[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
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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
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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.
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\13\ Telephone conversation with Michael Hansen of Consumers'
Union, April 28, 1997.
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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\
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\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.
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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.)
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\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.
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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.
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\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.
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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.
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\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.
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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.
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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\
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\20\ WHO Factsheet 113.
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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.
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\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.
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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.
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\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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