[Senate Hearing 107-1060]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 107-1060
 
                           MAD COW DISEASE: 
                     ARE OUR PRECAUTIONS ADEQUATE?

=======================================================================

                                HEARING

                               BEFORE THE

                   SUBCOMMITTEE ON CONSUMER AFFAIRS, 
                      FOREIGN COMMERCE AND TOURISM

                                 OF THE

                         COMMITTEE ON COMMERCE,
                      SCIENCE, AND TRANSPORTATION

                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             APRIL 4, 2001

                               __________

    Printed for the use of the Committee on Commerce, Science, and 
                             Transportation







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           COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                     JOHN McCAIN, Arizona, Chairman
TED STEVENS, Alaska                  ERNEST F. HOLLINGS, South Carolina
CONRAD BURNS, Montana                DANIEL K. INOUYE, Hawaii
TRENT LOTT, Mississippi              JOHN D. ROCKEFELLER IV, West 
KAY BAILEY HUTCHISON, Texas              Virginia
OLYMPIA J. SNOWE, Maine              JOHN F. KERRY, Massachusetts
SAM BROWNBACK, Kansas                JOHN B. BREAUX, Louisiana
GORDON SMITH, Oregon                 BYRON L. DORGAN, North Dakota
PETER G. FITZGERALD, Illinois        RON WYDEN, Oregon
JOHN ENSIGN, Nevada                  MAX CLELAND, Georgia
GEORGE ALLEN, Virginia               BARBARA BOXER, California
                                     JOHN EDWARDS, North Carolina
                                     JEAN CARNAHAN, Missouri

                  Mark Buse, Republican Staff Director
               Ann Choiniere, Republican General Counsel
               Kevin D. Kayes, Democratic Staff Director
                  Moses Boyd, Democratic Chief Counsel

                              ----------                              

                   SUBCOMMITTEE ON CONSUMER AFFAIRS, 
                      FOREIGN COMMERCE AND TOURISM

                PETER G. FITZGERALD, Illinois, Chairman

CONRAD BURNS, Montana                BYRON L. DORGAN, North Dakota
SAM BROWNBACK, Kansas                JOHN D. ROCKEFELLER IV, West 
GORDON SMITH, Oregon                     Virginia
JOHN ENSIGN, Nevada                  RON WYDEN, Oregon
GEORGE ALLEN, Virginia               BARBARA BOXER, California
                                     JOHN EDWARDS, North Carolina
                                     JEAN CARNAHAN, Missouri



                            C O N T E N T S

                              ----------                              

                                                                   Page
Hearing held on April 4, 2001....................................     1
Statement of Senator Brownback...................................     9
    Prepared statement...........................................    10
Statement of Senator Burns.......................................     7
Statement of Senator Dorgan......................................     7
Statement of Senator Ensign......................................    48
Statement of Senator Fitzgerald..................................     1
    Prepared statement...........................................     2
Statement of Senator Smith.......................................    51

                               Witnesses

Campbell, Hon. Ben Nighthorse, U.S. Senator from Colorado........     3
DeWaal, Caroline S., Director, Food Safety Program, Center for 
  Science in the Public Interest.................................    68
    Prepared statement...........................................    70
Durbin, Hon. Richard J., U.S. Senator from Illinois..............    10
    Prepared statement...........................................    13
Hodges, James H., President, American Meat Institute Foundation..    65
    Prepared statement...........................................    67
Hueston, William D., D.V.M., Ph.D., Professor and Associate Dean, 
  University of Maryland Campus, Virginia-Maryland Regional 
  College of Veterinary Medicine.................................    39
    Prepared statement...........................................    41
Johnson, Richard T., M.D., Special Advisor, National Institute of 
  Neurological Disorders and Stroke, National Institutes of 
  Health.........................................................    15
    Prepared statement...........................................    16
Lurie, Peter, M.D., MPH, Director, Health Research Group, Public 
  Citizen........................................................    58
    Prepared statement...........................................    61
Schroeder, Chuck, Chief Executive Officer, National Cattlemen's 
  Beef 
  Association....................................................    52
    Prepared statement...........................................    55
Sellers, Richard, PAS, Vice President, Feed Control and 
  Nutrition, American Feed Industry Association..................    74
    Prepared statement...........................................    76
Sundlof, Stephen, D.V.M., Ph.D., Director, Center for Veterinary 
  Medicine, Food and Drug Administration, Department of Health 
  and Human 
  Services.......................................................    34
    Prepared statement...........................................    35
Torres, Alfonso, Deputy Administrator for Veterinary Services, 
  U.S. 
  Department of Agriculture; accompanied by Linda Detwiler, 
  Senior Staff Veterinarian, Animal and Plant Health Inspection 
  Services.......................................................    30
    Prepared statement...........................................    31

                                Appendix

Response to written questions submitted by Hon. Peter G. 
  Fitzgerald to Stephen Sundlof, D.V.M...........................    85
Response to written questions submitted by Hon. Gordon Smith to 
  Alfonso Torres.................................................    86
USDA Executive Summary: National Emergency Response to Highly 
  Contagious Animal Disease......................................    87
USDA Report: Bovine Spongiform Encephalopathy (BSE) Response Plan 

  Summary........................................................    92


                            MAD COW DISEASE:



                     ARE OUR PRECAUTIONS ADEQUATE?

                              ----------                              


                        WEDNESDAY, APRIL 4, 2001

                               U.S. Senate,
                 Subcommittee on Consumer Affairs, 
                      Foreign Commerce and Tourism,
        Committee on Commerce, Science, and Transportation,
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 9:31 a.m. in 
room SR-253, Russell Senate Office Building, Hon. Peter G. 
Fitzgerald, Chairman of the Subcommittee, presiding.

        OPENING STATEMENT OF HON. PETER G. FITZGERALD, 
                   U.S. SENATOR FROM ILLINOIS

    Senator Fitzgerald. Good morning, everyone. I open this 
hearing of the Subcommittee on Consumer Affairs, Foreign 
Commerce and Tourism. I am going to give my opening statement 
and then we will go to Senator Campbell, and then we will go to 
opening statements of other Senators if they have one. I 
believe Senator Durbin is also on his way to testify as well. 
The two Senators will testify first and then we will have two 
panels of expert witnesses.
    Mad cow disease is back in the news. Although reports of 
bovine spongiform encephalopathy, or BSE, are down 
significantly in Great Britain, where the disease peaked in 
1993 with an estimated 1,000 cases per week, other European 
countries once thought immune to the disease are now reporting 
cases of BSE.
    The spread of the disease throughout Europe invites our re-
examination of the measures in place in the United States to 
prevent transmissible animal diseases. Additionally, we have 
recently witnessed graphic images of the mass slaughter of the 
animals in Britain to control the latest outbreak of foot and 
mouth disease, a blight unrelated to BSE. Some consumers 
apparently did not distinguish between foot and mouth disease 
and mad cow disease and other questions are arising as well.
    Beginning in 1988, our government, through the United 
States Department of Agriculture, the Food and Drug 
Administration, and various other agencies, has employed a 
number of different measures to safeguard the American public 
from BSE. As Newsweek reported earlier this month, ``the United 
States, to its credit, has shown foresight. Not a single mad 
cow has been reported in this country.'' Let me repeat that 
again: Newsweek recently reported that ``not a single mad cow 
has been reported in this country.''
    In addition to the preventative measures adopted by 
regulation and the vast ocean that separates us from Europe, 
initiatives within industry and differences between the way the 
U.S. and Europe traditionally feed and slaughter cattle may 
help the United States remain BSE-free. We hope to examine some 
of these initiatives and differences today.
    But while the risks may be low, we cannot be complacent. 
The recent focus on BSE has invited examination of our 
defenses. By 1988, researchers in Britain knew that their 
cattle faced a deadly epidemic. They had identified BSE as a 
neurological disease, thought that it was probably transmitted 
through cattle feed derived from animals such as cattle, sheep, 
and goats, and knew that thousands of cattle may have consumed 
contaminated feed.
    To date there have been over 170,000 cases of BSE reported 
in Europe, the vast majority of them in Great Britain. At the 
hearing today, this Subcommittee will examine the nature of the 
disease as well as the measures taken in this country to 
prevent the disease's establishment and spread in the United 
States.
    Concerns have also been raised about our primary efforts to 
keep the infection out of the country. The effectiveness of our 
import prohibitions is also an issue we will explore. The 
Subcommittee would like answered some very basic questions, 
such as what is BSE, how much do we know, who are the experts 
in the field, how do they assess the risk, should consumers be 
concerned, what are we doing to prevent BSE, should we be doing 
more?
    By examining these issues publicly, it is our hope to help 
answer questions posed by consumers. As former Secretary of 
Agriculture Dan Glickman wrote in response to a recent magazine 
article on BSE, ``The American public is far more likely to be 
affected by salmonella, E. coli, or listeria than by BSE.'' I 
look forward to hearing from our witnesses today about whether 
they agree with that statement, whether our defenses are in 
place, and whether there is anything further we need to do.
    With that, I would like to welcome Senator Campbell and 
invite him to make his remarks.
    [The prepared statement of Senator Fitzgerald follows:]
            Prepared Statement of Hon. Peter G. Fitzgerald, 
                       U.S. Senator from Illinois
    Mad cow disease is back in the news. Although reports of Bovine 
Spongiform Encephalopathy, or BSE, are down significantly in Great 
Britain--where the disease peaked in 1993 with an estimated 1,000 cases 
per week--other European countries once thought immune to the disease 
are now reporting cases of BSE. The spread of the disease throughout 
Europe invites our reexamination of the measures in place in the United 
States to prevent transmissible animal diseases. Additionally, we have 
recently witnessed graphic images of the mass slaughter of animals in 
Britain to control the latest outbreak of foot and mouth disease--a 
blight unrelated to BSE. Some consumers apparently do not distinguish 
between foot and mouth disease and mad cow disease, and other questions 
are arising as well.
    Beginning in 1988, our government--through the United States 
Department of Agriculture, the Food and Drug Administration, and 
various other agencies--has employed a number of different measures to 
safeguard the American public from BSE. And as Newsweek reported 
earlier this month, ``The United States, to its credit, has shown 
foresight . . . Not a single mad cow has been reported in this 
country.'' Let me repeat that again, Newsweek recently reported that 
``Not a single mad cow has been reported in this country.'' In addition 
to the preventive measures adopted by regulation--and the vast ocean 
that separates us from Europe--initiatives within industry and 
differences between the way the U.S. and Europe traditionally feed and 
slaughter cattle may help the United States remain BSE-free. We hope to 
examine some of these initiatives and differences today.
    But while the risks may be low, we cannot be complacent. The recent 
focus on BSE has invited examination of our defenses.
    By 1988, researchers in Britain knew that their cattle faced a 
deadly epidemic. They had identified BSE as a neurological disease, 
thought that it was probably transmitted through cattle feed derived 
from animals such as cattle, sheep, and goats, and knew that thousands 
of cattle may have consumed contaminated feed. To date, there have been 
over 170,000 cases of BSE reported in Europe, the vast majority of them 
in Great Britain.
    At the hearing today, this subcommittee will examine the nature of 
the disease, as well as the measures taken in this country to prevent 
the disease's establishment and spread in the United States.
    Concerns have also been raised about our primary efforts to keep 
the infection out of the country. The effectiveness of our import 
prohibitions is also an issue we will explore.
    This subcommittee would like answers to some very basic questions: 
(A) What is BSE?; (B) How much do we know?; (C) Who are the experts in 
the field?; (D) How do they assess the risk?; (E) Should consumers be 
concerned?; (F) What are we doing to prevent BSE?; (G) Should we be 
doing more?
    By examining these issues publicly, it is our hope to help answer 
questions posed by consumers. As former Secretary of Agriculture Dan 
Glickman wrote in response to a recent magazine article on BSE, the 
American public is far more likely to be affected by salmonella, E. 
coli, or listeria than by BSE. I look forward to hearing from our 
witnesses today about whether they agree with that statement, whether 
our defenses are in place, and whether there is anything further we 
need to do.

          STATEMENT OF HON. BEN NIGHTHORSE CAMPBELL, 
                   U.S. SENATOR FROM COLORADO

    Senator Campbell. Thank you, Mr. Chairman, for calling this 
hearing and allowing me the opportunity to testify on an issue 
that has certainly a direct impact on our state of Colorado and 
the rest of the nation as a whole.
    Let me state, perhaps repeat what you have already alluded 
to, and that is that the purpose of this hearing should not be 
to whip up people's fears so they go off pell-mell into some 
kind of a stampede of hysteria. Frankly, the media is doing 
that quite well without government help. I was looking at the 
Newsweek Magazine that you spoke about and in reading the 
article, you were right, they say that not one single case has 
been reported of mad cow disease. But holy smokes, if you just 
look at the cover of that magazine, ``Mad Cow Disease'' in big 
print, the slow deadly spread of it and how it could become an 
epidemic, that cover really instills needless fears in people, 
I think.
    The day does not go by now that we are not reading about 
mad cow disease or related diseases like hoof and mouth. It 
seems to me that we need as elected officials here in 
Washington to proceed in a prudent, cautious way to do 
everything we can to prevent the spread of any cattle disease 
or any livestock disease, but certainly only then can we 
continue to elicit confidence in the consumers in the American 
food supply.
    History has certainly taught us that inaccurate or 
insufficient information leads to destructive rumors. It has 
also taught us that the public perception of inadequate 
government responses to their concerns can also lead to 
groundless fears.
    But the genie is out of the bottle and certainly the 
mainstream press is carrying stories almost daily, as I 
mention. But it is neither wise nor prudent to scare people, 
but it is not wise nor prudent to totally avoid it, as some 
have suggested.
    Regrettably, there are some people in this country already 
who are whipping it up, and while we are working here today to 
try to make sure that people know that the American food supply 
is safe, I was reading with great interest the comments made by 
the head of PETA, the People for the Ethical Treatment of 
Animals, in stating her hopes that foot and mouth disease does 
spread to the United States. The lady, Ingrid Newkirk, the 
president of PETA, said in an interview: ``If that hideousness 
comes here, it would not be any more hideous for the animals. 
They are bound to a ghastly death anyway. But it would wake up 
consumers. I openly hope that it comes here. It will bring 
economic harm only for those who profit from giving people 
heart attacks and giving animals a concentration-like 
existence. It would be good for the animals, good for human 
health, and good for the environment.''
    That is why this hearing is important, because of some of 
the irresponsible, destructive rumors that increase the fears 
with inaccurate information.
    The American people have already expressed their concern 
about mad cow disease. According to an ABC News-Washington Post 
poll conducted in January, 44 percent of the respondents said 
they had heard of the disease and they were very concerned or 
moderately concerned that it would become a problem in the 
United States. That percentage increased to 65 percent in those 
responding to a similar question in the Gallop Poll, so clearly 
it is out there.
    Those poll numbers make it clear that Congress cannot 
simply stick its head in the sand like an ostrich and pretend 
that the public is not aware or not concerned or simply refuse 
to talk about it because it might hurt sales.
    As a rancher myself and having heard from fellow cattlemen, 
I have personal as well as policy concerns about this disease, 
as well as other related diseases. Colorado is the home of 
12,000 beef producers and 3,150,000, head of cattle. I repeat 
that number because it is more than the human population of 22 
states. Nationwide, Colorado ranks fourth in cattle on feed and 
tenth in overall cattle numbers. Nearly one-third of our 
counties in Colorado are classified as either economically 
dependent on the cattle industry or the industry plays a vital 
role in their economies. Many counties across the country are 
also dependent on the cattle industry.
    Therefore, it is critical that we in Congress do everything 
we can to protect this industry with careful contingency 
planning.
    What we are seeing overseas is a rapid spread of three 
categories of diseases. This hearing deals primarily with the 
first, but I would like to mention a little bit about all 
three. That first category that you spoke about is mad cow 
disease. It is a disease formed by a mutated protein in the 
brain. Even if the infected animal is destroyed, the disease 
can spread through the distribution of cattle feed.
    Animals which are inflicted with the mad cow disease are 
basically cloven-foot animals: cows, sheep, and goats. The 
symptoms which the infected animals exhibit include drooling, 
arching the back, shedding weight, losing balance, waving their 
heads, weaving, and threatening other animals.
    A particularly disturbing aspect of this disease is that it 
can be found to spread to humans, as you know. A recent news 
program included footage of a patient in Europe inflicted with 
mad cow disease and it is certainly a heart-wrenching and 
disturbing sight. But as you also said, so far mad cow disease 
has not been found in the United States ever, not ever.
    But we have had some recent scares that have been portrayed 
pretty graphically in the newsprint and over television, too. 
Just 2 weeks ago, a herd of quarantined sheep in Vermont was 
feared to be infected with that disease. The sheep had come 
from Belgium 3 years ago and might have been fed contaminated 
feed. The USDA seized that herd, as you know, and killed the 
sheep and tested them and they were tested negative. There was 
not any disease in that herd.
    The second herd of quarantined sheep in Vermont was seized 
and also killed and tested. They were also tested negative. 
Then a week ago a herd of cattle in Texas, there was some fear 
that it might have been infected with the same disease. They 
were imported from Germany in 1996, before the 1997 ban was 
placed on the importation of European livestock.
    In all three of those herds, not one animal was found 
infected. There is now, of course, as you know, a ban on 
animals, imported feeds, and products and so on.
    The second category I would like to just mention is just a 
little bit outside the scope of this hearing, but I think 
important, is foot and mouth disease. This disease is known to 
cause blisters and lesions on an animal's tongue, lips, mouth, 
and hoofs. The animals infected show signs of lameness and 
anorexia. The ones that are infected with foot and mouth 
disease are generally the same--cows, sheep, goats, pigs, 
cloven-footed animals--and wild animals such as elk and deer 
can also become infected.
    It does not affect humans, but humans can be carriers 
simply by walking through a contaminated pasture and then 
walking through a fresh pasture where animals are grazing. 
There is no cure for it, but it can run its course in a short 2 
or 3 weeks, and the ones that do survive take about 6 months to 
fully recover. But during that time, if they are dairy herds, 
milk production is affected very significantly and that 
certainly could affect the dairy industry.
    It is just about out of control in England and on the 
European continent, too. The first outbreak of foot and mouth 
disease in England was about 6 weeks ago and today the entire 
country is under quarantine. In the past 3 weeks there have 
been confirmed cases in France, Ireland, and Northern Ireland.
    Fortunately, in the United States the last incident of foot 
and mouth disease was in 1929. But with the ease and speed of 
how viruses travel with all the modern transportation systems, 
a recurrence in the United States certainly is in the realm of 
possibility. In fact, just a few days ago a hog was suspected 
in North Carolina of having foot and mouth disease. It turned 
up negative, as the other tests have turned up, too.
    The third category includes livestock-related disease, such 
as the chronic wasting disease. We are seeing that disease more 
often in Colorado and many of the western states among our 
herds of elk and deer, but it certainly does affect domestic 
livestock, too. It affects the brain and central nervous system 
and causes these animals to lose massive amounts of weight, 
which in turn leads to death. Just 2 days ago, wildlife 
officials in Colorado began killing 300 deer in northeastern 
Colorado to try to control spread of that wasting disease.
    So certainly I believe, as I think you do, that Congress 
must do everything we can to protect the supply of food without 
causing any kind of a panic. I might mention that last Friday 
at the Chicago Board of Trade the markets for livestock and 
grains did drop because of some of these potentially damaging 
rumors--and I mention the word again, ``rumors''--about the 
livestock-related disease in North Carolina. That is I think 
what we should try to avoid.
    We can see this need at the state level and in the private 
sector. Some states are not going to wait for the Federal 
Government to do more to prevent the influx of any of these 
diseases, including mad cow. Colorado, along with North Dakota 
and Montana, have issued emergency directives that impose their 
own restrictions, such as increasing the kinds of animals 
banned or requiring disinfectant baths for certain animals.
    My state, Colorado, went further by broadening the ban to 
include horses and companion animals such as cats and dogs, 
which are not covered by the Federal ban. The Colorado 
restriction will stay in effect until the country from which 
the animals originated are free from that disease for 6 months.
    The private sector is also taking important steps. Recent 
news reports indicate that both Burger King and McDonald's are 
requiring meatpackers the prove that the cattle they buy have 
not been fed with feed containing animal byproducts. Hopefully 
that will assure their customers that their food is safe in 
those chains and I certainly commend them for that.
    I recently introduced Senate Bill 534 on March the 14th of 
this year, which establishes a Federal Inter-Agency Task Force, 
to be chaired by the Secretary of Agriculture, for the purpose 
of coordinating actions to prevent the outbreak of the 3 
categories I mentioned earlier. The agencies in the task force 
will include Agriculture, Commerce, Health and Human Services, 
Treasury, Food and Drug Administration, the National Institutes 
of Health, the Centers for Disease Control, and Customs, and 
other agencies that the President deems appropriate.
    Currently APHIS, the Animal and Plant Health Inspection 
Service, is already working with Federal agencies like Customs 
and a number of others to try to do that. This bill that I 
introduced would expand this Federal effort, formalize the 
creation of a task force, and increase the impact of Federal 
efforts through better cooperation. I think that this bill 
would also require that no less than 60 days after the 
enactment that the task force would submit to Congress a report 
that would describe the actions the agencies are taking and a 
plan to prevent the spread of these diseases and make 
recommendations for the future that we can deal with.
    I certainly look forward to working with this Subcommittee 
in hopes that that bill will get a hearing and it will be 
passed. But clearly, if we fail to take action in some kind of 
swift and timely and prudent manner, we certainly will be 
accused to being a party to how the West was lost.
    With that, Mr. Chairman, I thank you for the time and look 
forward to working with you.
    Senator Fitzgerald. Without objection. We thank you very 
much for coming, Senator, and we will put those materials in 
the record. Can we keep the map here during the rest of the 
hearing?
    Senator Campbell. I am going to stay as long as I can, yes, 
sir.
    Senator Fitzgerald. That is great.
    Senator Burns, you were here first, and then we will go to 
Senator Dorgan.

                STATEMENT OF HON. CONRAD BURNS, 
                   U.S. SENATOR FROM MONTANA

    Senator Burns. Thank you very much, Mr. Chairman.
    I get a big kick in this town. You know, we usually call 
the disease on the farm and ranch ``hoof and mouth,'' but here 
in Washington it is ``foot and mouth.'' There is a little bit 
of a difference, but not much. I will tell you that.
    Mr. Chairman, thank you for this hearing. It is important, 
I think, that we recognize one thing as we hear from our 
witnesses today. When the first instance of mad cow disease in 
1985 broke out, many states, and especially our Department of 
Agriculture, took note of that and reacted immediately. I want 
to congratulate those folks in the livestock business, who did 
not let one instance go by without us taking precautions to 
protect our own herds and our own consumers in this country. We 
started to put things into motion right away, and in fact it 
was just 4 years later in 1989 when we banned all imports from 
the countries where BSE was known to have been. Of course, with 
95 percent of that disease being in the U.K., it was fairly 
easy to localize and to prevent that from spreading in the 
United States.
    The European Community did not take the precautions at the 
same time that we did and naturally it did spread into Germany 
and into France. But they still do not have the problem that 
the U.K. has.
    So I am here this morning to say congratulations on our 
agencies, who reacted immediately, as they always do. I realize 
that coming back from overseas, some of our international 
travelers have to spend a little more time getting through 
Customs, dealing with the Agriculture Department and filling 
out those questions and going through some procedures if they 
were known to hike or to participate in activities where you 
were in contact with the agricultural areas of the U.K. or in 
Europe. But it was a necessary thing, and we are very, very 
aware of just how important it is that we react now to these 
type of things.
    So this hearing should be very enlightening. We do not have 
one single case in the United States, due to the action and the 
reaction of our agencies right away whenever the situation 
broke out in the U.K.
    Thank you for having this hearing this morning. I look 
forward to hearing from the witnesses.
    Senator Fitzgerald. Thank you, Senator Burns.
    The Ranking Member, Senator Dorgan.

                STATEMENT OF HON. BYRON DORGAN, 
                 U.S. SENATOR FROM NORTH DAKOTA

    Senator Dorgan. Mr. Chairman, thank you very much.
    Senator Campbell, thank you for your testimony. The point 
that you made is an important one: There is no mad cow disease 
in this country. We have had surveillance for some 10 years, 
and it seems to me that only by aggressive steps we can make 
sure that we prevent the spread of mad cow disease into the 
United States and protect the interests of both livestock 
producers and also consumers.
    All of us represent consumers. Some of us represent 
livestock producers. So there is a kind of a natural tension in 
hearings like this, only because some are worried that if you 
hold a hearing of this type you sort of spread the alarm. Yet 
at the same time, all of us recognize, including those in the 
livestock industry, that we must take aggressive steps always 
to be sure that we prevent the spread of diseases like this and 
we protect both the livestock industry and consumers.
    The livestock industry, of course, would be devastated in 
this country, as it has been in some parts of Europe, by the 
spread of this disease. But much more important in many ways, 
it puts many consumers at risk. Senator Campbell, you held up 
Newsweek and I brought it over as well: ``Mad Cow Disease, the 
Slow Deadly Spread.'' One would conclude from this that mad cow 
disease is rampant in the United States. Of course, it is not. 
There is not one case reported of mad cow disease in this 
country.
    But it is paramount that we have a safe food supply. To do 
that in a global economy is becoming more and more difficult. 
Senator Campbell, you have taken the lead on legislation and I 
also have joined you, both on legislation and in a letter to 
President Bush suggesting that he create an inter-agency task 
force to coordinate all the steps that we need to be taking, 
both with respect to mad cow disease and also foot and mouth 
disease, and to help prevent the spread of that to our shores. 
I appreciate your leadership on that.
    But we also should think through the proposition of the 
need for additional resources for food inspection. When you 
understand that we have a global economy and we have shut off 
the shipment of cattle from England, for example, since 1985 
dealing with this issue, it is reasonable to ask the question, 
however, if we are moving cattle in from Canada and Mexico, how 
are those cattle being fed?
    We say to our producers, for example, that they must sign 
affidavits and go through a regimen, which I support, with 
respect to their cattle. Yet in a global economy we have cattle 
coming across our border in several different directions, and 
the legitimate question is how are those cattle being fed, with 
approved feeds or with feeds that include organ material from 
dead cattle?
    I just think that we need to do a lot in a lot of areas. I 
would encourage the President to form an inter-agency task 
force. I support the leadership of Senator Campbell and many 
others here in the Senate and am pleased to work with them, and 
hope that this hearing will provide a substantial amount of 
information for the American people and for the Congress, and I 
hope it provides us some additional avenues in which we can 
produce more dollars for research and also for testing and 
ensuring food safety in this country.
    It is my hope that we can look back in a rear view mirror 
10 and 20 years from now and say that mad cow disease did not 
spread to this country because we took the right and aggressive 
steps, on behalf of the American consumer and on behalf of our 
livestock industry to prevent its spread to this country.
    Senator Fitzgerald. Senator Dorgan, thank you.
    Senator Brownback, if you have an opening statement.

               STATEMENT OF HON. SAM BROWNBACK, 
                    U.S. SENATOR FROM KANSAS

    Senator Brownback. Yes, I do. Thank you very much, Mr. 
Chairman and thank you for calling the hearing.
    I first want to congratulate and thank my colleague Senator 
Campbell for putting forth this bill. I am a co-sponsor of it. 
I think it is a good measure for us to put forward. And Senator 
Durbin, for your participation and work on this.
    This is a big issue in my state, as you might guess, with 
the number of cattle that we have on feed and the beef 
processing industry. I was Secretary of Agriculture in the 
state for 6 years. My family farms. I talked to my brother last 
night about the cattle that he runs and he is deeply concerned.
    I want to make sure, though, that we know that this is not 
taking place in this country, that our food supply is safe, as 
Senator Dorgan noted, because what tends to take place is as 
these get on the front page of magazines and newspapers here is 
people think, ``Well, this is in America.'' It is not in 
America. If we take the right steps, aggressive steps, it is 
not going to come to America. We are going to keep it out of 
this country, so that the food supply, the meat supply in 
America, is safe. It is very safe. It is a high quality, well 
maintained, high produced food supply that is in this nation.
    So I think these are important things for us to do to be at 
the very outset quite aggressive on making sure that BSE does 
not ever hit our shores. I was recently in Dodge City, Kansas. 
In their feed yards, 50,000-70,000 head of cattle, people are 
deeply concerned and taking every precautionary step to make 
sure that nothing like this gets anywhere close.
    I am glad to see Customs Service stepping up. USDA is 
stepping up. So I hope this hearing, Mr. Chairman, actually can 
be used to do two things. One is to make sure we are doing 
everything we possibly can as a government in supporting the 
Campbell bill to do that.
    The second, Mr. Chairman, is to tell the consumers of 
America this is not in America. The meat supply in this country 
is safe, and we are going to do everything we possibly can to 
maintain the safety of the meat supply, and it is going to be 
maintained. We could do both, I think, service to both areas if 
we emphasize what needs to continue to be done and recognize 
what is being done and also tell the country that the meat 
supply in this nation is safe.
    Mr. Chairman I would ask as well unanimous consent that my 
full opening statement be submitted to the record as if read.
    [The prepared statement of Senator Brownback follows:]
               Prepared Statement of Hon. Sam Brownback, 
                        U.S. Senator from Kansas
    Mr. Chairman, thank you for holding this hearing on such an 
important topic. The recent European outbreak of Bovine Spongiform 
Encephalopathy--a disease affecting the brain and nervous system in 
livestock, has stirred concerns at home about efforts to protect our 
food supply. This is a serious issue since the disease can fatally 
affect humans who eat contaminated meat. The fact that the U.S. has not 
suffered the fate of Europe thus far, is not luck--too often we take 
for granted the strong safety precautions put into place by USDA, FDA 
and other Federal agencies to ensure we have the safest food supply in 
the world.
    That being said, we can never be too safe. When the stakes are as 
high as they are with this disease--possible contamination of our food 
supply and loss of consumer confidence in our food safety process--we 
cannot afford to rest on our laurels. This is particularly true because 
an outbreak in the U.S., where livestock production is concentrated in 
the middle of the country, would cause significantly more damage than 
it has in Europe. This is why I joined with Sen. Campbell in co-
sponsoring legislation to coordinate across different government 
agencies to make sure we are taking all possible precaution. I am 
specifically interested in making sure that Customs is doing all it can 
to more closely inspect travelers from Europe given the circumstances. 
I am also curious to hear from FDA regarding the role they currently 
play in this issue and the additional measures that you have identified 
as necessary safeguards.
    It is important that we examine this issue carefully, and stick to 
the facts. There is a tendency to sensationalize stories like this--but 
that does not bring us closer to the solution. BSE is something we 
should take seriously and continue to strive to prevent its spread. 
However, it is wrong to give the American public the impression that 
our meat supply is in immediate danger from this disease, that American 
meat is in any way unsafe--or that our government is not taking the 
threat seriously. Farmers, food processors, inspectors and consumers 
are all on the same side on this issue: we all want to maintain the 
safest food supply in the world. I hope this hearing will help us 
continue to reach for this goal.
    I applaud USDA for taking the precautionary measures which have 
helped keep these diseases out of the U.S. so far. Your current 
practice of banning meat imports from countries dealing with this 
disease is an important first step. I would also encourage you to make 
any recommendations to us that you feel will assist you in tackling 
this disease.
    If there are any additional resources you need to tackle this 
issue, we ask that you identify them and respond to us promptly. Again, 
I support the action that USDA has already taken and I encourage even 
more aggressive steps to prevent and prepare for the continued 
protection of our food supply.
    Thank you for coming and I look forward to the information you will 
provide for us.

    Senator Fitzgerald. Without objection. Thank you, Senator 
Brownback.
    Senator Brownback. Thank you.
    Senator Fitzgerald. Senator Durbin, thank you very much for 
coming and we welcome your remarks.

             STATEMENT OF HON. RICHARD J. DURBIN, 
                   U.S. SENATOR FROM ILLINOIS

    Senator Durbin. Thank you very much, Mr. Chairman. I 
appreciate the opportunity to join this morning in this 
important hearing.
    Mad cow disease, more properly known as BSE, has really 
grabbed the attention of the whole world, as Senator Dorgan, 
you and others have noted. We have seen these awful scenes in 
Europe, video clips of trembling cows barely able to move or 
even feed themselves, images of teenagers wasting away from a 
mysterious illness linked to eating contaminated beef, pictures 
of millions of head of cattle destroyed in hopes of stopping 
the spread of this terrible disease.
    My message here today, my reminder to the American people, 
as the panel as said: These are European scenes. Europe is 
afflicted with BSE. We are not. Europe is suffering from hoof 
and mouth disease. We are not. Europe has cases of vCJD, the 
human illness related to BSE. We do not.
    The United States has long had the safest food supply in 
the world. We owe this to the expertise of our farmers and to 
the safety consciousness of the food industry and to the 
Federal Government in its regulatory capacity. We owe it as 
well to having the world's best system of regulation and 
oversight for food safety.
    Hoof and mouth was eradicated in the United States in 1929 
and has not been seen since. BSE, first identified in Britain 
in 1986; 15 years later, neither the animal nor the human 
version of this has ever occurred to our knowledge in the 
United States. Our vigilance has paid off and will continue to 
provide us an unparalleled degree of protection.
    At the same time, though, we have to acknowledge how 
dramatically the food system has changed. The globalization of 
commerce has affected our food supply as radically as any other 
commodity. Automobiles or clothes or computers purchased here 
in the United States are put together with components from all 
over the world. So are our food products. We have become used 
to buying fresh grapes in the middle of winter. It is easy to 
forget those grapes have crossed thousands of miles and several 
national borders before coming to rest in our supermarkets. 
Animals are shipped worldwide, as are animal products and 
animal feeds.
    As the complexity of international trade in food and feed 
products has multiplied, so too have the demands on our food 
safety system. Federal agencies have not always responded as 
fully as they might.
    Last year, in response to my request, the General 
Accounting Office reported widespread noncompliance with many 
of the measures put in place the protect our country from BSE. 
Noncompliance rates as high as 28 percent were reported in some 
segments of the industry, with virtually no enforcement 
response from the Food and Drug Administration. Although the 
compliance picture has improved somewhat, there is still need 
for additional safety measures.
    I will be introducing soon the National Food Security and 
Safety Act to better fortify our nation's defenses against BSE 
and other related animal diseases. This legislation will 
strengthen our three primary firewalls against BSE: First, our 
national borders. The National Food Security and Safety Act 
will update information requirements on imported foods and 
feeds so that Federal agents at the border will not have to 
play a guessing game as to whether a product does or does not 
contain meat and, if it does, whether that meat is from a cow 
or from a country where BSE is known to occur.
    This information, which is not currently required, limits 
the ability of inspectors at the border to keep out unsafe 
foods. Governor Perry of Texas has called for intensified 
inspections at our border to ensure the safety of our livestock 
and our food supply. More than 3 billion pounds of meat 
products enter our country every year. The provisions of my 
bill will allow for much more focused and effective inspections 
of these imports.
    No. 2, protection of food and feed supplies. BSE and 
similar diseases are known to concentrate in the central 
nervous system of ruminant animals such as cows and sheep. So 
why do we continue to feed these tissues to animals or, for 
that matter, to people? My bill eliminates ruminant nerve 
tissue from both the human food and animal feed supply. It also 
prohibits the use of material from any animal with symptoms of 
neurological disease.
    I am also proposing to expand the current feed ban so that 
at the very least ruminant animals are not eating feed that 
contains any material--blood, bone, or fat--anything from other 
ruminants. The bill would put in place a certification program 
that makes use of the best in class certification programs 
already in place. I am also evaluating a further extension to 
the feed ban so that ruminant feed does not contain an animal-
derived materials.
    Third, surveillance. My bill calls for the creation of a 
national task force, as others on the panel have suggested, to 
report back to Congress on priorities for conducting the best 
possible surveillance program for detecting BSE and related 
diseases as a means of further ensuring that these diseases are 
not present in the U.S. in either livestock or in humans.
    The fourth is non-food products, and I think we often 
overlook this. In addition to better protecting the food 
supply, we need to remember that animal products are used in 
many non-food items, including supplements, cosmetics, and 
medicines. For instance, pharmaceutical companies sometimes use 
blood or fetal calf material in the production of vaccines. My 
bill would make mandatory several strategies that are widely 
recognized to provide an appropriate measure of safety, but not 
always practiced.
    A colleague of mine recently visited a major drug company 
in his district and came to learn that one of their miracle 
drugs depended on the intestine of sheep that were being raised 
in Scotland. These sheep now are being protected with a mile-
and-a-half quarantine around the farm, for if they are 
ultimately destroyed it will have devastating impact, not only 
on this pharmaceutical company, but also on the people who 
depend on this important drug.
    Science is central to our food safety system and we have 
got to make sure that the best scientific information available 
to industry and to Federal agencies is there. It has been the 
best, most trustworthy guide to keeping our food supplies safe. 
The National Food Security and Safety Act empowers agencies to 
make changes or exemptions to the bill's requirements when such 
an action is justified by sound science.
    Let me conclude by saying that I have one other issue that 
I think frankly relates directly to what we are discussing at 
this hearing. That is the fact that because of a number of 
factors, we have perhaps the safest food in the country, the 
safest food system, I should say, in protecting the food in our 
country, but we also have an incredible proliferation of 
Federal agencies that are responsible. Some 12 different 
Federal agencies have jurisdiction over the safety of food in 
America, some 35 different laws.
    Senator Charles Percy of Illinois had a hearing in the 
1960s asking that we finally consolidate all of our food safety 
inspection into one scientifically driven agency. I have 
legislation to accomplish that, and I am trying to encourage my 
colleagues, when they step back from food safety issues, to 
realize that unless we can put aside the competition of Federal 
agencies, of committees of jurisdiction, and of special 
interests downtown, and finally come up with one agency that 
makes sense, we will continue to have this piecemeal approach.
    The American people expect a lot more. To suggest that if a 
pizza has pepperoni on it it is the U.S. Department of 
Agriculture's responsibility, but if it is a cheese pizza it is 
the Food and Drug Administration's responsibility, is a little 
hard to explain in Illinois or anywhere in this country.
    So I hope that as part of this conversation about food 
safety we will look at mad cow disease, the imminent problem, 
but also realize we have a larger problem that should be 
addressed with bipartisan cooperation.
    Thank you, Mr. Chairman.
    [The prepared statement of Senator Durbin follows:]
             Prepared Statement of Hon. Richard J. Durbin, 
                       U.S. Senator from Illinois
    Mr. Chairman, thank you very much for the opportunity to speak here 
this morning.
    Mad cow disease--more properly known as BSE--has grabbed the 
attention of the whole world. We've all seen the awful scenes in 
Europe. Video clips of trembling cows, barely able to move, or even 
feed themselves. Images of teenagers wasting away from a mysterious 
illness linked to eating beef. Pictures of millions of head of cattle 
destroyed, in hopes of stopping the spread of a terrible disease.
    My message here today--my reminder to the American people--is that 
these are European scenes. Europe is afflicted with BSE. We are not. 
Europe is suffering from foot and mouth disease. We are not. Europe has 
cases of vCJD--the human illness related to BSE. We do not.
    The United States has long had the safest food supply in world. We 
owe this to the expertise of our farmers and to the safety-
consciousness of the food industry. We owe it, as well, to having the 
world's best system of regulation and oversight for food safety.
    Foot and mouth was eradicated in the U.S. in 1929 and has not been 
seen since. BSE was first identified in Britain in 1986. Fifteen years 
later, neither the animal nor the human version of this disease has 
ever occurred in the U.S. Our vigilance has paid off, and will continue 
to provide us an unparalleled degree of protection.
    At the same time, we need to acknowledge how dramatically the food 
system has changed. The globalization of commerce has affected our food 
supply as radically as any other commodity. Automobiles or clothes or 
computers purchased here in the U.S. are put together with components 
from all over the world. So are our food products.
    We've become so used to buying fresh grapes in the middle of 
winter, that it's easy to forget those grapes may have crossed 
thousands of miles--and several national borders--before coming to rest 
on the supermarket shelves. Animals are shipped worldwide, as are 
animal products and animal feeds.
    As the complexity of international trade in food and feed products 
has multiplied, so too, have the demands on our food safety system. 
Federal agencies have not always responded as fully as they might.
    Last year, in response to my request, the General Accounting Office 
reported widespread non-compliance with many of the measures put in 
place to protect our country from BSE. Non-compliance rates as high as 
28 percent were reported in some segments of the industry, with 
virtually no enforcement response from FDA. Although the compliance 
picture has improved somewhat, there is need for additional safety 
measures.
    For that reason, I will soon be introducing the National Food 
Security and Safety Act to better fortify our nation's defenses against 
the introduction of BSE and related animal diseases. This legislation 
will strengthen our three primary firewalls against BSE.
                         one: national borders
    The National Food Security and Safety Act will update information 
requirements on imported foods and feeds so that Federal agents at the 
border will not have to play a guessing game as to whether a product 
does or does not contain meat, and if it does, whether that meat is 
from a cow or from a country where BSE is known to occur.
    This information, which is not currently required, limits the 
ability of inspectors at the border to keep out unsafe foods. Governor 
Perry of Texas has called for intensified inspections at our borders to 
insure the safety of our livestock and food supply. More than three 
billion pounds of meat products enter our country every year. The 
provisions in my bill will allow for much more focused and effective 
inspections of these imports.
                 two: protecting food and feed supplies
    BSE and similar diseases are known to concentrate in the central 
nervous system of ruminant animals such as cows or sheep. So why do we 
continue to feed these tissues to animals, or for that matter, to 
people? My bill eliminates ruminant nerve tissue from both the human 
food and animal feed supply. It also prohibits the use of material from 
any animal with symptoms of a neurological disease.
    I am also proposing to expand the current feed ban so that, at the 
very least, ruminant animals are not eating feed that contains any 
material--blood, bone, fat-- anything from other ruminants. The bill 
would put in place a certification program that makes use of the best-
in-class certification programs already in place.
    I am also evaluating a further extension of the feed ban so that 
ruminant feed does not contain any animal-derived materials.
                          three: surveillance
    My bill calls for the creation of a national task force to report 
back to Congress on priorities for conducting the best possible 
surveillance program for detecting BSE and related diseases, as a means 
of further insuring that these diseases are not present in the U.S. in 
either livestock or in humans.
                           non-food products
    In addition to better protecting the food supply, we need to 
remember that animal products are used in many non-food items, 
including supplements, cosmetics, and medicines. For instance, 
pharmaceutical companies sometimes use blood or fetal calf material in 
the production of vaccines. My bill would make mandatory several 
strategies that are widely recognized to provide an appropriate measure 
of safety, but are not always practiced.
                                science
    Central to our food safety system has been the application of the 
best scientific information available to industry and to Federal 
agencies. Science has been the best, most trustworthy guide to keeping 
our food supply safe. The National Food Security and Safety Act 
empowers agencies to make changes or exemptions to the bill's 
requirements when such an action is justified by sound science.
    By updating and expanding our food safety system, the U.S. food 
supply will continue to be the safest in the world.

    Senator Fitzgerald. Thank you, Senator Durbin and Senator 
Campbell. Thank you both for coming.
    We will go to our first panel of expert witnesses. We have 
Dr. Richard Johnson, who is a Special Advisor at the National 
Institute of Neurological Disorders and Stroke at the National 
Institutes of Health; Dr. Alfonso Torres, Deputy Administrator 
for Veterinary Services at the USDA; Dr. Stephen Sundlof, 
Director of the Center for Veterinary Medicine at the FDA; and 
also Dr. Will Hueston, a Doctor of Veterinary Medicine, 
University of Maryland, the Virginia-Maryland Regional College 
of Veterinary Medicine.
    So we have a panel made up exclusively of doctors.
    Doctors, welcome. Thank you all for coming.
    Dr. Johnson, if you would like to begin. We are going to 
limit each of you to 5 minutes. We ask if you could not read 
prepared remarks, but instead summarize as best you can your 
testimony within the 5 minutes allotted. Thank you.
    Dr. Johnson.

        STATEMENT OF RICHARD T. JOHNSON, M.D., SPECIAL 
          ADVISOR, NATIONAL INSTITUTE OF NEUROLOGICAL 
      DISORDERS AND STROKE, NATIONAL INSTITUTES OF HEALTH

    Dr. Johnson. Thank you, Mr. Chairman. Good morning. I want 
to thank you for asking me to talk on the transmissible 
spongiform encephalopathies or, as I will call them from now 
on, TSEs. My name is Richard T. Johnson. I am a board-certified 
Neurologist and a Professor of Neurology, Microbiology, and 
Neuroscience at Johns Hopkins University School of Medicine and 
at the School of Public Health and Hygiene. I am also a special 
consultant to the National Institutes of Health on TSEs.
    The diseases are a series of fatal neurodegenerative 
diseases, uniformly fatal, that show distinct brain pathology 
of spongiform changes. Hence the name, the title. They are 
transmissible to other species, the same species, and at times 
across species. They have long incubation periods, sometimes 
over decades. And they are due to an unusual agent which has 
been termed a prion. This is probably an abnormal folded 
protein, as was mentioned by Senator Campbell.
    The animal TSEs include bovine spongiform encephalopathy--
that is BSE or mad cow disease--scrapie in sheep, which has 
been recognized for hundreds of years, and varying recent forms 
which have been identified in cats, mink, elk, deer, exotic zoo 
animals.
    In humans, the Creutzfeldt-Jakob disease is the most 
important, and there is the recent distinct variant of this 
disease called variant Creutzfeldt-Jakob disease, which seems 
to have a common origin with BSE and has been limited to 
England and several cases in France. Creutzfeldt-Jakob disease 
as we know it here in the United States is a rare disease. It 
occurs about one million per population per year, and therefore 
we have about 200 cases per year in the country. 90 percent of 
these occur sporadically, without any known exposure or any 
known origin. 10 percent are genetic diseases and are 
inherited, usually as a dominant gene.
    In the early stage of the disease there is loss of 
cognition, there are a variety of motor abnormalities that 
occur, characteristically monotonic jerking, a rapid 
progressive descent without remission, usually leading to death 
in a period on average of about 4 to 5 months. 90 percent are 
dead within 12 months. So it is a rapidly progressive pre-
senile dementia. The average age death is 67 in this country.
    Now, the variant CJD is a very different disease, what has 
been seen in England. It is a disease that is clinically and 
pathologically distinct and the more it is studied the more 
distinct it appears. The average age of death is 29. The 
average from the beginning of the disease--the average 
survival, median survival, is 14 months instead of 4 or 5.
    Pathologically, the symptomatology is different and 
pathologically there is far different deposition of this 
abnormal protein in the brain in very characteristic patterns.
    Now, as of April the 2nd the United Kingdom had reported 97 
probable or confirmed cases of deaths from variant CJD. There 
have been two or three in France. There have been none in the 
United States. The timing of the cases in England make them 
appear to relate to the BSE epidemic and, furthermore, the 
nature of the agents transmitted to mice from the cattle in the 
BSE epidemic and from the patients with variant Creutzfeldt 
disease appear to be the same. So there seems to be an identity 
of the agents.
    BSE is not restricted, of course, to the U.K. since it has 
now been reported in France, Portugal, Germany, Spain, the 
Republic of Ireland, but there have been no cases of BSE in the 
United States.
    Where did it come from? One theory is that it came from 
scrapie, the sheep disease, which has not been shown to be 
transmissible to humans, and the practice of feeding rendered 
carcasses to livestock--including sheep--to cattle, as a 
protein-rich supplement. There were changes in the rendering 
industry in about 1980 which may have led to the removal of 
solvents, change in the composition of the bone meal, which may 
have led to this movement of the agent across the species.
    It may also be that cattle spontaneously develop the 
disease and that hypothesis is out there and unproven.
    If variant VD is related to the consumption of meat, why 
have not more people come down? Why have there been only 97? 
The difference is probably exposure to dosage, what one has 
been exposed to, and the species barriers which we know these 
diseases have, such as scrapie, which has never been 
transmitted to humans, and there are also genetic factors that 
are now becoming clear that predispose people. There is one 
particular gene--there is one particular area in the prion 
genome which has been found to be consistent in those 97 in 
England that have come down.
    I know you have a keen interest in measures being taken to 
prevent it. An essential part of that are efforts for the 
detection and diagnosis. There are ongoing studies on the 
biology of prions being carried on, supported by the National 
Institutes of Health, and there is recently a major effort to 
develop contracts to develop pre-symptomatic testing so that 
animals going to market or people before getting ill can be 
tested for the disease.
    This concludes my testimony. I would be pleased to answer 
any questions.
    [The prepared statement of Dr. Johnson follows:]
   Prepared Statement of Richard T. Johnson, M.D., Special Advisor, 
   National Institute of Neurological Disorders and Stroke, National 
                          Institutes of Health
    Mr. Chairman and members of the subcommittee, good morning, and 
thank you for inviting me to speak to you about the transmissible 
spongiform encephalopathies, referred to as TSEs. My name is Dr. 
Richard T. Johnson. I am a board-certified neurologist with 
appointments in the Departments of Neurology, Molecular Biology and 
Genetics, and Neuroscience at The Johns Hopkins University School of 
Medicine. I also hold a joint appointment in the Department of 
Molecular Microbiology and Immunology at The Johns Hopkins University 
School of Hygiene and Public Health. My professional expertise is 
primarily in the fields of neurology, neuroimmunology, and 
neuropathology, and in 1986-87, I served as the primary neurology 
consultant for a Public Health Service interagency epidemiological 
study of human growth hormone and Creutzfeldt-Jakob Disease. I am 
currently serving as an expert consultant to the National Institute of 
Neurological Disorders and Stroke and to the National Institutes of 
Health on the TSEs.
    The TSEs are fatal neurodegenerative diseases of humans and 
animals. They share a characteristic brain pathology which has the 
appearance of ``spongy'' holes in the brain; a long incubation period--
sometimes decades long; and the probable causative agent--proteinaceous 
infectious particles--known as ``prions.'' Prions are transmissible 
particles that are devoid of nucleic acid and seem to be composed 
exclusively of a modified protein. According to the prion hypothesis, 
an abnormal conformation, or folding, of the normal protein carries the 
disease, and recruits normal prion proteins to the harmful 
conformation. The notion of an infectious agent that lacks the nucleic 
acids--the molecules which carry hereditary traits from one generation 
to the next and trigger the production of specific proteins--is 
revolutionary, but the preponderance of scientific evidence supports 
this hypothesis.
    Animal TSEs include bovine spongiform encephalopathy, known as BSE 
or ``mad cow disease,'' scrapie in sheep, and varying forms which occur 
in cats, mink, elk, deer, and exotic zoo animals. Creutzfeldt-Jakob 
disease, known as CJD, is the most common human TSE; other lesser known 
and rarer human forms include Fatal Familial Insomnia and Kuru. A 
distinct new variant form of CJD--vCJD--has been recognized only since 
1996, the onset of illness in the first case having occurred in early 
1994. I will briefly discuss the symptoms, incidence, and likely routes 
of transmission of classic CJD first, and then discuss variant CJD and 
its link with BSE.
    In the early stages of the disease, CJD patients may have failing 
memory, behavior changes, impaired coordination and visual 
disturbances. As the illness progresses, mental deterioration becomes 
pronounced, and involuntary movements, blindness, weakness of 
extremities, and, ultimately, coma may occur. CJD usually becomes 
apparent in later life, and the disease typically leads to death within 
1 year following the onset of symptoms--in the United States, the mean 
age of death is 67 years.
    CJD, while the most common human TSE, is still very rare; it 
afflicts only about one in a million people each year. About 90 percent 
of these cases are sporadic--meaning they appear to occur 
spontaneously, about another 10 percent are an inherited genetic 
disorder, and less than 1 percent are transmitted. The failure to find 
increased incidence of CJD in persons who have come into even close and 
regular contact with CJD patients suggests the disease is not 
contagious through normal routes. However, inadvertent human-to-human 
transmission has been reported from corneal transplantation; direct 
contact with contaminated medical and surgical instruments; inoculation 
of growth hormone prepared from contaminated cadaver pituitary glands; 
and grafts of dura mater--the tough fibrous membrane covering the brain 
and the spinal cord and lining the inner surface of the skull--obtained 
from cadaveric donors who had unsuspected CJD.
    Variant CJD is also fatal, but is clinically and pathologically 
distinct from classic CJD. Clinically, vCJD patients have an earlier 
age of onset--mean age at death is 29 years compared to 67 years in 
CJD. They usually present with behavioral changes, loss of the ability 
to coordinate muscular movements, and peripheral sensory disturbances 
such as loss of sensation, rather than changes in mental activity and 
thinking ability, and do not show the usual brain wave activity changes 
of CJD. Variant CJD patients have a longer duration of illness from 
onset of symptoms to death--median survival is 14 months in vCJD 
compared to 4 months in CJD. Pathologically, an unusual form of plaque 
is present in the brains of people with vCJD: a florid or ``daisy'' 
plaque in which an amyloid core--a hard, waxy deposit that results from 
the degeneration of tissue--is surrounded by ``petals'' of spongiform 
change.
    As of April 2, 2001, the UK has reported 97 probable or confirmed 
cases of deaths from vCJD since 1995, and a few more have been reported 
in continental Europe. No cases of vCJD have been reported in the 
United States. Because of the timing of the appearance of vCJD in the 
UK in relation to the BSE epidemic, a link between the two diseases was 
deemed likely. So, I will briefly discuss BSE and the evidence in 
support of this link, as well as the concerns it raises.
    We do not know exactly how BSE, or ``mad cow disease'' as it 
frequently referred to in media reports, originated, but we do know 
with some certainty how it spread and reached epidemic proportions in 
the UK. As explored in an article by Dr. Paul Brown and others in the 
January-February 2001 volume of the journal, Emerging Infectious 
Diseases, one theory for the origin of BSE is that it originated from 
scrapie, an endemic TSE of sheep and goats that has been recognized in 
Europe since the mid-18th century, and has since spread to most sheep-
breeding countries. Until 1988 in the UK, the rendered carcasses of 
livestock, including sheep, were fed to ruminants, such as cattle, and 
other animals as a protein-rich nutritional supplement. Although not 
proven, it appears likely that changes in the UK's rendering process 
around 1980 allowed the causative agent in infected carcasses to 
survive, contaminate the protein supplement, and infect cattle. Cattle 
carcasses and carcass wastes were then recycled through the rendering 
plants, increasing the levels of the now cattle-adapted pathogen in the 
protein supplement and eventually causing a full-scale BSE epidemic. An 
alternative explanation, proposed in the recent UK ``Report of the BSE 
Inquiry'' which investigated the emergence and identification of BSE 
and vCJD, is that a spontaneous disease-causing mutation occurred in 
cattle in the 1970s. Either of these hypotheses satisfies the need for 
a causative agent to survive the altered rendering process, and to 
escalate through recycling of an ever-larger number of infected 
carcasses.
    BSE is not restricted to the UK; cases have been reported in 
France, Portugal, Germany, Spain, and the Republic of Ireland, among 
others, probably as a result of imported live animals or livestock food 
supplements. However, no documented case of BSE has occurred in the 
United States or other countries that have historically imported little 
or no live cattle, beef products, or livestock nutritional supplements 
from the UK, even though rendering procedures in other countries 
underwent changes similar to those in the UK during the late 1970s.
    While there were concerns about human infection resulting from the 
BSE epidemic, these were generally allayed by the presumption that BSE 
originated from scrapie, and scrapie was not a human pathogen. UK 
surveillance and epidemiological studies further muted these concerns. 
During the 10 years after the first case of BSE was identified, cases 
of CJD in the UK did not increase in groups at high risk, and continued 
to occur in the general population at the same rate and with the same 
spectrum of clinical and neuropathologic features as before the 
appearance of BSE. However, then the onset of the variant form started 
to appear in 1994, and the suspected link between BSE and vCJD has now 
been convincingly established. Laboratory studies have shown the 
distinctive biological and molecular features of the pathologic agent 
isolated from BSE-infected cattle and human cases of vCJD to be 
identical. The source of transmission appears to have been beef, with 
infection most probably resulting from consumption of beef products 
contaminated by nervous system tissue.
    Although the amount of infectious tissue ingested is probably a 
critical factor in the transmission of BSE to humans in the form of 
vCJD, a human genetic susceptibility in the prion protein gene--PRNP--
appears to play an important role in infection. It is possible that a 
very specific genetic constitution, or genotype, is necessary for BSE 
to be able to replicate in a human as vCJD. It is also possible that 
certain variations of this susceptible genotype are comparatively 
resistant to the disease, and only become ill after longer incubation 
periods. As noted in Dr. Brown's recent article cited above, the 
difference between the incidence of BSE and vCJD may be due to limited 
exposure to very small infectious doses that, except in genetically 
susceptible persons, cannot surmount the combined effects of a species 
barrier--from cattle to human--and a comparatively inefficient route of 
infection--the digestive tract as opposed to direct central nervous 
system contact. On the other hand, the ultimate extent of the vCJD 
outbreak is unknown largely because the incubation period for vCJD is 
unknown.
    Mr. Chairman, I know that you have an appropriately keen interest 
in measures being taken to prevent the occurrence and propagation of 
BSE in the United States. An essential aspect of any such preventive 
efforts is detection and diagnosis, the precision of which can only 
extend as far as our understanding of the nature of the disease. The 
NIH has a long history of research on the TSEs. This is reflected in 
the awarding of the 1976 Nobel Prize for intramural work begun in the 
1950s that established the transmissibility of these diseases, and of 
the 1997 Nobel Prize for extramural work on the prion theory. Recent 
and ongoing studies address many aspects of TSEs and prion biology 
including the normal functions of the prion protein, animal models of 
TSEs, the molecular mechanisms of prion diseases, the role of genetics, 
and exploratory studies of therapeutic strategies. Finally, a major 
contract effort is working to develop presymptomatic tests.
    This concludes my testimony. I would be pleased to respond to any 
questions you might have.
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    Senator Fitzgerald. Well, Dr. Johnson, thank you very much.
    We will go through all the panelists and then we will go to 
the question portion of this hearing.
    Dr. Torres.

     STATEMENT OF ALFONSO TORRES, DEPUTY ADMINISTRATOR FOR 
            VETERINARY SERVICES, U.S. DEPARTMENT OF 
         AGRICULTURE; ACCOMPANIED BY: LINDA DETWILER, 
 SENIOR STAFF VETERINARIAN, ANIMAL AND PLANT HEALTH INSPECTION 
                         SERVICE, USDA

    Dr. Torres. Good morning, Mr. Chairman and Members of the 
Subcommittee. Thank you for the opportunity to speak on behalf 
of the U.S. Department of Agriculture and my agency, the Animal 
and Plant Health Inspection Service, on the activities that we 
conduct in prevention of BSE coming into the United States.
    My name is Alfonso Torres. I am the Deputy Administrator 
for Veterinary Services. I also serve as the Chief Veterinary 
Officer of the United States before the International Office of 
Epizootics, which is the WTO unit that provides the 
international standard-setting for----
    Senator Fitzgerald. Dr. Torres, could you pull the 
microphone more directly in front. That is better, thank you.
    Dr. Torres. Sorry, Senator.
    As has been mentioned before, BSE is now affecting 13 
additional European countries in addition to the United 
Kingdom. APHIS has taken comprehensive and stringent measures 
for prevention, education, surveillance, and response in 
cooperation with USDA's Food Safety and Inspection Service, 
FSIS, and the FDA.
    To prevent BSE from entering the United States, APHIS has 
prohibited the importation of live ruminants from countries 
where BSE is known to exist in native cattle, starting in 1989. 
Other products derived from ruminants, such as fetal bovine 
serum, meat and bone meal, or offal, fats, and glands, are also 
prohibited from entry.
    In December 1997, APHIS extended these restrictions to 
include all of the countries in Europe due to concerns, 
widespread risk factors, and inadequate surveillance for BSE in 
those countries. As of December 2000, USDA prohibited all 
imports of rendered animal protein products, regardless of 
species, from Europe to prevent potentially cross-contaminated 
products from entering the United States.
    USDA also works very closely with other Federal agencies 
involved in the prevention of BSE introduction. For the past 5 
years, USDA agencies including APHIS, FSIS, the Agricultural 
Research Service, and the Cooperative State Research, Education 
and Extension Service have worked closely with CDC and the FDA 
on technical issues regarding TSEs. In addition, APHIS 
officials work with representatives from these agencies and our 
Canadian and Mexican counterparts on a tripartite TSE working 
group.
    As part of USDA's surveillance program for BSEs, we have 
examined the brains of cattle with neurological or ambulatory 
signs for the possibility of BSE. As of February 28th this 
year, brains from 12,212 high-risk animals in the United States 
have been examined, with no evidence of TSE detected.
    APHIS, in cooperation with FSIS, has also prepared an 
emergency response plan to use in the event that BSE is 
identified in the United States. This plan details 
comprehensive instructions for USDA staff as to who is going to 
do what, when, where, and how in case of such an emergency. 
USDA, HHS, and other Federal and state partners are now 
integrating this plan into a governmentwide plan including 
actions to be taken by FDA and the CDC.
    While BSE has never been diagnosed in the United States, 
other TSEs do occur in our country. Scrapie has been reported 
in the United States, primarily in the Suffolk breed. It is 
important to note, as Dr. Johnson has mentioned, that there is 
no scientific evidence to indicate that scrapie poses a risk to 
human health or can be transmitted to humans. Attempts to 
control scrapie are carried out through scrapie flock 
certification programs that have been in place since October 
1992.
    Chronic wasting disease, CWD, is a TSE of deer and elk that 
has occurred in limited areas in the western United States. 
First recognized in 1967, it is typified by chronic weight loss 
leading to death. To date there is no known relationship 
between CWD and any other naturally occurring spongiform 
encephalopathies of animals or people.
    As in the past, Mr. Chairman, APHIS in cooperation with 
other Federal agencies and state authorities remains committed 
to preventing the introduction, establishment, and spread of 
foreign animal diseases such as BSE. USDA will continue to take 
every action possible to safeguard domestic livestock and the 
U.S. food supply from this serious disease.
    Thanks, Mr. Chairman and Members of the Subcommittee, for 
granting me this opportunity. I will be glad to answer any 
questions at an appropriate time.
    [The prepared statement of Dr. Torres follows:]
    Prepared Statement of Alfonso Torres, Deputy Administrator for 
          Veterinary Services, U.S. Department of Agriculture
    Mr. Chairman and Members of the Subcommittee, I thank you for this 
opportunity to testify on behalf of the U.S. Department of Agriculture 
(USDA) and my Agency, the Animal and Plant Health Inspection Service 
(APHIS), on the activities that USDA conducts to prevent the 
introduction of bovine spongiform encephalopathy (BSE) into the United 
States.
    BSE, widely referred to as ``mad cow disease,'' is a chronic 
degenerative disease affecting the central nervous system of cattle. 
The disease was first diagnosed in 1986 in Great Britain. As you know, 
BSE has had a substantial impact on the livestock industry in the 
United Kingdom. The disease also has been confirmed in native-born 
cattle in Belgium, Denmark, France, Germany, Ireland, Italy, 
Liechtenstein, Luxembourg, the Netherlands, Northern Ireland, Portugal, 
Spain, and Switzerland. APHIS is enforcing import restrictions and is 
conducting surveillance for BSE to ensure that this serious disease 
does not become established in the United States.
    BSE is classified as a transmissible spongiform encephalopathy 
(TSE). The agent responsible for BSE and other TSEs has not been 
completely characterized. Other TSEs include scrapie (which affects 
sheep and goats), transmissible mink encephalopathy, feline spongiform 
encephalopathy, and chronic wasting disease of deer and elk. In humans, 
TSEs include kuru, Creutzfeldt-Jakob disease (CJD), 
GerstmannStraussler-Scheinker syndrome, fatal familial insomnia, and 
variant CJD, which has been linked to BSE.
    In cooperation with USDA's Food Safety and Inspection Service 
(FSIS) and the Food and Drug Administration (FDA), APHIS has taken 
comprehensive and stringent measures for prevention, education, 
surveillance, and response. To prevent BSE from entering the country, 
APHIS has prohibited the importation of live ruminants from countries 
where BSE is known to exist in native cattle since 1989. Other products 
derived from ruminants, such as fetal bovine serum, bone meal, meat-
and-bone meal, blood meal, offal, fats, and glands, are also prohibited 
from entry, except under special conditions or under USDA permit for 
scientific or research purposes.
    On December 12, 1997, APHIS extended these restrictions to include 
all of the countries in Europe due to concerns about widespread risk 
factors and inadequate surveillance for BSE. As of December 7, 2000, 
USDA prohibited all imports of rendered animal protein products, 
regardless of species, from Europe. This decision followed the 
determination by the European Union that feed of nonruminant origin was 
potentially cross-contaminated with the BSE agent. The restriction 
applies to products originating, rendered, processed or otherwise 
associated with European products. USDA took this emergency action to 
prevent potentially cross-contaminated products from entering the 
United States. The same type of rendered product from ruminant origin 
has been prohibited from BSE-infected countries since 1989.
    USDA also works very closely with other Federal agencies involved 
in the prevention of BSE introduction. For example, for the past 5 
years, USDA agencies--APHIS, FSIS, the Agricultural Research Service 
(ARS), and the Cooperative State Research Education, and Extension 
Service (CSREES)--have worked closely with the U.S. Department of 
Health and Human Services' Centers for Disease Control and Prevention, 
National Institutes of Health, and Food and Drug Administration on 
technical issues regarding TSEs. In addition, APHIS officials work with 
representatives from these other Federal agencies and our Canadian and 
Mexican counterparts on the Tripartite TSE Working Group.
    As part of USDA's surveillance program for BSE in the United 
States, pathologists at APHIS' National Veterinary Services 
Laboratories (NVSL) in Ames, Iowa, histopathologically examine the 
brains of these suspect animals for signs of BSE. Specifically, samples 
are tested using a technique called immunohistochemistry, which tests 
for the presence of the protease-resistant prion protein, an indication 
marker for BSE. NVSL also examines samples from neurologically ill 
cattle and nonambulatory (downer) cattle identified on the farm or at 
slaughter and from cattle submitted to veterinary diagnostic 
laboratories and teaching hospitals that tested negative for rabies.
    In addition, veterinary field pathologists and field investigators 
from APHIS and FSIS have received training from their British 
counterparts in diagnosing BSE. FSIS officials inspect cattle before 
they go to slaughter; the inspection procedures include identifying 
animals with central nervous system conditions. Animals with such 
conditions are considered suspect for BSE, prohibited from slaughter, 
and referred to APHIS for examination. As of February 28, 2001, the 
brains from 12,212 animals in the United States and Puerto Rico had 
been examined with no evidence of BSE or other TSEs detected.
    APHIS also monitors the remaining cattle imported from Great 
Britain, Belgium, and other European countries before the bans on 
imports from those countries went into effect. As of December 31, 2000, 
of the 496 cattle imported from Great Britain and Ireland between 1981 
and 1989, four animals were still alive. The animals are quarantined 
and observed regularly. APHIS continues to attempt to purchase the four 
live animals for diagnostic research purposes. The 24 European cattle 
imported in 1996-97 that are still alive are currently under 
quarantine, and APHIS is attempting to buy these animals as well.
    There were also two flocks of sheep imported from Belgium and the 
Netherlands in 1996 that were under state quarantine in Vermont since 
October 1998 due to probable TSE exposure. Four sheep from one of the 
flocks have tested positive for an atypical TSE of foreign origin. 
There is no simple test to determine whether the sheep are infected 
with BSE or another TSE, such as a European strain of scrapie--a TSE 
that affects sheep and goats. Nevertheless, it is highly likely that 
the animals were exposed to feed contaminated with the agent that 
causes BSE before they left Europe.
    The owner of an additional flock that contained female progeny from 
these imported sheep sold his entire herd to USDA in July 2000. On July 
21, 2000, then-Secretary of Agriculture Dan Glickman issued a 
Declaration of Extraordinary Emergency authorizing the seizure of the 
two imported flocks. However, the owners of these flocks contested the 
decision and sought to have the seizure blocked through the legal 
system. On February 6, 2001, the U.S. District Court for the District 
of Vermont ruled that the owners of the flocks must comply with the 
Declaration of Extraordinary Emergency and surrender the sheep to USDA. 
The owners subsequently filed an appeal with the 2nd Circuit Court of 
Appeals in which the original decision was upheld. USDA took the first 
flock on March 21, 2001, and the second flock on March 23, 2001. The 
sheep have been euthanized, samples for further diagnostic tests were 
taken, and the carcasses were disposed of in a safe manner.
    APHIS, in cooperation with FSIS, has also drafted an emergency 
response plan to be used in the event that BSE is identified in United 
States. The plan details comprehensive instructions for USDA staff as 
to who is to do what, when, where, and how in the case of such an 
emergency. USDA, HHS, and other Federal and state partners are now 
integrating this plan into a governmentwide plan, including actions to 
be taken by FDA and the Centers for Disease Control (CDC).
    In 1998, USDA entered into a cooperative agreement with Harvard 
University's School of Public Health to analyze and evaluate the 
Department's measures to prevent an introduction of BSE. The Harvard 
study, which is expected to be completed in the next few months, 
reviews current scientific information, assesses the pathways that BSE 
could potentially enter the United States, and identifies any 
additional measures that could be taken to protect human and animal 
health.
    APHIS' TSE Working Group monitors and assesses all ongoing events 
and research findings regarding TSEs. APHIS continually revises and 
adjusts prevention and diagnostic measures as it receives new 
information and knowledge.
    As an additional preventative measure, APHIS supports the FDA 
regulation (effective August 4, 1997) prohibiting the use of most 
mammalian protein in the manufacture of animal feeds given to 
ruminants. The final regulation also requires process and control 
systems to ensure that ruminant feed does not contain the prohibited 
mammalian tissues.
    While BSE has never been diagnosed in the United States, other TSEs 
do occur in this country. For example, scrapie has been reported in the 
United States primarily in the Suffolk breed. It is important to note 
that there is no scientific evidence to indicate that scrapie poses a 
risk to human health or can be transmitted to humans.
    In 1952, the Secretary of Agriculture declared a state of emergency 
in an attempt to eradicate scrapie in the United States. Although that 
goal has not yet been achieved, USDA continues to identify the disease 
and attempt to eradicate it through the Scrapie Flock Certification 
Program that was implemented on October 1, 1992.
    This voluntary program is a cooperative effort among producers, 
allied industry representatives, accredited veterinarians, state animal 
health officials, and APHIS officials. The program provides 
participating producers with the opportunity to protect their sheep 
from scrapie and enhance the marketability of their animals through 
certifying their origin in scrapie-free flocks. In addition, APHIS 
regulations restrict the interstate movement of sheep from scrapie-
infected and source flocks.
    Chronic wasting disease (CWD) is a TSE of deer and elk that has 
occurred only in limited areas in the Western United States. First 
recognized as a clinical syndrome in 1967, it is typified by chronic 
weight loss leading to death. To date, there is no known relationship 
between CWD and any other naturally occurring spongiform encephalopathy 
of animals or people. Further research continues in this area.
    Surveillance for CWD in Colorado and Wyoming has been ongoing since 
1983 and, to date, has confirmed the limits of the endemic areas in 
those states. An extensive nationwide surveillance effort was started 
in 1997-98 to better define the geographic distribution of CWD. This 
ongoing surveillance effort is a two-pronged approach consisting of 
hunter-harvest cervid surveys conducted in Arizona, Colorado, Idaho, 
Kansas, Maine, Michigan, Montana, Nebraska, Nevada, New Jersey, 
Oklahoma, South Dakota, Utah, and Wyoming, as well as surveillance 
throughout the entire country targeting deer and elk exhibiting 
clinical signs suggestive of CWD.
    As in the past, APHIS remains committed to preventing the 
introduction, establishment, and spread of foreign animal diseases such 
as BSE. APHIS, in cooperation with FDA and other agencies, is enforcing 
stringent import restrictions and is conducting a comprehensive 
surveillance program to ensure that BSE does not become established in 
the United States. USDA will continue to take every action possible, 
including prevention, preparedness, response, and recovery measures, to 
safeguard domestic livestock and the U.S. food supply from this serious 
disease. Again, I would like to thank the Chairman and Members of the 
Subcommittee for granting me this opportunity to explain APHIS' key 
role in addressing issues involving BSE.

    Senator Fitzgerald. Thank you very much, Dr. Torres.
    Dr. Sundlof.

 STATEMENT OF STEPHEN SUNDLOF, D.V.M., Ph.D., DIRECTOR, CENTER 
            FOR VETERINARY MEDICINE, FOOD AND DRUG 
    ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Sundlof. Thank you, Mr. Chairman. Thank you for the 
opportunity to participate in today's hearing on the Federal 
Government's efforts to prevent BSE from occurring in the 
United States.
    I am Stephen Sundlof. I am a veterinarian and a 
toxicologist and I serve as the Director of the FDA's Center 
for Veterinary Medicine.
    Many FDA-regulated products contain bovine ingredients, 
including food, animal feed, drugs, vaccines, tissues, dietary 
supplements, cosmetics, and medical devices. Also there are 
theoretical concerns about transmitting CJD and variant CJD 
through donated human blood.
    While NIH's focus is on research, the FDA and its Federal 
and state partners focus on prevention. In August 1997, the FDA 
issued a regulation that prohibits the use of most mammalian 
protein in animal feeds for ruminants. Even though there is no 
evidence of BSE in the U.S., FDA prohibited these feeding 
practices in order to prevent the spread of this disease should 
the disease get into the United States.
    To ensure compliance with this rule, FDA launched a 
rigorous inspection program, including an extensive educational 
component. We enlisted the assistance of the states, and since 
January 1998, state regulators and Federal regulators have 
conducted over 10,000 inspections of renderers, feed mills, 
ruminant feeders, feed-haulers, and distributors.
    Now FDA is re-inspecting noncompliant facilities. In 
January FDA field offices were directed to re-inspect all those 
firms that were not in full compliance with the rules. Re-
inspections are being conducted to date and show that only one 
firm is out of compliance when re-inspected.
    Education has been an important part of the compliance 
program. FDA sponsored workshops attended by state 
veterinarians and feed control officials from all 50 states, 
Puerto Rico, the Virgin Islands, and Canada, and FDA held 
briefing sessions with trade associations and consumer groups 
and developed supplemental guidances to the industries.
    FDA currently has two import alerts in force. One calls for 
the detention of bulk shipments of high-risk bovine tissues 
from BSE countries. The second instructs FDA field personnel to 
detain animal feed and other products for animal use that 
contain ingredients of animal origin from any animal in those 
countries in which BSE is present.
    Assuring the compliance with FDA's feed ban and having 
strong protections at our borders are the key strategies in 
preventing the occurrence and spread of BSE within the United 
States. Let me briefly mention some other activities that the 
agency has taken to protect the consumers of dietary 
supplements and medical-related products, such as drugs, blood, 
vaccines, and medical devices.
    Since 1993, FDA has sent a number of letters of guidance to 
manufacturers on the use of bovine materials from countries 
affected by BSE. In 1993 and again in 1996, FDA requested that 
manufacturers of FDA-regulated products intended for human use 
not use bovine-derived materials from BSE countries. Again in 
2000, FDA re-issued advisory letters to dietary supplement 
manufacturers and to vaccine and other biological product 
manufacturers.
    In September 1997, FDA released guidance for industry on 
the sourcing and processing of gelatin products for human use 
so that consumers of gelatin products such as candy or capsules 
can be confident of their safety. In November 1999, FDA issued 
guidance to blood centers to reduce the theoretical risk of 
transmission of variant CJD to recipients of blood products. 
This precautionary measure recommended procedures for deferring 
potential donors who may have been exposed to BSE due to travel 
or residence in the United Kingdom. Further revision to this 
guidance may be forthcoming as new information becomes 
available.
    In July 2000, our Vaccines and Related Biological Advisory 
Committee and our TSE Advisory Committee jointly concluded that 
for licensed products the risk to recipients, if any, was 
theoretical and remote and was outweighed by the benefits of 
vaccines. The committee nonetheless recommended that if bovine 
materials were found to be used in vaccine production that 
manufacturers change the sources of vaccines of those products 
to non-BSE countries.
    Let me close by reiterating that currently there is no 
evidence that BSE or variant CJD exists in the United States. 
Nonetheless, we are alert to the threat and FDA will continue 
to aggressively protect the health of the American public and 
our animal population by minimizing the risk of BSE 
introduction or spread into the United States.
    Thank you again, Mr. Chairman, for the opportunity to 
testify.
    [The prepared statement of Dr. Sundlof follows:]
Prepared Statement of Stephen Sundlof, D.V.M., Ph.D., Director, Center 
 for Veterinary Medicine, Food and Drug Administration, Department of 
                       Health and Human Services
    Mr. Chairman, Members of the Committee, thank you for the 
opportunity to participate in today's hearing on measures by the 
Federal Government to prevent bovine spongiform encephalopathy (BSE) or 
``Mad Cow Disease,'' from occurring in the United States (U.S.). I am 
Dr. Stephen Sundlof, Director, Center for Veterinary Medicine, Food and 
Drug Administration (FDA or the Agency).
    Let me state at the outset that currently we have no evidence of 
BSE in the U.S. and FDA and other Federal agencies are working 
diligently to keep it out of the U.S. FDA has been actively involved 
nationally and internationally in efforts to understand and prevent the 
spread of BSE. FDA collaborates extensively with its sister Public 
Health Service agencies, the Centers for Disease Control and Prevention 
(CDC) and the National Institutes of Health (NIH), relevant agencies 
within the U.S. Department of Agriculture (USDA), the Customs Service, 
and many other Federal and state agencies, as well as with affected 
industries and consumer groups.
     background on bse and variant creutzfeldt-jakob disease (vcjd)
    BSE belongs to the family of transmissible spongiform 
encephalopathies (TSEs) diseases. TSEs are a group of transmissible, 
slowly progressive, degenerative diseases of the central nervous 
systems of humans and several species of animals. Animal TSEs include, 
for example, bovine BSE in cattle, ``scrapie'' in sheep and goats, 
``chronic wasting disease'' (CWD) in deer and elk, feline spongiform 
encephalopathy in cats, and mink spongiform encephalopathy in mink. 
Scrapie and CWD are found in the U.S. to a small extent in certain 
herds of these animals.
    Human TSEs include kuru, a disease of the South Pacific Fore people 
and Creutzfeldt-Jakob disease (CJD or ``classical'' CJD), which occurs 
throughout the world, including the U.S. (where it occurs at a stable 
rate of about one per million population per year) and new variant CJD 
(vCJD), which was first reported in the United Kingdom (U.K.) in 1996. 
It is believed that vCJD may be acquired from eating food products 
containing the BSE agent, and there is strong epidemiological and 
laboratory evidence for a causal association between vCJD and BSE. The 
onset of illness in the first case of vCJD, occurred in early 1994. As 
of April 2, 2001, 97 probable or confirmed human cases of vCJD were 
reported in the U.K., three in France and one in Ireland. The absence 
of confirmed cases of vCJD in geographic areas free of BSE supports a 
causal association. There is no evidence to date of vCJD in the U.S. 
There is no known treatment for any TSE, and they are all fatal.
    BSE has a prolonged incubation period in cattle, ranging from 3 to 
8 years; for vCJD in humans, the incubation period is unknown, but is 
at least 5 years and could extend up to 20 years or longer. BSE was 
first discovered in the U.K. in November 1986. Epidemiological evidence 
established that the wide-spread amplification of BSE throughout many 
of the British cattle herds was related to the production and use over 
many years of BSE-contaminated meat-and-bone meal that was fed 
primarily to young calves. The original source of the BSE outbreak is 
uncertain.
    The vast majority of BSE cases have been reported in the U.K. About 
180,000 cases of BSE have been confirmed there in more than 33,000 
herds of cattle. The U.K. epidemic peaked in January 1993 at nearly 
1,000 new cases per week. Surveillance in Europe has also led to the 
identification of cases of BSE in Belgium, Denmark, France, Ireland, 
Liechtenstein, the Netherlands, Portugal, Switzerland and most 
recently, in Germany, Spain and Italy. European countries have 
instituted a variety of public health control measures, such as BSE 
surveillance, the culling (removal from the herd) of sick animals, the 
banning of specified risk materials, the banning of animal proteins in 
animal feed, or a combination of these, to prevent potentially BSE-
infected tissues from entering the human food chain.
                            fda protections
    Many FDA regulated products contain bovine products, including 
food, animal feed, drugs, vaccines, tissues, dietary supplements, 
cosmetics, medical devices, and there also are theoretical concerns 
about transmitting CJD and vCJD through the human blood supply from a 
donor infected with CJD or vCJD. At this time there is no documented 
transmission of CJD or vCJD through blood/blood products. FDA has a 
long-standing commitment to consumer protection involving BSE and vCJD.
    The focus for FDA and its Federal and state partners in other 
agencies has been prevention. Using the best science known at this 
time, the U.S. has an aggressive, multi-faceted program in place to try 
to prevent the establishment and spread of BSE within the U.S. FDA's 
restrictions on certain cattle feed ingredients and its import 
restrictions on various items and products are critical parts of this 
program.
          cattle feed restrictions, inspections and education
    As I have stated, rendered feed ingredients contaminated with the 
BSE agent are believed to be the means by which BSE is amplified in 
cattle herds. The amplification is most closely associated with feed 
for cattle, particularly young calves that include ingredients 
processed from remnants of slaughtered animals, such as meat-and-bone 
meal, which may harbor the agent that causes BSE. Although the material 
is cooked, the BSE agent can survive.
    In order to prevent the spread of BSE through feed, in August 1997, 
FDA published a regulation that prohibits the use of most mammalian 
protein in the manufacture of animal feeds for ruminants (Title 21, 
Code of Federal Regulations (CFR) Part 589). Even though there is no 
evidence of BSE in the U.S., FDA prohibited this feeding practice so 
that we established in our country feeding practices consistent with 
the best epidemiological knowledge available to prevent the spread of 
this disease throughout the U.S. cattle herd should it get into the 
U.S. With the strong support of renderers, cattle owners, feed 
manufacturers, and feed lot owners, FDA launched a compliance and 
education program, including a rigorous inspection program. The goal of 
these efforts is to achieve as close to 100 percent compliance with the 
labeling, record keeping, and contamination avoidance provisions of 
this new regulation as soon as possible. FDA recognizes that there were 
some early problems with compliances, as cited in the General 
Accounting Office's (GAO) report, ``Controls Can Be Strengthened to 
Reduce the Risk of Disease Linked to Unsafe Animal Feed'' (GAO/RCED-
00255).
    FDA and state regulators have conducted over 10,000 inspections of 
renderers, feed mills, ruminant feeders, dairy farms, protein blenders, 
feed haulers, and distributors since January 1998. On first inspection, 
about three-quarters of these establishments were found to be in 
compliance. Most of the establishments that had problems during the 
first inspection were found in compliance upon re-inspection.
    FDA is continuing its compliance efforts by conducting additional 
inspections and re-inspecting non-compliant facilities. In January 
2001, FDA field offices were issued an assignment to re-inspect 834 
firms that were not in full compliance with the rule. Of 184 re-
inspections conducted by April 2, 2001, only one firm continued to be 
out of compliance.
    Education is also an extremely important part of the compliance 
program. FDA has sponsored workshops attended by state veterinarians 
and feed control officials from all 50 states, Puerto Rico, the U.S. 
Virgin Islands, and Canada. In addition, FDA has held briefing sessions 
with trade associations and consumer groups, and has developed 
additional guidances for complying with the regulation.
                            import controls
    FDA and the USDA's Animal and Plant Health Inspection Service 
(APHIS) work in close cooperation with the Customs Service on items 
related to imports.
    APHIS establishes and enforces import restrictions covering animals 
and animal products offered for import into the U.S. to prevent the 
importation of foreign exotic diseases. Beginning in 1989, APHIS has 
taken several actions to ban animals or products under their 
jurisdiction because of concerns about BSE.
    FDA issues Import Alerts and Import Bulletins regarding problems or 
potential problems with imported products under FDA's jurisdiction. FDA 
coordinates its Import Alerts and Bulletins closely with APHIS. The 
Agency has issued the following:
     On September 1, 1992, FDA issued Import Bulletin 99-B03, 
alerting field units to imports, from BSE countries, of animal by-
products and regulated products containing animal by-product 
ingredients.
     On October 19, 1994, FDA issued Import Alert 17-04 
(replacing the 1992 Import Bulletin) calling for the detention, without 
examination, of bulk shipments of high-risk bovine tissues and tissue-
derived ingredients from BSE countries (at that time this included the 
U.K., France, Ireland, Oman, Switzerland, and Portugal). FDA updated 
this alert whenever APHIS revised the list of BSE countries it included 
at 9 CFR Sec. 94.18.
     On January 24, 2000, FDA updated the existing Import Alert 
17-04, which called for detention of bulk shipments of high-risk bovine 
tissue from BSE countries to include countries in most of Europe, 
following APHIS's extension of import restrictions to those countries.
     On December 20, 2000, FDA issued Import Bulletin 71B-02, 
alerting FDA field personnel of the APHIS restrictions on animal feed 
ingredients from 31 countries, and instructing them to coordinate entry 
review with their local APHIS office. This Import Bulletin was canceled 
on January 23, 2001, after the issuance of Import Alert 99-25.
     On January 20, 2001, FDA issued Import Alert 99-25, which 
instructed FDA field personnel to detain animal feed, animal feed 
ingredients, and other products for animal use consisting of, or 
containing, ingredients of animal origin from the 31 countries where 
BSE is known to exist and/or have less restrictive import requirements 
then those that would be acceptable in the U.S.
     On March 1, 2001, FDA issued Import Bulletin 99B-14, 
alerting FDA field personnel that APHIS further prohibited the 
importation into the U.S. of certain edible ruminant products from 
Europe, Oman, and BSE at-risk countries. The Bulletin advises that FDA 
entry review should include assessment of product ingredients to 
determine whether they contain or may contain ruminant material subject 
to the APHIS prohibition.
   protecting fda-regulated medical products and dietary supplements
    FDA also has taken steps to protect medical products (such as 
drugs, blood, vaccines, and medical devices) for human use. Since 1993, 
FDA also has sent a number of letters to manufacturers of FDA-regulated 
products providing guidance on the use of bovine materials from 
countries affected by BSE and taken other actions.
     In 1993 and again in 1996, FDA requested that 
manufacturers of FDA-regulated products intended for humans not use 
bovine-derived materials from BSE countries.
     In September 1997, FDA released a Guidance for Industry, 
``The Sourcing and Processing of Gelatin to Reduce the Potential Risk 
Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated 
Products for Human Use.'' FDA recommends that gelatin-containing 
products such as candy or capsules imported from the 31 countries 
identified as having BSE or at risk for having BSE be manufactured 
under specific guidance. Gelatin is to be made from non-BSE herds and 
use only specific parts of BSE-free animals.
     In April 2000, FDA's Center for Biologics Evaluation and 
Research (CBER) issued a letter to manufacturers of biological products 
reminding them of the Agency's strong recommendations not to use 
materials derived from ruminant animals from countries where BSE is 
known to exist. This action was taken as a result of learning that its 
recommendations regarding the sourcing of bovine materials for the 
manufacture of vaccines had not been followed in at least one instance.
     In May 2000, CBER requested that all vaccine manufacturers 
review the source for all bovine-derived materials used in the 
manufacture of their products, including bovine derived material used 
to prepare working cell and seed banks.
     In July 2000, assessments of risk and recommendations 
regarding additional vaccines manufactured with bovine derived 
materials that had been obtained from European countries on the USDA 
list were discussed in a meeting held in July 2000 between CBER's 
Vaccines and Related Biological Advisory Committee and FDA's TSE 
Advisory Committee. The joint committees concluded that for licensed 
products, the risk to recipients, if any, was theoretical and remote 
and outweighed by the benefits of the vaccines. The joint committees, 
nonetheless, recommended that if bovine materials were found to be used 
in vaccine production that manufacturers change sources. They also 
agreed with CBER that if the working cell and seed banks were derived 
(after January 1, 1980) using bovine materials from countries on the 
USDA list, manufacturers re-derive those cell and seed banks using 
bovine materials from countries not on the USDA list. Manufacturers 
have agreed to, and have begun implementing, all of these changes.
     In November 2000, FDA sent a letter to manufacturers and 
importers of dietary supplements. The letter states the Agency's strong 
recommendation that firms manufacturing or importing dietary 
supplements that contain specific bovine tissues take whatever steps 
are necessary to assure themselves and the public that such ingredients 
do not come from cattle born, raised, or slaughtered in countries where 
BSE is known to exist. Since 1992, FDA has issued four letters to the 
dietary supplement industry to make sure the industry was aware of the 
problem and that they should be taking appropriate action.
    FDA inspects manufacturers of FDA-regulated products to determine 
if manufacturers are following the Agency's current recommendations as 
part of current good manufacturing practices. In addition, as 
applications for new products or changes to products are submitted, FDA 
ensures that the recommendations are being followed, if those products 
are required to have FDA clearance prior to marketing in the U.S.
                      protecting the blood supply
    In November 1999, FDA issued guidance to blood centers to reduce 
the theoretical risk of transmission of vCJD to recipients of blood 
products. This precautionary measure recommended procedures for 
deferring potential donors who may have been significantly exposed to 
BSE due to travel or residence in the U.K. FDA's present guidance 
recommends that blood centers exclude potential donors who have spent 
six or more cumulative months in the U.K. between January 1, 1980, and 
December 31, 1996, from donating blood. Further revision to this 
guidance may be forthcoming as new information becomes available 
regarding other countries' BSE experiences.
                         tse advisory committee
    FDA has constituted a TSE Advisory Committee, which is composed of 
non-government experts in TSE matters and meets publicly on at least a 
semi-annual basis. This committee was chartered originally in 1995. The 
purpose of the TSE Advisory Committee, as with all of our advisory 
committees, is to consider policy and scientific issues and then 
provide FDA with insight and recommendations. One standing agenda item 
of this committee is review of current regulations and guidance to 
prevent exposure of the U.S. population to the agent(s) of BSE/TSE 
through blood, tissues, and other regulated products. FDA's TSE 
Advisory Committee recently offered advice on revising the guidelines 
to include potential donors who have lived an aggregate of 10 years in 
France, Ireland and Portugal. FDA is developing revisions to its 
current industry guidance and will consider the advice of the 
committee.
                interagency coordination of tses issues
    Protecting the U.S. from BSE and all TSEs are top priorities of the 
Department of Health and Human Services (DHHS or Department). Secretary 
Thompson has made BSE one of his priorities, and has initiated a 
process to strengthen coordination of BSE/TSE activities across the 
Department.
    In January 2001, FDA established an Interdepartmental Steering 
Committee for BSE/TSE Affairs. This committee is chaired by the Acting 
Commissioner of FDA and includes representatives of: CDC, FDA, NIH, 
USDA (FSIS, APHIS, FAS), the U.S. Trade Representative, the Office of 
Management and Budget, the Customs Service, the Department of State, 
the Department of Defense, the State Association of Feed Control 
Officials, the National Association of State Departments of 
Agriculture, and the White House Office of Science and Technology 
Policy.
    The committee assures:
     Ongoing coordination between agencies.
     Integrated contingency planning for the possibility that a 
case of BSE or of vCJD might be found in the United States.
     Identification and action on high priority cross-
departmental issues in the U.S. regarding BSE and vCJD.
     Coordination of risk communication plans by the various 
agencies.
    DHHS. BSE/TSE activities can be divided into four major components: 
Surveillance, Protection, Research and Oversight. Surveillance for 
human disease is primarily the responsibility of the CDC. Protection 
and Surveillance of animals, feeds, and foods are responsibilities of 
FDA, which it shares with USDA. Research is primarily the 
responsibility of NIH, although FDA also conducts important research. 
Oversight is primarily the responsibility of the DHHS Office of the 
Secretary.
    Within the Department, there also is a Public Health Service Blood 
Safety Committee (BSC) that is chaired by the Assistant Secretary for 
Health, who serves as the Blood Safety Director for the Department. The 
BSC includes among its members the directors of CDC, FDA, NIH, and the 
DHHS Assistant Secretary for Planning and Evaluation. The purpose of 
this committee is to enable threats to the safety or availability of 
the blood supply to be brought immediately to the highest levels of 
DHHS. The BSC has been convened on an urgent basis to review proposed 
recommendations to defer blood donors at risk of transmitting BSE by 
virtue of prior residence in the U.K. The BSC also met to consider 
issues relating to the development of CJD at an unusually young age in 
a hunter who had been a long time plasma donor. In addition, members of 
this group met to review issues related to the discovery of a poorly 
characterized TSE that recently appeared in flocks of East Freisian 
sheep, which had been imported to Vermont from Europe. The group stands 
ready to be convened for similar matters in the future.
    The Department intends to ensure timely, accurate, thorough, and 
clear communication to the public about the nature and extent of the 
threats posed by BSE/TSE and about the actions that each agency of 
government is taking to protect the public from these threats. FDA has 
announced that it will hold a public meeting for consumers on BSE on 
April 16, 2001, in Washington, D.C. The purpose of this meeting will be 
to inform the public about FDA's BSE-related activities and to hear 
from various consumer groups about their concerns with and suggestions 
for addressing the challenge of BSE.
                               conclusion
    Let me close by again stating that currently there is no evidence 
that BSE or vCJD exists in the U.S. Working together with many 
counterpart agencies in the U.S., around the world and with various 
industry and consumer groups, FDA will continue to work to protect the 
health of the American people and of our animal population by acting to 
minimize the risk of BSE introduction or spread into the U.S.
    Thank you again for the opportunity to testify.

    Senator Fitzgerald. Thank you, doctor.
    Dr. Hueston.

        STATEMENT OF WILLIAM D. HUESTON, D.V.M., Ph.D., 
          PROFESSOR AND ASSOCIATE DEAN, UNIVERSITY OF 
          MARYLAND CAMPUS, VIRGINIA-MARYLAND REGIONAL 
                 COLLEGE OF VETERINARY MEDICINE

    Dr. Hueston. Thank you, Mr. Chairman. I appreciate this 
opportunity to testify. I am Will Hueston, Professor at 
University of Maryland and Associate Dean of the Virginia-
Maryland Regional College of Veterinary Medicine. My specialty 
is veterinary epidemiology. I have spent the last 12 years of 
my life working with this disease, including time in Great 
Britain on the investigatory team and also 6 years as a member 
of the Spongiform Encephalopathy Advisory Committee for the 
United Kingdom.
    It is a very interesting disease and interesting for us to 
look back now. Since this disease was first identified in 1986 
in the United Kingdom, the United States has taken a series of 
preventive actions, including, as you have heard, import bans, 
feed bans, guidance documents, extensive education, and 
aggressive surveillance, which have been successful to date.
    Why have these been successful? Because each step was 
scientifically sound, and our system has been sequentially 
enhanced as new scientific information becomes available. In 
addition, our prevention steps have been implemented with the 
cooperation between Federal agencies and also with the affected 
industries.
    Interestingly enough, I think the response to BSE stands as 
an excellent example and the best example I am aware of of 
collaboration between both animal health and human health 
agencies within the Federal Government.
    Well, have these steps been adequate, then? Yes, to date 
they have been adequate.
    I would like to digress for a moment and address a comment 
that I feel is irresponsible that is being put forth by the 
media. That is a statement that says what the United States 
faces now is exactly what Europe faced 10 years ago. That 
statement, Mr. Chairman and Members of the Subcommittee, is 
absolutely ludicrous and incorrect. In fact, the other European 
countries that have identified BSE within the last 6 months 
realized and knew that they had a massive exposure to risk 
factors. They ignored that information. They failed to 
implement the corrective measures, and, in fact, now they are 
paying the price for their complacency.
    While the risks of BSE in the United States are the lowest 
that they have ever been, it is not by accident, Mr. Chairman 
It is by a series of well thought out, scientifically sound 
steps.
    Interesting, though, this challenge of prevention. There is 
an interesting conundrum for those of us who make prevention 
our life's career. If, in fact, we are successful, we will be 
criticized for wasting resources for a problem that has never 
occurred. If, on the other hand, we are unsuccessful, we will 
be criticized for not taking sufficient steps.
    So let me follow that statement by saying this. The 
likelihood of BSE in the United States is very low. It is not 
zero. We realize there are potential exposures to BSE in the 
United States, but they are very, very few and very low. 
Nevertheless, the impact should this disease occur in the 
United States is quite large.
    What are the next steps that need to be taken? We need to 
continue to look at ways to expand our risk communication, to 
replace perception with accurate, scientifically sound 
information. We need to continue to strengthen our surveillance 
program by focusing primarily on older cattle, those cattle 
that have potentially been exposed and have lived long enough 
to potentially develop the disease. Third--testing slaughter 
cattle, as an example--would be a complete and total waste of 
time and energy and money because those animals are not old 
enough and have not lived long enough to develop the disease 
even if they are exposed.
    In our system, then, if we want to go for another step that 
has a potential for precluding potential exposure for animals 
and humans, that step ought to be driven by science and by an 
examination of risk. The highest risk, most risky tissues that 
have been mentioned before, are central nervous system, brain 
and spinal cord.
    Well, if in fact, additional prevention steps are 
warranted, are taken, then they must be based on science and 
carefully planned implementation for those steps. In the 
absence of a careful implementation plan, we will be walking 
down the same path that some of our European colleagues have 
taken--to proclaim that they are taking additional prevention 
steps, but not have the wherewithal to carry them out.
    Mr. Chairman, I would like to conclude with one comment. 
Healthy livestock are the foundation of safe food. I think the 
biggest concern that I see right now, and that perhaps my 
colleagues are constrained from saying, is the loss of 
infrastructure in the United States to respond to animal 
diseases. We desperately need an upgrade in our diagnostic 
laboratory capability for animal diseases. We need, in fact, to 
strengthen the infrastructure so that we can support both the 
surveillance and respond should there be an outbreak of 
disease. Finally, we need to dramatically increase the amount 
of research dollars that are going into assuring healthy 
animals. Healthy animals are the basis of safe food.
    Again, I thank you very much for the ability to present to 
this Subcommittee, and I would ask that my full statement 
appear in the minutes.
    [The prepared statement of Dr. Hueston follows:]
Prepared Statement of William D. Hueston, D.V.M., Ph.D., Professor and 
   Associate Dean, University of Maryland Campus, Virginia-Maryland 
                Regional College of Veterinary Medicine
    Mr. Chairman, I am Dr. Will Hueston and I am the Associate Dean of 
the Virginia-Maryland Regional College of Veterinary Medicine. I am 
here today to provide testimony based on 12 years of professional 
experience with bovine spongiform encephalopathy (BSE), commonly 
referred to as ``Mad Cow Disease.''
    For the benefit of the committee, I have had the privilege to serve 
on both the U.S. and the UK scientific Advisory Committees on 
spongiform encephalopathies, so that I can compare the U.S. precautions 
to the situation that has evolved in Europe over the past 15 years.
    I am pleased at the opportunity to present testimony before this 
committee and briefly share my thoughts on the adequacy of the current 
U.S. precautions.
                       emergence of new diseases
    New animal diseases emerge as a natural response to changes in 
disease agents, their animal hosts, and the environments in which they 
live. Discovery of new diseases is a regular occurrence throughout the 
world. Therefore, the emergence of new diseases such as BSE is to be 
expected and we must be prepared to respond to each new discovery.
       foreign animal disease surveillance and emergency response
    The disease BSE was first discovered in 1986 in the UK through the 
cooperation of a concerned animal producer, an astute veterinarian and 
a dedicated laboratory scientist. Investigation of the cause of the 
disease in 1987-1988 identified animal feed containing rendered animal 
protein (meat and bone meal) as the source of the disease exposure. 
Therefore, BSE can be described as a common source feedborne epidemic. 
The most likely origin of BSE appears to be the sheep disease scrapie, 
a similar spongiform encephalopathy that is widespread in the UK. The 
first precaution taken to prevent BSE in the U.S. was the training of 
Federal and state veterinarians and strengthening laboratory diagnostic 
capabilities so that the disease could be identified quickly should it 
occur.
        exclusion of foreign animal diseases through import bans
    The second step taken to exclude BSE from the U.S. was a ban on the 
importation of potentially infected animals and animal products. 
Importation of affected animals (cattle and other ruminants) and 
contaminated products of animal origin such as meat and bone meal 
represent the greatest risk for the introduction of BSE to the U.S. The 
U.S. initiated bans on the importation of live cattle and cattle 
products after the UK announced the results of their epidemiology 
investigations of the new disease BSE. These bans were based on 
scientific evidence concerning the nature of the disease and its major 
routes of transmission.
                        scientific risk analysis
    A risk analysis assessing the potential for BSE occurrence in the 
U.S. was initiated in 1989 immediately after the import bans were put 
in place. The risk analysis addressed the question of whether BSE would 
occur in the U.S., and if so, whether the U.S. would expect to see an 
epidemic of the magnitude of that unfolding in the UK. Serendipitously, 
the risk analysis identified that very few cattle (a total of 496) and 
very little meat and bone meal (<20 tons) had been imported from the UK 
and Ireland around the time of the emergence of BSE (1981-1989). 
Furthermore, major differences were identified in the livestock 
demographics and cattle industry structure between the U.S. and the UK. 
The risk analysis results concluded that while the possibility of a 
case of BSE in the U.S. could not be completely excluded, the 
likelihood of an epidemic of the magnitude of that seen in Great 
Britain was remote. The risk analysis also identified specific high 
risk populations of cattle where the disease would be expected to occur 
first, if it occurred at all in the U.S. The risk analysis process 
helps identify the most important precautions necessary to prevent BSE 
from occurring in the U.S.
             targeted surveillance of high-risk populations
    Identification of BSE depends on the testing of brain material from 
cattle. No blood test or live animal diagnostic test is currently 
available. BSE has a very long latency period so that infected cattle 
do not show clinical signs of the disease until 3-5 years after 
exposure to the BSE agent in their feed. The disease can only be 
diagnosed close to or after the clinical signs appear. Therefore 
disease surveillance must be focused on older animals which have both 
the potential for exposure and sufficient time for the disease to 
develop. The risk analysis helped identify specific high risk 
populations for BSE such as the cattle imported from the UK and older 
dairy cattle which had been fed meat and bone meal in the U.S. 
Therefore, the BSE surveillance program in the U.S. was targeted toward 
these high risk cattle populations beginning in 1990.
                    risk communication and education
    Training of veterinarians and educating of producers began 
immediately after the British identification of this new disease and 
the results of the initial epidemiologic investigation. U.S. government 
veterinarians were sent to the UK to learn more about the disease and 
British experts were invited to the U.S. for consultations. Extensive 
educational efforts accompanied the risk analysis process. Futhermore, 
education of animal owners and veterinarians was and is a key component 
of the ongoing surveillance program.
                       guidance to manufacturers
    The incorporation of infected cattle tissues into biologics or 
medical devices represents another potential route for the transmission 
of BSE. Consequently, the Food and Drug Administration issued a series 
of guidance documents to manufacturers concerning the risks associated 
with BSE and the safe sourcing of raw materials of bovine origin.
                          industry initiatives
    As the epidemiology of BSE became clear, producer groups and 
industry took voluntary initiatives to reduce the potential for BSE 
occurrence in the U.S. The rendering industry took steps to reduce the 
use of sheep potentially affected with scrapie as raw material for the 
production of rendered animal protein, such as meat and bone meal. 
Further, many of the animal industries inaugurated education campaigns, 
urging producers to assist in the identification of high risk cattle 
for the surveillance program. Finally, the cattle industry played a 
critical role in helping to purchase and destroy many of the cattle 
imported from the UK which represented the greatest risk for the 
occurrence of BSE in the U.S.
                additional enhancements to surveillance
    The targeted surveillance of high risk cattle populations was 
expanded to include non-ambulatory cattle (downers) in 1993 as a 
further step to identify BSE if it existed in the U.S. Additionally, a 
second diagnostic test, immunohistochemistry (IHC) was added to the 
surveillance system to augment the histopathology used to test brains. 
The U.S. was the first country to implement IHC testing as part of the 
regular surveillance system. Throughout the 1990s, the numbers of high 
risk cattle screened for BSE grew annually. The U.S. developed the most 
extensive surveillance system of any country in the world outside of 
Europe where the BSE epidemic was centered.
      feed bans to bar the potential for recycling of infectivity
    Upon the recognition that the BSE agent was associated with a human 
disease, variant Creutzfeldt-Jakob Disease (vCJD), efforts were 
initiated to remove ruminant-derived meat and bone meal from U.S. 
cattle feed. The cattle producers initiated a voluntary program to 
exclude ruminant meat and bone meal and subsequently, the FDA 
promulgated a rule banning the feeding of most mammalian proteins to 
ruminants. The ban was science-based, targeting the feed ingredients 
that would be of highest risk for transmitting BSE should the disease 
be identified in the U.S.
                        extension of import bans
    Recognition of the BSE risk for humans and the spread of BSE in 
Europe led to expansion of the import bans placed on cattle and cattle 
products from all of Europe. Extension of the bans further reduced the 
likelihood of potentially infected materials entering the U.S.
                    adequacy of current precautions
    Since the first identification of BSE in the UK 1986, the U.S. has 
taken a series of steps to prevent the entry of the disease into the 
U.S. or the propagation of the disease if it occurred. All of the 
precautions against BSE taken by the U.S. have been science-based, 
targeting known risks. These prevention strategies have been successful 
to date, in that no BSE has been diagnosed in the U.S.
               opportunities for strengthening safeguards
    Ignorance, complacency and lack of resources are the three greatest 
threats to the prevention of BSE and rapid diagnosis and response if it 
occurs. Precautions taken to preclude BSE from the U.S. must be 
regularly re-evaluated and enhanced when new science becomes available 
or weaknesses in the current system are identified. Documentation of 
our BSE status and rapid response to any potential BSE occurrence 
depends on an aggressive surveillance system. While the U.S. has the 
strongest surveillance system outside of Europe, the identification and 
testing of high risk cattle populations must be expanded. Testing of a 
broader sample of older cattle will strengthen our surveillance system. 
The testing also needs to target older cattle dying on the farm and 
debilitated animals that are euthanized or presented for slaughter. No 
additional surveillance benefit would be gained by testing of routine 
slaughter cattle, however. Most cattle in the U.S. are slaughtered 
before 24 months of age, which is too young to detect the disease even 
if these had been exposed. The most efficient and effective 
surveillance targets the high risk populations, i.e., cattle imported 
from Europe and U.S. cattle greater than 3 years of age which have been 
potentially exposed to feeds containing rendered ruminant protein. In 
terms of risks, the greatest remaining potential risk for animal or 
human exposure to BSE is cattle brain and spinal cord, the two tissues 
containing the highest infectivity in BSE affected cattle. Removal of 
brain and spinal cord from the raw material stream for rendering and 
from the human food supply would provide one additional safeguard 
against BSE. Continued education of animal producers, agribusiness and 
consumers represent a key component of the prevention program. The 
producer and consumer play an important role in managing risk. Finally, 
the U.S. lags behind Europe in diagnostic laboratory capabilities and 
research dollars directed toward BSE. Futhermore, the animal health 
infrastructure in the U.S. has eroded over the past two decades, 
reducing our potential for prevention, rapid detection and response.
                               conclusion
    The U.S. has implemented a series of prevention measures that have 
kept BSE out of the U.S. to date and created a series of safeguard to 
protect the American cattle herd and consumer if BSE should occur here. 
Surveillance, regulatory actions and voluntary initiatives taken by the 
U.S. Department of Agriculture, Food and Drug Administration, animal 
producers and agricultural industries have all contributed to this 
prevention effort to date. The future adequacy of the precautions taken 
by the U.S. must rely on the latest science available. As new risks are 
identified, the U.S. must respond quickly to strengthen the 
surveillance system, and if warranted, implement additional prevention 
measures. The conundrum of prevention is that, if it is successful, 
then people will ask why monies were spent on something that never 
occurred. On the other hand, if BSE occurs in the U.S., people will ask 
why more prevention measures were not taken. Given the insidious nature 
of this disease and its widespread ramifications for animal and human 
health, I would argue on the side of aggressive prevention. Protecting 
America's livestock populations is the first line of defense against 
BSE.

    Senator Fitzgerald. Thank you very much, doctor, and we 
will take your full statement. That will be inserted into the 
record.
    Senator Ensign, did you have an opening statement?
    Senator Ensign. No, just questions.
    Senator Fitzgerald. That is great.
    Well, we will go right into questions. I was struck by the 
unanimity of opinion that we are doing a good job in the United 
States. A question arises, though, because a lot of Americans 
travel to Europe and clearly, as that map shows and all of you 
have testified, they have had a real problem in Europe, 
particularly Great Britain.
    Would any of you care to weigh in on whether any 
precautions should be taken by American citizens traveling 
abroad as the summer months come upon us? Would any of you like 
to venture into that territory?
    Dr. Torres.
    Dr. Torres. Mr. Chairman, the distinction needs to be made 
that BSE is not a contagious disease, meaning that people 
cannot catch it just from being in contact with the animals. 
There is a lot of confusion between foot and mouth disease 
right now and BSE.
    Senator Fitzgerald. I think that is clear, but what about 
eating beef products in Great Britain while you are in Great 
Britain or anywhere in Europe this summer? My understanding, 
too, is that cruise ships in the Caribbean are advertising 
their meat as USDA-inspected.
    Dr. Johnson.
    Dr. Johnson. Certainly the amount of BSE in England has 
been cut back dramatically with the killing of herds. So at the 
present time the risk, small that it was before, is greatly 
diminished from that level.
    I think that, to put it in perspective, food-borne disease, 
which we all worry about, is a big problem worldwide. We have 
5,000 people a year in the United States die of food-borne 
illnesses. None of them are from TSE, none. So the danger of 
leafy green vegetables is greater. You can name a whole list of 
other foods, even potato salad, of which you might be more 
concerned than you would be about eating beef at this time, at 
least in my mind.
    Senator Fitzgerald. Dr. Johnson, I have a question for you. 
You are very knowledgeable about prions. This is the first 
infectious disease that I have ever heard of that is not a 
bacteria or a virus. I guess it is a transmissible protein, and 
those were not discovered until the 1970s, 1976. Somebody won a 
Nobel Prize, is that correct, for discovering prions?
    Dr. Johnson. Two Nobel Prizes have been given in this area 
now. The person who really started the work back in the 1950s, 
Carlton Gajdusek, was in the intramural program at NIH, NINDS. 
He received the Nobel Prize for being the first to establish in 
humans the transmissibility of TSEs.
    Then, more recently Stanley Prusiner, who is a recipient of 
NIH grants at the University of California, San Francisco, has 
gotten the Nobel Prize for the prion hypothesis and showing 
that the causative agent is associated with a human protein 
that is modified in its shape, not in its composition. So it 
looks like a post-translational modification. That is a very 
unique idea, and how that modified shape induces the 
modification of other proteins of that sort remains a mystery.
    Senator Fitzgerald. Are there any other prions that 
manifest themselves in any kind of animal or human disease 
other than TSE?
    Dr. Johnson. Well, by definition no, there are none.
    Senator Fitzgerald. There are not.
    Dr. Johnson. TSEs include all of them, and thus far all of 
them have shown this similar punched-out pathological change. 
Whether they are involved in some other kinds of diseases from 
different pathology, that has not been shown at all as yet.
    Senator Fitzgerald. Let me ask Dr. Torres of the USDA. 
Although they are believed to be the most infectious part of a 
BSE-infected animal, I am told consumers can still buy brain 
and spinal cord tissue at the local grocery store. Should these 
sales be allowed to continue and is it possible that some of 
these products may have been imported into the United States 
and do not come from United States beef cattle?
    Dr. Torres. Since the ban has been in place, we are not 
importing animals or animal product from any BSE country. In 
addition to that, in 1997 we included countries that, although 
at the time did not have BSE, we felt that they were at high 
risk to having BSE, and so there is a number of countries from 
which we ban importation of those products. So if brain and 
spinal cord is available in the market, it would be from U.S.-
origin animals and as far as we know that product is safe.
    However, as mentioned by FDA, those are the risky materials 
that we need to continue to evaluate whether or not should be 
continued to be in the market or not. But at this point in 
time, there is no evidence that it would be an unsafe product.
    Senator Fitzgerald. Apparently, in health food stores you 
can also buy brain supplements, some of which come from bovine 
sources. Would we be able to offer assurances that those do not 
come from any BSE-infected countries?
    Dr. Sundlof. The answer to that is yes, that there is a 
prohibition, just as there is a prohibition on animal proteins 
coming into the U.S. from those countries that have BSE, and 
there is about 31 of those countries presently, there is also a 
ban currently, import alert, on any dietary supplements or raw 
bulk materials that contain animal protein from those 31 
countries.
    So if a product on a shelf in a U.S. grocery store contains 
bovine material, glandular material, spinal material, whatever, 
those firms are supposed to be operating in a manner such that 
they are not obtaining any of their source material from those 
31 countries where BSE is present.
    Senator Fitzgerald. Finally, some have been critical of 
regulations that allowed advanced meat recovery and 
mechanically separated product into processed meats. Could the 
public be eating brain or spinal cord tissue in processed 
meats? Are there risks to eating these neurological tissues?
    Dr. Torres or Dr. Sundlof.
    Dr. Torres. Mr. Chairman, could I ask Dr. Linda Detwiler--
she is our expert on these issues--to answer the question?
    Senator Fitzgerald. Absolutely.
    Dr. Linda Detwiler.
    Dr. Torres. Yes.
    Senator Fitzgerald. Dr. Detwiler, thank you.
    Dr. Detwiler. This actually comes under the jurisdiction of 
the Food Safety Inspection Service and there are currently 
directives for the advanced meat recovery process to remove 
spinal cord. Brain material does not go into that product, so 
that is removed in these processes.
    Senator Fitzgerald. Thank you very much.
    Dr. Detwiler. These too, the tissue in all these processes, 
is also being looked at in a risk assessment conducted by 
Harvard University, contracted by the Department of 
Agriculture.
    Senator Fitzgerald. That report is due out shortly, as I 
understand; is that correct?
    Dr. Detwiler. Right.
    Senator Fitzgerald. Thank you, doctor.
    Senator Dorgan, if you would like to ask some questions.
    Senator Dorgan. Mr. Chairman, thank you very much.
    First of all, I found the testimony from all four witnesses 
very interesting. Dr. Hueston, are you under contract with any 
of the Federal agencies?
    Dr. Hueston. No, sir, I am not.
    Senator Dorgan. The reason I ask that question is, while I 
have great respect for the Federal agencies here, they 
obviously would want to come here and say, we are doing 
everything we can and doing a great job. Incidentally, I share 
that assessment, but that is what they would want to tell a 
Senate committee. You have a slightly different perspective, 
coming from perhaps a more independent side of this.
    Again, the testimony from all four of you was interesting 
and I think very useful for us to have a better understanding 
of what the scientific community sees and how they assess this. 
But let me ask just a couple of other questions if I might.
    I mentioned that we live in an increasingly global economy. 
Let me just tell you a quick story. I was on a dock in Seattle 
one day just trying to see what Customs and FDA and everybody 
is doing about our food supply. One of the containers that came 
off a container ship was opened and they had frozen broccoli 
from Poland. This was coming into our country to go into our 
marketplace, perhaps to be served in a restaurant somewhere, 
because this was chopped broccoli frozen in large bags.
    I asked: Does anybody here know the conditions under which 
this broccoli was produced? Anybody know the application of 
chemicals that might have been applied to this broccoli? No one 
had the foggiest idea the conditions under which that broccoli 
was produced.
    In fact, it would only be serendipitous to have that 
particular container opened. Most of them would never be 
opened. They would come in and the bags would go to a 
restaurant somewhere.
    The point I learned that day, as I have learned previous to 
that and since that time, that there is very little inspection 
done on all this food that comes back and forth across the 
border from all around the world. We have cattle coming in 
also, both live and slaughtered cattle from Canada and Mexico. 
We have in this country guidelines and requirements with 
respect to certification of the feed supply by American 
producers of cattle. Are we able to assure the same 
circumstances with respect to the cattle that are coming into 
this country from Canada and Mexico, as an example, that they 
are not being produced with a feed supply that would include 
prohibited materials that we want to keep out of the food 
chain? Can anyone respond to that?
    Dr. Torres. Senator, Canada has a feed ban similar to ours. 
Mexico does, too. Mexico implemented that more recently than 
Canada.
    Senator Dorgan. Do you have any assurance at all that there 
is an enforcement of that ban, for example, in Mexico? I am 
well familiar with a lot of Mexican laws that read really well, 
but are not enforced at all. Just to use that as an example, do 
we have any conditions that would lead us to believe that it is 
enforced?
    Dr. Torres. I know it is enforced. I do not know the what 
level it is enforced, Senator.
    Senator Dorgan. Well, I raise the question--Dr. Hueston, 
you wanted to respond?
    Dr. Hueston. Senator, I might interject that Canada 
suffered the unfortunate circumstance of having BSE in a cow 
that they imported from Great Britain. So they take this 
disease extremely seriously, and I have no doubt whatsoever 
that they have an aggressive enforcement and compliance in 
place.
    Senator Dorgan. I only make the point that as this economy 
is increasingly global, now almost totally global in all 
respects, it makes our job even more difficult because we are 
not dealing just with an internal marketplace.
    Dr. Sundlof.
    Dr. Sundlof. Yes, thank you. Just an addendum to that 
statement is that we are inspecting several of the feed mills 
in Canada who we know are importing products into the United 
States. So our inspection authority goes outside of our borders 
and into Canada.
    Senator Dorgan. Can I ask, Dr. Hueston, you made a comment 
in your testimony about the need for additional research and I 
believe implied at least the need for additional inspectors. If 
you are going to be vigilant about this, you have to have the 
resources at the front end. You know, we are going through this 
right now on the floor of the Senate on the debate about the 
budget. Some are satisfied with the recommendations that are 
being produced, others are not.
    For example, in agricultural research we see a proposed 
cutback in funding this coming year, which I will oppose and 
will join some others of my colleagues to try to, in fact, 
increase, rather than cut.
    But were you responding to that sort of thing when you made 
your comment, Dr. Hueston?
    Dr. Hueston. I was, and I was also commenting about the 
level of support for agricultural research that is now in place 
in Europe, including the United Kingdom. I think we can learn a 
great lesson. They put a tremendous amount of resources to back 
up their compliance plans and to back up their prevention 
measures by doing research--discovery of additional diagnostic 
tests, determination, in fact, a study of the epidemiology of 
this disease and evaluation of alternative prevention measures.
    Senator Dorgan. Are you saying we are short of resources to 
do that at the present time, in your opinion?
    Dr. Hueston. Yes, sir, I am.
    Senator Fitzgerald. How would others of you respond to that 
allegation, recognizing that you are also in a delicate 
position speaking for your agencies on a larger issue? But I do 
think this really is a very important question. To provide the 
assurances that you have provided and will want to provide in 
the future, we also must have the resources to make sure that 
the research and the food inspections to assure a safe food 
supply are adequate.
    Dr. Hueston suggests that that is not the case.
    Dr. Torres. Senator, in my previous life I used to be a 
university researcher dealing with animal health. As Dr. 
Hueston said, healthy livestock is an insurance of the safety 
of the food as well. The amount of money available to 
extramural research funding from USDA for universities is very, 
very meager. It is I think $12-$14 million, compared to the 
billion dollars that NIH has in extramural research programs.
    Just an increase in that amount of money that could be 
allocated to universities for competitive grants on animal 
health will increase significantly the amount of knowledge and 
the expertise in this country for animal health in general.
    Senator Dorgan. Thank you very much, Mr. Chairman.
    Senator Fitzgerald. Thank you, Senator Dorgan.
    Senator Ensign.

                STATEMENT OF HON. JOHN ENSIGN, 
                    U.S. SENATOR FROM NEVADA

    Senator Ensign. Thank you, Mr. Chairman.
    Let me just begin by stating that I am very proud of the 
veterinarians on the staff. It is obvious veterinarians can do 
a lot of good other than what people normally think that 
veterinarians do. So I am very proud of you on the panel here 
today.
    I do have some questions relating to the transmission and 
the possible etiology. Obviously, we do not know what the exact 
etiology is. But when we are looking at possible transmission 
between the disease, when you were stating that you can really 
only diagnose this in older animals, yet we have it out there, 
it is endemic in these various countries, but yet it is not 
highly contagious.
    So do we know the transmission routes? OK, we say it is 
from ingestion, but do we really know that, in that we cannot 
diagnose it until later in life, but yet most of the food 
products, especially with the zoonotic aspect of this is from 
eating younger animals. So is it transmissible, I guess, before 
the pathological signs are shown, or is it as soon as they are 
infected then those animals are then infectious? Or do we know 
that?
    Dr. Hueston. Senator Ensign, the infectivity is associated 
the specific tissues. Late in the course of the disease, you 
have the brain and the spinal cord that achieve the highest 
level of infectivity. Much earlier in the pathogenesis of the 
disease, you have infectivity identified in the lower GI tract, 
the distal ilium. It would appear from all the epidemiologic 
evidence that it is incorporation of this infective material in 
animal feeds or rendered animal products incorporating these 
materials that are the source of the exposure.
    It turns out that the infective dose is very, very small. 
Less than 1 gram of infected brain material will cause a cow to 
develop the disease.
    The other epidemiologic evidence you might find interesting 
is, if a farmer purchased an affected animal prior to its 
showing clinical disease and that animal developed clinical 
disease on the farm, as long as that farmer has never fed feeds 
containing this infected material the other cattle on the farm 
are at no additional risk.
    Senator Ensign. Having said that, do we know, are 
peripheral nerves involved at all, or is it just central 
nervous?
    Dr. Hueston. The tests to date looking at peripheral nerves 
have detected no infectivity. The closest is that you have 
brain, spinal cord, and then you have some of the nerve bundles 
coming directly off of the spinal cord. You have the dorsal 
root ganglia and the trigeminal ganglia. But the work today of 
transmission studies looking at these nerves out in the rest of 
the body, none of those have proven or have demonstrated any 
infectivity.
    Senator Ensign. It just seems to me, with the difficulty in 
transmission, it would seem to me to be a disease that you can 
rid a country of. Are the Europeans countries taking the steps 
necessary, and is that something that the United States needs 
to be involved in? There is always this big debate over foreign 
aid and to me foreign aid is especially appropriate when we 
have a vital U.S. American interest, and this is certainly a 
vital U.S. American interest involved.
    How are we involved in helping the Europeans, or do they 
need our help?
    Dr. Sundlof. Thank you, Senator Ensign. Well, I think you 
raise a very valid point and I think there is agreement that 
this is a disease that is subject to eradication because you 
can control it by controlling the animal feed.
    I think that most people will agree that this is a disease 
which can be eradicated, which should be eradicated. Your 
question about what has happened in Europe that has led to the 
current situation--I just brought a quote with me that I 
thought was insightful and pertinent to this discussion. It is 
from David Byrne, the European Commissioner for Health and 
Consumer Protection. This was presented to the Commission 
Policy on Health Aspects of BSE in Brussels in February of this 
year. He says--this is the person responsible, now, for 
managing the European situation. He says: ``It disappoints me 
that every time the crisis takes a new turn the response is to 
immediately look to some magic solution or to some new measure 
which will impress the public. If the same effort was given to 
the implementation of measures already in place, I am convinced 
that the situation would be far less serious. Unfortunately, 
again and again the Commission has found that BSE is only taken 
seriously when the damage is already done. Left to account for 
past mistakes, the reaction is far too often to call for new 
measures, rather than to acknowledge past failures.'' I thought 
that was particularly insightful.
    Senator Ensign. The reason I brought up that question was 
also because of scrapie as one of the TSEs that we have in this 
country and the difficulty in eradicating scrapie. Why have we 
not been able to eradicate scrapie in the United States?
    Dr. Torres. Senator, there are multiple factors. One is the 
diagnosis. In scrapie, like in other TSE diseases, we need to 
almost see the dead animal or clinically ill animal to be able 
to provide diagnosis. We do not have a reliable in vivo 
diagnostic test. We have now a new test being evaluated, but 
that test, it helps, but it is not the ultimate test to detect 
the animals early on in infection.
    If I may make a comment about your previous question, one 
thing that we are going to see perhaps is an increase of BSE in 
less developed countries that imported a lot of the 
contaminated meat and bone meal from Europe unknowingly to 
them, and we are going to see a peak in a few years of a lot of 
less developed countries and those are going to need our aid.
    Senator Ensign. Last, just real quickly because I want to 
make sure I get the question in, has to do with the importation 
of zoo animals. Do we have anything in place as far as trying 
to prevent some of these things from coming as far as zoo 
animals are concerned?
    Dr. Torres. The only zoo animals that we know were affected 
were those that received the contaminated feed in the United 
Kingdom. So there are provisions to be sure that animals that 
come in have not been fed contaminated--ruminant origin 
proteins in the countries affected.
    Senator Ensign. Dr. Hueston, did you have a comment?
    Dr. Hueston. I was just going to add to the comment about 
scrapie and scrapie eradication. Another of the challenges, you 
will understand, is that there was insufficient money to carry 
out the programs regardless of how scientifically sound the 
programs have been in the past. In addition, I think there is 
an important point here that, unlike some of the earlier 
scrapie efforts, there has been a very strong collaboration in 
these current prevention actions for BSE between government 
agencies and between the potentially affected industries and 
the government agencies.
    Senator Ensign. Do you think that is something, as far as 
the scrapie, the reason for the funding, because of the lack of 
zoonotic potential there?
    Dr. Hueston. I think that, too. A disease of sheep does not 
gain a whole lot of public attention or is not a very highly 
visible and attractive area for Congress to support in terms of 
funding.
    Senator Fitzgerald. Thank you, Senator Ensign. It is good 
to have a veterinarian in the Senate. I guess we have two now, 
you and Senator Allard, and maybe you can be even more helpful 
in the future.
    Senator Gordon Smith has joined us. I do not know if you 
have an opening statement or would like to ask any questions of 
this panel. We are going to have another panel shortly.

                STATEMENT OF HON. GORDON SMITH, 
                    U.S. SENATOR FROM OREGON

    Senator Smith. Thank you, Mr. Chairman. I do not have an 
opening statement. I came out of, frankly, an interest in the 
issue, but also wearing two hats, one as a Member of the 
Commerce Committee and your Subcommittee, but also as the 
Subcommittee Chairman on European Affairs in Foreign Relations.
    I think my question is more one to elicit information for 
the general public, Americans who may want to travel to Europe, 
and concern that they may have about being infected by these 
issues, these diseases, or the possibility of their bringing 
them back to our shores. I wonder if, for the sake of our 
European friends, if you can speak to this issue as their 
relates to tourism, as it relates to other commerce that we 
have with Europe, so as not to unnecessarily alarm the American 
public or to unnecessarily disadvantage our European brothers 
and sisters who would like to see us over there this summer.
    Any comments?
    Senator Fitzgerald. Dr. Johnson, you kind of touched upon 
this earlier. Maybe you would want to reiterate what you said.
    Dr. Johnson. I think there are two different issues. One is 
Britain, where there has been concern in the past and where the 
number of animals with the diseases has plummeted to very low 
levels now. It is obviously much safer now to eat beef in 
Britain, although I must say I have eaten beef in Britain 
throughout this thing. It is a personal taste.
    In Europe, and in the other countries where there have been 
cases, there have been small numbers so far of cases and there 
have been no human cases except in France and Ireland, and 
those are trivial numbers.
    The danger of driving to the airport is probably greater 
than the danger of eating meat in Europe, I would just on a 
relative risk basis put it at the present time. I would 
reassure your constituents to feel free to travel.
    Senator Smith. So if they want to go and hunt and fish and 
things like that, they are not going to be getting it on their 
shoes and bringing it back?
    Dr. Johnson. That is a different disease, and they may not 
be able to hunt in England because of that, but that is another 
issue.
    Senator Smith. I understand that they are different, but I 
do not think the general public does. I think it is important 
to elucidate this for them, because I have heard comments, you 
know: Can I go and eat at McDonald's? Can I go golfing? Can I 
go fishing? Will there be farm soils that I bring on my shoes 
that will somehow be problematic for this country? Your answer 
is, no, it will not be?
    Dr. Johnson. As far as BSE is concerned. The foot and mouth 
problem is a very different problem, with very different 
solutions.
    Senator Smith. Thank you, Mr. Chairman.
    Senator Fitzgerald. Thank you to this panel. You have all 
been wonderful, very good expert testimony, and we appreciate 
all of your coming here today. Thank you very much.
    We will move now quickly to the second panel. On the second 
panel we are going to have: Chuck Schroeder, who is the CEO of 
the National Cattlemen's Beef Association; Mr. James Hodges, 
President of the American Meat Institute Foundation; Mr. 
Richard Sellers, Vice President, Feed Control and Nutrition, at 
the American Feed Industry Association; and Ms. Caroline Smith 
DeWaal, Director of the Food Safety Program, the Center for 
Science in the Public Interest; and finally, Dr. Peter Lurie, 
the Deputy Director, Health Research Group, at Public Citizen.
    All of you, thank you very much for coming. I will start 
with Mr. Schroeder. We anticipate that while you are testifying 
there is going to be a vote coming up, and when there is just a 
few minutes left for the vote I am going to temporarily adjourn 
this hearing, and then we will come right back as soon as the 
votes have been concluded, but there might be a temporary 
respite. We are going to go right up until we have a few 
minutes to get over to the floor to vote.
    So, Mr. Schroeder, welcome and thank you for being here.

STATEMENT OF CHUCK SCHROEDER, CHIEF EXECUTIVE OFFICER, NATIONAL 
                  CATTLEMEN'S BEEF ASSOCIATION

    Mr. Schroeder. Senator Fitzgerald, thank you and thanks to 
the Members of your Subcommittee for the opportunity to provide 
some testimony today on what is clearly one of the major 
challenges facing our industry.
    I am Chuck Schroeder. I am Chief Executive Officer of the 
National Cattlemen's Beef Association. We are a producer-
directed, consumer-oriented trade association representing 
America's cattle farmers and ranchers.
    I hope that the testimony I provide today and that of my 
colleagues will help this body take actions that will ensure 
that American consumers continue to have the safest, most 
wholesome food supply in the world. I also hope that through 
the course of this hearing we can remind American consumers, as 
well as our producers and our consumers abroad, of three very 
important points about the BSE situation in this country:
    No. 1, as has been pointed out by the previous panel, there 
has not been a confirmed case of BSE in this country, and that 
is no accident. We have taken important actions.
    Second, the U.S. Government, with full cooperation from 
America's beef cattle industry, has taken and continues to take 
steps that are necessary to prevent the introduction of the 
agent that causes BSE to this country.
    Third, it is important that the United States, with the 
support of the Congress, continue to set the world standard for 
research, for inspection, for surveillance, and for food safety 
monitoring systems that will instill confidence in our 
consumers, again both domestically and around the world.
    Speaking of consumer confidence, it is important to note 
that a recent consumer survey which we had conducted indicates 
that consumer confidence in the safety of beef has actually 
increased, in spite of negative media coverage of BSE and other 
safety issues and the fact that 81 percent of American 
consumers have demonstrated that they have heard something 
about BSE in the last quarter. In spite of that, their 
confidence has increased.
    Again, we believe that that current high consumer 
confidence in our beef system is not just an accident. It is 
the result of industry and government efforts to insist on 
science-based measures, science-based decisions to keep our 
industry free from the disease and to keep our consumers 
confident in the wholesomeness of our product.
    Three important steps have been taken and they have been 
described in some depth by previous panelists, so I will just 
highlight them. But those three firewalls have been very key to 
protecting the U.S. beef industry and reassuring consumers that 
BSE is not present in the U.S., nor in the U.S. beef supply.
    First is the ban of all imported products that could 
contain the BSE agent from all countries who have cases of BSE. 
You have heard that described in some detail.
    The second firewall is the continued ban on the feeding of 
ruminant-derived feed products to ruminants. Again, you have 
heard the details of that.
    Third, and an extremely important one, is an active BSE 
surveillance system that is targeted to animals over 30 months 
of age that have symptoms of neurological disorders. We have 
had that system in place since 1989, and since that program was 
put in place we have examined post-harvest more than 12,000 
tissue samples from animals that have been analyzed, that 
showed some signs of potentially having the disease.
    Despite that 10 years of surveillance, we have not had one 
confirmed case in this country. While we believe that 
surveillance system has been sound, NCBA does support USDA 
actions to double the number of animals that are undergoing 
testing in the surveillance system, to further reassure 
consumers that indeed the disease has not arrived in this 
country.
    It is important to remember that, given the fact that the 
BSE agent is exclusively localized in brain and spinal cord, 
several years ago USDA and the processing industry took steps 
to ensure that those tissues do not inadvertently enter the 
human food supply, and we had a question on that here earlier.
    It is important to note as well that this is a North 
American effort. We had some discussion about risks from our 
neighbors. Currently, Canada and Mexico have taken the same 
steps that the U.S. has to protect their industry from 
introduction of the agent and to prevent its spread should it 
ever be found in North America.
    NCBA met with our counterparts, the CNG in Mexico and the 
Canadian Cattlemen's Association, at our recent convention the 
reaffirm, which we put out in a joint statement, our collective 
commitment to seeing that we are complying with the regulations 
that are in place and that we in North America are protecting 
our beef herds.
    We would encourage Congress and Federal agencies to 
maintain their focus, as Dr. Hueston recommended earlier, 
maintain their focus on science-based decisionmaking. We would 
urge you to avoid policy changes that are proposed by those 
seeking to accomplish political objectives that simply do not 
support the science-based animal disease firewalls that we have 
in place. We ask that any decisions you make be based on the 
best available science and we have tried to support continuing 
discovery in these areas.
    As referenced earlier, USDA has asked the Harvard Center 
for Risk Analysis to review what has been done and to assess 
the risk of BSE in this country. The preliminary findings of 
Dr. George Grey, who is the Center's Program Director for Food 
Safety in Agriculture, confirms our belief that indeed BSE is 
``not likely to occur here.'' Dr. Grey has stated that, 
``Although our work is not complete, what we have learned so 
far suggests that consumers have little to fear. In our 
judgment,'' he says, ``the risk that mad cow disease could 
happen in the USA is low and the risk that it could spread as 
it did in Europe is lower still.''
    I would like to offer three recommendations to Congress, 
recommendations in three areas. First, in the area of 
regulatory enforcement, as Dr. Sundlof I believe stated, we 
would encourage you to remain focused on enforcing the 
regulations that we currently have. Congress should provide 
support for state departments of agriculture, for the Food and 
Drug Administration, and private industry to ensure 100 percent 
compliance with the FDA feed ban that again was discussed by 
the previous panel.
    We also would request that Congress provide the resources 
that are required by USDA, the Food and Drug Administration, 
and Customs to enforce the fully regulatory framework that will 
keep our beef industry free of BSE.
    Second, in the area of research, we are calling upon 
Congress--and Senator Dorgan, I appreciated your question 
earlier--we are calling upon Congress to commit to doubling 
funding for agricultural research to $2.4 billion annually over 
the next 5 years. We think it is critically important. This 
funding would include construction of a national animal disease 
center at Ames, Iowa, at a cost of approximately $400 million.
    Third, in the area of discretionary funding, we certainly 
understand as we work around this town the many priorities and 
interests that are competing for limited resources. But to 
protect our industry from today's animal health concerns, we 
believe that we have to commit to providing the resources that 
are needed to protect livestock health.
    Specific increases in funding we believe are needed for 
USDA's Animal and Plant Health Inspection Service, for the 
Agricultural Research Service, the Cooperative State Research, 
Education, and Extension Service, and the Food Safety 
Inspection Service.
    The cattle producers and our colleagues across the 
industry--and you will hear from some of the rest of them here 
today--are absolutely committed to ensuring that the U.S. 
continues to remain free of BSE and that the safety and health 
of the U.S. beef industry is maintained. Further, we are always 
committed to protecting our consumers. If they are not buying 
our product, we are all out of business.
    Mr. Chairman, I thank you for the opportunity to provide 
this testimony. I would be glad to answer questions as we get 
to that point.
    [The prepared statement of Mr. Schroeder follows:]
    Prepared Statement of Chuck Schroeder, Chief Executive Officer, 
                 National Cattlemen's Beef Association
    I would like to thank the Chairman and members of this Subcommittee 
for the opportunity to testify today. My name is Chuck Schroeder and I 
am the Chief Executive Officer of the National Cattlemen's Beef 
Association. NCBA is a producer-directed and consumer-focused trade 
association representing America's cattle farmers and ranchers. I hope 
that my testimony today can help this body to take the appropriate 
action to ensure that American consumers continue to have the safest 
and most wholesome food supply in the world.
    NCBA hopes that this hearing and others like it will help us 
clearly point out the facts regarding BSE to both our consumers around 
the world and our producers here in the United States:
     No cases of BSE have ever been identified in the U.S.
     The U.S. government, with full cooperation of the U.S. 
beef industry, continues to take actions to prevent the introduction of 
the agent that causes BSE.
    The U.S. Government, at the request of beef producers and 
consumers, invests 100s of millions of dollars annually to prevent the 
introduction of foreign animal diseases such as BSE. The United States 
must continue to set the world standard for research, inspection, 
surveillance and food safety monitoring systems to instill confidence 
in our beef customers, both domestically and abroad.
                               background
    NCBA has been involved in making sure that the U.S. continues to be 
free of Bovine Spongiform Encephalopathy (BSE) for a number of years. 
NCBA would first remind Senators that BSE has been and remains a 
foreign animal disease. American consumers have been bombarded with the 
scenes from the United Kingdom, almost on a daily basis in every form 
of media for months. While the U.S. needs to learn from the crisis in 
Europe, NCBA's focus continues to be on keeping the U.S. and North 
America free of BSE. We believe it is vital that U.S. consumers are 
assured that their beef supply continues to be safe and BSE free.
    A recent consumer survey conducted on behalf of the beef industry 
indicates that consumer confidence in beef's safety has actually 
increased despite the fact that 81 percent of consumers have heard of 
BSE since the fourth quarter of 2000. The NCBA believes that current 
high consumer confidence in our beef system is not an accident. It is 
the result of industry and government efforts to insist on science-
based measures and decisions to keep our industry free from disease and 
our consumers confident in the wholesomeness of our product.
    The absence of BSE in this country is due to great and positive 
cooperation between the public and private sector. The American cattle 
industry and the U.S. government have been working together for more 
than a decade to keep BSE out of the United States and North America 
and keep it from spreading if it does appear. The U.S. has taken the 
following actions that are fully supported by all facets of the beef 
industry:
    1. Import ban of all products that could contain the BSE agent from 
all countries with cases of BSE.
    2. Ban on the feeding of ruminant derived feed products to 
ruminants.
    3. Active BSE surveillance system targeted to the animals over 30 
months and with symptoms of neurological disorders.
    NCBA believes that as an industry and as a nation we can be proud 
of our success in keeping the U.S. cattle herd healthy and free of 
diseases like BSE and Foot and Mouth Disease. These three steps are 
keys to protecting the U.S. beef industry and reassuring consumers that 
BSE is not present in the U.S. or the U.S. beef supply.
                               import ban
    In 1989, the USDA banned the importation of all cattle and animal 
products that could carry the BSE agent from the United Kingdom. Cattle 
imported from the United Kingdom prior to this ban were traced and 
eliminated with the exception of 4 animals that are essentially pets. 
They will never enter the food supply.
    In December 1997, the USDA banned the importation of all cattle and 
products that could possibly carry the BSE agent from all of Europe. 
All cattle imported from Europe prior to this ban have been traced. 
None will enter the food supply and efforts are underway to purchase 
them and submit them to the BSE surveillance program. Since this ban 
was put into place, the U.S. has stopped the importation of many 
products including bone china, fish food, and supplements.
                              feeding ban
    In an effort to remain proactive and aggressive in our protection 
of the U.S. livestock industry, in 1996, NCBA asked the beef and dairy 
cattle sectors in the U.S. to stop feeding meat and bone meal to cattle 
derived from all ruminants, meaning cattle, sheep, goats, deer, elk, 
etc. Beef and dairy producers have worked hard to meet the challenge 
and have taken a number of steps to assure compliance within the 
industry. NCBA also asked the Food and Drug Administration to develop 
regulations in this regard. The FDA agreed with NCBA and new 
regulations went into effect on June 2, 1997. The U.S. was the first 
country to take this major step before there was any evidence of the 
disease. Since that time, virtually all other beef-producing countries 
in the world have followed suit.
    This adds additional protection and ensures they do not represent a 
risk for use in other species. Meat and bone meal is a high quality 
product, not any different conceptually to giving your dog a steak 
bone. In this case it is processed to destroy all known bacteria, 
viruses or spores and transformed so animals can more readily utilize 
these valuable and much needed nutrients.
                              surveillance
    The United States has had an active BSE specific surveillance 
program since 1989. We have always had an aggressive surveillance 
program for neurological disease due to the threat of Rabies. Since the 
BSE surveillance program was instituted, more than 12,000 brain samples 
from animals old enough and with conditions that might share symptoms 
with BSE have been analyzed. It is important to note that these samples 
have been taken from cattle considered to be the highest risk of 
identifying BSE if it were present. Our surveillance program exceeds 
the international requirements set by the Office of International 
Epizootics, the international animal health organization linked to the 
World Trade Organization. Despite over 10 years of active government 
surveillance for the disease in the United States, not a single case of 
BSE--not one--has been found in the U.S.
    From the beginning, the U.S. surveillance program has been ahead of 
its time. Starting in 1993, the diagnostic program began using an 
Immuno-Histo-Chemistry (IHC) method. This method is as sensitive as any 
system in use in the world today. It can pick up BSE more than 3 weeks 
prior to the animal showing any signs. All samples submitted are 
evaluated by both histology (how the brain looks under a microscope) 
and IHC.
    The USDA has announced it will double the number of animals 
submitted to the surveillance program, a move we fully support. The 
current testing program gives us great confidence that we have 
successfully kept BSE out of the U.S. As a result of the steps taken to 
prevent BSE in the U.S., we are confident the animal protein by-
products produced from U.S. cattle are BSE free.
                     additional information on bse
    The BSE agent has NEVER been identified in the U.S. or in beef. In 
March, the USDA held a comprehensive BSE research briefing in 
Beltsville, Maryland. Dr. Danny Mathews of the Veterinary Laboratory 
Agency in Weybridge, United Kingdom, discussed current research on the 
disease. It is important to note that they have reaffirmed that the 
ONLY tissues from cattle that carry the BSE agent are brain, spinal 
cord and part of the intestine. Blood from animals with BSE has NEVER 
been shown to carry the disease agent. Once again, they documented that 
beef itself NEVER carries the infectious agent, even from cows with 
full-blown BSE.
    Given the fact the that BSE agent would exclusively be localized in 
the brain and spinal cord, several years ago the USDA and packing 
industry took steps to ensure these tissues do not inadvertently enter 
the human food supply. For this reason, the use of pneumatic, air-
injection stunning devices has been discontinued in the U.S. and spinal 
cords must be completely removed in packing plants.
    NCBA and the U.S. beef industry are focused on more than just 
keeping the U.S. BSE-free. We have joined with our Canadian and Mexican 
counterparts to develop a North American plan to keep BSE from our 
continent. Currently, Canada and Mexico have taken the same steps that 
the U.S. has to protect their industry from introduction of the agent 
and its spread should it ever be found.
                     suggested congressional action
    The NCBA requests that Congress consider the following steps to 
continue the prevention and introduction of BSE into the U.S.:
                     science-based decision-making
    We ask that any decisions you make be based on science. NCBA asks 
that you avoid decisions based on rumor and rhetoric spread by those 
more interested in stopping the consumption of beef and meat products 
than protecting the rights and needs of consumers. NCBA also urges you 
to avoid policy changes proposed by those seeking to accomplish 
political objectives that do not support the science-based animal 
disease firewall but would prevent the U.S. producer from operating in 
a global market.
                         regulatory enforcement
    We must remain focused on enforcing the regulations we currently 
have. If we continue to do so, we will remain BSE free and our beef, 
dairy cattle, and consumers will be protected. Congress should provide 
support for state departments of agriculture, FDA and private industry 
to ensure 100 percent compliance with the FDA feed ban. Private 
industry and state partnerships with the FDA play a significant role in 
ensuring compliance. We know how to prevent BSE in the United States. 
To date, we have accomplished this important task and the U.S. remains 
free of BSE.
    NCBA has asked that USDA, FDA and Customs officials continue to 
monitor their own actions and programs to look for ways to improve the 
firewall that protects U.S. livestock producers and keeps the U.S. free 
of the diseases of immediate concern. We request that Congress provide 
the resources needed by USDA, FDA and Customs to enforce the 
regulations that will keep our beef industry free of BSE.
                            research funding
    The NCBA calls upon Congress to commit to doubling funding for 
agricultural research to $2.4 billion annually over the next 5 years. 
This funding would include construction of a National Animal Disease 
Center at Ames, Iowa at a cost of $350 million. This facility could 
help provide important diagnostic, monitoring, and surveillance for 
diseases that could infect the national livestock herd. The cost of 
this facility may seem high, but it would provide long-term benefits 
for agriculture, particularly in light of the Foreign Animal Diseases 
that exist around the world.
    implement improvements suggested by harvard bse risk assessment
    USDA asked the Harvard Center for Risk Analysis to review what has 
been done and to assess the risk of BSE in this country. The 
preliminary finding of Dr. George Gray, the center's program director 
for food safety and agriculture confirms our belief. BSE is ``not 
likely to occur here'', according to Dr. Gray in a preliminary finding. 
Gray further stated that ``Although our work is not complete, what we 
have learned so far suggest that consumers have little to fear. In our 
judgment, the risk that mad cow disease could happen in the USA is low, 
and the risk that it could spread as it did in Europe is lower still.'' 
The preliminary report from Harvard would further indicate that even if 
an infected animal shows up in this country, the safeguards in place 
would keep that animal from reaching the human food chain.
    NCBA is confident that the final version of the Harvard Center for 
Risk Analysis, due out in the coming days, will be supportive of the 
systems for surveillance and testing already in place. We must take the 
steps needed to ensure that we will be ready in the future. A failure 
to prepare for future challenges will leave us in a precarious and 
unpredictable condition during some future challenge.
                         discretionary spending
    The NCBA understands that there are many priorities and many 
interests competing for limited resources. We are hopeful that NCBA and 
current events have demonstrated the need for significant spending on 
the discretionary side. We are also optimistic that you can support 
these programs to the greatest degree possible given the allocation and 
budget constraints with which you must comply. To protect our industry 
from BSE, FMD and other diseases, the NCBA believes that we must commit 
to providing the resources needed to protect our livestock health.
    Specific increases in funding will be needed for USDA's Animal 
Plant Health Inspection Service, Agriculture Research Service, 
Cooperative State Research Education and Extension Service, and Food 
Safety Inspection Service. Additionally, other areas in USDA and FDA 
will have new and additional needs that must be addressed to provide 
for any measures that may be required in the future. In recent years 
the United States has followed the EU model of supporting agriculture 
with increased levels of funding for commodity programs at the expense 
of many of the systems that provide support for our firewall against 
foreign animal disease. New losses in funding in these critical areas 
would undermine our ability to protect our consumers, our producers and 
the livestock of the United States.
                               conclusion
    The NCBA appreciates the opportunity to visit with you today. More 
information about BSE can be found at our peer-reviewed site http://
www.bseinfo.org. BSE has been of concern to the U.S. beef industry 
since it was first identified in the UK in 1986. NCBA has supported the 
actions that the U.S. government has taken to protect the U.S. beef 
industry and U.S. consumers from BSE. BSE has not ever been identified 
in North America and we will continue to take steps to ensure that it 
does not occur. We will pay careful attention to the results and 
recommendations in the Harvard BSE Risk Assessment. NCBA looks forward 
to working with Congress, the Administration, BSE experts and our 
partners in the beef industry to make sure that all scientifically 
justified measures that need to be taken, are taken. The NCBA is 
committed to ensuring that the U.S. continues to remain free of BSE and 
that the safety and health of the U.S. beef industry and our consumers 
is protected.

    Senator Fitzgerald. Thank you, Mr. Schroeder.
    We are going to go adjourn now temporarily for a vote, and 
I think there is a second vote right after that. We will try 
and rush back quickly, and then, Dr. Lurie, we will open up 
with you after the break.
    [Recess from 11:02 a.m. to 11:57 a.m.]
    Senator Fitzgerald. Thank you all very much for your 
patience. That was a long roll call, and we are pleased the 
resume the Subcommittee hearing.
    Dr. Lurie, you are next. So please give us your testimony. 
Thank you for being here.

             STATEMENT OF PETER LURIE, M.D., MPH, 
        DIRECTOR, HEALTH RESEARCH GROUP, PUBLIC CITIZEN

    Dr. Lurie. Thank you for having me. I am Deputy Director of 
Public Citizen's Health Research Group and also a member of 
FDA's TSE Advisory Committee.
    The theme of my testimony is that, even though we heard 
much about the safeguards that USDA, FDA, and so forth have in 
place, there are, in fact, a number of holes in these 
safeguards that need to be plugged, for in these safeguards 
there are a number of exemptions, there is clear evidence that 
enforcement is often poor, and in many cases, although not 
clearly stated today by the agencies, compliance is, in fact, 
voluntary, and that is especially true for FDA.
    On the last page of my testimony, we have listed 17 
concrete actions that we think the government could take that 
would reduce the risk of transmission of BSE to cattle or vCJD 
to humans, and I urge you to look at those closely.
    The first question that I will address is how the BSE agent 
could actually enter the country. We heard somewhat about the 
Customs inspectors and what is being done at the borders. What 
was not said is that the current Administration has proposed an 
overall 7 percent cut in the USDA budget and no increase 
whatsoever in the APHIS budget, even though they now are 
expanding the testing of downer cows and they have to look at 
the increasing problem of foot and mouth disease.
    I think that you really cannot adequately police the 
borders if the demands are increasing, yet the budget remains 
the same.
    We are very worried about dietary supplements as a way of 
the BSE agent entering the country. In 1994, the government, 
unwisely in our view, effectively deregulated the dietary 
supplement industry through the Dietary Supplement Health and 
Education Act, called DSHEA. It is literally possible, despite 
the assertions of FDA, if one were an unscrupulous manufacturer 
to source material for a dietary supplement, which often 
includes such delectable materials as pineal, brain, pituitary, 
you could literally source that from a BSE country, dry it out, 
crush it up, put it in a pill, and then import it into the 
United States.
    Yes, there is an import alert, but the FDA only inspects 
about 1 percent of all materials that enter the country and the 
import alert is, in fact, voluntary. So we are not in the least 
bit reassured by the statements of FDA this morning.
    Now, if the BSE agent actually entered the country, how 
might it spread? Well, the first place would be through feeding 
practices. As you know, there is a mammal-to-ruminant feeding 
ban, but we know from FDA inspections that commingling of the 
food that is allowed to be fed to cows and that which cannot be 
fed to cows is, in fact, not only possible, but, in fact, has 
happened. The most recent reports from the FDA show that 14 
percent of renderers and 13 percent of FDA-licensed feeding 
mills do not have adequate procedures to prevent mammalian 
parts from being recycled and entered into the ruminant feed 
chain.
    This is what has resulted in the need for the slaughter of 
1222 cows in Texas after exactly that kind of commingling 
happened. It is precisely that kind of commingling that led to 
the great expansion in the BSE epidemic in Britain. We need to 
cut it off at the pass.
    But the problem is that 23 percent of renderers and 63 
percent of FDA-licensed feed mills still have not been 
inspected for compliance by the FDA and there are another 6,000 
to 8,000 feed mills that do not even have to register with the 
FDA. So it is fine and well to have a ban, but it does not do 
much good if inspection rates are low and compliance is not all 
it should be.
    There are also exemptions, as I mentioned earlier, to the 
feed ban. One of them is on so-called plate waste, which is 
leftover food that has been prepared and/or served to humans, 
and that is collected by that industry and can, in fact, be fed 
to ruminants. The European Union, Canada, and Mexico do not 
permit such practices and neither should we.
    Chronic wasting disease is a disease not shown so far to be 
spread to humans, but it is true is that if you had a herd 
which has a positive animal based on looking at the animal's 
brain, sure, that animal would not enter the food supply, but 
the remaining animals could, in fact, enter the food supply. 
One of the reasons for that is because there is no ability to 
compensate the farmers for their herds.
    So, I think that the Congress needs to take action or else 
regulatory action will be necessary that would exclude any 
animal from a chronic wasting disease--CWD (Chronic Wasting 
Diesase)-affected herd from entering the food chain.
    Now, the second issue is meat processing and I think that 
Ms. DeWaal will talk about this in perhaps more detail, so I 
will just mention a couple of things. One are pneumatic 
stunning devices, which are used at least in some parts of the 
industry. These devices stun the animal, in part by injecting 
compressed air into the brain. This has been shown to spread 
neurological tissue to various parts of the animal.
    These devices have been banned for use with cattle in 
Europe and they ought to be banned here as well. Moreover, 
European countries require that the brain and spinal cord be 
removed early in the slaughtering process, but in this country 
there is very little regulation of the slaughtering process and 
practices vary widely across the country. So I think that we 
need a regulation that would require removal of the brain and 
spinal cord early on in the slaughtering process.
    Ms. DeWaal will talk about advanced meat recovery, so I 
shall not get into it in detail, except to say that it is 
literally possible through either of these processes to include 
parts of the spinal cord in material that might end up in the 
food chain, including in ground beef. Although it is stated 
that advanced meat recovery, one of these two processes, does 
not include spinal cord, in fact, documents obtained by the 
Government Accountability Project from the USDA in 1997 showed 
that 4 of 34 advanced meat recovery samples that were sent to a 
laboratory for suspicion of containing spinal cord, in fact, 
did contain spinal cord.
    The USDA began a rulemaking 3 years ago to clarify the 
rules on advanced meat recovery so that this kind of 
contamination of advanced meat recovery product would not 
happen, but 3 years later they still have not been finalized.
    Is the U.S. doing enough to detect the disease? I think 
that up to now the answer is no, but I think that there is an 
effort now to expand particularly testing of the downer cow 
population and I think that that is a reasonable step and 
should be supported, not only in general, but with funds.
    Surveillance for human and new variant CJD is coordinated 
through the CDC and a group of pathologists up at Case Western 
Reserve University. However, they only see about 39 percent of 
the brains of patients with CJD, whereas in Germany and Britain 
essentially all of the patients with CJD have their brains 
examined by a pathologist. Canada has also improved its system 
lately, but we are trailing far behind.
    Part of the problem is that autopsy rates have been falling 
dramatically in this country ever since World War II, when the 
autopsy rate was about 40 percent. It is down to under 10 
percent at present and not all of those have brain specimens 
taken. One reason is that hospitals and families wind up 
bearing the cost of autopsies, and obviously, that reduces the 
probability that autopsy will actually happen.
    Finally, are there medical practices that might transmit 
BSE and vCJD? The TSE Advisory Committee on which I sit 
recommended a ban on blood donations from any donor that had 
spent a cumulative total of 6 months in Britain between 1980 
and 1996. I think that was a good plan. Earlier this year when 
new cases of vCJD and BSE started to show up in Britain and in 
Europe, we extended this recommendation to include France, 
Portugal, and Ireland, although with a longer cumulative 
residence requirement because the number of cases in those 
countries is much lower than in Britain.
    The FDA needs to adopt that committee recommendation. It is 
now 2 months since the recommendation, and I just think we need 
to make sure that gets adopted.
    I think there should be similar travel restrictions placed 
on cadaveric cornea donors because there have, in fact, been--
depending on how you count them--as many as three cases of CJD 
that have been transmitted through cornea donation. So I think 
we need to worry with regard to that, and travel restrictions 
similar to those for blood donors need to be in place. The U.S. 
is a net exporter of corneas, so I do not think we need to 
worry about creating any kind of shortage from a doner fund 
restriction.
    I want to close off by talking about the debacle of 
vaccines. The story as told this morning focused on the low 
risk of vaccines with regard to variant CJD for the American 
population and I think that that is actually true. But there is 
an untold story here and this is it. Back in 1993, the FDA 
wrote to the manufacturers of FDA-regulated products and in a 
voluntary guidance asked the manufacturers to no longer source 
their materials from BSE affected countries. It repeated that 
admonition in 1996.
    But six manufacturers who produced eight vaccines at a 
minimum decided not to follow that guidance. They did not need 
to follow the guidance because it was a guidance and not a 
regulation. They went ahead and made eight vaccines and 
millions of doses were injected into Americans, including into 
small children.
    Again, I do not think that the risk of vCJD was high, but 
there are two lessons from this. Lesson one, if the government 
has a chance to take action it should do so by regulation, not 
by voluntary guidance. Second, if we leave the industry with 
the ability to exploit voluntary guidances by simply ignoring 
them, in some cases the industry will step in and do just that, 
and then we wind up with the vaccine situation.
    So the lesson of the vaccine debacle applies more broadly 
to our efforts to reduce the risks of BSE and vCJD in this 
country. For the public to be protected, the government needs 
to take forceful action. We need to have bans that have fewer 
exemptions. We need bans that are truly bans and are not often 
voluntary, and we need to make sure that the better of the 
existing bans are adequately enforced.
    Thank you.
    [The prepared statement of Dr. Lurie follows:]
Prepared Statement of Peter Lurie, M.D., MPH, Director, Health Research 
                         Group, Public Citizen
    While the U.S., to the best of our knowledge, remains free of both 
Bovine Spongiform Encephalopathy (BSE), otherwise known as ``Mad Cow 
Disease,'' as well as its human counterpart, variant Creutzfeldt-Jacob 
Disease (vCJD), the experiences of European countries that grew 
complacent and now are suffering from epidemics of BSE and, in some 
cases, vCJD should make us more vigilant than we are at present. The 
agent that causes BSE has often found a way to pierce small chinks in 
the public health armor. For this reason, it is critical not only to 
maintain our defenses but also to strengthen them in the several areas 
I will highlight in this testimony.
    I will address four areas: 1. How the agent that causes BSE might 
enter the country; 2. How the agent, if it entered the country or arose 
spontaneously within the country, could spread; 3. Whether the U.S. is 
doing enough testing to detect the disease; and 4. Whether there are 
medical practices that might spread the disease.
               how could the bse agent enter the country?
    We have serious concerns about the ability of customs inspectors to 
adequately police the borders. With the dramatic increase in global 
trade, the workload of these inspectors is only likely to grow. 
Transhipments between countries can make determining the origin of meat 
and bone meal quite difficult. This is, of course, an issue that 
extends well beyond BSE to encompass broader issues of food safety.
    An issue of particular concern is that of dietary supplements. In 
1994, the government, unwisely, essentially deregulated the dietary 
supplement industry. Whereas, prior to the Dietary Supplement, Health 
and Education Act (DSHEA), the industry had the burden of demonstrating 
the safety of its products, now the Food and Drug Administration (FDA) 
must demonstrate that a particular dietary supplement is unsafe before 
it can take action. Moreover, this now-$14 billion industry is not 
required to prove the efficacy of its products and the FDA has still 
failed to issue Good Manufacturing Practice (GMP) regulations for 
dietary supplements 4 years after the agency commenced rulemaking on 
this issue and 7 years after DSHEA. Manufacturers are not required to 
register with the FDA and the agency only inspects approximately 1 
percent of imported items subject to its jurisdiction, a fraction that 
may be still lower for dietary supplements. The agency has issued an 
Import Alert for materials sourced from BSE countries, but compliance 
is voluntary.
    For BSE, this means that an unscrupulous manufacturer could 
literally take a British cow brain, crush it, dry it out, formulate it 
into a dietary supplement and export it to the U.S. Indeed, a letter by 
Dr. Scott Norton in the New England Journal of Medicine mentions a 
product available in the U.S. with 17 cow organs including brain, 
pituitary, and pineal gland. Due to DSHEA, the FDA is limited in what 
it can do. Instead of claiming that its regulatory authority over 
dietary supplements is adequate, as it often does publicly, the agency 
should be coming back to the Congress to undo the damage done by DSHEA. 
The best option would be to simply repeal DSHEA. In the alternative, we 
recommend a variety of improvements, including a mandatory adverse 
event reporting requirement for all dietary supplement manufacturers, 
mandatory risk warnings, requirements for company and product 
registration, and identification of the raw ingredients and the source 
(by country) for each of the ingredients in each product. This is, of 
course, a problem that goes well beyond the risk of vCJD; over 100 
people have been killed by ephedra, and the agency seems essentially 
powerless to act. Releasing the GMP regulations for dietary supplements 
is necessary, but will not suffice to adequately protect American 
consumers from vCJD that might be caused by these products.
       if the bse agent entered the country, how might it spread?
A. Feeding Practices
    Since 1997, the FDA has had a ban on the feeding of mammalian parts 
to ruminants (e.g., cows, goats, sheep), the main route by which the 
BSE epidemic occurred in Britain and would be amplified in the U.S. 
This ban requires that manufacturers take action to prevent the 
commingling of two types of feed: those intended for ruminants, and 
those intended for non-ruminants (e.g., pigs, fish, chickens which can 
be fed material from mammals).
    FDA inspections to date provide evidence that this commingling is 
possible. The March 2001 FDA inspection report findings (http://
www.fda.gov/cvm/index/updates/bsemar3.htm), while improved from the 
January 2001 findings, still shows that 14 percent of renderers and 13 
percent of FDA-licensed feed mills do not have adequate procedures to 
prevent mammalian parts from entering ruminant feed: i.e., cows could 
still be recycled and fed to other cows. (This is precisely what 
happened in the Purina Mills plant in Texas in which, purely through 
the voluntary admission of the company, the FDA learned that cow parts 
had entered cow feed. One-thousand, two-hundred and twenty-two cows had 
to be removed from the food chain.) Moreover, 23 percent of renderers 
and 63 percent of FDA-licensed feed mills have still not been inspected 
for compliance with the feed restrictions and some 6,000 to 8,000 feed 
mills are not even required to register with the FDA. Of the 1,829 non-
FDA licensed feed mills that handle material prohibited from use in 
ruminant feed, 18 percent do not have adequate procedures to prevent 
the recycling of mammalian parts as feed for ruminants. If the industry 
does not come into better compliance with the mammal-to-ruminant ban, 
the FDA should consider whether a mammal-to-mammal ban is justified.
    In addition, the FDA feed ban contains an exemption that should be 
ended. Despite U.S. Department of Agriculture (USDA) objections, the 
FDA permits the feeding of so-called plate waste (leftover food that 
has been prepared and/or served to humans) in feed for ruminants. The 
European Union, Canada and Mexico have banned such practices and so 
should we.
    Finally, there is the issue of Chronic Wasting Disease (CWD), a 
Transmissible Spongiform Encephalopathy (TSE) of wild and captive elk 
and deer. While there exists no evidence that humans have become 
infected from eating deer or elk, current USDA procedures permit deer 
and elk from a herd with a proven case of CWD to enter the food chain. 
The problem is that deer and elk are exempt from the USDA's Meat 
Inspection Act, under which the packer has the burden of demonstrating 
the safety of his or her product. Instead, deer and elk would have to 
be restricted under the FDA's Food, Drug and Cosmetic Act, which places 
the burden upon the agency to demonstrate potential harm and provides 
no funds to compensate farmers if their herd is seized. This creates an 
incentive for farmers not to be forthcoming about CWD in their herds. 
This could be addressed either by a specific regulation excluding CWD-
affected herds from the food chain and providing for compensation for 
the rancher or by bringing deer and elk under the Meat Inspection Act, 
which does provide for compensation.
B. Meat Processing
    The processes of slaughtering and processing are not, by their 
nature, extremely precise ones. Infectious material from the most 
infectious parts of the cow, the brain and spinal cord, may spread to 
other parts of the animal. Pneumatic stunning devices, which stun the 
animal prior to slaughter by injecting a bolt and compressed air into 
the head, have been shown to spread potentially infectious brain tissue 
to other parts of the body. Although the industry appears to be 
reducing its use of pneumatic stunning devices, this should be given 
the force of Federal regulation and banned. These devices are now 
banned for use in cattle in Europe.
    European countries require that the brain and spinal cord be 
removed early in the slaughtering process. However, in the United 
States, processes vary widely and are not effectively regulated. We 
therefore support a regulation that would require the removal of the 
brain and spinal cord before further processing, since these organs 
contain the highest levels of infectious material.
    Two other meat processing methods have also come under scrutiny. In 
one, mechanically separated product (MSP), bones with attached muscle 
are crushed and pushed through an extruder to create a paste. Bone 
fragments are removed by a sieve-like mechanism. Both spinal cord and 
dorsal root ganglia (nerve tissue next to the vertebrae), which have 
demonstrable BSE infectivity, can enter MSP. In the other processing 
method, advanced meat recovery (AMR), muscle fragments are also removed 
from bone; this material can become part of ground beef. Early AMR 
machines used a belt to shave meat off bones, but later AMR machines 
use a ``bone press'' that differs from MSP only in degree. While MSP 
inherently involves the crushing of bones and is thus more likely to 
introduce nerve tissue into the product than AMR, 1997 USDA inspection 
records obtained by the Government Accountability Project through the 
Freedom of Information Act clearly demonstrate that spinal cord can be 
part of the material generated by AMR. Four of 34 AMR samples sent by 
USDA inspectors to a USDA laboratory because they were suspected of 
containing spinal cord tissue turned out to actually contain central 
nervous system tissue. It is possible that AMR machines could be 
redesigned to minimize the probability of crushing bones and thus 
including spinal cord. The USDA began such a rulemaking procedure 3 
years ago, but the rule has still not been finalized. To prevent vCJD, 
we therefore support a ban on the production of MSP from vertebrae and 
the issuance of a final rule for better-designed AMR processes that 
would prevent the inclusion of spinal cord.
        is the u.s. doing enough testing to detect the disease?
    To date, the U.S. surveillance efforts for BSE have been quite 
inadequate. Only 11,954 cow brains had been examined by the USDA in the 
10-year span ending in 2000. (Some 40 million cattle are slaughtered 
annually in the U.S.) By comparison, France, a country which, 
importantly, has a proven BSE epidemic, is now testing about 20,000 
brains per week.
    Under current USDA procedures, all cows with neurological symptoms 
are supposed to be tested for BSE and, regardless of the result, 
excluded from the food chain. Cows that are unable to ambulate, so-
called downer cows, are only occasionally tested. The USDA did not 
begin testing downer cows until 1993 but has now increased such testing 
to about 1,900 in 2000 (http://www.aphis.usda.gov/oa/bse/
bsesurvey.html).
    This represents about 1 percent of all downer cows brought to 
slaughter in the U.S. The USDA has promised to increase such testing to 
5,000 per year in 2001, a move we fully support. Testing of healthy 
cows does not seem justified in the U.S. at present as the prevalence 
of disease would almost certainly be lower than in downer cows or those 
with neurological symptoms. Moreover, even in countries with clear BSE 
epidemics, BSE-positive normal animals have only been detected 
extremely rarely if ever, even as the disease is detected in downer 
cows and those with neurological symptoms.
    Testing for the presence of BSE in cow brain can be very time-
consuming. However, while three rapid tests for BSE are on the market 
in Europe, none are on the market in the U.S. It is imperative that 
these tests be evaluated by the FDA and that test performance 
characteristics be made public.
    Surveillance for human CJD and vCJD is coordinated through the 
Centers for Disease Control and the National Prion Disease Pathology 
Surveillance Center at Case Western Reserve University. The Center has 
examined the brains of about 300 patients with CJD in the past 4 years. 
This represents an estimated 39 percent of patients with CJD in 2000, 
whereas in Germany and Britain the brains of almost all patients with 
CJD are examined by pathologists. Canada has recently revamped its 
surveillance system and provides much more funding for such efforts 
than does the U.S.
    The U.S. Government also needs to do more to increase the overall 
hospital autopsy rate in this country, which has declined from over 40 
percent after World War II to under 10 percent at present, as well as 
to increase the rate of examination of brain material specifically. 
Currently, hospitals and families bear the costs of autopsies, 
including transportation costs; they should be reimbursed for these 
costs. The government should also consider creating a network of 
regional pathology centers to do brain examinations for CJD and needs 
to do more to contact all neurologists to inform them of the current 
surveillance system.
     are there medical practices that might transmit bse and vcjd?
    In weighing whether products that are transfused or transplanted 
into humans should be restricted, the essential questions are: 1. What 
is the probability of transmission of infection?; 2. Are their suitable 
alternatives to the material?; and 3. Would the restriction of the 
material produce a shortage of a vital medical product?
    While there has never been a documented case of CJD or vCJD 
transmitted by blood transfusion, the agent is present in white blood 
cells (inevitably present to some extent in even red blood cell 
transfusions) and, in an experiment, a sheep was recently infected by 
transfusion from a cow with BSE. In 1999, the FDA's TSE Advisory 
Committee recommended a ban on blood donations from potential donors 
who had spent more than a total of 6 months in Britain between 1980 and 
1996. The Committee determined that the impact on the blood supply 
would be manageable and data collected since the restriction on British 
donors confirm that the supply of blood remained stable after the ban 
was enacted. In January 2001, with cases of vCJD in France and of BSE 
in Europe mounting, the Committee extended this recommendation to 
include France, Portugal and Ireland, although with a 10-year 
cumulative residency requirement, since BSE and vCJD case rates are 
lower in those countries than in Britain. The FDA should adopt the 
Committee's recommendation.
    Similar travel restrictions should be placed on cadaveric cornea 
donors, especially because as many as three cases of CJD due to corneal 
transplantation have been documented. Due to the existing shortages of 
other transplantable organs such as heart and bone marrow, and the 
failure to document CJD transmission associated with their 
transplantation, a travel restriction on such organ donors is not 
justified. On the other hand, because the U.S. is a net exporter of 
cornea, we are not concerned that there would be a shortage of cornea 
were a travel restriction to be implemented.
    Finally, there is the issue of vaccines. In 1993, the FDA wrote to 
the manufacturers of FDA-regulated products and in a voluntary Guidance 
instructed manufacturers to no longer source materials for their 
products from BSE-affected countries. It repeated the admonition in 
1996. Nonetheless, at least six manufacturers simply ignored the 
Guidance, which does not have the force of a regulation, and continued 
to source bovine materials for the production of vaccines from BSE-
affected countries. The FDA only learnt that its recommendation had 
been disregarded in early 2000. By then, millions of doses of vaccines 
such as polio and diphtheria, tetanus, and pertussis (DTP) were 
injected into Americans, including small children. At a TSE Advisory 
Committee meeting in July 2000, Committee members agreed that the risk 
of disease transmission through these vaccines is extremely small and 
that there is no evidence that vCJD has been spread through this route. 
Nonetheless, this event was a reminder of the dangers presented by 
agencies that fail to regulate and industries that act in arrogant 
disregard of the government.
    The lesson of the vaccine debacle applies more broadly to our 
efforts to reduce the risks of BSE and vCJD: for the public to be 
adequately protected, government will have to take forceful action--
regulations, not guidelines--and not simply depend upon voluntary 
actions by industry.
summary of actions necessary to reduce the risk of bse and vcjd in the 
                                  u.s.
     Increase inspection capacity at the borders.
     Repeal the Dietary Supplement Health and Education Act.
     As an alternative to repeal, pass legislation that would 
require mandatory adverse event reporting for all dietary supplement 
manufacturers, mandatory risk warnings, company and product 
registration, and identification of the raw ingredients and the source 
(by country) for each of the ingredients.
     Release Good Manufacturing Practice regulations for 
dietary supplements.
     Enforce compliance with the mammal-to-ruminant feeding 
ban.
     Remove the plate waste exemption from the feeding ban.
     Assure that CWD-affected deer and elk herds do not enter 
the food chain.
     Provide compensation for ranchers with CWD-affected deer 
and elk herds.
     Ban pneumatic stunning devices.
     Remove brain and spinal cord from slaughtered cows before 
further processing.
     Ban mechanically separated product produced from 
vertebrae.
     Issue regulations on advanced meat recovery to preclude 
the introduction of spinal cord.
     Continue to expand testing of downer cows.
     Expand the current CJD and vCJD surveillance system and 
notify neurologists of its existence.
     Adopt the FDA's TSE Advisory Committee's recommendation 
restricting blood donations from those with extensive histories of 
residence in France, Portugal and Ireland.
     Create travel restrictions for cornea donors similar to 
those for blood donors.
     Promulgate regulations preventing the sourcing of 
materials for the production of vaccines from BSE-affected countries.

    Senator Fitzgerald. Thank you very much, doctor.
    Mr. Hodges, you are next.

           STATEMENT OF JAMES H. HODGES, PRESIDENT, 
               AMERICAN MEAT INSTITUTE FOUNDATION

    Mr. Hodges. Thank you, Mr. Chairman. I represent the 
American Meat Institute, the nation's oldest and largest 
meatpacking and processing association. I speak to you today as 
a meat scientist with 30 years experience in the meatpacking 
and supermarket industries, as well as having some time at 
USDA's Food Safety and Inspection Service.
    Never in my career have I seen so much public concern over 
an animal disease as I have seen over BSE. Given our nation's 
phenomenal history of animal disease control, it is perplexing 
and disappointing to see attention being focused on what we are 
doing wrong instead of what we are doing right.
    I have three messages to leave with you today. First, we do 
not have BSE in this country. Second, we have taken prudent 
steps to prevent BSE from entering this country. Third, if, 
heaven forbid, BSE were ever to find its way into this country, 
we can diagnose it, isolate it, contain it, and prevent it from 
reaching consumers in a swift and decisive way.
    Our risk of BSE in domestic cattle is not zero, nor can it 
ever be. But our risks are lower today than at any time since 
the disease was determined to be a potential threat to our 
domestic cattle population.
    Let me focus for a moment on my first message. We have no 
evidence that BSE exists in this country. That fact bears 
repeating over and over because it has been largely lost in 
some hysterical and speculative news reporting. The British and 
now the European situation has provided strong incentive for 
the U.S. Government and the U.S. beef industry to take 
aggressive actions to prevent this devastating animal disease 
in the U.S. herds.
    In fact, we took action so early that some people now seem 
to question why we are not announcing major new efforts today. 
The answer: We took swift, science-based actions early on that 
have protected our livestock and given us the coveted 
distinction of being a BSE-free nation. The U.S. approach to 
BSE prevention can best be described, as it has been earlier, 
as a triple firewall strategy.
    Because BSE is not present in the U.S. herds, the first 
critical firewall in protecting U.S. cattle involves protecting 
U.S. borders. As early as 1989, USDA banned the importation of 
cattle and most beef products from countries with BSE.
    The second critical firewall involves careful surveillance. 
Veterinarians are present at every U.S. meatpacking plant and 
check cattle for signs of any disease, including BSE. No animal 
can be processed from meat without inspection. Additionally, 
USDA routinely conducts laboratory tests for BSE in animals 
most likely to exhibit the disease.
    For a country in which BSE has never been detected in the 
native cattle population, the U.S. has one of the most 
statistically sound and comprehensive surveillance programs in 
the world. Of the roughly 1200 animals tested for BSE thus far, 
as you have heard earlier, none have been positive.
    The third critical firewall involves controlling what 
cattle are fed. Evidence indicates that BSE may have been 
spread in the U.K. and Europe by contaminated feed. Even though 
we have no evidence that BSE exists in the U.S. cattle 
population, the feeding of any protein derived from ruminant 
animals to cattle is prohibited. In fact, there is a growing 
trend within the beef industry to require certification from 
producers that cattle have met all requirements with respect to 
complying with FDA regulations. AMI has provided its members 
with model certification language and we understand that it is 
beginning to be utilized widely.
    Taken together, all of these efforts provide the best 
reasonable assurance that U.S. cattle will remain BSE-free and 
that U.S. consumers will not be exposed to any related health 
risk. That is not to say that we should rest on our laurels. We 
must continually evaluate and improve our preventative control 
measures if they are warranted and we must assure our 
regulatory agencies are provided the necessary resources to do 
their job.
    It is important to remember that BSE has been diagnosed 
only in livestock of European origin. The U.S. is a long way 
from Europe. Our livestock populations are very different, as 
are many of our rendering, feeding, and production practices. 
In addition, Europe is in the midst of a crisis. Crisis 
warrants strong and dramatic action. In contrast, we do not 
have a crisis in the U.S. It is critical that our BSE 
prevention policies reflect that fact.
    While our media have begun to mirror British tabloid 
coverage of BSE, our cattle herds are and will remain very 
different from those in the U.K. and Europe. Our policies must 
reflect these differences and be supported by the best 
available science, lest we head down the slippery slope of 
creating our own hysteria.
    Thank you, Mr. Chairman.
    [The prepared statement of Mr. Hodges follows:]
           Prepared Statement of James H. Hodges, President, 
                   American Meat Institute Foundation
    Good morning, Chairman Fitzgerald and members of this subcommittee. 
I represent the American Meat Institute, the nation's oldest and 
largest meatpacking and processing industry association. Our members 
slaughter and process 70 percent of the nation's beef, pork, lamb, veal 
and turkey products. Most of our members are small, family owned 
businesses with a single manufacturing plant. However, we also 
represent some of the largest meat companies in the world.
    I speak to you today as a meat scientist with 30 years of 
experience in the meatpacking and supermarket industries, as well as 
USDA's Food Safety and Inspection Service. Never in my career have I 
seen so much public anguish over an animal disease as I've seen in the 
last 6 months over BSE. Given our nation's phenomenal history of animal 
disease eradication--we are world leaders in this regard--it is 
perplexing and disappointing to see attention being focused on what we 
are doing wrong instead of what we are doing right.
    I have three messages to leave with you today. First, we do not 
have BSE in this country. Second, we have taken prudent steps to 
prevent BSE from entering this country. And third, if, heaven forbid, 
BSE were ever to find its way into this country, we can diagnose it, 
isolate it, contain it and prevent it from reaching consumers in a 
swift and decisive way. Our risk of BSE in domestic cattle is not zero, 
nor can it ever be, be we are a long way from a BSE crisis in the U.S.
    Let me focus for a moment on my first message: We do not have BSE 
in this country. That fact bears repeating because it's been lost 
lately in some hysterical and speculative news reporting.
    The BSE crisis in Europe has been a frightening situation to watch. 
It was tragic when it first impacted British cattle. And it was 
horrific when science began to support a relationship between eating 
products contaminated with the infective agent and the development of a 
human illness by young people in Britain.
    The British problem--now shared by 12 other European nations--has 
provided strong incentive for the U.S. Government and U.S. beef 
industry to take aggressive actions to prevent this devastating animal 
disease in U.S. herds. In fact, we took action so early that some 
people now seem to question why we aren't announcing major new efforts 
today. The answer: we took swift, science-based actions early on that 
have protected our livestock and given us the coveted distinction of 
being a BSE-free nation.
    The U.S. approach to BSE prevention can best be described as a 
``triple firewall'' strategy. Because BSE is not present in U.S. herds, 
the first critical firewall in protecting U.S. cattle involves 
protecting U.S. borders. As early as 1989, the U.S. Department of 
Agriculture (USDA) banned the importation of cattle and most beef 
products from countries with BSE.
    The second critical firewall involves careful surveillance. 
Veterinarians are present at every U.S. meat packing plant and check 
cattle for signs of any disease--including BSE. No animal can be 
processed for meat without inspection. Additionally, USDA routinely 
conducts laboratory tests for BSE. For a country in which BSE is not 
endemic--has never been detected in the native cattle population--the 
U.S. has one of the most statistically sound and comprehensive 
surveillance programs in the world. Of the roughly 12,000 animals 
tested for BSE by the U.S. Government, none have been positive.
    The third critical firewall involves controlling what cattle are 
fed. Evidence indicates that BSE may have been spread in the U.K. and 
Europe by contaminated feed. Even though the U.S. has no BSE in cattle, 
the feeding of any protein derived from ruminant animals to cattle is 
prohibited in this country. In fact, there is a growing trend within 
the beef industry to require certification from producers that cattle 
have met all requirements with respect to complying with FDA 
regulations. AMI has provided its members with model certification 
language and we understand it is beginning to be widely used.
    Taken together, these efforts provide the best reasonable assurance 
that U.S. cattle will remain BSE-free and that U.S. consumers will not 
be exposed to any related health risks. That is not to say we should 
rest on our laurels. We must continually evaluate and improve our 
preventative control measures, if warranted, and we must assure our 
regulatory agencies are provided the necessary resources to do their 
job.
    It is important to remember that BSE has been diagnosed only in 
European livestock. The U.S. is a long way from Europe. Our livestock 
populations are very different, as are many of our rendering, feeding 
and production practices. In addition, Europe is in the midst of a 
crisis and crises warrant strong and dramatic actions. In contrast, we 
do not have a crisis in the U.S. It is critical that our BSE prevention 
policies reflect this fact. While our media have begun to mirror 
British tabloid coverage of BSE, our cattle herds are, and will remain, 
very different from those in the U.K. and Europe. Our policies must 
reflect these differences and be supported by the best available 
science lest we head down the slippery slope of creating our own 
hysteria.

    Senator Fitzgerald. Thank you, Mr. Hodges.
    Ms. DeWaal. Is that the right pronunciation?

       STATEMENT OF CAROLINE S. De WaaL, DIRECTOR, FOOD 
   SAFETY PROGRAM, CENTER FOR SCIENCE IN THE PUBLIC INTEREST

    Ms. DeWaal. Yes, that is. Thank you so much, and good 
morning. I guess it is early afternoon now.
    I want to start out first, off my written text, with the 
fact that I agree with Secretary Glickman's letter. That was 
kind of how you started the hearing. I think what we are 
dealing with in this hearing is something that is a potential 
risk and it is very serious, but we should also be aware there 
are very real risks associated with the food supply, things 
like E. coli 015787, listeria, campobacter, things that are 
making people sick, putting them in the hospital, and 
sometimes, tragically, even killing them. Those things exist in 
the U.S. food supply. Luckily, mad cow disease does not.
    I want to thank you for inviting us. We represent 850,000 
members and subscribers to our Nutrition Action Health Letter.
    Thankfully, as I have said, no cases of BSE are in the 
cattle population in the U.S., and that is good news both for 
the cattle producers and very much for the American public. 
However, as we have seen the recent outbreak of foot and mouth 
disease in Europe, this reminds us that even the absence of 
diseases is really no excuse for complacency. So I am glad you 
are having this hearing.
    To the government's credit, USDA has instituted a critical 
first line of defense to prevent BSE from infecting U.S. cattle 
herds, and we have heard a lot about that today. It was done 
back in the late 1980s. They banned cattle from countries with 
BSE. More recently, in 1997, they have banned cattle and cattle 
products and ruminant products from all over Europe.
    This precaution has paid off, both for consumers and for 
the meat industry. But we need more precautions instituted to 
protect the human food supply if we are to prevent American 
consumers from the crisis in confidence that has emerged in 
Europe in recent years.
    In the late 1980s, or it may have been the early 1990s, BSE 
jumped the species barrier between cattle and humans during an 
epidemic of disease that started in Great Britain. Unlike the 
human form of the disease, which seldom strikes those under 50, 
the variant Creutzfeldt-Jakob disease shows up in young men and 
women. It often starts with leg pain and difficulty walking, 
but eventually leads to progressive brain damage that leaves 
its victims hallucinating, unable to see, speak, or feed 
themselves, and ultimately it kills them.
    In 1996, vCJD killed 10 people in Europe. Last year it 
killed 27. In all, nearly 100 people have died from this 
disease in Europe. No one knows how many more are already 
infected with this horrible disease.
    BSE in cows and vCJD in humans are both caused by prions. 
These are virtually indestructible proteins that have the 
remarkable ability to induce other proteins to become deformed. 
Scientists are not certain how prions do their damage, but it 
is clear that we must keep these prions out of the food and the 
feed supplies.
    Major efforts have been made to prevent bovine material 
from getting into animal feed, cattle feed, and that is good. 
However, recent studies indicate that these standards are not 
adequately enforced. With just a few hundred inspectors at FDA 
to examine the safety of over 57,000 food manufacturers and 
warehouses in the U.S., it is clear that feed mill inspections 
by the Federal Government, by FDA, are a rare event at best.
    FDA has only a handful of inspectors who are regularly 
tasked to check feed mills for compliance with its 
requirements. CSPI has called for doubling FDA's food safety 
budget the increase their number of inspectors so there can be 
more, both for food plants and feed mills.
    These holes in the firewall protecting cattle feed support 
the need for another layer of protection to safeguard the human 
food supply. For the last 5 years, CSPI has urged USDA to erect 
a firewall to protect consumers from the possibility that 
infectious prions could enter the meat supply through advanced 
meat recovery systems. Advanced meat recovery systems that use 
infected parts of cattle with BSE could clearly transmit this 
disease to humans.
    These machines take the bones with attached meat and put 
them through a device that removes the meat from the bone. 
Advanced meat recovery systems produce a product that is called 
meat and it is labeled ``meat'' on the package. If spinal cord 
is attached to the spinal columns that enter these machines, it 
is bound to be incorporated into the meat that is produced. 
Spinal cords from cows with BSE, which we hope do not exist in 
this country, but we know we cannot be dead certain that there 
are not cows here, spinal cords from cows with BSE are highly 
infectious.
    The advanced meat recovery systems provide the best single 
opportunity for BSE-infected material to enter the food supply. 
This meat is used in several staples of the American diet, 
including hot dogs, hamburgers, and sausages. In fact, the USDA 
says that hot dogs and sausages can contain up to 20 percent 
mechanically separated beef or pork.
    In 1997, following a request by the Center for Science in 
the Public Interest, USDA directed its employees to 
periodically check the product going into the advanced meat 
recovery systems to ensure that the plant's employees are 
``completely removing spinal cord from neck and/or back bones'' 
before the bones enter the AMR, the advanced meat recovery 
system.
    In addition, inspectors were instructed to sample the 
product if they thought that plant employees were not 
adequately removing spinal cord. There was no other enforcement 
outlined in this directive.
    Evidence to date suggests that these inspections are rarely 
performed, in part because USDA has said that they are not 
critical to protect food safety. Between 1998 and 2000, fewer 
than 60 samples of meat were analyzed under this directive. 
This is a pitifully small number, especially considering that 
in just one of those years 45 million pounds of beef was 
produced using advanced meat recovery.
    Two of the 60 samples were positive for central nervous 
system tissue and others were positive for peripheral nerve 
tissue. Clearly, this system is not adequate to protect 
consumers if--and ``if'' is an important word here--if BSE were 
found in U.S. cattle. Therefore, CSPI will petition USDA next 
month to ban the spinal column and neck bones from cattle in 
advanced meat recovery systems. We believe the magnitude of the 
human illness justifies these precautions in meat production.
    Europe has opted for a more radical solution. This year the 
European Union outlawed the production of all mechanically 
separated meat that comes from cows or sheep.
    By any public health measure, the U.S. program to control 
mad cow disease appears to be a success so far. We have no 
documented cases of the disease in either the human or the 
cattle populations. However, the seriousness of the public 
health concerns means that regulators cannot be complacent. 
There are gaps in the firewall constructed by both FDA and USDA 
and these gaps should be filled before, long before, the first 
case of mad cow disease in the U.S. is ever discovered. 
Otherwise, we will face the very real risk that the consumer 
concerns that we are seeing in Europe about food safety overall 
could spread to the U.S., and I think we will all agree that is 
something we would like to prevent.
    Thank you.
    [The prepared statement of Ms. DeWaal follows:]
    Prepared Statement of Caroline S. DeWaal, Director, Food Safety 
           Program, Center for Science in the Public Interest
    My name is Caroline Smith DeWaal and I am director of food safety 
for the Center for Science in the Public Interest (CSPI). CSPI is a 
non-profit organization based in Washington, DC. Since 1971, CSPI has 
been working to improve the public's health, largely through its work 
on nutrition, food-safety and alcohol issues. CSPI is supported 
primarily by 850,000 subscribers to its Nutrition Action Healthletter, 
the largest circulation health newsletter in North America.
    Thank you for inviting us to present testimony today on ``Mad Cow 
Disease: Are Our Precautions Adequate?'' Thankfully, for both American 
cattle producers and the public, no case of bovine spongiform 
encephalopathy (BSE), the scientific name, has ever been identified in 
U.S. cattle. However, as the outbreak of foot and mouth disease in 
Europe has recently reminded U.S., the absence of disease should not be 
an excuse for complacency.
    To USDA's great credit, in the late 1980s, it instituted a critical 
first line of defense to prevent BSE from infecting U.S. cattle herds. 
Before the human health consequences were even known, to protect U.S. 
cattle herds, the USDA banned the importation of ruminants (cattle, 
sheep, and goats) and ruminant by-products from the United Kingdom and 
other countries where BSE had been found.\1\ In 1997, the ban was 
extended to cover all of Europe. Clearly the U.S. Government has been 
very proactive to prevent mad cow disease from infecting our animal 
population. This precaution has paid off, both for consumers and for 
the meat industry.
---------------------------------------------------------------------------
    \1\ U.S. Department of Agriculture, ``U.S.D.A. Actions to Prevent 
Bovine Spongiform Encephalopathy (BSE),'' April 1998, available at 
(http://www.aphis.U.S.da.gov/oa/bse/bsechron.html). Internet.
---------------------------------------------------------------------------
    The meat industry also deserves credit. Up until 1998, many 
slaughterhouses stunned their cattle with an air-injection rifle before 
killing them.\2\ But then, CSPI disclosed several studies in Nutrition 
Action Healthletter showing that the explosive blast of air could 
scatter brain tissue throughout the carcass. In cows with BSE, brain 
tissue is highly infectious. First, the meat industry did a study that 
confirmed the risk of spreading brain tissue using this type of 
stunning equipment, then companies voluntarily changed to safer 
devices. According to an industry representative, no one is even 
manufacturing the air-injection stunning equipment in the U.S. 
anymore.\3\
---------------------------------------------------------------------------
    \2\ Schardt, David and Schmidt, Stephen, ``Mad about BSE'', 
Nutrition Action Healthletter, Vol. 24, No. 6, July/August 1997.
    \3\ Personal conversation with AMI Representative.
---------------------------------------------------------------------------
    While these steps have been very important, there is more that must 
be done in order to protect American consumers from the crisis in 
confidence that has emerged in Europe in recent years.
                     tses are devastating diseases
    BSE is one of a family of neurologic diseases called transmissible 
spongiform encephalopathies (TSEs), which are characterized by a 
relatively long incubation period, short duration of clinical signs, 
and a 100 percent mortality rate.\4\ TSEs have been documented in a 
wide number of species, including sheep (scrapie), cattle (BSE), humans 
(Creutzfeldt-Jakob disease or CJD), deer, mink, cats, and others.
---------------------------------------------------------------------------
    \4\ 1U. S. Department of Health and Human Services, ``FDA Proposes 
Precautionary Ban Against Ruminant-to-Ruminant Feedings,'' HHS News, 
P97-1, January 2, 1997, p. 1.
---------------------------------------------------------------------------
    Many cases of TSEs, including 90 percent of CJD cases, are 
sporadic, which means that the disease can show up in an individual 
with no apparent cause.\5\ The disease is also infectious. TSEs can be 
spread mainly through consumption of infectious tissue. TSEs can be 
transmitted from one species to another, although significant barriers 
exist to prevent this.
---------------------------------------------------------------------------
    \5\ The World Health Organization, ``Bovine Spongiform 
Encephalopathy (BSE),'' Fact Sheet No. 113, (Revised), December 2000, 
p. 3, available at http://www.who.int/inf-fs/en/fact113.html Internet.
---------------------------------------------------------------------------
    Sometime in the late 1980s or early 1990s, BSE jumped the species 
barrier between cattle and humans during the British BSE epidemic in 
cattle.\6\ Consumption of BSE-infected cattle has been linked to the 
development of a new variant of CJD in humans. Unlike the sporadic form 
of the disease, which seldom strikes those under age 50, the variant 
Creutzfeldt-Jakob Disease (vCJD) shows up in young men and women. It 
often starts with leg pain and difficulty walking but eventually leads 
to a progressive brain damage that leaves its victims hallucinating, 
unable to see, speak, or feed themselves, and, within a year or two, 
dead.
---------------------------------------------------------------------------
    \6\  Id.
---------------------------------------------------------------------------
    In 1996, vCJD killed ten people in Europe; last year it killed 
27.\7\ In all, nearly 100 people have died from the disease in 
Europe.\8\ No one knows how many more are already infected and will 
develop vCJD, which can take 5 to 10 years to emerge. BSE in cows and 
vCJD in humans are both caused by prions--virtually indestructible 
proteins that have the remarkable ability to induce other proteins to 
become deformed.
---------------------------------------------------------------------------
    \7\ UK Department of Health. ``Monthly Creutzfeld-Jakob Disease 
Statistics,'' March 5, 2001, p.1., available at http://www.doh.gov.uk/
cjd/stats/mar01.htm Internet.
    \8\ Id.
---------------------------------------------------------------------------
                      tracking bse in u.s. cattle
    U.S. law currently requires that a Federal veterinarian check every 
cow or steer before it is slaughtered. If a cow appears to be suffering 
from a central nervous system disorder, it is segregated and 
slaughtered separately. If a cow is suspected of having BSE, its meat 
is held while its brain is sent off for testing in an Animal Plant and 
Health Inspection Service (APHIS) laboratory. Currently, the brains of 
about 1,000 suspicious cattle are tested each year by the government. 
But in 12,000 tests conducted since 1990, not one has been positive.\9\
---------------------------------------------------------------------------
    \9\ U.S. Department of Agriculture, Animal and Plant Health 
Inspection Service, ``BSE Surveillance,'' p. 5., available at http://
www.aphis.U.S.da.gov/oa/bse/bsesurvey.html Internet.
---------------------------------------------------------------------------
    In addition to this government-run system, every veterinarian and 
university researcher in the U.S. knows that being the first to 
identify a case of mad cow disease will bring a certain prominence that 
can be helpful in getting future research funded. If the disease was 
present in the U.S. cattle population, it would likely show up in the 
dairy cattle population first, but no cases have been documented. While 
the absence of a positive doesn't prove that BSE isn't here, it does 
increase our level of confidence. If it is here at all, BSE is very 
rare.
    But it may take only one infected cow to spread the disease. Since 
1996, when BSE was first identified as a human health hazard, the U.S. 
Government has tried to create ``firewalls'' to prevent BSE from 
gaining a foothold here. One firewall protects cattle from BSE; the 
other prevents people from getting sick if the first part fails. 
Currently both parts have holes in them.
                    protecting u.s. cattle from bse
    The first firewall was USDA's import ban covering cattle from 
countries with BSE. In 1997, the Food and Drug Administration (FDA) 
erected a second firewall by prohibiting cattle operations from feeding 
meat-and-bone meal supplements made from rendered cows or sheep to cows 
or sheep. However, several gaps in the feed ban need to be filled.
    The banned meat-and-bonemeal can still be fed to pigs and poultry. 
While cows get BSE and sheep get a BSE-like disease called scrapie, 
there is no evidence that pigs and poultry get BSE-like diseases from 
their food. However, processing ruminants into animal feed opens the 
door for banned material to inadvertently be fed to cattle.
    Recent events have shown that this is fact happening. In a survey 
of feed mills and renderers, FDA found that more than 20 percent had no 
system in place to prevent commingling and cross-contamination, as 
required by the feed ban. And 85 feed plants of over 400 surveyed 
didn't label their feed with a warning about which animals it was (and, 
more importantly, wasn't) intended for.\10\
---------------------------------------------------------------------------
    \10\ General Accounting Office. Report to the Honorable Richard J. 
Durbin, U.S. Senate. ``Food Safety Controls Can Be Strengthened to 
Reduce the Risk of Disease Linked to Unsafe Animal Feed,'' September 
2000.
---------------------------------------------------------------------------
    The problem made headlines in January, when a Texas feedlot 
inadvertently fed meat-and-bone meal intended for pigs and poultry to 
more than 1,200 cattle.\11\ A clerk at Purina Mills in St. Louis had 
mistakenly mixed the pig-and-poultry supplement into the company's 
cattle feed. Although the meal was produced in the U.S. from BSE-free 
cattle, Purina Mills said it would purchase the animals to keep their 
meat out of the food supply.\12\ If further breaches like this occur, 
FDA should consider banning the use of meat-and-bone meal in all types 
of animal feed.
---------------------------------------------------------------------------
    \11\ ``Texas Cattle are Quarantined to Determine Mad-Cow Risk,'' 
New York Times, January 27, 2001, p. A8.
    \12\ Blakeslee, Sandra. ``Agency Clears Texas Cattle in 
Quarantine,'' New York Times, January 31, 2001, p. A18.
---------------------------------------------------------------------------
    Unless Congress gives FDA additional inspection resources, 
violations of the feed ban are certain to occur. With just a few 
hundred inspectors to examine the safety of over 57,000 food 
manufacturers and warehouses in the U.S., feed mill inspections are a 
relatively rare event. FDA has only a handful of inspectors regularly 
tasked to feed mills to check for compliance with its requirements. 
Although feed mills and renderers are trying to remedy the situation by 
setting up third-party verification systems, that is not a substitute 
for government enforcement of the law.
    In addition, FDA needs to strengthen enforcement of the feed ban by 
using modern scientific tests to ensure that companies are complying. 
When FDA developed the feed ban, it did not require companies to 
utilize a sampling system to check that the feed is free of prohibited 
material. This testing is critical to effectively enforce the feed ban. 
The British government uses a test that differentiates mammalian from 
non-mammalian tissues to enforce their mammalian-to-ruminant feed 
ban,\13\ and a similar test should be used in the United States to 
enforce the feed ban. Otherwise, enforcement largely depends on a paper 
trail.
---------------------------------------------------------------------------
    \13\ Telephone conversation with Michael Hansen of Consumers' 
Union, April 28, 1997.
---------------------------------------------------------------------------
    These regulatory holes in the firewall protecting cattle feed are 
troubling. They also support the need for another level of protection 
to safeguard the human food supply. For the last 5 years, CSPI has 
urged USDA to erect another firewall to protect consumers from the 
possibility that infectious prions could enter the meat supply through 
advanced meat recovery systems.
                   protecting u.s. consumers from bse
    Advanced meat recovery systems that use infected parts of cattle 
with BSE could transmit the disease to humans. These machines take 
bones with attached meat and put them through a device that removes the 
meat from the bone. They claim to detach the meat without crushing, 
pulverizing or grinding the bone itself. According to the Food Safety 
and Inspection Service (FSIS), bones must emerge from these machines 
essentially intact and in natural conformation so that they are 
recognizable, i.e., comparable to those resulting from hand-deboning. 
Advanced meat recovery systems produce a product that can be called 
``meat'' under current government requirements.\14\
---------------------------------------------------------------------------
    \14\ U.S. Department of Agriculture, Food Safety and Inspection 
Service, Proposed Rule, Meat Produced by Advanced Meat/Bone Separation 
Machinery and Recovery Systems, 9 CFR Parts 301, 318, and 320, Docket 
No. 96-027P.
---------------------------------------------------------------------------
    If spinal cord is attached to the spinal column that enters these 
machines, it is bound to be incorporated into the meat that is 
produced.\15\ Spinal cords from cows with BSE are highly infectious. 
Advanced meat recovery systems provide the single best opportunity for 
BSE-infected material to enter the food supply today. And this meat is 
used in several staples of the American diet, like hot dogs, hamburgers 
and sausages. In fact, the USDA says that hot dogs and sausages can 
contain up to 20 percent mechanically separated beef or pork. (An even 
riskier process is used to produce mechanically separated meat, one 
that allows the spinal cord to become part of the meat produced. This 
practice should clearly be banned.)
---------------------------------------------------------------------------
    \15\ B.P. Demos and R.W. Mandigo, ``Chemistry and Composition of 
Mechanically Recovered Beef Neck Bone Lean,'' Journal Series, Nebraska 
Agricultural Research Division, Paper No. 10997, p. 64-65.
---------------------------------------------------------------------------
    The parts of the cattle known to carry the infectious agent that 
can cause BSE include the spinal cord, brain and retina.\16\ Great 
Britain has banned ``specified bovine offal'' from the human food 
chain, including the brain, spinal cord, tonsils, thymus, spleen and 
intestines. To minimize the risk of BSE entering the human food supply, 
it is critically important that FSIS place restrictions on the use of 
those cattle parts in mechanical meat recovery systems.
---------------------------------------------------------------------------
    \16\ European Commission Listing of Specified Risk Materials: a 
scheme for assessing relative risks to man. Opinion of the Scientific 
Steering Committee adopted on 9 December 1997 (Re-edited version 
adopted by the Scientific Steering Committee during its Third Plenary 
Session of 22-23 January 1998), available at http://europa.eu.int.comm/
food/fs/sc/ssc/out22--en.html Internet.
---------------------------------------------------------------------------
    In 1997, following a request by the Center for Science in the 
Public Interest,\17\ the USDA directed its employees to periodically 
check the spinal columns going into the advanced meat recovery systems 
to ensure that plant employees are ``completely removing spinal cord 
from neck and/or back bones before the bones enter the [AMR] system.'' 
\18\ In addition, inspectors were instructed to sample product if they 
thought plant employees were not adequately removing the spinal cord.
---------------------------------------------------------------------------
    \17\ Center for Science in the Public Interest, Letter to Secretary 
Glickman and Administrator Billy, January 7, 1997.
    \18\ U.S. Department of Agriculture, FSIS Directive 7160.2, 
``Meat'' Prepared using Advanced Mechanical Meat/Bone Separation 
Machinery and Meat Recovery Systems, 1997.
---------------------------------------------------------------------------
    Evidence to date suggests that these inspections are rarely 
performed, in part because the USDA believes they are not food safety 
violations. Between 1998 and 2000, fewer than 60 samples of meat were 
analyzed under this directive. This is a pitifully small number, 
considering that 45.3 million pounds of beef was produced by A.M.R. 
systems in just one of those years. Two of those samples were positive 
for central nervous system tissue, and peripheral nerve tissue was 
found in other samples as well.
    Clearly, this system is not adequate to protect consumers if BSE 
occurred in U.S. cattle. Therefore, CSPI will petition USDA next month 
to ban the spinal column and neck bones from cattle in advanced meat 
recovery systems. We believe the horrifying human illness justifies 
that additional precaution. Europe has opted for a more radical 
solution. This year, the European Union outlawed the production of all 
mechanically separated meat that comes from cows or sheep.\19\
---------------------------------------------------------------------------
    \19\ The European Commission, Health and Consumer Protection 
Directorate-General Press Release, ``Commission approves further 
protection measures against BSE,'' Brussels, February 7, 2001, p. 3, 
available at http://europa.eu.int/comm/dgs/health--consumer/library/
press/press106--en.html Internet.
---------------------------------------------------------------------------
    In addition, USDA should ban the use in human food of all bovine 
offal that has been identified as containing the infectious agent for 
BSE, including but not limited to the brain, retina, spinal cord, 
spleen, thymus, nostrils, and intestines. Britain has also banned 
``beef on the bone,'' for example, T-bone steaks. Such a ban would 
mirror the recommendation of the World Health Organization, as well as 
the ban implemented by the British government.\20\
---------------------------------------------------------------------------
    \20\ WHO Factsheet 113.
---------------------------------------------------------------------------
                      other fda-regulated products
    The Food and Drug Administration (FDA) has responsibility for 
assuring the safety of a number of products that could transmit BSE 
from cattle to humans. Here is a brief review of some matters regulated 
by FDA:
     Gelatin is an animal protein that comes from the hides and 
bones of cows and pigs. It's what makes Jell-O gel and gummy bears soft 
and pliable. It's used as a thickener in some yogurt, ice creams, and 
other foods. And it's in the capsules, gel caps, and coatings of many 
over-the-counter supplements and prescription drugs.
    Is gelatin infectious if it's made from animals that have mad cow 
disease? Probably not. Skin and hides don't seem to carry any risk, 
while bones have a ``low infectivity'' (because they contain bone 
marrow), according to the World Health Organization. Few, if any, BSE 
experts see a problem.
    Even so, in 1992, the FDA asked gelatin manufacturers not to use 
hides and bones from cows that were raised in countries where BSE has 
been found. The industry says that it's complying. Food companies also 
point out that much of the gelatin used to make desserts and candy 
comes from pig skins, not cow hides or bones.
     Vaccines are often made using cattle by-products that 
could be infectious. In 1993, the FDA asked vaccine manufacturers to 
stop importing animal products from countries where BSE has been found 
or where there isn't adequate surveillance for BSE. Last year, though, 
the government learned that five vaccine-makers hadn't complied.\21\ It 
ordered them to do so. There is no evidence that any of the world's 
cases of variant Creutzfeldt-Jakob Disease were caused by contaminated 
vaccines, and the U.S. Public Health Service recommends that children 
and adults continue to be immunized.
---------------------------------------------------------------------------
    \21\ U.S. FDA, Bovine Spongiform Encephalopathy (BSE), MMWR Notice 
to Readers: PHS Recommendations for the Use of Vaccines Manufactured 
with Bovine-Derived Materials, available at http://www.fda.gov/cber/
bse/bse.htm Internet.
---------------------------------------------------------------------------
     Glandular dietary supplements are made from animal glands. 
Example: Rejuvex, which is marketed as a tonic for menopausal women, 
contains extracts from cow mammary, ovary, uterus, adrenal, and 
pituitary glands. But the uterus and adrenal gland of cattle with mad 
cow disease can contain infectious prions, according to the World 
Health Organization. So can the placenta and thymus, which are found in 
other supplements.
    Supplement-makers say that they're complying with a 1993 FDA 
request that they not use cow organs from countries where BSE exists. 
Rejuvex labels, for example, say that its cow gland extracts come from 
``countries that are certified to be BSE-disease free.'' They are also 
planning to utilize a third-party auditing system to address the lack 
of FDA oversight.
    The National Nutritional Foods Association, a trade group of 4,000 
health food and supplement producers, distributors, and retailers, is 
urging its members to eliminate all cow neurological tissues from their 
dietary supplements.\22\ But the FDA has no system in place to monitor 
what supplement companies actually put into their products.
---------------------------------------------------------------------------
    \22\ Zwillich, Todd. ``Group Says Cow Tissue in U.S. Supplements 
Risky,'' Reuters Health, March 19, 2001, available at http://
dailynews.yahoo.com/h/nm/20010319/hl/supplements--madcow--1.html.

    Senator Fitzgerald. Ms. DeWaal, thank you.
    Mr. Sellers, thank you very much for being here.

STATEMENT OF RICHARD SELLERS, PAS, VICE PRESIDENT, FEED CONTROL 
                 AND NUTRITION, AMERICAN FEED 
                      INDUSTRY ASSOCIATION

    Mr. Sellers. Mr. Chairman, my name is Richard Sellers and I 
serve as Vice President for Feed Control and Nutrition of the 
American Feed Industry Association and am an animal 
nutritionist. Thank you for the invitation to be here today to 
explain how the feed industry views the U.S. efforts to prevent 
mad cow disease--or BSE--from entering the U.S.
    We commend you, Senator Fitzgerald, for calling this 
hearing. This forum gives both the Federal Government and 
animal agriculture the opportunity the describe our actions and 
demonstrate our collective commitment to keep BSE out of the 
U.S.
    AFIA is the national trade association representing more 
than 75 percent of the nation's primary feed producers of 
livestock, poultry, aquaculture, and pet food. AFIA's 
membership is nearly 700 companies, with state and regional 
affiliates, and represents more than 5,000 facilities in all 50 
states.
    Food safety and consumer confidence in foods of animal 
origin are AFIA's highest priority. We are justifiably proud 
that no case of BSE has ever been detected in the U.S. and are 
united in our resolve that an effective marriage of government 
and industry actions will keep the U.S. BSE-free. We have been 
involved with the groups in this room and others for more than 
a decade to ensure that government actions and programs 
instituted by industry create the necessary firewalls to 
prevent BSE from entering the U.S. and also to reinforce 
government safety initiatives.
    AFIA calls on Congress to do two things to help industry 
and government live up to their joint commitment to keep the 
U.S. BSE-free. First, Congress must ensure FDA and USDA and 
other Federal agencies have adequate funding to conduct 
government BSE prevention and control programs. We are 
especially concerned about the limits of budget in both FDA, 
and especially APHIS', budget. They seem to be stretched to the 
limit at this time dealing with both BSE prevention and foot 
and mouth disease.
    Second, we urge Congress to assist industry and government 
in making sure that public discussions of BSE are free of 
hyperbole, emotional exaggeration, and inaccuracies. This 
hearing is an important step in making sure the public record 
is accurate and objective. We must avoid the mistakes made in 
Europe and learn from the lessons of their experience.
    AFIA has been involved in the battle to control and exclude 
BSE for more than a decade by working with our sister 
organizations in Europe and supporting government initiatives 
like the FDA's regulations governing use of animal protein in 
ruminant feed. AFIA worked with a coalition of animal 
agriculture organizations to support a voluntary ban on these 
products in 1996 and asked FDA to broaden its proposed 
restriction in 1997. This broadening was needed because of the 
practicality of separating these types of materials in feed 
mills. FDA opted to provide limited exceptions to the rule 
based on scientific studies regarding the transmissibility of 
infected tissue. AFIA continues to support the existing 
exemptions based on the sound science.
    In early February, AFIA's board of directors approved the 
creation of a third party certification program to assure 
consumers of the continued safety of feed and food. The 
Facility Certification Institute, or FCI, was created as a 
stand-alone nonprofit entity. It provides the entire feed 
industry with the opportunity to have facilities certified for 
compliance with FDA's regulations and acts as an adjunct 
program to the current government inspection.
    There are approximately 500 to 1,000 feed inspectors at the 
state level in the United States. Every state has a feed law. 
Most of these states are cooperating with the Food and Drug 
Administration in the inspection process. Nearly 80 percent of 
the inspections have been done by state feed control officials.
    FCI has two levels of certification. Level one is for those 
facilities that do not use restricted use proteins in 
facilities manufacturing ruminant feed, that is dairy or cattle 
feed. Level two certification is for those facilities using 
these products in ruminant feed facilities, but fully complying 
with the FDA regulations regarding prevention of commingling of 
products.
    To date, over 100 facilities, including six major 
facilities in Canada, have been certified since the program 
began on March 13th. These facilities are listed on FCI's 
website at www.certifiedfeed.org by state. Facilities are 
required to notify their customers of decertification, notify 
FCI of any noncompliance with government inspections, and any 
changes in procedures affecting certification. So the program 
has teeth.
    AFIA shares FDA's goal of 100 percent inspections and 100 
percent compliance, as witnessed by our industry's third party 
certification program. FDA's most recent compliance report 
shows substantial progress toward that goal. Nearly all the 
firms inspected met the recordkeeping requirements of FDA's 
rule, but several had problems with labeling and commingling 
prevention plan requirements.
    This report has generated customer and media attention. As 
for the general media, covering a complex issue such as BSE is 
understandably difficult. However, media must take a 
responsible approach to its reporting of the issue, not as a 
food safety issue. Media must resist the temptation to demonize 
the ingredients, which have a long history of safe and 
nutritious use.
    Again, we do not have BSE in the United States. What the 
public needs is straightforward factual reporting on the issue.
    In conclusion, AFIA believes the mandate is clear. A 
marriage of science-based Federal Government and industry 
proactive measures is the working mechanism to prevent BSE from 
entering the U.S. These measures are working and adequate to 
control BSE introduction into the U.S. However, vigilance and 
continued innovation are required as situations and scientific 
evidence may shift.
    Congress can assist this effort by ensuring Federal 
agencies are adequately funded for research, surveillance, and 
compliance and can assist industry in assuring that the public 
debate over BSE is accurate, measured, and fact-based.
    Mr. Chairman, let me assure you that industry support and 
innovation will continue, and we appreciate the invitation the 
appear here today. Thank you.
    [The prepared statement of Mr. Sellers follows:]
   Prepared Statement of Richard Sellers, PAS, Vice President, Feed 
       Control and Nutrition, American Feed Industry Association
    Mr. Chairman, members of the Subcommittee, my name is Richard 
Sellers. I serve as Vice President for Feed Control and Nutrition for 
the American Feed Industry Association (AFIA). Thank you for the 
invitation to be here today to explain how the feed industry views U.S. 
efforts to prevent so-called ``mad cow disease'' from entering the U.S.
    AFIA commends you, Sen. Fitzgerald, for calling this hearing. This 
forum gives both the Federal Government and animal agriculture the 
opportunity to describe our actions and demonstrate our collective 
commitment to keeping bovine spongiform encephalopathy (BSE) out of the 
U.S.
    I respectfully request, Mr. Chairman, that AFIA be allowed to 
provide the full text of its statement, along with several pieces of 
documentation, for the formal record of this hearing.
    AFIA is the national trade association representing more than 75 
percent of the primary livestock, poultry and pet food sold annually in 
the U.S. AFIA's membership of nearly 700 companies is supported by 30 
national, state and regional associations. Together we represent more 
than 5,000 facilities in all 50 states.
    Food safety and consumer confidence in this nation's production of 
foods of animal origin is AFIA's highest priority. We share this 
priority with every group sitting at this witness table and with every 
agriculture organization and company in this room today.
    We are all justifiably proud that no case of BSE has ever been 
detected in the U.S., and we are united in our resolve that an 
effective marriage of government and industry actions will continue to 
keep the U.S. BSE-free.
    This consensus extends well beyond mere philosophy or lipservice. 
AFIA, the American Meat Institute, the National Renderers Assn., the 
National Cattlemen's Beef Assn., the National Milk Producers 
Federation, the American Sheep Industry Assn., and others have worked 
consistently and collectively for more than a decade to ensure that 
government actions--and programs instituted by industry--create not 
only the necessary ``firewalls'' to prevent BSE introduction to the 
U.S., but also reinforcement or redundancy to these government safety 
initiatives.
                      dollars and restraint needed
    AFIA calls on Congress today to do two things to help industry and 
government live up to their joint commitment to keep the U.S. BSE-free. 
First, Congress must ensure adequate funding is available to the Food & 
Drug Administration's (FDA) Center for Veterinary Medicine (CVM) and 
the U.S. Department of Agriculture's Animal & Plant Health Inspection 
Service (APHIS) and other Federal agencies. These monies are needed to 
conduct government BSE prevention and control programs in the most 
effective manner possible.
    This funding is necessary to increase and accelerate research on 
prion disease transmission, to find quick diagnosis and analytical test 
methods, increase manpower and technology at U.S. ports of entry to 
detect prohibited products and animals from entering the U.S., and 
should the unthinkable occur, contain any BSE outbreak to prevent any 
spread.
    Second, we urge Congress to assist industry and government in 
making sure that public discussions of BSE are free of hyperbole, 
emotional exaggeration and inaccuracies. This hearing is an important 
step in making sure the public record on BSE prevention--is accurate 
and objective.
    We must avoid at all costs mistakes made in Europe. We must take 
lessons from the European experience--adopting effective measures where 
justified by science--and constantly moving forward, ensuring the 
public is not the victim of demagoguery, grandstanding or propaganda.
               afia's involvement in the world bse debate
    AFIA's involvement in the battle to control and contain BSE goes 
back more than a decade to our initial consultations with sister 
organizations in Europe. These began in the late 1980s and early 1990s, 
as the BSE situation in the United Kingdom and continental Europe 
reached crisis proportions, both through independent meetings and 
through AFIA's role as an officer in the International Feed Industry 
Federation.
    AFIA strongly supported the emergency USDA/APHIS ban on ruminant 
animals with confirmed cases of BSE in 1989, and likewise supported the 
expansion of the ban to include at-risk ruminant products from the same 
countries. AFIA advocated the formalization of these bans, as well as 
the intensified U.S. surveillance and testing that began here in 1990-
93.
    In 1996, based upon our consultations with international feed and 
scientific organizations and visits to European nations struggling to 
control the BSE outbreak, AFIA met with U.S. livestock and professional 
animal health groups. These discussions led to formation of a 
coalition, which announced a voluntary industry program to cease the 
use of ruminant-derived proteins in ruminant feeds. At the same, 
industry urged FDA/CVM and USDA/APHIS to accelerate their review to 
determine if additional regulations were needed to prevent the 
introduction of BSE to the U.S.
    FDA announced in 1997 that it intended to ban the use of ruminant 
products in livestock feed. AFIA and the coalition of producer and 
scientific organizations successfully urged FDA to broaden its proposal 
on restricted proteins to include a restriction on all at-risk 
mammalian protein used in ruminant feeds.
    This broadening of the Federal restriction was needed for two 
reasons: First, all materials posing a potential risk to ruminant 
animal health needed to be segregated to use in non-ruminant feeds. 
Second, the broader ban recognized the logistical reality of the 
rendering, feed and feeding industries, and would not unnecessarily 
cause economic hardship nor take legitimate feed ingredients for non-
ruminants out of the feed chain.
    FDA opted to provide limited exceptions to the list of restricted 
use protein products (RUPP). These include blood, milk or gelatin 
products, and equine and porcine proteins derived from species not 
demonstrated to develop transmissible spongiform encephalopathies (TSE) 
naturally. AFIA supports the existing exceptions based upon sound 
science.
             afia's facility certification institute (fci)
    AFIA believes there cannot be too many industry or government 
science-based precautions, firewalls, or safety program redundancies 
when it comes to BSE prevention. Putting money, effort and manpower 
behind this belief, AFIA capitalized on its ongoing membership quality 
control programs and has modified its general Q/A recommendations to 
provide specific education and assistance to members and nonmembers 
relative to feed mill compliance with the government's RUPP rule.
    AFIA's Board of Directors approved in early February creation of a 
third-party certification program to assure consumers of the continued 
safety of feed and food. This certification program was created as an 
entirely stand-alone entity--the Facility Certification Institute 
(FCI). It provides the entire feed industry the opportunity to have 
facilities certified for compliance with the FDA's mammalian protein 
regulations.
    AFIA created FCI, and its Certified Facility Program for RUPP, to 
incorporate FDA's inspection program for compliance with Title 21, CFR 
Sec. 589.2000, Substances Prohibited in Ruminant Feed. The program is 
designed for an independent certifying agent to visit facilities which 
use restricted use protein products, as well as those that do not use 
these products. The agent reviews procedures, examines records and 
issues interim certifications to those facilities, when an inspection 
finds the facility meets the program's requirements.
    FCI provides two levels of certification, based upon third party, 
in-plant inspections. Level 1 certified facilities do not use 
restricted use protein products in their ruminant feed manufacturing 
facilities. Level 2 plants use restricted use protein, but conform to 
FDA's regulations. FCI has contracted with certifying agents to handle 
the program, and is adding more trained personnel as demand dictates. 
All personnel have extensive feed industry/FDA compliance experience.
    Upon certification, facilities are authorized to use one of two 
distinctive seals and the FCI logo, as well as statements regarding the 
program. These will be promoted widely as quality certification marks. 
The program is open to any feed manufacturing, rendering or related 
facility.
    To date, over 100 feed and rendering facilities have received FCI 
certification, with 10-15 applications arriving daily. To provide farm 
and ranch customers additional service, all certified mills are listed 
on the Institute's website--www.certifiedfeed.org. In addition, if a 
facility loses or gives up its certification, that facility is listed 
separately. Facilities are also required to notify their customers if 
they surrender their certification for any reason. Likewise, if a 
facility is found in violation of Federal or state rules during a 
government inspection, it is required to notify FCI.
    FCI is designed to grow into other areas needing third party 
certification as needed. It represents the organization which will 
contract for certifications, invoicing and processing and form links 
and partnerships with other groups and organizations to further 
strengthen its mission, which is to provide certification with 
integrity.
                        fda compliance reporting
    AFIA shares FDA/CVM's goal of 100 percent compliance with the RUPP 
rule as quickly as possible, as witnessed by our industry third party 
certification program.
    The most recent FDA/CVM compliance report shows substantial 
progress toward this goal. The report, released March 23, shows that of 
the estimated 1,290 licensed feed mills in the U.S., FDA has inspected 
1,069, and of that universe, 397 mills (37 percent the licensed mills 
inspected) report handling RUPP materials.
    Of those 397 mills, 99 percent are in compliance with recordkeeping 
requirements, i.e. where they bought RUPP materials, in which feeds it 
was mixed, and to whom those products were sold; 87 percent have a 
written in-plant program to prevent commingling, and 85 percent were in 
compliance with labeling requirements, i.e. ``do not feed to ruminant 
animals.''
    There are approximately 6-8,000 non-FDA licensed feed mills in the 
U.S., and FDA/CVM has conducted inspections of nearly 5,100. About 
1,800 mills report handling RUPP materials. Again, more than 99 percent 
of these facilities are in compliance with recordkeeping requirements, 
82 percent are in compliance with requirements for written plans to 
prevent commingling, and 67 percent are in compliance with labeling 
requirements It should be noted FDA/CVM began these inspections over 3 
years ago, and published its interim ``compliance report'' in January 
2001. This report, taken on its face, reflected high compliance with 
paperwork and recordkeeping requirements, but less successful 
compliance with labeling requirements and required written programs to 
prevent commingling.
    AFIA believes this compliance report reflects an evolving 
government compliance inspection program, one coordinated between and 
among the FDA/CVM and state inspection programs under contract to the 
Federal Government. Anecdotal field reports indicate some inspected 
facilities were made aware of deficiencies, corrected them on the spot, 
but showed up as ``out of compliance'' on reports to FDA.
    This report has generated customer and media attention. As for the 
general media, covering an issue as technically complex as BSE is 
understandably difficult, especially given the amount of unresolved 
scientific debate and ``urban myth'' that has sprung up around the 
issue. However, media must take a responsible approach to its reporting 
of this animal health issue--you'll note I did not say ``food safety 
issue.'' Media must resist the temptation to demonize ingredients, 
practices, industries and food products. What the public needs is 
straightforward factual reporting on this issue. There is no room for 
journalistic shortcuts.
                               conclusion
    AFIA believes the mandate is clear: A marriage of science-based 
Federal Government and industry proactive measures is the working 
mechanism to prevent BSE from entering the U.S.
    The firewalls, reinforcements and redundancies to ensure prevention 
include the following:
     FDA/USDA/Customs Service enforcement of import controls on 
animals, meat products and animal byproducts.
     FDA/CVM's rules prohibiting the feeding of restricted use 
protein products.
     FDA/CVM in-plant compliance inspections on its restricted 
use protein products rule.
     APHIS is conducting on-going animal, tissue and brain 
testing.
     Industry has initiated private third party certification 
of rendering facilities.
     Industry has initiated private third party certification 
of feed facilities.
     Industry has initiated livestock sales affidavit programs 
on livestock feeding.
     Industry has initiated certification to retailers on 
ingredient, feed and feeding compliance.
    These measures are working, and are adequate to control BSE 
introduction to the U.S. However, vigilance and continued innovation 
are required as situations and scientific evidence may shift.
    Congress can assist these efforts dramatically by insuring that 
FDA, USDA and other Federal agencies are adequately funded to conduct 
research, testing and diagnostics development and other necessary 
research on prevention, detection and containment of this animal 
disease.
    Congress can also assist industry in assuring that public debate 
over BSE is accurate, measured and fact-based. We must avoid the 
hysteria that has led to food panics and Europe.
    AFIA stands by the joint industry statement issued by 12 animal 
agriculture and scientific organizations in January of this year.
    ``(W)e affirm our commitment to effective implementation and 
enforcement of sound, science-based measure to prevent BSE in the 
United States. Active surveillance has not revealed a single case of 
BSE. BSE regulations have a firm scientific foundation. They reflect 
the wisdom of careful consideration and open debate. Surveillance and 
enforcement in the U.S. have been vigilant.''
    And, Mr. Chairman, let me add, industry support and innovation, 
will continue.
    Thank you again for the invitation to appear here today. I'll 
answer any questions you may have.

    Senator Fitzgerald. Thank you very much, Mr. Sellers.
    That was exactly 5 minutes. Thank you very much.
    I would like to direct this question to Mr. Schroeder. In 
your testimony you say that the industry has worked with the 
USDA to protect the public against the risk of contamination 
from bovine brain and spinal cord. What measures have been 
taken?
    Mr. Schroeder. Mr. Chairman, perhaps my colleague Mr. 
Hodges would like to address it from the packing industry's 
perspective. Our role from the producers' perspective has been 
focused very heavily on the feed ban that has been described 
significantly here today. We put out a directive very early on 
when the voluntary program began that we encouraged producers 
to follow that ban. Since the mandatory ban was put in place, 
we have made it clear that we support 100 percent compliance in 
seeing to it that those at-risk feed products do not enter the 
feeding system for our livestock.
    We have taken a number of measures to encourage that 
activity, including a joint meeting of all industry sectors at 
our offices here in Washington back in December, the 
establishment of a joint statement from all sectors that we are 
committed to 100 percent compliance, and we have continued to 
encourage both the industry and the regulators to see to it 
that that is done.
    Senator Fitzgerald. Based on Mrs. DeWaal's testimony, I 
would like to ask Mr. Hodges and Mr. Schroeder if you believe 
that brains and spinal cords are kept out of the human food 
supply.
    Mr. Hodges. I would be happy to answer that, Mr. Chairman 
The issue of brain and spinal cords I think can appropriately 
be addressed as follows. No scientific evidence exists to 
document that these materials or advanced meat recovery 
materials present a food safety risk. The reason that they do 
not present a food safety risk is BSE is not present in this 
country. Therefore, any products derived from the beef animal 
are safe.
    Furthermore, FSIS requires spinal cords to be removed from 
raw materials used in advanced meat recovery systems. They are 
further prohibited from being used to formulate meat food 
products, primarily because spinal cords are not meat by the 
regulations. Before we would change any of these regulations to 
eliminate these products from the food supply, I would suggest 
that we need a thorough, careful evaluation of what risk, if 
any, that they present.
    Senator Fitzgerald. Would Dr. Lurie or Ms. DeWaal wish to 
talk about that?
    Dr. Lurie. If the question was do brains or spinal cord 
enter the American food supply, the answer is simply, yes. 
There are about a million cattle brains a year that are 
consumed by American consumers. It is legal to buy cow brain 
and eat it in this country. So the answer is yes.
    Now, a subsidiary question is whether or not the advanced 
meat recovery process, for example, which is supposed to have 
meat, might have spinal cord in it. Whereas FDA regulations are 
supposed to preclude it, the empiric evidence as presented both 
by myself and Ms. DeWaal show that, in fact, on occasion there 
is spinal cord that does enter into the food chain.
    It is no surprise. These processes involve in part the 
crushing--and this is not supposed to happen with advanced meat 
recovery, but it does--the crushing of bones, including the 
vertebral column, such that the contents of the vertebral 
column, i.e., the spinal cord, could very well enter into the 
food supply.
    Finally, the point I made earlier is that in the processing 
process or the slaughtering process one might remove brain and 
spinal cord early the way they do in Europe, but at present 
that is not the situation in the United States.
    Again, the answer to your question is very simply, yes.
    Ms. DeWaal. I would just like to make one further comment. 
The spinal cord is allowed in products that are not called 
meat. So for example, in mechanically separated meat spinal 
cords do make their way into the process.
    The issue about advanced meat recovery--we would like to 
see that stopped. The issue about this issue of spinal cord 
showing up in the meat and whether it should be allowed is one 
of a firewall. When the first cow with BSE is discovered in the 
U.S. is not the time to start making these changes, as we have 
seen. We have seen success in keeping infected animals out of 
the U.S. starting in 1980. We have seen success perhaps in 
keeping--in a feed ban to prevent transmission of the disease 
to cattle, all of this before we have had our first case 
identified in the U.S.
    I think consumers deserve the same level of protection. 
Before the first cow is discovered we would like to see 
additional firewalls to protect the human food supply.
    Thank you.
    Senator Fitzgerald. Mr. Schroeder, your testimony also 
discusses a USDA briefing that the National Cattlemen's Beef 
Association participated in this month. At this briefing, you 
write that ``In addition to the brain and spinal cord, a 
speaker from the U.K. identified part of the intestine as an 
animal part that carries the infectious agent for BSE.''
    Are we taking any precautions with respect to the animal's 
intestines?
    Mr. Schroeder. Mr. Chairman, our position all along in this 
process is that we need to be using the very best available 
science. I know that there is scientific examination of that 
issue, are there other beef animal products that we should be 
concerned with. If the science confirms that, tells us that we 
ought to be making that change, we would be supportive.
    Again, as cattle producers we have to trust the leadership 
of scientists in this field, both domestically and 
internationally. By the way, we are putting together a group of 
qualified scientists and technicians to help us look at a broad 
range of issues related to BSE so that we can continue to look 
down the road and be proactive. Certainly this is one of the 
issues that we would expect to be examined.
    Senator Fitzgerald. Mr. Sellers, in your testimony you 
describe a new voluntary certification system for renderers, 
feed mills, and related facilities. What do you expect will be 
the significance of certification?
    Mr. Sellers. Thank you. This is obviously being driven by 
market requests from customers, purchasers of beef. It is an 
adjunct program with the government inspection to ensure 100 
percent compliance and 100 percent inspections.
    Senator Fitzgerald. So, the certification would be that 
they are 100 percent complying with government requirements?
    Mr. Sellers. Yes, sir.
    Senator Fitzgerald. Some purchasers are requesting this?
    Mr. Sellers. Yes, sir.
    Senator Fitzgerald. I understand--Mr. Schroeder, again to 
you. I understand that Federal regulators prohibit the use of 
animals showing signs of neurological damage in the human food 
supply. Are these animals kept out of the animal food chain?
    Mr. Schroeder. They are. Again, any animals that are 
presented for slaughter are examined, as Mr. Hodges presented 
here, by qualified veterinary medicine practitioners to 
determine whether indeed they are showing any neurological 
signs that might be related to BSE. When those animals are 
identified, they are held separately, are examined to determine 
whether or not they show the post-harvest signs, examining 
brain and spinal cord tissue, of the disease, and certainly if 
that were ever confirmed they would not enter either the animal 
or the human food supply.
    I cannot speak with authority, frankly, on other handling 
of those animals beyond that process. My colleagues might.
    Senator Fitzgerald. Mr. Hodges, if you have anything to 
add?
    Mr. Hodges. Any animal that exhibits a nervous system 
disorder is condemned on ante-mortem inspection. ``Ante-
mortem'' means before slaughter. Those animals are then 
disposed of outside of the feed and food supply. The Animal 
Health Inspection Service collects samples, in this case brain 
samples, from those animals and sends them to the National 
Veterinary Service Laboratory for analysis.
    Those animals that exhibit central nervous system disorders 
never enter the feed or food supply.
    Senator Fitzgerald. Dr. Lurie suggested in his comments 
that perhaps Congress should move more carefully to control 
deer and elk meat. Apparently, deer and elk meat is currently 
exempted from the Meat Inspection Act. Mr. Hodges and Mr. 
Schroeder, do you believe that deer and elk meat should 
continue to be exempted?
    I guess just yesterday the USDA made some announcement with 
respect to a deer herd in northern Colorado. Apparently the 
chronic wasting disease is found commonly in North American 
deer and elk. I wonder about the wisdom of exempting those 
meats from the Meat Inspection Act.
    Mr. Hodges. Chronic wasting disease has been diagnosed in 
elk and deer herds, in Wyoming, Colorado, and parts of Nebraska 
and other domestic herds that have originated from those areas. 
This question was addressed by the TSE Advisory Committee that 
looked at the risk posed to consumption of deer, elk, and if 
association with those animals presented any human health risk.
    There is no evidence that chronic wasting disease in these 
species has had any implications for human health, and the TSE 
committee essentially said that at this time that they would 
not take additional actions.
    Senator Fitzgerald. Dr. Lurie, I would like to ask you, 
then, what is the medical basis for your recommendation?
    Dr. Lurie. Since I sit on that committee, it is a true 
statement that the committee could not find any evidence of 
transmission. Obviously, trans-species transmission of TSE 
agents has happened. That after all is why we are here today. 
So there is legitimate reason for concern even if there has not 
been a documented case.
    The committee decided that the risks had not been 
demonstrated, but the committee did not vote, as I recall it, 
in any way on whether or not further action was necessary. That 
was not something put before us. Many of us were upset to learn 
from the USDA that, in fact, animals from a CWD positive herd 
could, in fact, enter into the food supply. The reason for 
that, as I said, is because there is a lack of compensation for 
the farmer. So that we are more or less stuck in that position, 
and that in turn related to the exemption from the Meat 
Inspection Act.
    So I think that this is an area where the precautionary 
principle certainly applies. Even in the absence of clear 
evidence of transmission, I think that once you have infected 
herds then I think you have to take action. No one is saying do 
not eat deer or elk meat. We are saying do not eat deer or elk 
meat from infected herds.
    Senator Fitzgerald. Well, with that I am going to conclude 
this hearing. I want to thank the panelists both from the first 
and second panel. I think this has been a very good hearing and 
I appreciate all of you coming forward. I look forward to 
working with all of you in the future and compliment you on 
your interest and expertise. Thank you all very much.
    This hearing is adjourned.
    [Whereupon, at 12:43 p.m., the hearing was adjourned.]
                            A P P E N D I X

Responses to Written Questions Submitted by Hon. Peter G. Fitzgerald to 
                        Stephen Sundlof, D.V.M.
    Question 1. Is the FDA up to date on inspections of feed mills and 
renderers to ensure compliance with the regulations concerning meat and 
bone meal?
    Answer. Since issuing its BSE feed rule, FDA and its state partners 
have conducted 10,725 inspections of renderers, feed mills, protein 
blenders and other relevant operations. Currently, FDA is completing 
the remaining initial inspections. In addition, we have begun 
reinspections of those establishments with compliance deficiencies 
found during their initial inspection. FDA will take, as appropriate, 
enforcement actions. FDA is on schedule to complete all initial 
inspections and currently identified reinspections by the end of fiscal 
year 2001.
    FDA and the United States Department of Agriculture (USDA) will 
continue to aggressively enforce their regulations and to work closely 
with those in the cattle and feed industries to minimize the risk of 
BSE introduction or spread in the United States (U.S.) cattle herds. 
FDA will develop new guidance and regulations as the scientific 
knowledge about BSE expands.
    Working together with many counterpart agencies in the U.S. and 
around the world and with various industry and consumer groups, FDA 
will continue to do its best to protect the health of Americans and 
American cattle herds.

    Question 2. What steps have you taken to work with state veterinary 
and agricultural agencies to prevent outbreaks of BSE or Foot and Mouth 
Disease?
    FDA continues to work closely with USDA, state agricultural and 
veterinary agencies on implementation of the BSE regulation and on 
controlling imported products that might introduce BSE into the U.S. 
States have conducted approximately 80 percent of the inspections under 
the BSE regulation. USDA and FDA have worked closely to develop import 
alerts that ensure all animal products that might contain the BSE agent 
are identified and listed in the alerts/bulletins and are prevented 
from entering the U.S.
    FDA has conducted two conference calls open to all 50 states 
including state veterinary and agricultural agencies in January and 
April to discuss the BSE issue. Both FDA and USDA participated in the 
call. FDA has met with the National Association of State Departments of 
Agriculture and American Association of Feed Control Officials to 
discuss FDA regulation on prohibited materials and BSE and other 
transmissible spongiform encephalopathies and Foot and Mouth Disease 
(FMD). FDA conducted one seminar on feed issues including BSE and FDA 
regulations during the week of May 1st in Texas and will conduct 
another seminar during the week of May 14th in Minnesota. It is 
expected that 100 feed control officials from all 50 states will attend 
the two seminars.
    FDA has jurisdiction over a number of products that could 
potentially initiate or exacerbate an outbreak of FMD in the U.S. FDA 
resources for this issue would be focused on regulating those 
commodities over which the Agency has direct authority. That would most 
likely include animal feed (and possibly human food) products 
contaminated or potentially contaminated with FMD virus. These products 
may be considered adulterated under the Federal Food, Drug, and 
Cosmetic Act. FDA will need to carefully consider how its feed-related 
inspectional resources can best be apportioned between the need to 
control FMD and the need to prevent and/or control, for example, BSE, a 
disease that has both significant animal health and human health 
implications. FDA is working to the best of its ability with USDA to 
limit importation and movement of such products into and within the 
U.S. in an effort to prevent or curtail FMD. FDA would coordinate with 
USDA on BSE, FMD and other animal related issues.
   Responses to Written Questions Submitted by Hon. Gordon Smith to 
                             Alfonso Torres
    Question 1. What contingency plans does USDA have in place should 
either BSE or FMD appear in the U.S.?
    Answer. USDA's Animal and Plant Health Inspection Service (APHIS) 
has developed emergency response plans for several highly contagious 
animal diseases including bovine spongiform encephalopathy (BSE) and 
foot-and-mouth disease (FMD). Because APHIS officials are currently in 
the process of updating the specific plan, or redbook, for FMD, we are 
enclosing a copy of our more general emergency response plan for highly 
contagious diseases that includes FMD operational guidelines. In 
addition, we are enclosing a copy of our BSE response plan summary; we 
are also revising our BSE response plan to include updated surveillance 
statistics and reflect the new Administration's personnel changes.

    Question 2. Are current funding levels for USDA's APHIS adequate to 
fully implement necessary inspections at ports of entry?
    Answer. Due to the recent outbreak of FMD in the United Kingdom 
(UK), USDA has increased staffing at all U.S. ports handling flights 
from the UK and other European Union (EU) countries. USDA is also 
training additional Beagle Brigade teams to assist with inspection 
efforts. Secretary Veneman has recently authorized the use of an 
additional $32 million from APHIS' user fee account to hire 
approximately 350 added APHIS personnel at international air and sea 
ports to augment our safeguarding efforts during fiscal years 2001 and 
2002.
    Although we are confident that our port of entry inspection program 
will successfully prevent the introduction of foreign animal diseases, 
including FMD, we expect to take additional steps to strengthen 
surveillance on farms and at livestock markets, zoos, theme parks with 
designated wildlife areas, swine garbage feeding operations, and 
wildlife refuges. We are evaluating these activities and related 
resource needs.
    While increased international passenger inspections are covered 
from the user fee account, we must also intensify our inspections along 
the Canadian and Mexican borders. No user fees are currently charged 
for these inspections. We are currently evaluating the need to hire 
more inspectors and acquire more x-ray machines for these activities. 
Also, we are evaluating the need to enhance inspections .at high risk 
cargo ports of entry. There would be costs associated with additional 
cargo inspectors and canine teams for these port of entry activities as 
well.
    Secretary Veneman has personally contacted officials at the 
Department of the Treasury to ask for their assistance in our 
inspection efforts. The Secretary has also requested the Customs 
Service's continued vigilance in referring travelers who are carrying 
any agricultural goods with them, or have visited farms in FMD-affected 
countries, to APHIS port officials for further inspection. In addition, 
at the local level, APHIS port officials and other state agricultural 
officials are meeting with Customs and other Federal Inspection 
Services leaders at high-risk ports to stress the need for a heightened 
awareness of possible FMD pathways at this time. This is especially 
true at smaller, less active U.S. ports of entry, where USDA has no 
presence and relies on Customs personnel to inspect for and confiscate 
prohibited agricultural items. APHIS also utilizes Customs' electronic 
data base system to identify import shipments that potentially pose a 
risk for the introduction of exotic pests or diseases. Customs 
officials can identify such high-risk shipments according to the tariff 
codes they are assigned in the electronic data base and flag them for 
APHIS inspection.

    Question 3. What steps have you taken to work with state veterinary 
and agricultural agencies to prevent outbreaks of BSE or FMD?
    Answer. APHIS' Transmissible Spongiform Encephalopathy (TSE) 
working group cooperates with state veterinary agencies to conduct 
surveillance for BSE within the United States. As of March 31, 2001, 
the brains from 12,341 animals in the United States and Puerto Rico had 
been examined with no evidence of BSE or other TSEs detected. Many 
state laboratories initially screen brains from rabies-negative cattle 
for evidence of BSE. In addition, APHIS officials work with state 
counterparts to provide information and education about this disease.
    APHIS officials have been working closely with state counterparts 
to coordinate exclusion efforts for FMD for 20 years. Over the last 5 
years, APHIS veterinarians have been meeting with officials from 
several states to help plan and discuss the states' responses to any 
highly contagious animal disease such as FMD. At these meetings, APHIS 
officials give the states an overview of FMD, USDA's exclusion 
activities, and USDA's response system and emergency management plans. 
APHIS has designed, coordinated, and participated with several state 
agencies in working through a scenario for the initial response to a 
diagnosis of FMD.
    APHIS has assumed a leadership role in the creation of the National 
Animal Health Emergency Management Steering Committee (NAHEMS), created 
in 1996. NAHEMS is a joint state-Federal-industry effort to improve the 
United States' ability to deal successfully with animal health 
emergencies. These emergencies can range from flood and drought to 
introductions of deadly foreign animal diseases such as FMD, hog 
cholera, or African swine fever. In addition to addressing the threat 
of a major foreign animal disease outbreak, NAHEMS looks at 
bioterrorism, emerging diseases, and diseases that pose a threat to 
production and international trade.
    By being better able to deal with animal health emergencies, we 
reduce the threat to the nation's food supply and help maintain the 
economic well-being of U.S. animal agriculture. Our focus is on four 
key elements: prevention, preparedness, response, and recovery.
    APHIS is also collaborating closely with state officials in their 
extensive outreach to garbage feeders.

    Question 4. Does the Administration believe new restrictions on 
imported cattle or meat products would substantially help to prevent 
these diseases?
    Answer. We can assure you that one of our highest priorities is 
preventing these foreign animal diseases from entering the United 
States, and we have in place a comprehensive set of measures to 
safeguard the United States from BSE and FMD. Preventive measures have 
included prohibiting imports of cattle, other ruminants, and ruminant 
products from countries where BSE is known to exist. USDA import 
regulations now also cover all ruminant and ruminant-origin products 
and other rendered animal protein products from Europe.
    After FMD was confirmed in southeast England in February, APHIS 
immediately moved to suspend imports of live ruminants and swine, 
semen, embryos, and other products from the UK. Fortunately, many of 
these products were already included in the list of animals and goods 
prohibited due to concerns about BSE. These FMD restrictions, which are 
identical to those applied to other countries currently considered 
affected by the disease, effectively prevent the importation of 
products susceptible to infection with the FMD virus, such as fresh 
meat and milk and other ruminant or swine byproducts.
    While some products, under certain specified conditions, are still 
allowed entry into the United States from FMD-affected countries, such 
products must either have been processed in an approved manner that 
kills the FMD virus or must be destined for a USDA-approved facility 
for suitable processing. Importers interested in bringing these 
products into the United States must first apply for and receive a 
veterinary import permit from APHIS. To receive a permit, the importer 
must provide APHIS with government certification from the country of 
origin attesting to the product's processing. APHIS recently extended 
these restrictions to cover all EU countries after learning of an FMD 
case in France. These stringent import restrictions will remain in 
place for as long as necessary to protect U.S. livestock.
                               __________
   u.s. department of agriculture animal and plant health inspection 
                                service:
   National Emergency: Response to a Highly Contagious Animal Disease
                           executive summary
    This document provides guidance for a response to a highly 
contagious animal disease and includes a Concept of Operations, 
Movement Control Guidelines, and Foot-and-Mouth Disease Operational 
Guidelines.
concept of operations for an emergency response to a highly contagious 
                             animal disease
    The goal of an emergency response plan is to detect, control and 
eradicate a highly contagious disease as quickly as possible to return 
the United States to free status. A presumptive positive case will 
generate immediate, appropriate local and national measures to 
eliminate the crisis and minimize the consequences. A confirmed 
positive case will generate additional measures on a regional, national 
and international scale.
    During the investigation of a suspect Foreign Animal Disease / 
Emerging Disease Incident (FAD/EDI), the Foreign Animal Disease 
Diagnostician (FADD) will use clinical signs, history and professional 
experience to determine the likelihood of a highly contagious disease 
(See VS Memorandum 580.4). They will classify the assessment as 
``unlikely'', ``possible'' or ``highly likely''.
    For ``unlikely'' and ``possible'' scenarios, the FADD should at a 
minimum request that the producers voluntarily quarantine themselves 
until laboratory results rule out an FAD/EDI. A policy of officially 
issuing a state quarantine until laboratory results rule out an FAD/EDI 
should be considered. The following focuses exclusively on the ``highly 
likely'' scenario.
    When the FADD determines that the condition under investigation is 
``highly likely'' to be a FAD/EDI, the FADD notifies and consults with 
the AVIC and/or state Veterinarian. The samples submitted to an 
approved laboratory are considered Priority 1 so that a presumptive 
diagnosis can be reached in less than 24 hours. Based on the outcome of 
the consultation, a state quarantine will be placed on the farm; an 
appropriate movement control zone will be established around the farm 
(see Appendix 1); the local agricultural and emergency officials will 
be notified; and all contacts to the farm will be traced.\1\ Before 
leaving the farm, the FADD will work with the producer to institute 
appropriate bio-security and public health measures, if warranted, and 
will thoroughly clean and disinfect their clothing, equipment and 
vehicle. Until a presumptive diagnosis is made, the FADD will not go on 
any other farms of unknown or negative status. If the presumptive 
diagnosis is positive, the FADD should not go on another farm of 
unknown or negative status for at least 48 hours.
---------------------------------------------------------------------------
    \1\ Trace-backs should be applied for a minimum of 2 times the 
maximum incubation period before the onset of clinical signs. Trace-
forward should be applied up to the time the quarantine is imposed.
---------------------------------------------------------------------------
    If a highly contagious FAD/EDI is classified as a presumptive 
positive or confirmed positive case the following actions would occur.
    Presumptive Positive (Index Case): Clinical signs consistent with 
an FAD/EDI plus the following: (1) sample is positive (antigen or 
antibody); (2) other epidemiological information is indicative of the 
FAD/EDI. Once the laboratory indicates it has positive sample, a 
cascade of events will occur starting with a conference call between 
the Laboratory, state Veterinarian, AVIC, FADD, and EMLT. This 
conference call will outline action steps, some of which are listed 
below.
    The State Veterinarian will:
     Quarantine the affected premises.
     Consider stopping movement of animals within the state.
     Consider active case finding based on suggestive clinical 
signs in the states to include the field veterinarians, FSIS, Extension 
Agents, Industry partners, and public awareness campaigns.
     Consider depopulation of affected herd in consultation 
with USDA, Industry and other stakeholders.
     Determine whether wild animals may be a risk factor in the 
dissemination or persistence of infection.
     Notify appropriate contacts (such as Commissioner of 
Agriculture, State Emergency Management Director, and others deemed 
necessary) that would be needed to support a response.
     Review the operational guidelines for a highly contagious 
FAD/EDI (see Appendix II, Foot and Mouth Disease Operational 
Guidelines).
     Identify the joint incident commanders and operations 
center with local APHIS officials and State Emergency Managers.
    The Area Veterinarian In Charge (AVIC) will:
     Notify appropriate contacts that would be needed to 
support a response (e.g., USDA State Emergency Board, field force and 
others as predetermined during discussions with the State 
Veterinarian).
     Prepare to participate in the Joint Incident Command as 
described in the State Emergency Plan.
    The Regional Emergency Animal Disease Eradication Organization 
(READEO) Director will:
     Notify all AVICs in the region of the presence of an FAD/
EDI and traceback findings.
     Give the READEO team members notice to be prepared for 
deployment.
     Prepare to support the Joint Incident Command in their 
actions or be Incident Commander in States unable or unwilling to take 
appropriate actions to control and eradicate the disease.
    The USDA, APHIS will:
     Conduct isolation and typing of the highly contagious FAD/
EDI agent.
     Initiate National and North American Communication Plans.
     Place National READEO leaders on high alert.
     Alert USDA Crisis Management Staff.
     Activate APHIS Emergency Operation Center.
     Institute active case finding based on suggestive clinical 
signs in all States, to include the State Veterinarians, FSIS, 
Extension Agents, Industry partners, and public awareness campaigns.
    Industry will:
     Communicate with their constituencies.
     Support State and National response efforts.
    Confirmed Positive Case: Agent is isolated and identified.
    The State Veterinarian, AVIC or Incident Commanders will:
     Initiate depopulation and disposal procedures of the 
infected herd/flock if not accomplished under presumptive positive 
diagnosis.
     Initiate the process to request a Governor's Declaration 
of Emergency thus implementing the State Emergency Response Plan.
     Continue quarantine and movement restrictions.
     Continue active case finding.
    The State Emergency Management Director/Emergency Management System 
will:
     Activate the State Response Plan.
     Support local Emergency Management System efforts at the 
site of the outbreak.
     Request a Governor's Declaration of Emergency.
     Enforce movement controls within the State.
     Evaluate the need for a request for a Presidential 
Declaration of Emergency thus implementing the Federal Response Plan.
    USDA will:
     Notify appropriate Federal agencies of the emergency 
declaration.
     Consolidate and present the official daily situation 
report to the Secretary.
     Coordinate the response activities of all USDA agencies to 
support APHIS and, until Presidential Emergency Declaration, coordinate 
all requests for the support of other Federal agencies.
     Impose on the affected State a Federal quarantine for 
interstate commerce and request enforcement by the affected state and 
adjoining states.
     Identify a source and start evaluating a process of 
acquiring an effective vaccine.
     Coordinate national surveillance activities.
    The Deputy Administrator of Veterinary Services through the APHIS 
Emergency Management Operations Center will:
     Provide international and national communication on the 
status of the situation.
     Involve Federal, state and Industry partners in the 
decisionmaking process with respect to the consequences of the disease 
on the U.S.
     Designate the Associate Deputy Administrator of Veterinary 
Services as the National Incident Coordinator.
    The Secretary of Agriculture will:
     Declare an emergency or extra-ordinary emergency, if 
necessary, to release the funds to cover expenses for response 
activities, including funds for indemnity.
     Call on other Federal Agencies to provide assistance.
     Mobilize Federal agricultural resources to assist the 
state.
    Industry will:
     Communicate with their constituencies.
     Support State and National response efforts.
     Coordinate efforts with State, national and international 
industry groups.
    Presumptive Positive (Secondary Case)--Subsequent investigations 
which identify an animal(s) with clinical signs consistent with FAD/EDI 
plus one or both of the following: (1) sample is positive; (2) other 
epidemiological information is indicative of the FAD/EDI, will be 
treated as confirmed case.
Glossary
    APHIS--The Animal and Plant Health Inspection Service of the USDA 
responsible for ensuring the health and care of animals and plants.
    Area Veterinarian in Charge (AVIC)--the lead Federal Veterinarian 
for APHIS Veterinary Services in an Area. Nationwide, there are 42 
Areas that encompass one or more states.
    Case classification:
     Suspect--Animal with clinical signs, which may be 
consistent with an FAD/EDI.
     Presumptive positive (Index case)--Animal with clinical 
signs consistent with FAD/EDI plus the following: (1) sample is 
positive; (2) other epidemiological information is indicative of the 
FAD/EDI.
     Presumptive positive (Secondary case)--Animal with 
clinical signs consistent with FAD/EDI plus one or both of the 
following: (1) sample is positive; (2) other epidemiological 
information is indicative of the FAD/EDI.
     Confirmed positive--Agent is isolated and identified.
    Case Priority Designation--Indicates APHIS response levels, sample 
handling and testing protocols. Designated 1 to 3 for investigations.
    Chief Veterinary Officer (CVO)--The Chief Veterinary Officer of the 
United States is usually the Deputy Administrator of Veterinary 
Services.
    Emergency Management Leadership Team (EMLT)--consists of VS leaders 
responsible for animal health emergency management.
    Epidemiological information--includes tracing all contacts with 
affected animals and premises including movements of non-susceptible 
livestock, humans, fomites, animal products or by-products, crops/
grains, feedstuffs.
    Foreign Animal Disease Diagnostician (FADD)--a veterinarian who has 
been through the foreign animal disease training course at Plum Island 
and receives continuing education in FADs and animal health emergency 
management.
    Foreign Animal Disease/Emerging Disease Incident (FAD/EDI) 
Investigation--On site assessment conducted by FADDs, as part of the 
national surveillance program for exotic or emerging animal diseases. 
The assessment includes: a history of clinical and epidemiological 
findings, results of physical examinations, necropsy findings, specimen 
collection and submission to approved laboratory, reporting, initiating 
appropriate control measures, et al.
    Highly Contagious Disease--rapidly spreading from animal to animal 
as well as herd to herd. Transmission can occur via direct and indirect 
modes; has above normal morbidity/mortality per unit time; could be 
based on species or production.
    READEO--Regional Emergency Animal Disease Eradication 
Organization--This is a USDA, APHIS, VS organization that has trained 
animal health emergency managers and can be mobilized to support and 
fight an outbreak.
    State Veterinarian--the veterinary officer for a particular state 
or territory of the U.S. in charge of animal health activities.

Appendix I--Movement Control Zones

    In the declaration of areas the following factors need to be taken 
into account:
     Industries involved.
     Environmental factors.
     Livestock movement patterns.
     Processing options (livestock and products).
     Natural vs. artificial barriers/boundaries.
     Nature of the outbreak.
     Livestock species involved.
     Wildlife involvement.
     Effect on non-risk commodities due to intrastate commerce 
restrictions.
Infected Zone
    The actual distance in any one direction for the zone is determined 
by factors such as terrain, the pattern of livestock movements, 
livestock concentrations, the weather and prevailing winds, the 
distribution and movements of susceptible wildlife, and known 
characteristics of the agent. The infected zone should extend at least 
6 miles (10 kilometers) beyond the presumptive or confirmed infected 
premises.
    In this zone:
     Conduct epidemiologic investigation to: Identify trace-ins 
and trace-outs; Determine source of infection.
     Movement restrictions are in place.
     To leave the zone: No animals or animal products can leave 
the zone; Vehicles, equipment and people may leave if strict 
biosecurity procedures are followed; Clean and disinfect; Shower out; 
Human-to-animal contact policies are dependent on the agent.
     Evaluate the possibility that state authority could 
depopulate all susceptible animals in this zone.
Surveillance or Movement Control Zone
    This zone will surround the infected zone. The exact boundary of 
the zone will be established to assure containment of the outbreak. 
Early in the outbreak all movement should be stopped. Once the extent 
of the outbreak is understood, susceptible livestock can move within 
that zone with permit but not out of the zone. Non-susceptible 
livestock or poultry can move within and out of the zone with a permit.
    In this zone:
     Conduct active case finding; Increased awareness by of all 
animal health professionals.
     Conduct surveillance at concentration points.
     Non-susceptible livestock and poultry can move out of the 
zone but require appropriate bio-security such as C&D of vehicles.

Appendix II--Foot and Mouth Disease Operational Guidelines

Depopulation and Disposal

     Depopulation and disposal operations are linked. If 
depopulation gets ahead of the ability to dispose of the carcasses, 
there will be bio-security, animal welfare and pest management issues. 
Procedure must keep the agent from spreading so it is important that 
disposal follow euthanasia as soon as possible.
     The preferred method of disposal of carcasses, milk and 
feedstuff is by burial rather than cremation. Burial is generally 
easier, quicker, uses fewer resources, and is less polluting. However, 
several factors, such as topography, soil type, and water-table depth, 
must be considered in selecting a burial site. Forty-two cubic feet are 
required to bury 1 bovine, 5 pigs, or 5 sheep.
     Burning, rendering, composting and alkaline hydrolysis are 
possibilities.

Cleaning and Disinfection

     Remove all organic material.
     Follow label directions.
     Use appropriate disinfectant. Agents that destroy FMD 
virus include; (See Appendix III): Acids (eg. as acetic acid); Alkalis 
(eg. sodium hydroxide, sodium carbonate).
     Any disinfectants or pesticides used must be approved by 
EPA.

Estimated Personnel Requirements

     Depopulation and disposal crew--5 for a heard of 40 per 
day.
     Vaccination Crew--3 for two herds of 40 per day (consider 
using farm personnel if the states practice act allows it).
     C&D Crew--3 and only one farm per day.
     Appraisal Crew--1 person can do a variable number of herds 
per day depending on appraisal process adopted.
     Trace back--1 person can do 1 to 3 traces per day.
     Epidemiological evaluation--1 person can do 1 to 2 per 
day.
     FAD/EDI Investigation--1 person.

Animal Welfare

     Animals will be treated humanely from the time animals are 
identified as presumptive or confirmed positive until they are 
depopulated. When depopulation occurs, euthanasia must be performed as 
rapidly and humanely as possible. Consideration must be given to the 
owners and their families and provided with complete explanation of 
what to expect.
     Lactating animals must be milked.
     Euthanasia will be carried out humanely by chemical, 
mechanical or electrical means.

Equipment

     Sources of equipment: With a Gubernatorial declaration, 
all states assets are made available. With a Presidential declaration, 
Federal assets are made available.

Indemnity and Appraisal

     Title 9, Code of Federal Regulations, Part 53.
     Three independent appraisals, eliminate the lowest and 
average the highest two.
     Future improvements would explore alternate procedures.

Milk and Milk Products

     Milk from known infected farms is destroyed on the farm.
     Milk from herds not known to be infected could be moved to 
processing plants within a control zone and processed to eliminate 
virus and distributed only within control zone.

Meat

     Meat products from FMD exposed animals are not a food 
safety issue.
     Clinically normal animals may be permitted to be 
slaughtered and processed. Fresh, chilled and frozen deboned meat and 
meat products should be marketed only within the infected zone.

Zoologic Parks

     Bio-security plans need to be in place to protect 
susceptible species.
     If infected, all animals will be placed on daily 
surveillance with sentinel animals to ensure the zoo is free of FMD 
before the quarantine is released.

Germplasm Centers

     Semen: FMD may be transmitted by infected semen (virus is 
shed in semen).
     Embryo Transfer: Follow USDA regulation.

Appendix III--Disinfectants for Foot-and-Mouth Disease--Field Use

 
----------------------------------------------------------------------------------------------------------------
                                            Dilution
                 Product                   (Percent)       Mixing Instructions                  Notes
----------------------------------------------------------------------------------------------------------------
5.25% Sodium Hypochlorite (NaOCl)                  3  Add 3 gallons of chlorine
 (household bleach).                                   bleach to 2 gallons of
                                                       water, mix thoroughly.
Acetic acid\1\...........................        4-5  Add 6.5 ounces of glacial     Vinegar is a 4% solution of
                                                       acetic acid to 1 gallon of    acetic acid.
                                                       water, mix thoroughly.
Potassium Peroxymonosulfate and Sodium             1  Follow label directions.....  Virkon-S.
 Chloride (i.e. Virkon-S).
Sodium Carbonate (soda ash) \1\..........          4  Add 5.33 ounces of sodium     The solution is mildly
                                                       carbonate to 1 gallon of      caustic, but can dull paint
                                                       hot water (or 1 pound to 3    and varnished surfaces.
                                                       gallons of hot water), mix
                                                       thoroughly.
Sodium Hydroxide (NaOH) (lye) \1\........          2  Add 1/3 cup of NaOH pellets   This solution is highly
                                                       (2.7 ounces of the lye) to    caustic. Use protective
                                                       1 gallon of cold water, mix   rubber clothing, gloves and
                                                       thoroughly.                   safety glasses. WARNING:
                                                                                     Always add the lye to the
                                                                                     water. Never pour the water
                                                                                     over the lye.
----------------------------------------------------------------------------------------------------------------
\1\ Section 18 application submitted and EPA approval is pending.

                               __________
  u.s. department of agriculture, animal and plant health inspection 
                                service
      Bovine Spongiform Encephalopathy (BSE) Response Plan Summary
                              Introduction
    The mission of the U.S. Department of Agriculture (USDA) is to 
enhance the quality of life for the American people by supporting 
production agriculture; ensuring a safe, affordable, nutritious, and 
accessible food supply; caring for agricultural, forest, and range 
lands; supporting sound development of rural communities; providing 
economic opportunities for farm and rural residents; expanding global 
markets for agricultural and forest products and services; and working 
to reduce hunger in America and throughout the world.
    USDA's Animal and Plant Health Inspection Service (APHIS) is 
responsible for ensuring the health and care of animals and plants. 
APHIS improves agricultural productivity and competitiveness and 
contributes to the national economy and the public health. USDA's Food 
Safety and Inspection Service (FSIS) is responsible for protecting the 
nation's meat and poultry supply--making sure it is safe, wholesome, 
unadulterated, and properly labeled and packaged. These two agencies 
have come together to lead USDA's actions in the prevention, 
monitoring, and control of bovine spongiform encephalopathy (BSE) in 
the U.S. livestock and food supply.
    The public knows BSE as ``mad cow disease,'' a disease linked to 
human cases of new-variant Creutzfeldt-Jakob disease (nvCJD). USDA 
knows BSE as the disease that devastated the livestock industry in the 
United Kingdom and shattered consumer confidence in Europe. BSE has 
affected international trade and all aspects of the animal and public 
health communities. It has called even greater attention to the U.S. 
Government's accountability for a safe food supply.
    No case of BSE has ever been found in the United States. Since 
1989, USDA has had a number of stringent safeguards in place to prevent 
BSE from entering the country. USDA conducts an ongoing, comprehensive 
interagency surveillance program for BSE. This surveillance program 
allows USDA to monitor actively for BSE to ensure immediate detection 
in the event that BSE were to be introduced into the United States.
    Immediate detection allows for swift response. As an emergency 
preparedness measure, USDA has developed this BSE Response Plan to be 
initiated in the event that a case of BSE is diagnosed in the United 
States. The Plan details comprehensive instructions for USDA staff as 
to who is to do what, when, where, and how in the event that BSE were 
to be diagnosed in the United States.
    APHIS and FSIS have come together to lead USDA's actions in the 
prevention, monitoring, and control of bovine spongiform encephalopathy 
(BSE) in U.S. livestock and the food supply.
                               Background
    APHIS is responsible for being prepared for potential foreign 
animal disease outbreaks. The purpose of such preparation is to provide 
a step-by-step plan of action in the event that a foreign animal 
disease, such as BSE, is detected in the United States. These plans, 
often referred to as ``Red Books,'' provide guidance by outlining 
certain actions that should take place, such as identification of a 
suspect animal, laboratory confirmation, epidemiologic investigation, 
and animal and herd disposition activities. Copies of Red Books for 
specific foreign animal diseases are distributed to agency headquarters 
and each regional and field office to have in preparation for a disease 
outbreak.
    In 1990, APHIS developed a plan to respond to a confirmation of BSE 
in the United States. In August 1996, a joint APHIS-FSIS working group 
updated the BSE Red Book in accordance with current science and 
research surrounding BSE and the related family of diseases called 
transmissible spongiform encephalopathies (TSE's). The BSE Red Book is 
officially entitled BSE Emergency Disease Guidelines.
    The APHIS-FSIS working group determined that the BSE Red Book, 
which detailed laboratory and field activities to be carried out in an 
emergency, needed another component. After the March 1996 announcement 
by the United Kingdom that BSE was linked to nvCJD, it became apparent 
to the working group that the Plan needed to address communication 
issues, both internally within USDA and the Federal Government and 
externally to the public at large. A confirmed case of BSE would affect 
such a vast array of stakeholders--consumers, cattle producers, the 
food animal industry, international trading partners, animal and public 
health communities, media, and others. Having clear, accurate 
information readily available would build trust and credibility and 
facilitate any response measures needed. There needed to be a 
notification plan. Who was responsible for notifying who, what, when, 
and how? The Plan needed to identify clear channels of communication as 
to ensure immediate collection and dissemination of accurate 
information.
    The joint APHIS-FSIS working group became formally known as the BSE 
Response Team and is responsible for the development of this BSE 
Response Plan. BSE Response Team members represent a mix of backgrounds 
and expertise, including veterinary medicine, food safety, public 
health, epidemiology, pathology, international trade, and public 
affairs. The Team is coordinated by two Team leaders, one each from 
APHIS and FSIS, who serve as liaisons and technical advisors to their 
respective agencies on regulations and policies regarding BSE.
    Over the past 2 years, the BSE Response Plan has been reviewed, 
edited, revised, and approved by officials at all levels of APHIS, 
FSIS, and USDA. The Plan has also been shared with other Government 
agencies, such as the Food and Drug Administration (FDA), the Centers 
for Disease Control and Prevention (CDC), and the National Institutes 
of Health (NIH), and other stakeholders, such as the Animal Ag 
Coalition.
    The BSE Response Team monitors and assesses all ongoing events and 
research findings regarding TSE's. The Team leaders are responsible for 
ensuring that prevention and diagnostic measures are continually 
revised and adjusted as new information and knowledge become available.
                Notification: Roles and Responsibilities
Surveillance
    As part of USDA's surveillance program for BSE in the United 
States, veterinary pathologists and field investigators from APHIS and 
FSIS have received training from British counterparts in diagnosing 
BSE. FSIS inspects cattle before they go to slaughter; these inspection 
procedures include identifying animals with central nervous system 
conditions. Animals with such conditions are considered suspect for 
BSE, prohibited from slaughter, and referred to APHIS for examination 
as explained below.
    Pathologists at APHIS' National Veterinary Services Laboratories 
(NVSL) histopathologically examine the brains from these condemned 
animals. In addition, samples are tested using a technique called 
immunohistochemistry, which tests for the presence of the protease-
resistant prion protein (a marker for BSE). NVSL also examines samples 
from neurologically ill cattle and nonambulatory (``downer'') cattle 
identified on the farm or at slaughter and from rabiesnegative cattle 
submitted to veterinary diagnostic laboratories and teaching hospitals.
Notification
    Because of their responsibility for examining condemned or BSE-
suspect animals, NVSL is the organization responsible for activating 
the notification and BSE response process. It is NVSL that will begin 
the activation of the BSE Response Plan. From the time a sample is 
submitted, it takes 14 to 18 days to confirm a diagnosis of BSE In the 
first 10 to 13 days, pathologists at NVSL have enough information to 
either rule out BSE or determine the need for additional tests. If it 
is determined that there is no evidence of BSE, the results are added 
to the more than 7,500 others that have also been negative. NVSL 
maintains these data.
    If additional tests do suggest a presumptive diagnosis of BSE, an 
NVSL pathologist will hand carry the sample to the United Kingdom for 
confirmation. It is at this critical point, when NVSL suggests a 
diagnosis of BSE and is preparing to send the sample to the United 
Kingdom, that this BSE Response Plan is initiated. The Plan begins the 
preliminary notification from NVSL to APHIS.
Preliminary Notification
    The director of NVSL is responsible for immediately notifying the 
APHIS, Veterinary Services (VS) deputy administrator when tests suggest 
a presumptive diagnosis of BSE.
    Once NVSL has made a presumptive diagnosis of BSE, APHIS and FSIS 
field activities will also be initiated. APHIS will receive 
notification (either confirming or not confirming NVSL's diagnosis) 
from the United Kingdom anywhere between 24 and 96 hours. (The 
international animal health community has recognized the United 
Kingdom's Central Veterinary Laboratory [CVL] as the world's reference 
laboratory for diagnosing BSE. Other countries, including Belgium, 
France, Ireland, Luxembourg, the Netherlands, Portugal, and 
Switzerland, have all sent samples to this lab to confirm their first 
cases of BSE.)
NVSL
    NVSL will provide all laboratory support in carrying out this BSE 
Response Plan and serve as the liaison with the CVL. NVSL will prepare 
its facility to receive and process additional samples from the suspect 
animal's progeny or herdmates or other suspects. NVSL will also 
coordinate any other assistance from state or university diagnostic 
laboratories if necessary.
APHIS, VS Deputy Administrator
    Veterinary Services is the animal health arm of APHIS and the 
program responsible for carrying out field actions in response to BSE. 
Upon notification of a presumptive diagnosis from NVSL, the APHIS, VS 
deputy administrator immediately notifies the FSIS, Office of Public 
Health and Science (OPHS) deputy administrator. APHIS and FSIS deputy 
administrators will alert the BSE Response Team leaders and instruct 
them to assemble the BSE Response Team and activate the Response Plan. 
The VS deputy administrator serves as the liaison between the BSE 
Response Team and the APHIS administrator The APHIS, VS deputy 
administrator notifies the APHIS administrator and the VS regional 
director of the state from which the suspect animal originated.
APHIS Administrator
    The APHIS Administrator immediately notifies the USDA Assistant 
Secretary for Marketing and Regulatory Programs. This immediate 
notification will be followed by an official informational memorandum 
from the APHIS Administrator, through the Assistant Secretary for 
Marketing and Regulatory Programs, to the Secretary of Agriculture. 
This memorandum will be prepared by the BSE Response Team; a draft is 
maintained by the Team leaders in the reserved section of their Plans.
    The APHIS Administrator is responsible for securing indemnity funds 
for depopulation of the herd if CVL confirms NVSL's diagnosis.
Assistant Secretary for Marketing and Regulatory Programs
    The Assistant Secretary for Marketing and Regulatory Programs, in 
conjunction with the Undersecretary for Food Safety, is responsible for 
notifying the Secretary. The Assistant Secretary serves as the liaison 
between APHIS and Department-level officials.
Secretary of Agriculture
    The Secretary has the authority to declare a Federal emergency if 
appropriate and approve funding as necessary. Information will be 
provided to the Secretary up the chain of command from the BSE Response 
Team.
FSIS, OPHS Deputy Administrator
    The OPHS Deputy Administrator, together with the APHIS, VS Deputy 
Administrator, alert the BSE Response Team leaders and instruct them to 
assemble the BSE Response Team and activate the Plan. The OPHS Deputy 
Administrator serves as the liaison between the BSE Response Team and 
the FSIS Administrator.
    The OPHS Deputy Administrator is responsible for notifying the FSIS 
regional director in charge of the state from which the suspect animal 
originated.
FSIS Deputy Administrator
    The FSIS Deputy Administrator is responsible for notifying the 
Undersecretary for Food Safety.
Undersecretary for Food Safety
    The Undersecretary for Food Safety, in conjuction with the 
Assistant Secretary for Marketing and Regulatory Programs, notifies the 
Secretary of Agriculture.
APHIS, VS Regional Director
    The APHIS, VS regional director in charge of the state from which 
the suspect animal originated notifies the VS Area Veterinarian-in-
Charge (AVIC) for that state. The regional director is the liaison 
between VS field staff and the VS Deputy Administrator at headquarters. 
In addition, the regional director shares all information with the BSE 
Response Team.
APHIS, VS, AVIC
    The VS AVIC, in cooperation with state animal health authorities, 
is responsible for coordinating the field activities surrounding the 
emergency response to BSE. The AVIC assembles the local VS staff to 
initiate activities outlined in the BSE Red Book, including tracing the 
progeny and herdmates of the suspect animal and beginning an 
epidemiologic investigation. The VS AVIC coordinates with the State 
Veterinarian to quarantine the suspect animal's herd of origin. The 
state has the authority to order a routine quarantine for a 
neurological disease. The BSE Response Team surveyed every state to 
determine if they would utilize this authority in the event that NVSL 
identifies a presumptive diagnosis of BSE. All states responded that 
they would issue a quarantine.
BSE Response Team
    The BSE Response Team leaders will notify each team member and 
instruct them to assemble in the Situation Room at APHIS headquarters 
in Riverdale, MD. The Team leaders are responsible for ensuring that 
all of the Team's duties are fulfilled. It is their responsibility to 
ensure that the technical information and expert recommendations reach 
the decisionmakers in a timely fashion. Together with VS' Emergency 
Programs staff, the Team leaders will obtain APHIS, VS administrative 
support staff in Riverdale, MD, to ready the room for use as BSE 
headquarters.
    The Team will begin gathering and assembling information from APHIS 
and FSIS region and field staff. The Team will pull the draft documents 
from the third section in the Team leaders' manuals and begin filling 
in current information as it becomes available.
Public Notification
    Should NVSL receive notice from CVL confirming a case of BSE, the 
next level of notification is activated. Each player will follow the 
same notification protocol as described above for preliminary 
notification to confirm the diagnosis of a case of BSE.
BSE Response Team
    The BSE Response Team will complete the informational memorandum 
for the Secretary.
    The Team will prepare the letter to the Office of International 
Epizootics (OIE), the international animal health organization, for 
signature by the APHIS, VS Deputy Administrator. OIE requires that all 
countries submit official notification within 24 hours of confirming a 
diagnosis of BSE.
    The BSE Response Team and the office of the APHIS, VS Deputy 
Administrator would coordinate a teleconference to inform all APHIS 
regional directors and AVICs.
    The BSE Response Team and the office of the FSIS, OPHS Deputy 
Administrator would coordinate a teleconference to inform all regional 
and field FSIS offices.
    The BSE Response Team would coordinate a teleconference to notify 
other Federal agencies.
    The BSE Response Team would coordinate a teleconference to notify 
key industry/consumer representatives.
    The BSE Response Team and APHIS' International Services would 
notify foreign embassies.
    The BSE Repsonse Team would establish a toll-free 800 telephone 
line for industry representatives, reporters, and the public.
    The BSE Response Team would coordinate with APHIS Legislative and 
Public Affairs and USDA Office of Communications to issue a press 
release the day the diagnosis is confirmed. The press release would 
announce a press conference to be held the morning after the diagnosis 
is confirmed.
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