In the matter of:

NATIONAL CONFERENCE ON

ANIMAL PRODUCTION FOOD SAFETY

Pages: 1 through 341

Place: St. Louis, Missouri

Date: September 6, 2000

BEFORE THE

UNITED STATES DEPARTMENT OF AGRICULTURE

\* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \*

In the matter of:

NATIONAL CONFERENCE ON

ANIMAL PRODUCTION FOOD SAFETY

Grand Ballroom, A-C, E and F

Hyatt Regency

One St. Louis Union Station

St. Louis, Missouri

Wednesday,

September 6, 2000

The conference was convened at 8:00 a.m.

MODERATORS:

DR. JOHN R. RAGAN

DR. KEN OLSON

DR. ALICE THALER

DR. JERRY GILLESPIE

SPEAKERS:

DR. BONNIE BAUTAIN

DR. DOUGLAS POWELL (Keynote)

DR. STEVEN SUNDLOF

DR. BETH LAUTNER

CAROLINE DEWAAL

DR. JERRY GILLESPIE

DR. GARY COWMAN

DONNA REIFSCHNEIDER

JOHN ADAMS

DR. DAN CUTHERMAN

DR. CINDY WOLF

STEPHEN PRETANIK

DR. ALICE JOHNSON

DR. CATHERINE WOTEKI

AL POPE

DR. CRAIG REED

DR. BARBARA MASTERS

DR. DAVID WHITE

DR. NORMAN STERN

SHANNON JORDRE

DR. WILLIAM LAEGREID

DR. STEVEN LEHOTAY

DR. MONTY KERLEY

[I N D E X]{.underline}

[SPEAKER]{.underline} [PAGE]{.underline}

John Ragan 4

Bonnie Bautain 8

Douglas Powell 15

Steven Sundlof 34

Beth Lautner 50

Caroline DeWaal 69

Jerry Gillespie 89

Ken Olson 103

Gary Cowman 104

Donna Reifschneider 113

John Adams 121

Dan Cutherman 134

Cindy Wolf 140

Stephen Pretanik 150

Alice Johnson 160

Alice Thaler 166

Catherine Woteki 167

Al Pope 186

Craig Reed 203

Stephen Sundlof 218

Barbara Masters 232

Jerry Gillespie 245

David White 246

[SPEAKER]{.underline} [PAGE]{.underline}

Shannon Jordre 274

Norman Stern 287

William Laegreid 300

Steven Lehotay 313

Monty Kerley 326

[P R O C E E D I N G S]{.underline}

DR. RAGAN: Good morning. It\'s nice to see a substantial crowd out there
all in place and ready to go. We\'re going to wait another moment here
for some of the folks loitering around the registration desk, and then
we\'ll be underway.

(Pause.)

DR. RAGAN: The group came to order so nicely I have the feeling we had
better go ahead while we have a quiet room.

I\'m John Ragan. I\'m National Livestock Program Leader for the Animal
Production Food Safety staff at FSIS. And on behalf of the long list of
cosponsors, which are on the back of your agenda, I would like to
welcome you to the National Conference on Animal Production Food Safety.

We do have a large number of speakers, distinguished speakers, scheduled
for today and tomorrow. So one of the things that you will see here is a
rather stern set of moderators insisting on keeping the program up to
schedule so that we can hear from everyone.

There will be some time as we go along, depending on the flow, for
questions. And then, tomorrow, at the breakout session, there will be
ample discussion time.

As many of you, perhaps most of you, are aware, a meeting somewhat
similar to this was convened five years ago, just over five years ago,
in College Park, Maryland, dealt with the same subject matter, animal
production food safety.

Over the last few days, as I reviewed the proceedings from that meeting,
I was struck with the number of similarities, first, in the agenda we
have for the next two days, and at the same time with a number of
differences.

A great many things have changed. HACCP was a strange animal that
everybody was concerned about and talking about and discussing in 1995.
Now it\'s a process and a watershed change in the way meat and poultry
is inspected, and it\'s largely implemented, depending on whom you speak
to.

But it\'s still a large matter of discussion. In fact, I doubt that very
many processes and procedures and programs have been so cussed and
discussed and analyzed. And I assume that will carry forth.

One of the great changes that I realized as I looked at that proceedings
is the raising of the bar. I think expectations in our government, in
our society at large, are dramatically higher than they were in 1995.

Fortunately, some of the answers to the questions that we didn\'t have
then we do have now. And as many of you are aware, there are an awful
lot of unanswered questions still, particularly with regard to the
on-farm side of food safety. Perhaps we can have some of those answered
this week.

We have a number of distinguished researchers, we have industry
representatives, and we have government agency representatives, as well
as consumer representatives.

So hopefully, together, with a cooperative spirit, high expectations, we
can find the way that we should best go in the future.

There are three themes to this meeting: quality assurance, research, and
education. And they are somewhat divided in the agenda, but we hope to
see them at the end all molded together into a document of proceedings
that will give us all some idea of how we should proceed.

I have taken the liberty this morning to ask for some remarks from a
speaker not on your agenda but known largely to this group and certainly
near and dear to those of us in animal production food safety.

Dr. Bonnie Bautain was, I think, the moderator at that first session in
\'95 and introduced the Undersecretary, and was involved heavily
throughout.

Dr. Bautain, as you may know, got her DVM at Colorado State. She got her
master\'s at the University of Hawaii. She was in private practice in
Hawaii up until \'89, I believe, and then came to the mainland and has
had a number of very productive and relevant positions since then.

She has worked for CSREES, FDA, finally for FSIS, was the first director
of the Animal Production Food Safety staff and certainly established a
sound basis for all of us to work on.

Bonnie is going to share just a few remarks with us about how things
were in \'95 and how they are from her point of view now. Bonnie.

DR. BAUTAIN: Good morning. It\'s a real honor to be here and to see such
a distinguished audience.

And with John\'s permission, I was going to tell a little story about
John in 1994. He told me he was curious about preharvest food safety,
and he wasn\'t quite sure just how it was going to fit into his job as
state veterinarian. And now you can see John is the National Program
Leader for Livestock and Food Safety.

And I think it represents that we\'ve all changed a little, some of us a
lot, since then.

And I believe that the past is prologue to the future. There\'s a lot
that we\'ve learned and a lot that\'s going to be shared today.

Six years ago could we have envisioned the most radical shakeup of food
safety hygiene rules?

Let me read you something. And this is a quote. \"The new regulations
will merge, harmonize, and simplify food hygiene policy applicable to
all food and all food operators, from the farm to the table.

\"The focus is on setting objectives while leaving business flexibility
in deciding the safety measures to take rather than prescribing them in
great detail.

\"On farms codes of good practice are to be used as the safety
management instrument given that, for the moment, full HACCP
implementation is considered overambitious in the farming context.

\"Producers must put in place procedures for traceability of all foods
and be able to withdraw products presenting a serious risk to consumer
health.\"

Six years ago, would this seem like fiction? Well, this quote is from
the European community\'s Health and Consumer Protection Commissioner,
David Byrne, as he proposed sweeping regulatory changes in Brussels just
a couple of months ago, in July, July 17.

My job for the next five minutes is to tell you where we have been in
animal production food safety at USDA and leave you at this meeting to
determine the future.

After the watershed tragic E. coli 0157 event in 1994, the Animal Plant
Health Inspection Service, APHIS, held the first preharvest food safety
national forum.

The result was a blueprint for preharvest food safety emphasizing the
collaborative veterinary infrastructure available to serve and to build
on food safety models such as the Salmonella enteritidis project in
Pennsylvania.

Later that year Congress reorganized the USDA, and those of us who
worked mostly on food safety in APHIS were transferred to FSIS, the Food
Safety Inspection Service, along with the Agriculture Marketing
Service\'s Egg Products Inspection program. The Undersecretary for Food
Safety position was established in USDA at that time.

From 1994 to 1995, APHIS, and later, FSIS supported the Animal
Production Technical Analysis Group, the TAG group.

These experts analyzed food animal production physical, chemical, and
microbial hazards all along the animal production chain and made some
very significant recommendations that still are very valuable today.

For example, the TAG suggested that food safety control points be
developed through research and that HACCP principles be applied to
quality assurance programs.

As John mentioned, from May 23 to 25 in 1995, FSIS hosted about 300
people in the National Forum on Animal Production Food Safety in College
Park in Maryland.

Earlier in 1995, FSIS had proposed its first major regulatory change in
almost 100 years, the passage and reduction in HACCP system\'s rule.
Needless to say, there was some anxiety in the production community over
FSIS\'s role in animal production.

The acting Undersecretary for Food Safety, Mike Taylor, invited all of
us, all stakeholders, to focus on the preventive approach to reducing
pathogens from farm to slaughter.

He asked us all to do several things at this meeting:

Define the current status of food safety hazards and possible and
promising risk reduction measures in animal production practices; to
work toward national consensus on research priorities; to identify
partnerships needed for research and education; to recommend effective
public and private funding; and to make recommendations for the role of
the new Animal Production Food Safety program in FSIS.

As its first director and chair of this forum, my staff and I
enthusiastically carried out a lot of the recommendations from the forum
in our programs.

For example, I just wanted to highlight some of the things that happened
since the last program and under FSIS\'s initiatives.

The Animal Production Food Safety staff helped to organize and guide the
discussions and the recommendations for the World Health Organization
Consultation held in Washington, D.C. in July ‑‑ or rather, June of
1995. And this consultation was entitled \"Economic Implications of
Foodborne Diseases and Consequences on Animal Production Food Safety.\"

Some of the important findings from that ‑‑ or recommendations from that
consultation was that animal production food safety is an integral part
of the farm-to-table strategy, that traditional animal disease
eradication processes of government regulation, eradication, and
compensation does not apply to animal production food safety and
microbial pathogens.

For pathogens, HACCP is currently most effectively applied at slaughter
and processing activities.

And there were some research priorities that the international community
agreed upon which really reflected much of the information that came out
of that \'95 forum.

We needed ecology and epidemiology of pathogens research, pathogens and
virulence in genetics, live animal HACCP models, economic analysis and
risk assessment, risk communication and technology transfer, and animal
identification enabling case controlled studies.

The Animal Production Food Safety staff led initiatives to support 18
state partnerships as a catalyst for sharing information at the local
level. Also, recommendations from the forum included a more cooperative
role that FSIS could play.

And under the brainchild of Dan Vitiello from the Animal Production
staff, he led the efforts which resulted in the agency regaining its
cooperative agreement authority instead of trying to work through
contractual relationships with our partners.

In 1996, industry supported and FSIS received the President\'s Food
Safety Initiative funding to fund multi-state epidemiology studies of
pathogens in sheep, chicken, swine, and nonfed beef. And currently
papers are being presented in the scientific journals as a result of
those epidemiology studies.

FSIS also funded a national survey of very small producers in
economically disadvantaged areas to determine their educational needs
and the challenges they are going to face in the HACCP era.

FSIS, with the former Livestock Conservation Institute, developed
innovative ways for education. We had the Food Safety Digest. We looked
at regional ‑‑ we had regional conferences on animal production food
safety. And then, we also had the Livestock Conservation Institute do a
clearing house for industry\'s educational programs.

Currently FSIS is supporting efforts in a virtual university so that we
can provide educational information to our schools.

What I\'m trying to point out is that we listened then, and we\'ll
listen today.

A lot has happened since the \'95 forum and the World Health
Organization Consultation, and we\'ll hear updates at this conference. I
believe that the past is prologue, and you\'re here to determine our
future.

So, welcome. Have a great conference, and help define our collaborative
future. Thank you.

(Applause.)

DR. RAGAN: Thank you, Bonnie. The next presentation will be somewhat
unique in my experience. Perhaps some of you with more experience will
not find it so.

But our keynote speaker, Dr. Douglas Powell, is unable to be with us
today for an unusual and bizarre reason that we won\'t go into at the
present time, but we would hope to hear from him in person in the near
future.

Dr. Powell completed his doctorate degree in the Department of Food
Science at the University of Guelph and is currently an assistant
professor in the Department of Plant Agriculture at the University of
Guelph.

He continues as a free-lance journalist, and many of you know him for
his Web site, FS Net, in which he deals with a number of subjects,
including food safety.

He produced his first book in 1997, entitled [Mad Cows and Mother\'s
Milk]{.underline}. And his next book, entitled [Reclaiming
Dinner]{.underline}, will be published next year.

And before we have a look at Dr. Powell on tape, I would like to thank
his wife, Dr. Wendy Powell, also a veterinarian in the food safety
agency, for bringing the tape to us last evening.

So if we can roll that tape, we will hear from Dr. Doug Powell.

(Whereupon, the videotape was played.)

DR. POWELL: Oh. Hi. Sorry I couldn\'t be with you. I was just sitting
here editing some news, you know, Animal Net, FS Net, all those good
things.

If you were at the International Association of Food Protection annual
meeting, you may have heard my tale of woe.

It seems that 20 years ago ‑‑ it doesn\'t seem ‑‑ 20 years ago I did
have a criminal conviction for bad driving. U.S. Customs found out about
this a couple of weeks ago and prevented me from going in.

So with the help of Kateegy \[phonetic\] here on the other end of the
camera, we sent the talk down.

We thought we would have this fixed by today; we haven\'t. So here we
are. We got a little more theatrical this time, give you a little early
morning entertainment, because it is only 8:00 in the morning down
there, I\'m aware.

So what are we here to talk about? Why is food safety important, and why
is it important on the farm?

Well, you can\'t go anywhere, you know. Newspapers, they\'re all full of
it, of food safety. They may be full of it, too.

Why, just on Friday the [New York Times]{.underline} had a letter.
There\'s been this argument about, you know, is organic better than
conventional and vice versa? You can ask Lester about that one. He may
know a little something about it. I think he\'s supposed to be there.

Anyway, on Friday the [Times]{.underline} had this letter from a person
saying, Look, you know, even if there is bacteria in manure, it doesn\'t
matter, because you can just wash it off the produce. Duh. Not quite.

And of course, these things, the trends that are out there and the level
of public discussion is actually quite disconcerting.

There are real risks out there that need to be reduced. They need to be
managed and need to be seen to be managed. At the same time, there is an
awful lot of New Age hucksterism going around.

Producers, processors, farmers, all of you folks have to be vigilant
about enforcing good food safety on the farm. Why? Well, we\'re going to
show you a couple examples over the next half-hour, but the bottom line
is, that\'s where some problems start, and in fact, in some cases, the
only place to fix them.

Having said that, let\'s not oversell the things. They\'re limited in
what we can do.

But you have to do them. You have to get the right data. You have to
make it public so people know you\'re making an effort. The lawyers call
this due diligence, and it will stand up in court. Furthermore, you have
to be perceived as doing the right thing.

People have an interest in how food is produced. In fact, that interest
is maybe at an all time high as so many ‑‑ there\'s so few people
involved in food production that people are now interested in how it\'s
produced because they don\'t have any idea.

How do we see this reflected? We see this in all kinds of New Age diets
where people are looking to link it to health. We see this in stories
about food safety. Every week, on and on and on, there\'s outbreaks, and
they\'re very nasty outbreaks.

We see it in concern about genetic engineering and agricultural
biotechnology. We see it in concern about animal welfare standards, a
whole array of concerns, even corporate control and concentration in the
food supply.

Not a day goes by that I don\'t have to sit here at this computer for
two or three hours editing stories that have appeared just that day.

So rather than viewing this as, Ooh, this is bad, this is an
opportunity. If you\'ve got a good story to tell, get out there and tell
it.

Now, one of the trends that\'s out there is where consumers, whether
rightly or wrongly, in response to all this they say, Well, I\'m going
to go for the all natural food because that\'s better for me.

Conversely, people think that food associated with factory farming is
bad.

Now, you may know, and I\'m sure many of you in the audience know, we
have had a terrible outbreak of 0157 in Walkerton, Ontario this summer.

Now, Walkerton is about 50 minutes away from here, north and to the west
a bit. One of my best friends is the dairy farmer at the edge of town.
And I can\'t begin to tell you how this has impacted on his life.

This is a town of 5,000 people, largely a farming community. They were
descended on. They had a media outfit worthy of the Gulf War. CNN had a
crew up there. There were helicopters. There were more helicopters for
the television stations than there were ferrying kids back and forth to
the sick kids\' hospital.

In the end, six people died and over 2,000 got sickened by 0157 that
apparently got into the water supply.

Now, a few weeks ago, the [Globe and Mail]{.underline}, one of Canada\'s
self-proclaimed national newspapers, came out with the headline on the
front page, E. coli linked to cattle. There\'s something to stop the
presses over, cattle shed E. coli.

What happened was, because in Canada we have not as open and transparent
a system, whether you like it or not ‑‑ I mean, you think there are
flaws, but it\'s not as bad as what is in Canada in terms of
reporting ‑‑ there had been no information on this outbreak, a lot of
speculation.

What that has led to is, Well, it\'s factory farms. It\'s these large
hog things.

And I mean, factory farms in Ontario, the definition is over 150 cattle,
and you\'ve got a factory farm.

This is not factory farming like in Iowa or North Carolina, with these
thousands of animals. These are actually small operations. I think the
biggest feedlot maybe is 5,000 head.

Never mind, the story took off that it was factory farming and it was
hogs, which of course doesn\'t really make sense in this context. And
these stories proliferated.

And others tried to come back and say, Well, hold on, wait a minute,
maybe it\'s not that. You know, it could be anything. It could be deer,
it could be cattle, you know. They all shed this thing. Well, that got
lost in the noise.

So when the story came out a couple of weeks ago, then, the lead was
they connected it to a farm, one of the farms in the area tested
positive.

This is guy, cow cap operation 100 head, hardly a factory farm. In fact,
he\'s a model producer. He does all the right things. He has an
environmental farm plan, good containment.

The point is we know cattle shed 0157. That\'s why we chlorinate water.
But in the absence of that kind of information, mythologies and rumors
and conspiracies take off.

This produces a challenge. Furthermore, it produces a real risk, because
people become impervious to risk. They think ‑‑ and I\'ve heard this so
many times this summer I can\'t begin to tell you ‑‑ I don\'t live near
a factory farm, therefore, I\'m not at risk.

A little girl in Montreal got sick from 0157 a little while ago. Her
father wrote in to ‑‑ or was quoted in the newspapers saying, Well, we
were using frozen patties, so it couldn\'t have been the hamburger; it
must have been the water.

Stories like that unfortunately are proliferating, and there\'s a real
danger there. And there\'s a lot of hucksters, as I said before, about
all natural stuff.

And I would argue that, for those folks in this room, science has a
responsibility, if not to inform, then, to lead that public discussion
about where risks are and what we can do to reduce them.

Now, when it comes to consumers, that kind of factory farming, what that
is is a stigmata, it\'s a symbol. I don\'t want to know all the details
about how 0157 may get into the water supply and get people sick.

I just know, big storm, Oh, I\'ve seen them spreading this stuff out
there, therefore it must be factory farming, and therefore, it\'s bad,
and I want to stay away from it.

Stigma is a very powerful shortcut that consumers use to view whether we
should, you know, worry about risks or not.

For example, the most famous case of this, and in fact, why a lot of the
on-farm food safety push got started, was these California strawberries.
Well, not these strawberries. These were bought at the store down the
road. Not bad for this time of the year.

In 1996 there was an outbreak of Cyclospora all across North America ‑‑
well, on the eastern side of North America. In the end, about a thousand
people got sick. You all know the story.

And at the time they said, Well, it\'s California strawberries. Turns
out it was probably Guatemalan raspberries. These aren\'t Guatemalan,
but they\'re raspberries. It\'s breakfast. You\'re probably sitting
there eating, too, so don\'t get mad at me eating. And it turns out it
was Guatemalan raspberries.

No matter. The California strawberry growers lost between 20 and \$40
million largely because their product became stigmatized. The details
became irrelevant. The producers were slow to get out there.

Look at it this way. Once the fingers start pointing ‑‑ and this is what
happens all the time. The journalists go and they write the stories, and
they say, They say it\'s you, and they say, It\'s not us, and the
journalists say, Prove it. And they say, It\'s not us.

Eventually they opened their books, but it was too late, and the damage
had been done.

Today if that happened and you went to the California strawberry
growers, they would say, Well, we don\'t think it\'s us, but here is
everything we do to reduce risks on the farm.

And they would show you these neat little hand washing stations that
they move around the fields. They would show you these neat little ways
that they warm up water so that they can have warm water to wash hands
out in the fields ‑‑ and it gets cold at night out in the fields in the
valley in California ‑‑ and so on. And they would be able to document
it.

Is that risk elimination? No. But is it risk reduction? Yes.

Now, this here is a greenhouse tomato. It\'s very uniform, nice color.

Leamington, Ontario has the largest concentration of greenhouses
anywhere in North America, and they produce this stuff. And well, with
the 65-cent Canadian dollar, we export most of it to the United States,
and you guys seem to like it.

Now, a couple of years ago I developed an on-farm safety plan for all
220 growers in the province. And it involves water quality checks and
employee sanitation, and so on, again, risk reduction. But it\'s
documented, it\'s on the Web. Consumers can get it if they want,
customers can get it if they want.

Why am I telling you all this? What\'s this got to do with animals?

Well, in the aftermath of Walkerton this year, every little town in
Canada has gone crazy on water testing.

We have had more boiled water advisories than you can begin to imagine
in Ontario and throughout Canada in the last year because all of a
sudden people are realizing, Oh, I thought Canada was pristine. No. It
can happen at home.

One of the things with on-farm food safety plans ‑‑ and I\'ve done a
number of them now ‑‑ and we survey the producers at the start.

And we always ask them, What\'s the biggest risk to the foods you eat?
Just like you do with consumers. And consumers for the last few years
would say microorganisms, bacteria, bugs.

What do farmers say? It\'s not bugs, it\'s not chemicals. Every time
we\'ve done this the answer is imports. It\'s always someone else. My
food is clean. It\'s that bad stuff from somewhere else.

And in Canada, we were certainly very guilty of this image of the
pristine environment and it couldn\'t happen here. Guess what, folks? It
did.

In the aftermath of Walkerton, then, a couple of newspaper reporters
actually called up these greenhouse vegetable guys.

And they said, Are you concerned that you\'re using water ‑‑ and we use
municipal water in Leamington, but it\'s well water elsewhere. Are you
concerned about growing your vegetables in this water that contains E.
coli? And that\'s where the story was going.

And the general manager of the greenhouse association said, Well,
actually, we are concerned about water quality, and that\'s why we put
in a plan over a year ago where we\'re testing water quality for every
grower, and I can show you all the data that says we\'re on top of this.

And that was the end of the story. It didn\'t go anywhere. The reason
why is the short form for HACCP. Say what you do, do what you say, and
be able to prove it, and you\'ll have some success.

But, hey, why just sit here and talk in my office? This is my office.
I\'ve got all these computers for the kids. Fortunately, this is the
first week of September now, and my kids have gone back to school.

Anyway, but if we\'re going to talk about food safety, I think we had
better go to the farm. So we\'ll see you there.

(Pause.)

DR. POWELL: Hi, folks. If we\'re going to talk about on-farm food
safety, let\'s talk on the farm.

Now, of course, this is a research facility. This is at the University.
We did not have time to go to a couple of friends\' farms, but you do
what you can do for theatrics.

Now, people don\'t necessarily think of it as food. They think of their
dinner plate. But on-farm food safety, this is where it starts. It
starts with research and getting that research out into the field and
having it make a difference. And that\'s a real challenge. But there\'s
been a number of successes that have happened.

You look at the Nebraska corn-fed beef program. And D. Griff has done a
great job getting all those producers on there. And what it really is is
a great QA program. The data is there, and they can prove what they\'re
doing. That\'s the best you can do.

People are always going to say, you know, my favorite line from Regis
Philben a few years ago on the gab fest with Kathy Lee before she left,
Anything from a cow is bad. Well, it\'s not. But there are risks, and
they need to be managed appropriately.

But there\'s a real danger, of course, in overselling these things. You
know, why are all these outbreaks happening at HACCP based facilities?

HACCP is a great tool to reduce risk, but it\'s not going to solve all
the problems. And we as an industry and as a government have to be very
careful not to oversell it, because there\'s always going to be
problems.

You can\'t have real HACCP on the farm. You can have HACCP-like
procedures. But remember, human behavior if very unreliable and very
difficult to quantify. So don\'t oversell things.

There\'s an old saying, and you\'ve probably heard me say it before:
Bullshit is the grease on the skids of innovation. So be careful about
that, because down the line your credibility will be harmed because,
remember, there\'s that consumer interest out there. They don\'t see
this cow. What they see is maybe that broken needle in their steak at
home.

You know, stigma is an incredibly powerful emotion that consumers use to
decide what\'s real and what\'s not. They don\'t want to know all the
specifics about bovine encephalopathy and transmissibles and New Variant
Kreutzfeld-Jakov disease. They just say British beef is bad. Yuck. I
want to stay away from it.

A good example is, talking about those California strawberries and
raspberries. The poor strawberry growers come back, and you know, six
months later they had an outbreak of Hepatitis A in the frozen
strawberries. It turned out that they were legally grown in Mexico and
sold to the U.S. school lunch program.

And they had an outbreak, vaccinated all kinds of kids. Well, of course,
strawberry sales collapsed all through North America.

I went to the grocery store with a couple of my younger kids who
weren\'t in school at the time. It was during the week. And we found
when we shopped, of course, that California strawberries were really
cheap, they couldn\'t give them away. I picked up a couple of pints.

And all these people in the produce section, they just stopped and
stared at me like I was, you know, a child abuser. And one of them
actually came up to me, and she said, Didn\'t you hear about the
strawberries? Don\'t you know they\'re poison?

So I looked at her, and I said, Gee, you know, I\'m a professor in food
safety, and blah blah. It didn\'t matter. She was gone. I had lost her.
She had concluded that I was a bad person. All she had heard was that it
was bad, and therefore, stay away from it.

I walked away. There was no ‑‑ she wasn\'t going to change her mind. I
was a child abuser in their minds. And of course, my kids are eating the
damn things in the cart because they\'re animals, nothing but animals.

Do they still do jokes about aggies and sheep?

(General laughter.)

DR. POWELL: Of course, most consumers, they don\'t go to the farm. They
go to the grocery store. They want to buy food they trust. Safety is not
negotiable. It\'s expected.

And of course, the other reason to do on-farm food safety is it can be
real hard to cook food safely. Dale Hancock is here. He can tell you
about hamburgers. He can watch and critique all the mistakes I\'m making
right now.

But the point is, people are not going to be perfect. It\'s the middle
of the day, you know, and what if I\'ve had a few pops and gotten a
little sloppy? Is that any reason for someone to get sick? I don\'t
think so.

So what we want to do is ensure that we\'ve got risk reduction across
the board. By the way, this cloth is just for wiping. It goes into the
laundry room. This plate goes straight into the dishwasher. These steaks
are pretty good looking.

So we want safety across the board because that\'s what consumers
expect. And if there ever is an outbreak, they\'re going to come back to
you and say, What have you done to reduce risks?

You know, I really need some corn to go with this. I\'ll be right back.

(Pause.)

DR. POWELL: Hi. I\'m standing in front of a field of genetically
engineered BT sweet corn.

This is a farmer friend of mine. His name is Jeff Wilson. He grows about
300 acres of fruits and vegetables.

And one of the things we did this year was we grew genetically
engineered and ‑‑ or Jeff grew genetically engineered and conventional
sweet corn and potatoes side by side. And because he has a farm market,
we were able to take it right through for consumer testing.

In fact, we just finished a press conference which announced the start
of the consumer testing, because we got our first harvest. This stuff,
oh, it will be another five days or so till it\'s ready.

But the idea is, we\'re bringing people to the farm. This is no
different than any other segment of agriculture. We have to get people
more involved in what\'s going on at the farm. Certainly the interest is
out there.

And you know, if farmers and the agriculture industry doesn\'t promote
an understanding of what\'s involved in today\'s food production in
terms of safety, in terms of environmental impact, and in terms of the
trade-offs that individual farmers have to make to produce a crop, then
others are going to do it for you.

And you may not like the results when, say, a particular group goes out
and says, This is what\'s going on at the farm. You\'re better to take
them out.

And I\'ve been very fortunate that Jeff has been willing to open up his
farm market so that we can do some consumer testing. We\'ve been very
open about this project, you know. And in Europe we couldn\'t do this. I
mean, they would come by and cut it all down. I\'d be standing in front
of a field of corn that was lying on the ground.

We actually have a three kilometer walking tour through the corn and
potatoes. No one has trampled the crops. In fact, there\'s been at least
a thousand people through over the last month or two.

So the idea is, get out there, show people what you\'re doing, and then
let them vote.

We were able to show people today ‑‑ and this is last Wednesday ‑‑ that
the genetically engineered corn had one treatment of herbicide, one
treatment of nitrogen, no insecticides. The conventional stuff had at
least three treatments of furodan \[phonetic\]. That\'s a human health
issue.

As a parent I\'m more interested in having my kids eat sweet corn ‑‑
which they eat a lot of ‑‑ that has the actual 100 percent fewer levels
of insecticide on it.

Further, we use BT as a spray, same thing, a lot of spraying. And what
about the impact on nontarget insects? The environmental aspects are
very significant.

So bring folks out, show them what\'s involved in agriculture, and get
your side of the story out there.

Now, you can see we\'ve got out genetically engineered corn and our safe
beef, and we\'re going to go have lunch. I hope you enjoy your day.

This may not be the best food or beverage for eight o\'clock in the
morning, but you understand I\'m taping this.

Anyway, I\'m really sorry I couldn\'t be with you. We all miss you. I
hope you have a good conference. And we\'ll see you in the future real
soon. Thanks very much.

(Applause.)

DR. RAGAN: Okay. We do have Dr. Doug Powell on the phone if there are a
couple of burning questions that you have for him. I think you can use
the mic up here.

Now, Doug is going to be really disappointed if somebody doesn\'t jump
on him here, and we do have him on the wire. And we will give you two
minutes to indicate that you want to ask questions.

(Pause.)

DR. RAGAN: Okay. I will tell Dr. Powell that the audience was
transfixed.

(General laughter.)

DR. RAGAN: And we will move ahead.

Thank you, Doug, if you\'re still on the line.

DR. POWELL: Oh, I\'m here.

DR. RAGAN: Okay. Very good. This is a shy group.

DR. POWELL: Yes. Apparently. Well, you know, these things work okay. My
department thinks I\'m in St. Louis, so I got out of the departmental
retreat today.

DR. RAGAN: Very good.

(General laughter.)

DR. RAGAN: I think we do have a question in the back of the room. Would
you come up to the mic, please?

VOICE: Dr. Powell, you had mentioned that on-farm HACCP is not possible
but HACCP-like processes is. Could you elaborate on that?

DR. POWELL: For the HACCP purists in the crowd, they will say that it\'s
difficult to have critical control points on the farm. It\'s not like
you\'re in a dairy where you\'re pasteurizing and you can measure the
temperature. But you can have HACCP-like programs.

It\'s the same idea. I don\'t get too hung up in the words, but some
HACCP purists do. So I just wanted to avoid that.

DR. RAGAN: Anyone else?

(No response.)

DR. RAGAN: Okay. I guess we\'re ready to move along. Dr. Powell, thank
you very much for being with us in voice and on the screen.

DR. POWELL: Thanks, John. We\'ll see you later.

DR. RAGAN: Okay. At this point we\'re going to move to looking at the
question of where we are with regard to animal production food safety or
food safety on the farm.

We have three speakers who will address this subject, from the
government perspective, from the producer\'s perspective, and from the
consumer\'s perspective.

Our first speaker will bring us the government perspective, Dr. Steve
Sundlof, very likely needs no introduction to this group. But I will say
a few words about him in any case.

He is director, as you know, of the Center for Veterinary Medicine in
the Food and Drug Administration; received his DVM and Ph.D. in
toxicology from the University of Illinois; is board certified in
toxicology; has served on the faculty at the University of Florida, and
held the rank of professor there.

And as you\'re well aware, Dr. Sundlof has published numerous articles
in scientific journals on drug residues and food safety.

He has presented more than 100 invited lectures at national and
international meetings. And he presently serves as chairman of the
WHO/FAO Codex Alimentarius committee on residues of veterinary drugs in
food.

He is past president of the American Academy of Veterinary Pharmacology
and Therapeutics. Please welcome Dr. Steven Sundlof.

(Applause.)

DR. SUNDLOF: Thank you. If you can just bear with me for a second while
I try and get the computer up and running. Oh. That was easy.

Thank you very much. This is the first time that I\'ve ever been asked
to represent the entire U.S. government in a public meeting, so I think
this is kind of cool.

But in the future I think I\'m going to do all my presentations by video
tape. That looked like it was a lot more fun.

Yes. I do want to talk on what the government perspective is on food
safety. Within the recent years there has been a great amount of
activity at the federal level in focusing attention on food safety and
on programs in which to improve food safety.

Well, the government, of course, has been involved in food safety. This
is one of the primary responsibilities of government, to make sure that
the food supply is safe.

Although it had been going on even in the 19th Century, it was early in
the 20th Century, under President Teddy Roosevelt, that the first Food
and Drug Act was passed in 1906.

And that was generally looking at certain foodborne issues such as
tuberculosis and trichinosis, which were major food problems at the
time, still are food problems but not nearly to the extent that they
were back then.

The major government entities, when we think about food safety and who
is responsible, we generally think about the USDA, especially Food
Safety and Inspection Service, but also APHIS and CSREES and ARS and ERS
and a number of other organizations within USDA that do have some
responsibility in food safety.

We also think about the Department of Health and Human Services, two
cabinet level departments in which HHS has the FDA, including Center for
Veterinary Medicine, Center for Food Safety and Applied Nutrition, and
the Centers For Disease Control and Prevention.

But we are aided by other parts of the federal government, including EPA
and the Department of Commerce through the National Marine Fishery
Service.

But more than a centralized government regulatory control program, we
rely extremely heavily on the states, on state and local authorities to
carry out these programs. And I don\'t think those programs get near the
credit that they deserve.

But without the states and local governments and organizations like
AFCO, we wouldn\'t have the safe food supply that we do. So that\'s very
important.

Well, since I am from FDA, I think it\'s prudent to talk about some of
the FDA\'s programs and some of the statements made. If I was from USDA,
I would be quoting Secretary Glickman. But I\'m from FDA, so I\'ll be
quoting Dr. Henney.

And in a speech last year Commissioner Henney remarked, While the U.S.
enjoys one of the safest and most bountiful food supplies in the world,
each year in our country millions of people become ill and thousands die
due to foodborne illness. We can and must do better.

And the government\'s assumption is that all food should be safe and
that the public has the right to the safest food supply that we can
possibly give them.

And this is occurring at a time when we are seeing new infections, new
infectious agents emerging in the food supply and we\'re more concerned
about certain chemical substances.

We do have ‑‑ much more of our food is imported. To a greater extent we
eat outside of the home, and we don\'t have direct control over food
safety.

We know of at least five times as many substances and organisms that can
cause foodborne disease than we did back in 1942. Some of the more
interesting organisms that have developed are things like Salmonella
enteritidis, which was not known until recently, transmitted
transovarian into the egg. That was a route of transmission that we
didn\'t know about.

BSE, it goes without saying, is a new foodborne infection. We just heard
about cyclospora as a new foodborne disease. And there are a number of
other new organisms that are causing disease.

We also are more concerned about naturally occurring and manmade
chemicals that pose threats at much lower levels than we thought of in
the past. The new EPA risk assessment on dioxin shows that the level of
risk of cancer may be anywhere from 1 in 100 to 1 in 1,000, fairly low.

We are also concerned about chemicals such as mercury, where new science
has shown that the risk may be greater than what we had previously
thought.

And we can detect these things at much, much lower levels than we could
in the past.

And in terms of the foodborne pathogens, CDC reports that of all the
foodborne pathogens, the diseases that they cause, we don\'t know what
the majority of them are. So we have a lot of work ahead of us in trying
to determine just exactly what organisms are responsible for foodborne
disease.

So what is the Government\'s approach? Well, we start out by saying
enforcement is the bottom line. That is the last resort for us.

We do have the authority to take regulatory action, both on the farm, in
the plants, or in the retail establishments, or anyplace in the chain.
But we try not to use that except where absolutely necessary. And both
the USDA and the FDA strongly believe that education and cooperation is
the real key to food safety.

This is an interesting debate now that is occurring in the European
Union, where they are looking towards a centralized food authority, food
safety authority.

And one of the criticisms they have received is that, although they have
a central authority, they have no direct enforcement authority. And that
involves the individual member countries of the European Union. And that
is somewhat unsettling to the public.

Through cooperation, though, we have had some very successful programs
to prevent food safety outbreaks that we\'ve seen in other places. The
BSE prevention program is an example of this.

And in this program, we work heavily with our state partners in getting
out there and inspecting all the rendering facilities, all of the
protein blenders and distributors, all of the commercial feed mills, and
many on-farm operations, as well, to make sure that they were in
compliance with our new feed laws that prohibited the feeding of
mammalian proteins back to ruminants.

And in the first go-round we decided that this would be an educational.
If we found violations of the regulation, we would first try and take an
educational approach to get people into compliance, then come back on
the second go-round and determine whether or not that had been
effective.

And in most cases, it has been effective in bringing people into
compliance merely through educational efforts.

What about seafood? Seafood HACCP is another program in which there has
been a great cooperation between the government, in this case the Center
for Food Safety and Applied Nutrition, the industry, and academia in
developing these HACCP programs.

In a survey, 78 percent of processors said they would not have been able
to develop a HACCP plan or comply with the HACCP regulation if they had
not been through this course developed by the alliance.

And the success rate was fairly high. Even before the first inspection,
roughly about a quarter of all seafood plants were in compliance. And so
this is an ongoing effort to bring more and more people into voluntary
compliance. And they expect that this will continue to grow.

But it is a tremendous problem. It\'s a little bit more difficult than
trying to inspect in federally regulated plants where you have thousands
of people out there producing.

We import over 50 percent of all seafood. And to make sure that those
other countries are in compliance is also very important.

Egg safety is another area that has received a lot of attention lately.
There was, in fact, just last July, there was a public meeting to
discuss the issue of egg safety.

There are some on-farm components to the egg safety plan. This was part
of the President\'s Council on Food Safety. And they identified egg
safety as a component of overall food safety and developed an egg safety
action plan.

And FSIS and FDA have issued some current thinking documents for public
discussion, which includes again on-farm actions designed to reduce the
levels of Salmonella enteritidis in eggs at the processing level.

And there will be another meeting this Friday in Atlanta which will be
discussing Salmonella enteritidis research.

Milk safety, another component of the government\'s plan to make sure
that the food supply is kept safe. This also emphasizes the importance
of states, but also of the dairy industry itself.

And it\'s regulated under a unique kind of a cooperative plan called the
Pasteurized Milk Ordinance.

And the National Conference on Interstate Milk Shipments meets every two
years to discuss changes to Pasteurized Milk Ordinance in order to
maintain food safety.

But it is a highly participative program that is a government, state,
and industry cooperative venture.

Well, we think in the government that there are really three major
things or areas that we want to emphasize in our approach to food
safety.

One of them is that it is a science-based approach. Interestingly in the
United States, science as an institution is deeply rooted in our food
safety programs.

This is not the case in many other countries, especially less developed
countries where science does not serve as the basis for decisions. Other
things that are much more important, political decisions, economic
decisions, and trade implications are much more important in developing
their regulatory process than science is.

In the United States science is very important and as an institution is
deeply rooted in food science. The best decisions we feel are made by
using an objective, scientific basis for those decisions.

And that presents certain problems, because as you know, the area of
food safety has become more and more complicated as we learn more and
more about these emerging problems. And trying to keep government
officials up to speed on the new science can be a very demanding task.

But we have a substantial investment in food safety research. And with
the food safety initiative, the budget for doing food safety research
has doubled within the past four years.

The food safety initiative has been a true watershed for the United
States in really focusing on the whole issue of food safety.

It also means looking outside of the federal government and looking to
the scientists in the scientific community, determining where the
research priorities ought to be, and making sure that those highest
priority research areas get funded and that there is not duplication of
efforts.

And I think we\'re going to be hearing from Dr. Jerry Gillespie later on
today, this morning, about the Joint Institute for Food Safety Research
that grew out of the food safety initiative and the President\'s Council
on Food Safety.

So science is one of our basic tenets for our food safety program. The
other one is ‑‑ Number 2 is risk-based. We want to take a more
risk-based approach to dealing with food safety.

We want to try and prioritize which are the most imminent threats to
public health and make sure that our resources are directed at those.

We are instituting risk assessment much more into the regulation of food
safety. And we\'ve seen a number of quantitative and qualitative risk
assessments that have been published lately to get more of a risk-based
approach.

We also are using our risk assessment in order to give our risk managers
the tools that they need, the information that they need to make the
proper risk management decisions.

Thirdly, we think that the process needs to be very open and
transparent. And this is the area of risk communication which Doug
Powell just talked extensively about. And risk communication has become
one of the mantras of modern food safety programs.

This concept includes telling the public where the risks are, trying to
explain those risks and the approaches that are being taken to minimize
those risks in a very understandable way.

It also means that when we do have a problem we get out there and we let
the public know immediately. That is absolutely critical to having a
system which has public support. And it means that everybody has a
chance to comment, that this is an open public process, that the public
is invited to make comments, and that the government is required to
respond to those comments in a timely manner.

And that\'s the reason for today\'s program, is to try and bring in more
outside input so that the food safety programs that we\'re all part of
can function better together so that we can meet the expectations of the
public.

So today\'s meeting is a focus on food safety, basically on the farm,
which is probably one of the areas that gets the least amount of
attention and one that is absolutely critical in maintaining the safety
of the food supply.

We\'re here to explain what government has done to promote food safety,
to find out and document what producers have done, and also to see what
more needs to be done.

We realize that the responsibility to improve food safety is not vested
in one agency or just one government, but we\'re all involved.

So food safety is our common goal. We request and want your thoughts.
Your comments and your criticisms are all invited.

And we certainly, as Bonnie Bautain indicated earlier, have come a long
way in five years, but we need to do a lot more. And we appreciate your
willingness to work with us. Thank you very much.

(Applause.)

DR. RAGAN: While we are changing our gear here, if there is a question
for Dr. Sundlof, he will respond.

VOICE: Hi. I\'m Clarence Surogee \[phonetic\] from Wisconsin State
Veterinarian. And I think the food safety approach on the farm is a very
laudable goal, and I think most of us in our states are working very,
very hard to get to that goal.

But every time I have producers and others sit down and meet and talk
about this, the first question they ask is, Well, what\'s going on with
the cooking of food, the preparation of food, and what\'s the funding
like in the inspection on the retail side?

I know it\'s easy to point the finger at the other direction, and I
don\'t really want to do that.

But sometimes it helps for me to answer that question if I were to know
that there is an equal effort say, for example, in restaurants where
there is inspections maybe once a year and some of the places even once
every two years, to know what\'s going on in that end so I can explain
to our producers what\'s happening there.

DR. SUNDLOF: Excellent question. Some of the things that are being done
under the food safety initiative is that one of the major areas of that
is education.

There is a program called Fight BAC! which is an educational program to
try and get the message down into the elementary school level.

There are a number of other educational programs that are going on
besides the Fight BAC! to try and get consumers to understand the
importance of food hygiene, of safe handling of food. So there are some
efforts being made there.

In terms of retail establishments, local restaurants, that is a very
good question and an interesting ‑‑ it\'s a difficult area to try and
regulate, especially in these days where it is becoming increasingly
difficult to try and find competent help in those establishments and to
make sure that they are conforming to the local and state laws regarding
food safety.

Most of the retail establishments and restaurants, et cetera are
inspected by state and local authorities, and they are strained in their
resources to do as adequate a job as we would like to have happen all
the time.

But there are a number of different areas in the whole area of food
safety, on-farm being one of them, public education, retail
establishments, testing, et cetera, et cetera that all need to have a
lot of interest paid to them. And I think that these are areas that we
need to be discussing here at this forum.

VOICE: Dr. Ann Rumen \[phonetic\], Illinois Department of Agriculture,
Meat Inspection.

I had a question as far as where FDA stands when you speak of risk
assessment as far as repeat violators on antibiotic residues when they
send them to market.

DR. SUNDLOF: Yes. Well, we ‑‑ the way we have established our
enforcement program is that first-time violators are generally given
letters by the Food Safety and Inspection System to let them know that
they were in violation.

Repeat violators go into a database, which FDA makes sure and ensures
follow-up action on the repeat violators. We also sometimes work ‑‑ we
work with FSIS in order to make sure that we have coverage on those.

But for the repeat violators we generally take a more strong enforcement
action. Generally it starts out with some warning letters. If that
doesn\'t seem to affect the problem, we get tougher.

And right now we have a number of dairies that are under consent decrees
that they are not able to market their product. We took legal action
against them. There are some individuals actually serving jail time as a
result of repeated violation of residues.

In most cases ‑‑ one of the nice things about it is that, in most cases,
the repeat violators are a very, very small proportion of the one-time
violators, and that generally means that people made a mistake and they
are willing to correct their mistakes.

But we\'re always interested in making sure that if there are egregious
violations that we target our enforcement resources on those which are
of the greatest magnitude. Okay. Thanks.

DR. RAGAN: Thank you, Dr. Sundlof. And now, to bring us the perspective
of food animal producers or animal-based food producers, if you will, is
Dr. Beth Lautner.

Dr. Lautner serves as the vice president of Swine Health and Pork Safety
for the National Pork Producers Council.

Dr. Lautner got her DVM at Michigan State and her master\'s at the
University of Minnesota, was involved in private practice for some time,
joined the National Pork Producers in 1992.

She is responsible for the development and coordination of food safety
and swine health programs and for information as they relate to pork
production and long-range policy planning.

Dr. Lautner represents National Pork Producers on the Secretary\'s
advisory on farm animal and poultry diseases.

She is the recipient ‑‑ was in 1994 ‑‑ of the Howard W. Dunn Memorial
Award for outstanding service to the American Association of Swine
Practitioners and later received the Animal and Plant Health Inspection
Service Administrator\'s Award in recognition for her contribution to
the advancement of animal health.

Also, as you know, Dr. Lautner has been an integral part of many
government/industry collaborative efforts in the area of animal health
and food safety.

So Dr. Lautner, if you\'ll bring us the producers\' perspective.

DR. LAUTNER: Thank you. I appreciate the opportunity to provide
overviews of animal production food safety activities since the last
conference in 1995.

Obviously in the short time period I\'m not going to be able to go
through all of them. But what I\'m trying to do is just give a synopsis
of them and an overview in many different areas.

Almost every talk on food safety starts out with a picture of the food
supply in the continuum. Obviously we understand that producers are at
one end, the farming community, and then we go all the way through to
the consumers.

And the important point with this is that there\'s impacts all along the
chain of activities, and any one segment can influence the safety of the
product that\'s received through all the chain.

A lot of attention, I think we all know, since 1995 by the producing
community, consumers, industry groups, governments, both national and
international governments, in food safety.

We also recognize, as we said, internationally, for many of the
commodity groups export markets are a key part of their profitability
and productivity for the future.

We recognize as we start having countries replace their domestic
supplies with imported supplies they ask a lot of questions about the
safety of the product that you\'re producing and try to make sure that
they are providing a very good, safe product to the consumers in their
country.

So as I said, I\'ll provide an update since the forum. I did actually
last night sit down and read the proceedings, and I think we\'ll have a
lot of new information to add in these areas.

I also surveyed the different producer groups for their input into this
presentation, as well.

It\'s going to be divided into four very quick areas, looking at
activities in the education area, research, monitoring types of
programs, policy, and marketing.

And actually, this area is a new area that we\'ve had significant
activity since actually the last 1995 meeting.

I\'m going to use examples from different industries as I go through
this to talk about activities.

One of the things that all of the groups have established is producer
food safety committees. And these committees consist of producers,
practitioners, academia. government is involved in some of those
committees, the food industry through to the retailers in some of these
cases.

They have different subcommittees that operate underneath them that may
deal with specific types of issues, the quality assurance programs, the
research programs that they have, specific topical areas of pathogens of
concern for that industry. There may be working groups in those areas,
as well.

Obviously QA programs are the flagship programs for all the commodity
groups to get food safety information to producers. And they have
different types of content. Most of them are based on the residue
avoidance.

The Turkey Federation had this program that\'s been out for a period of
time, Best Management Practices, that looks at the practices on the farm
and looks at some of the pathogen reduction strategies at the farm level
as well.

As I said, QA programs are really the flagship way to get information to
producers in an organized fashion by having key contacts that carry this
information out to the producers.

You\'ll see examples, and I think many, many ‑‑ I mean, you have
catfish, trout ‑‑ many, many QA programs out there at the present time.

I did see information out there and posters, with a five-star program in
the egg industry, on pork quality assurance. I think beef, most people
are familiar with the beef program. Sheep, dairy, veal, very active
types of programs.

And we\'re going to have updates later this morning also on more
specifics of the QA program, so I\'m not going to get into those in any
more detail.

We do definitely recognize when you deal with issues such as Dr. Sundlof
mentioned today on drugs residue avoidance that this is a producer
responsibility. It is not something which can be fixed or dealt with
later in the chain. It\'s directly an area that the producer has the
control over at the farm level.

As Dr. Powell mentioned today, there\'s a lot of discussion of whether
you call it HACCP at the farm, you call it good production practices,
good management practices, HACCP-like practices, best management
practices.

I really don\'t think it\'s relevant or really pertinent to the
discussion to get into a lot of debate of I think of what the
terminology is. Many groups use different types of terminology.

The important point is looking at what can be done at the producer
level, what types of controls can be in place, and how you can implement
those.

We also know that we\'re not producing in isolation. Obviously the next
step for our animals is to go into the packing and processing side of
the industry.

And as they have regulatory changes take place there, such as the
pathogen reduction and HACCP implementation, that their expectations of
producers can increase. And what they\'re looking for in those animals
or the information they want to have about the production practices of
those animals can increase, as well.

This is information we put together about packing plant changes
affecting producers, because even though they do not ‑‑ the regulations
do not touch specifically at the farm level, the way they are
implemented in the plant does require more knowledge about the animals
coming into the plant.

An area actually that we did not discuss, as I went through the
proceedings really didn\'t see a discussion of, is the antimicrobial
resistance topic, which is consuming a lot of time and energy and
research dollars and understanding to really look at the potential
impacts of antimicrobial resistance at the farm for public health
significance.

I\'m not going to spend a lot of time on it today. There are speakers
later this afternoon on this. And as we said, there\'s been many
workshops and conferences on this issue.

But it really came to me as I saw that in 1995 we were not having really
much discussions of it, it is one area that is going to receive much,
much, much more attention in the future.

And as information becomes available, you will see more and more
information put out to producers on their role in this and into the
quality assurance programs.

We\'re seeing some of this now with the judicious use guidelines. The
American Veterinary Medical Association has done an excellent job of
leading the way for the species specific practitioner groups on
developing guidelines for the industries.

The Food and Drug Administration is providing funds to have these types
of programs developed and information developed for practitioners and
producers.

It is an area we\'re going to see, as I said, much more information and
be included into quality assurance programs in the future.

That\'s a quick summary of education. And as I said, I think it\'s
important to take a look at the posters and the display booths that
provide more information in different areas.

Also, I would commend FSIS for the state specific projects that have
been funded. As you read through the projects and the results that are
coming out of those projects, there\'s good lessons for all involved in
quality assurance programs to look at how we can more effectively reach
all producers with those messages.

In the research area there has been numerous, numerous meetings since
1995 developing research agendas, both on a broad-based animal
production level, processing level, but then, also species specific
levels as well.

And this is important to come forward and reach agreement on what the
research agenda is, how can we move forward in these agendas?

We also are seeing the emergence of commodity and pathogen specific
working groups that bring together producers, scientists, and government
to sit down and look at what we know about a certain pathogen and what
we need to know and develop a very good detailed research agenda. Many
of these are in place, such as for salmonella, campylobacter, across
different industries.

Federal funding has increased for research. I think that has been very
good. It\'s been very supported by the commodity groups to put forward
more research at the animal production food safety level.

We\'re seeing progress, I think, on research agendas. If I would fault
maybe all of us in one area, it would be that we really don\'t have a
good way to communicate how we\'re making progress on research and
answering specific questions.

Many times one research project creates new questions. But we are moving
forward and developing progress on that research agenda. And I don\'t
think we\'ve developed a good way to communicate that to people, the
types of progress being made.

Just as a quick example, this is for the pork industry, our research
priorities for salmonella. And this is 1999, and this is 2001. And you
can see we are starting to hone down and funnel down on the questions.

We\'re starting to ask very specific questions about, how do you define
populations, how do you define interventions, how do you show progress
in pilot projects? But very clearly moving down from the early work,
which was really survey, just how much is out there, what\'s present,
and what can be done?

So a lot of progress is being made, but I think we have not found a way
to communicate that as well as we could.

The beef industry did a nice job of summarizing a research portfolio
that they have been involved with with regard to E. coli and putting
this information out. And I think that\'s been a very, very effective
way to deliver some of the information.

There\'s many questions that remain, though, as we are making progress,
is, can measurable progress be made when we\'re talking about pathogen
reduction at the farm level? What are the costs of this reductions that
might be made at the farm level? Presorting, there\'s interest in how
can you presort animals to slaughter? A lot of questions that come up in
that area, as well.

And then, probably the big question is, can improvements that are made
at the farm level, can we translate those to enhance food safety all the
way through the food chain? That\'s the question that in many cases
remains to be answered.

And it\'s confusing. And I think research is like that. You\'re creating
new information and trying to understand how that fits with the old
information that you had.

But for the producer community, as you\'re trying to develop guidelines
and information for producers and take messages that you can take to
them and say, These are messages, this is information that you can use
and implement and will make a difference, I think it\'s important to
understand that our information is evolving in many areas.

And I\'ll just very quickly go through four quick examples.

One of these is in the pork industry on feed formulation on salmonella
in swine. As you know, the pellet process for producing feeds will kill
the salmonella that might be present in the feed. If there is some
there, it will provide temperatures to destroy the salmonella.

So the thinking would be, farms that feed pelleted feed should have less
prevalence of salmonella in their particular animals.

Denmark had moved forward with a salmonella program at the farm, where
they actually were recommending to producers to switch to pelleted
feeds.

But what research has come out, both in the U.S. and Denmark ‑‑ and this
has been published several times ‑‑ is actually farms that were feeding
pelleted feed had a higher prevalence of salmonella in their animals on
the farm.

Now, that doesn\'t mean that you should not feed pelleted feeds. But
what it means is there\'s much more we don\'t understand yet.

The pelleted feeds were free of salmonella. But somehow when they\'re
processed in the gut, in the gastric intestinal tract, the environment
there that it creates is more conducive to survival of salmonella that
they might pick up through the environment as opposed to meal feeds.

And in fact, in Denmark they\'ve gone back to some of their farms that
they had switched to pelleted feeds and saying, For salmonella control,
we need to go back to meal feeds and mix a percentage of meal ground
feed back into the feeds.

So just as an example to show that sometimes intuitively what we feel is
not necessarily the science will find out as we move through projects.

And sometimes you have different goals at different places in the chain.
An example would be feed withdrawal in swine.

There is some conflicting work of withdrawing feed just prior to
shipment, just a few hours prior to shipment, can increase salmonella
shedding, might increase antibiotic resistance shedding of certain
pathogens as well.

However, in the processing plant, animals that have less feed in their
stomachs are less likely to have intestinal problems when you\'re going
to process those animals. So sometimes you can have different types of
conflicting research results.

We\'ve had studies with either increase or decreasing in shedding, but
then you also have differences in the next part of the chain of how they
handle it.

Another example would be a hypothesis that was put forward about
increased shedding of salmonella in poorer condition cows. Preliminary
results would say that they\'re not seeing those differences.

That doesn\'t mean you don\'t want to continue to look at those areas.
It means that there\'s confounders out there, as well.

Same, I think there\'s been different studies on effective diet on E.
coli 0157:H7 in cattle.

And when information comes out and producers think, Well, this is what I
should do, and then conflicting information comes out, this is what
someone else\'s interpretation of that study is, it\'s very difficult to
understand and go back to the farm with real concrete types of
recommendations to make for producers.

When we talk about research, I think producers definitely understand
that we need to support basic research, we need to look at detection
strategies, introduction of different types of methodologies, the basic
types of understanding virulence and pathogenesis of organisms is very
critical.

I\'m always interested in the applied research. How do you take that
research from the lab and take it out and start applying it? And then,
with field studies and demonstration projects.

Because as we take ‑‑ in looking at potential pathogen reduction out at
the farm level, we don\'t operate without other microbiological flora
there, as well. And we have definitely learned that when we alter the
flora, you can have some unintended consequences, as well.

Some of the things that you might do for reduction of salmonella might
actually increase campylobacter.

So those are the types of things you need to take out to the field out
of a laboratory setting.

Monitoring programs are very important to understand what\'s going on in
the industry. I hope everyone here is aware of APHIS\'s national animal
health monitoring studies.

These studies have been very good to provide descriptive information to
industries all across the industries as they do their five-year studies
of different industries. The last one was in dairy layers.

While they\'re asking animal health questions, they\'re also asking food
safety questions and investigating potential risk factors as well, and
doing biological sampling on the farm.

The commodity groups are very involved in the design of these studies
and put forward questions that they feel their industry needs to have
answers for as far as baseline type of information. This was a 1995
study.

A 2000 study for swine is going to expand and address other issues, as
well. These types of programs are very important on a national level.

It\'s also important, and I think this is an area we need to spend more
time on, the transfer of research results.

There\'s international and national meetings trying to put forward
information in food safety. Commodity groups have specific meetings to
try to put forward research information. It\'s always a challenge, I
think, to get current information into the hands of people who can act
with it.

This was a beef safety symposium held in 1997 that really brought
together not just what was known about the certain pathogens, but as we
look ahead, we\'re always looking over our shoulder at what\'s emerging
as well, some new issues that we need to deal with.

This is an example of information we use to communicate with plants to
try to help them understand the production food safety information
that\'s out there.

As we look at food safety in the future and producers\' views of this,
it\'s a very tough area to talk to producers about something that is not
causing production problems on their farm, that they may not be aware is
even an issue for others, something that is not an issue for them.

So many of the foodborne agents produce little or no disease in
livestock or poultry. So it\'s not something they may be sampling for in
their normal sampling for their farms.

Also, as you look at this, the presence of a potential pathogen on a
farm doesn\'t always mean that\'s the most effective control point.
Those are areas of research that we need to continue to move forward on.

Progress can be made in some of these areas, but there\'s many, many
confounders and much work that needs to be done to try to funnel down to
keep answering more and more descriptive questions.

Just to review again real quickly what FSIS\'s policy is on animal
production food safety ‑‑ this is from the pathogen reduction HACCP
final rule ‑‑ FSIS is cooperating with ‑‑ and I think this is a good
example of the types of cooperation to help get information out there.

And as I said, that as we put forward information about what
expectations are of packers and requirements of packers, this is
providing an increased interest at the farming level, increased
incentives for improving food safety practices at the animal production
level, as well.

And we are seeing these types of things, and I think you\'ll hear more
about it in the presentations this afternoon, that the changes that have
taken place in the packing plants are increasing the expectations of
packers of producers.

This is an area that was talked about in 1995 as things that are on the
horizon of market driven food safety programs that we may see in the
future.

Value chains are an area. All the producer groups, as they look to where
things are going in the future, you\'re seeing some vertical
integration.

You\'re seeing vertical coordination, as well, producers that are being
part of a chain that\'s going to market directly to the consumer and are
going together to say, We can describe these types of production
practices on the farm. And these are starting to happen now across
different industries.

We have supplier agreements where suppliers agree to provide a certain
type of animal raised under certain types of production practices.

And we\'re seeing, as Dr. Powell mentioned, organic marketing and
different types of those. We\'re seeing some direct consumer marketing.

Many people are trying to understand what were considered niche markets,
trying to understand what those really mean for the future and how big
those markets are.

Just a couple quick examples of things that we\'re seeing in the pork
industry. 1995, we reported that, with USDA, ARS, FSIS, and APHIS we
were working on a trichinae certification program.

This now is going into a pilot stage this fall in packing plants with
producers in several states and two plants to try to look at the
implementation of this.

And while we\'ve been developing this other groups have been saying,
What types of things could we put together into a chain concept?

Minnesota Certified Pork is a new area that\'s being worked on to
provide the market with quality pork traceable to the farms of origin.

It\'s independent producers going together and guaranteeing certain
types of things through audited certified production practices and have
different types of areas that they\'re putting in to try to start
testing into their food safety practices, as well, and have picked up
some of the things that have been looked at and have been developed.

We also are seeing groups that are starting to work with the USDA
process verified program. Premium Standard Farms was the first pork
unit. Farmland Foods has been right behind them as a cooperative that\'s
looking together to put together certain types of food safety practices
and have them audited and verified on the farm.

So some of these are being put forward as market driven programs. I
expect we\'re going to see more and more of these. We\'re seeing them in
other commodity groups.

And I think probably faster than any type of government regulation at
the farm level, I think the market driven programs are sending signals
to the industry of areas that need to be addressed.

And I would just conclude that as a producer community we do see that
we\'re part of the chain, that we have definite responsibilities at the
farm level, that we need to look through what types of areas that we can
address at the farm.

And to make sure as we look at the farm that the efforts that we do at
the farm are practical, economic based, science based, and really
produce a real and measurable difference to the final user of the
product. Thank you.

(Applause.)

DR. RAGAN: Okay. While we are working on the mechanics here a little
bit, I will go ahead and introduce our next speaker.

The third part of this equation is to look at animal production food
safety from the consumer standpoint. And to represent that viewpoint is
Ms. Caroline Smith DeWaal.

Ms. DeWaal is the director of the food safety program for the Center for
Science in the Public Interest. She represents CSPI in Congress and in
the regulatory arena on such issues as meat and poultry safety, seafood
safety, food additives, pesticides, unsustainable agriculture, and
animal drugs.

She has extensive media exposure in all these areas. And particularly if
you live in the Washington area, you will be familiar with Caroline.

She is a leading consumer analyst on the reform of laws and regulations
governing food safety, especially HACCP. So she can today and in the
breakout groups certainly speak HACCP with anyone who is interested.

She has substantial experience in testifying before Congressional
committees on this subject matter.

And prior to coming to CSPI, Caroline was director of legal affairs for
Public Voice for food and health policy. She spearheaded the Public
Voice lobbying effort on seafood safety in Congress, at the FDA, and in
the media.

She was chief legislative counsel prior to that for the Massachusetts
Commissioner of Insurance.

She graduated from the University of Vermont and the Antioch School of
Law and is a member of the Massachusetts Bar. Ms. DeWaal.

MS. DEWAAL: Good morning. Let me make a few adjustments up here so I can
actually give my talk this morning.

I must say this is a good size crowd, and this is the second time now
that I\'ve seen Doug Powell give a presentation by video tape, and he\'s
getting better at it. He\'s quite good.

I want to just tell you what my speech is going to cover, because once
we get in there sometimes it\'s hard to figure out what I\'m talking
about.

The speech is going to cover two big problems. Then it\'s going to give
us three reasons for hope. And finally, and because it wouldn\'t be a
speech by me if we didn\'t talk about the role of government and what
consumers expect from government.

The Center for Science in the Public Interest has been around since
1971. We represent about 800,000 consumers, both in the U.S. and Canada.

And we\'re known widely for our work on nutrition. The nutrition label
you see on the back of food packages are largely the result of our
advocacy, as well as the work we\'ve been doing on food safety and
focusing for the last six years, since I\'ve been there, on microbial
food safety. We publish a nutrition action health letter.

I\'m here to give the consumer perspective on why improvements are
needed at the animal production level to increase food safety.

Food safety is the number one food priority for our members. It tops
nutrition, it tops food additives, it tops everything else.

But with 75 million illnesses, 325,000 hospitalizations, and 5,000
deaths each year which CDC estimates are linked to contaminated food,
changes are clearly needed to reduce this terrible toll.

Steps need to be taken to improve food safety at the farm level, because
these changes will reverberate throughout the entire food supply and
result in great reductions in foodborne illnesses. Now, you don\'t have
to believe me. I\'m going to give you some evidence later in the talk.

But let\'s just look at it logically. If we can decrease or eliminate
the number of chickens contaminated with salmonella ‑‑ and I know
that\'s a radical concept, but stick with me for a minute.

If we can reduce the number of chickens contaminated with salmonella
going home with consumers to their kitchens or going into restaurant
kitchens, we\'re going to reduce the number of illnesses, because
there\'s going to be less salmonella to cross-contaminate with other
foods, there\'s less problems with undercooking.

And in fact, CSPI last year, to our somewhat dismay, especially by my
boss, we tested 50 turkeys for salmonella and campylobacter, and we
didn\'t find any.

And you can check our methods. It was done by a laboratory right outside
of Baltimore run by Glen Morris, who has done a lot of this work in the
past.

But we didn\'t find any salmonella. We did find some campylobacter, but
not a lot.

So in fact, when I go ‑‑ I give a talk almost every year on turkeys
right before Thanksgiving. And it was really a good news talk, that
maybe turkeys aren\'t as contaminated as some of the previous government
data tells us.

So addressing food safety problems at the source is very important to
consumers and will represent a significant step forward in food safety
protections.

While reducing pathogen levels as early as possible is critical to
achieving lower levels of illness, food safety at the animal production
level has been a low priority in this country for years.

The need to address on-farm practices is now undeniable, particularly
the problems of manure contamination and the subtherapeutic use of
antibiotics.

In the past few years, outbreaks traced to fruits and vegetables
contaminated with hazards which are normally associated with food
animals have become increasingly common.

Recent outbreaks also indicate that the problems linked to environmental
contamination of harmful pathogens are becoming more serious.

And I\'m going to go through here a series of outbreaks.

The first one occurred last summer in a New York county fair. About
1,000 attendees were sickened, and two people died; I believe it was one
young child and an elderly person.

The source for this outbreak was unchlorinated water contaminated with
manure runoff from the dairy barn. That\'s the best suspected source
that public health officials were able to identify.

This year a similar scenario occurred on a much more frightening scale
in a small Ontario farming community. E. coli 0157:H7 literally invaded
Walkerton, Ontario through the town\'s drinking water. The bacterium
sickened 2,000 residents and killed six.

Though the source of the outbreak hasn\'t been pinpointed, the same
strain of bacteria responsible for the outbreak was isolated from cattle
near the town, and in particular from a herd next to one of the most
contaminated wells. A government report has ordered that that well be
capped and abandoned.

The Walkerton tragedy shows that producers, their families, and their
communities are at risk if they are not vigilant about controlling
pathogens on the farm.

In fact, one study shows that people living in rural areas with high
cattle density are at higher risk of E. coli 0157:H7 infections than
people living in urban areas. These tragedies are likely to be repeated
unless steps are taken to improve safety at the farm level.

For example, there is another outbreak occurring this year at another
county fair, this one in Ohio. And contaminated water is the suspected
source of this outbreak, as well, although it hasn\'t been fully
investigated yet.

Contaminated water is only one of the problems with livestock manure,
however. Frequently foodborne illness outbreaks, especially produce
outbreaks, are linked to direct manure contamination.

And here are several examples. But I grew up in Vermont, and I know very
well what we need to do with dairy cattle manure. And it gets spread on
the fields. So it\'s a fairly common practice for people living in rural
areas. The key is how that manure is applied and whether it\'s composted
and how adequately it\'s treated.

In July 1995, over 70 Montana residents were sickened by lettuce
contaminated with E. coli 0157:H7. The lettuce was most likely from a
local farm that used composted dairy manure as fertilizer and kept sheep
near the lettuce field.

Another possible source for contamination was irrigation water from a
pond fed by streams running through cattle pastures.

In my next example, it occurred in 1996. Contaminated lettuce from a
small California operation caused a multi-state outbreak in which 61
people were sickened, at least 21 were hospitalized, and three people
developed serious complications.

Investigators found many potential routes for contamination, but one
thing was clear, cattle manure was the problem.

Some of the lettuce was grown in a field where cattle had grazed the
previous winter. Some irrigation water was drawn from a well located in
a cattle pasture. The open processing shed was located less than 100
feet from cattle pens, and lettuce was washed with water from a well
located 20 feet from the cattle pen.

Needless to say, opportunities for manure contamination were ample.

In May 1996, over 500 cases of Salmonella Montevideo and 100 cases of
Salmonella Meleagridis ‑‑ sorry, I\'m probably mispronouncing the types,
and I\'m sorry ‑‑ were linked to alfalfa sprouts.

The seeds for the sprouts were grown in fields where chicken manure was
used as fertilizer. Also, horses were kept, and their manure was stored
next to the alfalfa fields.

In 1997, a trace-back of an alfalfa sprout outbreak in Michigan and
Virginia that sickened over 100 people revealed that some of the seeds
came from fields next to cattle feedlots, which was the suspected source
of contamination.

And finally, in May 1998, 27 people were sickened by E. coli 0157:H7
contaminated cole slaw at a Kentucky Fried Chicken restaurant.
Investigators traced the cabbage in the cole slaw back to a farm with a
cow pasture next to the cabbage patch. The likely source of
contamination, fresh manure in the cabbage patch.

CSPI compiles a list of outbreaks, and these examples are just the ones
which we think provide the best illustration of the problem with manure
on produce.

Fruits and vegetables came out fourth among the foods most likely to
cause a foodborne illness outbreak according to the data we\'ve been
able to get from CDC, medical journals, and other sources. So there are
a lot of fruit and vegetable outbreaks. These are just a few.

These examples demonstrate that manure contamination is a pervasive
problem. While there doesn\'t seem to be an easy answer, the solution
clearly has to lie with the producers.

It is essential that animal producers control manure so it doesn\'t
contaminate water and crops. In addition, manure must be properly
composted to ensure that all pathogens have been killed.

Research is urgently needed on composting to determine the correct time,
temperatures, and methods to produce safe compost.

Antibiotic resistance is the next problem I want to outline.

Antibiotic resistance is clearly a problem with human medicines as well,
so I want to make clear that CSPI understands that. And in fact, in our
report, Crown Jewels, we talk about that extensively.

But antibiotic resistance stemming from drug use on the farm is another
food safety related public health concern where producers really hold
the key.

CSPI has been working for years to encourage producers and the
government to take strong action to preserve the effectiveness of
antibiotics for human use.

Although the practice of treating animals with subtherapeutic doses of
antibiotics to increase growth rates is widespread, the evidence to show
this practice really works is limited in the literature. It probably
works, because a lot of people are doing it, but it\'s really not a well
documented practice.

What is clear is that the use of antimicrobial agents can help to
establish reservoirs of resistant genes in bacteria, both in livestock
and on produce where it\'s applied, that may be passed on to human
pathogenic bacteria.

To hamper the development of antibiotic-resistant bacteria, CSPI has
petitioned the Food and Drug Administration to ban all subtherapeutic
uses of antimicrobial agents that are used in human medicine or that
might select for cross-resistance to antimicrobial used in human
medicine.

We have been joined in this effort by 52 scientists and health
officials.

For example, CSPI called upon the FDA to revoke its approvals for
subtherapeutic use of penicillin and tetracycline.

The FDA should also repeal the approval of fluroquinolones in poultry
and should only allow additional approvals of fluroquinolones for
animals if the drugs\' manufacturers can show that these uses would not
reduce their effectiveness in human medicine.

To increase the options available to producers, the USDA should fund
research on alternatives to antibiotics for growth promotion and disease
prevention in livestock, including competitive exclusions and
vaccinations.

The research also should quantify the current benefits of antibiotic use
in animal feed, if any, and identify alternate means of providing those
benefits.

The USDA should then publish practice guidelines to educate producers
about alternatives to antibiotics for growth promotion. That information
could be disseminated to producers through cooperatives, extension
services, and other outreach efforts.

Veterinarians can also play a direct role in controlling antibiotic
resistance. The FDA should develop a symptom-based formulary for
veterinarians that describe appropriate treatment for common livestock
infections. The treatment guidelines should be based on current
scientific data and susceptibility patterns.

Finally, antibiotics should be dispensed to animals only by veterinarian
prescription.

While these proposals may seem like a dramatic departure from current
practices, we believe they are highly appropriate given the problems
with antibiotic resistance and the need for effective medicines to treat
human illness.

Although the concept of on-farm controls, be it through manure
management or the appropriate use of antibiotics, may seem daunting, it
is feasible.

Both traditional risk assessment methodologies and actual on-farm
experiences have documented the promise of initiating food safety
controls at the farm level.

For instance, a Canadian quantitative risk assessment on E. coli 0157:H7
in hamburgers predicted that on-farm controls would be almost three
times more effective at reducing illnesses than a consumer education
campaign on cooking hamburgers.

Now, CSPI does consumer education. We\'re one of the private sources for
information. And we have an article coming out probably in our November
issue on practices in consumers\' kitchens. So this is our stock and
trade, and we believe that consumer education plays a critical role in
solving this.

But we are also optimistic that controls earlier in the food chain could
eliminate many food safety problems before they ever reach consumers.

These benefits are not just theoretical. On-farm control programs for
Salmonella enteritidis in eggs have proven successful in reducing both
salmonella contamination rates in shell eggs in the northeastern United
States and also reducing human illnesses linked to SE.

In April 1992, USDA began a voluntary pilot program to control
Salmonella enteritidis in Pennsylvania with the help of egg producers
and state government agencies.

The goal was to reduce SE contamination in shell eggs in Pennsylvania, a
state that had been particularly hard hit by SE.

While no longer funded by the federal government, the Pennsylvania Egg
Quality Assurance Program has been very successful. Today about 85
percent of the state\'s egg producers participate.

The voluntary program requires participating egg producers to follow
certain practices to identify, reduce, and eliminate Salmonella
enteritidis contamination in the flocks.

These practices include things like chicks for layer flocks are obtained
from SE-free breeder flocks. Manure samples from layer flocks are
regularly tested for SE.

Where the testing of eggs shows a positive for SE, all eggs from that
flock are diverted to pasteurization plants. There are security programs
and rodent control measures for the layer houses. And also, eggs are
required to be refrigerated at all times.

While the program was implemented in 1992, at that time multiple manure
and other samples were taken from the houses of 70 laying flocks in
Pennsylvania. And here are the results:

In 1992, 38 percent of laying houses had at least one SE positive. But
by 1995, only 13 percent of flocks had a positive SE sample.

In 1992, 23 percent of all the samples taken tested positive for SE,
down to only 3.2 percent of the samples in 1995.

And human illnesses, the most important measure of all, from SE in the
market area for Pennsylvania eggs, which included New York, New Jersey,
and Pennsylvania, also decreased between 1992 and 1995.

A team of 15 scientists from federal and state government agencies
attributed this decrease in part to the Pennsylvania program and
recommended that the interventions in the Pennsylvania program be
implemented by all egg producers.

PEQAP and other on-farm SE programs seem to be continuing to help reduce
human illnesses from egg related SE infections.

And the Centers for Disease Control and Prevention reported a 48 percent
decrease in the number of human illnesses from SE between 1996 and 1999
in it\'s food net surveillance sites. This reduction also has been
attributed in part to the PEQAP program and these other programs.

To further this progress, the President\'s Council on Food Safety
developed an egg safety action plan with the ambitious and achievable
goals of reducing egg related human SE illnesses by 50 percent by the
end of the year 2005, and the elimination of egg related human SE
illnesses by 2010.

Although the President\'s plan establishes control measures from the
production stage through retail, it emphasizes on-farm control measures
similar to the ones used in Pennsylvania.

Without on-farm control programs like these, it is unlikely that any
national plan could dramatically reduce foodborne illness.

The egg industry\'s example clearly demonstrates that well designed and
closely monitored on-farm programs can significantly reduce SE
contamination in egg laying flocks, as well as the number of infected
shell eggs reaching consumers.

This example should be extended to other segments of the food industry
where strong on-farm food safety programs will better protect all
consumers.

And another area where we\'re very optimistic is newly developed
technologies and treatments which will help producers to control hazards
on their farm.

I\'ve just included a couple of examples here, things like competitive
exclusion, the issue of changing the diet of cattle prior to slaughter,
removal of water from manure.

There are series of different technologies that are becoming available
or that are in the works that clearly could be very beneficial for
producers.

But while these technologies are being developed and soon may exist,
better government oversight is needed if we\'re going to provide
incentives for producers to use them.

And we run into the problem that we saw also in a meeting I attended
just a little over a year ago on egg safety where the producers actually
came in and said, Give us an on-farm program. Give us the mandate,
because otherwise there isn\'t a level playing field.

And industry needs ‑‑ in order to go through the expense of implementing
some of these technologies, industry and producers need the government
to come in sometimes and give them that kind of a mandate to provide a
level playing field for all the producers so everyone is having to face
the same expense and the same change in their business plans.

government directives can also provide a spur to the faster development
of these pathogen reduction technologies ‑‑ and I\'m again thinking in
the egg area ‑‑ I see my egg friends sitting right here in the front ‑‑
of the development and promotion over the last year of in-shell
pasteurization techniques.

Okay. My last hope, my last positive hope to leave you with, is the
issue of the European Union.

And our ‑‑ I never know whether to approach this from a competitive
standpoint as in, you know, they\'re doing it so, you know, you guys
better get on it, or whether to just approach it from the standpoint
that it seems to be working.

And I don\'t care how you want to hear it. The bottom line is the rest
of the world is somewhat ahead of us, if not greatly ahead of us, in
some of these areas of on-farm food safety.

So the EU has published ‑‑ and I haven\'t given you much information on
the slide ‑‑ but the EU has taken an active interest in controlling
pathogens at the animal production level using both new technologies and
sound production techniques.

The European Commission on Health and Consumer Directorate ‑‑ and I
think I have that wrong ‑‑ has published a series of recommendations
called [The EU\'s Measure on Foodborne Zoonoses]{.underline}.

The EU\'s approach to HACCP starts at the feed end farm. A poultry
program in Sweden has reduced campylobacter flock prevalence from 50
percent to 10 percent. There is also a program geared towards reducing
Salmonella enteritidis in flocks.

In many areas of the EU, the reduction in Salmonella enteritidis in
flocks has resulted in a significant reduction in human infections, as
we\'ve also seen the example in the U.S. I cited earlier.

An essential component to the EU poultry program is pathogen-free feed.
Producers have also introduced hygiene barriers and on-farm good
manufacturing practices such as all in-all out production. They have
also used vaccination and competitive exclusion technologies.

For E.coli 0157:H7 management, the EU proposes such on-farm controls as
manure management to prevent crop and water contamination.

It also suggests altered feeding practices to potentially reduce the
shedding of E. coli and recommends further research on this topic, as
well as on the effective calf management on shedding.

The EU\'s interest in reducing on-farm pathogens has already paid off
for SE reduction, and it is clear that they are well on their way to
achieving similar goals for other pathogens.

The Trans-Atlantic Consumer Dialogue of which CSPI is a member, in
conjunction with numerous other American and European consumer groups,
has called for broader adoption of the policies included in the zoonosis
directive, both in Europe, and it\'s likely they would be highly
beneficial here.

As you can see, on-farm programs show great promise in reducing and
eliminating foodborne illnesses. The earlier in the food chain that
pathogens are controlled, the less chance that consumers will be exposed
with the potential for illness or death, regardless of the route of
transmission.

Put another way, cleaner cows and chickens mean safer consumers.

However, producers have few incentives to reduce pathogens unless they
cause disease in their own livestock or otherwise impact their ability
to sell their products.

government action is needed to give farmers the incentives to develop
and use technological solutions to food safety problems that originate
on the farm. They must be built into a comprehensive on-farm food
protection system, which is a key component of a farm-to-table HACCP
system.

Today farmers are in a Never-Never Land of government food safety
regulation. While farmers benefit from government programs ranging from
crop insurance to assistance in addressing animal diseases, no federal
agency really has oversight to ensure that farmers are minimizing the
hazards in their products. This has to change.

Consumers are demanding safer foods and have come to realize that only
with a single federal food safety agency that has farm-to-table
oversight and responsibility will be truly achieve a safer food supply.

As you can see from both the U.S. and the European experience,
farm-based food safety controls are both effective and feasible.

And with the continuation of research and technological development, the
benefits of on-farm controls for both consumers and producers will only
grow.

To ensure their uniform adoption by producers, however, a program of
government oversight and incentive-based regulations are clearly needed.

And this is currently being recommended, and actually it\'s being
proposed in the area of egg safety. And this trend needs to be brought
into other segments of the animal production world, as well.

Thank you very much.

(Applause.)

DR. RAGAN: Thank you, Caroline. Good job.

Dr. Gillespie, our next speaker, has graciously suggested that we take a
break. And all opposed to that, raise your hand. The others will meet
outside.

Please be back in 15 minutes. That would make it 20 after 10:00 by my
watch. Thank you.

(Whereupon, a short recess was taken.)

DR. RAGAN: If we could come to order, ladies and gentlemen, we\'ll move
on. We are running a little behind. Thank you very much. Except for that
one guy in the back, if he could take a seat.

Our next speaker, Dr. Jerry Gillespie, is going to speak to the roles of
several of the players that have been mentioned already this morning.

If I told you all of Dr. Gillespie\'s credentials, he wouldn\'t have
time to speak himself, so I will just give you an overview.

He is the recently appointed Executive Director of the Joint Institutes
for Food Safety Research with USDA and HHS. And perhaps he\'ll take a
minute and explain that position and that organization a little further
to us.

Would somebody at the door over there urge those folks to come on in or
else close the door so that the rest of us can go along?

(Pause.)

DR. RAGAN: A high level of interest and enthusiasm, as reflected by the
noise level from the hall.

Dr. Gillespie was educated at Oklahoma State University and the
University of California. He has a long and distinguished career in
research and instruction at the University of California and more
recently at Kansas State University from which he came to his new job.

Dr. Gillespie has been involved in numerous research related activities,
both nationally and internationally, ranging from clinical equine
medicine to food safety. And we\'re fortunate he is now well focused
onto the food safety direction.

The recipient of numerous awards, is a member of numerous national and
international organizations, and will give us a little overview of at
least some of the roles in animal production food safety. Dr. Gillespie.

DR. GILLESPIE: Thank you, John. Well, I\'ll spend just a very brief
moment talking about the new Joint Institute for Food Safety Research
and what is intended for this institute about which I am very excited.

If you survey across the federal government, there are at least 19
different agencies having different roles, many of them research, in the
area of food safety.

And my rather brief experience there is that it is a very dedicated,
very intelligent, very motivated group in these agencies in their
efforts to improve food safety and quality and keep, first of all,
consumers well fed in this country, but also make our producers
competitive internationally.

My task in the Joint Institute is to really assemble, with the
cooperation of these agencies, what they\'re about in doing research,
what are their priorities, what are their needs, link up with industry
and find out their needs.

And simultaneously find out what the world knowledge is scientifically
on the various areas relating to food safety, what the issues are, what
the gaps are in our knowledge, what we can do to address those gaps. And
many of them I think were well outlined by our speakers earlier this
morning.

To assemble that together with the 19 different agencies and work with
them and industry in setting priorities so that we make the very best
use of the money available to us to do research in food safety.

And it is also my view that if we do those things and do them well, we
will improve the quality of research that\'s being done, and therefore
the efficiency of our efforts to improve the science that underlies our
efforts in food safety.

So that\'s what the Institute is about. The Institute was founded on the
principle of term limits, so I have a two-year term, and then somebody
else will get a chance at doing it. And that\'s exciting.

I intend to make the best use of the time that I have there to do what I
can, but I also see a gate out if things go badly.

So in any case, I am excited, and I think it\'s a good thing for all of
us to have the Institute.

Well, I want to talk to you just a little bit about different roles and
the whole issue of on-farm food safety, that I\'ve had a lot of
experience, both firsthand, but also as a researcher and also as an
educator within the university system.

And one of the things that I really think we need to make sure we
understand ‑‑ and I think many of the speakers have focused on this ‑‑
but you can\'t approach food safety in an isolated way and ignore other
issues that are out there confronting the producer. And I want to list
some of those and bring up some of those.

And the first part of my talk I\'m afraid will be just a little bit
negative. And then I hope to recoup in the last part in terms of saying
there is some hope.

But I think I would be really very naive to think the whole issue of
addressing on-farm food safety is at all safety, because it\'s a very
complex environment that we\'re in.

And the changes that are going on in production agriculture today and
for the last two decades are phenomenal. And I know that you recognize
that.

But certainly there is a new reality, and there certainly is an issue of
globalization. We\'ve talked about where our food comes from and where
we need to send our products.

There\'s increased expectation on the consumers\' part in terms of safe
food and the quality of the food. There\'s certainly a profitability
increasing dependence upon our being able to sell food both locally and
internationally.

And the market access will increasingly depend upon verification, not
just practices, but verification of production and processing practices
of safe food.

And I think it would be incredibly wrong of us to assume that USA has a
place forever in the world marketplace without addressing a number of
very complex issues.

Well, this list I\'m sure you\'re familiar with. But I want to put it up
again to remind ourselves of the complexity of these issues. And when
you talk about food safety, you\'re not just talking about microbes or
chemicals or foreign bodies. You\'re talking about environmental issues
that are very, very complex.

Now, when you start talking about where water is and where it goes and
where it\'s been in a farm unit, it gets very complex.

All of these issues can be focused and have a role in the on-farm, and
it certainly is changing the dialogue down on the farm.

It\'s not as though producers aren\'t aware of these problems and are
trying to address them. But it is a complex issue and one that certainly
has changed the whole issue of raising food.

It\'s now a matter of an international market, consumer driven, and
therefore very complex. It\'s very competitive. It requires attention be
paid to such things as food safety, food quality, environment, animal
health and welfare.

And again, we need to pause from time to time and think about the
complexity of doing and addressing these issues on the farm, and at the
same time, it\'s got to make economic sense. And increasingly in the
United States, it just may not.

Things are changing in the world environment, and they all affect the
production of safe food, for example, increasing disengagement and lack
of understanding of consumers of agriculture and food production.
That\'s been mentioned earlier by speakers.

But there\'s a political issue here, because if they\'re disengaged in
terms of how that food is produced and what\'s needed, then they take on
a different attitude in terms of nonagricultural use of land or how
land, water, and air are used.

And the thing of urban sprawl is not just a California thing or not just
a Virginia thing, it\'s everywhere.

And when I survey the county that I was in in Kansas, I can identify
three farmers that are legitimate full-time farmers left in that area.

Greater conflicts in use and management of resources from nonagriculture
sectors result in increased regulatory inclusion and cost in resource
management. Make no mistake, no matter where the intervention is,
someone will have to pay.

Increasing spread between food retail income and production income
concurrent with escalating operating costs in production. These are
realities that are confronting production agriculture, and they\'re not
exclusive to how we go about addressing food safety.

Well, to try to take a more positive approach, what are some things that
we can do?

Certainly on-farm analysis is needed, and I will make the point a little
bit later, is a farm-by-farm analysis, an analysis of the practices and
their impact. And we\'re familiar with that from the HACCP concepts.

Risk assessment and analysis. And the more accurate the data that goes
into this, the more useful this can be in setting up a program.

Implementation of a comprehensive food safety program in a particular
unit.

Compliance assessment, in other words, evaluating the outcomes of the
practices that you\'ve initiated, and verification that the practices
are in fact being carried out.

Evaluation of new technologies and procedures that come along. And I
know a number of instances where good information made available to
producers is one of the big gaps that we have to fill. And they need to
know about new opportunities for technologies and procedures.

Quality safety testing at the end product, what\'s the total outcome of
all of the efforts you\'ve made?

Analysis of the outcome assessment must include an economic assessment,
adjustments and modifications. And you start at the top again and go
back through.

Different complexities on farms with different production resources and
practices mean that each farm has unique inputs, traffic patterns which
impact food quality and production programs.

And in our experience at Kansas State, in looking principally at beef
operations, the diversity of them really requires that there may be some
general principles, but that certainly specific operational food safety
and quality programs are often unique for each farm.

So if you look at the on-farm analysis, you have to look at all of the
inputs and how they mix on the farm. And increasingly there\'s labor
that\'s coming and going on the farm that impact the inputs and the
potential hazards on that farm. So you need to define the potentials and
assess the potentials for cross-contamination.

Analysis of practices and their impact. And if you were to really
carefully analyze the environmental issues, the way animals are managed,
the way crops are managed, the way feed is managed, the way other inputs
are managed, that\'s a requirement if you\'re going to have a good
outcome in developing a procedure for that farm, development of good
practices, then.

Education and implementation, a huge challenge. Telling a producer or
their labor what\'s needed and getting them to do it can be very, very
different things, because there\'s habits that are often difficult to
break.

Compliance assessment and outcome, how well are they doing? Someone has
to look, someone has to measure, someone has to bring back a message of
how well they\'re doing.

Finally, you need to test the final outcome. Have you actually done
anything with everything that you\'ve tried to do?

This can get very complex. And I won\'t spend a great deal of time. But
what you can do is break down a farm in terms of just a particular
organism and look at its various risks of spread within the farm. And
that\'s necessary if you\'re going to make an analysis of that
particular pathogen getting off the farm.

And if you view A, B, C, D, E, and F as persons on that farm working in
different areas, you can assess the sanitation level in those different
areas and assess and assign a risk in each of those areas.

And so it can get to be very complex in terms of the spread of an
organism from a Person A, who is a dominant worker with livestock,
throughout the rest of the family or workers. And those are the sorts of
assessments that would need to be made and I think are important.

So initiating a on-farm plan requires education and explanation of what
you\'re trying to achieve.

There has to be buy-in by the owner and managers. And if the top
management or the owners are lukewarm, you\'re not going to achieve it.

And of course, that\'s no different than in any other industry. If the
quality assurance programs are not supported by the CEO, they go
nowhere.

Farm-wide employee training and buy-in, but that\'s not a one-time deal.
It has to be repeated as employee turn-over occurs, which is often quite
frequent.

So who will carry on the farm safety program? Well, I see it as being
principally initiated by a private or public consultant that helps steer
the general program and advises it.

But it needs the owner, the operator/manager, the inspector or the
investigator that\'s actually going to see that it\'s operated and do
the certification. The veterinarian in the case of livestock operations
certainly is important. Employees are absolutely key, and you\'ll go
nowhere unless they have a buy-in and follow the procedures. And the
technical suppliers and vendors of all sorts.

So how do you get buy-in of all of these people? My own view is that
some way or other it\'s going to have to come out to be profitable.
There\'s too many other things pulling on these producers on a very
narrow margin to expect large buy-in unless it can be shown to be
profitable. And we\'ll come back to that in a little bit.

I don\'t think you\'ll find too many producers. I certainly haven\'t.
And in our research in Kansas and Nebraska we found enormous cooperation
with the producers to allow us to do epidemiological studies on
foodborne pathogens on their farms. It\'s the right thing to do, and
they want to do that.

But one of the scary things is that it\'s probably a necessity and part
of the new reality of agriculture that they will need to have a quality
assurance food safety program to market their products. And I think
that\'s increasingly so for all commodities.

Well, this is a model that we are beginning to test in Kansas, farm and
rural community.

We really feel that if you can get a community interested in doing
something, and there are definite boundaries to that community, and the
university/industry/government coordination of a particular program such
that you begin with education, and they begin to help you assess whether
or not it\'s a program that can in fact work in their community.

It takes professional leadership, and those leaders have to be in the
community. The veterinarians, the extension service, the public health
practitioners need to be in the loop. And certainly the community
leaders have to be behind it.

If the local banker pooh-poohs the idea to the agriculturalists, or if
the farm loan credit association is unenthusiastic, and when that farmer
goes in for his loan, you\'re not going anywhere.

Outcomes, certainly there is a great opportunity for research in solving
some of the problems where the gaps are.

There\'s great educational opportunities, there\'s innovation
opportunities. And I actually believe a lot of the improvement that we
will see are innovations that producers make that we later investigate
to see how well they work.

Improved food safety and public health is an outcome that we\'ve got to
aspire to have.

So the university can certainly do the data collection and analysis, and
they can provide educators and help with implementation.

The government can help set standards. And I would take a little
different approach than the previous speaker. I think, in fact, that
there\'s motivations otherwise, other than setting regulations on the
farm. But if not, they will no doubt come.

Practices, economic impact, profit, and pay for system, that\'s where
the industry really has to come to grips.

Who pays the extra cost of food safety and quality assurance? And we\'ve
got to address that question, and I don\'t think it\'s an easy one.

The consumer will ultimately be the one that will pay. But the gap
between the consumer willingness to pay and paying and what is returned
to the producer is a huge gap. And unless there is ways of paying for
these initiatives, they probably won\'t happen.

But certainly the consumers drive the system with their demands and
practices. And that, by the way, is nationally and internationally.
Retailers respond to the consumers\' demands.

And ATOL \[phonetic\], the largest international retailer, has made the
comment again and again that, as they spread around the world, they will
increasingly know everything about every product that goes on their
shelves. They intend to control the production through processing and
put it on their shelves. So they are responding to consumers\' demands.

Well, as we go on down through this chain that we\'ve seen, one of the
things that will have to probably occur is some sort of agreement with
all of the segments of the industry in terms of how they will in fact
certify and create a food safety program and what each segment\'s
responsibility will be.

But concurrently there\'s got to be a flow of payments from the consumer
down to the producer if it\'s going to work.

Well, in summary, then, I think we need to take a very holistic
approach. It is many variables that impact food safety. It\'s an
environmental issue, it\'s an air, soil, water issue.

Investigation, education, and implementation are key. Surveillance with
diagnostic tests to know the incidence of disease so you know the
standard against which you\'re measuring. Understand the ecology of
pathogens, from whence do they come?

It was interesting how wildlife was not mentioned this morning, but it
is certainly a part of the mix in terms of keeping these organisms in
the rural environment.

Investigate implementation of HACCPs on the farm. The health of rural
dwellers is a big issue that I think is often neglected. And
farm-by-farm approach.

So think cost, profit, HACCP, good management practices, education and
reeducation, outcome assessment and verification, problem solving with
tests and other data.

Thank you.

(Applause.)

DR. RAGAN: Thank you, Dr. Gillespie.

And I now turn the moderator\'s chores over to Dr. Ken Olson, who comes
to us from the American Farm Bureau Federation.

He is in the public policy division of that national organization and
directs the Federation\'s dairy commodity activities, coordinates animal
health work, and acts as secretary and support staff for various
commodity committees.

Educated at the University of Wisconsin, served on the faculty at the
University of Kentucky, and for some years has been active in the area
of food animal industry and government. Ken.

DR. OLSON: Thank you, John. This session our objective is to provide you
with an overview of some of the quality assurance programs of the
various livestock species and also how they fit into the food safety
efforts.

We have a distinguished group of presenters with a limited amount of
time for them to make their presentations in. So we\'ll try and move
things along as quickly as possible.

Our presenters are all deeply involved in the various quality assurance
programs and I think will provide an excellent overview of what is
transpiring there.

I\'ll keep my introductions short. If possible we\'ll have some
questions for them at the end of their presentations.

However, I think most of our presenters will be here throughout the
conference. So if we don\'t get to ask questions or get your question
asked at this time, we can cover them during our breakout sessions or
separately in the hall.

So without further ado, our first speaker in this panel presentation is
Dr. Gary Cowman from the National Cattlemen\'s Beef Association.

Dr. Cowman serves as executive director for the dairy, beef, and veal
quality assurance programs. He also works with the animal disease
research and quality assurance subcommittees, as well as the quality
assurance board for NCBA.

So please join me in welcoming Dr. Cowman.

(Applause.)

DR. COWMAN: Thank you, Ken. And as Ken indicated, there\'s a lot of us
on the program this morning. And the other thing, also, just to forewarn
others that will follow me, at least the agenda that John sent me, I was
at the bottom of the second page. And it said, the National Cattlemen\'s
Beef Quality Assurance Program, Gary Cowman, 10:45 to 12:00, and so
consequently I prepared for that.

But then, last night I turned to the other page, and there\'s about six
or seven others of you on there.

But I\'ll go through real, real fast and real short. And obviously John
Adams and a few of you have been around me before, because when I walked
up here, they said, Make it damn short.

So, anyhow, the thing is, I thought we had some very interesting
presentations and discussions this morning. The thing that I was most
impressed with, I think as a body and as a group we have finally come to
grips with some reality of the challenges that preharvest, on-farm, this
whole food safety face us out at the field level.

And the other thing is, I think at least my presentation or our
presentation, talking about the industry\'s quality assurance programs,
we\'re the troops in the field.

And we\'re the troops that have to deliver these education programs and
these initiatives and these messages out at the producer and production
level. So consequently, we\'ve certainly got a lot of challenges.

Real quickly, the beef industry\'s quality ‑‑ we started a quality
assurance program in 1987. And we continually face these challenges,
getting more people to participate in our program.

The one thing that the Cattlemen\'s program may differ a little than
other commodity programs ‑‑

And the other thing I wanted to point out being the first on this
program, we cannot make the error of comparing industry groups\' quality
assurance programs, because we\'re all structured ‑‑ each of our
industries are structured so differently out in the production sector.
What works for one commodity group more than like wouldn\'t fit and be
effective at the other level.

But our program is implemented on a state-by-state basis.

The other point I want to point out, our program, or the beef
industry\'s program, is 100 percent funded by cattlemen\'s check-off
dollars.

And the cattlemen feel that is a very important message for the consumer
and for the public to be aware of the fact that this is a dollar
investment, this is a funded investment by the cattle producers. We do
not take allied industry money. This program is supported only by the
cattlemen\'s check off their own dollars.

At NCBA, we in essence supervise or are involved in three quality
assurance initiatives that relate to beef and beef products.

The beef quality assurance, of course, BQA, is from the cow, calf,
through the feedlot.

The dairy animal, once the hide comes off and those cows go to town,
become in our food chain, so we have a dairy beef quality assurance
program.

And we also, through cattlemen\'s check-off dollars fund, then, the veal
quality assurance program, which Dan will talk about later.

But we have one quality assurance initiative at the national level with
these three different programs.

Some of the challenges we have in getting out in the field and making
these things happen is, you know, how do we reach the vast number of
cattle producers in our industry?

And I go back again. Our industry is structured a little different, at
least at this point in time, than so many others. But you know, how do
we meet the challenge of reach each and every producer?

If we look at the structure of the beef industry, we\'ve got something
like 33.7 million cows out there, and more important, 850,000 individual
beef producers that we have to get these messages and these guidelines
and recommendations out to.

And also on the dairy side, from the standpoint of dairy as a meat
animal or production of beef and beef products, about 9 million cows,
116,000 or so.

So we have a challenge in here of about 1.1 million producers, beef cow
producers, dairy, and feedlot operators that we have to get to, and a
major, major challenge.

And I make this point because, with our program, the key to where we\'re
at and where we\'re going and the opportunities that we have, the key is
to build a network. No single entity can reach each and every producer
in the beef sector.

And we\'ve had to and have been very successful and will continue to
build and build and build an army or a network out there of people,
through veterinarians, state beef councils, extensions, allied industry,
auction markets, media, to help get the message out to the producers,
because we\'re never any stronger than our weakest link.

And I always make a point here in working this program, in essence from
Day 1, the success that we\'ve had at this point in time with the beef
quality assurance program has been greatly the involvement the
veterinarian and the extension service.

They have given excellent support, the veterinarian profession, of
working with producers, helping in getting the quality assurance
messages out.

At the national level ‑‑ because we\'re structured on a state-by-state
basis. And at the national level, we provide national guidelines and get
those out to the states, and they get them on, then, out to the various
networks.

One of the key things or programs that we started in 1991 is developing
what we call quality audits or collecting baseline data.

And here again I think Dr. Gillespie and Dr. Lautner and all have made a
point. You\'ve got to have sound ‑‑ the recommendations you take to the
field, the production sector, need to be based on sound science or sound
data.

And we started what we call the quality audits in 1991. And from the
standpoint of both fed cattle and the market cow side, we repeat those
audits every five years.

And that, then, gives our producers and our quality assurance
initiatives and programs a chance to then benchmark, what different
issues and areas have we made improvement in, and where do we need to
maybe restructure an educational program?

We\'re in the process right now of doing the 2000 national fed cattle
quality audit.

Back in \'95 ‑‑ and this is the same protocol ‑‑ we\'re looking at
auditing about 75 percent of the federally inspected plants on how much
bruising, how much hide damage, what are our quality downfalls in that?

And from that we produce, then, what we call these executive summary
quality audits and get it out. Because as Dr. Gillespie mentioned,
we\'ve got a major challenge of getting this information out in
educational format to the producers.

And these things have been very successful, and some of them that
you\'ve seen.

One thing we came up with last year on our side of the industry, we got
the market cow, and sometimes that doesn\'t get quite the attention in
our initiatives as over on the Fed side. And I think you\'ve got market
sows, too, Beth. And so we have the nonfed audit or the market cow
audit.

But it\'s still difficult to get producers and cattle and dairymen\'s
attention to an animal they have already made a decision to take out of
production.

So we had the audit data to show them some of the problems and
challenges we had. And we came out with this video. And they\'re playing
that video out in the hall the next couple of days.

But what we\'ve done is put together a video showing the producer where
this market cow is ending up in today\'s food chain.

And once they saw this and got an idea of where that cow that animal was
going ‑‑ because most people felt like that the cow was ending up in
ground beef, which is not the market today.

But it\'s these kind of educational programs that we\'ve got to
constantly explore, I think, to get these messages out to the producer.

One other project that we started, was involved in about five years ago,
was what we call the quality assurance display, a very extensive, very
expensive display. It cost about \$30,000.

We had a pilot project in Alabama. And we took this in cooperation with
the Alabama Livestock Marketing Association, the LMA, took this display
at auction markets, because here again, that\'s where a lot of producers
go once a week, once a month, or whatever.

And this has been very, very successful. Many states now have this and
are using it in their education program.

I was questioning whether I should put this up. But we had an issue in
our industry about ten years ago. And we constantly, every quarter, we
monitor the progress we\'re making.

And somebody made this statement this morning, You know, HACCP doesn\'t
maybe, in the true definition of HACCP, fit on-farm.

But we feel that some of the science-based or the projects or programs
that we have are HACCP-based or HACCP-like, because we monitor the
progress that we\'re making.

And I use this slide to, in many audiences ‑‑ voluntary programs will
work if you structure the right educational material, have a network to
get this out to producers and to veterinarians. And I think that many of
the things that we and other quality assurance programs have done will
prove that.

We are progressing to the point, because we are on a state-by-state
basis, where now we have states that are moving into producer
certification.

Quality assurance at the production level certainly had to and needs to
and will continue to go through an evolution period. And we are now
seeing states move towards and are implementing producer certification,
and some states verification programs at the production level.

And as we look in the crystal ball ‑‑ and some of you have indicated
this also this morning ‑‑ this is the direction of the industry.

Some of the drivers that we see in the beef quality assurance arena or
program, some of the drivers will be the industry is obviously
continually consumer focused.

And as Dr. Gillespie indicated, there\'s tremendous changes in our
industry and all livestock industries in terms of markets and production
and this type of thing.

In our industry I think the marketing structures are changing so much
these will help drive quality assurance programs.

The increase in value-added and branded products are increasing the
acceptance and implementation of quality assurance at the production and
farm level.

And without a doubt, as indicated this morning, the filter-down of the
HACCP implementation at the processing plants certainly raises the
expectation at the producer level.

And I just go back again. We\'ve got a super challenge ‑‑ I will
challenge the comments or statement that a producer needs an incentive.

I think if you own a ranch, own a farm, the investment that livestock
people have today, you do have an incentive. You have an incentive that
you\'re going to stay viable. And they realize this. They see the same
news, the same everything that we do.

And food safety quality assurance is an easy sell at the production
level if you go out there with sound recommendations and things that can
be applied at the production level. Thank you. I did it pretty short.

(Applause.)

DR. OLSON: Thank you, Gary.

Our next presenter is Ms. Donna Reifschneider. Donna is representing the
National Pork Producers Council. She is a past president of the
organization. She is a pork producer from Illinois, where she served on
the Governor\'s task force on livestock production.

She has also chaired the former Pork Quality Assurance Committee, and so
is intimately involved with that activity.

So please join me in welcoming Ms. Reifschneider.

(Applause.)

MS. REIFSCHNEIDER: Good morning. I am Donna Reifschneider, a pork
producer from Illinois. In fact, I\'m just about 20 miles from home. And
we\'re in the metropolitan area that they were talking about that the
city is coming out to visit us.

My husband and I, we have a farrowing operation of 600 sows, and we sell
about 10,000 wiener pigs a year. That\'s a ten-pound pig that\'s
farrowed on our farm and finished other places.

I think these programs that we have are very important, and it\'s good
that we have these discussions.

I would like to caution you and have you certainly remember that, as you
are talking about what\'s happening on the farm, that there are real
producers that you\'re impacting. And certainly we want to send the
right messages and the messages that do make a difference. So keep that
in mind as we have these discussions in the next day or so.

I have a fairly long history with the pork quality assurance program,
because I was a member of the first Pork Quality Assurance Committee,
and I later chaired that committee, and I have been involved in the Pork
Safety Committee since its beginning.

Our PQA program began in 1989, and so there\'s a lot to talk about. But
with the time I have today I\'d like to tell you what the program is,
how it works, and where we\'re going in the future.

First and foremost, the PQA program is a food safety program. It was
designed and written to give producers that are responsible for the
day-to-day operation the information they need to provide the packer
with the safest, highest-quality product available.

There is a lot of food safety responsibilities for the packer and others
that handle our product from the time it leaves the farm till it gets to
the plant.

One of the things that they cannot do that we do on the farm is take
violative residues of animal health products out of the meat. That is
our responsibility, the producers\' responsibility, to ensure that
everything that we do, that the animal that is delivered does not have
violative residues.

Providing the producer with the information to get this done was the
pre-HACCP focus of the program and is one of the primary objectives, the
other being preventing physical hazards.

The logistics of the program go this way: The producer contacts a
verifier, usually a veterinarian, and tells that they are interested in
the PQA program.

Our verifiers are mostly veterinarians, but it could be an ag educator
such as from a community college or an extension agent.

The idea is for the verifier to be able to go through the program with
the producer and give them the expert advice about drug and animal
health product use in the operation.

The producer and verifier get together and go through PQA book and the
ten good production practices. These are presented in a way that
facilitates interaction and discussion.

And I can tell you, being through it many, many times, it is a good
discussion period between you and your vet. And you sit down from an
hour to even four hours, talking about what you\'re doing on your farm.

And it\'s good for the producers to go through that process periodically
to say, Oh, yes, that\'s why I do that, or, Yes, I better firm that up a
little bit.

The verifier and the producer both sign a card, an enrollment card, and
the producer says that we understand the good production practices, and
the verifier says that they have brought it to our attention and we have
talked.

The card is sent to NPPC, then, in Des Moines, and a certificate and
wallet card are sent back to the producer. And it\'s the goal of NPPC to
have that turnaround time in two weeks.

The PQA program currently has over 75,600 people that have gone through
the program.

NPPC gets about 1,500 PQA cards per week. And the quality controls that
they have in place includes automated detection of partial addresses or
duplicate names or addresses and adequate address entry.

And I can tell you they spend a lot of time making sure we don\'t double
up on producers and we certainly don\'t lose producers in the process.

I mentioned the ten good production practices. They are divided into two
sections. The first six deal with food safety and violative residue
avoidance, and the last four address issues to help keep our pigs
healthy and productive, which hopefully decreases the need for use of
therapeutic antibiotics.

To support this educational effort, NPPC has produced quite a number of
supporting materials. Videos explain the program and its importance.
Proper injection techniques, drug storage and drug handling, animal
handling and transport, and needle strength research are a few of the
subjects available to producers and verifiers.

And from a producer perspective, these have been very helpful. As you
get new employees, you tend to go over things and over things, and you
might miss something. But by putting a video and having posters and
other things, it makes sure that you go through all the points.

And we\'ve used them for ourselves, to remind ourselves, and certainly
have sent them home with our employees, that they are up to speed on
what we are doing and why we are doing it.

NPPC also has written materials showing proper injection sites and
needle and drug use information listing withdrawal times of some of the
antibiotic products.

They explain HACCP and how producers are affected, and explain
principles of judicious use of antibiotics to address the selection of
resistant bacteria. Those are also available and being distributed.

We\'ve had a lot of support in promoting the importance of PQA to the
producer, also. Our packers have told producers that this program is so
important in addressing HACCP responsibilities that they either have to
go through the program or are very strongly encouraged to go through
them.

And I belong to a coop marketing group. And part of that is we have to
turn in our PQA card as they come due to make sure that we continue to
be part of that coop.

This packer support has helped demonstrate the importance of the
program. It also has, though, made us aware that there is a need to help
youth that handle pigs through such as 4-H and FFA projects to
understand HACCPs and their responsibilities.

With the input of veterinarians and educators, we have developed a youth
PQA program that can be delivered to these young producers. Some of them
are our future in our industry, and it is important to make sure they
understand the importance of doing things right.

As of today, about 25,000 of our over 75,000 producers have completed
the program there in the youth category.

So how about the future of the PQA program? That, like it has always
been, is in the hands of us producers. Producers like me have directed
the program from the start through our Pork Quality Assurance Committee,
with experts, and now through the Producer Education and Pork Safety
committees.

We\'re having a PQA advisory group later this month that will be again
revising the PQA and looking at it and making sure that we\'re current
and having our next revision and delivery.

At this meeting we will be considering additional information about
topics such as rodent control, biosecurity, animal welfare, needle use
and broken needle prevention, antibiotic resistance, judicious use
principles, and how PQA relates to meat quality characteristics and how
a producer can use a self-assessment to see how their production stacks
up with the good production practices that could be included in the next
PQA revision.

We will be discussing possible ways to help standardize delivery to the
program to the verifier, something that we always need to keep on top
of.

PQA continues to be a work in progress. We aren\'t finished. We know we
have other things. And it\'s certainly not an end point.

I hope this has given you a brief overview of what we\'ve done and what
we\'re trying to do. It\'s something that producers, we\'ve funded
through our check-off program, and we think it\'s very important for our
industry. And it certainly is an accepted way of doing businesses.

And as these vertical integrations and these marketing groups, PQA is
certainly a basis for all of those.

Thank you very much.

(Applause.)

DR. OLSON: I believe we\'ll keep moving along with our presentations
here.

Our next presenter is John Adams from the National Milk Producers
Federation. John is director of animal health and farm services for the
organization.

He has been involved with development of the dairy quality assurance
program; the milk and dairy beef residue avoidance program, which is
known as the Ten Point program; also involved in a pilot project in the
Northeast working on overall quality assurance.

Additionally, he works with such things as the National Johne\'s Work
Group and the Animal Health Emergency Management Steering Committee. So
without further ado, let\'s welcome John Adams.

(Applause.)

MR. ADAMS: Thank you, Ken. And while we are getting changed up here, let
me compliment John Ragan and his team for this pictorial on the front of
your agenda here.

Finally, John, you got dairy where it belongs, right up on top. Okay?
The only thing I\'m wondering about, though, is that a new strain, a
holstein, you\'ve got there, or where did you come up with that?

You know, in preparation for this very important conference this week, I
couldn\'t help but think how fortunate I am to be up here representing
the dairy industry and not Firestone Rubber with all the problems they
have, so it\'s somewhat reassuring that we\'re not the only industry
with challenges at the farm level.

Well, I\'m here today to talk about dairy animal production food safety
and what the dairy industry is doing.

Our goal, if we have one major goal, is to constantly produce the safest
and highest quality milk and dairy beef possible by integrating the best
science, technology, and management practices, including alternative
organic and sustainable agricultural practices, thereby enhancing animal
health, welfare, and environmental quality. That\'s quite a challenge.

I think we all agree that food safety begins on the farm. And we began
to roll out our first initiative on a HACCP-based principled on-farm
quality assurance program in 1993.

But I would point out to the audience that we actually started this
initiative in 1987, long before the crisis hit us in the early \'90s
with regard to residues in the milk supply.

So this is a program that\'s been in existence now formally since 1993
and has become a benchmark for residue avoidance in the dairy industry
and is still being widely used as an educational program.

Our major dairy animal production food safety focus for 2000 and beyond
is in keeping with what you\'ve heard earlier today by other speakers.

Food safety has to be on top of the list, animal welfare issues and
concerns, environmental issues and concerns, and international market
expectations.

Now, when we look at on-farm food safety issues, there is a myriad of
issues to deal with. Here\'s a list that\'s been prepared by the
University of California team at Davis, and it\'s pretty comprehensive,
but it\'s not all-inclusive.

If you look at the issues that are confronting us from a zoonotic public
health standpoint, the list is challenging.

And as you can see on this list, it\'s somewhat prioritized. But if you
go down to the bottom of the list, I think you can see that a major
effort is going forward on Johne\'s. We\'ve had a major effort on
listeria monocytogenes. And certainly the staph aureus problem and the
Brucella problem have been well captured or at least the risk greatly
minimized.

And some of the other diseases you see on this list, the challenges
remain.

Well, how to build a program that\'s going to address this myriad
challenges is before us. And I think where we start in the dairy
industry is to build on existing programs. And I think we\'re fortunate
in the dairy industry to have a number of programs to build on.

First of all, let me say that without extension we couldn\'t hope to
address these many issues. And we believe that it\'s very unfortunate
that extension is not getting the funding support that it deserves at
the federal level.

The Grade A Pasteurized Milk Ordinance was mentioned earlier by Dr.
Sundlof. You know, food safety in the dairy industry on the farm is not
new, folks. We\'ve been with this since 1950. We\'ve had inspectors on
our farms twice a year since 1950.

So a lot of the concepts and principles that we\'re talking about today
have been longstanding issues with the dairy industry. And dairy farmers
are acclimated to on-farm food safety through the Grade A Pasteurized
Milk Ordinance.

The milk and dairy beef residue prevention program I have mentioned.

We have also developed pro-milk and mastitis quality programs, farm
assist, and now nutrient management programs to deal with runoff of
manure and control of manure; Dairy Breakthrough Management, which is a
California program; and the New York State Cattle Health Assurance
Program, which I am going to talk more about today.

I think one of the important realizations for us in the dairy industry
is that we couldn\'t begin to deal with all the myriad of challenges
without putting a regional focus on it.

There are just too many differences from region to region, cultural
differences, management practices, and so forth.

So our focus is going to be on best management practices that directly
impact herd health, food safety, animal welfare, and environmental
stewardship.

We want to keep the program voluntary to encourage producer adoption, we
want to emphasize herd biosecurity as a core focus, and we want to
develop resource networks to deliver the technical support and science
base that we need to build on.

We want to keep it simple. We want to utilize existing programs. We
don\'t want to necessarily reinvent the wheel. We\'ve got a lot of
resources out there to call upon.

We want to develop a farm herd health plan based on risk assessment,
which you\'ve heard other speakers mention.

We want the focus on integrating practical best management practices,
and we want to emphasize quality management and validate the use of
BMPs, which is a huge challenge. And we want to keep the overall focus
through all this on food safety.

One of the models that we are looking at very carefully in a pilot
program in the Northeast through 13 states in the Mid-Atlantic and
Northeast region is NYSCHAP, the New York State Cattle Health Assurance
Program.

This model was developed by Dr. John Huntly \[phonetic\], who is the
state veterinarian in New York.

Another similar program has been developed by the University of
California at Davis, at the Tulary \[phonetic\] Center, by Dr. Jim
Culler \[phonetic\] and his colleagues, called Breakthrough Management.

In many ways these programs are similar, with a slightly different
focus.

The NYSCHAP goals are to identify key livestock health, consumer, and
food safety issues affecting livestock and establish and implement
preventive intervention strategies that will enhance production and
product quality, right along the lines of things we\'ve been talking
about.

The BTM mission is a little more sophisticated in that they\'ve broken
it out into an internal and external mission statement.

But essentially what it\'s trying to do is systematize good management
practices on a daily basis to account for all the critical control
points in the dairy operations. And it\'s primarily aimed at the large
dairy enterprises that have developed in the West and now in the
Midwest.

Dairy BTM, how do you do the BTM program? It\'s pretty simple. You start
with the economic impact on animal health on the dairy industry or on
the dairy itself, and you discuss the public health, the environmental
health, and economic well-being issues.

Then you build your BTM team, which is your veterinarian, your herd
management group, your employees, all of the other people that have been
mentioned by Dr. Gillespie in his talk.

You then discuss the goals, create the mission statement, develop
standard operating procedures, training form, evaluation form, and
monitoring form.

So you can begin to see here that we begin to get a little more
sophisticated in our implementation process in terms of transferring
some of the principles of HACCP into standard operating procedures that
we can utilize each and every day.

And then, finally, implement training, and then introduce your
individual modules.

So what is dairy BTM? Simply put, it\'s team building, it\'s proactive
listening to employees, it\'s problem solving, it\'s process management.
It\'s a dynamic process that\'s ongoing to create a specific plan for
that enterprise.

The NYSCHAP is a similar approach, utilizing the team approach. But
it\'s a program that can address any size farm, because it\'s less
sophisticated in terms of involving facilitators and other people in the
team process.

But essentially again we\'re seeking to coordinate and focus the
combined efforts of the producer, the herd veterinarian, agribusiness,
university, government extension consultants, and a lot of other people
that get involved.

Some of the key issues can be diagramed when you look at this. We\'re
looking at animal health, we\'re looking at environmental stewardship,
we\'re looking at public health. And those are all of the issues that we
have to address in any program today of a comprehensive nature on the
farm.

The NYSCHAP concept is pretty simple. You have this core module that\'s
a biosecurity module. And around that biosecurity module, you build in
these other modules that can be developed and are in the process of
being developed to focus in on specific animal health issues that are
having an economic well-being impact on the producer.

The NYSCHAP approach, again, you look at the farm process as a dynamic
equilibrium. And you then propose intervention strategies to enhance
animal health by considering the areas that I\'ve talked about
previously.

Now, this is really, I think, one of the diagrams that shows the
progress we\'ve made, because now we\'re beyond the PMO in that we\'re
not looking at problems after the fact. We\'re not measuring bacteria
count and then going back to the farm and trying to correct the problem.

We\'re looking at the whole process as a dynamic process on an
equilibrium base and looking at all the inputs, how those inputs are
processed, and then, of course, the outputs.

The producers have the responsibility of choosing to participate and
implement the best management practices and implement the herd plan.

The veterinarian enrolls the producer, develops the herd plan, and
evaluates progress.

The university is responsible for helping with the diagnosis and
laboratory support that\'s necessary.

And in New York, the Agriculture Department validates, maintains a herd
file, a database, and helps with the development of the program.

So it\'s really a partnership here that makes this kind of an effort at
the farm level possible.

Two basic elements, again, the core program and the specific modules
that I\'ve mentioned. In the California plan, of course, and in the
NYSCHAP plan both, the biosecurity is central, because you go in as a
team, you do your risk assessment, and you\'re looking at all the
management practices that impact that operation from an overall
biosecurity standpoint.

And of course mastitis is one of the most important issues facing the
dairy industry from a cost impact standpoint. And we have still
challenges in the staph aureus and E. coli area. And E. coli-form
mastitis remains one of our major challenges.

But we\'re looking at it from a milk quality and public health
standpoint as well as an environmental health standpoint.

Another module under the Breakthrough Management is a milking parlor
module where we get into specifics of milk quality, milk hygiene, prior
preparation of the animal, udder preparation, a good milking time
practices, proper equipment maintenance, and post-milking hygiene.

Another module gets into calf raising. There are other similar modules
for raising heifers. But here we get into the feeding, the housing, the
disease prevention factors that are very important as far as preventing
antibiotic use and so forth.

The concept in the pilot program that we\'re initiating in the Northeast
and Mid-Atlantic region is to take the NYSCHAP model and begin to
regionalize it.

These are some of the modules that have been developed in cooperation
with Cornell University: the core module, the Johne\'s Disease module,
bovine viral diarrhea, salmonella, mastitis, milk quality, bovine
leucosis virus, and hoof health.

Again, the core module, as I said earlier, has minimum enrollment
requirements. Unique animal identification is absolutely critical, and
we will insist on it.

Herd health record system is very important. If the producer isn\'t
interested in maintaining herd health records, we\'re not interested in
having his involvement.

Goal setting, risk assessment, the herd plan based on the best
management practices, and finally a contract with the State Department
of Agriculture.

The program sort of can be diagramed in this fashion as a program flow
from goal setting through risk assessment and planning to execution and
then quarterly evaluation.

When we do the baseline assessment, we\'re looking at the farm
description, of course. We\'re looking at herd inventory. We want to be
sure we know where the animals are coming from.

We want to look at milk quality and udder health, the history of
treatment of those animals with regard to mastitis, reproduction issues
that could impact the quality of the product. Culling is certainly a
very important area, and lameness is another important challenging area.

The risk assessment gets into maternity. The maternity pen is probably
the most critical control point on any dairy farm, and that\'s where we
spend a lot of time.

The calf, the heifer, the pre-fresh stage, the lactating cow, the dry
cows hospital. And other risk factors include the animals, the manure,
the feed, the water, the facilities, the equipment, the people, and the
risk modifiers.

The intervention strategies are very important after all this is done.
We want to address identified risk. We want to present an outline, a
spreadsheet to arrange the risk factors in a usable form or guide for
the producer.

And here you can see an example of that, where the risk factors are
listed on the right, the risk information is in the next column, then
the risk factors on this particular farm and whether or not there\'s a
feasibility for addressing those factors.

Best management practice outlines for the producer to guide the
producers, the veterinarians, and the advisors in developing the
individual herd farm plan.

And finally, the herd plan itself, with farm specific goals, summary of
priorities, and a tactical plan form that can be reviewed quarterly.

And then, a detailed fact sheet with in-depth presentation of management
practices, the testing procedures that are necessary to support those
practices, disease control.

And of course part of the challenge is to catalogue what we need for
this specific farm from what\'s available in the literature.

And finally, an annual evaluation, which I\'ve talked about earlier,
which is extremely important. And I think one of the most important
aspects of the annual evaluation is not only what you\'re doing wrong,
but what you\'re doing right, and then setting some goals for the future
and then, utilizing proper teaching materials.

Here\'s an example of a case study that\'s been used as a type of
teaching material.

And finally, a certification process to give some validation to the
producers, some reward to the producers.

We have other components of each of the modules. Here\'s an example of
some of the module components that help support implementation of these
modules.

And we\'re doing this now, beginning to regionalize this, as I said,
through a 13-state area, developing the science-based modules to be
applied on a regional basis.

I think one of the advantages of doing this on a regional basis is to
share resources and expertise.

We\'re developing a regional implementation plan, and then, also the
financial support that\'s very necessary.

We want to regionally be able to integrate elements of the Grade PMO,
what we have in existence today, and the milk and dairy beef quality
assurance program and the other programs I have talked about to assure
marketing opportunities for the U.S. dairy industry, both domestically
and internationally.

So in summary, our organization, as a national commodity organization,
supports the development of on-farm dairy quality management programs
that address consumer needs, validate best management practices that
assure food safety, animal welfare and environmental quality, thus
enhancing global marketing opportunities for the U.S. dairy industry.

And we have some major challenges ahead. But we believe we have
developed some models and modules to begin to address these on-farm
issues. Thank you very much.

(Applause.)

DR. OLSON: Thank you, John.

We\'re now moving to the younger animals. And our next presenter is Dr.
Dan Cutherman, director of technical services for Strauss Veal Feeds.

Dr. Cutherman is a member of the board of directors of the American Veal
Association and also chair of the Veal Quality Assurance Committee. Did
his graduate work at the University of Kentucky.

And so we\'ll now ask him to fill us in on what\'s going on in the veal
area. Dr. Cutherman.

DR. CUTHERMAN: Got too many wires here. What ever happened to the good
old days of slides? Hopefully we have power.

Okay. Now that we\'ve got the big guys out of the way, we\'ll get down
to the little ones here.

I hope I\'m not going to be asleep on this. Now we\'re coming back.

I do have Laura Kwisnek \[phonetic\] with me, as well, on this trip to
St. Louis. She\'s our veal quality assurance coordinator, recently hired
at our office. And she\'ll be attending our booth out here. So if there
are any questions after the fact, she can certainly help out and can be
located at the booth, I suspect.

I wanted to just give you just a brief overview of the veal industry.
Primarily the American Veal Association and the veal quality assurance
program, we primarily deal with the special-fed veal industry. It\'s a
very specialized market.

We\'re looking at ‑‑ I think my mouse is locked, so unless there\'s a
keyboard way to get down to here, it\'s not going to go. Like I said,
what happened to the good old days of slides? Get back on track here.

Basically we\'re looking at harvesting approximately 650- to 700,000
calves annually. These are primarily nearly all holstein bull calves. We
raise them to a weight of approximately 450 pounds using about 600
pounds of feed, creating a 275-pound carcass on the end.

This meat is probably 95 percent going to the white tablecloth industry,
not a lot of it going to the retail chain through the grocery markets.

And one important issue that we have to deal with is we have very little
to no control over our source animals. Where 99 percent of them come are
going to come from sale barns. We have no control over the genetics over
those animals.

In our industry we have approximately five to six major feed companies
and ten or 12 smaller ones, eight or nine major packers and probably
half-a-dozen or a little better minor packers, smaller packers.

With considerable integration within the business, we\'re headed towards
a trend, I think, as most industries are, or most livestock industries
are, of fewer, larger growers.

And we do have one company that is completely vertically integrated,
from sourcing the animals through the feed, through the meat, and
through the meat sales to the retailer.

We have put together the veal quality assurance program. It\'s pretty
much a voluntary program that we\'ve got put out. Our goal is market
assurance through quality assurance.

We\'ve developed a two-level program. Level 1 is essentially a temporary
program that essentially holds that producer for a period of about six
months until they complete the requirements for Level 2 certification.
That is a two-year duration program.

In Level 1 the producer agrees to certain issues: Number 1, that they
maintain adequate records; that they maintain an adequate or a valid
veterinary client patient relationship, which is something I\'ve
personally struggled with and the definition of what is a valid VCPR?

Myself and as a committee, we\'ve had trouble with that in, what is a
veterinary visit? I\'d like to see that addressed at some point down the
road.

We also put in there a proper use of animal health care products; proper
management practices, best management practices, if you will; and
finally, a review of facilities and management practices to be sure that
that producer is on the right track.

For Level 2 certification, the producer needs to reaffirm or reconfirm
the Level 1 qualifications. There is a ‑‑ we\'ve put together a farm
plan self-assessment test that\'s done with the veterinarian.

We also ask that the VCPR is confirmed in writing, and that is
backtracked through the veterinarian to make sure that he does have a
valid VCPR with that producer.

And finally, we put together a VQA educational seminar which walks the
producer through animal health care product use issues, residue issues,
best management practices. That\'s usually performed by a verified
trainer and a veterinarian, as well. And we usually feed them, so that
tends to bring people in.

After the two-year period, the certification program can be ‑‑ or you
can be recertified by either reattending one of the certification
educational programs or through a written test.

And if anybody in the crowd is ever interested in looking at doing
something through a written test, my first recommendation would be, make
it simply multiple choice or true and false, no essay questions. That
can be problematic.

The results of the program so far, we have 867 Level 1 producers or
people that have gone through the Level 1 program to date. Level 2
producers, we\'re at 716.

I\'m always asked the question, what percentage of the industry are we
reaching? And we estimate that\'s about 90 to 95 percent of them.

It\'s a little difficult to get a handle on whether we\'re getting them
all. We do have a lot of people, multiple people registered or certified
through the same farm.

The meat packers have helped tremendously in this issue. The first of
last year, they vowed to only accept Level 1 certified calves, and the
first of this year, they vowed to take only Level 2 certified calves. So
it\'s put a lot of teeth into our program, and it\'s certainly helped us
out a lot.

The ultimate goal that we\'ve been looking for is on violative residues,
and we\'ve seen that drop from .86 percent to .075, so from roughly one
in 100 carcasses to less than one in 1,000. So I believe we\'re getting
very close to that.

As Gary Cowman had mentioned, we are working through the Cattlemen\'s
Beef Association for check-off dollars. This is a 100 percent check-off
funded program, so we need to abide by the same rules that the Beef
Association has to, as well.

We do have a Level 3 certification program that we\'re currently working
on. It is more for the people that are advising the producers. We have a
lot of people that are onto producers\' farms on a daily basis giving
them recommendations, and we\'re trying to find a way to certify those
people, as well.

We do have a certified supplier program that the suppliers need to go
through. That goes anywhere from feed to medication to equipment to
sanitizing agents.

And we ask that they go through that so they understand what the
recommendations or what the requirements are on our growers so that they
can also be certified.

And I believe that is all I have. I will be around later if there\'s any
questions. Thank you.

(Applause.)

DR. OLSON: Thank you, Dan.

Our next presenter is Dr. Cindy Wolf. Dr. Wolf is a member of the
faculty of the College of Veterinary Medicine at the University of
Minnesota, where she is a small ruminant specialist.

She chairs the Animal Health Committee for the American Sheep Industry
Association and is actively involved in updating the sheep quality
assurance program.

She also is the chair of the Sheep Health Committee for the National
Institute for Animal Agriculture.

So we\'ll now call on Dr. Wolf to provide us an update on what\'s going
on in sheep quality assurance. Cindy.

DR. WOLF: I\'m not a very good joke teller, but we could make a fair bid
to subsidize this meeting. Anybody want to run off with these computers?

(Pause.)

DR. WOLF: Okay. Well, thank you very much for having me.

My job this morning is to bring you up to speed with what\'s been
happening regarding sheep quality assurance activities.

And I\'ll just give you a little warning that two of my daughters are
very upset that their mother wasn\'t going to be there to take them to
school for their first day at a new school today, so they got to choose
the background. And they don\'t know it, but I took the sound away.

(General laughter.)

DR. WOLF: Sheep quality assurance is an interesting topic to me because
I work for the University of Minnesota and do some volunteer work for
the sheep industry.

But I and my husband also raise 1,800 commercial ewes in two states. And
so whenever we come back from meetings, he wants to know, Well, what\'s
new? What do I need to know?

And those of you who are involved in agriculture on a day-to-day basis
realize, that the farmer and the rancher are always the strongest critic
of what\'s happening in these meetings. So it keeps me honest.

In 1995, the American Sheep Industry published what I\'m going to refer
to today as the Green Book. And this book was put out similar to the
other quality assurance efforts for other species. The goal is very
similar as other programs.

Basically we have some recommended on-farm management practices
referenced in this book, preventive flock health programs, some detail
there, some detail left out on purpose because sheep production really
varies depending on the size of the flock and the area of the country.

And as Dr. Cowman mentioned, that\'s similar to the beef industry.

And then, we have some detail provided on the kind of record keeping
that really needs to be in practice on the farm level.

So I brought some copies of this Green Book for any of you who are
interested and will leave them out on one of the tables.

We chose green on purpose because we feel like producers need to sit up
and take notice of quality assurance programs, and so this was a good
color to help them do that. And if you raise sheep, green is also an
important color, because most of the sheep in this country derive a fair
amount of nutrition from grass.

As Dr. Cowman mentioned, the information in our book is again based on
published information, and a lot of that comes from a quality audit that
was done in the early \'90s.

The book has been reviewed a number of times and has been commended for
being presented in a producer-friendly manner.

This book was a joint activity between the extension service, the
College of Veterinary Medicine and Department of Animal Science at
Colorado State University, the American Sheep Industry Association, and
the University of Minnesota.

And it looks like a sort of small and simple book, but I think that
that, too, has been brought out today, that when preparing things that
we want producers to use, we need to keep it simple so it will be
adopted.

Different than some other industries, the packers have not required or
strongly encouraged sheep producers to participate in this program. And
let me flip that around and tell you that they haven\'t discouraged it,
either.

And I think the sheep industry is entering a new era in that producers
and packers are now having more dialogue than ever before.

And some of that is because of a 201 trade action case that was brought
forward and won by the American Sheep Industry, and it requires that
producers and packers stay in a little closer dialogue than they had in
the past and work together.

And I think that, as this is happening and will continue to happen quite
aggressively over the next two years, we\'re going to see more packers
looking for lambs produced out of flocks that are actively engaged in a
quality assurance program.

The other edge that it will give us is that the lamb industry faces a
lot of challenge from imported lamb meat, and we as a national industry
should be proud if we can get more and more packers onboard that the
lamb produced in this country is produced under a bona fide quality
assurance program.

I\'m not saying that all imports that come in are not, but certainly
it\'s not something that\'s aggressively marketed today by imported
lamb.

Just as other quality assurance programs, we go through, as I mentioned,
some of the management practices. So I thought you were probably getting
tired of looking at word slides, so feeding management, facilities,
handling, and transportation.

And I just want to digress for a minute. We\'re really proud in the
sheep industry and perhaps a bit fortunate at the same time in that
pathogens were not a major defect found at the quality audit. And the
major defect is bruising.

And sheep are a little unique in that many times they come from small
farms that don\'t have nice handling setups. And the other feature
that\'s unique is that they have wool. And while we shouldn\'t handle
them by using their wool as handles, it occasionally happens.

So we just made sure we really focused and tried to give people good
information on how to improve their handling and minimize bruising to
make that quality defect go down in prevalence.

We also touched on the milking area. Certainly milk sheep are not a big
aspect of our industry, but they do contribute human products, and it
needs to be addressed and will continue to be addressed.

And then, in the feedlot I\'m bringing a little new information ‑‑ about
a year old ‑‑ to you today. This would be a feedlot probably out in the
Colorado area.

And we had a study done by Dr. Steve Lavalley \[phonetic\] and some
graduate students; he\'s from Colorado State University. And they looked
at a combination of 12 treatments in feeder lambs in feedlots. And this
actually wasn\'t done at a university setting. This was done in a
feedlot.

And basically the treatments were shorn versus unshorn lambs; crutched
versus not crutched; and then, environmental manipulation, bedding with
primarily straw bedding versus not bedded, and wet versus dry, because
those of us who come from more high rainfall areas like myself can\'t
always control how much rain we get when these lambs are in the feedlot.

And we found something quite interesting ‑‑ and it\'s also been found in
other countries ‑‑ is there were actually no differences between
treatments on the carcass bacterial load at slaughter.

On the other hand, the producers have had to adopt the strategy that the
majority of lambs sold today are shorn, and that\'s a management
practice that\'s in place primarily because the packer can make more
money off the pelt if it\'s been shorn about three to six weeks prior to
the lamb being marketed.

So that\'s interesting how things come together whether they have
scientific basis or not. And that\'s what sometimes feedlots can look
like even with fairly regular scraping. Like I said, we could get days
and days of rain.

Okay. We also have a section on shearing. I thought that since this is
about food safety we wouldn\'t spend much time on wool quality. And also
have a section on flock health, injections, use of drugs.

We are expanding that section to include an area on judicious use of
antimicrobial and resistance. That section also has some detail on
record keeping and some other basic flock health procedures.

The sheep industry is fairly well positioned when it comes to individual
animal identification in that the APHIS voluntary flock identification
program mandates individual animal ID. And so we\'ve had probably about
six years now of trial and error of, what\'s a good form of ID in sheep?

And while this is not a picture of the tamper-proof ear tag that\'s been
developed for this program, it\'s a prompt to remind me to discuss that.

And so this ear tag is very producer-friendly in that the numbers are
big enough that you can read them without glasses. They have very good
retention rate in the sheep, and they are difficult for producers to
remove. Nothing is impossible for the producer to remove.

The other two aspects that are somewhat unique to sheep production is
the majority of sheep going to slaughter in this country never eat out
of a feeder for very long, and so we have very good retention rate of
ear tags in general.

And lastly, we have something called wool, which means that if we have
animals that have been treated and for some reason are not ear-tagged,
we have wool-friendly paints that can be applied to those sheep.

And the way we use it in our feedlot, for example, we keep a hard copy
of which animals have been treated, but we also spray paint the last
date that animal was treated, and then, there\'s a code of which
antimicrobial was used in that animal so that anybody can look at that
lamb when they\'re sorting for lambs going to market and not by accident
put that lamb on the trailer.

Okay. That\'s a little bit of where we are today. And now, where are we
going?

Well, at the moment, the Green Book is under revision to bring it up to
date. And we expect to have that new edition published in the next few
months.

And sometime later this year or early next year, additional training
materials will be developed to do a number of things: 1) to encourage
more producer participation; and 2) to allow that we have standardized
training not only of producers, but of the trainers.

And those trainers, just as it is true for other programs, will be a
combination of extension personnel and veterinarians.

So there is just some of the format that is going to be used. CD Rom,
video, standardized training sessions. A Web Site is being developed.

And we need to get into third-party verification. It\'s not something
that\'s required at the moment in our program, but we\'re moving in that
direction and expect to have that component onboard in 2001. With that
component, it will be a database development such as was talked about
with PQA. And they are to be commended on what they have done.

In the verification area, we have heard from our other species groups
that there is definitely a need to have standardized training with your
trainers.

So we have talked a little bit with the American Association of Small
Ruminant Practitioners and the AVMA to work in conjunction with us so
that we have some standardized training of the third-party verifiers.

And I think the net result is fairly obvious, is that we\'ll have a more
credible program to everybody who examines it.

Who is updating our program for the American Sheep Industry Association?
Really it\'s a team effort. The National Institute for Animal
Agriculture, under the leadership of Glenn Slack, and Colorado State,
under the leadership of Dr. Gary Smith.

I\'m not really sure why I put this over here. But anyway, we as an
industry continue to encourage people to keep their records out in front
of them, and that\'s something we\'re going to push harder in our new
program.

Something that\'s a little different than some industries perhaps is we
have to focus fairly heavily on parasite control.

And while I don\'t believe FSIS looks hard for residues at Antalmentix
\[phonetic\], it\'s probably one of the most common products used in
sheep, way above antimicrobial. So again we\'re trying to tie management
and responsible use of these drugs together.

We are real serious to have a strong producer campaign and get more
producers onboard. And this is probably going to happen through multiple
methods.

And lastly, I\'d like to thank the number of people who have been
working on this updated effort in the last several months.

And with that, thank you.

(Applause.)

DR. OLSON: Okay. Thank you, Cindy.

We\'re now moving to the poultry side. And our first presenter is Steve
Pretanik, who comes to us from the National Chicken Council, where he is
director of science and technology.

Steve\'s current responsibilities include addressing food safety issues,
both in live production and in the processing area.

So please join me in welcoming Steve Pretanik.

(Applause.)

MR. PRETANIK: I want to thank all of you for this opportunity to share
with you some of the programs that our industry has adopted to address
food safety at the production level.

Our industry is a little unique in that we are structured as a
vertically integrated industry. What this means from a food safety point
of view is that we have control of all of the inputs affecting our
finished product, all the way from the breeder farms through processing,
and again, to the finished product.

For those of you who are not familiar with the structure of our
industry, a typical operation would consist of the integrated company
owns the feed mill, hatchery, processing facilities. They\'ll contract
with local farmers to produce the hatching eggs, and the breeders are
company owned, generally purchased from a primary breeder.

The eggs after hatch go to a local farmer where they\'re generally grown
under contract until market age and then to the plant for processing.

Feed is provided to both operations and the companies also provide
veterinary care to the breeder farm operations and the grow-out.

So you can see we pretty much have control over all aspects over all
elements affecting our product.

Because of these controls, our industry felt that the best way to
address food safety issues was to put together, develop, and adopt
industry-wide good manufacturing practices which encompass the whole
spectrum of our industry, again, all the way from the breeder operation
to the finished product.

In the interest of time, I\'m going to briefly go over those elements
that apply to the live production side and highlight those that are
specifically designed to address food safety concerns.

Management practices, as everybody has noted, play a very important role
in addressing food safety issues.

Our industry provides breeder broiler production manuals to their
growers. These manuals spell out in detail specifications with respect
to things such as pesticide usage.

And I\'d like to point out that growers are not permitted to use any
type of pesticide or insecticide without the express approval of the
company. If they do use them, they must then certify that they have been
used in accordance with all regulatory requirements.

And we missed a slide. Backing up, facility standards. This is also an
important element and has food safety implications not only with respect
to the type of equipment that\'s used, location of the facilities, it
addresses ventilation, water supply, and even physical pest control
measures.

Biosecurity is also another important element of these programs. The
intent here, of course, is to minimize contact with the flocks with the
diseases that may affect the flock, but also vectors that may introduce
foodborne pathogens such as salmonella and campylobacter.

And again, these standards are developed strictly enforced.

Animal health care is another important aspect of these production
practices. And here we have standards, strict standards for
pharmaceutical use.

Again I\'d like you to note that the growers are not allowed to use any
pharmaceutical that have not been provided by the company. If the
company determines that such usage is necessary, it\'s generally
provided in the form of medicated feed that\'s delivered to the grower,
or in some cases it may be administered in the drinking water.

Again, also ‑‑ well, okay, we\'ll get more into the pharmaceutical later
in the other operations.

Specific to the breeder operations, you can see feed again plays a very
important part not only with respect to formulation to meet nutritional
profile, but also we\'re concerned with the controls that address
pharmaceutical, microbiological, and chemical residues. These are all
part of a company program.

Monitoring breeder flock health is also another important aspect with
respect to food safety, since some diseases are zoonotic.

And here we have specific programs for controlling pathogens. And these
are generally dealt with through the National Poultry Improvement Plan
which the companies participate in.

And also, that program has taken on great importance with respect to our
exports to other countries. They\'re relying on this program for us to
meet disease-free certifications.

Another important element are procedures to interrupt eggborne poultry
disease transmission. This area is likely to be expanded in the near
future, as new information is being developed which suggests that some
foodborne pathogens such as campylobacter may be transmitted to the
flocks, and this may be a major source of that organism in the flocks.

So we will be expanding this area as new information and interventions
come along.

Monitoring and controlling egg cleanliness of course also is important.

And here\'s another important element from a food safety point of view,
and this is specifically targeted at Salmonella enteritidis.

And the broiler industry does not offer, for human or animal usage, eggs
that have not been pasteurized. If they\'re not going to pasteurize
them, they go to some other nonfood use. This is strictly adhered to
within the industry.

Within the hatchery operations, sanitation and cleaning are also very
important with respect to food safety concerns. Again, monitoring
programs are in place.

Specifically, we have microbiological testing programs in the hatchery,
not only in the general facility, but equipment surfaces as well. And we
also monitor air, again all with the intent of trying to minimize the
introduction of foodborne pathogens at the hatchery level.

Disposal of eggs is also another important issue. And again, grow-out
feed preparation, this is probably one of the most important areas on
the grow-out side, the feed provided to the birds. And here we\'re going
to get into some of the quality programs that are adopted and used in
the feed mills.

And you\'ll note that each company has specifications with respect to
microbiological quality in their feed ingredients. They sample these
ingredients to ensure that they meet their specifications. They also
test and sample ingredients for pesticide and other chemical residues.

And records are maintained of all of these activities. A typical broiler
flock going to a processing plant has a flock history that accompanies
it which details all of the medications, the type of feed, batch of
feed, et cetera.

So we can pretty well go back to any part, if a problem should ever
develop, and trace where it may have occurred.

Pharmaceutical inventory on site again is another important element.
This is to ensure that pharmaceutical are used properly and not
inadvertently added to a batch when they shouldn\'t be.

Again, only FDA approved pharmaceutical are used, and then only in an
approved manner.

And the industry does not use growth promotion hormones, and we have
continued that position since the late 1950s.

Sanitation and dust control are also important elements with respect to
contamination in the feed mill.

Pelleting of grow-out feeds we feel is beneficial in reducing the level
of microorganisms in the feed. And of course, we find that the birds do
perform better on pelleted feed.

We also have testing programs for finished feed with respect to again
the pharmaceutical, residues, chemicals, et cetera.

And cleaning of equipment after batches are made of course are very
important so that you don\'t get contamination in the next batch,
particularly with respect to drug usage.

Environmental conditions are also element of concern, particularly with
respect to water quality and air quality.

On the grow-out side again, control of feral animals. This is not only
to keep diseases out of the flocks, but also foodborne pathogens, which
a lot of these animals can serve as vectors.

Again, pesticide usage can only be ‑‑ is only done in accordance with
company instructions.

Litter selection programs and management programs are also very
important, particularly with respect to any residues that may be present
in wood shavings or other litter materials.

And an ongoing daily assessment, culling of sick birds, and alerting of
the company if there\'s anything unusual that requires a veterinary
investigation.

Preslaughter chemical residue testing and monitoring is also another
element in our industry, as well as ensuring proper drug withdrawal
procedures and proper feed and water withdrawal prior to the birds being
delivered to the plant to help minimize fecal contamination when the
birds are processed.

Transport of birds for slaughter is another consideration. This is a
recommendation, really.

And the problem the industry faces here, even though we recognize this
could really help us improve the micro profile of the birds coming to
the plant, currently there are no effective cleaning and sanitizing
systems available to the industry.

So from a practical sense, this application really does not exist. Those
that are in existence don\'t do a very good job at all.

I would like to take a few minutes to talk about a new program that we
initiated last year and which has been adopted by our industry. And this
is our Food Safety Enhancement Program, and it addresses both the live
production level and the processing level.

And the intent of this program is to have a continuous ongoing program
to have real improvements in the microbiological profile of the raw
poultry products.

Industry has committed itself to adopt interventions, both at the live
production and processing level. And presently we have companies
representing over 90 percent of the U.S. broiler production have agreed
to participate in this program. We hope to get the others onboard pretty
soon.

Some of the interventions that are being tested by the industry, and if
shown to be effective, adopted throughout the company include various
hatchery disinfectants such as formaldehyde, peroxide, quaternary
ammonia compounds, litter treatment primarily to address the moisture
issue, and the PH, which helps to reduce the level of foodborne
pathogens that might be found in the litter.

Various organic feed additives, organic acids added to the feed, again
trying to reduce the micro level in the feeds.

Treatment of drinking water with chlorination, organic acids, ozonation,
peroxide. Again we\'re trying to address potential foodborne pathogens
that may be transmitted through the watering system.

And the use of competitive exclusion products. We hope to see a lot more
in this last area. Currently only one product has been approved for use.
There are several in the pipeline at FDA, and we hope to see them come
onboard shortly so we can see how they work under actual field
conditions.

And that pretty well wraps up what we\'re doing in our industry. I\'ll
be glad to answer questions later on. Thank you.

(Applause.)

DR. OLSON: Thank you, Steve.

We are going to make one adjustment in our program this afternoon since
we are pushing up on the lunch hour. And our final speaker, Al Pope,
will be on the program later in the afternoon.

So our final presenter for this session will be Dr. Alice Johnson, vice
president of scientific and regulatory affairs for the National Turkey
Federation.

Dr. Johnson comes with a background from veterinary medicine, as well as
from the regulatory side.

She works with regulatory impacts on producers and provides technical
information on food safety.

And we\'re pleased to have her talking about the quality assurance on
the turkey side.

DR. JOHNSON: I thought that the only thing standing between you and
lunch would be Al Pope and me, but now they\'ve got it down to where
it\'s just between lunch and me. So I\'m going to go pretty quick
through this, and I\'ll spare some of my slides.

I\'d like to thank Dr. Ragan and his staff on behalf of the National
Turkey Federation for putting on this conference. It is a wonderful
conference, and we appreciate the opportunity to walk through what
we\'ve done with our best management practices.

The Turkey Federation started in 1996 looking at what they call the food
safety best management practices. In 1997, the first edition of the best
management practices were published.

We had said at the time that this would be a changing document, and it
needed to keep up with new technology. Little did we realize that it
would need to be changed so quickly.

And in 1999, we started working on the second edition for publication in
the year 2000, which is what we have today that we have made available.

It\'s available to all of our turkey company members, turkey processors,
and turkey growers, as well as the allied industries associated with
turkeys and the extension and universities.

There are special acknowledgements to Dr. Peter Poss; Dr. Steven Clark;
Roche Vitamins, now Alpharma, provided us the support to put our best
management practices on CD Rom, which has worked out real well; and Dr.
Allan Rain from Michigan. More acknowledgments.

The best management practices started from the turkey industry and one
of the live production meetings in which there was a workshop, an
all-day workshop, where all the growers got together and started talking
about what they do within their grow-out facilities that work and what
they have found out that doesn\'t work.

Part of the food safety best management practices that NTF has put out,
we talk about HACCP and the definition of HACCP.

As I said, it was developed by the turkey industry. It identifies the
live production CCP\'s and is used to enhance food safety.

We\'ve had a lot of the state federations as well as the extension
agents associated with the counties and the universities who have gone
out and used the best management practices to help work through some
training courses.

We have several different modules that I\'ll talk about in just a
minute.

But all the modules are equipped with the flow process chart, how you
establish critical limits, critical control points, monitoring, and
documentation and the need for documentation and the awareness of what
the documentation means, that you\'re not just documenting for the sake
of documenting.

We do emphasize that this is a voluntary on-farm program. But we\'ve had
good success with the growers adopting this program because they\'ve
found out that it does improve the flock health and performance.

And as I said, it does emphasize education and documentation. And again,
you\'re not just documenting for the sake of documentation. You\'re
documenting so that you can go back and look and see what works and what
doesn\'t.

There are five modules, foundation multiplier breeding, the commercial
hatchery, the meat bird production grow-out, live haul transportation,
and then, feed manufacturing and delivering.

In each module they talk about the ways to prevent, eliminate, or reduce
physical, chemical, and microbiological hazards.

In 1992, the Turkey Federation did put out a chemical residue avoidance
program that has been put into the food safety best management
practices.

As I said, there\'s a flow chart, talk about control steps, monitoring,
and then, documentation.

And this is what the flow chart looks like for the meat bird production
and grow-out module.

I know this is hard to read. But as you can see, you have on one side is
your flow chart; in the middle are what we call the control points, the
critical control points; and then, what is referred to as M, the
monitoring the feed back. It includes such things as sampling, your
environmental cultures, disease diagnosis, and then, documentation is
included within that.

And here\'s just a closeup of some of what we consider: your vector
control, drinking water sanitation, litter management, feed management,
and then, disease diagnosis.

We\'re going to go pretty quick, I think, if I can here.

The purpose of the food safety best management practices is to produce
the safest turkey or broiler for food consumption that is possible with
today\'s technology.

And as we try to emphasize to everyone who sits through any of these
training classes or who uses the CD Rom, that this will change.

And you\'re going to have to keep your programs updated. You\'re going
to have to sit down every once in a while and look to see what\'s
changed within your facility.

I won\'t go through this in detail. We do go into specifics about
certain areas, as far as making a diagnosis, what you need to do. You
can see you have the control points, and then, your monitoring and
feedback.

The importance of biosecurity; vaccinations; the chlorination of your
water system; the importance of ventilation in your houses; medication.

And then there is actually a BMP checklist that, Have you done all
these? Do you have them documented? Do you have a program that you can
pull out and review?

And can you look at your documentation and determine where you might
have problems, and is there anything that leads up to what the problems
possibly were based on your documentation?

I\'m going to end the slide presentations right there.

But I would like to say that we\'ve talked several times today about
litter management for turkeys, manure management in the cattle industry.

And as a part of the food safety best management practices, when the
growers get a copy of the disk or the hard copy they also get a copy of
what NTF put out late last year, which is the environmental guidelines.

While this is basically litter management, comprehensive nutritional
management programs, and phosphorous nitrogen testing, it also includes
part of proper litter storage and application to prevent, you know, any
possible runoff that may occur.

And thank you again for the opportunity.

(Applause.)

DR. OLSON: I would like to thank all of our speakers again this morning
for their presentations. I apologize that we didn\'t have time to ask
questions of them individually. Again, we will have the final
presentation from this session later in the afternoon.

But I think that the depth of the presentations you saw today, the
difficulty of fitting them into a ten-minute slot shows the commitment
that industry has and the importance that we place on quality assurance
and food safety.

I encourage you to find the speakers during the breaks or in the
breakout sessions tomorrow to ask questions. But do thank you for your
attention.

And now I believe we\'re to adjourn for lunch, which is down the hallway
in Ballrooms A and C. So, thank you.

(Whereupon, at 12:23 p.m., the meeting was adjourned for lunch, with a
presentation to be given at lunch.)

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DR. THALER: I\'m Dr. Alice Thaler. I\'m the director for the Animal
Production Food Safety staff for the Food Safety and Inspection Service,
USDA.

And it\'s my pleasure to introduce our luncheon speaker.

To summarize our luncheon speaker\'s career in a few words, one could
say that Dr. Catherine Woteki has devoted her career to food.

Her education in biology and chemistry includes a Ph.D. in human
nutrition.

She worked early in her career at USDA and then returned to us. Her
earlier experience was in the area of human nutrition.

She has served in several high profile positions, including Acting
Undersecretary for Research, Education, and Economics; Deputy to the
Associate Director of Science of the Office of Science and Technology
Policy; and Director of the Food Nutrition Board.

Since 1997, Dr. Woteki has been Undersecretary for Food Safety for the
U.S. Department of Agriculture.

She is here today to share her unique perspective on how we can achieve
our food safety goals.

(Applause.)

DR. WOTEKI: Thank you very much, Dr. Thaler.

And it is really a pleasure for me to be with this group today. I am
really pleased at how many people have showed up for a, for me, very
interesting day-and-a-half meeting.

It really, I think, indicates the level of interest in animal production
and the contributions that can be made by focusing on animal production
towards improving the safety of our food supply and ultimately the
health of our population.

I want to thank all of you, then, for participating in this meeting.

We\'re expecting, out of the breakout sessions tomorrow, to gain some
additional insights into research that is needed to answer unanswered
questions, and also as far as educational activities that will help the
producers here in the United States in furthering the safety of food
safety at the animal production level.

I would also like to extend to you greetings from the Secretary of
Agriculture, Dan Glickman.

He has had food safety as one of his primary priorities, really top
priorities, during the five years that he has been Secretary of
Agriculture. And he is very interested as well in the outcome of this
meeting.

I\'ve been asked to talk about, how can we achieve our food safety
goals?

And I think it\'s worthwhile to consider that it\'s only been five years
since the Food Safety and Inspection Service first articulated its food
safety goals and a strategy to achieve them.

To refresh your memory, that strategy was part of the 1995 proposed rule
on pathogen reduction and HACCP systems.

And one element of that strategy was the need to approach food safety
broadly and to address potential hazards that arise throughout the food
production and delivery system, including before animals enter FSIS
inspected establishments and after meat and poultry products have left
those establishments.

While FSIS articulated the strategy, it was by no means a job that FSIS
could carry out alone. It required a team effort among government
agencies, including those that are represented here and that are
cosponsors of this meeting, the industry, academics, and consumers. And
each had an important role to play in achieving the goals through that
strategy.

Nor could all of these changes be made at once. FSIS chose to focus most
intensely at first ‑‑ and I believe appropriately so ‑‑ on regulatory
oversight of slaughter and processing establishments.

The pathogen reduction and HACCP rule, which mandated HACCP and set
performance standards for salmonella that plants have to meet, has now
been implemented in all of the federally inspected and all of the
state-inspected plants across the country.

I think this has been a major achievement, and thanks to the very hard
work of industry as well as of our own employees in the Food Safety and
Inspection Service.

HACCP implementation from my perspective has gone very smoothly, and it
has also accomplished some dramatic reductions in salmonella prevalence
in meat and poultry products.

Now I believe we\'re seeing the progress we\'ve made at the in-plant
level spreading to other segments of the farm-to-table chain.

Certainly the strategies developed for use in slaughter and processing
plants are not the same strategies that are appropriate for animal
production.

We\'ve all known from the very beginning, five years ago, that a
different approach would be needed, basically one that would be focusing
on voluntary quality assurance programs coupled to very research base
and educational outreach, all of these carried out through partnerships.

And I think we\'re now beginning to see the fruits of that labor, as
you\'re hearing during this conference from the various presentations.

Certainly many challenges remain, but I believe we\'re in a better place
than we were five years ago when the strategy was first articulated.

Now, this progress is timely, because we\'re seeing increased attention
being focused on hazards to human health that can arise because of
practices carried out at the animal production level.

Examples include the focus on animal agriculture\'s role in
antimicrobial resistance, agricultural runoff from the farm and its
effects on water as well as food safety.

And very recently, environmental hazards have resurfaced once again as
an area of primary interest with the release of the new risk assessment
on dioxin that indicates that this is a problem in concentration in
animal tissues.

The experience in Europe with BSE, the Mad Cow Disease, also has focused
additional attention on animal production as a source of food safety
problems.

At the recent international conference on emerging infections that was
held just this past July, it was reported that three out of every four
recent emerging diseases of importance to human health arose from animal
infections. In other words, most new human diseases are of animal
origin.

An example is the Nepa \[phonetic\] virus that killed 105 people in
Malaysia last year and destroyed the country\'s swine industry.

Thus the animal production community has an important role in protecting
public health more broadly. And also, there is increased pressure on the
animal production community as well as processors, transporters, and
retailers, to take whatever steps they can in order to do so.

I believe the growing attention to food safety at the animal production
level reflects the fact that food safety problems are multifactorial in
origin, and therefore, the solutions have to be multifactorial as well.

As products traverse through the farm-to-table continuum, there are many
opportunities for contamination to occur, and many opportunities as well
for it to be checked.

This becomes very clear when you look at several of the outbreaks
related to E. coli 0157:H7 that occurred just this past summer.

The outbreaks are still under investigation in many cases. No definitive
causes have been identified. But it is possible that causes of illness
that are still under investigation have included the following:

Children petting farm animals without washing their hands before they
then went to eat; contaminated product leaving an inspected
establishment; and also a very large outbreak has been associated with
poor preparation and cross-contamination in a restaurant setting.

Just as you wouldn\'t expect to prevent a robbery if you locked just one
door in your house and left all of the windows open, one intervention
along the farm-to-table continuum isn\'t going to work to prevent all
food safety problems, either.

So to prevent hazards to human health, interventions are often going to
be needed at several points in the farm-to-table chain, and we all need
to step up and do our part.

With that challenge before us today, I\'d like to focus on three
questions. First to talk about what are our food safety goals, and have
they changed over the past five years? Secondly, what progress have we
achieved so far? And lastly, what remains to be done?

First let\'s look at the food safety goals. We know from foodborne
illness data that are frequently quoted now, recently released from the
Centers for Disease Control, that an estimated 76 million illnesses,
325,000 hospitalizations, and 5,000 deaths a year occur in the United
States, and that this burden of foodborne illness is therefore very
significant.

One major way that food safety goals have been set in this country is
through the Healthy People initiative. It\'s a national health promotion
and disease prevention program that sets objectives every ten years for
a variety of health concerns. And food safety is one of the major areas
of the Healthy People initiative.

The success of improvements in food production, processing,
distribution, and preparation can be measured, then, through the
reduction in outbreaks of disease caused by foodborne pathogens.

Fortunately we are seeing progress in meeting the Healthy People goals.

Surveillance data show us that we have already met our year 2000 targets
for the reduction of foodborne illnesses caused by four key pathogens:
salmonella, campylobacter, E. coli 0157:H7, and Listeria monocytogenes.

The Healthy People objectives for the year 2010 are the ones that we\'re
working on now, and they set a very ambitious target of an additional
reduction of 50 percent in each of these illnesses.

In order to meet these Healthy People objectives, a number of
government-wide activities are ongoing.

In 1997, the President announced the food safety initiative. And this
initiative was very significant in that it provided funds to fill
existing gaps in the food safety system; it certainly raised the
visibility nationally of food safety; and it improved coordination among
the various government agencies with food safety responsibilities at the
federal, state, and local levels.

It also was significant in that it provided a comprehensive framework
for making significant improvements in food safety, a framework that
encompasses surveillance, outbreak response, risk assessment, voluntary
as well as regulatory approaches such as inspections, and also research
and education.

Now, the food safety initiative\'s efforts have focused really on a
half-dozen pathogens that are the primary causes of foodborne illnesses
in the United States.

In 1998, President Clinton announced formation of his Council on Food
Safety which, among other things, was charged with developing a more
comprehensive strategy for federal food safety activities.

A strategic plan, then, is the one of the objectives of the council. And
the plan is broader than the food safety initiative in that it addresses
all hazards associated with food, not just pathogens.

We\'ve held numerous public meetings to gain a variety of viewpoints and
insights to help in the development of the plan, and we expect that the
council is going to present the draft strategic plan to the President in
the very near future.

The plan provides goals, objectives, and actions for the U.S. food
safety system and evaluation strategies to determine whether our public
health goals are being met.

Now, what progress have we made through these various initiatives? I
think the answer is we\'ve made quite a lot of progress. And let me
briefly give you just a few examples of that.

In the area of foodborne disease surveillance, the existing network,
called Foodnet, has been expanded to provide better data on the
incidents of foodborne illness.

Foodnet began with data collection in five areas of the country in 1995.
Today there are eight sites that are in place. Colorado will be added in
the year 2001, so very soon. And the total U.S. population that is now
covered by the Foodnet system is about 25 million people, or about 10
percent of our population.

In the area of outbreak response, FSIS has joined with other public
health agencies such as the Food and Drug Administration and the Centers
for Disease Control to form the interagency Foodborne Outbreak Response
Coordination Group, or it goes by the acronym FORCE G.

Because we work so closely with the states in outbreak response, one of
our major goals has been to strengthen the infrastructure at the state
level, particularly through the state health departments.

Another important development also in collaboration with the public
health agencies in the states is the Pulsenet national laboratories that
perform DNA fingerprinting on foodborne bacteria.

Pulsenet has enabled us to many times now, since it\'s been in place,
link outbreaks of illnesses with specific food products.

What took us weeks to accomplish just seven years ago, in 1993, as far
as linking illnesses with common food sources now is taking as little as
48 hours with Pulsenet being widely in place and being widely used.

Risk assessment is another important area of emphasis where we\'re
making, I believe, some very substantial progress.

Risk assessments are being looked to play an increasing role in
establishing public policy for food safety here in the U.S. as well as
internationally.

In 1998, USDA completed our first ever farm-to-table quantitative risk
assessment for a pathogen in a food product. It was the risk assessment
for Salmonella enteritidis in eggs and egg products.

And that risk assessment is being used as a major resource in the
development of improvements in egg safety that we\'ve articulated in an
egg safety action plan.

FDA has also been leading in developing a risk ranking for Listeria
monocytogenes in ready-to-eat food products and will soon be releasing
that risk assessment.

FSIS is also completing work on a risk assessment of E. coli 0157:H7 in
ground beef.

And with help from researchers in industry, we\'ve also been making
progress in designing voluntary as well as mandatory regulatory
approaches such as HACCP in meat and poultry plants and the voluntary
quality assurance programs at the animal production level.

Designing and implementing these approaches from farm to table
necessitates a very close working relationship among federal, state, and
government agencies, along with the producer community and the academic
community.

I believe we\'ve made quite a bit of progress in working among those
communities all along this farm-to-table continuum.

Research is another area of emphasis because it provides us with
information and tools that we really need in order to continue to make
progress on food safety.

This afternoon we\'re going to be hearing from a variety of
researchers ‑‑ and I\'m really looking forward to these presentations ‑‑
about the progress related to animal production food safety.

Food Safety and Inspection Service, for which I have oversight, is not a
research agency, but we are a research reliant organization that has
long been interested in encouraging food safety research to answer the
very specific questions that the agency has.

FSIS began in 1996 to articulate very clearly its research needs and its
food safety research agenda.

Now, the President\'s food safety initiative has provided very
substantial funding increases for research to federal agencies and
through them also to academic scientists.

It\'s also established the Joint Institute for Food Safety Research that
you heard a little bit about this morning from Mr. Gillespie.

The Institute is charged with developing a strategic plan for conducting
food safety research and coordinating the federal food safety research
activities.

And it also has a very broad mandate to also work closely with the
private sector and with academic scientists in the development and
coordination of that research agenda.

We\'re certainly looking forward to the Institute\'s feedback on the
status of the research that has been conducted to date that relates to
FSIS\'s food safety research agenda. And we\'re also looking forward to
your comments today as far as providing further indications of
directions that the federal research portfolio should be taking.

We\'ve also made some progress in education at all levels. The Fight
BAC! campaign, the result of the public-private partnership for food
safety education, is spreading the word to consumers about taking some
fairly basic steps in sanitation and food handling to protect themselves
and their families from foodborne illnesses.

And at the animal production level, information delivery systems have
been developed to reach producers, especially those that are not parts
of a commodity organization or another industry group.

The implementation of HACCP within slaughter and processing plants
necessitated a very extensive education and outreach program, especially
for the small, and most especially for the very small plants that did
not have much experience with HACCP.

Now, lastly, let\'s look a little bit to the future. I think we do face
some major challenges for the future, and the first is that we have to
continue progress in all areas of research and risk assessment along
this farm-to-table continuum.

For example, in animal production we need to identify what I would call
cost effective practices that can be carried out on the farm to reduce
food safety hazards.

These practices can then be incorporated into quality assurance and
production control programs that can be then widely used by producers.

In addition, I think government agencies need to get more experienced in
using risk assessment to guide our risk management strategies.

I think this is happening. We are, as I told you, developing a number of
new risk assessments, and I think it\'s going to naturally follow that
we will gain more experience in how to use this relatively new tool in
formulating risk management strategies.

Secondly, I think we also need to recognize the links between these
various segments in the farm-to-table continuum so that that chain of
responsibility is also felt.

I still am somewhat disheartened at times that segments within this
continuum continue to express lack of responsibility.

The producers say, particularly if referring to pathogens, You know,
it\'s not my problem, it\'s natural. God made these organisms. There\'s
not much I can do about it.

The slaughter processing companies say, You know, I got bad product to
begin with. It\'s not my responsibility. If only the consumers would
cook their product.

And sometimes the consumers say, It\'s not my fault, and it\'s true. And
sometimes they say, It\'s not my fault, when there were some steps that
they should have and they could have taken in order to properly prepare
and even store foods.

Now, I\'m not saying that these attitudes are widely pervasive these
days. I think there has been an enormous change in attitude towards food
safety among all of those segments that I have just mentioned. But there
are still some who express these attitudes.

So one approach that I think that we need to take is to recognize and to
accept that there is interdependency among the different segments in
terms of both industry\'s responsibilities, government\'s
responsibilities, and consumers\' responsibilities.

One example of this is that FSIS is pilot testing a project wherein our
inspectors will be able to move more freely between their
responsibilities in-plant and oversight of product, meat and poultry
product, that is in distribution locations in order to ensure the
integrity of the marks of inspection on meat and poultry products.

That approach also requires that federal, state, and local government
officials work together better to coordinate their own resources and to
make sure that in following product as it moves from plants through
distribution that we\'re making effective use of what are very limited
inspection resources at local, state, as well as federal levels.

Thirdly, I want to encourage the animal production community to continue
to look beyond its own immediate sphere of interest and expertise and to
participate in food issues at a much broader level.

The adage, Think globally and act locally, probably applies here.

For example, I encourage industry representatives at all levels to
participate in the activities of the Codex Alimentarius Commission.

The animal health and food safety standards that are set by the
commission really do have broad ranging implications for animal
production practices as well as for overall public health improvement,
and they also have impacts on our economy as well as on our
international trade. So it\'s important that we participate in the Codex
Alimentarius.

Fourthly, I think we have to continue to strengthen the partnerships
between government and industry in order to continue the progress that
we\'ve seen so far.

I believe we\'ve made progress in animal production food safety. I think
we\'ve heard evidence of that already in presentations this morning. And
much of that is attributable to the voluntary quality assurance programs
that we heard about just before lunch.

Now, the topic I was asked to talk about was, how can we achieve our
food safety goals? And I think the take-away message that I would leave
you with is that we need to keep our focus on farm-to-table, cost
effective interventions.

Clearly there are going to be a lot of obstacles that will be
encountered in the development of that very simply articulated but very
complex goal.

But in closing, I\'d like to remind you of the words of Henry Ford, who
said that obstacles are those frightful things that you see when you
take your eyes off your goal.

So I\'m confident that, if we remain focused on our goal of improving
food safety, that we can succeed. We\'ve got good evidence that so far
that has served us very well.

And your recommendations on research and education I think are going to
be very important in moving us forward.

So I look forward to the presentations this afternoon. And I thank you
very much for your active participation in this meeting. Thank you.

(Applause.)

DR. THALER: Okay. Well, that will pretty much wrap up lunch.

The message I have is we\'re going to try to squeeze a little more time.
I have about 1:20 on my watch. We want to be 1:30 in the room to start
again. And Al Pope, you get to go first.

We\'ll wrap that up and then move on, pretty close to what our agenda
is.

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1:37 p.m.

DR. THALER: Good afternoon. We\'re going to go ahead and start this
session.

We\'re going to follow up by finishing out our updates on quality
assurance activities.

The last speaker, that was kind enough to wait until after lunch, is Mr.
Al Pope, United Egg Producers. He joined the UEP in 1974 as the general
manager. UEP in general represents 80 percent of total U.S. egg
production. He has been president since 1978.

He is also president and founder of the United Egg Association, who
represents 90 percent of the further processors and major suppliers to
egg industry of services and equipment.

He is a council member and past chairman of the International Egg
Commission, so he reaches out very broadly in the world of eggs.

And I don\'t think he needs any more introduction. He wanted to save the
introduction so he would have a couple of extra minutes to speak, so I
will honor that. Mr. Al Pope.

(Applause.)

MR. POPE: Thank you, Alice.

Well, it looks like we lost about half of the group. So if I could get
you folks at the door to come in, please, or we\'re going to call you
out by name.

If you\'ll humor me for just a minute, if everybody would just stand up
one more time. There\'s a few coming in yet. So would everybody just
stand up for a moment, please? This is just for, you know, our
newsletter type thing, you know. So ‑‑

(General laughter.)

MR. POPE: No, no, no, no. Now, I can\'t ‑‑ I don\'t have the
opportunity, as much as I\'d like to, to shake everybody\'s hand, so if
you would just ‑‑ we\'ll do this in the film. Okay? So if you would like
shake my hand. Okay.

Now, put your other hand out there, too. I want to see that. Okay. Get
it all in here. Okay. All right.

Now, everybody has been so nice so far. I\'m not as nice as they are.

Well, the first thing I wanted to do today was to thank everybody and
thank especially the staff and John for inviting us to participate with
the groups this morning. And I really look forward to the opportunity of
sharing a few words with you.

But before I get started, one of the things that I need to tell you
about is how tough egg producers are.

Now, if I was on Johnny Carson\'s program and I said that, Egg producers
are really tough ‑‑

VOICES: How tough are they?

MR. POPE: How tough are they? Okay. Well, we have a tradition. On our
board we have a sheriff. And this sheriff makes sure that everybody
comes in on time and no cell phones go off during the board meeting. He
makes sure they come back from break on time, and he finds them all if
they\'re late and so on and so forth. This is a tradition we\'ve had for
25 years. And it just works great.

The problem is that there\'s also another tradition that comes with it.
Our sheriff ‑‑ his name is Ed Houseton \[phonetic\], and he\'s from a
little town in south Georgia called Lumber City, Georgia.

And I\'ve known Ed for 30 years, and he still doesn\'t know my first
name. He calls me Pope, Pope, you know, that\'s it. He says, Pope, what
are you doing here or what are you doing there?

Well, egg producers are so tough that I get paid once a week. I get paid
on Friday based on what I\'ve done that week. I mean, that\'s tough. How
many of you do that?

So every week, Ed Houseton calls me on Friday. This Friday, actually,
I\'m going to be with him.

And once again he\'ll say, Pope, how has your week gone this week? And
I\'ll say, Great. Of course, we were off Monday, didn\'t get down there,
but I still went into the office, and I went through my presentation so
that I\'d make sure I was timed right and everything.

And I said, Then I went to St. Louis. And I said, I was on the program.
And I said, Man, there was 250 people in the audience or something like
that.

And he says, Well, what was it about? And I say, It was about food
safety and eggs.

And he said, Well, we\'ve had a lot of problems there. He said, How well
did you do?

I said, Do? I said, It was great. I got a standing ovation. Look at
these pictures.

(General laughter.)

MR. POPE: So I hope that I get paid a little bit more this week for
this.

First of all, I want to start by saying eggs have been the poster child.
I don\'t know how many of you agree with that, but certainly our egg
producers feel like they\'ve been a poster child on food safety. And I
think we were kind of the first ones on the block.

And this year, so far this year, our industry has lost an estimated 175-
to \$200 million through the end of August. Very hard to implement food
safety programs, animal welfare programs, environmental programs,
because you can only do that to the extent that you have resources
available. So as a poster child, we\'ve been picked on.

Now, my associate down here, Ken Clippen \[phonetic\], I said, I\'m
going to tell them who has abused me here, how many people have abused
me. And he\'s going to say, No. Challenged you, Al; how many have
challenged you?

Well, I said, No. I said, I\'ll give you credit, and I\'ll say that you
said challenged, but I\'m going to use the word, abused.

Secretary Kessler abused me and abused UEP. My good friend is here in
the audience today, Joe Madden. Joe Madden has abused me. Caroline has
abused us. Secretary Billy \[phonetic\] has abused us.

And you know what? The last straw was the Saturday morning address, two
weeks in a row, President Clinton abuses us.

Well, we\'re not down and out, and we want to come roaring back.

And so I\'d like to share with you today how they brought us to the
water trough, and how we felt like we went there, and how this
partnership has worked, and what have the results been? Because that\'s
what the bottom line is.

It is not all peaches and cream, because you have to fight not only with
your administration, with your staff, but with your members as well, and
trying to keep your consumer uppermost in your mind, your customer.

So these are all things that I think are really tough. And I\'d like to
share with you today, I think, where we were, what happened to us, and
where we\'ve been.

Well, first of all, we got our wake-up call in 1988, so that\'s 12 years
ago. CDC came out with this report. I couldn\'t even say Salmonella
enteritidis. And then, transovarian transmission was completely out, and
we didn\'t even know what that was.

And we had to look those things up, we had to call our vets, we had to
find out what all that meant, and we didn\'t believe it.

So the producers\' reaction was, I think, expected. They were alarmed,
they were in denial. They said, No way. There\'s no way you could have
transovarian transmission. It\'s impossible. Until Charlie Baird
explained to us that it was possible.

We were depressed. I mean, we\'d just come off of 20 years on the
cholesterol issue and were just making some big science-based roads
back, where the egg was being redeemed, and all a sudden, it\'s getting
beat up again.

So we had a lot of things we felt like we had to do. And so it took a
team effort. And I\'m going to talk about that team in a little bit.

But it reminded me in the beginning of this. Remember the old dealy on
Abbot and Costello, Who\'s on First, What\'s on Second, and Why is on
Third? Well, that\'s the way we felt back in 1988. And we had to do
something.

It was confusing, and it was chaos, and it had many, many questions we
didn\'t have any answers to, and there was no one single answer. You
couldn\'t put your finger on it.

So unlike Abbott and Costello\'s comic relief, it was no laughing matter
to us, because we could see what kind of damage it might do to our
industry.

So we started doing some things in the beginning. We felt like we were
proactive. But still we had an adversarial relationship ‑‑ I\'ll be
honest with you ‑‑ with the administration, and we didn\'t see eye to
eye. And we were the first ones they were targeting in some respects.
And so we were both learning as we went along.

We did go to Congress, and we got money from Congress to set up the
pilot project in Pennsylvania.

We developed a food safety quality assurance program, which is our
five-star program. And I want to just mention it a minute, because
we\'ve expanded dramatically what comes under the five-star program. It
has a number of other components to it.

It has, of course, the food safety component. It has an environmental
component.

And the environmental component has just ‑‑ we have just signed a
historic agreement with EPA to do a better job through an Excel project
that\'s going to be proposed hopefully and developed by November 1 of
this year and then will be rolled out across the country to those that
want it.

It\'s a voluntary program. It\'s a tough one to meet. But we\'ve worked
with EPA on that to demonstrate our proactiveness.

On the animal welfare issue, I would challenge any commodity in the
United States, or in Europe, as far as that goes, that has gone as far
as the egg industry has gone.

We put together an animal welfare committee, had no producers on it. It
was only scientists, and we only selected one of those. You had to start
somewhere. And we had no limits on them.

They have presented their paper to the UEP Board, who has adopted it in
total. It will be a dramatic change over the next ten or 15 years.

But I\'m just trying to demonstrate how proactive the egg industry has
been.

We have GMPs developed. And, of course, today I want to focus on food
safety.

On our five-star program, which we have copies out at the booth today,
and we have added since we have started third-party monitoring, both
APHIS and AMS have offered that service to us, and we really appreciate
it.

We have added a validation or a testing procedure to it, and I\'ll get
on that a little bit more later.

But we\'ve worked with the Department, worked with the stakeholders, all
the stakeholders, consumers alike. And I think we\'ve come up with to
agreement on what we think a good food safety program for eggs can
really entail.

We called for breeder testing through MPIP. You heard that earlier. We
supported eggs being on the FDA high risk ‑‑ I forgot what the name of
it is called right now. Let me go back there. Just a minute here.

(Pause.)

MR. POPE: Yes. The hazardous food list. We proposed and supported a
national refrigeration law, which many of you know. We established a SE
assessment working group.

Our American Egg Board became a founding member of the partnership with
the White House on President Clinton\'s food safety initiative.

We recommended that liquid pasteurized egg product be used in food
service and especially institutional settings with immuno-compromised
patients.

If you look at the outbreak records and look ‑‑ this is the most
critical area. We think that the Department has not given enough credit
to looking at the developments that have been made on vaccines and the
important role that they can play in any quality assurance program.

We need to work hard on that. And during this regulatory process that\'s
coming up, we\'ll certainly focus on that.

We have sponsored HACCP workshops for the egg industry, both production
and processing. We established egg handling and preparation tips for
food service and consumers.

You know, I heard a comment earlier which is true. Our producers were in
that group that first said, Well, you know, these consumers have a
responsibility, too. And I think we all agree with that.

But it\'s our product. And if we don\'t want them to stop eating our
product, then we also have a major responsibility at the consumer level.

Now, I was real pleased. You heard there were some hearings last month
where they delivered the current thinking papers. I was delighted to see
there that they focused on what needed to be done on the education part
with the consumer, too. And I applaud the Department for that.

But we have the major responsibility. If we want them to eat eggs,
they\'ve got to feel like eggs are safe. So we tried to put a teamwork
approach together.

And I share this with you because it\'s just kind of our way of
presenting it, I guess, and we think it\'s an easy way to do it.

You see our five-star program is on the left, our logo there. And
here\'s who we have as our players.

We have on first base we have the producer-processor, and marketer. On
Second Base, we have the industry organizations, Third Base, government.
And then, in the outfield there\'s just a tremendous number of support
team members. And then, certainly at the Home Plate we have the
consumer. And I\'d like to take a look at each.

On First Base, we have the producer-processors. And we heard this
earlier. They have to, first of all, recognize the challenge. And then,
after that, they have to make a commitment. It\'s a state of mind. They
have to be obsessed over this.

They have to be obsessed when they see rodents in their facilities. They
have to be obsessed to get them out. They have to be obsessed about the
water and the testing. And they just have to ‑‑ it\'s just something
that has to happen, and it just doesn\'t happen in every operation. And
you can imagine how hard it is.

I was listening to John Adams this morning talking about how many he had
to go out, how many farms and so forth and so on. And I\'m glad we\'re
not faced with that.

And then, you have to have people to implement them. You have to come up
with a quality assurance program. You have to have record keeping so
that they know exactly what their responsibilities are and what records
they need to keep. And we gave them all of that.

In our five-star book out there, it has the actual records for the
producers and processors to use.

And then, the resolve and determination to the programs. And then, of
course, the research, identifying the research.

And then, on Second Base, we have the industry organizations. We have
to, in our membership ‑‑ and this is where it is really difficult. And I
can share the frustration.

But by the way, you notice I didn\'t have one of the people that picked
on me was Dr. Woteki. She didn\'t pick on me. She\'s been very nice to
me. So I appreciate it a lot. I just want you to know that. And the
others have all become friends, I hope. I hope I haven\'t alienated them
too bad.

But you have to be tough on this. You have to be tough on it, we have to
be tough on it. Our producers expect it, your administration expects it,
your school expects it. We all have to be tough. We have to hang in
tough.

And so our responsibility was to get our membership up to date on the
issue, recognize that there\'s a problem, and then try to be proactive.

Try to develop uniform programs for our members so that we don\'t have
an uncompetitive or a competitive advantage or disadvantage by
geographic area, by state, by whatever. And that\'s very difficult to
do.

You seek input from all stakeholders. And I think that we\'ve all tried
to do that. Certainly I don\'t know that I\'ve ever seen really
government try harder to get input from all stakeholders.

Identify the research needs and find available funding, not an easy
project. You know, it\'s programs like this and animal welfare and the
others that are burdensome to the agriculture community.

We have an economy that is just steaming along here. But I\'d like to
have anybody hands raised in agriculture, are we sharing any part of it
or a big part of it or a little part of it or any part of it?

We\'re not really sharing in any part of it, are we? If you ask any
agriculture people, they\'re not.

And one of the reasons they\'re not is that during these times consumers
are very receptive to these kinds of social programs, and yet we\'ve got
to try to come up with the money to afford them, not an easy project. So
we need to identify the research.

We need to work with the government agencies that have the authority.
And then we need to communicate in public relations efforts.

This has been hard for us. We haven\'t done as good a job as we would
have liked to have done. But, you know, you see Jill, and you see Ken
and myself, and Gene down in Atlanta, and you\'re looking at 50 percent
of our staff.

So you know, it\'s kind of hard to expect a great public relations
program and a great communications program. You\'ve got four people
running around trying to just respond to regulatory challenges.

So this is one that we\'re weak on, and we\'d like to strengthen it up.
We need to do that to educate our stakeholders, and that means our own
members, too.

Third Base, obviously this is the government part of the team. They have
an obligation to protect the consumer interests. They also have an
obligation to be even-handed.

They have a major obligation in education, of course. They need to work
with the industry and all stakeholders. They need to provide some
resources and research assistance to us. And we still need help in this
area.

And we hope we can help here at the meeting, and we hope we can help
Friday down in Atlanta, where they\'re specifically going to look at SE.

If appropriate, develop uniform food safety programs with input from all
stakeholders. Now, we\'re in the process of doing that now with the
Department.

We didn\'t think we\'d get to that point, quite frankly. But if we\'re
going to have a program, then it only makes sense that everybody in the
country be on a level playing field. So we\'re trying to be as least
intrusive as possible with a maximum amount of effectiveness.

So that\'s what our goals are. And it\'s a multiagency effort, and
we\'re all interested in that.

In the outfield ‑‑ and this is just a short list. I mean, CDC; academia;
vaccine manufacturers; chemical cleaning; disinfecting; rodent
specialists; testing labs; communications; food safety consultants.

Congress has to get involved or has gotten involved; other regulatory
agencies that are affected by this; Food Market Institute; National
Restaurant Association. All of these organizations need to be involved.

How do you get over and visit all of these? It\'s tough to do. The
health care industry deserves to know that their eggs are safe. And so
it\'s a real challenge for us.

And so we\'ve picked up the slogan, Eggs, Safe at the plate. And it
takes this team to really make this possible, to have eggs safe at the
plate.

So what are the results so far? This team has been working for a pretty
short period of time, to tell you the truth. I mean, even though we\'ve
been working on it ten years in different aspects, the team has been
only working the last three or four years, in fact, maybe the last
year-and-a-half really closely together.

So the SE scoreboard ‑‑ now, this is all SE, of course. The total
outbreaks have gone from 85 to 44; the illnesses have gone from 2,600
down to 1,080; the health care facilities have gone from 12 outbreaks in
\'90 to two in 1999. So that\'s the good news.

I mean, we have a lot more that we can do, and we are going to do a lot
more.

These statistics are based on CDC\'s outbreaks. They\'re not all egg
related.

Here is the egg SE scoreboard. Basically out of those outbreaks that we
had in 1990, 26 of them were egg related, and in 1998, there were 15.
The illnesses went from 1,059 to 369; the health care facilities, down
to one.

It\'s kind of interesting on the bottom here. And I want to point out
Rick Bretmyer \[phonetic\] is here from California. They have a terrific
program in California. There\'s a terrific program in Ohio; there\'s one
up in Maine.

I don\'t mean to overlook anybody\'s state program, because they\'re all
based on the same principles that the five-star program is on. They all
deserve credit for what they\'ve done.

But if you look at the percentage of producers on the program, we had
nothing in 1990 practically, or you could say that. And in eight years,
we\'re up to 84 percent. Now, under the administration\'s program,
we\'ll be at 100 percent.

And obviously our outbreaks are going to continue down. We know that\'s
going to happen. That\'s just the way it\'s going to be.

So here is basically what\'s happened on the Foodnet score. From \'96 to
\'99, we\'ve already had a 48 percent reduction. And if you\'ll look
back, you\'ll see that that increase, of course, was ‑‑ where am I here?

The increase is this 5 percent to 84 percent, so obviously that had
something to do with this 48 reduction. It does demonstrate that those
are on quality assurance programs.

Are they doing as good as they ought to? No. Are they record keeping as
good as they ought to? No.

You know, I can do all those things. But if you look and you look at how
many are on the program now, and you look at the results of it, I think
you\'ve got to say this thing really works.

So it takes this team effort to hit a homer, and our homer is ‑‑ who is
our homer here? We all know who that is. Here he goes, BAC; so to knock
bacteria out of the park.

And on behalf of United Egg Producers, we want to thank the egg
organizations and the support folks on this team who contributed to
making eggs safer at the plate. Thank you.

(Applause.)

MS. THALER: And then, I\'ll call your attention to just one small change
in the program. Dr. Reed will go next, and then, Dr. Sundlof has asked
to be moved up so he can make his plane.

Dr. Craig Reed is the administrator for the U.S. Department of
Agriculture\'s Animal and Plant Health Inspection Service.

APHIS conducts domestic disease programs and also protects the nation\'s
agriculture from dangerous foreign animal, plant, pests, and diseases.

Before coming to APHIS, Dr. Reed served as deputy administrator of the
office of field operations at USDA Food Safety and Inspection Service
and director of the Agricultural Marketing Service\'s science division,
and dealt with food safety matters.

He was also in private veterinary practice at one point, so hopefully he
has a real strong tie back to producers prior to joining USDA.

His topic today is APHIS\'s supportive role in animal production food
safety.

DR. REED: You\'ve got to love all these Power Points, don\'t you?

Thank you, Alice. And thank you, everyone, for inviting me here today.

I\'m glad I wasn\'t the first one without a Power Point. I\'ve been
inundated by the technology today. I must say directly following Al was
not in my plan. It\'s kind of hard to follow, Safe at the plate. But I
felt like I was in the on-deck circle over here.

(General laughter.)

DR. REED: And Al talks about being tough. It\'s easy for the egg guys to
talk tough. They\'ve got a shell; the rest of us have skin.

(General laughter.)

DR. REED: After that, I have to say that Al saved me one time from being
hit with a pitch back in \'95, when FSIS took over the egg products
inspection program.

I was down in Atlanta with a bunch of angry egg products producers, and
Al pulled me off to the side and said, You\'re going to get nailed here,
so be ready. So I appreciate that, Al.

Well, I\'ve had 27 years in the food safety business in one way, shape,
or form. And it\'s a pleasure to have worked in FSIS and AMS.

Now I\'m the administrator of APHIS. And I need to tell you a little bit
about what we\'re doing as a support agency. But before I do, I think
it\'s important for all of us to put a little of perspective on what we
just finished, and that was lunch.

And despite what anybody says, that chicken and those potatoes, the
apples, the whipped cream and other dairy products, everything on those
tables we took for granted as being safe.

Some of us might have given it a little bit of thought, but not long
after the fork reached the lips.

I also need to give a lot of credit to other players in the food safety
arena, including producers, veterinarians, most importantly, state
officials, and of course everybody at USDA. These people work hard every
day to keep our animals and food safe.

And integral part of maintaining animal health is preventing entry of
exotic pest and disease threats. That\'s probably the main theme of the
Animal and Plant Health Inspection Service duties, although we have
others.

Through our veterinary services program, we work to make sure that the
livestock industries get protected from foreign animal diseases and
pests. And we also work to eradicate domestic livestock diseases and
conduct animal health certification programs and do quarantines to
facilitate trade.

If you don\'t think trade is important ‑‑ hasn\'t come up but a few
times. I noticed John Adams\' presentation did identify that. And most
of us need to know that probably 30 percent or more of our local
production is dependent on moving it abroad.

We\'ve saturated consumption here in this country, so the only way our
producers are going to stay viable is to ship it overseas.

One of the first things I\'d like to mention is our joint operations
with the Agricultural Research Service, ARS, and others.

We have three locations that I\'d like to bring to your attention today:
Ames, Iowa; Plum Island, New York; and Fort Collins, Colorado.

Plum Island is home to the Plum Island Animal Disease Center. And
although ARS is the primary agency in charge of the center, the director
shares responsibility with our agency\'s chief of the foreign animal
disease diagnostic lab, also located at Plum Island.

In Fort Collins, we have our home of our Centers for Epidemiology and
Animal Health. Our agency\'s lab have a close relationship of working
with ARS, the primary research arm of USDA. This close relationship
enables us to actively exchange data and information with ARS officials
as they study a variety of ag subjects, including those involving animal
production food safety.

What I\'d like to do now is talk a little more in-depth about our
facilities.

First, our national vet services lab in Ames\' main charge is to protect
the health of animals and contribute to public health by providing
timely, accurate, and reliable lab work to our customers.

Our customers include local and state government agencies and labs,
other federal agencies, educational institutions, foreign governments,
and, of course, producers.

We normally focus our efforts on diagnosing pathogens that cause disease
in animals. However, we can and do lend ourselves to institutions
studying zoonotic agents, which are those that affect humans and animals
both.

Last year, when crows in the New York City area started dying from a
mysterious illness, our agency scientists at NVSL took samples from
birds and isolated the virus.

They sent those samples to the U.S. Department of Health Human Services
Centers for Disease Control and Prevention, and it was confirmed that it
was the West Nile virus.

This disease that affects both humans and animals and was responsible
for the deaths of seven people in New York City in 1999.

At our NVSL facilities in Ames, our agency has been involved with
several projects that have had an impact on animal production food
safety.

Among other things, we have aided in the study of transmissible
spongiform encephalopathies and salmonella.

Lately TSE\'s have been receiving a great deal of media attention. I
won\'t talk about Vermont today. These degenerative neurological
diseases, which include scrapie and bovine spongiform encephalopathy, or
Mad Cow Disease, are characterized by very long incubation periods and
100 percent mortality.

In Great Britain, BSE has been linked to the deaths of at least 48
people from New Variant Kreutzfeld-Jacov disease and has caused over \$6
billion damage to the livestock industry.

Right now in Vermont our agency is working hard to acquire the last two
flocks of three after four animals were confirmed positive for TSE.

Unfortunately, when we did our Western Blood analysis, Western Blood
indicated it wasn\'t quite scrapie, and it wasn\'t quite BSE.

If it was just scrapie, we would have handled it strictly as an animal
disease, but we\'re seizing the flocks to make sure that nothing gets
into the human food chain.

Our agency also works with ARS to learn more about TSE so we can enhance
current diagnostics and develop new diagnostics for live animals.

Since the mid-\'90s, when Mad Cow Disease came onto the national scene,
we have been performing surveillance and exclusion activities for
TSE\'s.

Our scientists have trained employees of state labs across the country
in diagnosing these diseases, and we have provided samples from high
risk or affected flocks to research scientists.

We have also helped researchers determine if certain tests are practical
or if they detect a certain percentage of cases.

NVSL, along with our Centers for Epidemiology and Animal Health, which I
will talk more about shortly, have played an instrumental part in
testing two experimental diagnostic procedures that may become standard
soon, the third eyelid test used for diagnosing scrapie, and the
capillary electrophoresis test used in diagnosing BSE.

By providing such support to ARS researchers, we are helping to enhance
testing and diagnostic methods. We believe this will lead to healthier
animals and ultimately a safer food supply.

In addition to the work we do with TSE\'s, NVSL has also cooperated with
researchers studying salmonella in poultry.

CDC officials have used the data we gather from testing poultry to
determine the dispersal and infection rate of different strains of
salmonella.

NVSL performs the diagnostic tests on the poultry samples. CDC then uses
that information to project where the disease might be thriving and the
areas in the country where it will be most likely to infect human
populations.

Again the work we do at NVSL is used to support another agency and their
work concerning animal food safety.

And I\'m not sure whether the lab still does the typing for salmonella
strains for the egg products inspection program. Most of that work was
screened at Gastonia in North Carolina and then sent on to Ames if there
was a salmonella positive.

As part of NVSL, our diagnostic facility at Plum Island, the foreign
animal disease diagnostic lab, shares its goal of protecting the health
of animals and contributing to public health by providing reliable lab
support to our customers.

While the Ames facility\'s main focus is domestic animal disease issues,
FADDL, as we call it, works with diagnosing exotic pathogens that must
be worked with under biocontainment conditions.

Currently the majority of agents that we deal with here, like Foot and
Mouth Disease and African Swine Fever Virus, do not affect human health.

However, if Plum Island\'s biosecurity level is upgraded, we may begin
to study zoonotic agents. I\'ll be discussing this possible upgrade a
little bit later.

Right now on Plum Island our agency is responsible for testing imported
animals, biological products, and some animal products to ensure they
are free of foreign animal disease agents.

We\'re also involved in the production of reagents used in diagnostic
tests for foreign animal disease and the testing and evaluation of
vaccines for these diseases.

Our other efforts on Plum Island include training other veterinarians
and animal health professionals to recognize and diagnose foreign animal
diseases.

Through our work at this facility, we again are helping to keep the
country free of foreign diseases and in the end ensure safer products
for U.S. consumers.

Our Centers for Epidemiology and Animal Health, as another part of our
agency, is responsible for generating studies and gathering and
distributing information about animal health and other agricultural
issues.

Here we gather information about animal health, animal production,
animal product wholesomeness, animal welfare, and the environment.

Through our national animal health monitoring system, CEAH, as we call
it, works closely with federal and state animal and public health
agencies, universities, diagnostic labs, producer groups, and private
interest groups.

Working with these groups, CEAH officials identify key information gaps
facing those in animal production. They then design studies to fill
these gaps and gather data through state and veterinary services
employees in the field.

After analyzing gathered data, CEAH officials compile statistics and
estimate risk factors affecting animal health, food safety, public
health, and the viability of U.S. agriculture.

Once completed, the studies are widely distributed electronically and as
hard copy.

In summary, CEAH many times poses the question that needs to be answered
by the researchers. What is the researchable question?

For example, CEAH officials have published several reports with regard
to animal production food safety, including studies of the prevalence of
E. coli and salmonella in U.S. dairy operations. They have also worked
with the swine, poultry, equine, and beef industries to determine the
prevalence of these and other microbial pathogens.

By compiling such data, CEAH gives animal health experts and producers
information that may help them reduce risk factors in animal food
production.

Our Center for Veterinary Biologics contributes to American agriculture
by not only being responsible for helping diagnose animal diseases and
distributing information about them, but also ensuring that veterinary
biologics are pure, safe, potent, and effective.

Our Center for Vet Biologic ensures that the quality of vaccines,
commercial diagnostics, and immunotherapeutics have the quality that we
need in the animal industries.

We set standards, license product, inspect manufacturing plants, and
perform confirmatory testing.

Although we are mainly concerned with preventing and treating animal
diseases, the work we do at the Center for Veterinary Biologics can and
does affect animal production food safety. After all, if we can prevent
a disease, it\'s one less that we have to treat.

For instance, CVB licenses test kits for bovine TB, which is used
conclusively to diagnose this disease in livestock herds.

There are other safeguards in place to prevent bovine TB from entering
the food supply. Milk is pasteurized and cows are inspected at slaughter
facilities.

However, diagnosing an animal before it even enters the production
process is the best way to prevent it from affecting the general public.

We also license the Salmonella enteritidis vaccine. The purpose of this
vaccine is not to control the disease in birds, but to reduce the
potential risk of egg contamination. You could say it\'s a vaccine for
food safety.

In addition to licensing veterinary biologics and performing
confirmatory testing, Center for Biologics officials are also involved
in the research and testing of plant-derived biologics. This is an
exciting new area of study that may soon have major ramifications on
animals as well as human health.

Plant-derived biologics are plants genetically engineered to produce
immunogens of disease agents.

With this new technology, feeding animals modified corn, potatoes, or
soybeans would produce the same effect as administering them with an
oral vaccinations. In some cases producers would no longer be required
to treat their animal feed with antibiotics.

As an example of one that\'s currently under field test, there is a corn
that\'s been engineered with the rabies attenuated virus as part of the
corn. And when animals eat the corn, they vaccinate themselves for
rabies. I don\'t know what could be a better deal.

The study and testing of plant-derived biologics is very exciting but is
still in its infancy.

Since our agency regulates vet biologics as well as the production of
genetically modified plant and plant products, we feel a great
responsibility to the American public to ensure that this new technology
and these products are as safe to use as the products produced through
traditional methods.

Towards this end we are working closely with the Food and Drug
Administration, various state Departments of Agriculture, and the EPA to
prepare our regulations that satisfy everyone\'s first need for safety.

Let me talk a little bit about proposed upgrades to Ames and Plum Island
facilities. Since I\'ve got you here, you get to hear the sermon.

As you can see, our agency is doing a lot of good work across the
country in conjunction with ARS, the CDC, FDA, and other agencies.

To further this good work we have undertaken two important initiatives
that will improve our diagnostic research and vaccine evaluation
capacities.

These two initiatives will strengthen our relationship with ARS and
allow us to provide even more support to their research efforts into
animal production and food safety issues.

Currently our two agencies are developing plans to construct a
world-class facility for biocontainment research, diagnostics, and
vaccine evaluation in Ames. ARS budget for fiscal year 2001 includes a
request for \$9 million to begin designing this facility.

Plans include the construction of a laboratory building to be shared
between ARS and APHIS, renovation of our current National Veterinary
Services lab. And our Center for Veterinary Biologics will be used as a
joint administration building, and construction of joint animal
biocontainment facilities would occur.

This new construction would strengthen our readiness for possible animal
disease outbreaks, a threat to us all, and improve customer service and
enhance the overall lab environment.

USDA is also considering upgrading the biosafety level at the Plum
Island Animal Disease Center. Some of you have read about this in the
paper.

The center is the only place in the United States where scientists can
conduct research and diagnostic work on highly contagious exotic animal
diseases.

The facilities on Plum Island currently operate at the Biosafety Level
3. This means that they are equipped to handle microorganisms that are
highly contagious to animals and could cause them serious illness or
even death.

The proposed upgrade of the facilities at Plum would allow us to conduct
research and diagnostic work on Biosafety Level 4 agents that affect
both humans and animals. By definition, the Level 4 agent is a dangerous
or exotic agent that poses a high risk of life-threatening disease for
humans and for which there is no cure or vaccine.

However, I must point out again that we would only work on those Level 4
agents that can affect both humans and animals. Such an agent would pose
a serious threat not only to our ag industries, but also to human
populations.

We would not work on Level 4 agents that infect only humans, such as
Ebola. That\'s best done at Atlanta or at USAMRID.

The proposed upgrade would improve our ability to evaluate the impact of
emerging or foreign diseases and develop new strategies for disease
diagnosis, prevention, and control. This in turn would enhance animal
production and food safety efforts.

In conclusion, the prevention and detection of animal diseases, even if
they\'re not transmissible to humans, helps to ensure a predictable and
safe food supply.

Our agency stops problems before they start through a variety of
programs, most notably our veterinary services program on both Ames and
Plum Island.

However, I would like to point out ‑‑ and it was only touched upon by
one other presenter ‑‑ there is an increasing threat from wildlife
populations, whether it\'s birds and Avian Influenza and New Castle
Disease, whether it\'s Hog Cholera in the swine industry, Foot and Mouth
Disease, and a number of other agents that are easily transmitted from
foreign animal populations.

And whether it\'s coincidence or whether it\'s something we can expect
to see, the outbreaks of Foot and Mouth Disease in South America which
we expected would be free of Foot and Mouth Disease in the relative next
few months are not going to happen.

We also see more and more Foot and Mouth Disease in countries
surrounding and in China. So all of the countries, Malaysia, Taiwan,
Korea, China, Russia, everything around China seems to have Foot and
Mouth Disease all of a sudden.

We\'re also worried about the United Kingdom, where Classical Swine
Fever or what we know as Hog Cholera has popped up, and it\'s been
relatively absent in the United Kingdom for a long time. We\'ve got a
lot of spare ribs that used to come into this country until a couple
weeks ago from the United Kingdom.

And don\'t discount Cuba. It\'s only 90 miles away. The small boat
traffic is almost uncontrollable no matter what you do. Don\'t ask me.
Ask ATF and DEA.

But all of these are threats to our animal industry. And even though
it\'s an animal pathogen, it\'s got to be wholesome before you can put
it on the table.

Thank you.

(Applause.)

DR. THALER: Okay. And our next speaker again is Dr. Stephen Sundlof
again, who has already been introduced, so I won\'t do that again.

He is going to speak on the importance of sound scientific research to
support animal production food safety decisions. And it will just take
him a moment to get hooked up here.

(Pause.)

DR. SUNDLOF: Well, thank you. And I want to thank especially Dr. Masters
for trading places with me. I do have a short connection to my airline.

I also want to say thank you to John Shide \[phonetic\], who has been
instrumental in putting together my presentations for today.

And again I want to compliment the people who have put this program
together. It\'s truly an excellent program, and the attendance is
wonderful.

I want to talk about some of the interesting scientific issues.

We see in the paper a lot about the negative parts about food safety,
the threat of food safety incidences.

And I want to talk about some of the other kinds of science that we\'re
seeing that is at least coming through the FDA on an everyday basis.

I want to talk about some of the interesting advances in science that
are being presented to us. Not all of this is on food safety. But just
to kind of give you a flavor for the things that we are starting to see.

These are some of the things that FDA is faced with having to come up
with the scientific expertise to start regulating in some of these
areas.

This is a polymer scaffold on which they are growing live endothelial
cells now. In the future we will be growing our own tissues. And some
interesting work has already been conducted. It\'s not too far off where
we\'re going to be able to grow some of the tissues that we need for
replacements in people.

FDA\'s building, the one that I\'m in, is actually in the shadow of
Solara, the company that, along with the human genome project, has now
unraveled the expressed human genome.

And all kinds of wonderful things and interesting things are going to
evolve from this. And we\'re already seeing being able to screen
patients who have genetic deficiencies. We can look at how drugs
interact with these people.

We\'re going to be looking in the future about ‑‑ this will be an active
area for food safety research. All kinds of interesting things will be
coming as a result of our understanding of the genome, and I think most
people recognize that.

Other interesting things that have just happened within the last few
months: We\'re starting to see things like robotic surgeries where the
physician is in a different city from the patient, and yet, through
these approved products and procedures, are able to do intricate
surgical procedures through the use of these medical robots.

And even more futuristic now is the nanotechnologies. We\'re starting to
see these nanomachines, extremely small microscopic machines that
actually can move around and do things.

This is a nanobot. It is not a real product yet. But in the near future,
we\'re going to be able to develop these machines that will actually be
injectable, and they can roam around in your body and report out good
information to the physician.

So all kinds of interesting things that are happening as we see a
convergence of all these new sciences, the genomics and proteomics and
information sciences and biochemistry and a lot of different things all
of a sudden starting to coalesce and give us these wonderful products
that we\'re going to have to somehow figure out how to regulate.

Because oftentimes the science that goes into making these things
possible is not the science that allows us to make determinations as to
whether they\'re going to be safe or effective for their intended
purposes.

Here\'s one that\'s been developed recently in FDA, I think with some
outside help, as well. But it\'s the Fresh Tag Biosensor. This is a food
safety issue.

And you can put this biosensor on a package that\'s used now for fish,
and if you get a reading of 4, 3 to 4, you know that that fish is not
safe to eat anymore.

So now we\'re starting to see real sensors. And these things are
becoming economical enough that you can actually put these on the
package, and they will give you some indication about the freshness of
the product and the wholesomeness of the product.

Okay. Last, and again back to the genomics issue. These are some of
these DNA array microchip technologies that are quickly being developed.

Within about the next year or two, we will be able to see the entire
genome being placed on a microchip the size of a postage stamp. And the
limits are just about boundless about all the different things you can
do.

And of course the human genome will be shortly followed by many of the
animal genomes. So again an area where we\'re going to see lots and lots
of things happening in the future.

Again, these kinds sensors can be used for disease diagnostic purposes,
for food safety, for bioterrorism, for epidemiology, all kinds of
interesting things. We can also look at gene sequences, in my case, for
antimicrobial resistance.

So what are the public\'s expectations in light of all of this new
science and technology that they\'re being confronted with?

And our Commissioner has said that the public trusts the FDA to
safeguard their health by making timely and credible independent
scientific judgements, no matter how complex the circumstances.

And as I talked about a little this morning, we are constantly trying to
catch up with all of this new science that\'s being presented to us, and
we\'re constantly looking for outside help to help us make these kinds
of very, very important decisions from the public\'s point of view.

Dr. Woteki talked about this at lunchtime, at least two of these
surveillance systems. We\'re recognizing how important it is to have
good surveillance systems for foodborne diseases.

She talked about Foodnet and Pulsenet. And there\'s another one up
there, NARMS, the National Antimicrobial Resistance Monitoring System.

Without these kinds of systems, without these kinds of on-the-ground
intelligence systems out there for surveillance, from a regulatory
standpoint we\'re basically flying blind. We don\'t have any idea of
whatever regulatory action we might take.

What is the outcome of that? If you don\'t have some way of monitoring,
continuously getting feedback and information back from the actual
field, you don\'t have much of a food safety program.

So sometimes these are not as glamorous as some of the other new
sciences coming out. But they\'re absolutely critical in our ability to
do our job in protecting the public.

Foodnet is the foodborne disease active surveillance network. And its an
active system gathering information from patients, actual human
patients, in catchment areas around the United States that represents 10
percent of the population.

So Foodnet presently samples from about 10 percent of the population to
give us a fairly good sampling of what is actually happening in terms of
foodborne diseases.

As Dr. Woteki mentioned, it is growing, so that there will be new active
surveillance sites as time goes on taking into account more diseases,
getting better information from the patients to try and link that back
to the source and the practices that may have caused that disease.

The goals of it is to describe the epidemiology of new and emerging
bacterial, parasitic, and foodborne pathogens; estimate the frequency of
foodborne diseases in the United States; and determine how much
foodborne illness results from eating specific foods such as meat and
poultry and eggs.

The other exciting area, and one that does take advantage of the new
science and biotechnology, is Pulsenet. And Dr. Woteki also talked about
that.

It\'s a national computer surveillance network of public health
laboratories developed by CDC in conjunction with FDA and USDA and state
health laboratories.

And it uses DNA fingerprinting in order to make the connections between
foods and the disease caused in people.

So if you see, this is a pulse gel electrophoretogram. You can see that
the two lanes on the, I guess it would be on your left side, pretty much
match up.

The first one is from a patient; the second one is actually from ‑‑ this
is Salmonella Agona from cereal, from a commercially prepared breakfast
cereal, which is not a place you would normally think of looking for
salmonella, but there it was.

The third lane is an isolate that is not related to the two. So you can
see how these two match up.

The interesting thing is that this is all Internet based so that anybody
at a Pulsenet site around the country can scan their gel into the
system, and it will match it up to any other gel that\'s in the system
from anywhere in the country.

And this has been instrumental in making some outbreaks of as little as
two people. You can have outbreak detections with as little as two
people coming from different states or even from across the ocean. So,
amazing system.

This is a CDC slide that Joe Lovett \[phonetic\] from Sissan
\[phonetic\] likes to use a lot. And it\'s kind of a what-if. This is a,
What if we would have had Pulsenet back in 1993, when we had the
Jack-in-the-Box incidents with E. coli 0157:H7?

As it turned out, we had 726 cases back in 1993 because we didn\'t
understand the outbreak at the time.

If we had had Pulsenet, it\'s estimated, in hindsight, that there would
have only been 235 cases of E. coli 0157.

So having this technology and looking at it in these kinds of what-if
situations really gives you a flavor of how much we\'ve accomplished in
really a relatively short period of time.

NARMS is the National Antimicrobial Resistance Monitoring System. And
again, it is a collaborative program with the Centers for Disease
Control using Foodnet.

It\'s also a collaborative association with USDA looking at their
slaughter samples through the HACCP programs and trying to find out
where antimicrobial resistance is, measuring it in animals and also in
the public. And you can make that association.

We\'re using NARMS in order to set a regulatory course for dealing
antimicrobial.

Science and risk assessment: I talked earlier this morning about the
importance of risk assessment, that this is a more ‑‑ it\'s a less
subjective way of analyzing information and making sound regulatory
decisions.

It still is in I would consider it to be a very rudimentary state. As we
learn more about risk assessment I\'m sure our risk assessment models
will get a lot better.

But even now, even in their infancy, they are providing us with a much
better picture of what is causing foodborne diseases.

And here are just some examples of how these are being all done through
the regulatory agencies.

And we have microbial. Dr. Woteki talked about E. coli 0157:H7 risk
assessment. There\'s also a Salmonella enteritidis risk assessment
that\'s been conducted. Listeria monocytogenes, which she also
mentioned, will be released fairly soon from Sissan.

We recently have completed a campylobacter risk assessment looking at
the incidence of resistance to fluroquinolones and campylobacteriosis in
humans.

In addition to microbial risk assessments, which I maintain are the most
difficult to conduct, there have also been recent risk assessments on
dioxin, mercury, and other agents such as BSE.

So risk assessments are becoming part of the landscape for regulatory
work.

Our campylobacter risk assessment that I mentioned earlier looks at
basically chickens that were given a fluroquinolone antibiotic and
developed fluroquinolone-resistant campylobacter, and what is the impact
on public health?

And the impact that we\'re looking at is people who have
campylobacteriosis are prescribed a fluroquinolone to treat the disease
and don\'t respond to the treatment. And we estimate somewhere around
5,000 people per year are affected by that.

And we can just go on from there. A little cartoon that\'s come up
lately: Sometimes I hate being an antibiotic. What doesn\'t kill me only
serves to make me stronger.

And that\'s one of the real problems that we face, is that the microbes
seem to have a mind of their own.

An area that we\'re rapidly becoming more and more engaged in is the
area of transgenic animals. And this is the kind of ‑‑ you heard about
eggs being the poster child for food safety. Well, this is the poster
child for genetically modified animals.

And this shows a salmon and its sibling, virtually, being born or
hatched on the same day. But one of them has been transgenically
modified to insert growth hormone genes. And so this fish is producing
growth hormones at a faster rate than the one on the bottom.

And the results of that are very, very impressive. And it\'s hard not to
get excited when you\'re a fish producer and you see the kinds of
benefits that modern biotechnology may be able to provide.

But it raises all kinds of public issues, the Frankenfood, and
Frankenfish in this case. You\'ve all heard about it.

So fish are the first transgenic animal that we\'re having to deal with
at the FDA. But there are a number of other ones that we\'re sure are
coming because the industries are in there talking to us about pigs and
chickens and other animals that are now being genetically modified.

And we must as regulators be prepared to apply science to determine
whether a product produced by biotechnology is safe, not an easy thing
to do.

First of all, we have to determine, Is it different? Is that food
different from the food that would be derived from an animal that
wasn\'t genetically modified? Will inserted genes turn into silence
genes or block needed genes?

There\'s all kinds of questions about, once you insert these genes, how
do you know what\'s going to happen? How do you know if they\'re going
to affect other genes or turn into something that has unintended
effects?

And so there\'s a lot of interesting very technical scientific questions
that we don\'t have all the answers to yet. But we\'re rapidly attacking
some of these issues.

Biotechnology can simply provide alternative methods to deliver a drug
substance to animals. That was the case of the transgenic salmon.

We have approved BST, bovine somatotropin, for cattle as a drug. Now
that you\'ve put the genes in the animal to create the growth hormone,
we\'re trying to regulate that also as a drug, and it seems to make
sense for us.

For us it\'s just another drug delivery system. And we have to make
sure, again, that all of that is safe.

In terms of transgenic animals, we\'re really looking at two different
kinds of biopharm animals. There\'s been a lot of efforts and now some
products coming to market from food animals that are genetically
modified to produce pharmaceutical drugs.

What happens to those animals once they\'re no longer little drug
factories? Where do they go?

Well, the FDA has to answer those questions. Can they may be used in
animal feeds? Can they be used for human feeds? What about the animals
that are considered no-takes, in other words, you tried to genetically
modify them, but it didn\'t work? Are those animals safe to go into the
food supply?

So we\'re constantly being asked to address those questions as to
whether or not those animals can be eventually used as food or animal
feeds.

The ag biotech ones I\'ve already talked about. Those are animals that
are genetically engineered to either resist disease or produce a
pharmacologically active substance or grow faster or knock out some gene
that prevents growth, a lot of different things. So they all have food
safety implications.

And a lot of our future, we believe, is going to be trying to address
some of these very difficult issues.

But we believe that science will always underpin everything that the
federal regulators do in food safety. We are committed to staying on
that path of science and that the future of food safety must be built on
that kind of science in order to provide the public with the assurance
that it needs to feel safe about the food supply.

So, thank you very much.

(Applause.)

DR. THALER: Next I want to introduce Dr. Barbara Masters. She got her
Doctor of Veterinary Medicine from Mississippi State University and did
a food animal internship at Kansas State University.

She has been with the Food Safety and Inspection Service for eleven
years and is currently the director of the slaughter operations staff at
the technical service center in Omaha, Nebraska.

The slaughter operations staff provides services related to all aspects
of meat and poultry slaughter, pathology correlations, and residue
information.

And she\'s going to talk some today on the FSIS implementation of the
National Residue Program.

DR. MASTERS: Good afternoon. I, too, appreciate the opportunity to be
here. I\'m not sure if Mr. Pope is a harder person to follow or Dr.
Sundlof.

I certainly have nothing as exciting as nanobots or little stickers you
can put on your fish to get 4s and not eat them. I think that\'s pretty
cool.

But I am pretty excited about my topic, our National Residue Program.
And I think it provides an excellent example of exactly what we heard
about at lunch today.

And it\'s an example of a good cooperative program that requires
cooperation amongst all the federal agencies, as well as the industry,
as well as the animal production folks. So I think it\'s a good example
of a lot of cooperation.

I want to talk about some of our current initiatives and some of the
things we\'re working on for the future. But to get there I wanted to
provide at least an overview of our National Residue Program so that we
would all kind of be on the same page as I talked about some of the
things that we\'re moving to in the future with our National Residue
Program.

Basically what we do within FSIS is we test meat, poultry, and egg
products for violative residues from pesticides, animal drugs, and
potentially hazardous chemicals.

Under HACCP, that is now mandatory in all of our meat and poultry
establishments, the industry has become responsible for preventing
violative residues in their products.

If violative residues are considered reasonably likely to occur in their
operations, then they must address drug residues in their HACCP plan.

That certainly does not mean every establishment out there has a
critical control point for drug residues. That is going to depend on the
type of animals they slaughter and the incidence of drug violations in
those animals.

We\'ve had a good example in some of our cull cow establishments, where
in fact they do consider drug residues reasonably likely to occur, and
they have addressed those in a critical control point at the receiving
step in their process.

They then rely on information feedback and education to the producers to
ensure that they don\'t get repeat violators bringing those animals back
into their establishment.

They send letters to those producers when they get violative drug
residues.

They provide that information to our agency, which in turn could be
provided to the FDA so that cases can be written up on these producers
to ensure that we\'re all working together to help this producer
understand the responsibility they have in bringing animals that are
free from drug residues to the slaughter establishment.

Our National Residue Program basically is designed to provide us a
structured process for identifying and evaluating compounds of concern
by production class.

I think Dr. Wolf talked about, for example, in sheep Antalmentix might
be a bigger concern than antibiotic residues.

So we try to look across the production classes and make some assessment
of which drug residues we should be testing for in the different classes
of animals.

We also have a program that is intended to be designed to provide us the
capability to analyze for those compounds of concern.

We want to ensure that we can have appropriate regulatory follow-up, as
well as having a system to provide for collection, analysis, and
reporting of that data.

I put in a little bit of information on residue violations from 1/99
through 11/30/99, so almost the entire year last year, for 1999.

And I did that because I wanted to demonstrate that, in spite of all the
excellent work that we heard about this morning with these on-farm
quality assurance programs, there\'s still work to do.

There is still a level of residue violations that we are picking up at
the slaughter establishment level, primarily in dairy cows, but also in
some of the other classes of animals. So a lot of good work going on,
and a lot more work to do.

The regulatory component for residues is in fact a shared responsibility
across the spectrum of federal agencies.

The Food Safety Inspection Service works very closely with the FDA, also
with EPA, GIPSA, and the state governments in enforcing our National
Residue Program.

To kind of give you a little better sense particularly on FDA and FSIS
and their roles, FDA plays the primary role in determining drug dosages,
routes of administration, duration of treatment, withdrawal time, and
residue tolerances.

So when FSIS in fact detects a residue, it is in turn determined how
much of that residue exists, and that is then compared to the residue
tolerance that has been set by FDA. If it exceeds the tolerance by FDA,
that is when an enforcement action will take place.

The enforcement by our agency goes towards the establishment that is in
fact slaughtering animals with residue violations. The information from
our agency is also turned over to FDA so that FDA in turn can write up
cases on these producers.

I think we learned from Dr. Sundlof this morning that they primarily
start with information and education to a person that has presented a
violative animal, and then after that move through the enforcement
levels, all the way up to imprisonment for in fact producing animals
with violative drug residues.

At FSIS, our National Residue Program consists of several different
types of testing programs. We have monitoring testing, contamination
response, special projects and surveillance, and enforcement or
inspector sampling.

Our monitoring program is our random sampling. We in fact look at
healthy animals, randomly select those animals, and try to get some
sense of the level of violations that are occurring for particular
compounds throughout a year\'s time.

Those animals are randomly selected based on directions to our
inspection personnel to take those samples from a healthy animal to give
us some sense of whether or not those residues are occurring in healthy
animals.

We do pick up a very low level of violations through our national
monitoring program, and that again does give us a sense of what kind of
violations we\'re getting in particular compounds.

Special projects are more information gathering studies. They might not
be conducted for 12 months, for example. They might be done where we
don\'t have precise slaughter volume data. We might in fact do them
where we don\'t have violative levels set, or we could even do them to
develop information on the frequency and concentration at which residues
occur.

Surveillance sampling is actually a type of a special project, but it\'s
a little more defined in that it\'s actually a targeted sampling with
the intent to distinguish compounds where we have residue problems
existing, measure the extent of the problem, and evaluate the impact of
actions taken to reduce the occurrence of the residues.

I want to talk about one example of a surveillance project.

Very timely, I spent yesterday putting gel packs into sample boxes to
ship out to the field. We are starting a Phenylbutazone cull cow
surveillance project. It is an example of a surveillance project that
was started by our agency due to potential abuse of Phenylbutazone in
food-producing animals.

Phenylbutazone, as we all know, is a compound that is not permitted for
use in food-producing animals. We have considerable concern about the
use of this compound in animals because it does in fact cause a
potential public health concern where there is a residue.

Because it\'s an illegal compound to use in food- producing animals, any
level that is found in these animals is considered violative, and that
carcass would be condemned.

We did a pre-pilot study to get some sense of how we might in fact go
out and do this special project.

In that pre-pilot study, we looked at about 285 animals, and we did
detect Phenylbutazone violations at about 2.8 percent, which is a fairly
high percentage of animals that in fact did have Phenylbutazone in their
system, and those carcasses were condemned.

That has a direct impact on our agency in trying to protect public
health, it has a direct impact on those establishments slaughtering
those animals from a cost perspective, and certainly an area where the
people that are producing animals can have a direct impact in stopping
that residue from occurring.

So I wanted to point that out because we will be starting that project
next week. Very timely, and a very good example of how animal production
does play a direct role in what we are doing from the Food Safety
Inspection Service.

Our enforcement sampling or inspector generated sampling is that
sampling that is done at the inspection establishments in which the
inspector detects some abnormality either on antemortem or postmortem
inspection or based on a herd history.

They also will take inspector generated samples as a follow-up when
animals are marketed by a producer that had a previous residue
violation. And they also do drug residue testing to verify industries\'
HACCP programs.

I do want to comment that, in regards to our follow-up on animals where
we do testing on these animals, our agency very recently received a
request that was signed by five major trade associations requesting that
our agency consider working hand-in-hand with FDA to provide a repeat
violator list that would in fact provide the names of those violators
confirmed by FDA.

And that our agency would put those confirmed violators on our Internet
for public access so that the establishments would have access to the
names of individuals that were repeat violators so they can make more
informed decisions in purchasing of that livestock.

The agency has a small work group working on a response to that request,
and we expect to have a response very soon.

But I think it\'s a fairly significant request by the industry to make
that information public so that they can in fact make very informed
decisions in regards to their HACCP program.

From the technical service center, where I am located, some of the
initiatives that we\'re working on:

We are currently doing pathology residue correlation sessions, trying to
emphasize uniform application of our cattle residue testing program.

We recently, in the last year or so, made some changes to our residue
testing program.

It was brought to our attention by one of our very astute inspectors in
charge that they were finding higher levels of drug residue based on
postmortem pathology findings than they were based on the antemortem
findings that we in the agency had traditionally used to select
carcasses for residue testing.

We implemented a notice that described those conditions that our
inspectors should be looking for to do residue testing.

And since we did not have training for that, we instituted these
correlation sessions at the tech center where we bring in animal tissues
and correlate with our veterinary medical officers to help them better
understand which animals we believe are most at risk for violative drug
residues.

In addition to that, we are in the process of completing a report on the
National Residue Program, and we titled it, Uniform Application in Cull
Cow Plants.

Basically we\'re developing this report in an attempt to ensure that we
are, in fact, uniformly applying our residue program in the cull cow
plants.

In response to doing these correlations, we started wondering, How
effective are our correlations? Are we in fact uniformly implementing
our program? Is our correlation effective in helping us to do that?

We began this project the week of July 12. We have a final draft due to
Headquarters within 90 days of starting the project. And if you have
your calendars out, you can quickly calculate that I have a draft report
due to Headquarters next Monday.

And that will go through a clearance process. And then we will have a
public report that will document our findings from the survey.

Basically we got a group together that tried to come up with the
questions we would ask to determine whether or not we were uniformly
applying our program. We developed survey instruments, and sent a team
of folks out to go into some of the top 40 cull cow plants to do some
actual on-site visits.

They interviewed the veterinary medical officer, they observed the
veterinary medical officer performing the screening tests, and they also
observed the veterinary medical officer select those carcasses that they
believed to be at risk for drug residue.

They recorded their responses, and we are in the process of evaluating
those and formulating some recommendations to our Headquarters
management on some things that we think might be appropriate to ensure
that we are in fact uniformly implementing our residue program.

Some of the things our policy office is working on related to drug
residues is they are working on some initiatives to implement a target
tissue market residue policy. It\'s been in the news a lot lately.

Basically what they are considering is implementing a policy that would
in fact require the condemnation of carcasses based on target tissues.

Currently within FSIS we test carcasses through a screening test at the
in-plant level. If there is a positive on the screening test, then there
are tissues sent to our laboratory for confirmatory analysis.

We at our agency will currently test both the target tissue, which might
be, for example, the kidney, the liver, and we will also test muscle
tissue, and we will use both of those to look at FDA tolerances.

FDA regulations currently set target tissues as a means of determining
whether edible tissues should be used. Their target tissues are
typically things like the liver, kidney, or fat. And basically if the
level of drug residue is exceeded in the marker or target tissue, that
would result in condemnation of the carcass for edible food.

So that\'s one initiative that our policy office is considering.

And the other initiative that they\'re working on is publishing a
[Federal Register]{.underline} notice and holding a public meeting to
really discuss the effect of full HACCP implementation on our residue
program.

I talked about one example that\'s been very effective in a cull cow
establishment related to dealing with drug residues.

But I think we all recognize the difficulty when we hear the animal
production folks talking about drug residue avoidance in their quality
assurance programs, you hear the industry talking about trying to
address it through their critical control points in their HACCP plans,
and we as a federal agency working in conjunction with our other
agencies to enforce it.

It really is a multi-pronged approach, and there\'s a lot of discussion
that we believe needs to take place on that topic.

So we hope to hold a public meeting in the near future so that we can
all discuss it and come up with the best policies to ensure that in fact
we are considering residues appropriately in a HACCP environment.

I hope, in summary, that you can understand FSIS\'s role in the National
Residue Program and some of the challenges we\'re going through in
ensuring that we\'re in fact uniformly implementing our program.

I hope you also understand the challenges to the animal production side
and that, to really produce the safest food possible, it does require
the animal production folks implementing the quality assurance programs
that we heard about this morning, the industry addressing drug residues
and ensuring they\'re only accepting those animals free of drug residues
to in fact ensure that we do have safe food available.

I appreciate your time, and I\'ll be available this afternoon for any
questions. Thank you.

(Applause.)

DR. THALER: All right. Moving on, I have to point out that Dr. Eileen
Kennedy was unable to be with us, so Dr. Jerry Gillespie has offered to
be the moderator from here on. And he\'ll be starting with food safety
research in support of animal production practices.

DR. GILLESPIE: Those of you who know Dr. Kennedy know that she is very
disappointed that she could not be here. And those of you that know her
know how dedicated she is and what an asset she is to have as a leader
in the area of research, education, and economics in the USDA.

Now, she has provided a message for the group that, because of time
constraints that we now have for the session, I will simply capsulate,
because many of the points that she has raised in her text I think have
been covered.

And in essence, she sends, first of all, her best regards to all of you
and congratulates your participation in this program. And she also
highlights some of the progress, as other speakers have, that has been
made between this and the previous meeting of this sort. And she also
predicts that we\'ll be doing this again to continue to monitor our
progress.

And finally, she wishes the sessions good success, which again I know
that she sincerely means. And I\'ve had the pleasure of getting to know
her well, and again I want to emphasize how lucky we are to have someone
so dedicated to the research enterprise.

What I\'d like to do is move on to our next speaker, who is Dr. David
White, who is going to speak to us about antibiotic drug resistance.

Dr. White has traveled from Massachusetts through Vermont, Kentucky,
Penn State, Tufts, North Dakota State University, to his present
position. And in 1999 he accepted a position as a senior research
microbiologist for the Office of Research Center for Veterinary
Medicine, FDA.

The purpose of his research program at CVM is to collect and scrutinize
data concerning the prevalence of multiple antibiotic resistance among
various bacterial pathogens, certainly a very timely, very important
area.

And I would like now to invite Dr. White to the podium to make his
presentation.

(Applause.)

DR. WHITE: I think a few things came unplugged when my boss had his
spill up here before, so we have to replug everything in.

(Pause.)

DR. WHITE: Well, a pleasure to be here, and I\'m sure right about this
time everyone is having that post-lunch tiredness right now. So I\'ll
try to move this along.

I\'ve been working in this field for a while in antibiotic resistance,
and it\'s pretty ironic that I have, because I found out a few years ago
from my mother that I had meningitis when I was about two years old, and
the only thing that saved me was penicillin.

So it\'s very ironic that ‑‑ I wish I could say that I knew at two years
of age that I was going to go into this field. But it is ironic that
I\'m back into this. And I want to kill these little buggers to make
sure they don\'t do the same thing to somebody else.

Now, antimicrobials have been around for over 50 years now. They came
into commercial use about 1945, near the end of World War II. And they
were considered miracle drugs. They were also haled as the magic
bullets.

When antibiotics were introduced, they seriously decreased morbidity and
mortality associated with many infectious diseases where, at that time,
if you came down with it, the only solution was to pray and hope you got
better. There was no treatment whatsoever.

As you can see in this picture from World War II, Thanks to penicillin,
he will come home.

However, what we\'re seeing more and more these days is pictures like
this on both laymen\'s journals and scientific journals. And what we\'re
seeing is that the efficacy of antimicrobials is dwindling down rapidly.

We have reports now of bacteria that are only susceptible to one
antibiotic, that\'s it.

If you\'ve heard of the acronyms VRE or MRSA, they stand for
Vancomycin-resistant enterococcus and Methicillin-resistant staph
aureus.

In some of these cases, these bacteria are resistant to almost every
single antimicrobial we have. So it\'s almost returning back to a
pre-antibiotic era where, if you do come down with that in a bacteremia,
the only way to survive is to pray.

Now, resistance is not a new phenomenon. If we remember back to our
introductory biology class and remember about Dr. Charles Darwin, the
origin of species, it\'s a process of natural selection, survival of the
fittest.

In any population of cells, be it bacterial or eucaryotic, there\'s a
small proportion that have mutations. It\'s intrinsic.

It\'s estimated in bacteria, for instance, that are resistant to
quinolones that one out of 10^7^, 10^8^ organisms is naturally
resistant. That\'s just the mutation rate. So resistance can happen that
way.

We also have antimicrobial resistance that is due to intrinsic
resistance. And what that means is that the bacteria are normally
resistant to that drug.

For instance E. coli, salmonella are intrinsically resistant to, say,
erythromycin, and that\'s because the drug can\'t get through the LPS of
the outer barrier.

We also have external acquisition of resistance genes. And this is where
we\'re seeing more of our resistance coming from, is the acquisition of
DNA on mobile transmissible elements.

And the way to think about this, believe it or not, is bacterial sex.
They can exchange genes all over the bacterial genera. It\'s not anymore
from E. coli to E. coli; it can be from E. coli to enterococcus, believe
it or not. They don\'t really care what that other bacteria is they\'re
giving their genes to.

Now, we can also have selection of resistant variants from within an
animal within a patient. So what this means is that we have a
preexisting pool of resistants, maybe a small percentage of the normal
flora. But when you are confronted with selection pressure, we kill off
the susceptible bacteria, and your resistant bacteria overgrows.

And lastly, we can have cross-infection, which another term would be
nosocomial infections you may have heard in the hospitals, where you go
in there for, say, a knee surgery, and you come down with enterococcus
bacteremia. You acquired that in the hospital.

Now, what\'s amazing is, though, even though we have hundreds of
antibiotics in both human and veterinary medicine, they only work by
inhibiting one of four steps in bacterial growth. That\'s it: one of
four steps.

These include inhibiting cell wall synthesis of the bacteria, and the
drugs that are most known to do that are the betalactiums like
ampicillin, penicillin, bacitracin, and vancomycin.

Those antibiotics that inhibit some type of step in nucleic acid
synthesis are the fluroquinolones like superfloxicin or efampin
\[phonetic\].

The antimicrobials that inhibit some type of step in bacterial growth.
That would be the sulfa drugs like sulfamethoxazole and the potentiated
sulfonamides, trimethoprim sulfa.

Lastly, the greatest number of antimicrobials that we have are aimed at
inhibiting some step in protein synthesis of the bacteria. And these are
the amino glycosides, your phenicols like chloramphenicol and
fluoramphenicol, tetracycline, macrolides, glucosamides, streptogrammins
\[phonetic\].

So it\'s amazing, though. Like I said, there\'s all these
antimicrobials. They only work by inhibiting one of these four steps.
And how they do this, remember, is a concept called selective toxicity.

We\'re trying to find a drug that exerts its effect on a procaryotic
cell but leaving our eucaryotic cells alone. So over time what\'s
happened is bacteria have evolved ways to circumvent the activity of
antimicrobials.

And just like the antibiotics have four main mechanisms of action,
bacteria circumvent the effects of antibiotics by one of four ways.

One is through inactivating the antibiotic. And this is how bacteria
survive in the presence of betalactiums, aminoglycosides,
chloramphenicol, and streptogrammins, is they produce an enzyme that
either inactivates or degrades the antibiotic.

We also can have alteration of the target enzyme or the target binding
site. And this is usually due to mutation.

For instance, the fluroquinolones are due to mutations. One base
permutation in the DNA gyrus gene is enough to allow bacteria to survive
in increased concentrations of the drug.

We also have now more cases of reduced cellular uptake and active
efflux. What\'s happening here is the cell has these mechanisms turned
on where the antibiotic can\'t get into the cell anymore, and if it
does, it\'s pumped right back out, like a sump pump in your house. So
the drug never reaches its target.

Just to show you an example, here\'s a bacterial cell, and in white is
something called a plasmid, which is an extrachromosomal DNA element.

Most of the time we have a lot of resistance genes on here. In this
case, we have three genes of different color, green, purple, and yellow.

The green gene here on this plasmid encodes an efflux pump. So what
happens, here is our antibiotic trying to get into the cell. When this
efflux pump is made, it just pumps it right back out, so the drug never
reaches its target.

In purple here we have a gene that, say, encodes an antibiotic-degrading
enzyme. As the antibiotic gets into the cell, this enzyme chews it up,
making it ineffective.

And lastly, we can have a gene here that can be an antibiotic-altering
enzyme. This is like through adenotransferase or acetyltransferase,
where they add a group to the antibiotic, rendering it ineffective.

And you can see in this case there\'s three. And this will be a point
I\'ll make later on, is that multi-drug resistance is the rule these
days rather than the exception.

Now, when we\'re talking about potential transfer of antimicrobial
resistance determinants, you have to remember that all of the ecosystems
are linked, be it agriculture, veterinary medicine, or human medicine.

And if we\'re going to do something to stop this resistance development,
we\'re going to have to take steps in each one of these three areas
because they\'re all linked. As you can see, the arrow goes both ways.
It\'s not solely from animal to human. There are cases actually of going
back from human pathogens infecting animals.

And agriculture is not an area that we\'re going to really touch on. But
they use quite a bit of Streptomycin as a spray to treat bacterial
diseases of plants.

So in terms of our focus at CVM and a lot of other people in this room,
as well, what are the potential consequences of antimicrobial use in
animals?

And as we know, this is not a new issue. It actually first raised its
head in 1969 with the release of the Swann report in Great Britain.

If you can go back to that initial report and take out some quotes, and
if I put it up on the screen here, you would think they were something
that we talked about today, but they\'re actually almost 30 years old.

First, one of the consequences, of course, increase in the prevalence of
resistant bacteria.

Secondly, transfer or these resistant bacteria, be it pathogens or
commensals. And the commensals is fairly new. We\'re starting to think
about commensal bacteria as potential reservoirs of resistance genes. So
even though they don\'t cause disease, they still carry like suitcases
the resistance genes that can transfer to other bacteria.

And this transfer is either via direct contact with animals or through
consumption of contaminated food or water.

We then could have transfer of the bacterial resistance genes to other
bacterial genera and species inside us. We then see an increase in
incidence of human infections caused by resistant pathogens, and lastly,
potential therapeutic failures in animals and humans. That\'s the
scenario we have to follow.

Now, when you try to look at this and say, Yes. Indeed this resistant
salmonella we have came from an animal or this resistant enterococcus
came from an animal, there are certain things we have to follow.

And first of all, we have to determine if the genes are identical or
not. And we do this by either DNA sequencing a gene or determining the
genetic organization of the resistance determinants. Before we can make
any claims, we need to make sure that those genes are identical. If
they\'re separate genes, well, they\'re separate.

So we need to do a little bit of molecular biology to determine the
relatedness between an animal strain and a human strain.

Next we also have to determine if we can transfer it, because that\'s
one way how we want to see a resistance occurs is to transfer it between
a resistant bacteria and a susceptible bacteria.

And usually it\'s in vitro, meaning we do this in the laboratory. We
take a strain that has, say, a resistance gene on a plasmid, we do a
conjugation study where we actually mix it together with a susceptible,
and we see if transfer occurred.

One thing we\'re lacking, though, is in vivo studies, actually what
happens in the animal. And I think we need some future focus in this
area to see if resistance transfer is occurring inside the animal.

Now, there have been many cases actually of resistance gene transfers
being documented between bacteria of different genera, for example,
tetracycline, in three different cases where they found the exact same
tetracycline resistance gene in very diverse bacteria.

They found the tet resistance gene, enterococcus, which of course is in
both the animal and human intestines. They found the exact same gene in
Streptococcus pneumonia and Listeria gonorrhea.

And how they document this is the same gene, it has 99 percent DNA
sequence identity. So you\'re only talking a couple bases different
between these.

Now, we don\'t know, of course, which way that gene transferred. But
what this does show is that the gene did transfer. We just don\'t know
the direction.

Likewise with erythromycin, which is very interesting. You\'re talking
the RNG gene found in Bacillus verrucas, which is a normal soil
organism. They found the exact same gene in Bactorius fragilis, a
clinical isolate in humans; the exact same gene.

Once again we don\'t know the mechanism of transfer, how it got there or
which way it went. But we know we can document it.

So how are these resistance genes transferring? Okay. There\'s three
main mechanisms how resistance genes can transfer. One, of course, is
through transformation, number one. And this is the uptake of naked DNA.

So what happens, of course, when bacteria die, the release their DNA
into the environment. What can happen is that a cell in the immediate
environment can actually uptake DNA and incorporate it into its genome.

So when people think a dead bacteria is a good thing, that\'s not always
the case, because even dead bacteria can transmit their resistance
genes.

Secondly, we have conjugation. This is plasmid transfer, where we have a
bacteria that has a plasmid that can duplicate it and give it to another
strain that does not have it, but then making that resistant.

This is also known, as we said, bacterial sex, because there has to be a
sex pilus formed between the two. They have to come into close proximity
with each other, and they can exchange resistance genes.

Lastly, they can exchange genes by a method called transduction. This is
via a bacterial virus. Those of you who do not know, yes. There are
viruses that even infect bacteria.

And this is how the shigatoxin supposedly arose in E. coli, is that they
were caught on a bacterial virus that picked it up from shigella and
infected an E. coli, bringing over the toxin.

So these are the three main mechanisms how resistance genes can
transfer.

Now, there is a cycle of antibiotic resistance that I think if we can
interrupt any one of these steps, then we can reduce the impact of
antibiotic resistance.

The first one starts off with a preexisting pool of antibiotic-resistant
bacteria.

And if you go back in the literature, they\'ve actually found
antibiotic-resistant bacteria from glacial ice in the Arctic that
they\'ve dated to over 2,000 years ago. That\'s a little bit before we
invented antibiotics. Also, they\'ve found resistance in preexisting
historical cultures before antibiotics were used.

So antibiotic resistance, like I said, is not a new thing. It\'s out
there. There\'s a preexisting pool.

And one thing to think about is, before we started inventing all these
synthetic antimicrobials, a lot of our antibiotics that were discovered
by the pharmaceutical companies, do you remember where they came from?
They came from soil organisms: Actinomyces, Chlormycetes. So these exist
in the soil. They produce crude forms of the antibiotic.

Well, a lot of our bacteria, of course, exists in this environment, as
well: E. coli enterococcus.

And what they\'ve found is, if you look at some of these resistance
genes over time, and you do a genetic search on them, they actually have
similarity to genes found in the actual antibiotic-producing organism.

Think about it. If an organism is producing an antibiotic, it doesn\'t
want to kill itself, so it needs to have a mechanism to protect itself.

So what\'s happened over time is that those genes have evolved into what
we see today. So there\'s a preexisting pool already out there.

Well, what can happen is this gene gets incorporated onto this plasmid.
Like I said, it\'s a mobile DNA element. Pathogen picks up this plasmid
here. The yellow is the gene.

These bacteria come in contact with some type of selection pressure. And
it doesn\'t have to be an antibiotic, we\'re finding out. It could be a
heavy metal, it could be disinfectant, because I\'ll show you later on
is that sometimes all three of these are all linked together.

So it has to be an antibiotic that\'s selecting for resistance. It can
be a disinfectant or even a heavy metal.

What happens is the selection pressure kills off the susceptible
bacteria. The one that has this gene that confers resistance is able to
divide and proliferate, and the whole cycle starts up again.

So if we can somehow interrupt these steps, we can reduce the impact of
resistance.

So what\'s responsible for the widespread dissemination and diversity of
resistance phenotype small bacteria?

And it\'s really due, I think, to these transmissible elements, these
transferrable elements that can move from bacteria to bacteria, that
confers resistance.

And the three major players are plasmids, transposons, and integrons.
The last two sound like something out of Star Trek. And I\'ll try to
explain these to you in a little bit.

Plasmids I\'m sure you\'ve all heard of. They\'ve been around a long
time. Initially discovered in 1959 in Japan in shigella. Okay. So we\'ve
known about these for a long time.

They were initially called R factors. I think you can take a guess what
the R stands for. It\'s not Ragu. It\'s resistance. Right?

This is an interactive talk. Sorry.

They can possess multiple antibiotic resistance genes. And they are
conjugated, meaning they can mediate their own transfer from a resistant
strain, donating that plasmid to a susceptible strain.

We also have transposons. And transposons, the layman\'s term is jumping
genes. These are segments of DNA that can jump from the chromosome to a
plasmid and from one strain to another. They also can possess multiple
antibiotic resistance genes.

But what\'s interesting about the transposons sometimes is that they
have toxin genes interspersed in between.

So in that case, if you have an antibiotic resistance gene next to a
toxin gene, think about what\'s happening. Using an antibiotic is
selecting for virulence in that case.

These can also move, like I said, back and forth from plasmid to
chromosome.

The last mechanism is something called an integron. And this is a fairly
new DNA mobile element. It\'s been described in the past ten years or
so. And they can possess single or groups of mobile gene cassettes.

And these gene cassettes are interesting. Each gene cassette is an
antibiotic resistance gene.

So far they\'ve found 50 different antibiotic resistance gene cassettes
in these integrons. And they include such diverse resistances as those
to betalactimaces, aminoglycosides, sulfa trimethoprim, and
chloramphenicol resistance.

We can find these integrons on plasmids and chromosomes. They are in
pretty much every gram-negative bacterial species there are. And they
definitely contribute to the dissemination of antibiotic resistance.

Right now they\'ve been grouped into four classes. Class 1, 2, and 3 are
primarily found in the gram negatives like E. coli and salmonella. Class
4 has only been found in vibrio.

Just to give you kind of a simple schematic of what an integron looks
like, there is two conserve segments ‑‑ that\'s what the CS stands
for ‑‑ a five-prime conserve segment and a three-prime conserve segment.

The five-prime conserve segment encodes an enzyme called integrase which
allows for the combination of resistance genes into this fragment.

The three-prime conserve segment ‑‑ now, this is the backbone. Okay.
Every Class 1 integron has this. The three-prime conserve segment has
two genes in it, one called Quack Delta E. This is the gene that
actually confers resistance to quaternary ammonia disinfectants. The
Cell 1 gene encodes resistance to sulfonomides.

So in the backbone of the integron we already have resistance to sulfa
drugs and quats.

And what can happen here is we get insertion of an antibiotic resistance
genes in between these.

And it\'s like molecular flypaper. These integrons can start catching
other genes and put them right next to each other. And I\'ll try to
demonstrate how this happens.

So here\'s our typical integron here. There\'s nothing in between. It
comes in contact with a gene cassette. Okay. This is just a gene here
that confers, say, resistance to chloramphenicol.

And what happens is the gene gets inserted in between the two conserve
segments, and the gene is expressed. So now this bacteria is resistant
to chloramphenicol.

So from the last picture, here is our gene cassette, now with
chloramphenicol resistance. Another guy comes along, another gene
cassette, and what happens, it\'s put right next to it. Okay. So it
starts accumulating genes right next to each other.

And the biggest one they\'ve found so far is six antibiotic resistance
genes back to back to back to back to back.

So in that case you\'re talking one antibiotic can select for resistance
to six, because they\'re all linked to each other.

Just to show you that these things are real, you can make up PCR primers
to the conserve segments and amplify. And what you do is, you purify the
DNA, and you send it out for DNA sequencing, and it determines what the
genes are.

So here are just some examples. Here\'s Salmonella Typhimurium. When we
do PCR with the conserve segments for integrons, we get two bands, and
it\'s characteristic of DT104. And here\'s some Salmonella Derby,
Salmonella Natum \[phonetic\].

This is interesting here. When we sequenced all these bands, they were
all identical. So we found the same gene in very much diverse, different
salmonella species, which is pretty common.

An interesting story here is this integron in an isolate of Salmonella
Brandenburg, when we sequenced it, we identified it as a gene that
conferred resistance to norciathricin. This is an antibiotic that is not
used in North America. It was actually used in East Germany years ago.

And I thought that was kind of weird until I figured out what the name
of the salmonella was. If you think about it, it\'s Salmonella
Brandenburg, originally identified, guess where? In Germany.

So it makes sense even though this strain we isolated it in the United
States, it originated in Germany. And it took with it a resistance gene
from the antibiotic that was used in East Germany 15 years ago.

So what we\'re finding out now is that, in terms of transferrable drug
resistances, it\'s pretty much every single drug we have out there,
except for quinolones; for those of you who are familiar with
fluroquinolones, resistances due to chromosomal mutations.

However, there was a report two years ago of plasmid-mediated
fluroquinolone resistance. However, they have not gone into detail yet
on the mechanism, so that\'s still a question mark.

Now, as I said before, multi-drug resistance is the rule, not the
exception. And I\'m trying to create a little pictograph here. With
selection pressure and the environment increased over time, we already
have a strain of bacteria that has a plasmid in it for a resistance
gene. It\'s preexisting, as we talked about.

When you introduce ‑‑ this arrow denotes an antibiotic selection
pressure. When we introduce a new selection pressure, say, another
antibiotic, what happens is these bacteria accumulate another resistance
gene. Okay. So now they\'re resistant to two antimicrobials.

And into that environment comes another antimicrobial. And guess what
happens? It picks it up again.

So these bacteria are accumulating resistance genes in a scientific
phenomenon that I like to call snowball-rolling-downhill effect; not the
most scientific term, but it\'s really the best way to describe how
resistance genes are accumulated.

Remember the snowball down the hill, it gets bigger and bigger and
bigger? The same thing happens with these bacteria when they accumulate
resistance genes.

Now, how do we go about stopping this or reducing the evolution of
resistance?

One way, of course, is to get out there the message of using
antimicrobials prudently.

And this is a message put out by the Academy of Veterinary Pharmacology
and Therapeutics. And their statement is, The use that maximizes health
benefits and minimizes the development of resistance and prevents the
occurrence of unsafe residues.

So that\'s three main factors in there: maximize health benefits,
minimize resistance, and prevent the occurrence of unsafe residues.

This is what we want to do, but sometimes these don\'t all merge with
one. For instance, like pushing on one end of a balloon, the other end
gets bigger.

So if we\'re going to fulfill this, we\'re going to have to take a
closer look at all of these things.

Now, one way to show you judicious use is to show you some inappropriate
use or injudicious use.

When I was in North Dakota, I was head of diagnostic microbiology. And
North Dakota is mostly a cow/calf operation state. And we have a lot of
old-timers that ‑‑ well, calf scours is the number one disease.

And we have these cows, you know, one to two days of age with diarrhea.
And they usually don\'t come into the diagnostic lab to determine what
antimicrobial.

So what they do is something called the shotgun approach. And what that
is here is, they would give them these gelatin capsules full of pills.
And they would come up, and they would go, Oh, Doc, here\'s what I\'m
giving them.

And I\'m like, What the hell is that? You know, it\'s definitely not
prudent use.

So what we would do ‑‑ it was Mike Appley \[phonetic\] and I. And I
asked him to take it apart and identify it. And this is what we found in
this gelatin capsule they were giving to two-day-old calves:

Okay. First of all, we had an antihistamine; we had sulfamethoxazole
trimethoprim; Vitamin C; kephalexin; tetracycline; and a couple of other
tablets we had no idea what they were.

So this is what they were giving two-day-old calves in an attempt to
cure the diarrhea. That definitely, I think, falls under the definition
of inappropriate use.

One thing to keep in mind, too, is that antibiotic resistance does not
respect national boundaries.

Whatever we do in the United States has to be done globally, as well,
because resistance that develops in Mexico or Canada, as we know, can
come here very quickly due to travel and importation of food.

This is a picture from my old technician, who went down to Mexico on a
trip, as you can see. This is over-the-counter availability of
antibiotics. You could just walk in and buy any antibiotic over the
counter.

So if you have the sniffles, you go buy an antibiotic, that\'s
definitely inappropriate use, as well.

As you can see here, Amoxycillin, 50 percent off. They had a big sale.
One thing I notice as well here, though, is Prozac was 28 percent off.

(General laughter.)

DR. WHITE: So you can get a bunch of stuff down there in Mexico.

So how do we promote the prudent use of antimicrobials in ag? I think
first of all is through improved surveillance of bacterial antimicrobial
susceptibility and resistance. And this is being done by the NARMS
program, Foodnet, Pulsenet.

I think we also need to focus on improved antimicrobial administration
and maybe look at short-term narrow spectrum high dose therapies, and
also start implementing correct PK/PD parameters.

This was mentioned before, but I think we need to encourage research
into antimicrobial alternatives. We know that antimicrobials promote
growth. But there\'s got to be a way to get that effect without using an
antibiotic.

And also, increased education of all involved groups. This includes
physicians, veterinarians, clinical labs, ag producers, pharmaceutical
companies. And of course, encourage always the appropriate use of these
agents.

And I figure at the type of meeting we\'re at, that we need to put some
ideas for the future and maybe to think about for tomorrow, as well.

I think there are some future research needs that need to be addressed
if we\'re going to conquer this antibiotic resistance dilemma. And one,
of course, is a growing area of research is, what is the contribution of
the normal flora to antimicrobial resistance? That is, are there
innocent bystanders?

Even our simple E. coli, are they reservoirs of resistance genes for
other bacterial pathogens? More people that are publishing are
suggesting that is indeed the fact.

Now, what factors contribute to the selection of resistant microbes?

So I think we need more researchers in this area in veterinary medicine
looking at pharmaco-kinetics, pharmaco-dynamics, and looking at those
parameters on the selection dissemination of resistance.

And this is looking at the dose, frequency, duration, exposure, and the
environment.

Also, what is the frequency of selection for resistance-specific
antimicrobials? Are there some antimicrobials that resistance evolves
faster to over another?

How do these mechanisms evolve? Are there other sources of resistance
genes and organisms out there? Are there other reservoirs that we don\'t
know about yet? And are there other selection pressures out there?

There are some cases where we still see chloramphenicol resistance in E.
coli, after this drug was banned 15 years ago. What\'s happening there?
Is there something else? In every one of those strains that\'s
chloramphenicol resistant, they\'re also tetracycline resistant.

There\'s a possibility that those genes are linked now so that the use
of tetracycline is selecting for chloramphenicol resistance.

And lastly, of course, how is resistance transferred and how often?

These are simple questions, but in vet med and agriculture, we don\'t
really have that many answers yet.

We need to know how much transposable elements contributes to
resistance, and like I said, the gene linkage aspect.

When we see multi-drug resistance, we need to see if these genes are
linked to each other or if they\'re independent.

Now, in summary, I\'d like to conclude with an analogy that may be
applicable to our situation.

For those of you that remember, or at least those of you who saw that
Tom Hanks film a couple years ago, Apollo 13 mission going to the moon
had a few problems on its way. They had a catastrophic explosion, and
they were losing their oxygen and their energy, and it was a great
possibility they were going to die up there.

And what happened at NASA is, a diverse group of scientists, be it
engineers, technicians, they got together, put their heads together to
try to get these guys home. The end result was a good thing. They made
it home.

What I\'m trying to get at here is we face a similar situation, one
maybe not as dramatic as the Apollo 13 mission, but one that has
significant impact both in human and animal health. And that is the
emergence of bacteria that are multi-drug resistant.

So our challenge is, can we put our heads together, all groups involved,
put on our thinking caps, draw up plans, develop and implement
intervention strategies that reduce the public health impact of
antibiotic resistance?

Thank you.

(Applause.)

DR. GILLESPIE: Mary Torrence had an emergency and was unable to come.
And so her paper on epidemiology will not be given.

So we\'ll go immediately to the break, which will be ten minutes ‑‑ ho,
ho, ho. And we\'ll be back as close as we can to 3:45 to start the next
session.

(Whereupon, a short recess was taken.)

DR. GILLESPIE: While people are making their way back in, I would like
to begin the introduction, if I could, of Dr. Norman Stern, who will be
our presenter this afternoon.

And he\'s going to speak to us about the strategies and successes in
pathogen control during poultry production and processing.

Dr. Stern serves as research leader of the Poultry Microbiological
Safety Research Unit, USDA Agriculture Research Service, Athens,
Georgia.

In this capacity he directs a major research program with emphasis on
developing knowledge and technologies which will prevent or control the
prevalence of human bacterial pathogens in eggs and on-farm chickens.

The program consists of two primary areas, controlling colonization of
poultry by campylobacter and controlling colonization by salmonella.

Dr. Stern has approximately 25 years of research experience in
microbiological safety of foods.

Dr. Stern.

DR. STERN: Thank you, Mr. Chairman. Ladies and gentlemen, good
afternoon.

I\'m happy to say we\'re having technical difficulties. With that, we
will work through this. Really, I can either dance or sing a song. The
CD is being loaded. Let\'s see how this goes.

(Pause.)

DR. STERN: I think I\'ll just start by saying that it\'s not the
government that makes food safe. There, I said it. It really is the
industry.

And happily, I\'ve gotten terrific cooperation from a number of my
industry colleagues to work together.

And these colleagues really are the folks who have stepped up ‑‑ is that
me? This is unacceptable.

These people have stepped forward, and they\'re probably the top 10
percent. They\'re proactive individuals.

And I figure that\'s as good as I can do, because if we can get the top
10 percent of the proactive parts of the industry working together to
resolve the problems, then the rest of the 90 percent will come along,
or else they\'ll go out of business. And that\'s okay with me, too.

We\'ve got four laptop computers here.

(Pause.)

DR. STERN: You know, you plan the talk, and you have the presentation,
and you kind of want to go with the slides. So I could muddle about.

(Pause.)

DR. GILLESPIE: Surely someone today has said something about you need to
be flexible. And we\'re going to be that. And I appreciate our
speakers\' willingness to reschedule themselves.

And Shannon Jordre has agreed to move his presentation up. And he\'s
going to talk about feed contamination.

He is the commercial feed and animal remedies specialist with the South
Dakota Department of Agriculture and has worked in that position since
1990.

He has had experience with USDA Meat Animal Research Center at Clay
Center, Nebraska and holds a baccalaureate degree in microbiology from
South Dakota State University.

And he is currently the president of AAFCO, Association of American Feed
Control Officers, and is active in the South Dakota Environmental Health
Association.

Shannon, I appreciate your moving up in the schedule.

MR. JORDRE: I was a little intimidated this morning watching everybody
come up here with these really nice, slick Power Point and electronic
presentations. And I\'m thinking, Here I\'ve got the old fashioned, low
tech overheads.

But it\'s nice to be useful, and if for nothing else, I\'ll be
remembered as the odd man out, so to speak, somebody who didn\'t use an
electronic presentation.

Just to briefly explain: Yes. I\'m with the South Dakota Department of
Agriculture. I\'m the feed and animal remedies specialist there.

It\'s my job to regulate the commercial feed and the animal drug
manufacturers that do business in the state. And the way we do this is
through collecting samples, by analyzing for guarantees, nutrient
guarantees, as well as possible contaminants at times.

We do feed mill inspections, monitor for good manufacturing practices.
We monitor ingredients that are going into the feed supply.

And so if you look at my first overhead here, Oh, boy, it\'s dog food
again, it really does kind of illustrate or it makes a point why we
regulate the feed industry.

In the case of pets, it\'s not uncommon for the pet to eat the same diet
for years, and so you want to make sure that that diet is both safe and
nutritionally balanced.

In the case of food animals, we want to be able to eat those animals
once they reach their physical maturity, and thus we want to make sure
that the feed that they\'re eating is safe.

I\'ve been asked to speak about contamination. And I\'m not a
researcher, and I don\'t represent a research association. So what I\'m
going to do is provide it from more of a regulatory type perspective.
And to do that, I\'m going to explain what AAFCO is.

AAFCO is the Association of American Feed Control Officials. And this is
a quote that\'s out of our association philosophy:

The purposes of the corporation shall be to establish and maintain an
association through which officials of any state, dominion, federal or
other governmental agency charged with enforcing the laws regulating the
production ‑‑ on and on and on about animal feeds and livestock
remedies ‑‑ may unite to explore the problems encountered.

The following page just follows up on that. A basic goal of AAFCO is to
provide a mechanism for developing and implementing uniform and
equitable laws, regulations, standards, definitions, and enforcement
policies for regulating the manufacturing, labeling, and distribution,
et cetera of feed.

The association promotes new ideas and innovative procedures and urges
their adoption by member agencies for uniformity.

In other words, one of our projects is to come up with model feed
labeling standards which the various states ‑‑ because the states do
most of the regulation of the feed industry ‑‑ the states can adopt a
uniform standard.

Companies can devise a label that works nationwide so they don\'t have
to, in most cases anyway, come up with state-by-state labeling.

AAFCO consists of 23 committees, task force. These committees and task
force work year-round on projects.

We have 28 feed ingredient investigators, and there are 40 agencies
represented on committees or as investigators.

And I should back up and say first that AAFCO is now over 90 years old.
It\'s an international association. All 50 states are members; USDA,
FDA, EPA are members; Puerto Rico is a member; and we have international
membership as well. Canada has been a member for many years, and more
recently, Costa Rica is also a member.

So we do have a large group that\'s active. And so we\'ve got something
like 60 different members. And 40 of those members do get involved in
some of the committee and investigator work.

Our committees, we have, as I said, 23 committees. A couple of them that
are of primary interest probably to this group.

The Feed Manufacturing Committee, they set up good manufacturing
practices for feed mills. They are also working on a voluntary
self-inspection program for medicated feed mills.

What our hope is is that, if we can install some sort of voluntary
self-inspection for that segment of the industry that really doesn\'t
need much help, we can spend more time working with the other segments
of the industry that really do need some help.

And then, because the current good manufacturing practices are designed
for those feed mills that make medicated feeds, and we realize that
medicated feeds present only one type of contamination risk, we\'ve also
started the process to look at devising some good manufacturing
practices for feed mills that manufacture feeds that don\'t contain
medications.

There\'s all kinds of problems that you can get into in a feed mill
setting. You can have copper carry over between a hog feed and a sheep
feed. That\'s probably more of a threat than an antibiotic residue would
be.

Another committee that\'s highly involved in feed safety and
contamination, the Ingredient Definitions Committee. This is the
committee that works on establishing new feed ingredient definitions.

We work very closely with the FDA to establish a definition. And if
there are some safety issues or contaminant issues with a feed
ingredient or potential feed ingredient, we would incorporate some
either labeling guidance, manufacturing guidance, or some other type of
guidance into the definition that would address contamination or safety
issue.

A couple of other committees that are involved. The Environmental Issues
Committee is looking at contamination due to environmental factors. Lab
Methods and Services, working on new laboratory techniques that could be
useful in contaminant analysis.

And we recently established the Feed Safety Steering Committee to help
organize all of our feed and food safety efforts.

The purpose of this slide is just to advertise our Web site. In case you
want to know who your local state contact is or a federal contact, you
can look up on our Web site there.

Like I say, our group is primarily made up of regulators either at the
state or local level ‑‑ or state or federal level. And so the way we
deal with contamination is to try and regulate it, which is not always
easy to do. But that\'s the framework that we have, and so that\'s what
we try to use.

Everybody is familiar with mycotoxins. There\'s a variety of mycotoxins;
we have aflatoxin, vomitoxin. Fumonicin \[phonetic\] is the new one.

There\'s been a fair amount of research on the aflatoxin and vomitoxin.

And what we\'ve been able to do, then, in the regulatory process is
establish some kind of guidelines or framework that says if you\'ve got
an animal such as a dairy cow, for example, that you want to be very
careful about how much aflatoxin you\'re feeding the dairy cow, because
there is a pretty good transfer of aflatoxin from the feed into the
milk.

So you feed the dairy cow a low level of aflatoxin or not at all. But
you want to keep it to a low level.

On the other hand, if you have a feed that\'s contaminated with
vomitoxin, for example, and you\'re in the business of feeding cattle in
a feedlot, the cattle are fairly tolerant of vomitoxin, and so you can
feed a higher level.

And that\'s the advantage of having research to fall back on. You can
establish a science-based, reasonable way to regulate some of these
contamination problems.

Fumonicin is the new mycotoxin on the block. And we don\'t have a real
lot of information about that one yet, but likely it will probably
follow the same concept in terms of regulation as the other mycotoxins
do.

And there are well over 100 other kinds of mycotoxins that we can
identify. We can\'t quantitate them all, and we don\'t know necessarily
which ones are problems. But likely there will be additional mycotoxins
identified down the road that we would like to try and control.

Drug residues, we had some discussion already today about the drug
residues, tissue residues.

I think we\'re all agreed that the number of violative animals is down.
In large part this is probably due to QA programs sponsored by the
producer groups.

Sort of the new interest in drug residues has to do with antibiotic
resistance development. And we\'ve heard some excellent points about
that today.

Likely, as more research unfolds, this may result in some additional
regulations, in which case we\'ll have to incorporate those.

The third point, mistakes, environment vandalism. In a feed
manufacturing setting you have ample opportunity to make mistakes.
Hopefully, you have adopted good manufacturing practices that try and
help keep those to a minimum.

But you get into situations sometimes where there\'s some ‑‑ as I
alluded to earlier ‑‑ where there\'s some copper in the ‑‑ you made a
swine feed, for example, that contained a high level of copper, and you
followed that with a sheep feed. Sheep aren\'t very tolerant of copper.
So you have to deal with issues like that.

Sometimes you have a case where you\'ve manufactured a cattle feed,
you\'ve labeled it as a cattle feed, and then somebody takes it home and
feeds it to their sheep anyway. It\'s not really a contamination, but
that\'s the type of accident that happens occasionally.

All kinds of environmental issues come into play, poisonous plants.
Where I\'m from, in central South Dakota, we have high levels of
naturally occurring selenium in the soil and in the plants. You have to
deal with factors like that.

And occasionally you hear about some incidents of vandalism or
negligence or some other things that cause contamination events.

Some emerging issues that we\'re dealing with: BSE is one; dioxin is
another. And we\'re waiting for additional science before we move on
those issues, or move on those issues beyond what we\'ve done so far, I
guess.

Another emerging issue, we\'ve heard several speakers talk about animal
waste. It\'s another issue that we need to watch.

Some of the agencies that regulate animal waste are advising or
suggesting to the people that they deal with that feeding is one option
for disposal of their animal waste. And while that may be true, it\'s
not something that\'s simple to do in all cases. I mean, it\'s something
that has to be managed very carefully.

And then, the bottom point here is economics. Let\'s not forget that
there is an economic factor to many, many kinds of contamination.

You\'ve got a farmer who has harvested his wheat, and he\'s got a bin
full of wheat, and it\'s got too much vomitoxin to go to the food
market. He still needs someplace to dispose of that.

In the case of wheat, most of that is geared to go to food manufacturing
first and foremost. If it\'s not good enough for food manufacturing,
then, the feed market is the next most likely outlet.

If it can be used as feed, let\'s use it for feed. But if it\'s not,
let\'s be very careful about how it\'s handled. Let\'s find some other
way to use it.

There\'s always an economic incentive, and the feed and the livestock
industry have become very dependent on byproducts of manufacturing.

And it\'s pretty normal for me to get a call probably once a week or
every couple weeks, anyway, from some food manufacturer who has got some
byproduct that they\'re trying to find a use for. Rather than sending it
to the waste water treatment plant or to the landfill, they would like
to explore the idea of livestock feeding.

In many cases, it\'s a viable option. In some other cases, it\'s not.
But we need to be very careful about doing some of that.

Well, how do we handle these issues? AAFCO would like to propose three
different approaches: research, education, and regulation.

Research, we would like some additional research on animal nutrition. We
know a lot about nutrition, but we don\'t know everything. There are
some frontiers yet, and especially as we deal with some of these
byproduct feeds.

There\'s all kinds of geographic issues that come into play, weather
factors, lots of different things.

We need some additional research on analytical methods. We all know that
there is a wide variety of contaminants out there. Many of them we can
qualitatively analyze but we can\'t quantitate. And if we can\'t
quantitate them, it\'s hard to manage them. And we need some additional
research on the contaminants themselves.

The next slide that I\'ve got here comes from the Arizona Department of
Ag newsletter. And they\'re reporting on some ARS research regarding
aflatoxin in cottonseed. And it\'s just a good example of how we can
make the food supply a little safer.

We also want some education. We need to educate the producers, the
livestock producers in particular, but also some of the people that are
providing these ingredients to the livestock producers and to the feed
industry.

Here\'s a good article out of [Feedstuffs]{.underline} just a couple of
weeks ago, \"Tradeoffs Evaluated When Pricing Byproduct Feeds.\" It\'s
all about the economics of using byproduct feeds. And it\'s a very good
article, and economics are very important to livestock producers.

The article does indicate that, if you do feed a byproduct, for example,
you might lose a little bit of your rate of gain.

It doesn\'t say anything ‑‑ so it does advise the producer that his
performance might be affected a little bit. But it doesn\'t say anything
about possible safety concerns or the fact that there might be some
additional vitamin or supplementation necessary if you do choose to use
some of these byproducts in your feeds.

So we would like to see some additional education to the feeders as well
as industry.

And, yes. We do think that regulation is necessary. I think that\'s
probably not a surprise to you coming from me, a regulator.

But the regulations that we do have now, they do allow for good uniform
labeling, product identity. There are some standards for manufacturing
process control; there are some standards for contaminant levels. And
these only serve to help the people who are using the products and to
make a more level playing field for the industry.

We do want that regulation to be flexible. And there is a need for the
local agencies to have some of the regulatory authority and flexibility
to deal with some of these local issues. The regulation does need to be
science-based.

What does the future hold? As several of the other speakers have already
said, there\'s been a huge amount of attention to the area of animal
feeds in the news. You see it in the newspapers, people\'s Web sites;
lots of attention to animal feed safety. A lot of it is driven by the
BSE issue, the more recent dioxin issues.

And there is a huge amount of international trade involved, which means
that something that the Europeans want typically is something, then,
people in America start to try and achieve. So you have that
international trade aspect also involved.

Recently there was a new Codex task force, a task force on animal
feeding. AAFCO has made a big step, and we are participating in that
task force. And they\'re looking at trying to establish some worldwide
standards for livestock feeding.

Some of these possible standards might include on-farm inspections,
additional restrictions on ingredients that are usable.

And speaking on behalf of AAFCO, we\'re very interested in getting
feedback from the groups represented here in terms of what your thoughts
are on some of these issues.

In conclusion, contamination is a huge topic. We could talk about
contamination all week and barely scratch the surface.

I hope the presentation I have given today has identified some areas of
research that we as the regulatory community think would be helpful,
some areas of education that we see there needs to be some more emphasis
placed on, and also some regulatory issues that we feel are important,
as well.

And I also hope that I\'ve provided a little bit of information on AAFCO
for those of you who aren\'t familiar with our group. Thank you.

(Applause.)

DR. STERN: Thank you, again. Do you want to hear the introduction?

In addition to the individuals listed on the screen, I do want to
acknowledge that the National Chicken Council, individuals, various
individual companies were involved, as well as the people who are listed
here were primarily involved in much of the work that I\'m presenting
today.

I also think that the Food Safety Inspection Service has worked
cooperatively with the Agriculture Research Service to gather some of
the data. So, I thank you.

Okay. As said already today, the Year 1 was a terrific success story on
the part of the industry in reducing the presence of salmonella in the
broiler carcasses. And you know, I think we don\'t want to shortchange
that.

Before, we had in excess of 20 percent of our carcasses positive, and
really the industry worked very hard to reduce that level substantially.

So I think the industry should be applauded. And I hope Caroline
appreciates all the hard work that the industry has done.

All right. Now, controlling pathogens in poultry products reduces human
health hazards, but it does not enhance poultry production.

Basically, as we\'ve heard already, the industry has to make money. And
just because the chicken does or does not have salmonella or
campylobacter does not change their bottom lines.

Consumers do want safer food, but the industry really was stopped short,
because the only effective intervention that was available to them was
the use of disinfectants during the processing of the birds.

So, indeed, we have to just recognize that our consumers and really even
in international trades, places such as China, as Japan, and Great
Britain will not allow disinfected poultry to be shipped to their
countries. And if we want to continue expanding our international trade,
we will have to deal with these.

I don\'t believe that disinfection is a long-term solution, so we do
need to create these pathogen control points during production.

And so the question is, how are we going to get there? This is a pinata,
and the kid is aiming, blinded, at the target. We all want to get there,
but we best take off our blindfolds. And that\'s the goal.

So what we want to do is to identify the representative poultry
operations, and we have done that in this country. We want to determine
where contamination comes from during the production all the way through
to the consumer and then gather information without the constraint of
adverse litigation.

And this I believe is a scale of justice. So we don\'t want to have to
deal with justice in this particular case. I think it\'s fair to give us
a chance to identify where the problems come from rather than just say
we\'ve got to fix it.

Yes. We\'ve got to fix it, but it does take time, and we don\'t need
lawyers to tell us that we\'re not there yet. We\'re not there yet.

All right. What have we been doing within the United States? And the
question is, how does government and industry work together?

And part of our responsibility in agricultural research is to come up
with ideas that perhaps do effectively reduce the pathogens.

So what we did in the poultry industry was to work together very closely
with the companies around the United States.

And we just created this particular epidemiologic study to look at 32
different flocks around the country from two farms per location, a high
and low production facility, and these were sampled through all the four
seasons of the year, to give us 32 flocks.

And so I know that\'s not representative of the entire industry, but it
took an enormous amount of work to get that done.

But what kind of things did we learn? Well, we looked at each of these
items here on the board insofar as production, just about everything
that you can imagine. And we sampled approximately 350 samples per flock
in post-production, transport crates, all the way through to carcass
rinses, which really represents the consumer exposure.

So we went through this in great detail. And it was quite an endeavor,
but I\'m pleased that we learned a fair amount out of that particular
study.

What we learned in part was that some of the sources of salmonella in
operations can come all the way from the breeder stock through to the
broiler and on to the processed carcasses. Other strains came from a
variety of other environmental sources.

And these data really enabled us to come up with a large-scale proposal
for on-farm intervention. We\'re not there yet. But indeed now we think
that it is plausible to go forward and begin controlling salmonella in
production, or at least making a dent in this particular arena.

Shifting a little bit, I want to tell you a little bit about
campylobacter, because 20 years ago nobody could pronounce it, and now
everybody can pronounce it. But let me just briefly go through.

The organism distinguishes itself from salmonella in that it\'s a
sporadic outbreak transmission primarily.

I will say that raw milk certainly has been the most frequent vehicle
for outbreaks of campylobacter. But there are a number of very large
outbreaks documented being waterborne. And I will say that approximately
30 percent of transmission to humans does come from pets. So again we
have some complications.

So how do we go about tracking campylobacters? Well, there actually are
a number of different ways of tracking campylobacter, and each one is
appropriate for their own situation, but my laboratory has come up with
a particular method that\'s involving a gene sequencing. And just a very
brief description:

We discovered on the flagellan genome if the Y axis is variation in
campylobacter strains, we have a terrific amount of variation in the
short variable region, the SVR, that is flanked by highly conserved
regions.

So if we take each of these nucleotide sequences, we can compare one
campylobacter to the next much in the same way as you compare people
around the room, with hair, without hair, height, you know, any number
of comparisons.

And this gives us a fairly inexpensive, fairly rapid means of comparing
one campylobacter with the next so that we know if we\'re tracking one
through a system.

So using this system, we conduct our polymerase chain reaction, run it
through a DNA sequencer, and analyze the results.

And of course, A and C are very closely related; D is just several base
pair differences and likely to come from the same sources; but B is very
different. So I\'m just showing this as an example as we look at one
example of our U.S. epidemiology study for campylobacter.

Used to be that you if you would get 100 isolates around the pie-shaped
chart, you would have such information. And you wouldn\'t be surprised
to have campylobacter in fecal droppings, in carcass rinses, on crates;
all of these are possible.

But the question that would be unanswered is, what role did this wild
bird feces have on the contamination of the carcasses?

And so to answer that question, we used DNA sequencing to obtain these
data.

And what you can tell in this particular flock is that the bird
droppings were the same as the wild swabs, as the mouse intestines, as
the boot swabs, as we found on the carcasses and so forth. And these
were all really very closely, maybe one base pair different from one
another. So we would conclude they were all the same.

However, when we got out to 1-1/2 percent difference and 2 percent
difference, that\'s enough to suggest strongly that they likely have a
different point origin.

And so it gives us the ability to see where the campylobacters are
coming from.

Of course, the other element of this is, if we only found that the mouse
intestinal dropping was positive ‑‑ or the mouse intestine was positive
after the birds began excreting, it would tell us that the birds gave it
to the mouse. Right? So temporal relations are important.

So, you wonder, Why Iceland? Right? Why is that they produce 100 percent
of their poultry that they consume; we have a bead on the breeder eggs,
all originating from Sweden; and many similarities exist between the
countries.

But I found it very interesting that they would have rates of even 158
per 100,000 persons while we had rates of only 20 per 100,000 in the
United States, although they consumed only one-fourth the poultry.

And so this enabled us to have a prospective study on the flow of
campylobacter to humans.

So what we did was to gather three months of poultry isolates, as well
as we excluded all human isolates that were in that country from people
who were on foreign travel so that we knew that it was not obtained from
foreign travel.

And then we sequenced them and compared the clones of the poultry
isolates with the human isolates.

And what did we find? The different colors indicate what we found. The
yellow match with the blue isolate at the very top, and that was a
distinctive clone, as did this large group in between. These are all a
particular clone. But again we had isolates from poultry and the same
clones really found in humans.

Another flock of birds were found to be identical with the human
strains. And then, we had a number that were not associated with poultry
isolations.

So really Iceland allows us to have a country that\'s 1/1,000 the United
States that enables us to have a very detailed epidemiologic study that
we could never do in the States.

So, then, how do we wind up controlling campylobacter? Well, we would
like to see that the temporal relationship between isolates from the
environment to the excretion of the pathogen in chickens.

We would like to determine the levels of isolates, because certainly we
want to address sources that have higher levels of campylobacter or more
consistent sources of campylobacter. And we would like to create
interventions.

What I have here is something really quite remarkable, and that is, in
Iceland, we have identified the flow of campylobacter in the poultry
production of Iceland.

And you could draw another box up here where the eggs come from Sweden.
We know the egg producers in Sweden.

And then, we have another box down here which is the human incidence of
campylobacter.

So we can trace campylobacter very carefully in Iceland. And at every
level, we\'ll be able to isolate campylobacter and determine clonality,
which is really an exciting opportunity such that we will take this
information, whatever we learn, and see whether it holds for the United
States.

And of course, if we were to find interventions that apply and
effectively reduce campylobacter in the humans, we would say this is a
pretty good model for us to use.

All right. I think we found a pretty interesting observation on the
transmission of campylobacter from the breeders to broilers.

In the past, because we couldn\'t isolate campylobacter from hatching
debris, we wound up concluding that campylobacter never came from the
breeders.

So what we did was to obtain droppings both on the breeder flocks as
well as in the broiler flocks, and then we went about our DNA sequencing
as well as ribotyping. So in this study we used two. And actually, we
also did pulse-field gel electrophoresis and obtained the following
types of data:

In our ribotyping analysis, in Arkansas the breeders had campylobacter
with exactly the same pattern as did the broilers, and those flocks were
20 miles apart.

Again, the breeders manifested ‑‑ here we had a breeder pattern for
ribotyping that was exactly the same as the broilers.

And we had a third isolate in this breeder that was precisely the same
as the broilers.

We analyzed all these again by sequencing, and we found the relationship
that ‑‑ oh, this ‑‑ you can\'t see the relationship. That\'s curious.
But anyway, the breeders again were very closely matched or identical
with the broilers in spite of the breeders and broilers being 20 miles
apart.

This one shows it a little better. And of course these breeder isolates
are precisely the same as the broiler isolate.

All right. So we believe that campylobacter can be transmitted from
breeders to broilers. We don\'t know how important that is yet, although
in our national study in the States, we did not find environmental
contamination before we found the birds excreting. So we think we\'ve
come onto an important potential source, and we\'d like to follow that
through.

The last topic I want to talk about is competitive exclusion.

This is a train in Tokyo. This guy is salmonella, these people are the
competitive exclusion, and this train is the intestinal tract.

I want you to remember that by nature birds are copraphagic, and they
used to live in nests. And what does that mean? That means the little
chicks used to eat mama\'s droppings in the nest. We now remove those
eggs from the hen, and we hatch those birds out in large hatcheries.

So what we intend on doing with competitive exclusion is to provide
normal flora from healthy mature donor birds, and we then subculture
that.

And this was patented by ARS, originally patented as mucosal competitive
exclusion flora. Continental Grain licensed this as mucosal starter
culture. And this is a diverse natural microflora from the adult birds.

Although it was originally created for campylobacter, it really does
work better against salmonella.

We have a number of commercial field trials that we have already run in
Puerto Rico, Georgia, Arkansas, Alabama, Brazil, and Japan. And each of
those have demonstrated efficacy in controlling salmonella.

So salmonella was reduced both on the farm and, happily, all the way
through to the processed carcass. And that is something important.

So to conclude the talk, really microbiological safety does depend on
the poultry industry. I don\'t think we can create illusions.

We need to have cooperation with the industry and Agricultural Research,
and this has been mutually beneficial.

Again I want to applaud industry for subjecting themselves to
self-evaluation so that risk factors can be identified and suggest
intervention strategies that will work, especially for salmonella
control.

Campylobacter can come through the egg to seed the broiler flocks.

And international cooperation seems to be important here in identifying
risk factors for campylobacter.

And I think that salmonella can be reduced, in any case, by measures of
competitive exclusion.

So I thank you for your attention. And we\'ll take your leave.

(Applause.)

DR. GILLESPIE: Thank you very much. Our next speaker is Dr. William
Laegreid.

Dr. Laegreid obtained his veterinary and Ph.D. degrees from Washington
State University, and he is currently research leader of the Animal
Health Research Unit at the USDA ARS U.S. Meat Animal Research Center in
Clay Center, Nebraska.

His research interests include pathogenesis of viral and bacterial
infections and hosts to infection, as well as transmission agents within
and between livestock populations.

He\'s going to discuss with us today a very important topic, pathogen
detection and sampling, which I think is a very crucial area.

DR. LAEGREID: Thanks, Dr. Gillespie. If we can hold on for just a second
here, I\'ll be up and running.

(Pause.)

DR. LAEGREID: When I was asked to give this talk, I had a bit of a
pause, because pathogen detection is a huge problem.

There are a number of ways to detect pathogens. There\'s, you know, a
huge number of diagnostic platforms out there right now. There\'s a
whole bunch of issues associated with each one, what targets, what
approaches to use to detect a given pathogen in a given sample.

And when I started to put that together it was very clear that that was
more than probably anyone wanted to see even before I knew it was going
to be 4:30, five o\'clock in the afternoon.

So I decided to take and look at one issue that is really important in
terms of all diagnostic tests, and that\'s how we evaluate them and how
we know whether they\'re actually telling us the information that we
think they\'re telling us.

Now, underlying the entire field of preharvest food safety is this
hypothesis, and that is that the prevalence of these bacteria on
carcasses or in product is somehow related to the prevalence of
infection in the live animal.

Now, that seems very intuitive, and in some ways it is. But in fact,
there was damn little data for it in terms of cattle up until recently,
when we\'ve shown that there is in fact ‑‑ at least for 0157:H7, and we
would assume for other fecal bacteria ‑‑ a very good correlation between
prevalence in the live animal and carcass contamination at slaughter.

Again, that\'s intuitive, but it\'s also something we knew before.
That\'s really the basis for our original food inspection systems in
this country.

Historically we knew that sick animals probably had things that could be
transmitted to people. So if we saw enlarged lymph nodes or we knew an
animal was sick when it walked in the door, those animals were condemned
or routed some other way.

And that was based on the fact that a contaminated animal was likely
to ‑‑ or an infected animal was likely to contaminate product and thus
cause a human health problem.

Recently, though, we\'re dealing with agents that don\'t cause disease
in livestock in most cases. Most salmonella cases, certainly all
enterhemorrhagic E. coli cases in cattle, are subclinical. There\'s no
disease. There\'s nothing to see. Those animals are perfectly healthy.

And we\'ve looked at a lot of parameters to try and show that there was
some disease aspect to, for example, 0157:H7 infection in cattle, and in
fact there is nothing. There\'s nothing to see.

So we\'re dealing, then, strictly with a laboratory approach to
diagnosis. There\'s no other way to know if an animal is infected other
than to do some sort of laboratory test.

Now, we are actually talking here about diagnosis. And in a live animal
it\'s a little different than swabbing a carcass or looking at some
other environmental contamination. We\'re actually diagnosing whether an
animal is infected or not infected.

And diagnosis is not just the test result. The test result is part of
what goes into making a diagnosis. But it really has to be an
interpretation of all the available data to give us a probability of
whether an animal is infected or not infected.

And like any interpretation, there is an error rate associated with it.
That\'s partly of the function of the test, partly a function of the
people doing the interpretation.

Now, those of you that are Star Trek fans will recognize this right
away. But this is the ideal. This is what we\'re all shooting for, is
the tricorder, the little thing that they wave over the patients and it
automatically diagnoses whatever strange virus they\'ve gotten on Planet
X.

It\'s fast, it\'s noninvasive, it\'s portable. This is what we\'re
looking for. And nobody is even close, despite what some of the salesmen
will tell you.

All of the tests we have have some error rate associated with them. And
we have to have some criteria for evaluating whether a diagnostic test
is likely to give us the right answer or not.

We use a series of measures to evaluate diagnostic tests. Sensitivity
and specificity are commonly used, and these are just the probability
that a test will give us the correct answer in either an infected or a
noninfected animal.

Sounds very simple. It is mathematically quite simple. But the
interpretation of this is very difficult, because in order to derive
sensitivity and specificity in most cases, you have to already know
whether the animal is infected or not.

We do that in the cases of cancer and some other a little bit more
readily diagnosed diseases on the basis of some gold standard test.

If you\'re developing a test for a particular form of cancer, you\'ll
have a biopsy; you can look at it under a microscope; you can say, yes,
that\'s an adenocarcinoma, and yes, it correlates with this serum test
or whatever other diagnostic test you\'re trying to evaluate.

It\'s fairly straightforward to classify individuals into diseased or
not diseased or infected or not infected.

For infectious diseases in general, there are no gold standard tests. So
it makes it very, very difficult to evaluate diagnostic tests, and this
has led to a lot of confusion in the literature and a lot of confusion
out in the research community in general.

For tests where there is no gold standard, all you can really generate
is a relative sensitivity and specificity. You can compare one test to
another and say it\'s either better or worse, and that\'s about as good
as you can get with them.

And when you do that, it\'s very, very important that the populations
that are being tested, the samples that are being tested, and the
individuals doing the testing are as equivalent as possible. Otherwise
the comparisons are completely invalid.

Now, let me just give you a quick example of how this has worked for E.
coli 0157:H7. This is a comparison of two tests from the literature.

All of the data that I\'ll show you this afternoon will be based on
paired fecal samples. Those will be samples from an individual cow
taken, split into two, and tested by ‑‑ or handled independently. So
they are paired samples on an individual animal at a given time.

And what you find here is that this Method A gave us four out 50
positives, for an 8 percent prevalence. And four of those agreed with
Method B. Method B, on the other hand, gave us 23 out of 50 positives,
for 46 percent prevalence.

Now, that\'s a pretty straightforward example. Clearly Method B is
detecting more positives.

Now, we can\'t say that it\'s detecting all the positives. We can\'t say
for certain based on this data ‑‑ there\'s other data that does suggest
this. But we can\'t say based on this that some of these positives that
Method B detects that Method A misses are not false positives.

I can tell you based on other data that they\'re not false positives,
but from this simple analysis, you can\'t say that.

So we\'re seeing here an almost 83 percent reduction in apparent
prevalence based strictly on culture methodology. Now, that\'s a huge
difference.

And you don\'t have to have been on the Titanic to know that, if you
don\'t see a big part of the iceberg, you\'re going to be in big
trouble.

Low sensitivity diagnostic tests, ones that detect only one out of five
positives, are really only seeing a very small part of the overall
problem.

Higher sensitivity tests will see more of the problem, but we don\'t
know that we\'re seeing the entire problem.

Now, culture methods are part of the issue. Culture methodologies are a
part of a diagnostic test. But diagnostic tests include more than just
the culture methodologies or other testing methodologies.

There are sampling issues associated with diagnostic testing. And in the
case of culture, there are isolate characterization issues that go into
determining whether a test is accurate or not.

Now, the actual specificity and sensitivity of any diagnostic test
really needs to be evaluated on this whole process, not just on that
culture methodology or other direct diagnostic test.

I\'m going to give you a couple of examples of this. Again, paired fecal
samples from the same animals. And in this case, we took a rectal swab
from the animal ‑‑ this is a very common sampling methodology ‑‑ and
immediately afterwards went in with a grab sample of ten grams of feces,
so paired samples off of each animal.

And you can see here that, with a rectal swab, we got about 10, 11
percent of those individual positives. With ten grams of feces, we got
32 percent positive. Again, you know, a three to one ratio of positives
based simply on sample size.

These were cultured identically. They were evaluated by the same
individuals in a blinded fashion. And a very significant difference in
apparent prevalence of E. coli 0157 in these animals.

Sample handling is another issue. If you culture E. coli 0157 fresh
versus samples that are refrigerated overnight, again we see from fresh
species ‑‑

In this case identical sample sizes, ten grams in this case, identical
culture methodologies, you see a difference of in this case almost a 12
percent prevalence versus a 5 percent prevalence, and a 50 to 60 percent
difference in apparent prevalence.

Now, what does all this mean? Well ‑‑ and this is a very simple
analysis, and there are assumptions in here that I\'m sure certain
people would take exception to, and I don\'t want to be held to this as
an absolute analysis, but I think it illustrates the point.

If we look at the reduction due to sample size and the reduction due to
refrigeration and the reduction due to culture method sensitivity and
start out with an assumption of a true prevalence, the actual number of
infected animals in the herd, of 35 percent, if you factor in all of
these potential errors in a multiplicative fashion, you get an apparent
prevalence of about 1 percent.

And I just did this the other day, this analysis. We\'ve had the data
for quite some time. I had never put it all together like this.

But in fact, this is about the difference in apparent prevalence that we
see in the literature between some of the newer culture methodologies
and some of the historical data in the literature.

So what we see here is, you know, a 97-1/2 percent reduction in apparent
prevalence relative to true prevalence. That\'s a huge difference.

Well, does that make any difference? I mean, who cares? Right?

Yes. The absolute number may be way off, but maybe the trend is right,
or maybe we\'re just seeing those animals that are shedding the most E.
coli, and so that\'s probably okay. And those are the ones we\'re
interested in, anyway.

I\'ve heard all of those arguments. And in some cases, those may be
valid.

But for example, someone this morning was talking about sorting animals
at slaughter and slaughtering the clean ones first and slaughtering the
ones that were shedding a foodborne pathogen later on in the process.
That\'s a variation of this sort of test and cull, test and treat,
quarantine approach to disease control.

Well, if you\'re only accurate detecting one out of ten truly infected
animals, this isn\'t going to have any effect on public health.

In the case of evaluation of control measures, relative rates may be
okay. I mean, whether it\'s 4 percent or 40 percent, if it goes down by
a half, maybe that\'s okay. That assumes that these tests are going to
behave the same at various prevalences across the board. But that may be
all right.

However, when we\'re talking about things like epidemiologic
surveillance, and when we\'re talking about control measures in the case
where we start with 4 percent, and maybe we get a 4 percent reduction,
it looks like we\'ve eradicated the agent, and in fact there may still
be an awful lot present in the herd.

In the case of epidemiologic surveillance, the absolute number of
apparently infected animals may be different, but we also may be
misclassifying groups of animals, slaughter lots, herds of animals. And
I\'d like to just show you a quick example of that.

If we take an example of a herd of 250 animals, again with a true
prevalence, 35 percent of these animals are truly infected with the
agent.

If we look at the number of samples required to accurately classify that
herd as being infected or not infected, with Method A we would have to
test 195 of those animals to have a 95 percent chance of accurately
classifying that herd as infected.

If we test 100 animals, we\'re probably not going to accurately classify
many herds.

With Test B, ten animals will accurately classify that herd.

So the differences between these tests are more than academic interest.

One of the things that we still hear is that there are very few herds
actually infected with E. coli 0157:H7. That\'s not true. We actually
have trouble finding a herd that\'s not infected.

And I think that a lot of it is based on these sorts of sensitivity
differences in diagnostic testing.

And a good example of this was provided to us by Rod Moxley \[phonetic\]
at University of Nebraska.

He had been using a test that a group up at the University of Idaho had
developed. It\'s a very laborious test, but it should work reasonably
well on paper.

But when you go out to field samples, we found that it doesn\'t work
very well. And Rodney found pretty much the same thing.

In the summer of 1998, he tested almost 1,000 cattle in Nebraska
feedlots; he found one positive.

Now, I would say, at the same time we were testing in Nebraska feedlots,
and we were finding about somewhere in the 25 to 40 percent prevalence
range.

He switched to the method that we were using the next year. He tested a
few more animals, but he found a lot more positives.

Now, the difference between a .1 percent prevalence and a 23 percent
prevalence is fairly significant in terms of estimating the magnitude of
your disease control problem.

Now, I\'ve talked about sample handling, and I\'ve talked about culture.
I\'m not going to talk about the characterization of those isolates. But
you get the general idea.

The same sorts of issues are in play in the characterization step. The
serotyping, the testing for the presence of virulence genes and those
sorts of things. If those are not done correctly, you\'re going to
misclassify a lot of individual animals and misclassify a lot of herds.

And this is also true regardless of whether you\'re talking about
culture methodology, you\'re talking about rapid tests of this is a very
simple antibody based test, whether you\'re talking about, someone
mentioned gene chips for diagnosis today, PCR, various other diagnostic
methodologies. These same issues apply.

If you\'re not handling the samples properly, you\'re not taking an
adequate sample, you\'re going to have problems with sensitivity of your
overall diagnostic test.

So in conclusion I just want to leave you with two points.

The first is that ‑‑ and I am kind of hammering this, but it is
something that gets ignored often, and that is that diagnostic tests
include the entire process from sampling to interpretation. And anywhere
along the line you can have mistakes that will result in
misclassifications.

And insensitive tests will result in misclassification both of
individual animals and of groups of animals. And that\'s quite
important.

So since these diagnostic tests are used to make decisions, either
disease control, regulatory, or other decisions that are going to affect
the livelihood of producers and affect public health, I would feel that
these tests really need to be rigorously evaluated, need to be evaluated
on samples from naturally infected animals.

And they need to be evaluated in a pair-wise fashion and compared to
tests that are in use in the diagnostic community.

And with that, I\'ll take any questions.

(Applause.)

DR. GILLESPIE: Our next speaker is Dr. Steve Lehotay. And Steven is lead
scientist in the Food Safety Research Unit at the Eastern Regional
Research Center in the USDA Agricultural Research Service in Wyndmoor,
Pennsylvania.

He\'s going to speak to us today about chemical residue. Steven.

DR. LEHOTAY: This is my first Power Point presentation, and I hope it
goes smoothly. I prefer slides for a number of reasons, but didn\'t have
time to prepare them. So this has the advantage of being something you
can prepare out in the audience when others are speaking.

I\'m at the Agricultural Research Service, Eastern Regional Research
Center in Wyndmoor, Pennsylvania. I\'ve been lead scientist there since
April.

Before that I had worked in pesticide residues in Beltsville
Agricultural Research Center for seven years.

This talk I\'ll try to go through in a reasonable time frame considering
the situation. And we\'ll see what I skip on this.

One of these that I\'ll skip is this one. And I just wanted to give two
perspectives about chemical residues.

I\'m really surprised and glad that there has been so much discussion
about chemical residues. I expected that microbiology would rule the
day, as it has for the last several years in these situations. Research
funding has been decreasing for chemical residue work. So it looks like
there is starting to become a comeback.

But there are two perspectives. Perhaps you\'ve had time to read it. And
the other perspective perhaps you could say that we should not use
synthetic chemical residues.

But the middle ground is what the current situation is in regulatory
agencies.

And we must keep the benefits in mind. If we can recognize problems with
chemical residues in food and the environment ‑‑ which is often a
lacking issue or point of discussion or point of thought in regulatory
environment ‑‑ is that if we have the means to measure, monitor, and
control residues, then we should do so, and within a reasonable cost.

And that\'s what I hope my research does, is to address this issue
within a reasonable cost. So I hope to develop methods that are low cost
that can be used to solve residue issues without bankrupting people or
within the limitations and resources.

So with that, there\'s several needs for chemical residue methods
research, method development. And that is mainly for compliance,
enforcement, monitoring.

Dr. Masters talked about this earlier in the National Residue Program of
FSIS. And that is one of our main customers in the Agriculture Research
Service, and we try to meet their needs.

The international trade issues is a very important issue for chemical
residue methods, the trade barriers that are created in relation to
chemical residues.

Data for risk assessment, reregistration, particularly for pesticides.
Since the implementation of the Food Quality Protection Act, the EPA is
using the results from methods that are used in states widely for
reregistration.

And these methods that are used by the EPA have done a lot of good to
save registration of many organic phosphate pesticides.

Verification of organic food labeling, or conversely, marketing of
residue-free products. There are programs that show that, if you can
demonstrate that your product is residue-free, it\'s just as good in the
mind of the public as organic food.

Antimicrobial resistance, which has been discussed a widely in today\'s
meetings.

Hormone and endocrine disrupting effects, which has not really addressed
at this meeting. But the risk assessment of chemical residues is an
entirely different process than something that\'s an acute toxicity or
acute effect such as pathogens.

Chemical residues have unknown long-term effects. And it\'s a much
different problem. And you need data for risk assessment. And that is
the key component, is having good solid data. Garbage in equals garbage
out.

Protection from deliberate adulteration. This is another way of saying
terrorism. This has become an issue. And chemical residue monitoring
might be able to help address those.

And monitoring in HACCP plans, you are more familiar with this than I.
And whether or not HACCP plans need chemical residue monitoring is
something that I\'d be very interested to know about. And I\'m glad I\'m
here.

And if you would like to discuss such needs with me, I would like to
listen.

Current methods that are used by regulatory agencies and industry and
contract laboratories, academia, around the world often are out of date.
Many of them are 20, 30 years old and still being commonly used, using
technology that ‑‑ well, there\'s certainly better technology now.

They\'re time consuming, often laborious, inefficient, and single
analyzing, many of the methods developed by registrants, for example.
They only are for one pesticide or drug in one commodity, which is what
they were registered for. That is not useful for multi-residue
regulatory monitoring.

So the desire for new techniques, of course, you want everything. You
want your cake and eat it, too. Rapid, automated, inexpensive,
uncomplicated, waste-free, sensitive, portable, rugged, and universally
selective.

The chances of something that can meet all of these needs is basically
nil. So an old engineering maxim is, Select any five or seven of these
desired traits, and you just have to live within the limitations.

The Agriculture Research Service is divided into these areas. And in the
past, when chemical residues, in the early 1990s, was a big issue, there
were six locations with many scientists working on very different
problems.

Then we went through a period, in the last six, seven years, where
residue issues were not part of the food safety initiative. I personally
applied for grants ‑‑ couldn\'t even apply for grants because chemical
residues were not part of food safety.

FSIS, for example, went through seven years where they did not submit
any residue requests for their research program.

This year we had 33 requests, so we\'re grateful for that. ARS had to
send them back and narrow it down to 15, of which I think three or four
were picked up by ARS locations that are currently doing residue
research. This would be Fargo, Peoria, and Wyndmoor.

The Wyndmoor area, which I am the lead scientist on the program using
advanced techniques for veterinary drug and pesticide detection method
development.

In Fargo, North Dakota, Richard Larson is head of the group working with
dioxins, contaminants.

And Connecticut, for veterinary drugs, David Smith is doing that one.

And Jerry King is exploring supercritical fluid extraction in Peoria
concerning veterinary drugs and pesticides.

But in the meantime, while the ARS had been consolidating and mainly
focusing on expanding in the direction of microbial pathogen research to
address the immediate needs, which certainly were worthwhile ‑‑ and I\'m
not in any way saying that chemical residues rate as highly as pathogens
in terms of food safety, at least not in the acute, short term.

But the Food and Drug Administration and others are doing chemical
residue research, of course. And I wanted to mention that. Industry,
academia, and states, also.

So in our group at the Eastern Regional Research Center, our goal is to
develop better approaches using advanced technologies and techniques for
the rapid and reliable analysis of chemical residues in food. And this
overall goal, the approach that\'s used will be lab-based and also
field-based.

So we\'re doing ‑‑ two scientists will be doing veterinary drugs
analysis using lab-based instrumentation. And I\'ll be the pesticide
residue chemist, and that\'s for both fruits, vegetables, and animal
products.

In developing methods and defining needs, it\'s critical to assess these
purposes, to define the purpose of analysis.

And you have to have a balance with the need for the data and the cost
of the data and what it is worth. And that is something that has to be
very carefully defined before you go into providing the necessary
resources and personnel.

I currently think there is a misbalance between what the needs are and
what requirements they require of analytical methods.

There\'s a number of veterinary drugs and pesticides. It\'s a very big
problem, and it takes a lot of effort and research to assess these
problems.

We want multi-residue, multi-class techniques and an efficient process
that regulatory agencies and others can use. We have a long way to go.

How do we assign our priorities? The selection process that we follow ‑‑
and that is to get customer feedback from the agencies and industry, a
number of USDA agencies, Food Safety Inspection Service as well as
APHIS, AMS, and the Grain Inspection, Packers and Stockyards
Administration, FGIS, as well as EPA and FDA, as well as other
international agencies and industry.

We take this feedback, and we look at what the adequacy of current
approaches are. And if there really isn\'t ‑‑ if it ain\'t broke, don\'t
fix it. So if something is working well now and they have what they
need, then we won\'t perform research on that.

But we have to look at the technological capabilities of overcoming the
problems, and we have to look within our laboratory resources and
personnel to say whether or not we can meet these needs.

And personally as an ARS scientist, we must assess our own goals, and we
try to make an impact as best as possible. And I can assure you that all
ARS scientists have this in mind.

And goals are rapid methods, of course. If we can increase the
percentage of the food supply monitored, then it will better ensure food
safety. And that is an overriding goal.

And there\'s a number of projects that we have ongoing. And we\'ve
gotten feedback from FSIS, and all of these have needs in terms of ‑‑
fluroquinolones in particular have antibiotic resistance concerns.
Thioureastats are banned substances, growth-promoting substances. EU is
particularly concerned about these in trade practices.

Beta agonists is another one of the growth promotants. Anaracopamine has
certainly made the news recently that we\'re including in our mass
spectrometry studies. And we have several projects concerning
pesticides.

Here\'s an example of the florescence method that we\'re using for
fluroquinolones in chicken. And you can see that from five to 50 parts
per billion can be detected in real chicken liver using a microdialysis
approach.

This is an on-line automated system, little cleanup, and the use of
nonhazardous solvents. This is a real sample we incurred.

But in the coming years what we\'re focusing on is mass spectrometry. It
took several years for me to get an LCMS instrument that we\'ll be using
for our studies to do multi-residue, multi-class analysis, which is
something that has been sorely lacking in the laboratory. It is both
confirmatory and quantitative, and it can be done simultaneously.

It\'s able to distinguish trace levels in a complex matrix, which saves
on cleanup, which is a major labor saver.

And as time goes on, like computers, such techniques as mass
spectrometry is increasing in quality while costs are going down. So
benefits exceed the costs.

Here\'s an example of something that it took me about two weeks, when we
started applying mass spectrometry, to do, that John Pensovenny
\[phonetic\] in our group had been working on for some time using a
nitrogen phosphorous detector. You know, we did a derivatization in ‑‑
the details don\'t matter.

But here is an example of confirmation of .1 parts per million of four
thioureastats, growth promotants, at 100 nanograms per gram spiked in
meat.

And over here we have unambiguous confirmation using MSMS techniques.
And this meets EU standards for banned substances, which requires four
points of identification, and MSMS does that.

And I\'d just like to point out that the baseline is flat. And if you
had seen this using the traditional approach, the nitrogen phosphorous
detector, the whole thing would just be graphs, and you would see four
peaks that you could not know really what they are.

So I\'m very keen on this approach and looking forward to doing more
work using these techniques.

And here\'s another example of what can be possible with low-pressure
gas-chromatography mass spectrometry.

The traditional method for these 20 pesticides would take, at the
minimum, 20 minutes.

This peak out here, which you might not be able to see too well, is
Delta-metharine, which is a very late eluding \[phonetic\] pesticide.

And here we have dichlorovos \[phonetic\], which is the earliest eluding
compound, and in between we have a range of all pesticides. And this is
a six-minute analysis with very good sensitivity and sample capacity.

Another approach that I\'m very hopeful for is direct sample
introduction for gas-chromatography mass spectrometry, tandem mass
spectrometry. And the procedure is simply four steps or five steps.

You weigh the sample, and you add some salt if it\'s moist. You add some
acetonitrile and blend it. You centrifuge it if you\'re in the
laboratory. If you\'re not in the laboratory, you might be able to
separate it by another means. Then you add some anhydrous magnesium
sulfate to dry it, and you just inject it.

No cleanup, no sample preparation, no filtration. It\'s sensitive,
confirmatory, and quantitative. And furthermore, it\'s a very rugged
approach because the nonvolatile residue sample components that would
contaminate your system stay in a little microvial.

It still has some concerns that you can\'t have your cake and eat it,
too. It\'s not portable, it\'s manually run at this moment. And it can
be automated. But it\'s also only for targeted analyzing.

Here\'s a picture of what it entails. You take your sample extract, you
put it in this little microvial, put the little microvial into the
probe, and you put your probe into your MS. It\'s a five-minute sample
preparation procedure, really, and a ten- to 15-minute analysis for, we
can do maybe 40 pesticides.

So one of the other problems is, if we build it, will they come?
Acceptance criteria, it\'s a very difficult problem to transfer
technology, and that\'s the end result of our work. It must be
transferred.

I mentioned supercritical fluid extraction. ARS scientists, there are
three of us who spent seven years on supercritical fluid extraction
because we thought it was the next coming technology that would
revolutionize how sample preparation has been done.

Well, in my case I spent seven years on this project, and just this last
year AOAC method has been approved ‑‑ well, more or less ‑‑ it\'s going
to be approved. The statistics were validated.

But of course, in that meantime, supercritical fluid extraction
technology died for a number of reasons. Good reliable instrumentation
was one of them.

But each of these has to be met. Capital is also very important.

The removal of arbitrary barriers. And I just want to point out that of
course there are arbitrary barriers, and we must recognize how ‑‑ what
is the purpose of such an obstacle that is placed in technology
transfer? So that\'s something I would like to talk about at some point
in the future with customers, and I have in the past.

And this shows in any new technology there is implementation costs
involved. And in theory you will have a savings out at some distance
time. And it takes some time to get there. But the status quo is
generally rising.

So with that, I hope that the work that we\'re doing at the Eastern
Regional Research Center and other places in ARS will have these
impacts:

Higher lab efficiency; lower costs; increased monitoring rate, which
will better ensure food safety; provide statistically valid and accurate
results; overcome trade barriers that have been problematic; and improve
understanding of endocrine destruction and microbial resistance; and of
course, greater consumer confidence.

So with that, thank you.

(Applause.)

DR. GILLESPIE: Our next speaker is Dr. Monty Kerley. And his talk today
is on the management of water and manure. Dr. Monty.

DR. KERLEY: I\'m going to take a page out of Al Pope\'s book. And when I
get back, I\'m going to tell my chairman, I had the paper everyone
couldn\'t wait to hear today.

(General laughter.)

DR. KERLEY: I won\'t tell him that it was the last paper of the day. I
also will take license that if I skip a few slides, I\'ll assume nobody
will protest about that, either.

The only thing, in connection to the waste, manure management and water
will be, the approach we\'ve taken in our research and laboratory is, if
we take the pathogen, whether it\'s animal related or human related, out
of the equation, it\'s going to be hard for the manure to have that or
for it to recontaminate the water.

Now, the whole approach we\'ve taken there is, we want to do things
that\'s going to improve intestinal health of the animal.

And the way I define intestinal health currently is, we\'re going to
take the bad bacteria out of the equation, and we\'re also going to
promote proper function, if you will, of the mucosal and cirrhosal layer
of the intestine. So that\'s how I define intestinal health.

Now, I think in the future what we\'re going to see is a movement into
how the bacteria signal the gut, peptides that may be important in the
gut, and then, how that second largest endocrine gland in the body ‑‑
i.e., the intestinal tract ‑‑ communicates with the body systemically.

So, the approach to our work: We start with the substrate. What\'s
important about this is we can, to a large degree, affect the population
of bacteria that are present in the colon and throughout the intestine
of an animal by the substrate that we give those bacteria to ferment.

Whatever substrate is present the bacterial species can set up a unique
advantage or niche to ferment that over other species, that bug is going
to become a dominant player in the gut.

So that\'s how we make an indigenous bacterial species, or these good
guys that are present in the gut, come about and, related to what Norman
talked about, some competitive exclusion at work.

What do they do? Two things. First and foremost, they make short-chain
fatty acids whenever they ferment the fiber. They do this by simply
fermenting the carbohydrates to acidic, propionic, and butyric acid.

And if you remember some of the biology of the gut, butyric acid is the
one we\'re most concerned about, because that\'s the preferred fuel for
a colonosite in the gut. So we can make a healthy intestine with that.

The other thing the short-chain fatty acids have been attributed to do
is to control growth of various pathogenic bacteria in the gut. So
besides keeping the gut healthy, we also have some suppressive effect on
the bugs we don\'t want to grow, some advantage, then, to the bugs we do
want to grow.

The indigenous bacterial species in the gut are also known to produce
antimicrobials or bacteria that prevent growth of pathogenic bacteria.
If you know about niacin and how it\'s used in human industry, in large
part that\'s how it works.

So both of those things come into play, and we have a positive effect on
disease prevention.

I also want to show some work that we have done and that\'s been done by
ARS lab that we can also have an effect on foodborne pathogens, as well.

Mucosal proliferation differentiation, the thing I want to say here is,
the nice thing ‑‑ or at least my current take on what fiber does when
it\'s fermented in the gut, we have these short-chain fatty acids
produced. What they do is cause not only proliferation of the intestinal
tract, but also differentiation as well.

The importance there is that\'s the difference between cancer and normal
gut.

As we have differentiation at the same time as we have proliferation of
the gut, we\'ve seen increased digestibility. Our model we\'ve worked
with has been the young pig. We see increased digestibility when we have
this more normal functioning intestine. And all that hopefully comes
together as improved performance.

The way that we have approached this is, yes, we want to get rid of the
foodborne pathogens, we want to get rid of odor, some of those sorts of
things. But how does the producer get paid back for that? And if we can
tie in some performance advantages, then that makes an economic
incentive for the producer to do that, and we have the good benefits
that come along with it.

Okay. The other point I want to make about the short-chain fatty acids.
The concentration and ratio of the short-chain fatty acids are dependent
on the type of fiber we put into the gut. The reason for that is the
type of fiber selects the type of bacteria we\'re going to have present
or dominant in that intestinal tract.

So if I want more butyric acid, I need a substrate that\'s going to give
me as much butyric acid as I can get out of that fermentation.

Fermentability of the fiber will also affect the point in the gut where
the short-chain fatty acids are produced; i.e., if I have a very
fermentable fiber, then I can see short-chain fatty acids produced in
the terminal ‑‑ the small intestine, the cecum, and the proximal colon.

If I have a moderate fermentation, I can move that back further into the
colon of the animal. So I can control that in large part by the type of
fiber that I put in the diet.

We\'ve used short-chain fructooligosaccharide in the work we\'ve done,
and the reason for this is it\'s rapidly fermented. The second thing it
does is, it\'s uniquely fermented by Bifidobacteria.

We wanted to get a Bifidobacteria population established in the gut,
because they, like Lactobacillus, have been shown to be inhibitory to
growth of several pathogens that can affect both the animal and also
have some human foodborne concerns.

The short-chain FOS we\'ve used has a glucose of 2, 3, or 4 fructose
units bound to it. And what\'s important about that is the
Bifidobacteria is unique, and if they have a fructocidase enzyme, it
allows these fructose units to be cleaved off of these short chains.

The chains are short enough that they\'re soluble, and it\'s relatively
easy for the bacteria, then, to pull these oligosaccharides
intracellularly, where they can hydrolyze them and then ferment them to
short-chain fatty acids.

Okay. Some of the specifics on what the short-chain fatty acids do on
intestinal health: pathogen growth and mucosal development I\'ve already
mentioned; they increase intestinal blood flow.

Actually, if you look at colonic anastomoses that are done now in
hospitals, what they\'ll actually put those people on oftentimes rather
than bowel rest is some liquid type diet that has a fermentable
substrate ‑‑ i.e., FOS ‑‑ in it. The reason is the fermentation promotes
more rapid healing of the colonic tissue.

Stimulate secretory responses. If we have the right type of bug that\'s
attached to the intestine, my interpretation of some of the work is that
those bacteria will ferment some of the mucin that\'s produced and
actually sets up the right type of secretory mucin response by the
intestinal cell; i.e., intestinal health.

Enhances absorption, probably of most concern in young animals and
companion animals, certainly in preventing scouring.

The presence of short-chain fatty acids in the small intestine will
result in increased peristalsis of the small intestine; i.e., there is a
recognition there that overgrowth of bacteria is beginning. The gut
wants to shove that out of there, because it doesn\'t want fermentation
there in the small intestine.

The large intestine or the colon, just the opposite happens, the slowing
of peristaltic activity, allowing absorption of these short-chain fatty
acids the animal will use for energy.

Okay. We looked at several different oligosaccharides that were
purported to have bifidogenic properties of the oligosaccharides; i.e.,
promote growth of the Bifidobacteria.

On top of the bench, in culture, we looked at two. One is a short-chain
FOS that we were interested in studying. The second, the red-line, which
shows wild growth, or exponential growth, occurring later on, was a

xylooligosaccharide.

And we had interest in those two and how they might promote growth. And
we used the mouse as a model in this work.

We fed four diets, nutritionally complete diets, but we had either no
fiber in the diet, the control diet; we had the short-chain FOS that
we\'ve used; gum arabic, which is kind of a standard fiber, a positive
fiber control, if you will; and then, the xylooligosaccharide.

What I\'ve got in the three columns is the Bifidobacteria population at
10^8^ and then the total anaerobic flora that was present in the gut.
And then I expressed the percent of the total anaerobic flora as
Bifidobacteria.

Now, the thing that I think is important about this work is that it
shows, depending upon the fiber type ‑‑ and maybe what happens in the
test tube isn\'t exactly what\'s going to happen in the gut of the
animal. The FOS was the only fiber in the work that we\'ve done where
we\'ve seen an increase in Bifidobacteria populations in the gut.

Why is this important? There was some work that was done. We looked at
two populations of Bifidobacteria, 10^8^ and 10^7^. And then they set up
some mucosal cells in a continuous culture, and they looked at invasion,
then, by either pathogenic E. coli or salmonella.

And what they found was that the higher concentration of Bifidobacteria
got a little over 90 percent prevention of invasion by E. coli in the
cells and around 40 percent for salmonella.

So what happens here is the Bifidobacteria are providing some protection
against invasion by these pathogens to mucosal cells.

Well, knowing that information existed, we were interested in seeing if
we could set an animal model to study that.

We took pigs that were about eight days of age, put them on a complete
milk replacer ‑‑ and so day one would be eight days of age in the pig\'s
life ‑‑ fed that for seven days. And at seven days, then, we gave them
oral gavage of pathogenic E. coli, and at ten days, we took fecal
samples on those pigs and also looked for clinical signs of disease.

What we found, by day one, they were similar populations of the
Bifidobacteria and total E. coli ‑‑ this isn\'t just pathogenic ‑‑ total
E. coli.

On day 10, the pigs that did not have FOS in the diet, seven of the
eight showed clinical signs of disease. And if you look at the pigs
compared to those that were fed the FOS in the diet, there was a tenfold
higher concentration of Bifidobacteria and about a tenfold lower
population of E. coli when FOS was present.

We showed essentially the same type of results in a hamster model,
studying Clostridium difficile, protection against C. difficile
infection whenever the hamsters were fed a diet that had FOS. If you
look at the proximal colon and the distal colon data on this slide, we
measured ‑‑ crypt depth and proliferation is the only two I showed.

We were interested in these neonatal pigs, same-age pigs, what happened
to some of the intestinal morphology if we fed the diet with or without
FOS, snd again, these were milk replacer diets.

What we found was that, in both cases when FOS was in the diet, at the
proximal and distal colon, there was an increased crypt depth, increased
proliferation zone. I think this falls right in line with the work
that\'s been done looking at other fiber, the effects of other fiber
sources on intestinal morphology.

The indices we have are, we have a healthier intestine ‑‑ i.e., a
thicker mucosa ‑‑ and, we would think, perhaps a more active or greater
digestive capability.

The other thing I thought was interesting is some work we did. We looked
at small intestine morphology. So if you look, villus height was
increased in pigs that had FOS in the diet.

And this goes along with other work that\'s been done with fiber,
showing there is a systemic effect throughout the gut whenever fiber is
included in the diet and fiber fermentation occurs.

Now, we\'ve also seen an increase in nitrogen balance, which makes
sense, because we see an increase in growth of the pig whenever it\'s
fed FOS.

I thought an interesting concept was what happens to nitrogen digestion.
In this experiment, we fed either 0, 3/4, 1-1/2 grams of FOS per day or
1-1/2 grams of FOS then recommended a level of carbodox \[phonetic\]. We
looked at digestibility retention of nitrogen.

What we found in this work was a significant increase in nitrogen
digestibility, and the only way we have at present to explain that is we
had an intestinal tract that had greater functional capabilities in this
age pig to digest the protein that was presented with it.

Now, it\'s interesting. A lot of the bacteria, the salmonella,
clostridium, a lot of the bacterial species that cause disease or
foodborne pathogens also have the capability to take the aromatic amino
acids and to ferment those to skatole, indole, paracresol, those type of
compounds.

We had four diets, a factorial arrangement of either the short-chain
fatty acid or antibiotic, again using carbodox in this work, and then
took fecal samples ‑‑ doesn\'t include the urine ‑‑ but took fecal
samples and submitted those to Mike Williams at North Carolina in the
Animal and Poultry Waste Management Center and had a human panel
evaluation of those.

Why they use pleasantness to describe fecal smell is beyond me, but
it\'s not my area of research.

The point that\'s important about that is the combination of the FOS and
the antibiotic gave a pleasantness score of 5.1. 5.0 or lower is a
ranking that\'s nonobjectionable to humans.

So the point is, even on the odor front, and taking a microbial link
here, we can do much, I think, to have some control on odor in animals.

I show this slide because a combination of the FOS and the antibiotic
gave us essentially tenfold reductions ‑‑ and that should be paracresol,
not just cresol ‑‑ but gave us essentially tenfold reductions in fecal
excretion of these metabolites.

What I take away as important here and the possible link is food
quality. Skatole is one of the big problems in terms of how humans
associate boar taint to pork meat. And my understanding from some of the
swine people is that can transfer even to gilts as well.

So I have a curiosity here. If we go in, we reduce skatole production in
the intestinal tract, the colon primarily, can we then also reduce that
concentration in the meat and have some effect on food quality?

Early weaned pig growth. This is performance data. We looked at several
different levels of FOS and then the combination of FOS and antibiotic.

Two things that are important. If you look at the body weight ‑‑ and
this is weaning pigs at about 17 days of age ‑‑ and body weights, then,
at around I think four weeks beyond that, what\'s important is level.

I think we can, if we go in with a prebiotic approach to the gut, we can
do too much of a good thing. So there\'s an optimum, at least for the
FOS that we\'ve studied.

The second thing that I would point out that I think is interesting, if
you look at the .4 plus AB, that\'s FOS plus the carbodox, in the
experiments, where we\'ve seen a positive response to antibiotic, we
tend to see, or we have seen a positive to the fructooligosaccharide.

There\'s experiments were we don\'t see a response to antibiotic, and in
those we tend not to see a response to the fructooligosaccharide as
well.

The interesting part is, we essentially have always seen an additive
response to both antibiotic and the short-chain fatty ‑‑
fructooligosaccharide. The point is, we\'re having an effect on the
bugs, but it probably occurs through two different scenarios.

Final work I want to ‑‑ being a beef person giving largely a swine
study ‑‑ Jim Droulliard \[phonetic\] would know that I have to finish on
a beef slide just to feel good about myself.

Some work that Jim Russell\'s lab did at Ithaca, ARS scientists. And
what Jim showed, if you look at the acid-resistant E. coli
concentration, that whenever the cattle were fed hay, there was a
substantial decrease in acid-resistant E. coli, the guys that we really
want to get rid of from a foodborne pathogen standpoint.

If you look at that work, the whole effect there is primarily ‑‑ and I
think Jim\'s interpretation as well ‑‑ is primarily the consequence that
we\'re increasing pH, and we don\'t set that bug up, then, to have
acid-resistant capabilities.

So in conclusion, the first approach that I would really lobby for from
the standpoint of trying to have some control or reduce foodborne
pathogens as well as animal pathogens is start with the diet.

What can we do in that diet to manipulate the gut and the environment of
that gut?

Secondly is the indigenous microflora population of the digestive system
can be manipulated to greatly reduce if not alleviate foodborne pathogen
loads in food.

And then, the reduction in foodborne pathogens may also have beneficial
effects well beyond our current yardstick of just trying to reduce their
numbers or alleviate their numbers in the food products; namely, it can
be beneficial to animal performance to the producers who are producing
those animals and be a driving force for including those in the diet.

That\'s it.

(Applause.)

DR. GILLESPIE: I\'d like to have you join me in thanking all our
presenters.

(Applause.)

DR. RAGAN: Thank you very, Dr. Gillespie. I would just call your
attention to the reception in the same area that we had lunch at 6:30,
and to say that tomorrow is breakout group day, but we will all gather
here at eight o\'clock. And we will have information on where to go and
who is in charge.

Thank you very much, and have a good evening.

(Whereupon, the meeting was adjourned at 5:45 p.m., to reconvene
September 7, 2000, at 8:00 a.m.)

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[REPORTER\'S CERTIFICATE]{.underline}

IN RE: National Conference on

Animal Production Food Safety

DATE: September 6, 2000

LOCATION: St. Louis, Missouri

I hereby certify that the proceedings and evidence are contained fully
and accurately on the tapes and notes reported by me at the hearing in
the above case before the U.S. Department of Agriculture.

Date: 9/27/2000

[Phyliss Lund]{.underline}

Official Reporter

Heritage Reporting Corporation

1220 L Street, N.W.

Washington, D.C. 20005