DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
CONSUMER BRIEFING
BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES (TSEs)
1:00 p.m. Monday, April 16, 2001 Columbia Ballroom Holiday Inn Capitol 550 C Street, S.W. Washington, D.C.
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AGENDA Page Opening Remarks Sharon Smith Holston, Deputy Commissioner for International and Constituent Relations, FDA FDA Overview Murray M. Lumpkin, M.D., Senior Medical Advisor, Office of the Commissioner, FDA FDA Briefing Steven M. Solomon, D.V.M., Deputy Director, Office of Regional Operations, Office of Regulatory Affairs Stephen Sundlof, D.V.M., Director, Center for Veterinary Medicine 42 Robert E. Brackett, Ph.D., Senior Microbiologist, Center for Food Safety and Applied Nutrition Mark A. Elengold, Deputy Director, Center for Biologics Evaluation and Research Yuan-Yuan Chiu, Ph.D., Director, Office of New Drug Chemistry, Center for Drug Evaluation and Research David W. Feigal, Jr., M.D., Director, Center for Devices and Radiological Health Federal Collaboration Rima Khabbaz, M.D., Deputy Director, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention 80 Paul W. Brown, M.D., Medical Director, National Institute for Neurological disorders and Stroke, National Institutes of Health 86 Linda Detwiler, D.V.M., Emergency Programs Staff, Animal and Plant Health Inspection Service, U.S. Department of Agriculture 89 52 60 68 73 29 7 4
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Consumer Perspective Peter G. Lurie, M.D., Deputy Director, Public Citizen's Health Research Group Jean Halloran, Director, Consumer Policy Institute, Consumers Union 108 Brett Kay, Director for Food and Health Policy, National Consumers League 118 Richard Wood, Executive Director, Food Animal Consumers League 125 Comments and Questions by Consumer Organizations Janet Abrams, Safe Tables Our Priority David Cantor, Farm Sanctuary 135 132 98
Barbara Loe Fisher, National Vaccine Information Center 137 Felicia Nestor, Government Accountability Project 138 Sara Foer, American Association of Blood Banks Jeffrey Rau, The Humane Society of the United States 140 Christine Stevens, Animal Welfare Institute Responses, Wrap-Up, and Adjournment Mark A. Elengold Stephen Sundlof, D.V.M. Steven M. Solomon, D.V.M. Peter G. Lurie, M.D. Sharon Smith Holston 142 144 149 149 150 141 139
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P R O C E E D I N G S MS. HOLSTON: promptly. Okay. It is 1 o'clock and we are starting
Welcome to FDA's consumer briefing on bovine
spongiform encephalopathy and transmissible spongiform encephalopathies, also known as BSE and TSEs. I am Sharon Smith
Holston, and I'm FDA's Deputy Commissioner for International and Constituent Relations, and I will be serving as your moderator for this afternoon's meeting. Before we progress any further, let me just go through a couple of housekeeping items. First of all I would like to know, is
there anyone here--and you can raise your hand--who needs a sign language interpreter? Okay. All right. Fine, then we
probably won't be needing the interpreters that we have on standby for that purpose. The second item is the usual courtesy statement about cell phones and beepers. We would appreciate it very much, if you are
carrying any such items, if you would turn them off so that they will not in fact disrupt the meeting and the filming that's going on. Okay. On December 13th of last year the executive leadership
of FDA joined with consumer leaders to discuss consumer protection priorities, and this consumer roundtable was a continuation, really, and a reaffirmation of FDA's commitment to strengthening consumer involvement in our policy processes.
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Many of you may not be aware that in just five short years FDA will celebrate its centennial, and I think we can show you examples, probably from throughout our history but certainly within the last half of our history, where we have actively sought consumers' advice, sought for opportunities to involve consumers in our processes. It's really at the heart and soul
of how this agency operates and has been for a long, long time. So we view last December's roundtable as really the plenary session, and today's consumer briefing on BSE and TSEs as further progress toward the goal that we all have, and that is really to work together to ensure the best possible public health protection for this country. The recent increase in cases of BSE found in some European countries has revived public concern about the safety of products that may contain or are manufactured with bovine-derived ingredients. Today's briefing is intended to
provide an update on where we are as an agency in our risk management efforts. Each FDA Center, as well as our Office
of Regulatory Affairs, will address priority product issues, provide an overview of current FDA policies and preventive measures in place, as well as any emerging issues. And, in
addition, we have asked our Federal partners to join us here today, to update us on the role that they have in this collaborative effort and to discuss the key activities, their
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key activities concerning this issue. After the government presentations, we want to hear from you. We would like to have the consumer perspective as to how you think we're doing. We are fortunate to have on our panel today
four prominent and well-respected consumer advocates, who will assist in framing the consumer expectations for the government in terms of protection, help define for us the consumer risk perception, advise us on the best methods for communicating known risks, and offer suggestions for potential collaborations. Now, as this is a consumer meeting, we have devoted time for consumers to engage in an open discussion with the panelists, and we hope that this will allow for a valuable discussion on issues, concerns and suggestions, while maintaining, of course, a respectful environment for all viewpoints. I would like to extend a special thanks to FDA's Office of Consumer Affairs for suggesting this briefing, for taking the lead in putting it together, and for hosting it. They have
put a lot of hard work into this meeting to address what we perceive to be a priority public health issue. So, without any further delay, I would like to introduce the first person on our agenda, and this is Dr. Murray, "Mac" as we know him affectionately, Mac Lumpkin, who is the Senior Medical Advisor to the Deputy Commissioner. Mac has served
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as the agency focal point in the Office of the Commissioner on this issue, and as a spokesperson on crosscutting issues related to BSE and TSEs. DR. LUMPKIN: Mac? I would also like to, on behalf
Good afternoon.
of the immediate Office of the Commissioner, welcome all of you here. As Sharon said, this is part of the way we do business
here at FDA, and these are very, very important meetings for us. If there is any issue about which there is a great deal of controversy, not only in our country but around the world, it is the issue of BSE. And I think, as you will hear today, part
of the controversy stems from the fact that we are all continuing to learn about this particular disease. Now, one of the things that, in having these meetings in the past, that we have found is that it is usually helpful at the beginning to have someone try to set the background. We realize
that there are people in this room who understand this disease much better than do any of us sitting here at the table. We
also have people in this room who perhaps have not been spending as much time on this disease and for whom this disease is relatively new. We also have a very wide audience today in the various television audiences, and so we wanted to take about the first 15 minutes or so here and provide for everyone a bit of a background on
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this particular issue.
And then, in trying to set up the
remainder of the afternoon, at least from the government perspective, give you an overview of the FDA BSE/TSE program, not going into specifics--the representatives from all the Centers will be going into specifics for their Centers and their products--but try to give you an idea of where we as an agency have tried to develop the principles that we have agreed that are going to underlie our program, what the goals of our program are at this point in time, and what the five major focus areas of our program are. So, with that as an agenda here for the next couple of minutes, why don't we proceed? Next slide, please.
Well, unfortunately, we try not to use a lot of abbreviations when we have these kinds of meetings, but we all decided we simply had to use them this time, or we would be here until next week if every time it came up we had to say "transmissible spongiform encephalopathy" or "bovine spongiform encephalopathy." So to try to get through the alphabet soup, just to start with here, these are some of the abbreviations that you will be hearing as we go through the afternoon, the first one being that of TSE or TSEs. encephalopathies. These are transmissible spongiform
These are a family of diseases that we will
be talking about this afternoon.
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One of those TSEs that is obviously in the news a great deal at this point in time is one that is abbreviated BSE, or bovine spongiform encephalopathy. This is a TSE of cows, and it is
also known affectionately as "mad cow disease." There is another abbreviation that you might not have heard of quite as much, for which you might be hearing more of this afternoon, and that is CWD. This stands for chronic wasting
disease, and this is a TSE of elk and deer. And the last group of abbreviations that we will review here this afternoon is CJD and vCJD. CJD is an abbreviation for
Creuzfeldt-Jacob disease, now more often referred to as classical Creuzfeldt-Jacob disease because, as many of you are aware, there is now a variant or what is called a new variant of Creuzfeldt-Jacob disease, and these are two of the several TSEs that have been described in humans. Next. All right, let's talk about TSEs in general for a few
minutes, just again so that everybody is kind of on the same page as we go forward with our discussion this afternoon. group of human and animal diseases known as transmissible spongiform encephalopathies is characterized by what is described as a sponge-like appearance of the brain. These The
diseases are associated with deposits in the brain of unique proteins called prions. Unfortunately, to date the function and the biology of these
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particular proteins is still largely unknown.
It appears that
they do not cause disease in their so-called native state, but only when they become abnormally folded. What causes this
folding to occur, why hosts cannot dispose of or develop internal defenses against these proteins, and what factors other than the proteins themselves actually lead to the transmission of the TSEs, are also very poorly understood. While these particular prions are able to exhibit the ability to be transmitted from one host to another, interestingly, they do not exhibit other features more characteristic of the traditional infective microorganisms that all of us are more aware of, things such as bacteria or viruses or fungi. As such,
prions are not considered germs in the classic sense, but rather, for lack of a better term, most people today simply refer to them as agents of a specific TSE disease. And, most frustrating and most interesting and most concerning, as we have gone through the recent history of these particular organisms or agents is the fact that we have now learned that while we've known in the past that they could be transmitted within a species, there are several now that have shown the ability to be transmitted apparently between different species. As I mentioned a little bit earlier, TSEs occur in several different animal species. There is a disease called scrapie,
which is the TSE in sheep and goats, that has been described
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for several hundred years.
As I mentioned a few minutes ago,
there is a TSE called chronic wasting disease or CWD which is found in elk and deer, and has been reported in Colorado, Wyoming, and Canada for many years. There are, as you can see up here, other animals which have TSEs, including mink and cats, and I'm sure there are others, as people here will describe. Now, in the mid-1980s a new TSE called bovine spongiform encephalopathy or BSE was first described in cattle in the United Kingdom. The government of the United Kingdom initiated major
efforts to determine the origin of this disease and to try to control the epidemic of BSE or mad cow disease that followed the initial reports. Evidence to date implicates strongly certain animal feeding practices as the major route of the initiation of the disease in cows, and of further amplification of the disease throughout the British cattle herd. These feeding practices include
certain rendering procedures and recycling of certain animal tissues and byproducts into the cattle food chain through certain livestock feed supplements. The precautionary slaughter of millions of British cows and ever more stringent prohibitions on certain animal feeding and slaughter practices appear to have stemmed, although not eradicated, the epidemic of this bovine disease in the United
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Kingdom.
Unfortunately, these measures were not sufficient,
were not enforced stringently enough, or perhaps were not instituted timely enough to prevent the spread of the disease to continental European countries, as became evident this past summer. At present, the United States Department of
Agriculture officially recognizes 30 European countries and Oman as having either documented cases of BSE or being at high risk for BSE within their borders. It has been known for years that humans are also susceptible to TSEs. As we mentioned a few minutes ago, two of the
better-documented human TSEs are a disease called Kuru and a disease called classical Creuzfeldt-Jacob disease or CJD. Both
of these diseases have been described in people for decades. Kuru is a disease of a group of people in the South Pacific and has been historically associated with the consumption of human brains. Classic CJD, on the other hand, occurs throughout
the world at a stable rate of approximately one in a million people. The cause of classical CJD is not fully understood, although there is believed to be a specific genetic component to its human susceptibility. Transmission of classical CJD between
humans via transplant of dura mater or transplant of corneas from donors who had CJD, and by handling CJD tissues, has been documented.
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In 1996 a new variant of CJD, what is now called vCJD, was described in patients in the United Kingdom. Strong
epidemiological data implicate the consumption of beef products contaminated with the agent of BSE as the probable cause of this new disease in humans. Due to the long incubation period of the agent in humans--and by "long" here we're talking years--before variant CJD is clinically recognizable, the numbers of people who have been infected with the agent of variant CJD is unknown. As most
of you are aware, presently approximately 100 people in Europe, primarily in the United Kingdom, are known to have died from variant CJD. Unfortunately, the lack of any sensitive specific diagnostic tests for these diseases that can be used before death, in either humans or animals, limits surveillance and other research efforts at this time. Presently, diagnosis is usually only
confirmed by special postmortem examinations of brain tissue. There are, unfortunately, no known treatments for or vaccinations against the animal or human TSEs, and for the most part all of the TSEs are invariably fatal. Routine materials
and processes known to destroy traditional human and animal pathogens do not appear to fully destroy prions. Presently
there are no established methods of decontaminating or sterilizing articles contaminated with proteins.
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At present, there is no evidence of either BSE or variant CJD in the United States. However, it is clear that the Atlantic
Ocean itself is not a barrier to the spread of this disease. The presence of animal TSEs in North America, certain historic American animal feeding and animal importation practices, the continental European experience with BSE and variant CJD in the summer of 2000, the international commerce in animals, animal feed, and other products of bovine origin, and the heavy intercontinental travel by Americans, all raise significant concerns about the potential spread of TSEs, including BSE and variant CJD, into the United States. Based on the European experience to date with BSE, it is clear that the discovery of such a disease in cattle has been devastating to their cattle industry. The ultimate magnitude
of the human public health impact of BSE and variant CJD in Europe still remains to be determined. Nonetheless, due to the invariably fatal nature of the disease, the seeming lack of methods to destroy the agent, the ubiquitous presence of bovine products in most people's daily lives, and the very nascent level of scientific knowledge about prion disease, BSE and variant CJD clearly lead to understandable concerns both in the public, the government, and the private sector. I think and I hope, as you can tell from having gone over some
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of the history of this disease up to this point in time, you can see that there is indeed much that we all have to learn about this disease, how to approach this disease, hopefully how to manage this. And that's part of what we are here for
today, to share and to see where we are in the various constituencies that are obviously equally concerned about this disease. Now, as far as the response, and that's what we're spending the first part of the session here talking about, the response to this disease has been going on for a fair amount of time. In many respects we have been lucky that we've had the ability to look at the experience of our European counterparts, to see what has happened in their countries, to see what has worked, what appears not to have worked, in order to try to put together our plans on how we need to forward in this country to address this particular issue. And this is not an issue that is just and FDA issue, this is not an issue that is just a Federal issue. As you will hear
today, this is an issue that involves many different Federal agencies, it involves State agencies, and it involves the private sector. One of the steering committees within the Federal realm of this that has been active has been what is called the Federal Interagency Steering Committee. This is a committee that is
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chaired by the Commissioner of Food and Drugs.
It has
representation on it from within the Department of Health and Human Services, FDA, CDC, and NIH. From the USDA it has
representatives from the Animal and Plant Health Inspection Service, the FSIS, and the FAS. It has representation from
the Customs Service, from the United States Trade Representative, from OMB, from the White House Office of Science and Technology Policy, from the Departments of State and Defense, from the National Association of State Departments of Agriculture, and from the State Association of Feed Control Officials. This Steering Committee basically thus far has been looking at the ongoing coordination of efforts from those various Federal agencies that we just listed. It has been looking at
an integrated contingency planning mode and what one would do from a Federal perspective, were we to find a cow with BSE in the United States or if we were to find a person with variant CJD; the identification of and response to potential vulnerabilities, as we continue to learn more and more about this disease; and also coordination of risk communication, the messages that are going out, the information that we have, the way we can best share information with various stakeholders and get information back from the various stakeholders that are concerned about this.
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There is also a TSE Advisory Committee, which is one of FDA's public advisory committees. We have had upwards of 8 to 10
meetings of this particular advisory committee over the past five to six years, and we take a lot of our more vexing issues to this advisory committee, and it offers another forum to have public discussions about these issues, to get public input into these issues, as we and other Federal agencies go forward in trying to formulate public policies that will be leading to the best public health result that we can possibly get. There is also, within FDA, an FDA BSE/TSE Coordinating Committee. This has a representative from each of our Centers,
from the Office of Regulatory Affairs, from the Office of the Commissioner, the Office of Policy, and the Office of Chief Counsel. Many of the people whom you see sitting at the table
here are their Center's representatives on this particular coordinating committee. And this is a committee, as you can
imagine, within FDA where we try again to make sure that we all know what's going on in the various centers, that we're sharing information, and that we are using our resources as best as we possibly can to address the issues that seem to be most important and most pertinent at a given point in time. Now, I know this is not showing up well in the back with the lights, and I apologize for that, but as you hear the talks later this afternoon, some of the things that I think you might
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find interesting in trying to visualize this in your head, is that most of the policies that have been developed to date really fall within two different bailiwicks. The first fall to those above the darker line there, dealing with cattle, the feeding of cattle, trying to protect the American cattle herd from BSE, and putting into place policies that build upon the experiences that we have had, not only in this country but the experiences that people have had in other parts of the world that have had to deal with BSE in a much more dynamic way than we have had to do it here in this country. Now, the group below that is then also the issue of looking at the potential for spread from cattle or from materials made from infected cattle parts, through various and sundry products, many of which are FDA-regulated. And you see the list up there:
foods, drugs, medical devices, vaccines, dietary supplements, cosmetics, food additives, infant formulas. Those are all different categories of products over which FDA has certain regulatory responsibilities. They all, or many
within those groups, have indeed bovine components at some part in their manufacture. What role, if any, that could possibly
play in any potential spread is a very vexing issue that we are having to deal with. There is also the issue of talking about, well, if indeed you have a person who were to have this disease, what does the science
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tell us?
What does the experience tell us as far as potential
spread through blood transfusion or other tissue transplantations, again building on our experience from classical CJD, and then trying to figure out where does this fit, when indeed the science doesn't answer all those questions at this point. Now, I think you will hear, as we go through a lot of the policies here, there are in place certain policies that try to deal with the issues of protecting the American cattle herd and trying to prevent any amplification of BSE, were BSE ever to get into the American cattle herd. Now, there are issues about is that
strong enough, are there things that we need to do with that, are there vulnerabilities in our present system, and I think these are things that we are very interested in hearing from people on. They are issues that we continue to deal with, and
they are issues that are going to evolve as we go forward, learning more and more about this issue. The more vexing issue, and I think we get into this whole issue of getting from known, real risks into theoretical risks, and what do you do when the science isn't giving you clear-cut answers of how to deal with potential contaminations through products made from cattle, and how to sort out cattle that we consider safe to be primary sources for these products, and how to sort out cattle which we don't think are safe as primary
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sources for some of these products.
Again, very, very vexing Again, just kind of a
issues, as you will hear as we go on.
visual way for us to think about this as we go through the afternoon. So in finishing here, I would, as I said at the beginning, I would like to share with you a little bit, based on this background and based on kind of this whole issue of how this has been approached up to this point in time, and share with you what we--at least from an FDA perspective, and my colleagues from other Federal agencies can speak to this from their agencies' perspectives--what we see as kind of five fundamental principles that we are going to be using, and that we are using at this point in time as we try to develop the public policy and public health policy elements of this program; what the six major goals of our program are; and what the five major areas of focus are that we are looking at at this point in time. The first principle says that we believe that strong science-based knowledge is fundamental to addressing this challenge to public health. be grounded in that science. Number two, the science of these diseases will and must continue to evolve. FDA's actions must foster this evolution, and FDA's FDA's public health policies must
policies must change and respond to new knowledge. Number three, as we discussed a little bit earlier in looking
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at the history and where we have come with these diseases, these diseases uniformly have lethal outcomes, and the level of scientific knowledge about them is really quite nascent. Because of these factors, FDA believes that science and common sense tell us that when we are operating in an area of uncertainty, our public health policy should employ a very cautious approach, and must take into account the level of known risk, both real and theoretical, posed in each such policy arena. Number four, FDA will utilize public advisory committees and other public fora, along with intradepartmental and outside experts, domestic and foreign, as much as possible to advise us on scientific, regulatory, and communication policies. And, finally, FDA will communicate with all our stakeholders as openly and frankly as possible throughout our efforts to address this public health issue. Science-driven facts and
frank, transparent discourse are our best defenses against distrust and our best offenses against either over- or under-reaction. Based on those principles, we have developed six goals that we have for our TSE/BSE program at this point in time. Number
one, working with other Federal, State, and private sector entities, FDA will protect the public health of the United States by preventing, to the extent possible, the entry of the agent of BSE into the United States cattle herd.
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Number two, if the agent of BSE were to enter the U.S. herd, in coordination with other Federal, State, and private sector entities, there will be in place systems to identify, isolate, and destroy the affected cattle, and to prevent amplification of BSE through the U.S. herd. Number three, FDA will protect the public health of the United States by minimizing exposure of Americans to TSE agents through potentially contaminated food products; number two, other products that use potentially infected materials in their manufacture; or, three, exposure to FDA-regulated products or materials in or on which the agents may be present. FDA will protect the public health of the U.S. by facilitating the development of viable premortem diagnostic tests for humans and animals; viable therapeutic options for people afflicted with these diseases; and viable preventative options for both humans and animals. And, number six, FDA will protect the public health of the U.S. by developing and sustaining, in coordination with other Federal, State, and private sector entities, an effective communications program with our stakeholders on BSE/TSE issues. So those are our goals. striving to do. Those are the things that we are
Those are the goals that we have set for And I just
ourselves, and we have five major areas of focus.
want to list those five focuses, and that will be the segue
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into my colleagues here from the Centers who will be talking about some of the specifics in each of these areas of focus that are going on in their particular Centers. The first area is the prevention of exposure of Americans to the agents of TSEs through human and animal food products. This involves both feeding programs and finished human food products, and the importation of food products from areas that are considered at high risk. Number two, the prevention of exposure of Americans to the agents of TSEs through blood transfusions or tissue transplantation. Number three, the prevention of exposure of Americans to the agents of TSEs through other FDA-regulated products. And, as
we mentioned earlier, this is pretty much the gamut of products that we oversee: drugs, devices, vaccines, other biologicals,
cosmetics, food additives, pet foods, infant formulas, and dietary supplements, for example. Number four, establish a coordinated education and outreach program to inform consumers, practitioners, patients and industries of the risks of TSEs and their potential transmission through FDA-regulated products. And, finally, number five, continue and expand FDA's TSE-related regulatory research agenda. So I hope, in conclusion, that gives you a little bit of an idea of the history, we're kind of all on the same page here
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as far as the abbreviations we're going to be using, and gives you an idea of the program that exists at FDA at this point in time, at least as far as principles, goals, and major areas of foci. And now I'm going to turn the program back over to Thank you very
Sharon, who will introduce the next speaker. much. [Applause.] MS. HOLSTON: Thank you very much, Mac.
That was really very
comprehensive, and I think that it gives you a very good backdrop for the remaining speakers in today's program. The first panel of speakers are speakers from the Food and Drug Administration. As you heard from Dr. Lumpkin, this affects
virtually every Center within the agency, and therefore we do have representation from the Centers who are involved in working on this issue. The first speaker will be Steve Solomon, and Dr. Solomon is Deputy Director of the Office of Regional Operations in our Office of Regulatory Affairs. He will be followed by Dr. Steve
Sundlof, who is Director of our Center for Veterinary Medicine. Steve will be followed by Dr. Robert Brackett, Senior Microbiologist in our Center for Food Safety and Applied Nutrition. Then we will hear from Mark Elengold, who is Deputy
Director of our Center for Biologics Evaluation and Research, followed by Dr. Yuan-Yuan Chiu, who is Director of the Office
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of New Drug Chemistry in our Center for Drug Evaluation and Research, and then our final FDA panelist, Dr. David Feigal, who is Director of our Center for Devices and Radiological Health. They will speak in order, and I will not come back up to introduce them. And then we will have a short break, after which we will Dr. Rima Khabbaz,
hear from our Federal collaboration panel:
Dr. Paul Brown, and Dr. Linda Detwiler, who is en route and will be joining us shortly. after the break. So now I'm going to turn it over to Steve. DR. SOLOMON: Thank you. Good afternoon, everyone, and I also But I will reintroduce them again
want to offer that I'm pleased to have the opportunity to have this dialogue today, and I think I'll build upon many of the themes that Dr. Lumpkin laid out in his presentation. First, let me demonstrate where we're from. The Office of
Regulatory Affairs is the field operation of the Food and Drug Administration. This is the portion of the organization that
deals primarily with inspections and enforcement activities. As you can see from this map, we're broken up into five regional areas. There are 19 district offices located within these
regions, 137 resident inspection posts, and there's also another component, the Office of Criminal Investigation, that is located throughout the country.
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The major field activities in relation to the BSEs and the TSEs that I'd like to talk about will build upon the goals that were laid out earlier. The first area is import surveillance of Once again, this is aimed
FDA-related animal origin products.
at the goal that was laid out, to prevent entry of BSE to the extent possible. The second area which I'll briefly go over today is domestic inspection and enforcement of the BSE regulations. This is
aimed to prevent, this other goal mentioned, to prevent amplification of the BSE agent. And then, very briefly, the last portion of the field activities I'll discuss is our emergency response, which is our attempts to coordinate Federal, State, and local agency activities in response to entry of the BSE agent. The first area that we wanted to talk about is our import surveillance activities. We work, FDA works very closely with The Customs
the Animal and Plant Health Inspection Service.
Service is the Federal agency with primary responsibility for administering the U.S. laws related to imports. at multiple levels with these two agencies. On a national level, working from headquarters here in Washington, D.C., we coordinate policies and identification of products that pose concerns for the BSE agents. The second We coordinate
level is, we coordinate nationwide field activities by having
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nationwide phone calls with both APHIS personnel and FDA personnel, to make sure we have uniform implementation of those policies. And the third area is an extensive amount of local
coordination that occurs in the ports between FDA, Customs, and APHIS personnel located at ports of entry. Besides the coordination between the various agencies, there is a multiple layer review process for the BSE and the TSE agents. The first area is the U.S. Customs Service, where we provide harmonized tariff schedule codes for products of concern to the U.S. Customs Service, so that these products are flagged and directed for specific attention by the FDA. The second
area is, this data that comes from U.S. Customs Service is reviewed by FDA personnel at ports of entry, whether or not there is an FDA person stationed at those ports of entry. And
the third area is, the Animal and Plant Health Inspection Service reviews shipping manifest information as another layer of review for these products. The other issue that we have increased import surveillance is related to import brokers or filers. These are personnel that,
importers that provide the information for entry of products into the United States. We conduct assessments of these
individuals to assess the accuracy and the validity of the import data that they provide to the U.S. Customs Service and to FDA. The next overhead is to demonstrate the level of rise of entries
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of products.
This slide is not specific to BSE- or TSE-related
products, but is generally the trend over the past six years. You can see a tremendous increase in the number of import line entries that have occurred. To address these rising number of import entries, we use various tools. One of the tools that the FDA uses are known as Import
Alerts and Import Bulletins, to try and focus our attention on the products that are specifically of concern related to BSE and TSE agents. The FDA issues Import Alerts, which directs
our field offices to detain without physical examination and, if necessary, to refuse entry of the products into the United States. The second item, the tool that is used, is an Import Bulletin. This also directs FDA field offices, in the case of the BSE products of concern, this directs them to the Animal and Plant Health Inspection Service, which can prevent these products from entering into the United States under the USDA authorities. When either of these products, either the Import Alerts or the Import Bulletins, are used, they are entered into our electronic data entry system known as OASIS. These products then are
flagged, so that when an entry that meets the criteria from the 31 countries for the products that are of concern related to the BSE agents, they are flagged for our review by our import entry folks.
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You see before you a chronology of the various Import Alerts and various bulletins that have issued over the past numbers of years. You'll notice that the first Import Bulletin issued
in 1992, followed by--this was replaced by an Import Alert that identified bulk shipments of high-risk tissues and tissue-derived ingredients, including cosmetics, and dietary supplements were included in this. At the time that this was first initiated, I believe there were six countries identified that had BSE concerns, had BSE. As
the countries affected by BSE have expanded, these lists of these Import Bulletins had been modified to reflect that. In December of this year, we issued a new Import Bulletin related to animal feed ingredients, and this time this reflected all 31 countries. This Import Bulletin was later replaced in
January of this year by an Import Alert, 99-25, for animal feed, feed ingredients, and other products for animals or containing animal-origin products. And then the last is an Import Bulletin
that was generated in March of this year for referral of edible products of ruminant origin to the Animal and Plant Health Inspection Service, who has a ban on those products. The other issue of concern that has arisen is the issue of potential for smuggling or diversion of animal or plant products. Our Office of Criminal Investigation, which I
mentioned earlier, has been cooperating with various domestic,
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international, and other countries, including the FBI, U.S. Customs Service, the USDA Office of Inspector General, INTERPOL, and other countries, to try and look at the issue about smuggling or other criminal activity involving diseased animals, meat or byproducts, including animal feed from diseased animals that may be smuggled out of quarantine areas. To date, our Office
of Criminal Investigation is unaware of any illegal shipments aimed for the United States. Moving from the import area, let's move over to the domestic inspections and enforcement. The regulations that were applied
to the animal feeds are codified in the Code of Federal Regulations. They are animal and plant proteins prohibited We commonly call this the BSE
from use in animal feed. regulations.
I'm going to quickly go through our inspectional compliance statistics, our current FDA actions related to this regulation, some of the enforcement actions related to it, and some of the coordination that goes forth with the States. This is data we have compiled since the implementation of the BSE regulation in 1997. In total, between the FDA and the
States, there have been over 10,000 inspections that have occurred. The areas on the left-hand column of the slide, the
labeling provisions, the commingling provisions, and the record-keeping provisions, are the three primary aspects of
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the regulation that are of key importance. The groups that are subject to this include renderers, licensed feed mills, unlicensed feed mills, and ruminant feeders and on-farm feeders that are subject to this regulation. You can
see there on your charts the levels of compliance to date with that regulation. We're continuing to increase our inspections,
and in the next slide we have--excuse me. MS. HOLSTON: Let me apologize, first of all, for interrupting
Dr. Solomon, but I know that you all cannot see the slides. And therefore what I'm going to do is ask if we can just interrupt and take a five-minute break for adjustment of the lights, so that you all will at least be able to see the slides as he goes through the rest of his presentation. And we'll work on the
sound as well, but we're going to take just a quick break to adjust lights and sound. [Recess.] MS. HOLSTON: All right, would you please take your seats? And again, I apologize for And Thank you very much for your patience.
We're ready to get started again.
the interruption, but it was time for an impromptu break. so I will turn it back over to Dr. Steve Solomon. DR. SOLOMON: out. Okay.
Once again, sorry the slides didn't turn
There were copies that were outside when you came in,
and this will be posted for anyone that wants to take a look at this after the meeting.
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We were talking about the BSE domestic inspections for enforcement, and to increase our inspectional activity we have issued, the Center for Veterinary Medicine has issued several assignments to try and increase the number of inspections and to look at the compliance rate for the firms that are subject to this. The first inspection assignment issued in December of this year, there have been 347 firms that had been inspected, including that. These are firms that had never had a history of inspection There are 13 firms that still
for the BSE regulations by FDA.
were identified as having some deviations from the BSE regulations on those inspections. A second assignment was issued that had follow-up inspections for renderers, blenders, and feed mills that had initially been found to have some violations and required to be reinspected. That inspection assignment is still ongoing. As of last week There
there had been 551 firms inspected under that assignment.
were still 163 left to be inspected, and at the last count we had 40 firms that were identified that still had some deviations from the BSE regulation. In regards to enforcement of the BSE regulation, when this regulation first came into effect in 1997, the focus was--by both States and FDA, which both conducted inspections through it--the focus was primarily on voluntary compliance by education
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and by leaving a list of deviations with the firm.
Since that
period of time, under the current assignments we have tried to increase our enforcement aspects, and current inspections have resulted in warning letters and recall product if product has been distributed into commercial commerce. We are still
conducting follow-up inspections, and if we continue to find violations on firms, they may be subject to other provisions of the Food, Drug and Cosmetic Act that include seizure and/or injunctions. We also provide copies of all our regulatory actions and notices to State feed control officials or people that are in charge of licensing or registration by the States, and they may take separate action under their own authorities. We do an extensive amount of coordination with the States in relation to BSE. FDA contracts with States. For this fiscal
year we have contracted an additional 771 inspections with the 19 States that have currently been under contract with the FDA to conduct feed inspections. For next fiscal year we have sent
out a Request for Quotes to all 50 States, the 19 that have currently been doing work and the 31 other Sates, and we are requesting them to look at conducting up to 4,000 inspections of unlicensed feed mills. Other activities with the States, it's important to remember that many of the States conduct inspections and take their own
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enforcement actions of these facilities under their own authorities and programs. Many of these States get into these
facilities several times a year in addition to the FDA inspections that we're talking about. We coordinate with the States routinely through 50-State conference calls. The participants in those 50-State
conference calls include Departments of Agriculture, Departments of Health, and we have Canadian officials that participate in those 50-State calls. As Dr. Lumpkin mentioned earlier, we work with the American Association of Feed Control Officials, known as AAFCO. are officials, State regulators that deal with the feed industry. And they have charged a work group, in which FDA These
participates, to try and have full implementation of the BSE regulations. We also sponsor training for the States. We have had it
previously, and there will be two upcoming courses for training this fiscal year. The National Association of State Departments of Agriculture had their annual meeting in February of this year, and they provided the following statement on BSE: that BSE is a critical NASDA, the National
issue facing the animal agriculture today.
Association of State Departments of Agriculture, calls upon all States to obtain 100 percent compliance in meeting Federal
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feed regulations established in response to BSE. The Food and Drug Administration has set a goal of inspecting every facility, rendering facility and feed mill, in the United States to ensure compliance, and State cooperation is also necessary in order to maintain the BSE-free status of the United States. The last area I just wanted to briefly touch on is the area of emergency response in case there was a case of BSE or a notified case of variant CJD. plan. FDA has put out a BSE contingency
This will be constantly subject to revision as we learn This coordinates extensively with various
more information.
other government agencies, including USDA and CDC. We're planning to host an exercise, joint exercise of both the USDA, BSE response plan and the FDA plan, later this year. This will be a two-part process. We will first run a table-top
exercise and then run a full exercise. I appreciate the opportunity. Once again, my apologies for
the slides, and hopefully you will be able to get all the information following the meeting. [Applause.] DR. SUNDLOF: Just waiting here for the next slide to come up, Once again, I am Steve Sundlof, and
I'll introduce myself.
I am the Director of the FDA Center for Veterinary Medicine. We're responsible for the regulation that pertains to feed
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that I think you just heard Steve Solomon talk about. slide, please.
Next
So I'm going to talk a little bit about the regulation itself, what it entails, and a little bit about the enforcement that Steve Solomon previously talked about. But just to give you
an idea of when we did it, how we did it, the rule that I'll describe in a minute was actually published in June of 1997. It went into effect in August of that same year, and it has been, obviously, in place ever since. The purpose of that rule was to prevent the amplification of undetected bovine spongiform encephalopathy through animal feed, and I like to refer to this as the second line of defense. The first line of defense is generally regarded as primarily the responsibility of USDA APHIS, that is, to prevent the disease from entering this country. APHIS has the responsibility to
prevent foreign animal diseases from entering our domestic animal herds, and so that's obviously an extremely important effort. Should that fail in any respect, then the second line of defense is this feed regulation, because we understand the disease and how it spread throughout the United Kingdom, and now through Europe, it that it virtually exclusively is spread through the consumption of animal feed that contains infectious material from other cattle. That's how the disease spreads. We're
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fortunate in that respect, that there is a single control point whereby the disease can be controlled. Next slide.
The regulation prohibits the feeding of mammalian protein to ruminants, and there are some exemptions, and I'll talk about those exemptions right now. Blood and blood products. During the time that we were writing
the rule, we had originally proposed that all ruminant proteins be banned. The scientific literature at the time had some
fairly convincing studies that showed that the disease could not be transmitted orally to cattle through blood, and so blood was exempted. Additional studies have come to light since then. None of them
have given us any other indication that oral exposure of bovines to cattle blood products causes infection, but there are some other routes of administration in which blood may actually have some potential to be infective, so we're looking at those studies and determining whether or not we need to reevaluate in light of new information. Milk and milk products, I think there is general agreement that those, that milk and milk products, at least to this date, are not thought to be able to transmit the disease either to animals or to humans. Pure porcine, which is pigs, so swine and equine, which is horses, horse meat and bone meal, those two animal species,
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swine and horses, have never been shown to naturally be infected by any of the spongiform encephalopathies. And so, in light
of the fact that they are not infectious themselves, this was exempted. Gelatin and plate waste, gelatin is again a processed bovine material in which the infectivity, if there is any, is dramatically reduced by the process of making gelatin, such that it is believed not to be able to transmit the disease. Plate waste is a somewhat strange exception, in that it is material that has been cooked, offered for human consumption, and then discarded, and there are firms that work through the restaurants and pick up the waste and reprocess that. waste does have to be reprocessed into animal feeds. Plate
And again,
this is another area that we are continuing to look at to determine if this is indeed a safe practice. Some other things that are not covered because they are not proteins, tallow and fat from bovine animals are not covered, again because they are not proteinaceous in nature, and that's the nature of the infectious organism. Non-mammalian protein, poultry meal, fish meal, again, these particular animal proteins do not appear to be capable of transmitting the disease. And pet foods, we did not require
pet foods to carry the warning statement because it would not have the impact. Most people who purchase pet foods for their
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pets never intend those to be used in cattle. But what happens in some cases is that pet foods are salvaged. They for one reason or another are determined not to be saleable for animal foods. In this case those products, if they contain
prohibited meat and bone meal, must be labeled accordingly so that they cannot be fed to cattle. Next slide.
The regulation requirements state--this is the warning statement that is required on all animal feeds and feed products, feed materials that contain prohibited mammalian protein. They
must carry the statement, "Do not feed to cattle or other ruminants." They must have systems, firms that produce animal feeds, if they are using prohibited mammalian proteins and non-prohibited mammalian proteins, they must have ways of separating and maintaining separate systems for preventing cross-contamination, so that prohibited ruminant meat and bone meal does not cross-contaminate feeds that are intended for cattle. And this involves not only having the physical systems in place to prevent commingling and cross-contamination, but also there must be record-keeping in place and standard operating procedures in place that can be inspected. When the Office
of Regulatory Affairs goes out there or when the States go out and do the inspections, they must have some kind of proof to
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show that their systems are operating as they are supposed to. And, finally, there must be record-keeping in place to be able to trace, forwards and backwards, where did the incoming materials come from, did they contain prohibited materials or not, and then where are the finished products going, those only to be traced, so that if we do find product that's in violation, we can trace it back to the source. Yes, our enforcement plan. Next.
In 1998, in January of 1998 we
developed and enforcement plan, and during that time we decided that our goal would be for 100 percent inspections; that all facilities that handle prohibited mammalian proteins would be inspected, all the way down to the level of the feeder, of the ruminant feeder or the farmer. There are somewhere in the order Obviously it's
of about a million ranchers that raise cattle.
not possible to get to every one of those establishments, but we did do a sampling at that level. But everything on upstream from the farm level, so the renderers being at the top, because they are the industry that produces the mammalian protein; then feed mills, commercial feed mills that mix that rendered animal protein into finished animal feeds. There are middlemen in there, brokers, haulers, There are protein blenders and a number of other
distributors.
small firms that potentially handle this material, and they all are to be inspected.
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Again, our goal was 100 percent compliance, 100 percent of inspections of those facilities, with the first visit on education. That is, when our field forces went out to inspect
the feed mills or the renderers and found them to be in violation of one of these issues, whether it's labeling or cross-contamination or record-keeping, that they would--the first order of business would be to explain to the firm why they were not in compliance and to try and bring those firms into compliance. Most of the firms that we were inspecting had never seen FDA inspection before. Licensed feed mills all had been inspected,
but the majority of the commercial feed mills that operate in this country were unlicensed and therefore were not used to seeing an FDA inspector, so this was new for them. We expected
approximately, we anticipated that about 25 percent would be out of compliance, and this turned out to be pretty close to what was actually found on inspection. Enforcement actions were taken. We did do some recalls. We
have sent out warning letters, as Dr. Solomon has indicated. And we rely heavily on the States. There are approximately,
we learned that approximately 6,000 people throughout the States are involved in inspecting feed mills in those States, so that's a tremendous field force that we don't have, would not have directly available to us, and if it weren't for the States'
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involvement, we could not get the job done. But still we had anticipated that within a two-year period we would have all the feed mills inspected. Well, in the FDA things
come up, and there always seems to be one emergency or another emergency that requires the field to become involved, and so we were not able to complete all of our inspections on that two-year time schedule. We have renewed our efforts in light
of the recent situation in Europe and our concerns about making sure that we don't make the same kinds of mistakes that occurred in Europe and resulted in the new BSE cases that are occurring there. And so our new inspection assignments as of January 1 of this year are to complete all of the inspections, and Dr. Solomon already talked about this, following up on all the renderers. There were 394 FDA-licensed feed mills that were uninspected, estimating still around 2,000 non-licensed feed mills that need to be inspected. Dr. Solomon's statistics are more up-to-date
than what I can report, but we found that there were approximately 834 firms that were not in compliance. those have now been reinspected. Most of
The compliance rate is over We are still
90 percent, but that's still not good enough.
of the mind that compliance needs to be as close to 100 percent as possible. And we want to finish all of these, the first inspections and
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the reinspections, by September 30th of this year, at which time we will start developing plans, based on the information that we've gathered, to do routine inspections. So we don't
have a specific plan, but we need to, we want to get to the feed mills at least on an every other year basis, and for some of them more frequently than that. Next slide, please.
The inspection results are changing every day, as we get more information in, and they can be accessed at our web site, and we will keep you posted on those. That will be an ongoing,
running tally of the firms that are inspected, which ones are in compliance, which ones are out of compliance. please. Finally, we are in the process of looking at our feed rule and determining whether or not there need to be changes. We have Next slide,
had this rule in effect now for approximately two and a half years. It's time to reassess it, to look at some of those
exemptions that I've mentioned earlier and determine whether or not those are still valid exemptions. other things? Should we be doing
Should we be more protective?
And so those are some of the issues that we'd like to get some input from you folks today, to help give us some guidance on how to proceed in the future. attention. [Applause.] So thank you very much for your
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DR. BRACKETT:
Good afternoon, and I'll do the same as Steve. I'm Senior Microbiologist in the Center
I'm Bob Brackett.
for Food Safety and Applied Nutrition. As you can see from what Dr. Lumpkin has stated in the very first discussion, as well as what you heard from Dr. Solomon and Dr. Sundlof, the whole issue of BSE and TSE is very broad. It's a very multifaceted problem, and consequently it can be viewed and it is viewed by a number of different perspectives, depending on who you ask and who you happen to be interested in. It can end up being a trade issue and is being a trade issue in many countries. It is also an animal health issue, as Dr. It can also be a medical issue, as And also it can be
Sundlof just mentioned.
you will hear after I'm through speaking.
what I will discuss, and this is the issue for the Center for Food Safety and Applied Nutrition, which is a food safety and cosmetic issue, and that is what I will focus on this afternoon. There are a number of overall strategies that one can use, and because it is such a broad and far-reaching problem, it necessarily will be looked at in a number of different ways. Shown in yellow in this slide are the overall in-Center and in-agency strategies, and Dr. Lumpkin mentioned many of these. First and foremost is to work with our partners at APHIS to try to keep BSE out of the U.S., but there's also some additional
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components to that, and it includes restricting entry of other products and their usage; prevent transmission within the country, as has been done with the Center for Veterinary Medicine; and then also to establish some standards or develop some standards to reduce and eliminate the risks. they're small now, let's reduce them even more. Even if
We also want
to increase the surveillance so that we have an early warning if there is a problem, so that we can deal with this in the future, in both animal diseases as well as human diseases, CJD and variant CJD. CFSAN's responsibility in the regulatory authority for BSE and TSEs really revolves around food safety, as I mentioned. CFSAN shares responsibility for regulating foods with its partners at USDA, and in general we have different responsibilities, but those foods that FDA regulates for which BSE or TSE may be an issue are listed here. They include what And
I will call conventional foods, and that's what most consumers would think of as foods, but we have a subset of what most people think of as conventional foods. Ours include those such as foods containing less than 3 percent meats, and this might be something like a soup or some other combination product. It is made from products of non-amenable
species, that is, those types of species that USDA does not have regulatory authority over, and this includes meats such
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as elk and deer or other animals that some would consider to be sort of exotics. It also includes many ingredients of foods,
such as gelatin and many flavorings which may be animal-derived. We're also responsible for regulating dietary supplements. Now, many of the foods in many of the dietary supplements contain or can contain animal parts, and this includes primarily animals that might be considered normal farm animals like cows and swine and sheep, but they can also contain some ingredients of other animals as well, such as horses, rabbits, or different types of species. The types of ingredients that can be included in dietary supplements include different glandulars or parts of the animal, such as the brain or different organs. It can include tissues And it
or parts of tissues, such as bone meal or placenta.
can also include ingredients that may be made from tissues, such as hormones or fatty acids or amino acids. CFSAN is also responsible for regulating medical foods, and this is sort of a specialty subclass that's designated for people that might be in hospitals or that may have special needs, and of course some of these may have animal products as well, and so we're justifiably concerned about those also. And, finally, cosmetic ingredients. Cosmetics, like dietary Again,
supplements, can contain ingredients of animal origin.
these are such things as gelatin, tallow, collagen, or a variety
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of fatty acids. As mentioned earlier by all of the speakers so far, one of our primary first lines of defense is to keep BSE and these agents out of the product. thing? So how does CFSAN address this particular
It's the same as all of the other types of products
that FDA regulates, in that we work closely with APHIS to try to keep ingredients that might contain BSE out of the country, by supporting them. In addition to that, we also go and try to provide some other hurdles and have sort of a five-pronged approach that you've heard also, that also helps to ensure that these barriers might be in place, one which is to inform. That is to inform
consumers, and it's also to inform the industry as well. For example, one way we do this is by directly communicating with the industry via letter, and we have had a number of different letters go to different aspects or different facets of different industries. The example I've listed here are
letters to the dietary supplement industry which have been ongoing since 1992, and they continue, the most recent of which happened just this past winter in 2000. And in these letters
we will inform them of the BSE issue and perhaps give them ways that they might try to avoid having a problem with any ingredients, such as sourcing. Another way that we inform, and it is becoming increasingly
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important, is the internet.
We use web-based information not We
only to inform consumers but also to inform the industry.
post our letters on the world wide web, as well as our guidance documents. Examples of the places where these might be located
would be on the overall fda.gov web site, which has the "hot topics" area where you can reach some of these issues, as well as the CFSAN home page, www.cfsan.fda.gov, and there we have the "what's new." And as issues emerge, we tend to put these
sorts of, types of information on those web pages. It has also been mentioned that we use public meeting, such as this one and also our TSE Advisory Committee, as very important ways that we communicate with the public and consumers. As nice and convenient as the world wide web is,
it's not quite the same as meeting people face-to-face and hearing their concerns directly, and so it is very important that we have events such as this so that we can talk with consumers. A second means by which we try to keep BSE out and try to help keep the risk low in this country is by issuing guidance. Guidance is a way that we communicate with the industry to tell them what we expect of them and what are the best ways that we think, given the present science, that they can avoid having problems, in this case with BSE or TSE. One example of guidance
that we have issued in the past has dealt with sourcing and
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processing of gelatin into products that FDA regulates. Dr. Solomon has already mentioned import notifications in greater detail. This includes Import Bulletins, where we
notify the field staff of special concerns that we might have, and those stronger Import Alerts, and he mentioned some of the Import Alerts that we've had in the past. And these have gone
back to as far as the early and mid-90s, as far as BSE, so this is something that's not new, either. The fourth possibility for dealing with this is regulations, and Dr. Sundlof mentioned the ruminant feed ban that we have. And although this is really geared towards preventing TSE spread in our animal herd, this is indirectly a food safety regulation as well, because it keeps this agent out of food products that Americans consume. And so it is rightly a food
safety regulation, and if we have need, we would consider other regulations as well. And, finally, a very important part, especially when you have an issue like this where not as much is known as we really need to have known, is that of research or inquiry. The example
that I've got in here is one that was mentioned earlier, chronic wasting disease of deer and elk. Here we had an issue which
we knew very little about, and so consequently as a first step brought this issue to our TSE Advisory Committee to try and get the best science as we could on this issue before making
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decisions, and we are in an ongoing process of continually doing that, as well as supporting and encouraging research into this issue so that we can learn more about it and do what's best for the American public. And really all of what can be done can be summarized in this one slide, and that is that FDA is cooperating with other Federal agencies to prevent BSE--that is APHIS, as well as our partners at the Food Safety and Inspection Service--to try to have a cohesive approach towards preventing any problems like that in the United States. And a very important thing to remember
is that FDA continually reviews its policies and procedures to ensure product safety. That is, it's an iterative approach.
We do it over and over and over, looking for the holes, if you will, so that we can plug them. And, finally, FDA is making effort, and this is one of the ways that we do it, in this meeting, of informing stakeholders of the various BSE and TSE issues that might be of concern, as well as to learn from the public things that we haven't thought about. [Applause.] MR. ELENGOLD: Good afternoon. My name is Mark Elengold. I'm
Deputy Director of the Center for Biologics Evaluation and Research. I'm the first of the three speakers from the FDA's
medical products centers, the others being the drug and device
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and radiological health centers.
Our interest in this is a
little different from the speakers you heard so far, and as Dr. Lumpkin said, this is an issue that affects all of the products that we regulate. Well, I believe everyone does have copies of my slides, so since we are running a little late, I'll just start and hope we will catch up. In CBER, we regulate the medical products that are generally blood products and blood derivatives, vaccines, and therapeutic proteins such as TPA or interferons. Many of these are
manufactured using bovine-derived components, and therefore would be liable to potential contamination from BSE. We're
very lucky at CBER, and I just want to acknowledge Dr. David Asher here, in having our own expert on the subject on our staff and working with us as well as doing research on the subject. I'm going to concentrate on two issues where BSE has become involved in CBER policies. First is vaccine safety involving
BSE, and the second is the suitability of blood or plasma donors thought to be at increased risk of CJD. First, on vaccines, there is little reason to suspect vaccine as a source if vCJD. were born before 1980. unlikely as a source. In the U.K., most cases in individuals Contaminated vaccines are therefore And in the U.K., vCJD-associated risk
factors include residence in the U.K., genetic susceptibility,
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and a relatively young age.
Next slide, please.
The epidemiological evidence suggests that infectivity of BSE agents occurred through eating contaminated beef products sometime after 1980. And vaccines are prepared either from
killed or weakened disease-causing bacteria or viruses that stimulate a protective response by the body's immune system. Some of the actions that we've taken of a preventive nature, in 1991 we first expressed concern publicly about the safety of bovine source materials, and then in 1993 we sent a letter advising that bovine-derived materials from animals born in or residing in countries where BSE had occurred should not be used in manufacturing FDA-regulated products. In 1993 we also
issued points to consider in the characterization of cell lines used in the production of biologics, and that also pointed out to not use material from BSE countries. In 1996 we issued a letter advising that bovine-derived materials from animals born in or residing in countries where BSE had occurred should not be used in the manufacture of FDA-regulated products intended for administration to humans. Finally, in the year 2000 we issued a letter stating that manufacturers had used products that were from countries on the USDA list, and repeating the recommendations that we had previously. We reviewed our license applications, and we saw some material
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still being used was from countries on the USDA list.
This
prompted an inquiry about all licensed vaccines, and licensed vaccine manufacturers were again asked to reevaluate all the bovine source material and change the source. We had a special joint meeting of the TSE Advisory Committee that we've already spoken about, as well as the Vaccine-Related Products Advisory Committee, to discuss the transmission of vCJD by vaccines. It was concluded the risks posed by bovine
materials and vaccines were remote and theoretical, generally concurred that FDA recommendations were prudent. The FDA and
its advisory committees agreed the risk to be remote and theoretical, and that recipients could get vCJD from a vaccine is extremely remote. potential. The risks and benefits were discussed by that joint meeting, and it was decided that vaccines have clearly reduced the incidence of serious and life-threatening illnesses, and that in areas where vaccine use was reduced, these diseases recurred. Therefore, the risks were so remote that they were far outweighed by the benefits of continuing to use these vaccine products. Finally, in summary, FDA and other PHS agencies continue to believe that all vaccines currently licensed for use in the U.S. are safe and effective. Manufacturers of all affected However, FDA will continue to review the
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vaccines have agreed with FDA on the need to change the sourcing of bovine materials, and FDA expects by the end of 2001, most if not all vaccines on the market will be made using bovine-derived products from non-USDA BSE list countries. The next subject is blood and blood products. In 1987 FDA issued
a memo to blood establishments recommending all persons in receipt of human cadaver pituitary growth hormone be permanently deferred. This was the original source of transmission of
classic CJD in the United States. 1995, we added recommendations to defer other donors at increased risk of CJD: those with a family history of CJD;
recipients of dura mater grafts, which Dr. Feigal I'm sure will discuss. In addition, FDA recommended retrieval and quarantine
of all whole blood and blood components, including plasma, from donors subsequently diagnosed with CJD; retrieval and quarantine of plasma derivatives produced from pools containing those donors and recognized to have received human cadaver pituitary growth hormone. 1996, FDA issued a memo to all registered blood establishments and plasma establishments to quarantine and destroy in-date source plasma and plasma derivatives, transfusion products prepared from donors who were later recognized to be at increased risk of developing CJD. Finally, the memo again recommended
to permanently defer all donors with CJD or with the increased
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risk of CJD, except that persons who had a relative with CJD could be accepted. And here there is a typo in there. The aggressive spelling
checker changed "prion" to "prior" protein-encoding genes where normally, by nucleic acid techniques. 1998, based on a decision by the United States Surgeon General, who serves as the government's blood safety director, FDA modified its policy that plasma derivatives prepared from pools which donors have classic forms of CJD--that is, other than the new variant CJD--had contributed, would no longer be withheld or withdrawn, although donors would still be permanently deferred. This relaxed policy was considered
reasonable because transmission of CJD by human blood has never been convincingly documented, and because the process of fractionating plasma was demonstrated to remove very substantial amounts of infectivity from blood experimentally infected with the agents of forms of CJD. 1998, again, we continued to recommend that all pooled plasma manufacturers and intermediates, finished dosage plasma, defer any donor that had it and would withdraw the products. 1999, FDA accepted the TSE Advisory Committee advice to add an additional precaution for potential blood donors by deferring from donating blood if the donor had resided in the United Kingdom for any aggregate period of six months or more from
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January 1980 to the end of 1996. advice not to defer blood donors
FDA also accepted the TSEAC in any other BSE country.
This is fully described in the Guidance to Industry issued for public comment in August of 1999 and revised in November of '99. This year we developed a policy addressing the theoretical risk posed by donors who may have been infected with the BSE agent, while maintaining an adequate supply of blood components and plasma. FDA believes the theoretical risk can be substantially
reduced but cannot be completely eliminated. In summary, FDA guidance has been issued for all the restrictions on blood and plasma donors thought to be at increased risk of CJD, including donors potentially exposed to the BSE agent, and FDA inspectors expect manufacturing facilities to comply with the current Good Manufacturing Practices for blood and blood components. So, in summary, FDA inspections indicate the manufacturing establishments have consistently attempted to comply with donor deferral recommendations of the FDA issued in its guidances. And no test for rapid antemortem diagnosis of TSE or to detect TSE tissue has been demonstrated to sufficiently be specific enough to be scientifically valid. Finally, to follow the Center's actions and current guidances on this, you can visit our web site which is described here,
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or for any specific questions, address them to the e-mail addresses there. [Applause.] DR. CHIU: Good afternoon. I am Yuan-Yuan Chiu. I will speak Thank you.
on human drugs. Many drugs are derived from bovine materials. They can be used
as a component of drugs or they can be used as a reagent in the manufacturing of a drug. When it is used as a component
of a drug, it can be an active ingredient or it can be an inactive ingredient. Because our Center regulates animal-derived
drugs, so many active ingredients are used in drugs to provide a pharmaceutical, pharmacological effect of the product. They
can come from various tissues and organs, and several examples I can give you: surfactants extracted from bovine lungs;
polysaccharides extracted from intestines; and also proteins and other substances extracted from various other tissues. In terms of inactive ingredients, actually they are used to be as a filler or as a lubricant, a coating material, or as a solidifying agent, and in various dosage forms. They can
be classified into three types, and the first type is milk-derived, such as lactose. tallows, bovine tallows. And they can be derived from
They are things like glycerine,
magnesium stearate, fatty acids, and the fatty acid asters. They can also be like gelatins. Many people know gelatin is
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derived from bone or hide of cattle. And since we also regulate some of the biotech products, so such things like fetal bovine serum, fetal calf serums or bovine serums are used in the manufacturing to maintain cultural growths. In working with other Centers of the agency, we have taken several preventive actions, because what we are concerned is, we want to eliminate the possibility of drugs becoming vectors of transmitting BSE agent to humans. So the first and the
foremost important step is to make sure the source material is clean. So like other Centers, we also issue the industry letters. In 1993 we issued letters to drug manufacturers informing them they should not use materials derived from cattle resided or originated in BSE countries. We also recommend to identify
bovine material used, and also identify and document the country of origin, and to maintain traceable records and to maintain copies of the records on site. And those recommendation letters
were collectively issued in Federal Register on August 29, 1994. Now, in 1996 we issued similar letters to drug manufacturers. At that time we issued over 2,500 letters to manufacturers with drug applications with us, manufacturers who prepared active pharmaceutical ingredients, OTC drug manufacturers, as well as homeopathic products manufacturers. Altogether, 2,500
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letters and more were issued.
Next one.
In terms of inactive ingredients, we believe it's better not to work on individual drug but work on the different types of the substances. It is generally recognized that milk-derived They have not been found to transmit disease
products are safe.
yet, although some research is ongoing. In terms of gelatin, we brought the issue to our advisory committees in April of 1997. Based on the recommendation of
the committee to say that gelatin probably should not be exempt from the BSE policy, sourcing policy, so the agency issued a guidance document. As Dr. Brackett has mentioned to you, in
this guidance the risk assessment was based on the route of administrations. So the decision was made, when a product contained gelatins for injection or implantation or pharmic use, then the sourcing really should be coming from BSE-free countries. So our Center
has followed those guidances to assure that gelatin used in those products are indeed from BSE-free countries. In terms of tallow derivatives, we also brought the issue to advisory committee in April of 1998, and the committee has determined the tallow derivatives are safe when produced at a temperature above 130 degrees and a pressure of at least three bar for at least 20 minutes. The committee also determined for glycerine that it would be
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safe when manufactured by distillation. It is our understanding those conditions for manufacture are indeed the industry standards. Next slide.
During the course of our review of applications, we make sure the FDA's policies are followed. an on-line tracking system. In addition, we have developed
The tracking system tracks all
the INDs, NDAs and ANDAs, tracks the applications for drugs containing bovine active ingredients, containing bovine gelatins used in those special products, and also bovine serums used in reagents. The tracking system tracks the animal
species, tissue types used, and also the countries of origin. This way, we can maintain an updated database. Whenever USDA
identifies new BSE countries, we can always go back to our database and to make sure that our sourcing countries are now not affected by the new USDA determination. And the way, if
it does, we work with the company to make sure those countries are removed from sourcing. Next slide.
Even though, you know, we have a guidance document out for gelatin, we are constantly evaluating our policy, and to make sure up-to-date scientific data are incorporated in our policy determinations. And we are going to present to the advisory
committee, to discuss interim results of new studies conducted on gelatin and the activation studies contracted out by the gelatin manufacturers of Europe.
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So, in conclusion, our Center works with other Centers and to make sure the FDA policies are followed, to make sure the products are safe, and with respect to BSE contamination. you for your attention. [Applause.] DR. FEIGAL: Good afternoon. My name is David Feigal. I'm Thank
from the Center for Devices and Radiological Health, and I don't have slides. Well, what I thought I would like to just cover very briefly before the break, is to identify what kind of role CDRH plays with GSE, BSE, and CJD. There are four things that are distinct
and separate but related roles that we play. First, we have the responsibility for the approval of in vitro diagnostics and other types of diagnostic tests for human use, except for tests that are used to screen the blood supply. So, as we develop new diagnostics and as we are able to better measure and assess this family of diseases, the scientists and the manufacturers that are working with these new diagnostics will be working with us to bring those to the public, first in experimental use and then as they develop into full-scale public health and medical screening. The second way that we are involved is that, as Mark Elengold mentioned in the example of pituitary human growth hormone transmitting the disease, medical devices also have transmitted
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Creuzfeldt-Jacob disease. neurosurgical instruments.
They have transmitted it with It has been transmitted with tissue
devices crafted into devices such as human dura mater which has not been processed in a way that either detected that the source of the material was from a person that had CJD or was processed in a way that would reduce the risk. The Center's role in this way is to work with the Centers for Disease Control, with manufacturers, with health practitioners, to develop the methods that prevent transmission. learn what it takes for disinfection. We need to
We heard some
descriptions of the specific manufacturing that the Center for Drugs recommends for specific products. for surgical instruments, for example. There are some countries that have BSE that have considered taking actions that expand the precautions, to tailor the precautions to what is different about variant Creuzfeldt-Jacob than the classic CJD, and consider such things, for example, as using disposable instruments for surgery on lymphoid tissues such as tonsillectomy. These are the kinds of issues that the This is also an issue
Center will need to deal with, along with CDC, along with health professionals, to make sure that medical devices do not transmit these family of diseases. The third area that we're involved is that some medical devices are designed to be implanted or injected or otherwise placed
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in long-term contact with the human body, and some of those implants and devices are from bovine and other animal sources. Examples of this, cat gut sutures, the original disposable suture, is manufactured from bovine gut. probably be better called cattle gut. Bovine collagen is a product that's manufactured in a number of different forms, sometimes to be injected for structural changes, other times as a matrix. In fact, one of the most It would actually
recent bioengineered products of an artificial skin with cultured live human skins was contained in a bovine collagen matrix. Heart valves are manufactured from taking bovine pericardium, the lining around the heart, and crafting them into leaflets which are sown into a ring to construct heart valves for use, and the ability to actually control the size and the quality of the pericardium gives some advantages in particular settings. The Center has required controls, and has written the manufacturers, and has dealt with the issue like other Centers of therapeutic products, to exclude bovine sources from at-risk countries. But we are also part of the global consideration
that affects not just products for our citizens but products for citizens in other countries. And we find Europe asking itself whether or not the precautionary principles should be applied to the products and whether or
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not, if there is a non-bovine substitute for a product with a bovine source, whether that bovine source product should remain on the market. I think these are difficult decisions
when the product has a particular need, and it's a discussion that we need to play a part in as we look at ways of taking products with long safety and effectiveness records and assuring that they remain safe and effective in the future. And, finally, there are some medical devices that are not in contact with the body, that contain components of bovine sources. For example, there are hundreds of diagnostic tests It may be serum,
that use bovine proteins from some source.
it may be albumin, it may be some other type of protein. These don't present any risk to the person where the test is being done, because the bovine components in this case are used in a laboratory setting and never become injectable or implanted. But if the availability of bovine products, and
if some of the industries that develop these as byproducts are altered or collapse or use other parts of their markets, then that could have an impact on the availability of some diagnostics, and they would need to be redesigned to use other components. Well, what steps has CDRH taken? We have taken steps to prevent
the transmission of CJD from the products that are known to transmit CJD or are likely to, and we have considered the actions
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that the countries with BSE have taken, and will continue to actively follow that area to see if those are prudent and at what time they might need to be implemented. We have written to our manufacturers. Over the last decade,
we have compiled a database similar to the databases in other centers, of products that contain components from animal sources, so that we are able to identify the products that we need to take action if the situation changes for a given type of animal or animal-sourced product. We have published
guidances for industry and for our own review and scientific staff, and have directed the field staff to evaluate reports of possible new exposures from surgical instruments, so that we can work with CDC and others to minimize this type of hazard. In summary, we are committed to this being a transparent process. It's a process that we wish to be able to communicate clearly, so that we are able to make the science-based regulatory decisions that assess both the risks and hazards but also the benefits of the products that are used in this product grouping. Thank you very much. [Applause.] MS. HOLSTON: Well, I'd like to thank all of my colleagues from
FDA for giving their presentations about the efforts that this agency has been taking to come to grips with the issue of BSEs and TSEs. I think from what you have heard, you can easily
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recognize that the scope of the products for which FDA is responsible is quite vast and quite varied. But I think we
also have heard that every single one of our product centers has been very thorough in their efforts to try to assess and then contain any potential risk associated with the products under our responsibility, and our field force has made a valiant effort and is succeeding quite well in its efforts to continue to inspect all of our feed mills and associated facilities. We are going to take our break. We are somewhat behind schedule,
but I think we can still afford to take a 10-minute break, and at that time our speakers from our other Federal collaborators will be back to present the efforts that are going on in their agencies and departments. you again after the break. [Recess.] MS. HOLSTON: All right. If everyone would take their seats, I think two or three Federal And so we look forward to seeing Thank you.
we are about ready to resume.
collaborators are here right at the moment, and I'm certain Dr. Brown will be joining us shortly. Let me introduce again Dr. Rima Khabbaz, who is Deputy Director of the Division of Viral and Rickettsia Diseases. She is with
the National Center for Infectious Diseases at the Centers for Disease Control and Prevention. We also have with us Dr. Paul
Brown, Medical Director of the National Institute for
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Neurological Disorders and Stroke at the National Institutes of Health. And also Dr. Linda Detwiler, Emergency Program
Staff, Animal and Plant Health Inspection Service, from the U.S. Department of Agriculture. So I would like to first express my appreciation to them for joining us, and ask Dr. Khabbaz to begin. DR. KHABBAZ: Good afternoon. Thank you.
I'd like to start by thanking
my FDA colleagues for inviting CDC and giving me the opportunity to come and brief you on our activities in the area of CJD and variant CJD. I don't have any slides, either.
Our primary responsibility for CJD at the CDC is in the area of surveillance, surveillance for human disease, and we have been conducting surveillance for CJD since the mid-80s, whereby we monitor trends and incidence of disease. And our system
for surveillance relies on looking at mortality data. Unfortunately, CJD and variant CJD are uniformly fatal, and by the time a patient dies, a diagnosis is generally made, whereas early on, as the disease presents, it may be not as clear as to what the patient has. Again, the clinical course
is such that by the time the patient dies, a diagnosis is generally made. And so a diagnosis is entered in the death certificate, and we obtain this death certificate data from the National Center for Health Statistics that compiles them nationally, and we
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look at trends and incidence.
And over the past two decades
the incidence of CJD has been stable at about one per million. Now, you may ask or wonder, how good is this surveillance system? Is it complete? How sensitive is it? And we have had two One
opportunities to check on the sensitivity of our system.
I will address because we've done that in the wake of the variant CJD recognition in the United Kingdom, and the sensitivity is over 80 percent. That is, cases of CJD that are seen, have
a diagnosis on the death certificate, and we are able to see them through our system. In 1996, when the new variant CJD was recognized in the United Kingdom, we enhanced our system. and enhanced it in two ways. Well, first of all, we embarked on an active surveillance for this entity, actually for CJD and a special focus on variant CJD. We partner with local and State health departments in We looked at what we are doing
carrying out our public health function and our surveillance systems, and we have what we refer to as emerging infection programs that we have established through collaborations with State health departments in a number of large metropolitan areas. And so, using five of these population-based sites, we carried out active surveillance. We had State and local health
officials and academic centers contact neurologists in the area
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and inquire about CJD and variant CJD.
And that active
surveillance and contact, initially and then periodically, this is one of the studies that allows us to check our sensitivity, the sensitivity of our surveillance system, and also allowed us to quickly ascertain that we were not seeing variant CJD in those areas. areas. Subsequent to that, we initiated active investigation of all young CJD cases. We used the fact that variant CJD in the U.K. One of the ways that The And this is over 15 million population in these
is distinctive from the classical CJD.
it's actually distinguished is the age distribution.
median age for variant CJD is 27 years, whereas classical CJD is a disease of older people. And so we focused on the less than 55 years of age, and using the mortality data that we obtain, we initiated investigations. We get all clinical records, pathology records. We work with
State and local health officials, and go back and check on all such cases. And we've been doing it since 1997, and that's
again the basis or one of the bases of our saying we're not seeing variant CJD. The second component of our enhancement was working with the American Association of Neuropathologists. Again 1996, '97, we collaborated with them, and they reached out to all their members, a communication about variant CJD, features of it,
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encouraged reporting.
We also founded, co-founded with them,
the National Prion Pathology Surveillance Center, this is at the Case Western Reserve, and to provide pathologic diagnosis, confirmation of variant CJD. And I can tell you that over 300
suspect CJD brains have been examined at the National Prion Pathology Centers, and CJD cases confirmed, but no variant CJD. Now this is, in brief, our surveillance systems as they exist today. We also engage in investigations of suspect or proven As an example,
CJD cases of special public health interest.
we have conducted an investigation of CJD cases in young, three young persons who had been linked to deer, either hunters or had eaten deer meat, trying to establish whether there was an association with that, with that activity. investigations. So we do carry out
We do get reports from physicians of suspect
cases or confirmed cases where there is a concern of one issue or another, travel, etcetera, and we investigate these cases. Now, to get back to the surveillance, is it adequate? currently we can say it's adequate. it be enhanced? Yes. Is it ideal? I think Can
No.
Should it be enhanced?
We believe that
it should, especially in preparation.
If the epidemiology of
variant CJD as it's unfolding in the United Kingdom changes, especially if this age distinction disappears, then we may not be well prepared to monitor as we have been. And we are currently engaged in enhancing our surveillance
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systems on a number of fronts.
One is expediting what we refer
to as the postmortem surveillance, that is, obtaining and reviewing these death certificates, and follow-up active investigation of young cases. we actually have started. A number of States actually obtain these data directly. All And we're going to be working,
of them obtain them directly, but a number of States have started looking at their own vital statistics data, and we're working with them on that, and we hope that very soon we're going to be doing that with all States, basically. So that will expedite
and you will--currently we have a time lag, from the time this data is collected at the State level to when it gets to the National Center for Health Statistics for us to be able to look at it, so that will actually shorten that time. The other part of enhancement that we are actually engaged in pursuing has to do with the fact that autopsy rates are low in this country, and that's not just for CJD, that's for all conditions. And we are also partnering with the State partners
and looking to work with a number of them to explore ways to improve autopsy rates for CJD. One of the concepts that's being
explored is the establishment of possibly regional pathology centers in areas, and who will form a network and contact neurologists and work with families, and basically improve reporting and improve autopsy rates, and link that to the
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National Pathology Surveillance Center in existence at Case Western Reserve. I think I will stop here. [Applause.] DR. BROWN: My name is Paul Brown and I represent the NIH at Thank you for your attention.
this meeting. The Laboratory of Central Nervous System Studies, of which I have been a part for the past 35 years, historically has taken the lead in many aspects of this field. Today, however, for
reasons that I do not entirely understand, the NIH has decided to cease funding any further research in this field and is closing the laboratory. So you are looking at the last vestige of NIH research in this particular topic. I still dabble in research, mostly on the
issue of infectivity in the blood, but in general I think the future suggests that my role will be that of an eminence grise, a kind of ombudsman, if you like, trying to funnel the scientific research that is carries out elsewhere to the appropriate regulatory authorities. So I will be brief. As a consumer, what I'd like to know is
what if any risk is attached to anything that I might eat or use in the course of my daily living. The scientific evidence
bearing on this issue of risk, contrary to what you might have heard or expect, is really not as minimal as you might think.
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The answer to that consumer question really has only about three components. The first is, what if any infectivity is present in the tissue source of that product? What kind of processing is being used
on that tissue product which might reduce any infectivity that was present? And what is the use of the product to me? Would it be oral? What
route of infection might occur? be through the skin?
Would it
And so these are the three components
that will determine the risk to any material with which I come in contact. As an observer, I would say that the FDA and the USDA have set up a sufficiently rigorous series of prohibitions, both to the entry of infected material into this country and the amplification of any such material in livestock, to be fairly reassuring. There are a few remaining points, I think, of You have heard one or two I just mentioned. Plate waste could, of course, in
vulnerability.
Plate waste is one example.
a T-bone steak still contain the paraspinal ganglia if not the spinal cord, and at present they could be recycled into feeding of animals. But that is under consideration, and it's a e In fact, science does not
reasonably remote possibility.
exist, at least biological sciences, to provide you with absolutes and certainties. probabilities. What we provide you with are
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And I would say that based on the extremely restricted distribution of infectivity in cattle infected with BSE, based on the reductions of infectivity that much of the products or many of the products undergo in processing--as an example, for example, gelatin undergoes processing, in at least one of its major methods, precisely with the same kind of procedure that we would use in a laboratory to sterilize infected tissue, namely the exposure to very high concentrations of lye. And, third,
the comparatively inefficient routes of infection which are represented by feeding or, for example, cosmetics, compared to the direct inoculation of this material into the brain. All of these together persuade me that the likelihood that we will see a case of variant CJD in this country is very close to zero. Thank you. [Applause.] DR. DETWILER: Good afternoon. My name is Linda Detwiler.
I'm with the USDA's Animal and Plant Health Inspection Service, and I would like to thank the FDA for their invitation here as another collaborator. The USDA's Animal and Plant Health Inspection Service, actually our actions go over a decade of time, and they have been progressive in regards to BSE, and they change as science changes or the world events change.
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Our primary duties as an agency are to prevent the entry of foreign animal diseases into the country, protecting the health of the Nation's livestock and poultry and thus in turn protecting the health of the public. And the other main function of APHIS
is any control or eradication efforts of endemic diseases that do exist in the United States. So, in regards to BSE, our early actions were in the late '80s, starting in 1989 with the prohibition on the importation of live ruminants and most ruminant products from any country known to have BSE, starting with the United Kingdom and then proceeding on to Ireland in '89, France, Switzerland in '90, and then other countries as they found cases of BSE. In 1997, with the notification of cases of BSE, native cases in the Netherlands and Belgium, it was apparent to us that in looking at the movement of live animals and feed throughout Europe, that there would be--we anticipated other countries then having the disease being found. And given the long
incubation period, what happens in one year, you do not see the effects as far as in the animal when you can detect it until several years later. So when we looked at the world situation in 1997, we did anticipate that Europe would have additional countries. This
anticipation was correct, as we see now in 2000, Denmark, Germany, Italy and Spain finding cases. But in 1997 the
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department again took further action, restricting live ruminants and most ruminant products from the entire continent of Europe, and that was in anticipation. So for us in these
countries finding them in this year, it was not a surprise. That was in anticipation shown by our actions. The next thing that we have done, the next big effort by APHIS is the surveillance. This too, we have changed and adopted
and amended the surveillance as science or world situation has given us information to do that. We started in May, in 1990,
and at that point in time for the TSEs, basically what you had in your kind of toolbox of diagnostic tests was histology. So we started the program for looking for animals, deliberately for BSE, and those were classical lesions associated with BSE as characterized by the United Kingdom. In 1993 and in 1994 we again adjusted our surveillance program. We were the first country to start the implementation of the test, its called immunohistochemistry, and that's the test for the abnormal form of the prion protein. country to start to use this. So we were the first
At that time we used this
technique to detect the prion protein as an additional supplement for the histology on cases where we could not rule out an endemic disease in those animals that were neurologically ill. In that same time frame we also started to test those animals
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that we considered "downer" cows, and that's a catchall term. It's not a disease per se. that cannot get up. It's a catchall term for any animal
A "downer" cow may remain down or, with
treatment, may get up, so that's something that you look at clinically and a private practitioner monitors. And we started to test those that remained down and that were presented to the USDA, also in '94. That was done at that time
in a response to a theory by the late Dr. Richard Marsh at the University of Wisconsin, where he thought that downer cows may be a manifestation of another form of TSE in cattle. was done in response to Dr. Marsh's theory. So that
At that time,
though, the rest of the world did not think that was such a good target population for BSE, but we did maintain that level of surveillance in the downer cows, testing a couple hundred per year. In 1997 we again expanded the testing again, and at this time we tested all the animals that were presented to us both by histopathology and immunohistochemistry, that were presented to the National Vet Services Lab. So we incorporated the pure
P testing into our entire diagnostic regime. In 1990, again the Swiss are looking at the situation. Switzerland they started expanding their surveillance to testing of the downer cows or, as Europeans call them, the "fallen stock." In a country that had BSE, they found that In
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it was a very good population to go on, and they found as many cases in this fallen stock or downer cow population as was reported as neurologically ill. When we looked at that, we
then increased even more our surveillance, going from a couple hundred to last year testing close to 1,900 animals, as far as downer cows. So, basically, our surveillance comes from those animals that are over 20 months of age, in BSE it would be an adult animal, exhibiting signs of neurologic disease, either reported from the farm, from the field or veterinary diagnostic labs, and those in marketing channels. We are also assisted in this
effort by our sister agency, the Food Safety Inspection Service, in those animals that may go to slaughter as neurologically ill animals. And those, if they do present for slaughter, they
are condemned antemortem, so alive, and they do not enter the slaughter process. They are then turned over to APHIS, and
we euthanize the animal and take the sample. Since that time we've tested over 12,300 animals, with no evidence of BSE or another form of TSE found. We are five It's
times--there is an Office of International Epizootics.
the, kind of the animal equivalent to the WHO or the World Health Organization. This is a body that establishes recommendations
and guidelines for countries of the world in regards to animal diseases. The OIE, we are five times above what their
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recommendation is for surveillance for a country the size of the United States. And it's like CDC, can we do more? bet. Can we get better? You
I mean, that's how we've looked at our surveillance,
that's how we've looked at our programs over time, to always look and change as science changes, and change as world events change, and that's what we're doing now, working with the companies, with the test, with the fast tests that you hear about in Europe, to examine those and fit those into our diagnostic regime. I do want to point out, though, even with the fast tests, the confirmatory tests that are still being used in Europe are the immunohistochemistry and Western Blot and histology, so those are the tests that we are using that are still used as a confirmatory test. We have, another thing that we have been doing that we feel is very, very important is working with our colleagues in Canada and Mexico, and we have done this over the last four years, to meet at least once a year, and in smaller subgroups more than once a year, to address issues, knowing how important that we have trade across the borders, the land borders in the United States and in North America, to make sure that our import requirements and surveillance efforts stay consistent among the three countries, since they are our largest trading
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partners. And then the last thing is the Harvard risk assessment. Back
in 1998 the USDA signed a cooperative agreement, that's both APHIS and FSIS, with the Harvard School for Public Health. And we have asked them--we conducted a risk assessment on the U.S., meaning within house, APHIS. The Europeans, the European And we have also asked
Union, conducted a risk assessment.
a third party, this Harvard School of Public Health, to conduct this risk assessment, to look at the efforts of the USDA, to look at the pathways of entry of BSE into the country, into the livestock population, into the human food supply, and then to give us recommendations. by the end of spring of 2001. Thank you very much. [Applause.] MS. HOLSTON: Once more, I'd like to thank our Federal partners And that is due out, hopefully
for their presentations this afternoon, and I think every piece of new information we hear adds to the richness of both the briefing that we are providing, as well as I hope to the discussion that will ensue once we have heard from our consumer panelists. You are now going to have one more 5-minute stretch break so that we can change the cast of characters at the front and allow our consumer panelists to come forward, and at that time they
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will give presentations, and that will be followed by a period for open discussion. [Recess.] MS. HOLSTON: All right. We're going to start once more, if Let me So 5 minutes. Thank you.
all of our panelists could please take their seats.
once more extend our thanks to the members of the consumer panel who are with us this afternoon, for agreeing to be a part of this briefing. They are Peter Lurie, Dr. Peter Lurie, who is Deputy Director of Public Citizen's Health Research Group; Ms. Jean Halloran, Director of the Consumer Policy Institute for Consumers Union; Brett Kay, Director for Food and Health Policy for the National Consumers League; and Richard Wood, Executive Director, the Food Animal Concerns Trust. And I am going to let them start in just one moment. I would
like, however, to make one quick announcement, and that is that Dr. Detwiler does have a plane to catch this afternoon, and therefore may be leaving a little bit earlier than the rest of the panelists. We appreciate the fact that she did take
time out to be with us, and I know she will stay as long as she can, but if she leaves, it's because she does have another commitment. Thank you very much.
And now, Dr. Lurie. DR. LURIE: Thank you. I think what we've heard so far during
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the course of this presentation is a lot about all of the things that FDA, USDA, CDC, etcetera, have done. And the way I've
looked upon my responsibility is to talk instead about all the things that they have not done, and that's what I'm going to spend much of my time talking about. I'm going to speak, because this is an FDA meeting, really about FDA-related issues, and so not so much about those things that fall under USDA, such as arguably slaughtering practices or surveillance issues, or CDC, human surveillance issues, but to focus just on those things that are related to FDA itself. And the two themes of my talk are going to be the following: Firstly, that although a number of actions have been taken, too often they have been voluntary; and, secondly, even when they have been mandatory, for example, the feed ban, enforcement and compliance have been poor. And I'm going to address four
general areas, and I'll identify them as I get to them. The first would be how the BSE agent could enter the country, and we have serious concerns about what has been and can be done at the border level to adequately police the borders. The information presented by Dr. Solomon I think were very interesting, showing the import line entry history into the United States over the last decade or so, and you see this really enormous, almost a quadrupling of import materials beginning in about 1995.
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And what he didn't mention was, going along on the bottom of that graph, and you can look at it, those of you that have the handout, were the number of FTEs that the FDA has to police this enormously increasing amount of imports, and it's an absolute flat line. So I think that the reasonable conclusion
from that is that there simply has not been an increase in the number of FTEs to reflect the amount of additional work that is being presented before the Customs inspectors, particularly for difficult to police materials like meat and bone meal, which has, in some cases at least, an almost subterranean method of sale between companies and even between countries. think that we really need to beef up the borders-[Laughter.] Excuse the really unintentional pun. to God, didn't mean it. I swear to God, swear And so I
Everybody else has done very well so I do apologize.
far, and there I am, slipping into that.
The FDA is inspecting only about 1 percent of all materials presented for import, and even an increase of the kind currently contemplated under a potentially expanded budget for FDA in this area would not come close to really making a significant dent in the amount of inspections that are current. Now, another way that the BSE agent might enter the country is through dietary supplements, and we've heard a little bit about that, as well. What we haven't heard about, though, is
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how absolutely handcuffed the FDA is with respect to dietary supplements. The Dietary Supplement Health and Education Act of 1994 put the shackles on the FDA, and required that instead of the FDA being able to remove a product from the market or take action when the manufacturer was unable to demonstrate its product's safety, now the FDA has to provide affirmative evidence of imminent damage. And so that has really shifted the burden
to the point that it's very difficult for the FDA to take adequate action. Unfortunately, rather than going back to the Congress and complaining about this clearly inadequate piece of law, all too often the FDA stands up and says, "Well, no, our authority is just quite fine, thank you." I don't think that's the case.
About 100 people are dead from Ephedra already, and there is very little that the FDA has been able to do about that. Now, what does all this mean for BSE? What it means for BSE
is that if an unscrupulous manufacturer chose to do so, they could literally take a cow brain from Britain, dry it out, crush it up, put it in a pill, and bring it into this country, and the chances of it being apprehended at the border, despite the voluntary--voluntary --import alert are actually quite low. Now, I'm not asserting that this has happened, but the potential
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is there.
And I think that we have the glandular products
containing such organs as brain, pituitary and pineal gland, and this is an absolutely unnecessary source of risk for American consumers, and I think that we need to revisit the Dietary Supplement Health and Education Act. Moreover, the FDA has been threatening for some while now, four years, in fact, to finalize its Good Manufacturing Practice Guidelines for dietary supplements, and it still hasn't happened. That will not take care of the problem, but it is
a necessary step and we'd like to see that happen. Now, the second question would be, if the BSE agent entered the country, how might it spread? As we've heard before, the
FDA currently has a ban on the feeding of mammalian parts to ruminants, and this requires that manufacturers take action to prevent the commingling of two different streams, if you will, of feed: those that are intended for ruminants and those
that are intended for non-ruminants. Obviously, the idea is that never the twain shall meet. However, the FDA inspections to date show that they can, and in at least one case, the twain have met. The most recent
information shows that about 14 percent of renderers and 13 percent of FDA-licensed feed mills do not have adequate procedures to prevent that commingling, such that cow parts could be recycled and fed to other cows. Moreover, the Purina
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Mills episode of a few months back shows that not only can it happen, it actually has happened, in which some cow parts entered into feed intended for cows, 1,200 cows actually consumed them, and they had to be withdrawn from the human food chain. Moreover, there are a large fraction of renderers and feed mills that have not been inspected at all yet, even though there clearly is an attempt on FDA's part to expand that. Twenty-three percent of renderers, 63 percent of FDA-licensed feed mills, have not been or had not been inspected as of the end of February, and then there are some 6,000 to 8,000 feed mills that are not even required to register. There was mention of the--let me make a second point with regard to that, which is, we are concerned that not only might there be noncompliance with the commingling ban in effect at the feed lot level, but also on the farm, and I think that those two things combined suggest that the safer route would be actually to have a mammalian-to-mammalian feed ban rather than a mammalian-to-ruminant one, which is the one we currently have. But at a minimum the plate waste ban which has been mentioned before, that exemption for plate waste is completely unnecessary, as Dr. Brown I think tried to indicate. not need that. We do
In fact, USDA in their written comments to the
FDA on the feed ban, actually said there should be no plate waste exemption, but the FDA overruled them. I hope that gets
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changed. You mentioned briefly chronic wasting disease, and here we're in this sort of interesting area where we're kind of stuck between USDA and FDA. While it's true that there is no evidence
that humans have so far become infected with CWD, the problem is that deer and elk are exempt from the USDA's Meat Inspection Act. One of the previous speakers mentioned that. And under
that Meat Inspection Act, the packer has the burden of demonstrating the safety of his or her product. Moreover, they
have money to provide for compensation, should a herd turn out to be infected. But deer and elk are exempt.
So what is left for the government to take action is to use instead the Food, Drug and Cosmetic Act, under which the burden is upon the government rather than the manufacturer, and under which there is no possibility for compensation. And so the
problem is that you can have literally a herd with a TSE-infected deer or elk, and no way to compensate the farmer such that the remaining animals in the herd of unknown CWD status can be removed from the human food chain. rectified. Third question: Is the U.S. doing enough to detect the disease? I think that needs to be
I promised I wouldn't get into much about surveillance, either of cows or of humans, but I will say that since it falls under FDA's jurisdiction, there are issues with regard to diagnostics
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and a number of diagnostic tests that are on the market in Europe but not on the market here. I am not going to suggest that the FDA should automatically be approving those, because the standards should be no lower for those diagnostic tests that they are for any other diagnostic test. But I do think that those diagnostic tests are on the
market in Europe, it's important that they be evaluated rapidly in a public way, and as soon as they are shown to meet FDA standards, that they should be made available for us as well. The final question is, are there any medical practices that might transmit BSE or vCJD? With regard to blood, there was
a clear mention of how the committee, the TSE Advisory Committee, which incidentally I sit on, had developed a ban or recommended a ban, adopted by FDA, under which people who had spent a cumulative total of six months in Britain during the period between 1980 and 1996 would not be permitted to donate blood. Now, that is a proposal I certainly agree with. What wasn't mentioned, though, is that at the most recent of our committee meetings in January there was a recommendation to extend that ban to include people who have spent not six months but a total actually of 10 years in France, Portugal, or Ireland, and I think that that is a ban that makes sense to me. It was what our committee voted for, and I would like
to see the FDA adopt that as soon as possible.
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There are also issues of travel restrictions on corneas as well. There are, depending on how you count, as many as three cases of people who have gotten CJD, not variant CJD but CJD, from receiving a cornea transplant, and I think that it makes sense to consider and indeed for the FDA to adopt restrictions on the travel of people who would be cornea donors that parallel those that have been recommended by our committee with respect to blood. The final point I want to make has to do with vaccines, and I'll preface my remarks by saying that I agree with what was said earlier, that the problems with vaccines have not represented a significant risk to people, infants, children and adults in this country. But the story not completely told
in the FDA presentation is the following: Back in 1993 the FDA wrote to the manufacturers of FDA-regulated products and asked them in a guidance, a voluntary guidance, not to source their materials from BSE-affected countries. They wrote again in 1996. them. But the industry chose to ignore
Seven or eight different manufacturers decided that no,
they didn't really feel like following that rule, and after all, it was voluntary, so they were under no obligation to do so. And it was only in the early part of the year 2000 that we learned that in fact a number of these vaccines had in fact been using
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reagents or other materials involved in the production of these vaccines that were in fact sourced from BSE countries, including Britain. Again, I am not asserting that anybody has gotten
infected this way, but it brings me back to where I started. Too often in the history of this so far non-epidemic in the United States, actions have been voluntary. And when
voluntary, the industry, at least in this case with vaccines, has felt free to simply ignore it. And when it has in fact
been mandatory action, too often enforcement has been poor and compliance even worse. Thank you. [Applause.] MS. HALLORAN: I am Jean Halloran, from Consumers Union, known
to many of you as the publisher of Consumer Reports magazine, and I do want to thank FDA for inviting us here today and for inviting us critics to come and make criticisms directly on the podium. So I would be remiss if I didn't proceed with
criticisms, so here goes. Our concern has to do not really as much with FDA's steps to prevent importation of the BSE problem from across the ocean, but with the steps they have taken to prevent a home-grown version of the problem here in the United States. You've heard
how there is a steady incidence of CJD in people of about one in a million. Although our knowledge of these diseases is still
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limited and growing, it's not unreasonable to assume that this might also be the case in other mammalian species who get these diseases; that they might spontaneously occur at a rate of one in a million. As I understand it, we have about 100 million cows on the hoof out there. You could imagine that perhaps 100 of them a year
develop a disease like this all by themselves, which might or might not be a problem for people, might or might not be infectious, strains vary, and so forth. possibility that this could happen here. We also have sheep with scrapie in this country, which is the sheep version of the disease, and we have a very serious problem with deer in the western States, where the infection rate is running 10 or 15 percent. Now, this is much higher than the But there is the
infection rate in cows in Britain at the height of the epidemic. So we have TSEs here. We don't know too much about whether
they could become a form which was dangerous to people or might already be dangerous to people. So, what does this do? It behooves us to have a system, as
it were, which would protect us, that would be precautionary, that would prevent a problem from being amplified and becoming the kind of problem they had in Britain. And we must commend
FDA for taking some important steps, but we feel that the steps are not enough at this point. They are not enough.
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There are a series of exemptions, as the previous speakers have mentioned, from what they call their mammal-to-ruminant ban, but the exemptions are so great that I think it's more accurate to call it a ruminant-to-ruminant feed ban. exemption is swine. The biggest
It is perfectly acceptable to feed cattle The
protein to swine and feed swine protein back to cattle.
rationale for this was that these diseases don't occur in swine, but in fact they seem to occur in all mammals. And in at least one experiment in Britain when BSE material was fed to swine, the disease did emerge at a rather old age for a pig, I believe it was about six years old, but the animal did become infected. It is true that the disease was not noticed
on farms and so forth, but on the other hand, most swine are slaughtered well before they get to an age where they might exhibit this disease, so you might simply not be seeing it. For a while we thought that that protected us, because there was some thought that animals couldn't transmit the disease until they exhibited symptoms of the disease. But recent
experimental work has shown--this is work in mice--has shown that asymptomatic animals can be carriers of TSEs. So you can
have an animal which has been exposed to the TSE agent, it shows no symptoms. If you feed the brain of that animal to another So
mouse, the second mouse will come down with the disease. you can have asymptomatic carriers.
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To us, this raises a concern about this swine exemption.
There
is a possibility that you could have asymptomatic carriers among swine. So as a protective measure, we believe that the swine
exemption should be eliminated, and in fact we should have a mammal-to-mammal, a true mammal-to-mammal ban, or at least a true mammal-to-ruminant ban, not just ruminant-to-ruminant. A second important exemption is the blood exemption. Whenever
I start talking about this subject to people in my office, which often happens over lunch, it's sort of about here that they push their plate away and say, "Can't we talk about something else?" Okay, but thank goodness we're all done with lunch,
and so we can talk about some of these topics. Okay, one of the feeds that are used in agriculture today is the feeding of freeze-dried blood products to calves. And blood
products are now exempt from the ban, so you could have freeze-dried cow blood being fed to a calf. There's a number of problems with this. One is that Dr. Paul
Brown, who is sitting up here, has shown that blood can transmit infection. Another is that this blood has not been heated the
way rendered products are heated, and heating, while it doesn't eliminate infectivity, appears to reduce infectivity. So it
seems that this is an exemption, and I know FDA is looking at it, which really ought to be reconsidered, and perhaps may not have a massive economic impact or as massive an economic impact
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as some other measures that FDA could take. There is a third issue here. The World Health Organization
has made a recommendation that TSE-positive animals, known infected animals, should not go into any part of the human or animal food stream. a national policy. The United States does not have this as A known TSE-positive deer or a known
scrapie-infected sheep can go into the rendering stream and be fed to swine, or to poultry or fish or any of a number of other categories, but in particular to swine. We think that
this is a problem that should be addressed, and that this recommendation of the World Health Organization should be considered. We also agree with Peter's analysis of the problems with implementation and enforcement. The way FDA has set this up, Renderers and
this is a very complicated rule to carry out.
mills and feed stores and farmers must all maintain these separations of feeds and these labelings of packages, and making sure that the wrong thing is not fed to the wrong animal. This
seems to be, in many ways, like a very complicated tax code, to choose a timely topic, something that's intrinsically difficult to carry out, and that a mammal-to-mammal feed ban would be something much simpler and much easier to enforce, probably less expensive to enforce, much more practical to carry out, just in general a much more workable arrangement.
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We're happy that FDA has gotten it down to about a 10 percent violation rate, but that means that we are still, in 2001, feeding cattle protein to cattle, the practice which was believed to have led to the BSE epidemic in Britain. Why this
is happening in this country at this point is difficult to fathom, in our view. Okay, so what do we need to do, going forward? First of all,
as I said, we think a mammal-to-mammal ban is the most practical and the most protective arrangement and ought to be implemented. Although the U.K. actually bans any use in animal feed, in fact poultry and pet foods to us do not pose the same risks, in our view. Many scientists have tried to induce TSEs in birds It appears to be a mammalian affliction, so
and have failed.
a mammal-to-mammal ban seems to be the most sensible course. Secondly, we need to tackle this problem with deer and sheep, these TSE problems that we have in this country. One theory
in Europe is that scrapie in sheep crossed the species barrier and became more virulent. BSE evolved. There are many theories about how
Only time will tell what the correct one is.
But it seems prudent to deal with the problem we have in sheep. I know USDA once had a scrapie eradication program. lost in the Reagan Administration. to consider reviving. There also needs to be some consideration of keeping This was
It is perhaps something
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TSE-positive animals out of the human food supply.
Perhaps
I'm unaware of steps that FDA may be taking, but if we have scrapie-positive sheep, are our supplies lamb and mutton being adequately protected? Again, the argument is often made that
scrapie has existed for hundreds of years and we don't have direct evidence that it can cause harm to people. However,
as a preventive measure, WHO recommends that these foods not go in the human food supply. We have this problem with venison, when you're looking at it as a food, with deer and elk, and it exists both in farmed animals and in the wild animals. In terms of farmed animals, there
ought to be some efforts to look at keeping any positive animals out of the food supply. We might also consider the question of eating brains. a gourmet delicacy for some people. some ethnic groups. labels? But is it safe? It's
It's an ethnic dish for Should they have warning
Should there be warnings in particular to hunters in These
the West about being exposed to brains and eating brains? are all questions that need some serious examination.
We could also really benefit from some good epidemiology on CJD victims and whether they have certain dietary habits which may differ from the normal population. Some work was done many,
many years ago, actually by people associated with the NIH lab, which showed some relationship possibly to eating pork products
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or to eating brains.
The data is extremely old, the samples
were extremely small, and work is not being done of this kind now. Case controlled studies with CJD victims, this would be very useful to have at this point. And we think that the defunding
of the NIH lab is most unfortunate at this particular point in time, particularly when universities are in some degree abandoning their role in terms of public health and forming many, many partnerships with industrial and corporate entities, which to a certain extent cramps their ability to tackle some of these topics which simply have a public health benefit and are not going to generate profits for anyone. Finally, we think that there should be some improvement in the USDA surveillance efforts, although we're very happy that the levels have been increased to the levels that they are now at. But if you think of 100 million animals out there, what would be a level we would be worried about? Well, 1 percent of that would be a million. animals. Okay? That's a lot of That's
A tenth of a percent, that's 100,000.
still a lot.
A hundredth of a percent, 10,000 animals, you That's an
would probably want to know about that, too. incidence of 1 in 10,000 animals.
How do you find something
occurring at an incidence of 1 in 10,000 animals, if you decide that that's of interest to you?
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Well, testing 2,000 animals, you probably won't catch it. Testing 10,000 animals, still probably you could miss that one. You would probably have to do 20, 30, 40, 50,000 animals, like what they're doing in Europe today, so that would be quite an expansion of our surveillance program, but one that might be feasible using the fast techniques which are much cheaper that are now being employed in Europe. that be considered, as well. So finally, in summary, all indications are that the United States so far has been tremendously lucky, tremendously lucky in terms of this problem. We had, to a large degree, the same So we would suggest that
feeding practices that they had in Europe, but the disease has not erupted here. We are very fortunate. Our question is,
are we willing to count on good luck forever, or can we learn from the E.U. experience and institute some controls which will ensure that this current situation will continue? Thank you. [Applause.] MR. KAY: Good afternoon. I'm Brent Kay, Director of Food and
Health Policy at the National Consumers League, and I'm going to be brief today. of the afternoon. I was asked to give a consumer perspective on this issue of BSEs and TSEs. Many consumers are really confused currently I know that it's getting toward the end
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about all the press surrounding food and food safety issues right now. Mad cow disease, foot and mouth disease, E. coli
and Salmonella outbreaks, have all made headlines recently, and many consumers are wondering what's next. Despite all the assurances from USDA and FDA that there is no BSE in the United States, consumers remain skeptical. They
see what's going on in Europe, and they feel that it's only a matter of time before it hops the pond, and I think it's reasonable that they should be concerned. Since this is an FDA meeting, I'm going to limit my remarks as well to areas where FDA has oversight and regulatory authority. However, I urge that FDA do work closely with USDA,
CDC, and other regulatory agencies to ensure more seamless oversight and enforcement. BSE and TSEs are not bound by
regulatory turf, and neither should the efforts to combat them be. Unlike USDA, which requires by law that each and every meat, swine and poultry plant be inspected on a continuous and daily basis, FDA plants have no such statutory requirements. In fact,
most FDA food plants are not even inspected on a yearly basis. I'm particularly concerned about the fact that FDA has not inspected all the feed mills and rendering plants, since the animal feed is believed to be the original cause of the BSE problem.
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Of the numerous rendering plants and mills that we've heard about, FDA has really only inspected about 80 percent or so. Of those, approximately 25 percent were out of compliance. While I commend FDA certainly for increasing its inspection efforts and compliance rates in recent months, as we've heard about, there is still more that needs to be done. We support the ban on feeding ruminants to ruminants, and feel there should also be a ban on feeding ruminants to other mammals, as well. As you are aware, there are other TSEs in the United
States, as we've heard about, scrapie in sheep and chronic wasting disease in deer and elk herds in the West, and even in 1985 a mink in Wisconsin developed a prion disease after being fed downer cattle. So we must keep potential sources
of TSEs out of the food supply, both animal and human. Another cause of concern is that while animal feed containing ruminants must be labeled "Do not feed to cattle and other ruminants," we all know that complete segregation is not realistic, as other speakers have talked about. Currently FDA
allows ruminant-derived waste materials to be fed to hogs and poultry. Allowing this feed to be used at all for any livestock courts danger. It's too easily diverted, whether intentional or not, The recent problem
to other ruminants such as cattle and sheep.
with contaminated feed from a Texas feed mill is just the latest
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and most visible example of how easy it is for ruminant feed to be diverted. Since there is no effective test to detect BSE in feed or in live animals, it just makes sense to ban possible sources of transmission. It was this lack of oversight and enforcement
in Europe that led to the spread of BSE, and we cannot let that happen in the United States. Another area of concern is the lack of FDA inspections of imported product. While FDA is barely able to inspect domestic
plants on a regular basis, it does not even inspect a small fraction of the millions of foreign shipments that arrive daily at our shores. Less than 2 percent of all FDA-regulated Further
products that are imported into the U.S. are inspected.
complicating matters is the practice of port shopping, where importers seek entry for a product that has already been rejected for contamination, seeking another port where there's lax enforcement or one that's just simply too busy to screen all of the volume that's coming in. I'm not blaming the FDA for poor inspections. They are simply
overwhelmed and completely devoid of the proper resources and manpower to do their job, protecting the public's health and safety. As imports have skyrocketed over the past decade,
particularly in the last five or six years, FDA inspectors and funding have remained relatively stable, as the charts
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illustrated and as Dr. Lurie had mentioned previously. So I must urge Congress to import more funds for FDA inspectors. Additionally, FDA also I feel should adopt a model, and this is again a legislative fix, one more closely employed by USDA, which is a continual and daily inspection for plants handling products that are directly affecting human health and animal safety, as well. FDA needs to have more inspectors to handle While I'm
the increasing level of imported products.
encouraged to see that FDA certainly will be seeking more funds in the 2001 budget for more inspectors, I still feel that unfortunately will not be enough. In order to protect the public health, as Jean as just recently mentioned, FDA should adopt the World Health Organization's recommendation which states that no part of any animal which has shown signs of TSEs should enter the food chain, human or animal. All countries must ensure the slaughter and safe
disposal of TSE-infected animals, so that TSE infectivity cannot enter any food chain. Despite the total ban of ruminant-to-ruminant feed in 1997, there is no guarantee that the U.S. is free of BSE because of the long incubation period. We certainly have been lucky that
none of it has shown up, and that it is not here currently through what testing methods that they have. However, because of this
long incubation period, it may be possible that U.S. cattle
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may have been fed meat and bone meal derived from infected cattle. And, as Jean as mentioned, the freeze-dried blood is
part of the exemption, and so there's a possibility there that it might be going to cattle. We need better testing mechanisms, both for live animals and humans, to detect the presence of BSE and other TSEs. It was
disheartening to hear Dr. Brown say that the NIH lab is being closed that he does work on, especially in light of the NIH getting billions of dollars in funding increases recently to do other basic medical research. Consumer health and safety interests must be put at the forefront. There is definite increasing direct evidence that
BSE is responsible for the new variant Creuzfeldt-Jacob disease, with numerous cases being reported in the United Kingdom, and now in other areas as well. This disease has a long incubation
period, so it is not known how many people may develop this disease in the coming years, nor if it may appear in the United States. Immediate action must be taken. voluntary guidances. We cannot continue to have
Mandatory action needs to be into place.
The objective should be to keep TSEs out of human and animal food supplies, and the long-term goal should be to eradicate BSE and other prion diseases. Thank you.
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[Applause.] MR. WOOD: It's great to be last, and try to cut out everything
that everybody else has said that I'm also going to say, but I couldn't read my comments then at all. I think it is
interesting, though, to note some of repeating themes that we're hearing from consumer groups as we respond to the presentations that have been made here. I'm Richard Wood. I'm the Executive Director of Food Animal FACT is a nonprofit organization that
Concerns Trust, or FACT.
advocates for farm management systems that promote the safety of meat, milk and eggs. supporters nationwide. We currently have about 30,000 We were at the table when a national We were also a
strategy was put together to respond to BSE.
part of the discussions that led up to the rule that was put in place in 1997. I thank the FDA for this consumer briefing on BSE, and my comments today will focus primarily on the Center for Veterinary Medicine or CVM. FACT applauds the Center for responding to the threat
of mad cow with its efforts in 1997 to apply what was then the available science to a rule that seeks to prohibit American cattle from being infected with this disease. We are relieved
now to hear that the inspections will be completed by this fall. As others have said, it's that piece of the rule that is very bothersome and worrisome to us, and we're glad that they are
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moving forward. Now, almost four years after the rule was put into place, the Center should have sufficient evidence to determine how the rule and its enforcement can be improved and fine-tuned. We
also have the increasing and unfortunate experiences of other countries where BSE has appeared in cattle. Based on this
emerging information, FACT calls on the Federal agencies to take next steps necessary to protect both animal and human health. FACT believes that the next steps for CVM should focus both on what kinds of protein are allowed in ruminant feeds and what feed preparation practices will keep cattle safe. of protein should be allowed? one. So what kinds
Well, we want to focus just on This has also been mentioned
Others have been mentioned.
by others. FACT calls on the FDA to reexamine the allowed use of blood and blood products as a protein source in ruminant feed. In
1996 the United Kingdom implemented measures similar to the FDA rule that were to prevent the development of any new cases of BSE in that nation's cattle, and the number of infected cattle really did start to drop off. And yet this past fall the United Kingdom reported a disturbing new development. It was reported that eight new cases of mad At the
cow disease had appeared in cows born after the ban.
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time of the report, only one of the eight cows was confirmed to have BSE, but the others were showing symptoms. Scientists
are concerned that these cases may be linked to the allowed use of cow blood as a protein source in ruminant feed. In the U.S. there is a Federal ban on importing blood meal along with other animal protein sources from European countries. FACT calls on the FDA and CVM to follow this action by banning the use of blood and blood products in ruminant feeds until blood is conclusively determined not to convey BSE. Four years
go, the FDA stated that the research indicated that blood does not convey TSE-infective agents. It was good to hear earlier
today Dr. Sundlof state that this question now is back on the table. A second step for the FDA has to do with rendering and feed mill practices, and those establishments that produce products for both ruminant and non-ruminant feeds, or mix those feeds. We have also heard comments about this a little in the last remarks. We now have the results from the FDA compliance surveys regarding the feed ban, and we now almost have memorized the percentages of those feed mills and rendering establishments and non-licensed feed mills that are not complying. Labeling
compliance, where there also is failure, is a concrete, specific requirement. Even my two-year-old grandson can look at a
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package and tell whether or not it's labeled, and he can be trained. But systems to prevent commingling are more obscure and more difficult to regulate. As I understand it, in plants that
prepare or mix feed for non-ruminants like pigs and then in the same feed mixers, prepare feed for ruminants, the rule requires clean-out between these feed preparations. Clean-out
is also required for the storage and the hauling of the feed, and haulers need to be included in this loop. Scientists now believe that the early spread of mad cow in the United Kingdom was due to the failure of feed mills to segregate out potentially infected feed provided for the cattle. If the
American public is going to rely on a feed ban to protect itself from the mad cow disease, the potential for commingling and cross-contamination between batches is extremely dangerous. FACT calls on the FDA to revise the rule to require plants that prepare feed for both ruminants and non-ruminants to completely segregate all mixing, storing, and hauling processes. In terms of compliance, I understand that a protein test that was developed in Italy now exists, and that it can differentiate between ruminant and non-ruminant proteins. While this may
be an important enforcement tool, as we view it, it does not provide the safeguards needed. First, it is our understanding that this test cannot make the
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protein distinction with blood products.
Second, in a recent
conversation I had while in Denmark with the Danish Zoonosis Center, they said that the test was worthless in rendering plants because it is not effective in testing cooked protein. The level of failure to prevent commingling reported in March by the FDA is too high a level to allow confidence that the feed rule will protect cattle. Where plants prepare both feed
for ruminants and non-ruminants, the complete segregation of feeds must be the only allowable mixing process.
As with the others, FACT strongly supports increased funding for the FDA's BSE work. so crucial. Enforcement of the mad cow rule is
This is one area where the American public can At the same time as we
ill afford another unfunded mandate.
work on other human health concerns, we trust that sufficient funding will be there for BSE enforcement and further steps, so that other concerns for public health are not left wanting in the meantime. In terms of Federal collaboration, FACT is also concerned about USDA's surveillance rule. We look forward at another time to
talk at length with the USDA about the number of cattle tested in their surveillance program and the concern that we have, as well as others, with the sampling pool. In the long term, FACT believes that in addition to a strong feed rule, our best hope is also to develop a rapid, inexpensive
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test to detect the presence of BSE in living cattle.
We were
delighted to learn that $5 million has been designated by the USDA for research in this area. In the U.S., this diagnostic
tool could provide the U.S. cattle industry with an added safeguard, an alternative to the current practice where the entire herd is destroyed if one cow is found to have the disease. FACT calls on the FDA and the USDA to learn from the past four years and from the experience of other countries. We call on
them to take important next steps to protect the well-being of American cattle and people by banning blood in ruminant feed until it is conclusively determined that blood does not convey BSE; secondly, to change the rule to allow only segregated feed preparation and mixing processes; and, third, on USDA's part, to increase surveillance. Thank you. [Applause.] MS. HOLSTON: Thank you again for participating in our briefing.
We like to share information with consumers, as I alluded to earlier, but we also like to hear from consumers, and it really is part of how we do our job best. The rest of the time will
be now open for any comments that individuals may want to make from the floor. We do have a limited amount of time remaining, and therefore I ask that you keep your remarks short, and I do have a timer,
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just in case.
So I'm asking that you please try to keep any
remarks that you make to two or three minutes, and if it goes much more over that, I will have to interrupt. So just please
come to the mike and identify yourself, and then feel free to speak. Why don't you try to come to the podium? MS. ABRAMS: Thank you. My name is Janet Abrams. I'm here
representing STOP, Safe Tables Our Priority, which is a national nonprofit organization of victims of food-borne illness and consumers concerned about pathogens in our food supply. S.T.O.P.'s mission is to prevent unnecessary illnesses and deaths from food-borne illness, and we appreciate this opportunity FDA has offered today to submit comments. I had edited my remarks down because I know we're very limited on time. Our message is in line with the messages that you
just heard from the other individuals on the consumer panel, that we feel that we shouldn't be waiting for TSE to come to the United States, that it's already here in certain species and it's simmering, awaiting an opportunity to jump species barriers and be amplified through mass agribusiness practices and poorly enforced regulations. Just as other diseases that
S.T.O.P. has dealt with, such as E. coli 0157H7 and Salmonella have already done. aggressively now. We believe it's essential to act
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I have a few recommendations from Safe Tables Our Priority. Number one, FDA's Center for Veterinary Medicine must immediately finalize rules and enforce the full U.K. or E.U. ban on feeding any mammalian protein to any farm animal, processed animal protein to animals which are kept, fattened or bred for the production of food. This has been discussed.
Number two, FDA's CFSAN must immediately create a gelatin sourcing rule and enforce it. Gelatin raw materials, at a
minimum, should be prohibited from any country known to have BSE. The current guidance has existed for almost four years, And guidelines are
and a regulation is long overdue.
insufficient now, when regulations are not even followed due to lack of enforcement, which has been discussed. Number three, while FDA's CFSAN works towards regulations prohibiting the use of animal parts in dietary supplements, FDA must immediately implement a rule that dietary supplement manufacturers carry warning labels on their products if these products contain suspect animal parts, and the label must also reveal the country from which they are sourced. FDA must also
be prepared to implement recalls of such products if new information reveals BSE in herds that are used in the manufacture. Number four, FDA must immediately put into place a mandatory national registration program for manufacturers of dietary
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supplements, gelatin manufacturers, and dairies.
FDA must
equip itself with the ability to quickly notify all manufacturers potentially affected by TSE. This is merely the
first line of defense in a true readiness campaign to act against the disease. Number five, FDA must ensure that American consumers consuming mammalian meat in restaurants and through grocery stores are notified as to the country of origin of that meat. With the
list of BSE-infected countries or countries with suspect feeding practices exploding, consumers truly deserve the ability to make informed choices about the meat they eat. And finally, number six, FDA must fully disclose how many American consumers living in the U.S. have been exposed to the risk of BSE through the combination, unfortunately, of delay, insufficient guidance, and inadequate enforcement, as well as a misunderstanding of how widespread the problem has been overseas. Americans deserve to know the range of true public
health costs associated with delay and incomplete barriers. If there is only one lesson to be learned from the disastrous consequences of the infection of U.K. and European farm animals, it's that FDA and USDA must get ahead of the science. And as
long as the U.S. Government officials continue to act as though BSE is not yet here, we'll have slow and lax regulation and enforcement, and the results could be devastating.
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Thank you very much for your time. MS. HOLSTON: In the interest of time, if both mikes aren't
working, you can line up over here. MR. CANTOR: Hello. My name is David Cantor. I'm here We
representing the nonprofit organization, Farm Sanctuary. have about 75,000 members nationwide, and we run two large shelters for rescued farm animals.
And because this is an area
where our issues overlap with public safety, we submitted in 1998 this petition to the FDA and the USDA, and I'll just read the very bare bones, a couple sentences of the key components of it. "Petitioners request that the FDA and USDA immediately label all downed livestock as adulterated, pursuant to 21 U.S. Code, Section 342(a). This action is not only required by existing
statutes and the USDA definition of diseased livestock, but it will also take an important step in further protecting the health of the nation." Let me see. I'll skip a little bit here.
"As noted in the petition, tens of thousands of downed cattle are slaughtered for human food in the United States every year. `Downed' is an industry term describing non-ambulatory animals which have collapsed for unknown reasons and which are too sick to stand back up. There are a host of problems affiliated with Wholly aside from the humane issue
these downed animals.
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involved with the handling and processing of non-ambulatory animals, downed animals may pose a serious threat to human health." And BSE is one of those issues. The recent mad cow epidemic
in Great Britain dramatically illustrates the danger posed by food-borne illnesses such as BSE, etcetera. And a study
published after we filed our original petition showed that transmissible spongiform encephalopathies could occur in other animals besides cows. So we submitted this petition, and we believe that a very good way of protecting public safety in this matter would be not to let any downed animals enter the food stream. I did leave
a stack of flyers about this petition, that explain this in very basic terms, on the table outside the door. all read it. MS. FISHER: I hope you'll
And thanks very much for this opportunity. My name is Barbara Loe Fisher, and I'm President
of the National Vaccine Information Center, which is a nonprofit organization representing more than 30,000 parents and health care professionals concerned about vaccine safety. From a consumer perspective, I find it very disturbing that so many producers of products using bovine-derived material such as animal feed, and vaccine manufacturers, have ignored FDA requests to stop using bovine sources from BSE countries. The statement that the benefits of vaccines outweigh the risks
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is beside the point when it comes to ensuring the purity of vaccines that are given to every child in this country. And my statement really is in the form of a question to the FDA. I would like to know what plans the FDA has to move from
issuing requests for voluntary compliance to issuing directives for mandatory compliance that includes punitive sanctions for manufacturers who violate those directives. MS. HOLSTON: Let me just say that we will have some time at We will undoubtedly not be able to respond
the end to respond.
to each and every individual question raised, but we will try to capture some of them. MS. NESTOR: I am Felicia Nestor with Government Accountability
Project, and unfortunately I had a comment and a question for Linda Detwiler but she just left, but I'll make the comment anyway. GAP is also concerned, like the other consumer groups, about the number of animals being tested under USDA's surveillance program. We're further concerned because we've been hearing
from veterinarians around the country that animals with CNS signs and downer animals are being funneled away from the large plants where there's a vet on site. These animals are being funneled to little slaughterhouses off the beaten path, and at these plants they often only have a Federal inspector there. The inspector has to call first the
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USDA vet, who is on a circuit and could be hours away, and once the USDA vet gets there, they have to call the APHIS vet, who could be even further away, so this creates an impediment to testing. We want to know whether USDA's surveillance, random testing, takes these difficulties into account. And I know Linda is
not here and she can't answer, but that is our concern. MS. FOER: Hi. My name is Sara Foer. I'm with the American
Association of Blood Banks. I do have a question.
And I don't have a statement but
I did attend the TSE meeting in January and listened to a variety of the recommendations. I also happened to read the transcript
from this Friday night's CBS News story about mad cow disease and some of the recommendations that the American Red Cross was making, for example, extending the ban for blood donors to everyone in Europe who has been there for a total of six months. And I guess I would like to know when the FDA will be making a final decision on donor deferrals. I think many of us know
that less than 5 percent of our American population donates blood, and we do have the safest blood supply in the United States, but I think we also need to look at, again, weighing those risks against the benefits and what will happen to our blood supply.
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Thank you. MR. RAU: Good afternoon. My name is Jeffrey Rau. I'm an
animal scientist with The Humane Society of the United States. On behalf of The Humane Society of the U.S., the largest animal protection organization in the United States, and our over seven million members and constituents, we would like to express our concern for protecting the well-being of the animals involved in diseases such as BSE. Rather than reiterate recommendations and things like that that have already been expressed, I can just say that we for the most part agree with the majority if not all of the recommendations made by various organizations that spoke earlier today. We would like to express our concern that the industrialization of our livestock sectors had led to an infrastructure that exacerbates problems such as BSE, and so we call on the FDA, in cooperation with the USDA and others, to thoroughly evaluate the practices that come with the industrialization of our livestock sectors, with emphasis on research into more humane and sustainable systems of raising farm animals. Thank you for your time. MS. STEVENS: I am Christine Stevens with the Animal Welfare
Institute, and I mainly have questions that weren't answered at all in this long, long discussion.
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Renderers are very powerful in this matter.
Agribusiness is
at the heart of creation of BSE in England, no question about it. It is admitted widely, and the Guardian and Independent So I'd like to have somebody
are hammering away at it every day.
say something about the powerful rendering lobby and how come they can do all this stuff. MS. HOLSTON: All right. I mean, that's my question.
Are there any others who would like
to have comments before I turn back to our panelists to give both some response as well as some summing up of some of the points that they have heard raised here this afternoon? Okay, if not, I could ask each and every one of you to make a comment, but first there were a couple of questions that were specifically raised that we may at least want to respond to, if not definitively answer at this time. MR. ELENGOLD: I'll volunteer. Do I have a volunteer?
There were two issues that were
addressed to my Center, and I'll try and briefly discuss both. I'm sorry. Is this better? Okay.
As to the mandatory nature for vaccine regulation, as all the other members of the panel have discussed, FDA is always caught between the need for speed which is best addressed in guidance and the need for enforceability which is represented by regulations. One of the underpinnings of the notice and comment
rulemaking process is hard scientific evidence that ultimately will stand up in court, should the regulation be challenged.
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And, as we have heard here today, there is very little agreement on the scientific nature and threat of some of these items. So what we have tried to do is take a balanced approach, using guidance, and ultimately when the evidence has accumulated, be able to issue full regulations that are enforceable. And
we're still struggling, as are all the other Centers, with when that point becomes the one where we can move forward with mandatory regulations. As to the blood bank issue, there was a meeting of the TSEAC and certain recommendations came out of that. Shortly after
or actually just before, the American Red Cross issued some proposals they were going to implement. We're in the process
of evaluating both our original advice from the TSEAC and the Red Cross's proposal. We will be meeting with the people
involved, getting some more information, consulting with the two advisory committees that have interest in this, the Blood Products Advisory Committee and the Department's Committee on the Safety and Availability of Blood, and trying to forge a consensus opinion on what the appropriate level of deferment is. You asked for a time frame. I've been with FDA 30 years, and So as soon as
I've learned better than to give time frames.
we can to get it right is the only answer I can give you. MS. HOLSTON: Thank you, Mark. Steve?
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DR. SUNDLOF:
Thank you.
Yes, a lot of the issues that I heard,
both from the panelists representing the consumer organizations and from speakers from the floor representing their organizations, had a lot to do with--if I had to summarize it I would say, you know, "Good start, you, the FDA put in place a feed ban. That was the right decision, but there are some
issues with the feed ban that need to be addressed," and that we need to look at it from a scientific standpoint. And they were some of the exemptions that I mentioned earlier in my talk. Blood products came up quite a bit, and whether
or not those are safe to be fed to animals, or do those pose a risk, an unacceptable risk to introducing the disease into the cattle population in the United States. I heard concerns It was felt
about commingling, that commingling is a problem.
the Texas incident was an example of where, despite the best efforts of people, that there was still cross-contamination, and that such problems may continue to occur in the years ahead unless something is done. Then I heard other issues about moving further than the specific ruminant-to-ruminant bans and expanding it more in the area of all mammals to ruminants. Finally, let's see, I think I
heard things about, I did hear issues on how industrialization of farming may be contributing to some of the issues, and that that was something that the USDA and the FDA needed to address.
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The last comment was specifically to address the rendering industry, and I guess I'll just say that the rendering industry obviously certainly is involved in this issue, that the FDA does work with the various industries who in one way or another handle this material, and we are trying to do that in a very, very open manner so that there is no sense that the industry has undue influence with the FDA. The issues that I think you've all mentioned are issues that we do intend to reexamine. I think we've made it clear publicly We'll look and
that all of these issues are on the table.
determine where we feel that the science points us to vulnerabilities, and try and make sure that any vulnerabilities that currently exist are identified and that we try and move to minimize any of those vulnerabilities. The one thing I think I did hear from just about everybody is that the level of inspections, although it is ambitious that we're trying to do 100 percent of all those industries, that we need to get to those in a more timely manner; that we need to take more enforcement activities when we find companies, firms that are in violation; that we need to have a much greater presence in the field, inspecting the plants; that we need to have a greater presence at the border, making sure that our borders are secure so that the disease cannot come into the United States.
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I think we are very much in agreement with that; that our budget for the year 2002 calls for $15 million. Over two-thirds of
that is going specifically for increased inspections at the border and domestically in our feed mills and renderers. We
are also trying to develop better tests so that we can actually sample feeds and determine whether or not those feeds are in compliance. I think I heard one comment that indicated that the test that we were evaluating doesn't work on heated protein. It does.
It was tested in multi laboratories on rendered animal proteins, and it does work. It specifically was designed to
work on those kinds of materials. So, again, I think I have a lot to go back home and discuss with the folks in my Center, and I appreciate the comments here today. Thank you. Thank you. Dr. Brown?
MS. HOLSTON: DR. BROWN:
This just to show you all that science is not It often is,
necessarily always at variance with consumers. but often it doesn't need to be. comment and a question myself.
And so I would throw out a
This meeting would of course never need to have occurred if the practice of supplementing feed for livestock didn't exist. I mean, every single problem that has been discussed would be null. So the question is, what if animals simply were not
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fed anything that came from animals? And the information that I have never heard is what that would cost. It would cost something. It would, among other things,
eliminate the rendering industry, and that would be costly to the renderers. It would probably expand the growing of some It would
substitute dietary supplement, let's say soybeans.
certainly require an expansion of the incineration industry, which would have a great many more tons of carcass waste to destroy. Or suppose you go back even further to the 19th century
and revert to a practice in which only that much meat was consumed which could be produced by animals that were range-fed. These would undoubtedly be costly. They might even mean that These
American consumers would have to eat half as much meat.
are questions that could be maybe--maybe numbers could be applied to this. I've never heard any number from anybody as
to what all of these regulations would cost as opposed to simply reverting to a different practice of livestock raising and consumption. Would the American public accept, for example, if it were much more expensive, to pay three times the price that they now pay for meat? Perhaps they would. Would the American public Perhaps they
accept to eat one-third of the meat they now eat? would.
I really don't know the answers to these questions. But I think they are
I don't think anybody in the room does.
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not trivial questions and they should be answered. MS. HOLSTON: Thank you, Dr. Brown.
Would any of our other panelists like to give any closing or parting remarks? DR. SOLOMON: comments. Steve?
I'd just like to reiterate Dr. Sundlof's closing
We clearly heard the message about inspection and
enforcement that many people raised today, and we clearly have not met our objective of 100 percent compliance with this regulation. So we will continue to take the messages and
reinvigorate our inspection and enforcement, as we discussed earlier. And there was also discussion about looking at the
data that was collected, and we will carefully look at that and reevaluate our enforcement strategy for the future. MS. HOLSTON: DR. LURIE: Thank you. Yes?
I would just like to respond to Dr. Elengold's
comment about the balance between sort of mandatory and voluntary enforcement activities. I think he phrased the
question correctly, but in the end that kind of phrasing of it is always a justification for the guidance and voluntary process over the mandatory one. It seems to me that the vaccine case in particular is an excellent case of the failure of the voluntary approach. It is far from
being a case whereby, for the sake of expeditiousness, there was a rapid promulgation of a guidance followed by, in one
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possible version of Dr. Elengold's scenario, an attempt to regulate. What happened instead was the writing of the guidance
followed by absolutely nothing, including compliance by the industry. So I think that is an excellent example. I think
we need to pay attention to that and, as far as is practical, to tilt the balance of mandatory actions rather than voluntary ones, because all too often the industry will fail to comply. MS. HOLSTON: Thank you, Dr. Lurie.
Any other comments from any of our panelists before we close? All right. Let me thank again all of you for participating Clearly it was our intention to provide you
in this briefing.
with information about the activities that are going on, not only within the Food and Drug Administration but also with some of the other agencies in the Federal Government. But also important to us was hearing your perspectives and getting your reactions, your responses to this particular issue, and we very much appreciate what you did share with us. This
information sharing is a two-way street, and it's very important to us as we go forward in trying to grapple with all of the responsibilities that are given to us. We will have a transcript of this meeting, and I'm not exactly certain of the time frame, but you will undoubtedly be able to view it on our web site at a future date. Also, some of
you may be interested in actually getting a copy of the
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transcript, and I believe if you contact our Office of Consumer Affairs you can talk to someone about how you might be able to do that, as well. Again, thank you very much for being with us. your patience. We appreciate
And there will be more consumer briefings as
we follow up on our consumer roundtable from last December. We made a commitment then that there would be a series of briefings on ongoing issues in the FDA, and we will keep to that commitment. Thank you very much, and good evening. [Whereupon, at 5:00 p.m., the proceeding was concluded.]
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