TSE Committee.
The rendering industry supports the goal of the FDA to build a firewall around the U.S. cattle industry. This goal can be accomplished with the complete support of the rendering industry. As determined by your consultant, the Eastern Research Group, the cost to the rendering industry will be from $222,000 per day to $789,000 per day from the day the ban is enacted every day, forever. This equates to $81 to $288 million per year every year. This is the cost borne by the rendering industry and this is the cost if we do everything right and don't lose any of our historical markets.
As discussed previously, the U.S. rendering industry established the following goals in order to deal with the BSE issue: Protect the health of the consumer, protect the environment, and protect the North American Rendering Industry.
Work with the rendering industry. Let's build a firewall together. If we try to build it separately, we will not have a firewall. We will have put in place all the elements to ignite a disastrous fire.
Meat and bone meal has been safe for over 100 years. It is still safe. There is no science anywhere that indicates U.S. meat and bone meal is unsafe. We must not declare a product unsafe if it is not unsafe. We must not label a product unsafe if it is not unsafe. Unfair and unscientific characterization will surely come back and do damage to the rendering industry.
We ask that you build a firewall in a positive manner. The rendering industry supports that. Meat and bone meal approved for ruminant rations should be labeled appropriately. As an example, the label may read, pure porcine meat and bone meal, which has been specifically certified as safe to feed the ruminant animals. This certification can be on the shipping dockets, the invoice, and the labeling. This is positive certification and implies no unsafe condition for all other meat and bone meal for all other animals.
Characterization is critical to the continued well-being of the rendering industry. Do not underestimate its importance with the consumer, large food chains, and our enormous export customers. There is no room for error. There is no recovery once misunderstandings develop. We need to be able to continue to render and sell the product from 45 billion pounds of raw material every year.
This is not a legal issue. This is not a consultant's issue. This should not be a political or a senior administrative issue. This should be a scientific issue. You, as scientists, understand the reality of what it means to render 180 million pounds of raw material every day and the need to sell 72 million pounds of finished product every day. You understand what happens to the rendering plant when your finished product storage silo is full and you can't operate your plant because there is no place to store finished product.
We ask you, as scientists, to understand the real issues and make the right decisions. Work with the rendering industry so that we can continue to function, to fill our historical role. Listen to us, work with us, and be fair to us and we will continue to serve our country well. Thank you.
MR. GAYLORD: Thank you.
Yes, Mr. Talley?
MR. TALLEY: Mr. Chairman, members of the forum, I am Barry Talley. I am here this morning as a representative of the North American Rendering Industry TSE Committee.
With regard to that portion of the agency's proposed rule that would declare protein derived from ruminant and mink animals as non-grass or not generally recognized as safe because they potentially may contain the infectious agent of a TSE. The use of an on-grass designation by FDA is a major concern to the North American Rendering Industry. This proposal places an unwarranted stigma on these products which is not supported by available science.
In addition to the status of non-grass, these ruminant proteins could only be used as a food additive under the Federal Food, Drug, and Cosmetic Act. As such, without a food additive regulation or an exemption, its use in ruminant feed would be prohibited and considered to be an adulterant.
The rendering industry and the agency is dedicated to the preventing of the development of BSE in the United States. Ruminant protein meals have been in constant use in the United States for more than 100 years and have not been shown to contribute to the transmission of disease. They were accepted as safe prior to the development of grass regulations in 1958 and have continued to be accepted as safe to today.
The production of meat and bone meal for ruminant issue equals approximately 75 percent of the industry's end product. The proposed regulation and the non-grass designation could also affect the inclusion of animal protein in the rations of other species, resulting in a huge negative economic impact on the industry of agriculture.
The non-grass regulation appears to be a regulatory convenience. All of the affected parties must remain aware that the cause of BSE remains unknown and that BSE again has not been found in this country. Also, the risk factors in the United Kingdom do not exist in the United States.
The rendering industry requests the agency to consider the following alternatives to non-grass. Our primary recommendation is the use of the Compliance Policy Guide, CPG. The CPG has been successfully used in the past and is a workable option now to accommodate the FDA's desire to be preventive in this issue.
Secondly, we would propose that if that is not an acceptable alternative, that we look at the interim food additive regulation. Our industry is conscious that an interim food additive regulation is subject to conditions and is prepared to discuss the problems with the agency, which we feel would be a more workable rule than based upon a non-grass ruling.
The North American Rendering Industry requests the agency to review these proposed alternatives. Lack of grass status will cause a major disruption in foreign trade when compared with other countries that do not use grass status as a measure of acceptability as a feed ingredient. Thank you very much.
MR. GAYLORD: Thank you.
Dr. Gary Pearl, and he will be followed by Dr. Jerry Breiter.
DR. PEARL: I am Gary Pearl, a veterinarian and President of the Fats and Proteins Research Foundation. FPRF is a non-profit foundation established in 1962 to coordinate the financial support of viable research and highlight the attributes and safety of rendered animal products.
I thank you for the opportunity to comment on the proposed rule, and as one that has worked a considerable number of years with consumers and clients, I am going to restrict my comments to a specific area.
The proposed rule raises several labeling issues that are destined to be
