UNITED STATES DEPARTMENT OF AGRICULTURE

**PATHOGEN REDUCTION: A SCIENTIFIC DIALOGUE**

Georgetown University Conference Center

3800 Reservoir Road

Washington, D.C. 20057

Tuesday, May 7, 2002

8:30 a.m.

I N D E X

[AGENDA ITEM]{.underline}: [PAGE]{.underline}:

Welcome and Introduction of the Under Secretary 212

Karen Hulebak, Conference Chair

Opening Remarks 214

Under Secretary Elsa A. Murano

Panel 3: Performance Standards and Microbial 224

Testing

Chair: Gary R. Acuff, Professor of Food

Microbiology

Texas A&M University Panel

Panelists:

Standards and the Economics of

Compliance and Innovation

Dr. Elise Golan

Economic Research Service

U.S. Department of Agriculture

Microbial Testing for Control Verification

Dr. Robert L. Buchanan, Director

Office of Science, Center for Food Safety

and Applied Nutrition

Food and Drug Administration

Indicators and Surrogates vs. Pathogens

Dr. Frank Busta

University of Minnesota (Retired)

Performance Standards and Statistical

Sampling

Dr. Loren Lange, Assistant Deputy

Administrator

Office of Public Health and Science

Food Safety and Inspection Service

U.S. Department of Agriculture

Panel 3 - Discussion 287

I N D E X

[AGENDA ITEM]{.underline}: [PAGE]{.underline}:

[Afternoon Session]{.underline}

Panel 4: Intervention Strategies, Including 328

Verification of Effectiveness

Chair: James S. Dickson

Associate Professor and Chair

Microbiology

Iowa State University

Panelists:

Animal Production Intervention Strategies

Martin J. Firth, Manager

Policy and Strategies Division

Canadian Food Inspection Agency

Reduction of Contamination at Slaughter

John N. Sofos, Professor

Colorado State University

Characterization and Control of Foodborne

Pathogens

Dr. John B. Luchansky

Agricultural Research Service

Cost-Benefit Analysis and the Adoption of

Food Safety Innovations

Michael Ollinger, Economist

Economic Research Service

U.S. Department of Agriculture

Panel 4 - Discussion 398

Administrative Matters and Introduction of Deputy 426

Under Secretary

Closing Remarks 428

Merle Pierson

Deputy Under Secretary for Food Safety

Adjournment

P R O C E E D I N G S

8:44 a.m.

Welcome and Introduction of the Under Secretary

DR. HULEBAK: Good morning. Welcome back to Day 2 of Pathogen Reduction:
A Scientific Dialogue.

Before I introduce Dr. Elsa Murano, Under Secretary for Food Safety,
who\'s the opening speaker for this second day, David Boden, if you\'re
in the audience, would you please call your office as soon as possible?

Dr. Murano, who\'s the Under Secretary for Food Safety at the Department
of Agriculture, will open today\'s meeting. I mentioned yesterday she
was sworn in by the Secretary of Agriculture Ann Veneman in October of
this past year, and as Under Secretary, she oversees the policies and
the programs of the Food Safety and Inspection Service. She has
extensive public and private experience with food safety as a manager
and as an educator, and immediately before joining this Administration,
since 1997, was Director of Texas A&M University\'s Center for Food
Safety within the Institute of Food Science and Engineering.

She\'s a native of Havana, Cuba, and she holds a Bachelor\'s of Science
degree in Biological Sciences from Florida International University,
Master\'s of Science in Anaerobic Microbiology and a Ph.D. in Food
Science and Technology, both of those last two degrees from Virginia
Polytechnic Institute and State University in Blacksburg, Virginia.

She\'s previously served as Professor at Iowa State University in Ames,
and immediately before her appointment as Under Secretary, she was a
member of the USDA\'s National Advisory Committee for Meat and Poultry
Inspection.

Dr. Murano has defined five goals to guide FSIS as it works towards
achieving its mission of protecting the public\'s health through
ensuring the safety of meat, poultry and egg products, both domestic and
imported. These five goals are: (1) secure our food supply from
intentional harm; (2) base policy decisions on science; (3) improve the
management of agency programs; (4) improve coordination with sister
agencies; and (5) engage in aggressive education programs.

This scientific symposium, yesterday\'s and today\'s meeting, has been
planned by FSIS with Dr. Murano\'s five goals clearly in mind. As an
exercise in scientific dialogue, it is an activity that is centrally
focused on Goal 2, and with an eye to Goal 4, it also involves
substantive involvement from experts in our sister agencies within USDA,
FSIS, ERS, Economic Research Service, and Agricultural Research Service,
and with our Public Health Service sister agencies among HHS\' agencies,
FDA and CDC, and also through participation with our neighbors to the
south from Mexico and to the north from Canada.

And now, I\'d like to introduce to you the architect of these goals, Dr.
Elsa Murano.

(Applause)

Opening Remarks

DR. MURANO: What a nice introduction, my goodness.

Well, good morning, everybody. Very glad to see all of you returning
this morning for the second day of our Symposium on Pathogen Reduction.

Well, yesterday, we heard several presentations on how hazards are
introduced into the food supply, and I think you will agree that the
discussions set the stage beautifully for what will be presented today.
In fact, several questions posed to yesterday\'s speakers revolved
around performance standards and intervention strategies, topics that
will be covered today. So, Frank Busta, where are you? Get your panel
another cup of coffee because you\'re going to need it, I think.

Well, this symposium was planned as part of a series designed to address
various topics of significance to food safety. Our first symposium was
held in January in Atlanta and revolved around the science of
epidemiology. There are seven more meetings to follow this one. So, you
may ask why is FSIS engaging in these symposia? How are these meetings
different from others the agency has held in the past?

Well, when I came to Washington last Fall, it didn\'t take me long to
realize that in spite of the tremendous strides that we have made in
food safety over the last few years, there are many challenges ahead.
Yesterday, we heard that hazards are introduced into the meat and
poultry supply at various points along the farm to table continuum,
pointing to the complex task that we face.

We also heard from CDC about a decline in foodborne illness from 1996 to
2001, but due to the many variables involved, it is difficult to
attribute this decline to any one factor.

Well, because of these challenges as well as many others, policymakers
need to make the best decisions possible; decisions that will address
the underlying problems affecting food safety, decisions that will
provide solutions that can be measured in terms of public health. In my
opinion, these decisions must be based on science and not on the path of
least resistance.

There are three lessons that I personally came away with from
yesterday\'s sessions. One is that prevalence data derived from
regulatory testing is by its very nature biased data and will not
provide us with the true incidence of pathogens on meat and poultry.

Secondly, data on foodborne illnesses collected by CDC is incomplete and
does not provide adequate information on the contribution of various
factors on disease, such as the type of food involved. Both of these are
essential if we are to determine whether interventions, HACCP or other
factors are making an impact on public health.

Thirdly, yesterday\'s meeting helped put into perspective at least for
me which of the steps from farm to table are the key points where
contamination must be controlled in order to improve food safety, and
none of these things were revelations to most of us, yet I believe these
were facts that we all needed to agree on before moving forward with
today\'s discussions.

Well, since my confirmation last October, as Dr. Hulebak said, I\'ve
been going around the country telling people that I want to inject as
much science into the policymaking process as the system will take and
then some. There are several ways to do this, I believe, some of which
have been in use by FSIS for many years.

Risk assessment is one such method which has proven very helpful to us
in showing the true impact of several hazards to our food supply.
Another is research, and I am happy to see several people here from the
Agricultural Research Service on whom, along with academia, we
policymakers depend in order to determine the strategies that can be
applied to directly control hazards to our food supply.

Yet a third method of injecting science into the process is to avail
ourselves of the experience and expertise of the scientific community
and to engage in meaningful conversations that may help shed light into
trends and thus enable us to be proactive in our decisionmaking.

For this reason, we are having this scientific dialogue, so that we can
hear from scientists that have dedicated their life to the study of
these problems and who can provide us with the guidance we need to make
sound policy that will translate into positive public health outcomes.

Lately, I\'ve been asked by reporters to define what I mean by science.
In fact, they usually ask me about sound science. I tell them that
science by definition is sound. Otherwise, it\'s not science, is it?
Still, they want to know what I mean, sometimes implying that what is
science to some may not be to others.

Well, since we\'re at a scientific symposium, I think this as good a
place as any for us to define science. So, let\'s see if we can do that.
Well, simply stated, science is a body of facts gathered by observing
the physical universe. One question that arises from this definition is:
well, what are the facts? Well, a fact is something that is true. What
is true, you may ask, and how does one know that a supposed fact is
true?

Well, maybe the following story will help us answer these questions.
Back in the 1600s, there was a man named Jean Baptiste von Helmont, who
proposed that mice could be spontaneously generated in at least 21 days,
not 20, 21 days, by putting a sweaty shirt and grains of wheat in a
dusty box. The sweat supposedly supplied the active principle which
caused the wheat grains and dust in the box to become mice.

Well, every time von Helmont conducted the experiment, he found mice
gnawing out from the box within 21 days. Well, certainly we know that
mice don\'t spontaneously generate, right? Right? Well, as it turns out,
the design of the experiment was faulty. von Helmont failed to take into
account that the mice might be gnawing into the box.

So, what could he have done differently? Well, was this a controlled
experiment in your opinion? In fact, let me ask what should have been
his control? I\'ll go ahead and open it up to anybody who would like to
answer that question. What should have been his control in this
experiment? A secure box. Good. Say that again. Box without a sweaty
shirt. Interesting. Very good. A secure box is Rosemary. Anybody else?
You scientists out there?

Well, these are good ideas for sure, and he didn\'t include any one of
those. The fact is that he was attempting to support his widely-accepted
belief, you know. He believed in spontaneous generation, and since his
results supported his belief, he didn\'t see the need to restructure the
experiment or to include any controls.

Well, thank goodness for Louis Pasteur. Wouldn\'t you say that? Because
he, around 1800, devised a series of experiments which to this day are
valid and which disproved once and for all the notion of spontaneous
generation. He prepared several sets of infusions and sealed them in
flasks. He then sterilized the infusions by boiling, and he opened one
set of flasks along a dusty road, another set in a forest, and another
set up on the mountains.

Well, later, Pasteur examined the infusions and found that those opened
in dusty places contained abundant and varied microorganisms. Those that
were exposed to cleaner air, like the one opened in the mountaintop, had
fewer and different microorganisms. Well, these results urged Pasteur to
conduct his now-famous Swan neck flask experiment in which he showed
that infusions that were boiled and sealed in flasks with long winding
necks would remain sterile unless he tipped the flask so that the dust
particles trapped in the neck could enter the infusion at the bottom of
the flask. He repeated the experiment several times and always obtained
the same results.

So, Pasteur\'s genius came from having designed an experiment that would
prove or disprove a theory, that of spontaneous generation, through the
planning and execution of a controlled experiment followed by data
collection, analysis of the data and verification by repeating it and
obtaining the same answer.

So, these are the elements of the scientific process, and it is why
science should guide our decisions about food safety. It is why we have
organized this symposium, to hear from the scientific community so that,
along with risk assessment, research, and other science-based
activities, we can achieve the goal of improving the safety of our meat
and poultry and thus accomplish the mission of protecting the public\'s
health.

Well, speaking of public health, I\'d like to say that I believe
strongly that one does not need to have a degree in public health to
understand what it means or to contribute to it. All of us in this room
are food preparers, some better than others, as my husband will tell
you, but we all play an important role in protecting the health of our
families when we wash our hands, when we cook foods to the appropriate
temperature, when we refrigerate leftovers promptly.

There are many in the audience you produce and process food for a living
and play an important role in protecting the public health when they
follow the tenets of good manufacturing practices of sanitation and
HACCP, and there are others in the audience who engage in research
regarding the hazards that can be found in food and how these can be
mitigated.

In that way, they are also participants in protecting public health, and
some of us play a role when we draft policies based on the answers
provided to us by these researchers through the application of the
scientific process.

So, let no one doubt that we are all here because we are interested, in
fact, we are dedicated to protecting the public\'s health. This is why
our symposium is entitled \"A Scientific Dialogue\". We must all engage
in a dialogue with the scientists who are here to contribute their
expertise but without the rest of us, food producers, food processors,
consumers, and policymakers, this would just be another scientific
meeting.

So, I urge you all to participate in the discussions today, to leave
other agendas at the door and to come with an open mind, an open heart,
so we can get to the business of making food safer for all Americans.

Before I relinquish the microphone to Dr. Hulebak, let me challenge you
with a thought for today\'s discussions. Last week, I sat next to a
mother who testified before a congressional committee on how her son had
been very ill at age 10 after consuming an undercooked hamburger
contaminated with E.coli 0157:H7. Well, my opinion for that family, both
microbial testing and a zero tolerance policy for this pathogen in raw
product, failed miserably. Neither was able to ensure that the product
would be safe.

Ladies and gentlemen, I think we can do better, and I think we must do
better. We must not allow our policies to be guided by wishful thinking
nor by political expediency. So, I would like to submit to all of you
the following questions for discussion today.

What should be the appropriate role of microbial testing and zero
tolerance of raw versus cooked products, and how could HACCP or other
systems be applied best in order to ensure safety of meat to the
greatest extent possible?

Well, thank you for your attention this morning, for your commitment to
food safety and to public health. I certainly look forward to a great
dialogue this morning, and I will relinquish the microphone now.

Thank you very much.

(Applause)

DR. HULEBAK: Thank you very much, Dr. Murano.

I\'ll now introduce Dr. Gary Acuff, who is the Chairman for Panel 3 for
this symposium, which concerns \"Performance Standards and Microbial
Testing\".

Dr. Acuff obtained his Bachelor\'s of Science in Biology from Abilene
Christian University and then went on to get Master\'s and Ph.D. degrees
from Texas A&M. He currently is Professor of Food Microbiology and is
the Food Science Section Leader in the Department of Animal Science at
Texas A&M University.

His research focuses around microbiological safety and shelf life of red
meat. He\'s also interested in microbiological hazards of fresh produce.
He also carries a heavy teaching load for graduates and undergraduates
and has authored or co-authored over 75 articles in peer-reviewed
journals. He currently serves as a member of the National Advisory
Committee on Microbiological Criteria for Food. Actually, he served as a
member. A little moment of panic there.

Join me in welcoming Dr. Acuff and Panel 3.

(Applause)

Panel 3: Performance Standards and Microbial Testing

DR. ACUFF: Well, we have an interesting panel, I think, for your
enjoyment this morning.

I will chair and give you sort of a brief introduction, then we\'ll hear
from Dr. Elise Golan, Dr. Buchanan, Frank Busta and finish it up with
Loren Lange, and I have reviewed all of these guys\' presentations just
a little bit and they all look very interesting. So, I think you\'re
going to really enjoy it.

All right. Well, you remember how hard it was to stay awake in that 8:00
history class? Well, I don\'t want you to flash back but that\'s what
we\'re going to do. We\'re going to talk about some history.

This is a piece of art by Pisarro, and this is depicting a poultry
market about the turn of the 20th Century. This is the early 1900s, and,
you know, yesterday, we were talking about custom slaughter, and boy,
this is as close as you get right here. So, you go in and pick out what
you wanted, and you could take it home and slaughter it or they would do
it for you right there, and microbiological criteria and HACCP had
probably not entered their mind at this point. HACCP may have. You know,
I think HACCP actually has been around for a long time. We just never
called it that, but maybe they had HACCP plans, but I\'m not sure
they\'d meet the regulation.

Well, things have changed. We have mass production of products. The
consumer demands precooked products. They want lengthy shelf life on
everything, and there are new expectations of safety by the consumer
that we all have to deal with and that we all need to meet.

Well, the other thing is we have a lot more data than we used to have.
The Centers for Disease Control have provided us with extensive
information on foodborne disease, and as we know, there are lots of
holes in the data, but considering the information we used to have, we
have a boatload of information here that we can use to try to ensure the
safety of our products.

Well, when we began to collect data and when we have these pressures to
produce a safe product, one of the things I think that naturally comes
to mind is there should be some sort of number that we can use to
determine whether this is safe or not because we don\'t want to make
subjective decisions. We would like to have everything black and white,
and by golly, there should be a number that we can use to take care of
things, and this has been around for a long, long time.

If you look back in the 1950s, the City of Portland, Oregon, established
a retail meat standard with an APC of 10 to the 7th per gram. They
didn\'t enforce it because they didn\'t have any money to enforce it,
but it was a nice idea, you know. They put it out there.

In 1971, the state actually established standards, and this followed a
baseline survey that they did. They went around and collected data and
they said, you know, we\'re going to do this baseline survey and figure
out where everything\'s at and then they said, you know, I believe we
could set some standards and remarkably again they picked this greater
than or equal to 10 to the 7th per gram for APC and less than 50 per
gram Escherichia coli, and again it was published but not enforced and
most likely because of a lack of funding to provide enforcement.

Well, later on in the \'70s, there was a big push from consumer groups,
and actually this is a picture of Ralph Nader talking to Upton Sinclair.
Whenever I was looking for a picture of Ralph Nader, you had to pay
copyright stuff on that. So, it just happened to be about the time he
was running for President and his picture prices went way up. So, all I
could find was this one with the top of his head talking to Upton
Sinclair that A&M could afford, you know. So, this is the best we can
do. Actually, I think from that angle, he kind of looks like Mike Doyle
a few years ago.

All right. Well, anyway, there may be something there, Mike. Is there
any? I don\'t know. Well, these consumer groups were doing some studies
on their own collecting samples, you know, and looking at what was
available in the deli case and the retail meat market, and Consumers
Union got involved and they published in Consumer Reports a little
report that talked about how deli meats and retail meats were really out
of control, and they had dangerously-high levels of bacteria.

Well, I\'ve always wondered, you know, I see that in the papers all the
time, I\'ve always wondered what dangerously-high levels of bacteria are
and maybe we can define that in our science meeting today. When we get
that figured out, I think we\'ll all be in good shape.

But they recommended standards for ground meat again, and you see this
time, it was less than or equal to 5 times 10 to the 6. They\'re getting
a little more accurate there and less than 50 per gram for E.coli. They
held a public hearing. Consumer groups were very supportive of the
microbiological criteria. The industry said very little about it, and
they were passed.

Well, when these were implemented, they had a system where they would
come in and sample, and if you were in violation, then you had to
resample in 60 days, and they had a three-strike system. On the third
strike, you were issued a criminal citation.

So, in between \'73 and \'76, they filed criminal charges against 27
retail store managers, and they published a list of markets that were
found in violation every other month. Well, there was a big outcry by
the industry, and the legislature in Oregon decided that they should
look at this. They set up a hearing and someone from the Oregon
Department of Agriculture came in and explained that this was simply a
tool to force sanitation improvement, a hammer, if you will, and that
this force of enforcing microbiological criteria improved quality in
public health, and his data to support that or evidence to support it
was that they had 16 percent of samples in violation in 1974 but yet in
1976, only nine percent were in violation.

Well, the legislature didn\'t really know what to do. So, they set up a
committee to look at this, which is standard procedure, I guess, and
this ad hoc committee reviewed the situation and ultimately decided that
the standards should be revoked, and they had several reasons for this.
I picked out three that I thought were interesting.

First, they said the standards were not enforceable. Secondly, they said
there was no reduction in foodborne disease or improvement in quality,
and third, they said that there were erroneous consumer expectations of
improved quality and safety.

Well, based on that, the standards were taken away, but there has been
activity internationally and nationally as well in microbiological
criteria, granted with more data and with more information at our
fingertips to begin developing these.

In 1981, Codex published a document called \"General Principles for the
Establishment and Application of Microbiological Criteria for Food\",
and they said that \"criteria should be established and applied only
when there\'s a definite need and where it\'s both practical and likely
to be effective\". Their recommendation for raw products regarding
pathogens is that it\'s going to \"meet limited success because of the
extreme variability of the organism on the product\".

In 1985, the Green Book was published, and they looked at the possible
application of microbiological criteria to 22 different food groups and
food ingredients, and in this report, they stated that criteria were not
recommended because they wouldn\'t prevent food spoilage or foodborne
illness, and if you can\'t comply consistently with the criteria, it
makes no sense to set them.

Well, their recommendation was that you implement HACCP because we had
low numbers of pathogens present on raw products, criteria were not
likely to prevent that, but their control would be possible through a
HACCP system.

Well, there are a couple of texts that are published by the
International Commission on Microbiological Specifications for Food. The
first of these is a first edition of the Book 2, which recommended that
we establish criteria for certain foods. In the second edition, that was
discontinued because they said commodities frequently failed criteria
and that there was no relationship to quality or safety.

Now, these texts were primarily designed for international trade, and so
we\'re looking at port of entry products. However, it is stated in the
text that while that is primarily for international trade and port of
entry-type products, the principles are the same across the board and
are not different between international and local products.

Well, that brings us to pathogen reduction HACCP regulation. The
pathogen reduction HACCP regulation established HACCP to ensure safety
and this is through, of course, process control. Associated with that,
the HACCP rule established testing to verify that we did have this
control. Now, these criteria are performance criteria which I\'ve never
been crazy about that term. I always wished they\'d called it
performance criterion since that\'s the singular form of the word, but
anyway, they\'re called performance criteria, which now, you know, is
accepted in the dictionary as a singular form.

You know, if you use things wrong long enough, they finally accept it.
Anyway, performance criteria for E.coli and we had performance standards
for Salmonella. Now, these are designed in the system to verify the
control that we have in the HACCP system, and, of course, there has been
a lot of discussion and heartache about how some of these have been
applied and how they\'ve gotten established, but we\'re working through
those roadblocks and problems and trying to get things on line.

Well, our panel today contains some people who have been active in
ICMSF, some gentlemen that have been active on the National Advisory
Committee and commenting on some of the HACCP regulation and standards
and criteria. We have some people on our panel today who are probably
considered some of the world\'s experts on microbiological criteria.

So, we\'re privileged to get to hear what they have to say to us today,
and our first speaker is going to be Dr. Elise Golan, and while I\'m
introducing her, let me get her slides up here.

All right. Dr. Golan is an economist at USDA\'s Economic Research
Service. She received her Ph.D. in Agricultural Economics from the
University of California at Berkeley in 1989 and was awarded a
post-doctorate fellowship by the Israeli Higher Education Council from
1991 to \'93 for work at the University of Haifa in Israel.

Before joining ERS, she did consulting work for, among others, the World
Bank, International Labor Organization, the California Department of
Finance. She served as a senior staff economist on the President\'s
Council of Economic Advisors in 1998 through \'99.

At ERS, Elise\'s work has focused on the distributional consequences of
food policy, the economics of product differentiation in food labeling
and domestic and international food safety policy.

So, join me in welcoming Dr. Golan, and she\'s going to make our first
presentation.

(Applause)

DR. GOLAN: Good morning. Thank you for inviting me to join this panel.
Quite an honor.

My job this morning is to give the economist\'s point of view and
standards and why economists seem to be so enamored with performance
standards versus process standards.

We know that policymakers have a wide array of tools with which to try
to influence the behavior of private firms or consumers to achieve a
social or policy objective. A policy objective could be anything from
reducing pollution, reducing foodborne illness, improving nutrition,
reducing obesity or smoking, and the policy tools range from those that
are less intrusive to those that are quite a bit more intrusive.

Information, like labeling or education programs, are at one end of the
scale. They\'re much less intrusive than other policy tools. For food
safety, examples of education programs include FightBack and Thermi, the
FSIS walking thermometer. Label information for safety include safe
handling labels for fresh meat and poultry, and also in many states,
another example is they\'ll have labels on oysters telling you the
dangers of eating raw oysters during certain times of the year.

One of the most intrusive types of policy tools is prior approval, and
with prior approval, each product must be approved by an official
agency, a regulatory authority, before being released into the market.
For food safety, I really couldn\'t think of an example of strict prior
approval. I\'m hoping that maybe for airlines and huge jumbo jets,
there\'s some type of prior approval but that could be wishful thinking
on my part. I\'m not really sure.

Now, safety standards allow suppliers to release products into the
market without any prior control, but the supplier who fails to meet
certain minimum safety standards are out of compliance and they\'re
subject to regulatory or legal sanctions.

Now, standards or at least standards that I could think of for safety
take at least three forms. The least intrusive are target standards.
Now, target standards do not prescribe any specific safety standards for
a product or process, but they impose criminal liability for
prespecified harmful consequences which arise from the product. For food
safety, that would be you make someone sick, you pay the consequences.
Of course, for food safety, that\'s a big problem because it\'s very
difficult to draw the link between the foodborne illness and the
specific food that made you sick. So, target standards are pretty
unworkable for food safety.

Performance standards require certain levels of safety to be achieved in
a product that lead suppliers or manufacturers to choose the mechanisms
through which they meet such conditions. We have many standards for food
safety. Salmonella standards for powdered milk is one example.

Process standards are probably the most intrusive of the type of
standards that we could use, and they specify the type of production
method, the exact procedures to be used to produce a good. These
specifications could be either positive or negative. They could either
be compelling or prohibiting on a firm to use certain processes or
particular methods.

Examples of process standards for food safety include milk
pasteurization or specific product washes that may be specified in a
HACCP program. In many cases, process standards are just equivalent or
equivocated with best manufacturing processes.

Now, the fact that performance standards specify requirements in terms
of results and not production methods has pushed them to the top of
economists\' most favored policy tool list. The flexibility of
performance standards gives them a number of very good qualities.

First of all, performance standards encourage efficiency on the part of
those firms being regulated. Each firm can choose the production method
best suited for their firm\'s particular characteristic. Even within
this industry, and we talked about this a little bit yesterday,
different firms face different challenges meeting food safety
requirements. For example, technologies that are efficient solutions for
small firms may not be so efficient for larger firms.

With performance standards, the individual firm is given the flexibility
to choose the most efficient process to achieve a particular standard,
and in the best case, this flexibility leads to innovation, resulting in
completely new technologies and new approaches to production. This
pushes out the production frontier, creating more with less, hopefully,
and this is much preferable to being stuck in a situation where each
firm must use the same approach.

As Michael Porter from the Harvard Business School noted, past
regulations have often prescribed particular remediation technologies,
such as catalysts or scrubbers for air pollution. The phrase \"best
available technology\" and \"best available control technologies\" are
deeply rooted in U.S. practice and imply that one technology is best,
discouraging innovation. The regulators\' challenge is to create maximum
opportunity for innovation by letting industries decide how to solve
their own problems.

Now, in a HACCP situation, HACCP without performance standards runs the
risk of turning into a process standard, a best practices standard, and
it loses its ability to encourage efficiency and innovation.

Now, it\'s important to note that the logic that leads economists to
conclude that performance standards encourage efficiency and innovation
is built on the premise that the firm is ultimately responsible for the
safety of the product. Recalcitrant firms, firms who are not interested
in food safety, will only have an incentive to be efficient and
innovative if violation of performance standards means that the firm
will incur real costs and that the firm will ultimately be responsible
for rectifying the lapse in safety.

If instead the government is responsible for investigating safety lapses
and the government is responsible for deciding how safety lapses should
be rectified, then the economic logic of safety standards breaks down.
They lose their ability to encourage or inspire efficiency and
innovation and run the risk of HACCP.

Well, how should performance standards be set? We have a few guidelines.
A few guidelines can be gleaned from the environmental literature, and
we find as economists that often our discussion of safety, food safety
seems to be paralleling a discussion that\'s taken place in the
environmental literature maybe a few years ahead of our discussion.

Well, a few things that we\'ve learned from environmental literature,
one of the first things is that we should regulate as close to the end
user as practical while encouraging upstream solutions, and we know that
the food supply chain extends from this farm to the table and that a
safety problem introduced anywhere along the chain can ultimately affect
the safety of the final product, unless someone downstream of where the
problem is introduced takes actions to mitigate the problem. We know
that meat contaminated grinding will remain contaminated, unless someone
downstream introduces a step, such as irradiation or thorough cooking.

The best way to regulate the whole supply chain is to put pressure at
the end of the chain and then rely on the end user or the final
processor to put pressure on upstream suppliers for safe input. Several
studies have shown in fact that food producers adopt HACCP or other
safety mechanisms, technologies, to satisfy their downstream customers.

Using Jack\'s example from yesterday, these performance standards
applied to the end of the supply chain are analogous to making the final
processor the chief of police. It\'s analogous to making that final
processor responsible for reducing crime throughout his precinct,
reducing food safety problems throughout the supply chain.

Now, of course, there will be a lot of wrangling among the different
players in the supply chain as to who should have ultimate
responsibility for meeting standards, and we\'ve seen plenty of
wrangling in the environmental literature. We\'ve seen a lot of
wrangling between the oil industry and auto makers. Should the oil
industry be responsible for reducing emissions by producing cleaner gas
or should the car manufacturers be responsible for reducing emissions by
making cleaner running engines? Policymakers have had to deal with this
type of problem constantly in the environmental literature and it\'s
very similar to the type of problem we\'re dealing with now in food
safety.

A second guideline that we can see from the environmental literature is
that strict standards are usually preferable to lax. Now, if risk
analysts identify a standard that is challenging to meet, this is the
standard that they set because of human safety concerns, regulators
shouldn\'t necessarily shy away from these strict standards and choose
instead the standard that is defined by feasibility. We often see
regulators defining the standards as a means. They think that it\'s
feasible because half the firms are meeting the standard already and
half of them aren\'t. So, there must be some technology out there we can
use to get everyone up to a standard. We define the standards as a
means. It turns out that challenging standards are more likely to
encourage efficiency and innovation, and we shouldn\'t necessarily shy
away from them.

A third guideline is to regulate in sync or slightly before your
competitors in order to minimize competitive disadvantage. Now, in the
auto industry, we\'ve failed to set aggressive emissions standards, and
then we\'ve played catch-up with the Japanese for quite a long time to
get our cars up to Japanese levels as far as emissions went.

Another perk to standards that are well set and well recognized early in
the game is that those standards then become criteria for international
standards, and if we go ahead and set firm standards up front, those
standards may become the standards that are used for international trade
and food safety.

A fourth criteria for verifying compliance is that standards should be
informative, that is, they should be solidly linked to a policy
objective. They should be reliably measured. This is one problem we\'re
having with standards for non-biotech foods, is that one batch of food
that tests as a non-biotech batch at one point in the supply chain and
is tested later on in the supply chain and is actually tested as
biotech. So, the testing has to be reliable.

Also, the criteria should be flexible. We know that policy objectives,
production technologies, testing technologies, all of these are
changeable, that a standard or a way to measure a standard that is set
today could be irrelevant or in the worst case could be too binding in
the future, and, of course, the prime example of this is the Delaney
Clause, where testing methodologies became so fine and so precise, that
a zero tolerance level for carcinogens became impossible to meet with
testing methodologies that were developed, and those standards were so
rigid and set so inflexibly that it took an act of Congress to change
them. It would be nice not to get ourselves in the same kind of
situation.

Now, firms have a number of ways they can react to new regulation. The
least desirable outcome is that a lot of firms in the industry would
just simply drop out. So, sometimes this is not necessarily a bad thing.
Sometimes regulation does flush out some fundamentally-inefficient
firms.

Another undesirable outcome is that industry spends a lot of time and
resources fighting or trying to influence regulations. That\'s also an
undesirable outcome that policymakers are trying to avoid.

The best outcomes are, of course, full compliance and innovation. Now,
how do regulators tilt the balance to compliance and innovation? Well,
they have to try to minimize compliance costs. We know that standards,
because they allow firms to adopt the most efficient compliance
strategies, often are the best at minimizing compliance costs.

We also want to choose regulations that increase the benefits of
compliance and innovation. One way is to increase the market benefits,
and we know that standards that are widely recognized help to increase
the marketability of a product, both domestically and internationally,
and to increase the benefits of complying, you want to increase the cost
of non-compliance. You want to increase the probability of getting
caught and the cost if you do get caught.

Quantifiable standards are usually easier for government officials to
monitor and to regulate than qualitative standards and therefore are
often better at increasing the cost of non-compliance.

This is the picture that I actually want to leave you with, economist\'s
point of view, as we continue our discussion of performance standards or
process standards, to think about the regulator trying to tip the
balance towards compliance, tip the balance towards innovation, and the
role that performance standards play in tipping the balance.

Thank you.

(Applause)

DR. ACUFF: Thank you, Dr. Golan. Man, I\'m never going to get your name
right, am I?

DR. GOLAN: Think Heights.

DR. ACUFF: Oh, yeah. Okay. Good.

All right. Our next speaker is Robert Buchanan. We all call him Bob. See
his name tag is Bob over there.

He has a Bachelor\'s, Master\'s and Ph.D. from Rutgers. He did a
post-doc at the University of Georgia. His current position is with the
Food and Drug Administration, Center for Food Science and Nutrition, and
he is the Senior Science Advisor and Director of Office of Science.

He has previously worked for USDA at ARS and FSIS and has also worked
with Drexler University. He has done lots of work with ICMSF. He\'s
worked with Codex. He\'s done more than any of us, I think, in
microbiological criteria.

So, welcome, Dr. Buchanan.

(Applause)

DR. BUCHANAN: Thank you, Gary.

When I was originally approached by Karen, she said, \"Bob, we really
would like you to talk a little bit about microbiological testing, its
statistical basis and how you set standards, and, oh, by the way, you
have 20 minutes to do it.\" So, I\'m not going to spend a lot of time,
other than the fact to say that what I hope to do is just give a quick
overview of some of the principles of microbiological testing, a little
bit about decisionmaking process, how it fits into a decisionmaking
process, and then get into it more in the panel discussion.

So, this is just sort of a primer, and I\'d like to remind you that
microbiological testing, at least I consider it one of the important
tools we have for improving the safety of the food supply. It\'s
important to keep in your mind as I go through this talk that this is a
technologically-based statistically-based tool. It\'s dependent both on
the statistics that underlie sampling and it is also based on the
methods that you use. So, it\'s very hard to find hard and concrete
things because a lot of it\'s based on probability and a lot of it\'s
based on the methods that you employ.

It\'s also important to note that it is actually tools that we\'re
talking about here, and it\'s incredibly important to pick the right
tool for the right job, and much of the discussion that we have is
interpreting which tool is used and what attributes you\'re looking at.

Microbiological testing is one of the most apparent things that we do in
food microbiology, but it\'s also one of the most poorly-understood in
terms of the rationale and the procedures that are actually being used,
and I might note here that food microbiologists inherently understand
this much better than any other type of microbiologist. So, you can
figure out what clinical microbiologists, you know, their baseline that
they\'re starting with.

It\'s important to also note that when you ask about microbiological
testing \-- we\'ll make you an honorary food microbiologist, Anne Marie.
When we\'re talking about microbiological testing, there are different
types of microbiological testing, and so it\'s important to know which
one you\'re using for what purpose. I\'m going to be talking about two
of the four general types of testing that we do; that is, the safety of
batches and process control in my talk, and it\'s very difficult for me
to talk about process control without talking about also the safety of
batches.

To really understand, you really need to take the time to understand
what are the goals of these different approaches to testing, what are
the base assumptions that underlie the testing, and what are the
characteristics of the testing programs, and really to simplify it, what
we\'re looking at as we go through the difference between testing
batches for safety versus a process is we\'re looking at the difference
between within batch testing versus between batch testing, and they do
have different goals, assumptions and techniques that are used, and so
I\'d like to spend a couple of minutes talking about or comparing the
two before I talk more about process control.

Within batch testing is primarily there to demonstrate the safety of a
single lot of food. It is a very detailed snapshot of an operation. It
assumes no prior knowledge of the process or the food product that
you\'re looking at. It focuses on establishing the safety or if you\'re
looking at a quality attribute quality of that batch, it provides only
very limited capability of trend analysis of performance over time.
However, it can be used to set up appropriately to acquire data on the
state of the industry.

It is effective only within certain ranges of contamination, both in
terms of frequency and/or levels of contamination. Below or above those
ranges, it becomes increasingly ineffective. A general rule of thumb
that we use is that if the acceptable defect rate that you\'re looking
for is less than one percent, you should be thinking about other
approaches in terms of measurement because below one percent defect
rate, the number of samples that you have to take to demonstrate that a
product is free or operating at a level below one percent becomes a true
limiting factor.

This is in comparison to between batch testing. The primary function of
between batch testing is that a food safety system or process is
continuing to function as intended, and it\'s important to keep that in
mind, is that you have a system that you have set up and you\'re trying
to determine whether or not it\'s operating as you expect it was. It is
not designed to assure the safety of a batch. The safety of that batch
is assumed if you\'re working with a validated process that you know is
capable of delivering the safety you want and that that process is in
control.

It assumes that you have an intimate knowledge of your process, that you
know all the details, that you\'ve done prior analysis in terms of that
process\'s performance and variation, and that what you\'re determining
is whether it continues to function. It does require that you do
sampling over time. It also can be used to establish a national state of
the industry database.

Now, this is a statement that I\'ve used before, and I would like to
reinforce this. It is much easier to demonstrate that a process is not
functioning within a specification as compared to proving that something
is not present. It is much easier to prove that you\'re functioning as
you\'ve designed your process than to prove the safety of any particular
batch, and hopefully the rest of my talk will demonstrate why I make
this statement.

Now, I\'d like to remind you of a couple things as we go along in regard
to sampling and processes that we\'re looking at. One is, is that
microbiological contamination typically flows with a process; that is,
if you have a point of contamination, it will follow the process down
until it is eliminated. It typically, unless there is a loop back, it
does not go back up the process, unless you cross lines or some other
means of reintroducing the end product into the beginning.

The best way to think of this is if you took a thousand ping pong balls
and threw them into a stream, you would not walk upstream to find the
ping pong balls, you would find them distributed downstream. So, a
microbiological sample taken within a process provides a measure of the
microbiological attributes of that process. It\'s anything that was
above where you took the sample.

So, the way we can look at this is that the status of a multistep
process or anywhere within that process is basically the summation of
the initial levels of contamination and all the steps that increase or
decrease that level of contamination. That is, and I promise not to get
into a whole bunch of math, but I couldn\'t resist just one formula, the
microbiological status of any point in that process is equal to the
initial level of contamination, plus the sum of the increases in the
level of the microbiological concern, plus the sum of the reduction
steps that took place.

So, sampling \-- so, in putting this into perspective, what I just said
in the two previous slides, basically sampling end products integrates
the effect of the entire food safety system. So, if you could only take
one sample and try to get an integrative look at what was happening, the
sample that I would take would be at the end of the process. However, it
is very beneficial, particularly if you\'re trying to be proactive and
then eliminate problems, is actually to take steps or samples at several
points in the location so you can go back and when you start having
problems identify where those problems actually took place.

Now, the basis of control, process control statistics, which is what we
used in evaluating process control in microbiology, and I might note
that the statistics I\'m talking about here are nothing magic. They\'re
the same kinds of process control statistics that were developed for
making widgets in factories, for just about anything. It\'s looking at
performance over time, and the basis of that control process evaluation
is the collection of microbiological data over time, and typically we do
this in a graphical means. We collect the data and then we array it
graphically in the form of a controls chart, and so up on this top is
just a hypothetical control chart that I\'ve used in previous
presentations on this subject.

So, the first step in coming up with a process control activity is to
develop and then conduct a process control study. This is in
microbiology. This is what we refer to as baseline studies, and it\'s
basically using an under control process. We run the process for a
period of time. We collect a lot of data just to see what the
capabilities of that process are, and these typically involve collecting
two pieces of data, the central tendency, the mean or the median, how
the process normally works, and then we look at the variance, what kind
of variation is normally associated with this.

We also use this data, assuming that it comes out relatively normally
distributed, to set up, you know, potential at least initial critical
limits that we would run, and typically in the statistical world, we
might use three sigma factors to establish the upper control and lower
control values.

However, there is nothing magic about three sigma or six sigma. The
decision on whether to take a value, be it three sigma out or would it
be right on the mean, is a risk management decision that is dependent on
the capabilities of the system, your likelihood for improvement, and
decisionmaking process along those lines, similar to the ones that were
discussed in the previous talk.

Then, once you have established these criteria and you continue to
monitor the process, the loss of process control is just then assessed
by determining if your defect rate, the number of defects that you
detect when you take microbiological samples, is greater than what you
would expect by chance alone.

Now, we can do this approach using either variables-type approaches or
attribute. This is whether you\'re using quantitative data or whether
you\'re using attribute data which is either plus presence/absence data
or what we refer to as bend quantitative data, where you put it into
different categories.

Now, probably the one that is most familiar to you is an approach called
moving windows sum. This is one of the simplest but most powerful of the
process control statistics that are used, and what I wanted to do is
just run a simple example through with you about moving window and
basically a moving window is that you look at performance over time, but
you have set windows of time that you look at, and I\'m going to use for
my example a very simple process, and I decided I didn\'t want to use
food or food microbiology at all, but I do it to something that\'s a
little bit more concrete.

So, my example, I\'m going to have a three-step process that a
manufacturer receives blue marbles. His primary process is that he then
paints those marbles red and that he packages the marbles and that\'s
his finished product. So, we have a really simple process and that his
ability to paint these marbles is not flawless. In fact, he doesn\'t do
such a great job. He has about a 10-percent defect rate, but as long as
he meets that 10 percent, he\'s going to be able to sell his product and
everyone will be happy.

And so, what happens is after you\'ve gotten your central tendency and
your variation here, you then base the probability of finding more than
the expected number of defective responses within a specified window,
and that is, if you start having \-- say you\'re taking \-- you\'re
looking at marbles once every thousand marbles, if you have too many
blue ones, then you know that that was not by chance alone, that in fact
you\'re not doing such a good job of painting them red.

So, let\'s look at a couple of examples, and believe it or not, most
microbiologists intuitively understand this process, if you show them
the data. So, let\'s look, and I\'m going to ask the question: is this
process under control? Just to put it into terms, we\'re sampling one
out of every thousand marbles, and we\'re doing a really simple test.
Are they red or are they blue?

So, if we run this process through, we get a red marble, a red, a red, a
red, and we keep up sampling, and then all of a sudden we get a blue
one, and we go back, and we continue to sample, and oh, lo and behold,
another blue one came in, and we continue this process, and we just keep
sampling, and I think I get to the end of it soon. Yeah. Actually, \--
oops. So, the answer is most of you out there would intuitively look at
that and you\'d sort of in your mind say, well, the number of blue
marbles over a certain amount of time was about the 10-percent defect
rate, and yes, this process is under control, and in fact, it is. In
fact, I set it up that way so there would be no question about it.

So, now I\'ll ask you the second question, again going through an
intuitive example of how we process control. When is control of this
process lost? Again, it\'ll be the same blue and red marbles, and we go
through and we watch this process, and you can pretty much let you
follow it, and we\'ve got our first blue marble. That\'s our first
defect. You wouldn\'t be able to tell whether it was in control or out
of control, and you keep sampling and another blue shows up, and you
say, hmm, that seemed to have come too fast, but it still could be
chance alone, and then all of a sudden, another blue one came about, and
you\'re getting pretty suspicious at this point because the odds of
three coming up in that number of marbles is kind of unusual, and then
another blue shows up, and yeah, you\'re out of control now, and so it
gets even worse, I think.

But you can see intuitively that you would be able to say yes, that, you
know, something\'s happening here. I\'ve lost control of my process, and
I think I just have it continue like that, yeah.

Now, the ideal situation is to have a sampling plan that would allow you
to go and make really clearcut decisions. So, if that blue arrow that
you see on there was our decision point, the ideal operating curve would
be that you would go along at the top and all of a sudden at that line,
you would go all the way to the bottom and everything would fall nicely
into yes or no.

In reality, we have distributions around that. We have to deal with Type
1 and Type 2 errors. However, we can get the steepness of those
operating curves to take on the shapes we desire by manipulating both
what percent of assurance we would have, by the size of the sampling
window, and also by the number of positives within that sample window.

So, it\'s a very flexible tool that we have in terms of coming up with
something that is practical in terms of being able to detect when your
process goes out of control, but at the same time minimizing the number
of samples that have to be taken.

Now, seeing that this was a science conference that was put on by FSIS,
I think the best way of giving an example that would keep me out of
trouble was to pick one that FDA is working on. So, what I\'d like to do
is just show you some practical ramifications of this using our
newly-instituted juice HACCP talk about a couple practical attributes of
microbiological sampling.

A key attribute within our new juice HACCP regulation is the requirement
that all juices receive a 5-D performance standard. In this case, since
it is required, it is a standard, the more general term would be a
criterion. It\'s restricted to juice that has been \-- after the juice
has been expressed. We have verification of that process. However,
verification in this is based on process validation and review of
process records. It is not based on microbiological testing, and again
there was an underlying public health goal to establish a risk that was
less than the possibility of disease of less than 10 to the minus 5th
per year for the consumer.

Microbiological testing was not required for most people covered by the
reg because it is ineffective. The ineffectiveness of testing at very
low defect rates, and because the juice which was being treated, the
treatments were affecting all parts of the juice, and the processes that
were being employed were both validated and reliable, and just to give
you an example why we made that decision, suppose that we had in juice a
normal level of one enteric bacteria per milk and that\'s based pretty
much on some baseline studies that we did.

A 5-D treatment would reduce this down to one viable organism per 10,000
mils, and therefore to actually detect and evaluate the effectiveness of
that process, we would either need to take and sample a one 10-liter
sample, 10 one-liter samples, or 10,000 one-milliliter samples. To say
the least, we\'re usually set up to run one mil samples in microbiology,
and no one was volunteering to do 10,000 samples every time you wanted
to validate your process.

However, and I put this into perspective, we did provide one key
exemption for citrus juice processors, particularly the processors of
fresh juices. In this case, the fresh juice processors may count surface
treatments as part of their fulfilling either part of all of their 5-D
process, and this is based on the underlying assumption in scientific
data that we were provided, that for the most part, it doesn\'t appear
that the inside of oranges become contaminated with enteric bacteria.

However, in putting the reg together, we did for those processors who
opt to use surface treatments, we did put an additional HACCP
verification requirement of periodic testing for E.coli, again E.coli as
an indicator of fecal contamination, and in this case, they\'re required
to either take two 10-mil juice samples per thousand gallons per day or
at least once a week, if they produce less than a thousand gallons per
week.

The data is evaluated using process control statistics, using a
seven-sample window, one positive sample requires a process review, two
positive samples require diversion to a 5-D treatment after the juice is
extracted, that is, you have to treat the juice by normal pasteurization
or treatment processes, not just surface, until the cause of the
deviation can be identified.

This is designed and the purpose of the testing is designed to verify
that the original assumption that went into allowing for this exemption
is still valid, i.e., that pathogens were restricted to the surface of
fruits, because internalized pathogens, if you started getting pathogens
within the orange or the grapefruit, etc., would not be affected by the
treatment, that there is and we\'ve demonstrated at least in the
laboratory the potential growth of these pathogens within the fruit, the
fact that this type of approach is both effective in terms of detection
limits and is effective in terms of keeping the number of samples to a
minimum.

So, in summary, what I\'ve tried to do is give you some basic principles
for microbiological testing, indicating that it is an integral part of
any integrative program for verifying the effectiveness of a food safety
control system, but again you need the right tool for the right job and
you need to understand why you\'re using that tool.

Thank you.

(Applause)

DR. ACUFF: Thank you, Bob.

Our next speaker is Dr. Frank Busta. He has been with the University of
Minnesota. He\'s been at North Carolina State, University of Florida. He
was chair of Food Science and Nutrition Departments at both the
University of Florida and also the University of Minnesota.

He\'s published extensively, has at least a 125 refereed research
papers, and something that\'s very important for today, he spent 15
years with ICMSF or the International Commission on Microbiological
Specifications for Food.

He also was president of IFT, and see, he\'s coming to take me off the
podium now, and he says he\'s Professor Emeritus, which means he\'s
retired, and I don\'t believe that. So, maybe you can explain what
retirement is.

DR. BUSTA: Retirement is doing only what\'s fun. You don\'t have to go
to faculty meetings. You don\'t deal with budgets.

Thank you, Gary. It\'s very unnerving to have someone start a session
with history and find out that you remembered it all. Now, I\'m not
referring to Elsa\'s stuff. I don\'t remember Pasteur. The Swan flask
was a little before my time.

This is a challenge I\'m going to ask \-- today, I\'m setting a basis
for our questions that follow in the discussion. I thought the perfect
segue following Bob Buchanan was to cite him on definitions and you\'ll
see that the classic definitions are an index organism is a
microorganism group that is indicative of specific pathogens whereas an
indicator organism is a microorganism of microorganisms that are
indicative that a food has been exposed to conditions that pose an
increased risk that the food may be contaminated with a pathogen or held
in a condition conducive for pathogen growth.

Now, as we talk about today indicator organisms versus pathogens as
possible performance standards, I would like you to keep this classic
definition in mind because it is a little different thinking than we
hope to fill out today.

What does it indicate? It indicates when there\'s a positive test for an
indicator organism, it doesn\'t necessarily mean that there\'s a
pathogen there. If you detect an index organism, it points to the
occurrence of a related pathogen. These are classic definitions that may
not hold any longer.

Both of these are called microorganisms, and there are a number of other
microorganisms. Sometimes we call them models, sometimes we call them
sentinels, and sometimes we call them surrogates for specific kinds of
process evaluations and validations, and if I have time at the very end,
I\'ll mention a little bit more about surrogates.

What are some of the preferred qualities of ideal indicators? You\'ll
hear this a couple-three times, and we\'ll reinforce it until we\'ll be
able to all recite it together. The history and presence or absence of
food is related to the pathogen or toxin. The microbial metabolites, if
those are indicators being used, are present initially or after growth
of a pathogen that might be present. If we use growth of indicators as
an evaluation, it should be equivalent or greater than the target
microorganism under all conditions, and there\'s some big generalities
being stated here, and it\'s easily detected, quantifiable,
distinguishable, and preferably very rapidly.

What are some of the indicators that we\'ve used? We\'ve used specific
microorganisms and it\'s a range from total colony counts, Richmond
cultures, indirect county counts and a variety of other systems. We\'ve
used metabolites. We\'ve used PCR, and we\'ve used indirect methods for
general assessment, such as ATP.

The traditional requirements for an indicator of food safety. Easily and
rapidly detectable. That\'s very, very important because otherwise it
can probably do the pathogen, and we\'ll talk about that a little more.
Easily distinguishable from the normal flora. There\'s a history that is
associated with the pathogen. It\'s present when the pathogen is
present. The numbers correlate with the pathogen. The growth
requirements are equal to the pathogen. It directly parallels the
pathogen, and it\'s absent when the food is free of a pathogen. Ideal.

There\'s a variety of organisms that have been used through the years on
a variety of foods as indicators or have been proposed as indicators and
includes the entire family of the Enterobacteriaceae, which in turn
includes coliforms, fecal coliforms, and E.coli. These have all been
proposed or used in various situations as indicators of contamination.
Enterococci, bacterium, coliphages, all have been proposed or adopted as
indicator organisms.

If we look at the whole family of enterobacteriaceae, these are
anaerobes. This is taking you back to Introduction to Microbiology.
Mesophiles, they produce acid and gas and glucose, at least acid from
glucose, and some of them are psychotrophs that cover a whole series of
genera, and it\'s been at least in Europe and by certain individuals
recommended over any other type of individual genus in this family.

Coliforms have been used in a variety of places. Usually they\'re best
used in something that\'s been processed. They\'re general. They may or
may not be indicative of fecal pollution, and if you\'re dealing with
fecal pollution, one maybe goes on to fecal coliforms, whatever those
may be. That\'s a personal opinion. Fecal coliforms are defined as going
at a 44.5 or 45.5. There are a variety of strains that are recovered.
Some may or may not define fecal contamination. It\'s originally used in
water and just for our own edification, 0157:H7 doesn\'t really grow
very well at those temperatures.

E.coli, as you just heard Bob mention, is a very commonly used species
to indicate fecal contamination. Its use is broad spread and obviously
it\'s in the performance standards. E.coli is really regarded as the
most valuable indicator of fecal contamination. It\'s not necessarily a
reliable contaminant to indicate post-processing contamination because
it will grow in the environment, and it is \-- but it is an indicator of
inadequate processing.

Now, what indicator groups that I\'ve just mentioned may be or are
considered pathogens? Well, there are a lot of pathogens in the
enterobacteriaceae. There are potential pathogens in coliforms, in fecal
coliforms, in E.coli, and in enterococci. So, the concept of having
non-pathogens as an indicator or as an index is really inappropriate in
our current assessment.

What are some of the issues of using coliforms and fecal coliforms? Some
may be non-enteric. They indicate inadequate sanitation but maybe not in
the other situations. I put this up so that you look at what are some of
the issues as we look at the limitations of pathogens as indicator
organisms.

Some of the problems of using a pathogen as an indicator organism
hopefully is the concentrations are very low and difficult to relate to
other food safety situations. They may not compete well with the food
flora, and as many of you know, isolating and detecting pathogens in a
system has always been the challenge in many of the microbiological
methods.

The presence may not relate to another pathogen. E.coli may not be
present when Salmonella is present or vice versa. The presence may be
initiated regulatory action and therefore may be considered adulteration
and is that an index or indicator or is it merely an action item? And
that pathogens require special laboratory skills. We\'ve always
preferred a non-pathogen or indicator organism because of the easier
laboratory activities.

So, let\'s look at that same list of advantages pathogens may have as
indicator organisms. They may be easily and rapidly detectable. We\'re
working on that more and more. The methodologies frequently focus much
more on pathogens than they do on some other indicators. With this
methodology, they may be more easily distinguishable from the food
flora. They obviously are pathogens themselves, but the challenges, they
may also be associated with other pathogens that could be present in the
food.

That whole relationship to other pathogens is a major question, and
it\'s the numbers, presence, growth requirements, die-off requirements,
all of those may be appropriate for a pathogen to reflect other
pathogens or other safety or it may not.

When we look at performance standards, they\'re intended to effectuate
decreases in pathogens with the goal of improving public health. Fecal
contamination is a major source of enteric pathogens. We may use
microorganisms classified as indicators or index organisms to evaluate
this and a pathogen could be used if it meets criteria.

So, as we look at the performance standards, will or will not the
pathogen serve as an index or indicator organism, and if you\'ll notice,
I\'m starting to change to index because that\'s apparently what we
would like to show. An indicator in lieu of a specific pathogen, what
are the basic criteria? Similar survival and growth rate, common source,
direct relationship between a condition influencing the pathogen\'s
presence and the indicator and practical methods.

So, if we look back at the performance standards, can we \-- will the
pathogen that could be used as an index or indicator meet those
criteria? So, if we look at performance standards, is E.coli a good
indicator or index? Are Salmonella an indicator or an index? Or is
enterobacteriaceae an indicator, an index? Could those be used? Are
those used? Could they be really true indicators or indexes?

Again, one more repeat, what\'s ideal of an ideal index or indicator
organism? Presence and rapidly-detectable, history of association with
the pathogen of concern, the presence of the concentrations correlated
with the pathogens, easy to detect, growth requirements are similar, not
affected by other food components, resistant to injury from stress of
processing, and non-hazardous to testing personnel. Those are ideal.

I\'m going to skip over this one because I\'d like to mention a little
bit about surrogates. Surrogates are usually added to the food to
evaluate a process. Surrogates \-- I\'m still all right on time, aren\'t
I? Okay.

Surrogates are a special situation. Some people would like to use
naturally-occurring microorganisms as surrogates to evaluate a process
and to test a process and then to validate it. But as you all would be
well aware, no one likes to bring a pathogen into a processing
situation. So, we try to come up with a surrogate which would not
necessarily be a pathogen, maybe similar, but is a microorganism or
representative material, and I think that\'s important, that serves an
alternative for a target pathogen when we\'re evaluating or validating a
controlled process.

Hopefully, it\'s very, very similar to the organism. The criteria are
very similar to an index organism, but here non-pathogenic becomes very,
very important, but its inactivation characteristics, its durability,
its stability are similar to the target. You can prepare high
concentrations. It\'s stable. It\'s easily enumerated, easily
differentiated, generally stable, will not be established as a spoilage
problem, and it\'s resistant to sublethal injury or reversibility. If
we\'re going to validate processes, we also have to consider surrogates
or indicators that are not pathogens, naturally-occurring.

So, in summary, indicators or index organisms have been used over a
hundred years. So, this is not necessarily a new idea. We\'re back to
history again. Effective with extensive validation and qualifications.
There currently are no well-established relationships of indicators and
the occurrence of emerging water and foodborne pathogens. There\'s some
evidence of a relationship with well-established pathogens.

The direct sensitive and specific tests for detection and enumeration of
target pathogens and metabolites are available and that may permit us to
utilize them as index organisms themselves. The indirect association of
marker organisms where food safety and quality may not be reliable for
due diligence, if you look at the indicator, it may not hold. If you
don\'t look specifically for the pathogen, it may become increasingly
useful, indicators may become increasingly useful with new analytical
methods and the challenge is the selection and validation of the
appropriate organism.

Thank you for your attention. I do have a handout. I put a bunch of
research in it, and we\'ll talk about that later.

(Applause)

DR. ACUFF: Okay. I\'ve been told that for people standing in the back,
there are lots of seats up here in the front. Actually, there are. So,
if you guys want seats up here? It\'s kind of like church, you know,
nobody wants to sit up front.

Okay. My wife is a mathematician, and I watched her take classes like
Real Analysis, and I thought as opposed to what, you know, Fake Analysis
and Modern Algebra, and I thought, I guess I took Ancient Algebra. I
don\'t know. And my kids have learned that they do not say why do we
have to take this stupid math stuff, you know, because they\'re going to
get this long lecture, you know, and I\'ve sat through it several times.

I say that because our next speaker is a mathematician. He has a
Bachelor\'s degree in Mathematics from Iowa State in 1967, a Master\'s
in Applied Mathematics from Johns Hopkins in 1969, and I have a lot of
respect for anybody who can get multiple degrees in mathematics. So,
it\'s a tough road to hoe.

He has worked for the Naval Research Laboratories and the Food and Drug
Administration, Consumer Products Safety Commission. In 1979, he joined
the Food Safety and Inspection Service, and he\'s currently an Assistant
Deputy Administrator. He\'s going to speak to us about \"Performance
Standards and Statistical Sampling\".

Please welcome our next speaker, Loren Lange.

(Applause)

DR. LANGE: Thank you.

This is a hard group of speakers to follow. I was quite impressed.

I did learn yesterday that I had one thing in common with our Secretary
of Agriculture. Growing up, I was a member of 4-H and spent many years
in 4-H, and I was thinking back. One or two years, my 4-H project was I
was sort of a farm-to-table poultry processor. I raised chickens, and on
Saturday, I would \-- Friday night actually because you collected them
with a little hook and stuff from the trees, I had sort of \-- and I
would slaughter and process and clean and on Saturday, then I would
deliver anywhere from 25 to 50 fully-processed cut-up or whole birds to
neighbors and relatives and stuff like this.

I\'m not sure. I made a little money, but my father gave me the chicken
house free and the feed free. So, I\'m never sure whether my economics
was good, and I must say as I look back, my food safety was \-- that was
not a consideration in my process because one of the steps in my
production process was I had a dog that would retrieve the birds after I
had cut off the head. Anyway, enough of that.

This is \"Performance Standards and Statistical Sampling\". I could have
talked about, I don\'t know, a lot of variety of things under that
heading, but when our panel met, we did decide that I would sort of
focus on sort of two areas to summarize, and one was a little bit our
history of statistically-based studies or baseline studies, FSIS, and
then how the data from those baseline studies was used to develop the
existing performance standards.

One of, I guess, the first questions I thought about is what is a
statistically-based study? I guess there\'s a lot of things called
surveys and statistically-based studies that, I guess, statisticians
would certainly argue about, but I think in general, the important thing
is that there\'s an up-front design consideration. The accuracy of
estimates that are wanted. There\'s an up-front design of how many, you
know, samples are collected, so that one can consider how accurate of an
estimate they want, and certainly ability to sort of then put a
confidence interval around the statistics. So, that is sort of what I
think at least, is that there was some consideration of what you would
be able to do with the data when you sort of were planning the study.
So, I guess I considered that a statistically-based study.

As a little bit of background, we sort of looked in the files at FSIS,
and I found a couple papers that talked about we had a Micro Division
that was sort of first really a focus on microbiology in the mid-\'60s.
There was some history talking about how the microbiologists would do
surveys. They would get in their car and they would drive to
establishments. They would pick up samples and freeze them and take them
back at that time to a lab in Beltsville and conduct the results and
publish journal articles on surveys and stuff, but they were sort of
restricted to sort of how far they wanted to drive and sort of they
would call up regional offices and at that time area offices and find
out where they could go and get samples.

The first evidence of a sort of large statistical survey that we find
was actually in \'82 and \'84 where the three field laboratories were
all used, but it was \-- at that time, it was a single organism,
Salmonella, single product, young chickens, which sort of takes us to
the sort of then the \-- I would consider the modern era of national
baselines.

The first national baseline was actually started in October of 1992, and
on the FSIS website, I think the results of eight of the early, you
know, baseline studies are published on the website right now. They were
very different than some earlier studies. We also \-- I forgot to
mention. We found evidence in the early \'70s there was a ground beef
and trimmings study conducted that had over 1,400 samples, but it was
again just Salmonella. There was a \'90 and \'91 study but again just
\-- I think that was again young chickens and Salmonella.

But with these baselines, it was a decision to look at a large number of
organisms and to do a lot of laboratory analysis, and I\'ll get back to
that later. So, there was one point here as we started baselines in
\'92. Really, the development of the pathogen reduction HACCP rule began
in the Fall of \'94, after the first two baselines had actually been
initiated, and, of course, you all know standards were published in
1996.

The objectives. The objectives of those early baselines. I mean, they
were sort of pretty general. It was to collect data to provide a general
microbiological profile of the product for selected microorganisms, and
the second one to use that information and knowledge gained from those
baseline studies as a reference for further investigations and
evaluation of new prevention programs.

I do want to come back to that second objective a little later when I
get into the talk because it sort of raised a question in my mind now.

We have some newer objectives from those original when the baseline
studies started. They now are viewed as a support for risk assessments.
The Reorganization Act of 1994 sort of required risk assessment for
certain public health-oriented regulations that became effective in
April 15th, 1995. Important to note that the proposal for the pathogen
reduction HACCP rule was in, I think, February of \'95. So, it sort of
preceded the effective date of requiring risk assessment.

Risk assessment just in general in the discussions we\'re having in
OPHS, there\'s a lot of difference from thinking about process control
and risk assessment needs, and I\'ll use young chickens as an example.
We collect data at the end of the drip line carcass-by-carcass which,
you know, is probably an indication of the process control, but the risk
assessment people, I think, are far more interested in if we were
testing the final sealed packages because in their view, you know, each
package sort of is an opportunity to carry, you know, a pathogen into a
restaurant or into a kitchen. So, we have new objectives, and, of
course, we use the baselines to develop standards that were published in
1996.

I\'m going to talk real briefly about three key design factors in
baselines. We certainly have the number and the nature of the organisms
that are going to be tested, the desired accuracy, and cost and
laboratory resource considerations.

Excuse me for just a second.

(Pause)

DR. LANGE: In the eight baselines that are on the website, there were
six different pathogens that were tested for. I don\'t need to read
them. I\'ll leave it up for just a second. These were selected either
because they were associated with human illness, a large amount of human
illness or a severity of illness. So, they were selected for the
baseline studies, and there were three indicator organisms in all of
those early baselines, and they were sort of selected because they were
thought to be an indicator of either general hygiene conditions or
process control.

The second factor that I mentioned certainly was, you know, the sort of
desired accuracy. If you go to the baseline reports, you\'ll see that in
the steer/heifer carcass baseline, the cow/bull baseline and market hog
baseline, there were approximately 2,100 samples in those baselines. For
poultry carcasses, they were in the range of 1,200 to 1,300.

I went back to one of the design documents and it was talking about, of
course, the number of samples was going to vary with what you expect,
the level of pathogen or the level of organism, but just sort of as an
indicator, if one was looking for an organism that had a two-percent
prevalence, if I took 3,000 samples, one\'s talking about, you know, the
95-percent confidence interval is really plus or minus .05. So, you
would be between 1.5 and 2.5, and then if you went up to 6,000 samples,
you\'d get plus or minus .035, 10,000 samples, .027. So, you see, as you
move from 3,000 to 10,000 samples in a baseline, your range of
confidence really narrows very slowly. You have to go up very rapidly to
get that.

I would just point out what in our baseline, what the levels of
precision that we did proceed with the samples we got. In market hogs,
they estimated prevalence was 8.7 percent, the 95-percent confidence
interval is plus or minus 1.8. So, you\'re really sort of 95-percent
confident that the actual \-- at the time the baseline was done, the
real prevalence for Salmonella in market hogs was calculated at 7.5 to
9.9, I guess, would be the range, and for young chickens, it was 20 plus
or minus 2.16, in cows and bulls 2.7 plus or minus .78, and those were
all based on the samples that I talked about later.

I didn\'t put a slide up here actually on costs. Certainly cost was a
consideration. Our laboratory resources was a consideration, but it
isn\'t just numbers of samples. As I said, all those organisms, those
nine organisms in those baselines were not only, you know, the samples
are collected and shipped to the lab, but there was an attempt to
quantify everything. Besides doing a positive-negative test in those
baselines, everything that was possible was quantified, and I think
everything was quantified except for 0157:H7. Don\'t have figures on
actually what they actually cost, but they were expensive when you take
nine organisms, thousands of samples, and do quantitative levels of
microorganisms, which, when I was putting this together, is something I
think we and OPHS have to go back, and so the answer to that question
is, what do those baselines cost, and thinking to the future, were we
able to use that information and knowledge, you know, as a reference for
further investigations and evaluation of new preventive programs?

Besides the Salmonella prevalence, which I\'ll talk about now, and the
generic E.coli, we haven\'t been able to think about what the other \--
what was the other data used for? Has it been used outside? Was it
useful for academia, for industry, but it costs a lot of money to
collect. It\'s on the website, and inside, we\'re not sure of how it was
used.

Okay. With that, I\'ll move to my second topic a little bit. How were
the performance standards derived from baseline results? Colleagues
advised me that this is not the thing to do because I am going to have
some equations and stuff, but I\'m going to try to simplify it as much
as I can, and I think it\'s important because this isn\'t published in
the preamble to the rule, and I don\'t think it\'s in any document that
the agency has put out exactly how we took the baseline information and
then sort of created the sampling plan which has been known as the
sample set to sort of measure the performance in individual
establishments.

What was used from the baseline for the Salmonella standards was those
prevalence estimates from those baselines, and I\'m sure everybody\'s
pretty familiar with them. We have the seven different product
prevalences listed here. This baseline prevalence, what is it? It\'s an
estimate of the percentage of product that would test positive for
Salmonella at the point in time when the baseline was conducted. It can
also be viewed then as the probability that if you went out and took a
sample of any of those commodities, there\'s a probability that that
sample would be indeed positive.

FSIS sort of decided then that performance would be measured by a series
of samples which we have referred to sort of as a set of size, N. Now,
there could have been different sampling schemes. There could have been
one of these continuous windows that people have mentioned. That would
have been another alternative, but the agency decided to work in
discreet sets.

When one is sampling with two possible outcomes, positive or negative,
could be heads and tails, flipping a coin, success or failure, anything
that has two possible outcomes. The number of positives which we call X,
you know, and N independent samples is said to possess a binomial
distribution, where the probability of X positives equals this equation.
I won\'t go through it.

Every time I see this, I remember I was tutoring what I thought was a
would-be girlfriend at Ohio State, and she kept wanting to call those
excited numbers, and, you know, I wouldn\'t let her call them excited
numbers, and I said those are factorials, and she wanted to call them
excited numbers. Anyway, that was the end of that. I guess I was too
much into control.

But anyway, it\'s a probability distribution is sort of nothing but
it\'s a mathematical expression where you can calculate the probability
of any one outcome, if you want to, and, of course, then if you summed
up overall the possible outcomes, it has to equal one. That is the
simple definition of a probability distribution.

It follows on the next slide that if one wanted to look at C or fewer
positives in a set, one would calculate the probability of one positive,
two positives, three positives, and up to C positives, sum that up, and
I would have the probability of, you know, C or fewer positives.

The next decision that had to be made is that FSIS decided that an
establishment that was operating actually at the baseline prevalence
should have an 80-percent probability of passing. Dr. Buchanan referred
to this and he had actually an OC curve which I\'ll get into next.

Now, where did that 80 percent come from? It was a judgment. It was a
balance between the need to prevent the establishment from failing a set
based on just pure chance and the need to identify establishments that
are likely to be operating above the prevalence. So, 80 percent was \--
it was a decision. It could have been 90, it could have been 70, but
with the decision of 80 percent, then we had the equation. That
summation of probability of 1-2-3-4-5, we set that equal to 80 percent.
So, there was an 80 percent for each establishment. If they were
operating right at the baseline prevalence, they would have 80-percent
probability of passing one sample.

So, this is just an equation that can be solved, and with a computer
program, one can solve this with a whole bunch of Cs and Ns. One can
start N equal 1, C equal 1, then just run it up. You can run the whole
thing up so there\'s a whole range of Cs and Ns that actually answer
that equation, and FSIS then finally decided that the N that we wanted
would be greater than 50, so that our sampling would measure process
control over time.

So, in the final sort of solution to those standards, the N and C that
are in our regulations are the first combination where \-- of N and C
where N is greater than 50 and the probability of C or fewer positives
is actually equal to .8 or 80 percent for an establishment operating at
the baseline.

Finally, I\'ll just illustrate then an operating characteristic curve. A
sampling plan like this obviously each of them have a curve that sort of
illustrates the performance of that sampling plan and the risk of both
types of errors you could get, calling a failure when it was indeed a
pass, calling a pass when it was indeed a failure.

So, the OC curve will show the likelihood of passing at different levels
of prevalence. This is actually the operating characteristic curve for
the market hog standard. On the bottom, it\'s pretty hard to read, so
the bottom axis or the X axis is actually the establishment prevalence,
and going up on the Y axis is the probability of passing, and the dotted
line shows for that plant operating right at 8.7 percent, if you go up,
there\'s an 80-percent probability of passing.

If one shifts to the right a little bit and look at, well, what if a
plant was operating at 12 percent? Well, if you drew a line up from 12
percent, you would find out if the plant actually had a prevalence, a
true prevalence of 12 percent, it would have a 50-percent probability of
passing our set of 55 samples where they\'re allowed six or fewer.

On the other side, if you go down to a plant, a market hog plant that
had a true prevalence of six percent, they would have about a 99 \--
95-percent probability of passing. Now, what would happen had we chosen
.7 or .9 as opposed to 80 percent? Well, if you had 70 percent instead
of 80 percent, you can just think of that whole curve with a shift to
the left. If it was 90 percent, it would have shifted to the right, and
as we shift to the right, you sort of increase the probability of
passing regardless of where you\'re at. If you shift to the left, you
decrease the probability.

There\'s one final slide. As I said, there were a lot of combinations of
C and N that could have been chosen, and this is again the market hog
curve that if we would have had smaller set sizes. The colors show up
here? Yeah. The black line is the current performance of, you know, six
or fewer in 55 samples. The blue line in the middle would be if we had,
you know, an N of 36 and a C of 4, and the red is N of 18, C of 2.

Now, all of those sampling plans would have measured the performance and
they all would have had the same characteristics if operating at the
standard. There would be an 80-percent probability of passing but with
fewer samples, the curve tends to flatten out, and then the plants
operating above the standard have a greater probability of passing, and
if you went above the larger set size above 55, actually then the curve
starts to steepen a little bit.

So, I hope, you know, that that at least gives people a little flavor of
how we took that baseline prevalence, how that sort of was transformed
into this thing of a set and how we sort of then put that into
operation.

So, thank you.

(Applause)

DR. ACUFF: All right. Thank you.

Well, that concludes our presentations. We\'re going to have a panel
discussion following a break, and I have to brag just a little bit. I
got word that my daughter had been picked as outstanding student at her
junior high, and they\'re going to give her an award tonight. So, I
looked at the flight schedules. The only way I can get there is leave
right now. So, I did a quick risk analysis, and you lost or won,
depending on your perspective, you know.

But Dr. Busta is going to fill in in my place, and he\'s going to lead
the panel discussion. So, I apologize for leaving early, but I know that
he\'s going to do an excellent job.

So, we\'re breaking now until 10:50, and we\'ll start promptly back up
again at 10 till 11.

Okay. Thank you.

(Whereupon, a recess was taken.)

Panel 3 - Discussion

DR. HULEBAK: Thank you all for returning reasonably promptly from break.
The refreshments are really good. It\'s hard to tear oneself\'s away.
But thanks for coming back.

We\'re now ready to open up a moderated discussion period for Panel 3,
and I will turn the mike over to Dr. Busta.

DR. BUSTA: Well, those of you that didn\'t want to rise to the
microphone, we have cards, but first of all, I\'d like to open this up
for the first question from the microphone, if someone wants \-- is
anxious to do that. Otherwise, I can start from the cards. Does someone
want to go to the microphone and ask the first question? I see somebody
coming forward. I see two. I\'ll go with the individual in the red
because she made the first move.

MS. NESTER: I\'m Felicia Nester from Government Accountability Project.
I have two questions actually for Loren Lange.

You were saying that the prevalence reflected in the baseline was
indicative of the probability of finding Salmonella in the marketplace,
is that correct?

DR. LANGE: No. It\'s indicative of finding Salmonella in an equivalent
sample at the same sampling location, you know, where the baseline was
conducted.

MS. NESTER: Right.

DR. LANGE: So, it\'s not marketplace necessarily.

MS. NESTER: Right. But it would reflect nationwide, right, and the
combination of small plants, large plants, very small plants?

DR. LANGE: True.

MS. NESTER: Right?

DR. LANGE: But \--

MS. NESTER: Go ahead.

DR. LANGE: \-- one qualification. When you do a nationwide baseline like
this, you sample \-- the sampling is done based on production volume,
and it really is all the samples are from the establishment that
produce, you know, 99 percent of the product. So, there really isn\'t in
a nationwide baseline, there really isn\'t sampling of very small
establishments, but behind it is the fact that no matter what very small
establishments did, their proportion of production is so small, that it
wouldn\'t affect the estimate of the national product prevalence.

MS. NESTER: So, you\'re saying that very small plants were not included
in the baseline. So, you\'re saying large and small plants were included
in the baseline collection?

DR. LANGE: Baseline \-- when there\'s a nationwide baseline of
carcasses, particularly what gets sampled is the large establishments
and the larger of the small that really constitute \--

MS. NESTER: 99 percent.

DR. LANGE: Yeah. 99 percent of the product.

MS. NESTER: Okay. Then, based on that, I\'m looking at FSIS\' most
recent reports, and I\'m looking at the ground beef numbers, and even
before you aggregate for all years, the prevalence at small plants
accounts for something like, well, not half of the samples that you then
aggregate but a good bit of them, you know.

In other words, large plants account for something like 1/20th. They
contributed about 1/20th of the samples for the aggregate figure, right?

DR. LANGE: Yes.

MS. NESTER: But you\'re saying that the large plants actually produce
more than 1/20th of the ground beef on the market. So that, the higher
prevalence at the large plants should be weighted, shouldn\'t it, in
your aggregate figure if you want to talk about the actual prevalence of
Salmonella?

DR. LANGE: Well, in the reports that the agency has published to date,
it is just a report. These are the findings, and it is \-- they have \--
there are other ways to use that data and try to make a better estimate
of prevalence, but there hasn\'t been an attempt to sort of take the
data and sort of, you know, to do different things with it.

MS. NESTER: To weight it for volume?

DR. LANGE: Yeah.

MS. NESTER: Okay. So, this is FSIS\' best estimate?

DR. LANGE: Well, it\'s FSIS\' presentation of these are the samples that
were collected in the enforcement testing of the HACCP verification
testing and these are the results.

MS. NESTER: Okay. One last quick question. You exclude all but eight
sets in these presentations, right? I mean, you exclude the results from
sets that follow a failed set. So, I\'m wondering, what is the
percentage? Do you know what the percentage is of the sample sets that
were excluded from calculation in this last report?

In other words, \--

DR. LANGE: I don\'t know right offhand, but, yeah, the \-- what\'s
published on the website is the sort of sets from the initial eight
sets, and the results from follow-up, what we call B&C sets are not
included, but I don\'t right now, I haven\'t \--

MS. NESTER: Okay. And that, unfortunately, is not on the web. I was
looking for that. So, I\'m not really sure whether you\'re excluding one
percent of the sample sets from your calculation or whether it\'s 20
percent of the sample sets from your calculation. That\'s my last
question.

DR. LANGE: Okay.

DR. BUSTA: I can\'t tell. Jim Lindsey, can you hear back there? I mean,
can you hear the \-- okay. All right.

I think because this is going to be recorded, if you\'d identify
yourself, please.

MS. MUCKLOW: Certainly. I\'m Rosemary Mucklow with National Meat
Association.

This is not the pick on Loren Lange session. The one thing I\'ve
learned, and I told Loren this at the break, that instead of writing
letters to Tom Billey in 1999, I should have been in visiting with him
and learning more about mathematics and statistics instead of focusing
on microbiology and how much richer we might all have been.

I\'d like to ask if the \-- Loren gave us copies or copies were
available on the desk. Maybe this just goes to all of the presentations.
It really makes it much more helpful to have copies of that material,
and I don\'t know if the other slide presentations will be made
available because Dr. Buchanan shot through his very rapidly. Now,
clearly, a paper copy with all of those marbles flowing around would be
quite difficult, but it would be useful.

DR. BUSTA: They don\'t come through in red and blue.

MS. MUCKLOW: Excuse me?

DR. BUSTA: They don\'t come through.

MS. MUCKLOW: Yeah. Especially in different colors and so on, but it
would really be very useful to have those. I don\'t know if we can have
them by the end of the day or not, but certainly it was very helpful,
especially when Loren got into all that mathematical game planning and,
you know, at least having \-- I now know what that sum sign is and
thanks to my computer, but it would really be useful.

I\'d like to ask Dr. Golan, and I got in trouble on pronunciation
yesterday. I don\'t know if I got her name right or not, but I found her
presentation \-- I got it right?

DR. BUSTA: Golan.

MS. MUCKLOW: Golan. Okay. Excuse me. Golan. I don\'t want to be fingered
out again at the end of the day for getting the names wrong. I try to be
a conformist to the extent that I can.

When Dr. Golan talked about the criteria for setting standards, I\'d
like her to maybe respond to a slightly different question. I think most
of what she talked about was where there was a normal or homogenous
distribution when you\'re looking for the exceptions, and when we are
looking \-- and the product of my great choice is that which we eat 50
percent of, which is ground beef, we are looking at an abnormal or
heterogeneous distribution of what we\'re looking for, and from an
economic sense, I wondered if she could maybe talk to that unusual or
heterogeneous distribution as distinct from the homogenous distribution
that you would get in a pasteurized product or in juice or whatever.
That would, I think, be interesting and helpful from an economic
perspective.

DR. GOLAN: Are you speaking about heterogeneity within a product coming
out of the plant or a heterogeneity across plants?

MS. MUCKLOW: Well, in terms of ground beef, the person that makes the
ground beef will have bought the raw materials from several different
plants, and I have a peculiar passion about ground beef which probably
is understood better by this audience than maybe by you.

But that raw material comes from a variety of plants, even at a retail
store where they may be grinding product still. So, a lot of product
comes from a variety of sources.

DR. GOLAN: It comes from a variety of sources, but I\'m assuming that
some of that product coming from some variety of sources is more
contaminated than others, and so that then the person who is actually
mixing the batch of product would/could place some restrictions on what
type of product they\'ll buy. You could have a restriction saying I will
not accept contaminated product into my processing plant, into my
product.

MS. MUCKLOW: Okay. It\'s not considered contaminated product. It\'s all
USDA-inspected product, and again I\'m not here to \-- what I\'m looking
for is the economic justifications for something that does not occur
homogeneously in the product.

DR. GOLAN: You\'re right. If I took a lot of different bits of meat,
thousands of different \-- from thousands of different animals, I will
get some that are \-- have Salmonella or E.coli, and I will mix them
into my great big vat of meat, and I will have a sprinkling of this
Salmonella or E.coli throughout my mixture. Some clumps will be more
laden than other clumps, and sampling will be a very difficult problem,
and then that\'s a sampling issue. But from the economic point of view,
this is getting back to something that was mentioned yesterday about who
has the ultimate responsibility for ensuring the quality of a product.

Economists would say you would put that responsibility on the end
player. I am the person who is amassing all these great globs of meat.
I\'m the person who has a responsibility for putting safe product into
my final product. You put the pressure at the end and that end player
puts the pressure on the downstream players. That\'s what an economist
would say.

MS. MUCKLOW: Therein lies a major, major problem under the present
scheme of how product is produced because that end person has no
ability, no clear ability and no testing ability or interventions to
prevent or to do anything about that product that comes to them.

DR. GOLAN: That\'s very analogous to many of the problems that
environmental economists have had to deal with. I gave the example of
car manufacturers. Car manufacturers have the ultimate responsibility of
making sure their emissions out of their cars are below a certain
standard. Okay. Where do they put the pressure on? The pressure on the
people to redesign that engine or is it on the input, the gasoline?
Gasoline is as easily as mixed up as ground beef. The pressure is on
both parts of this chain actually there, but we can reduce levels of
toxic material in gasoline, we can reduce levels of Salmonella and
pathogens in meat and ground beef.

MS. MUCKLOW: But the big difference there is that gasoline is a
homogenized product whereas the raw materials for ground beef are a
heterogeneous collection of \--

DR. GOLAN: I don\'t really see it that different, but there are many
other examples. Incinerators who take in raw materials from across a
whole dump have a responsibility for making sure that their emissions
are below a certain standard, and the inputs that come into them can be
all over the place as far as toxicity.

It is common practice in environment management to apply the pressure at
the end of the chain. I really don\'t think that food safety needs to be
so completely different. It is not more difficult to measure outcomes in
food safety than it is for environmental policy.

MS. MUCKLOW: On that, we may have a fundamental difference, but you
speak as an economist and I speak as a practical industry individual.

Thank you.

DR. BUSTA: Thank you.

Come up to the microphone, but I\'m going to do a couple cards. One for
Bob Buchanan.

Given that bad safety is so difficult to verify, is taking a two-ounce
sample of ground beef and testing it for E.coli anything but futile?
Pull the microphone close.

DR. BUCHANAN: I guess I would have to reflect on the person that posed
that question, was what was the purpose for taking the two-ounce sample
of ground beef and testing it? If you were taking a two-ounce sample and
trying to make a decision about an entire, you know, batch of ground
beef, depending on what your criteria were and what was the level of the
likely contaminant in it, it could be/it could not be. It\'s really an
issue here of you would need some more in terms of specifics.

If you were using it again as part of an on-going process of evaluating
or verifying a process, again it might be, but it would have to be part
of a larger sampling scheme. I would suggest that a single two-ounce
sample of an unknown batch would probably be insufficient to make any
kind of assessment of safety. Usually typically we would be dealing with
a 375-gram composite of 25 different analytical units, and I can go into
the details and depending on the defect rate, you might need to have 60
subs or 30 subs or a variety of those, but it\'s dependent on your
degree. So, it\'s really hard to provide any kind of response to that
question without knowing more details.

DR. McNAMARA: Anne Marie McNamara from Sara Lee Corporation.

I think as food scientists, we can all agree that final product testing
for pathogens plays a role in validating our HACCP plans in periodically
assuring that our plans are attaining the food safety parameters that we
set up and their designs.

But yesterday, a clinician made a statement that I\'d like to get the
food science perspective on, and that was Dr. Robert Tauxe from the CDC,
who seemed to be implying that purchase specifications for pathogens was
one way to reduce the incidence of disease, and as a food scientist,
that disturbs me because one can never reasonably test enough to ensure
safety, and it is against what I consider the principles of HACCP which
is process control that we\'ve striven since 1994 to attain.

And as a clinical microbiologist, I think it upsets me more because
you\'re giving your consumers and your customers a false set of
expectations. So, I wondered if you could give me the food scientist
perspective of the value of pathogen testing for purchase specifications
when valid HACCP plans are in place.

DR. BUCHANAN: I\'ll take a shot at that, Frank, and attempt to put it in
perspective at least of the talk that I presented here.

The establishment of criteria, be it standards, guidelines or
specifications, depending on where they\'re applied, is a statement of
the degree to which one expects that a hazard will be controlled, and we
can either do this in rather vague terms, and most of our laws are
actually in rather vague terms, you know, than interpret those laws in
giving some more specifics to them.

I personally find that if you lay out a reasonable specification or
criterion, let\'s use criterion as the more general term, it is helpful
because then the people that are providing a good or service or whatever
know what level to design their programs to meet.

However, we\'re mixing and matching two different things here. It\'s
whether or not a criterion would be useful and whether or not you have
to use microbiological testing to verify that, that you\'re meeting that
criterion, and I fall back to the discussion that I had earlier. It
depends on whether or not you have any intimate knowledge of the product
that you\'re dealing with.

If you have absolutely no knowledge of the product, then what you\'re
doing is batch testing and that requires a great deal of sampling. It is
quite burdensome, and I\'m not sure that it can be used effectively in
most instances.

However, if you have a process for which you have a great deal of
knowledge and what you\'re doing is verifying that that process is under
control, that is amenable to microbiological testing, and it is one of a
number of useful tests that can be used, if appropriate. Again, it\'s
dependent on the reliability of the process, your comfort zone with the
people that are providing you their history of performance. It\'s a
complex issue in managing a risk.

So, I\'m not going to give you a definitive answer one way or another,
other than to say it depends, and you should use the right tool for the
right job, and batch testing normally, when you\'re getting down to low
defect rates, is \-- gets to be quickly burdensome in terms of the
economics.

DR. GOLAN: Let me just add one point. I\'m not really sure what Dr.
Tauxe was referring to in his comments, but if he was referring to maybe
the possibility that pathogens are introduced into the food from point
of final sale to retail, well, if that was the case, then there are
other ways to provide consumers with information about what has happened
to the food.

One possibility would be having a label that records temperatures.
You\'ve probably heard of that proposal, that the label would record the
temperature that the food has been kept at, and if it had dipped below a
critical point or gotten too hot or gotten too cold, that the label
would actually record that so the consumer at final point of purchase
would be able to know if the food had been \-- the quality or safety of
the food had been compromised. So, there are other ways to get consumers
information and all those ways are probably going to be very important
in making sure that the final product is consumed safely.

DR. BUSTA: Here\'s one for me, and I\'ll get right to you. It says, are
there currently reliable indicator index organisms for Salmonella and
Listeria? No. A little bit of Letterman there. I hope I made the major
point that we\'d need a lot of data and a lot of relationships and a lot
more information to come up with good indicator organisms that would
indicate a certain thing. We really are short on the data and
information to make good conclusive directions at this point.

MS. CHEN: Lauren Chen from the National Food Processors Association. My
question is also related to surrogate organisms.

I was wondering if genetically-modified organisms can be used as an
appropriate surrogate. You\'ve mentioned that one of the desirable
characteristics of a surrogate would be if it\'s genetically stable. So,
conceivable that we\'ve identified a surrogate that has a similar, for
example, heat-resistant characteristics to E.coli 0157:H7 and we can use
it to validate process, now to facilitate identification of the
surrogate, we transform the naturally-occurring surrogate to carry a
genetic marker and now we would have to grow the organism in the
presence of a selective agent, maybe an antibiotic, before actually
using it.

So, my question is, would the transformed surrogate be considered
generically stable, and would it be appropriate to use for \-- as such?

DR. BUSTA: That has been proposed, to take an avirulent strain, and if
it has all the rest of the characteristics of the original, then it
would be work as an excellent surrogate.

Some of the problems are that if you\'re looking for antibiotic
resistance, your selection marker, if that organism got out into nature,
there would be a concern about putting out antibiotic resistance into a
population, and depending on the reversion rate, if it was even a
natural mutant, there are some environmental questions about putting an
organism like that out into the plant with the possibility of it getting
into the normal system.

But I think with the appropriate safeguards, it would be an excellent
surrogate, and some people feel that in thermal processing, PA3679 is in
fact sort of a curative of Clostridium Botulinum that no longer was
toxicogenic. That\'s sheer speculation.

Jill, I need to do a couple cards and then we\'ll get to you.

Loren, has FSIS sampled all the large and small plants so that all
plants that produce 99 percent of the product have been tested at least
twice, if not at least once?

DR. LANGE: I understand the question is that have we completed a sample
set in every large and small plant, and I think the answer is certainly
in most. There is obvious characteristics \-- you know, unique
situations where, I\'ll use as an example, a ground beef plant sort of
is in and out of production, and we start a sample set and they stop
producing ground beef. We\'re working to improve sort of our tracking
system in that area, but it\'s possible then that, you know, the
inspector in charge in that plant asks what to do, and we probably said,
you know, return the forms to the lab and stuff, and we stopped, and
then until we get sort of information that yes, they\'re back up in
production, we may have missed that.

So, I can find isolated cases, I think, where we haven\'t completed at
least one set, but we certainly \-- you know, our attempt is to sort of,
you know, as we can keep track of the best information we can from
who\'s producing which of the products, we try to get everybody
scheduled.

MS. SNOWDEN: Thank you, Frank. Jill Snowden, SGA Associates, and thanks
to all the panel members for their informative presentations.

I have a clarification to ask and perhaps a suggestion for Dr. Golan. I
appreciated you coming up with guidelines, and I liked hearing the
economics perspective on that, the guidelines for setting performance
standards, but I want clarification on understanding what you\'re trying
to say when you say regulate as close to the end users as practical
while encouraging upstream solutions.

As I think of the farm to table, I think of the end user as being the
consumer, and I\'m assuming that if that\'s what you\'re thinking, then
the closest point to regulation there is going to be food service or
retail. So, that\'s my clarification.

Are you saying that we regulate close to the food service and retail and
push all the way back to production?

DR. GOLAN: I was actually thinking of the end of the production line.

MS. SNOWDEN: I\'m not hearing you.

DR. GOLAN: Sorry. I was actually thinking at the end of the production
line, but regulation well extends all the way to the consumer, and we do
have a lot of regulation or actually policy, policy directed towards the
consumer. We have a lot of education programs and labeling.

MS. SNOWDEN: Then I think my suggestion would be that as you do the oil
analogy of the oil move in in terms of the impact on pollution, I think
you need to \-- maybe the economic models need to be adjusted for the
fact we\'re dealing with biological systems. Bacteria, in particular, I
tend to think of as a web. I even challenge the farm to table approach
as too many because of the different points of entry that the
contamination can come in and because of the growth possibility or the
reduction possibility.

So, I\'ll leave that as a suggestion, that as you continue to develop
your models when applying this, that we think more weblike than we
necessarily do linear to pull the biology into our models.

DR. GOLAN: Because the biology is more complicated than in an oil
example, and because the pathogens can be introduced all along the line,
maybe it makes it even more important to focus on that end player.

MS. SNOWDEN: Thank you.

DR. BUSTA: Dr. Buchanan, can you please define validation and compare
validation between the food and drug industry, between the food and drug
industry? Is there a document or guideline on validation?

DR. BUCHANAN: Interesting. As we have gone back and talked about terms,
we\'ve come to the realization that if you go to different documents,
you\'ll find different definitions, and while they may vary slightly,
they do differ.

For me in terms of validation, I might note, also, in regard to the
National Advisory Committee for Microbiological Criteria for Foods, for
discussions that are taking place at the international level on Codex,
validation is typically designed to establish whether your food safety
system that you\'re using is capable of providing you with the level of
assurance that you actually intended it to have; that is, if I have a
system. For example, if I have a car, and I expect that that car can do
80 miles an hour and it can do it for a hundred hours, it\'s actually
somebody getting out and testing that model to make sure that it\'s
capable of doing that.

Typically, we would validate before we start a process up or, you know,
in the early stages of it, and then it would only be revalidated
periodically when the system changed so much as to require a reassurance
that the system is capable of delivering what was intended.

The sampling during normal operations is typically referred to as
verification and that\'s separated. If validation is determining if the
system is capable of delivering what you expected it would be or what it
was designed to do, verification would be is it continuing to actually
supply that, and so there is a difference between validation and
verification.

Increasingly, validation is looked at, at least in FDA, as a necessary
step before you start a food safety process.

MR. BAILEY: Stan Bailey from the Agricultural Research Service in
Athens, Georgia.

My comment and question is, I guess, both to the panel and possibly even
to people in the room. When we implemented the HACCP plan back in \'94,
it had the two components, one for Salmonella testing and one for the
generic E.coli testing. The environment at that time was pushing very
hard toward having all species, all animal species treated equally.

So, my question on the generic E.coli testing is (1) does the panel or
anybody else think that there is real value coming out of that testing?
It\'s pretty well established and Dr. Busta just referred to, it\'s not
an indicator, it\'s not a good indicator of the presence of Salmonella
or any other pathogen, and secondly, it\'s not really a measure of
process control, at least in the poultry industry, which I work in
mostly, and so I guess a two-part comment is (1) do we still consider it
a valid thing to treat all animal species equal in terms of the E.coli
testing, and what value are we getting, other than a fairly large
expense in doing the E.coli testing?

Thank you.

DR. BUSTA: Panel? Loren looks like he\'s about to address this.

DR. LANGE: Well, a lot of times, there\'s \-- one can get themselves in
trouble when their initial reaction is you don\'t know how to answer
that question, and then you try to answer it. So, I should probably
stick with I think the answer I would give is as a staff person in FSIS,
we really haven\'t done the follow-up study to evaluate, you know, what
we\'re getting from the requirement that the E.coli \-- you know, the
testing for generic E.coli.

I think the emphasis from the agency has been on trying to, you know,
make sure that, you know, it is being done, that the results are being
reported, but we haven\'t answered that question inside the agency of
what we\'re getting from it. That\'s the best I can do.

There may be someone in the audience that would like to answer that.

MR. BAILEY: I appreciate the honesty of that answer. One of the
preambles of the discussion at that time was the issue of measurement of
fecal contamination and this would be a good way to know what was going
on. I realize there were a lot of other backdrops as to why it was done.
I was aware of that discussion, but if one looks at the data within the
industry, at least in the poultry industry, and even your own data where
you\'re measuring fecal contamination, I think you\'ll find that
there\'s very little correlation between the level of E.coli and the
presence of fecal material.

As a matter of fact, the only time we really see blooms or outbursts of
E.coli or high levels in the poultry industry is if there\'s an
airsoculitis or some other disease problem, which is totally unrelated
to the food safety aspect of this.

DR. BUSTA: Comments from the panel? Bob?

DR. BUCHANAN: I\'m not going to address the specifics of the poultry
industry, but I would like to talk a little bit about E.coli as an
indicator and re-emphasize some of the points that Frank made in his
presentation.

One, as an indicator, we\'re talking about a state or condition. So, in
this instance, the state would be fecal contamination. What we need to
keep in perspective is that as you get down to the low levels where
you\'re exercising a high degree of control, you start to get in the
situations where you are having to deal with other sources of E.coli in
the environment, and so when you\'re getting down to \-- you\'re down to
a percent frequency of about two percent, then you have to start asking
the question, is the E.coli that\'s present in that environment down to
the point where it\'s no longer indicating fecal contamination, it\'s
indicating something else? That\'s just not to say that it\'s useful,
and I think it would probably be better to ask the people that are
actually in the industry what has been the usefulness of that indicator
in terms of their ability to maintain good strong sanitation programs
and pathogen reduction programs, and if it\'s not a useful indicator,
what would be an alternative in terms of something that would help them
monitor the microbiological status of their operation?

DR. BUSTA: Any industry comments on that?

(No response)

DR. BUSTA: How long do you wait? There\'s a question here for me that
says, if all Salmonellae are not equally pathogenic for humans, isn\'t
it futile to look for indicators in the indices or index organisms or
surrogates?

Well, as an optimistic academic researcher, nothing is futile. There\'s
always an opportunity, but I think as we develop greater and greater
genetic understanding and faster and better evaluations and
measurements, that we may be able to sort out the appropriate hazardous
Salmonella from the less hazardous Salmonella, the same with E.coli or
the same with Listeria, and be able to do that sorting, and then it may
be very appropriate to identify indicators of the presence or indices of
the presence of the actual pathogens or the hazardous organisms and
simultaneously have a real opportunity to pick surrogates for those
specifically hazardous organisms.

So, I think the opposite of futile. As we learn more and more about
these organisms, we\'d be able to do a better job with improved data
than we\'ve done in the past.

Sir?

MR. MARLER: William Marler. I\'m the attorney that represented the young
boy who developed HUS that Secretary Murano mentioned that she testified
with her mother.

My question is for Dr. Golan. Given how FSIS and USDA presently regulate
the industry and given that most people who develop a foodborne illness
never know what product they got it from and never know where it came
from, can you explain to me where the economic force is to have the
industry make any changes whatsoever in their food safety practices?

DR. GOLAN: Well, the economic force, the force is not market-driven,
because of the failure that you\'ve identified. We have a market failure
that the information is not available to consumers. They\'re not always
clear about the quality or the safety of the food that they\'re
consuming.

So, many of the market incentives for firms to produce foods, safe
foods, dissolves, which is why government regulators say we have a
reason to step in and regulate this industry. So, exactly what you\'re
saying is why we step in, why regulation is necessary.

DR. BUCHANAN: I\'m sitting in for Gary on this. There was a question
directed to him. It says, historically in the U.S., pork and poultry
have been thoroughly cooked while undercooked beef continues to be
generally accepted. While each has pathogens associated that can be
heat-killed, why the disparity between the species?

I\'m going to focus on pork and beef in answering this response because
it\'s an interesting history. Pork has traditionally in the United
States been cooked to a well-done state. In fact, if you go back to the
early part of the last century, there was a tremendous effort on the
part of the U.S. Government to convince consumers not to eat pork in
less than a well-done state.

It\'s one of the few examples we have in the country where food safety
education programs have been effective to the point where it actually
could be relied on to assure the safety of the product. This reflects
the fact that pork in the early part of the 20th Century had a fairly
high contamination rate with Trichinosis, and as opposed to beef, and
for any of you that are not familiar with Trichinosis, it\'s a parasite.
It\'s incorporated right into the muscle tissue. So, you had the \--
even if you \-- you couldn\'t have the assumption that the inside part
of the muscle was sterile, as opposed to beef. The working assumption
that if you take an intact cut of meat, the contamination is restricted
to the outside.

The reason why that\'s interesting is that it demonstrates how there are
different approaches to solving the same problem. In Europe, where pork
continued to be consumed despite the fact that there was Trichinella,
and they consumed it in the raw state, they relied on an entirely
different approach. They relied on carcass-by-carcass inspection of the
animals, taking a piece of the diaphragm and actually testing and
holding those animals to make sure that they were Trichinosis-free.

Got to the same point. Both were equally effective in terms of
controlling that disease, and we can see beginning in the early part of
the 20th Century the rate of Trichinosis associated with disease in this
country dropped dramatically as a result of this impact that we had on
the safety of that product.

Again, beef was not affected by these parasites. There has been a
working assumption that the inside of that muscle tissue is free of
pathogens, though, of course, we do get into instances where lymph nodes
may be contaminated. So, a little history.

DR. BUSTA: Bob mentioned earlier that this panel was a demonstration of
true graybeards. Gary\'s gone already, but the three of us.

Here\'s a question for any of the panel, but Bob, probably you\'re the
best on this. From the audience, the individual was surprised at the
level of Salmonella in ground turkey and chicken considering there is a
\"zero\" tolerance for Salmonella in shrimp and fish that is imported
into the U.S.

What is the reason or are the reasons for this discrepancy?

DR. BUCHANAN: Let me again give you a historical example and where
technology and changes in agriculture have generated a controversy or a
need to go back and relook at it.

Typically, shrimp were harvested from deep sea waters. They were in an
environment where Salmonella was a rare and transitory occurrence and
that Salmonella associated with this product was typically acquired as a
result of post-harvest contamination; that is, it was contaminated on
the boat or it was contaminated at the dock or it was contaminated in
the processing plant because Salmonella was just not a normal part of
the marine environment and that was the basis upon which a zero
tolerance for Salmonella was originally derived by FDA for that product.

The reason why it has now become an issue of controversy is that during
the last 20 years, there has been a shift from marine sources for shrimp
to fresh water shrimp, and we also now see a great deal of shrimp being
produced by aquaculture, and in such an instance, in fresh water ponds
and in aquaculture setting, the presence of Salmonella when you have
ponds that, you know, ducks swim in and, you know, animals come down and
run-off from agricultural lands, Salmonella now becomes a part of the
normal flora and there\'s been an on-going debate internationally
whether the zero tolerance for Salmonella is any longer justifiable, and
this is an issue that has been in front of Codex, for example, and
continues to be debated and discussed.

So, I can\'t give you an answer definitively, but it\'s an example of
how as the world changes, how we need to go back and relook at the
justifications because it may no longer be the same rationale that was
used originally.

DR. BUSTA: Loren, is it true, if a company were at the mean rate of
contamination, its probability of failing one test is 20 percent, the
probability of failing two tests is .2 or .04 percent, the probability
of failing three tests is .2 times or 22 or .008 percent, and therefore
the probability of passing three tests \-- passing with those three
tests is .992?

DR. LANGE: That\'s correct.

DR. BUSTA: He wasn\'t very close to the microphone but that was correct.

For the panel, how has test sensitivity changed over the last decade,
and what are the implications for performance standards? Test
sensitivity being that \-- I mean, we\'re going to have to define test
sensitivity. This would be \-- is that \--

DR. LANGE: The only thing I can think of, if the question is related to
\-- there was some discussion yesterday that there\'s been a different
laboratory method for 0157. There\'s been a \-- for FSIS laboratory, as
I understand, there\'s been a constant method for analyzing for
Salmonella through the baseline period and the post-HACCP period.

DR. BUCHANAN: The limiting factor right now in terms of testing
sensitivity since the tests are \-- the one for Salmonella and E.coli
are \-- have been around forever, and they haven\'t really changed much,
they\'re highly sensitive, detectable at levels practically down to
about one per 10 grams.

Basically, it\'s dependent on the size of the sample you take, and
those, as far as I know, have been kept constant.

DR. BUSTA: What about PCR? Has that improved the level at all?

DR. BUCHANAN: Typically, PCR, the level of detection at PCR is when you
take into account the sample size, which is actually quite small, and
you\'re taking smaller and smaller samples as you go to that, you really
\-- the limiting level of sensitivity for a straight PCR method is
actually down around one \-- you have to get up around 10 to the 4th
actually where you\'re detectable, and basically anything below 10 to
the 4th requires enrichment and still the most sensitive means of
detecting the organism is culturally, including all the classic
enrichment steps, and certainly you may be able to speed it up or
confirm it.

DR. BUSTA: My question was merely rhetorical.

DR. BUCHANAN: Right.

DR. BUSTA: But people expect that the PCR\'s going to give you instant
fast and wonderful results, and it\'s got limitations.

Mike?

MR. ROBACK: Mike Roback, Wayne Farms.

My question is related to performance standards. Again, we\'ve talked a
lot about performance standards, talked a little bit about indicator
organisms, index organisms, and I think we have a difference between
whether we\'re looking at a raw agricultural commodity versus a
ready-to-eat food on one hand that I think a distinction needs to be
drawn, and as we talk about the Salmonella performance standard in
particular, with raw meat and poultry, what is the true value of having
a qualitative performance standard versus a quantitative performance
standard when one cell is as damning as 10,000 cells?

I wonder as we\'re looking at measuring public health outcomes, if a
qualitative performance standard is really providing us with the
information and the standard that we truly need to improve food safety,
and I\'d just like to hear your comments on that.

DR. BUCHANAN: It\'s \-- Mike, it\'s not quite as clearcut as you think
because really whenever you go to a qualitative determination, as you
would in any attribute sampling, in reality, you can make a quantitative
estimate of what is actually occurring within that animal. If you\'re
down at a low level where only one out of every so many carcasses are
showing up as positive, you can \-- assuming a normal distribution of
that or even a log normal or others, you can actually make an estimate
of what the level was in order to have that positive.

That\'s the whole basis of an NPN, is that kind of approach. It\'s a
statistically-based approach, and it would not be hard to take any of
the results that are there for plus/minus and actually come up with a
best estimate of the mean concentration on that organism at \-- on \--
in that product, including confidence intervals around it.

So, this artificial designation or separation between qualitative and
quantitative really doesn\'t exist when you start dealing with
statistics. In order for you to get down that low on this kind of a
process control, you have to be down where there\'s just a few organisms
on the carcasses anyway or everything would be a hundred percent.

MR. ROBACH: Well, I don\'t know if that\'s necessarily the case, Bob. I
think it would be very interesting to run a validation on that theory,
and I think one of the points that was made earlier is that this
performance standard was really established prior to a risk assessment
being done, and I think the other point that needs to be made is that if
we\'re after improving public health, then it behooves us all to perform
the proper risk assessments to determine, you know, what is an
appropriate standard?

Just because you can easily measure an organism or it can be found in a
regular basis does not necessarily equate to an improvement in public
health if you indeed reduce that organism. So, I think as you point out,
it is a very complicated situation, and I think in meat and poultry,
we\'re in a situation where we have a HACCP system in a raw process,
where we do not have a terminal step, and we\'re doing what we can to
reduce or at least control contamination of product going through a
process, and we have to take into account (a) the initial contamination
coming into the plant and then do the best we can to reduce that or at
least control the numbers of organisms through the process, and I still
believe that a qualitative performance standard does not really give us
the proper measuring tool to accomplish that.

DR. LANGE: I would just add that in my presentation, I mentioned that
certainly the risk assessment people in OPHS, you know, are, as we make
decisions about allocating our laboratory resources, are certainly
interested in testing to find the quantitative levels, at least at some
point in the production process, whether even if it\'s at where we
currently test for poultry at the end of the drip line or consumer
packages. So, they are \-- for the development of the risk assessment
models, they do want quantitative levels.

DR. BUSTA: I\'m going to limit this now to two cards, and then we will
have a lunch break.

The last one for Dr. Golan. Golan. No one\'s ever going to forget that
except me. Golan.

If improving the safety of food costs money, how can we prove, I think
it\'s provide, safe food for everyone and just not the rich?

DR. GOLAN: Well, I\'m really not sure where to go with that. I mean,
policymakers for a lot of different social objectives decide that
everybody needs to have the same level of production or everybody in the
whole society needs to be \-- well, have the same safety, and in other
cases, policymakers decide that\'s not really important, that people can
decide how much risk they want to assume and how unsafe lives they want
to lead.

We make people wear motorcycle helmets in most states. We let people ski
without helmets in all states. So, sometimes we as a society decide that
certain risks are acceptable and certain risks are unacceptable, and it
is just a complete cost-benefit analysis and that\'s what economists in
the Federal Government end up doing a lot, particularly now. Probably
we\'re going to end up doing more and more with changes at OMB.

But these are \-- there\'s a careful calculation of how much safety the
society wants and how much safety a society is willing to pay for.
That\'s a difficulty.

DR. BUSTA: Funny you should mention motorcycle helmets. It was ruled
that that was an individual choice in the state of Minnesota, that they
don\'t have to wear motorcycle helmets. That was before we had a bald
governor.

Okay. I have \-- this is \-- this seems very appropriate for the last
question before lunch. If 100 sandwiches were set out, 25 with white
bread, 25 wheat, 25 rye, and 25 raisin, from a consumer safety or
performance standard view, which type of bread should be allowed to test
positive for Salmonella 49 percent of the time? Which one of the 82
samples? I didn\'t make it up, honest.

DR. BUCHANAN: That sounds like a mathematician is needed.

DR. LANGE: Now, we all hear different things. I heard that as a question
that was raised yesterday, as how did we justify allowing a different
level or prevalence of Salmonella in one product versus another, and the
answer is sort of \-- actually has a preamble to the \'96 rule in my
briefcase. I could read it, if it\'s \-- you know, a decision that there
was a sense of, you know, quality in requiring each segment of the
industry to operate at least at a level that had been shown as baseline
prevalence in a study, and it was determined that without a public
health outcome, that that would in fact generate reductions in pathogens
and therefore lead to reductions in the foodborne illness. If that\'s
how \-- that\'s what I heard. Now, maybe someone else heard a different
question.

DR. BUSTA: Well, I think it requires a research activity at lunch. Lunch
is on your own. Please be back sharply at 12:50, 12-5-0, 10 minutes to
1, and we\'ll reconvene with the afternoon panel and Jim Dickson.

(Whereupon, at 12:01 p.m., the meeting was recessed, to reconvene this
same day, Tuesday, May 7th, 2002, at 12:50 p.m.)

A F T E R N O O N S E S S I O N

12:58 p.m.

DR. HULEBAK: Good afternoon, everybody.

Welcome back from lunch and the beginning of our last session, Panel 4,
focused on Animal Product Intervention Strategies.

The chair of this afternoon\'s panel, my pleasure to introduce, Dr.
James Dickson, Associate Professor and Chair of Microbiology at Iowa
State University.

Dr. Dickson received his Bachelor\'s of Science in Microbiology from
Clemson University, from where he went to get his Master\'s of Science
in Dairy Science at the University of Georgia, and then on to the
University of Nebraska at Lincoln for his Ph.D. in Food Science and
Technology.

Dr. Dickson has had many and varied successful research strategies in
his career. He\'s developed a predictive model to estimate growth of
Salmonellae during cooling of carcasses which have had some singular
practical applications actually at USDA. He has conducted studies of
bacterial attachment, carcass washing and sanitizing that have seen a
number of practical applications.

He currently serves on the National Academy of Sciences Committee
that\'s looking at scientific criteria and performance standards, and he
chairs the Meat and Poultry Subcommittee of that committee.

So, it\'s with great pleasure I introduce Dr. Dickson and Panel 4.

Thank you.

(Applause)

Panel 4: Intervention Strategies, Including Verification of
Effectiveness

DR. DICKSON: Well, thank you, Dr. Hulebak.

I would like to say at the outset that for those of you who have ever
had the pleasure of assembling a meeting, especially a meeting of this
scale, you appreciate the challenges, if you will, of getting everybody
in order and everybody in the same place at the same time, and I have to
say that Dr. Hulebak and her staff have been very professional and have
done an excellent job of doing this in the relatively short time frame
that they had to work in.

Well, this afternoon\'s panel is on Intervention Strategies, and we have
a number of speakers this afternoon which I think you\'ll find
interesting, beginning with discussions on intervention strategies in
live animal production, intervention strategies at slaughter,
intervention strategies during processing, and then finally a discussion
of the benefits and costs of intervention strategies which may
ultimately determine the actual use of some of these interventions. The
reality is the best intervention strategy in the world is not useful if
it is too costly or too expensive to use.

I\'ve been asked today to give a few introductory comments on the
subject of intervention strategies and just to reiterate when we talk
about intervention strategies, we\'re talking about the entire food
system and that includes production, transportation, processing,
distribution, whatever the ultimate end point is, whether it is
commercial preparation in a restaurant or food service or retail sale,
and ultimately the consumer.

So, when we talk about interventions, bear in mind that there is no one
point along the way that we\'re speaking of interventions. We\'re
talking about interventions all the way through the chain.

I thought I\'d start out by saying what is an intervention, and for lack
of a better definition, I made one up, which is simply a procedure or
process or technology which reduces or eliminates a potential foodborne
hazard, and although our focus has been primarily microbiological, I\'d,
of course, like to remind everyone that it also includes chemical and
physical hazards as well.

Okay. To begin with, first intervention is prevention, and it doesn\'t
really matter how you approach this, whether you are a food service
employee or an animal production employee, however you approach this,
the first intervention is prevention of contamination and just to give
you a very brief example of this, if you apply an intervention, and I
don\'t care what intervention it is, that has a two log reduction, the
resulting product is much better off if you start out with 10 to the 4th
as opposed to 10 to the 6th bacteria of whatever bacteria you choose to
talk about.

So, when we talk about interventions, bearing mind that interventions
are part of the strategy of reducing hazards in the foods and that
definitely the first hazard by far and away is one of prevention. I
don\'t think there\'s an individual again that would say that they would
rather be in the business of solving a problem rather than preventing a
problem, and so let\'s bear in mind that intervention or prevention is
in fact our first line of interventions.

There are a couple of categories of interventions, whether we\'re
talking about on-farm or processing, slaughter or even at the retail
consumer level. Those are things like procedural interventions, and I
guess for lack of a better term, I\'ll call it procedural. These are
things, such as good agricultural practices, if you\'re talking about
production of crops or production of livestock, sanitation practices,
safe food-handling practices. Again, these fall into a procedural type
of category. These are things that tend to be, for lack of a better
term, again procedures that simply allow us to either prevent, reduce or
eliminate a potential foodborne hazard.

I\'m going to go through an example of how all these sort of fit
together here in a minute. But bear in mind, procedural is just that,
simply things like good sanitation practices at any point in the
process. Process interventions. These could be things like trimming and
washing processes on animal carcasses, cooking processes, even canning
processes. Canning process might be the ultimate process intervention,
if you will, simply because the product ultimately is sterile as it
comes out, but again that\'s a physical process or some type of process
that\'s applied to intervene, to reduce or eliminate some potential
foodborne hazard.

And the final group, I\'ll call it technology interventions, and these
fall under the general category of things like equipment design. Steam
pasteurization is a good example, just to pick one, of a technology
intervention. I think if 10 years ago, someone had said, well, why
don\'t we steam beef carcasses to kill E.coli, most people in the
industry would have said yeah, that\'s a nice idea, why don\'t you go
work on it?

But steam pasteurization is in fact a technology that has been developed
in the last several years which again does a very good job of reducing
potential foodborne hazards. Irradiation again is an example of a
technology intervention. Again, something that\'s out there, a
technology that exists that can simply be applied in a different format.

Now, when we talk about interventions, bear in mind, as I said, we\'re
talking about interventions across the entire food distribution chain.
We\'re talking about multiple interventions and for a couple of reasons.
First off, there is no magic bullet. There is no silver bullet. If there
were, none of us would be here today, okay, because we would have all
figured out what that magic bullet was and that\'s what we\'d be using
and there would be no problem.

So, there is no single answer that addresses all the issues, but the
second issue is opportunities for recontamination. As an extreme
example, let\'s talk about food service. You can take canned foods which
we will for the purposes of this discussion, we\'ll consider to be
sterile, open the can in a food service establishment, warm it up to
serve to a customer and have it handled by a food service worker
carrying hepatitis A, and your customer still will become ill with
hepatitis.

So, when we talk about opportunities for contamination or points in the
chain where contamination can occur, bear in mind that that goes all the
way through the system. We\'re not talking about cattle on a feedlot or
we couldn\'t talk about cattle on a feedlot, but we could just as easily
talk about food service workers in a commissary or a food service
establishment, for example, the one here in the Georgetown Conference
Center, that also needs to bear in mind that they have a role in
interventions.

I do have one example of this and how all these multiple interventions
come together and for the sake of discussion, we\'ll talk about
pasteurized milk and the Grade A pasteurized milk ordinance.

As many of you are aware, the Grade A pasteurized milk ordinance
includes interventions at several points, and it begins on the farm with
specific requirements for milking of dairy cattle, and those include
things such as equipment design, sanitation within the milking parlor,
temperature control of the product, in this case it\'s a raw product,
but there are temperature standards or guidelines for controlling the
product. So, there\'s actually a production intervention or several
production interventions.

At processing, we have pasteurization which, if you will, is the food
safety intervention. The time/temperature process used to destroy
foodborne pathogens which should at that point render the milk free from
pathogenic microorganisms and should render it safe for human
consumption, and ultimately during distribution in retail that we keep
the product at refrigeration temperatures in part to prevent spoilage
but also in part to limit the growth of anything that may have
accidentally come through the pasteurization system. So, we have a
system where multiple interventions work together.

No single step in that process could be eliminated. Okay. For example,
you would not want to remove the production controls on farm, the
sanitation, equipment design and things of that nature, at the source of
milking and simply say, well, we can fix all the problems with
pasteurization. Even though that may technically be true, the point is
that you don\'t want to remove it.

Likewise, you wouldn\'t want to say we\'re going to do all of our
interventions on the farm and therefore we don\'t need pasteurization. I
think history has proved to us that pasteurization of milk is probably
one of the best public health success stories we\'ve had. So, again what
we\'re saying is that we\'ll use multiple interventions at different
points in the process and not rely solely on one specific aspect or one
specific intervention to solve the issue.

I think we\'ll see that this afternoon as we go through the various
talks that we have on animal productions, slaughter processing and then
ultimately on cost-benefits.

We have a couple of discussion issues. I\'d like you to think about
these as you listen to the presentations. First off, what research needs
to be done to develop new technologies? How can USDA/FSIS provide
incentives to conduct the research? Again, think about these things as
we go through. How can you measure and verify the food safety impact of
interventions? These are questions to ask as you hear the presentations.
What new technologies have been developed that are ready for
implementation? How can USDA provide incentives to implement these
technologies? Ultimately, what can be said about likely benefits and
costs of interventions?

As I started out by saying, the best intervention in the world is
useless if nobody can afford to implement the technology. So, as I said,
think about those things as we go through the presentations, and with
that, I\'d like to introduce our first speaker, Martin Firth. If you\'ll
bear with me one second here, I promised that I would do \-- Martin
Firth.

Martin Firth is the Manager of the Policy and Strategies Division,
Canadian Food Inspection Agency. Martin is leading the development and
implementation of an agency-led recognition protocol for on-farm food
safety systems.

So, for those of us interested in on-farm food safety controls, it will
be quite interesting to hear what the Canadians are doing in that level.

Martin?

MR. FIRTH: I\'d like to take the opportunity to thank the organizers for
inviting me. It\'s not only a pleasure but an honor to be here and be
part of this discussion. It\'s been very informative from my focus, I
guess, in terms of HACCP and where we\'re going.

I guess there was some regional references to hellos and greetings and
so from my native tongue, I\'ll say good day to you all.

What I\'m going to try and make some sense into providing you with a bit
of a process that we\'re working with where the agency\'s leading the
recognition process, and I would like to try and describe that to you,
going through the participants\' roles and very briefly rules and
responsibilities and then end up with some of the intervention
strategies and programs that are involved in some of the individual
on-the-farm programs.

So, press page down. Just to give a quick background, we had \-- the
agency was created in 1997 out of four separate government bodies, but
more importantly for HACCP, before and after the creation of the agency,
there was certainly a strong support towards the industry adoption of
the principles, and we\'ve been working on a number of \-- basically two
programs for processing sectors.

The Food Safety Enhancement Program, which covers the agrifood and meat
and poultry sectors, and then for the Fish Programs, we have a mandatory
quality management program and just to get you right up to speed, we\'re
in the works of going down the road of mandatory HACCP implementation
for our meat and poultry sectors.

Broadly, I guess we\'ve been working with our industry and with the
processing sectors since about 1991, and then interest began about 1994,
and we formally engaged with on-farm commodity groups in 1995, and
through all this, our minister has provided some assistance, and I put
this bullet in for some of the food for thought you had up earlier.
There has been some assistance programs in helping industry adopt the
HACCP.

Some of the pressures facing the on-farm in general, these are pretty
broad. There\'s certainly consumer awareness and that\'s been well
presented earlier. What I will \-- what we\'ve been calling HACCP
pushback, and this relates to the discussion that\'s been presented
earlier regarding upstream. Liability, and this is an interesting one.
What\'s really come to the foreground on this one is that it\'s the
liability of not doing anything and that is becoming of greater concern
with the industry groups and the processors themselves.

The early-on discussions in liabilities was for the producer. If I put
something in place, then wow, I\'m going to be singled out. Through
their development of the programs, they soon realized that there\'s
actually more liability for doing nothing, and then buyer
specifications, and from this point, we\'re seeing a lot more pressure
for the producer groups to be on some form of HACCP-based program. We
have a large number of retailers that are starting to push back now, and
with the mandatory approach for our meat and poultry sectors, there\'s a
lot of development going on and pressures being put on the livestock
sectors to develop their programs.

Some of the principles that we\'ve been working with is that the
programs have to be HACCP-based, and I\'ll define that a little later
on, but the strongest point here is that these programs have to use
sound science in their development. They have to link with other
stakeholders, and probably it\'s more accurate to say that they have to
be linked with other sectors of that industry. So, therefore, there has
to be a clear linkage with the beef program towards the up to the
slaughter and then up to the processing.

In Canada, there\'s a shared jurisdiction between the Federal
Governments and the Provincial Governments. So, that has to be respected
at all times, and that it has been made clear that industry wants to
take the lead in the development and implementation of these programs.
So, we\'ve respected that, and the most important part is that these
programs are dynamic, that although they may be implemented at time max,
they certainly will change down the road and they will be expected to
change to keep current with science and regulatory requirements.

Not to bore you, but talking about making up definitions, we made this
one up at the federal process. So, it wasn\'t just me. So, I\'ll share
the blame. It\'s basically what we\'re looking at is a systematic
approach based on HACCP principles that represents a set of good
production practices or referenced earlier good agricultural practices,
including control measures, on-farm food safety program background,
including the HACCP generic model and its analysis, a producer manual,
and the management manual, and I\'ll try and describe those pieces a
little later, and it\'s developed to promote the production of safe food
at the farm level.

We are not trying to develop these programs and state that they will
definitely guarantee levels of safety because, as has been discussed
earlier, it\'s extremely difficult to take those measurements at the
consumer level, the impact of what\'s going on at the farm. So, we feel
pretty safe to say that these programs, if implemented, will provide
promotion of safe food.

I mentioned earlier I would try and define HACCP-based. The first piece
that we realized very early on, especially after talking to some
producers, that HACCP would be very difficult to implement in its pure
sense or the sense that we use it at the processing level, mainly
because of the management styles at the farm level and the environment
that they live in, and I use environment here loosely.

So, what we mean by HACCP-based is these programs at a commodity level
are developed through a technical committee. The committee membership
must include some members from academia, technical experts, as well as
producers and some government personnel as well.

The process that they work through is that they develop a generic model
for that commodity. They then go through the hazard analysis based on
that generic model and go through, using the seven principles, they work
through the process. They identify any critical control points, and they
also use that hazard analysis to give them direction in the development
of their good production practices, and the CCPs that are derived from
the analysis are also incorporated into those good production practices.

At the end of the day, what they have then is they have a generic
process that\'s allowed them to develop their producer manual, but they
also have a very clear record of decision as to where they went with
their decisionmaking.

Some of the background participants and kind of globally to the system
is we have our sister organization, Agrifood Canada, and they\'re
providing a lot of the developmental pieces in terms of financial
assistance, etc. We have Health Canada with us as they have primacy in
terms of standard-setting for food safety. We have ourselves. We have
the Canadian Federation of Agriculture, an industry organization that
has been administering the funds that the minister has allocated, and
then we also have the individual producer associations.

Just for a bit of a background, we\'ve identified, it may seem small
numbers to you folks, but nationally, we\'ve identified 22 significant
national commodity associations. Out of those 22, we have 21 represented
involved in this program. So, it\'s not only just livestock sectors,
it\'s the full spectrum of the input, including service groups, bean
sprouts, the whole bit. So, it\'s \-- we\'ve been pretty fortunate.

Just generally then, the program that we\'re talking about, the on-farm
food safety programs in general, then we can say that they\'re
commodity-specific. We are not excluding any commodity. So, we have
aquaculture at the table as well working on things.

We try \-- it\'s intended to identify all hazards in the program, that
they must be HACCP-based, that they\'re industry-driven, that the
producers develop the national \-- the programs are developed by the
national organizations, and they\'re delivered by networks of
organizations at the provincial or local levels, and that government
will provide support through recognition.

I\'ll try and give a graphical of this as we move a little bit through.
I\'m not going to bore you with reading every point on this slide, but
hopefully you\'ll get copies of this. I apologize for the organizers for
not making this earlier.

Anyway, there\'s three or four key points that I\'ll go through on this
slide. Notice on the first bullet, what we\'re saying is that the
Canadian Food Inspection Agency in support of these programs will
provide a technical review of the documented programs. So, what we mean
by that is with the provinces, we\'ll sit down, we\'ll take a look at
their hazard analysis, we\'ll take a look at their producer manuals, the
pieces that are getting down to the farmers, and we\'ll evaluate them
against their technical soundness, against common science and regulatory
requirements.

Once that\'s successful, the industry association then can go ahead and
implement their program. We\'re requiring them to have a third party
audit of their full system as it\'s implemented against their documented
program, and then once that\'s successful, we\'ll come back again with
the provinces and take a look at how the program is administered
nationally, and through the evidence of the third party audit and our
assessment, we\'ll provide recognition in support of that program.

So, how does this all shape up? So, the whole on-farm food safety
system, we\'ll call it, the whole structure, is very generically set up
in this manner. We have the National Association that develops the
program. What we mean by develop the program, they have, of course, the
background or the HACCP process. We have the producer manuals, but we
also have a documented management structure. So, they have clearly
spelled-out roles and responsibilities as the different participants.
Training materials for both the national structure and the on-farm
participants.

They then work out a form of delivery agent. That could be a provincial
government or a provincial body that works on their behalf in terms of
implementing the program at the field level, and from that point, we
have the producers themselves that get on to the program by the
implementation, and then they are audited by on-farm validators or
auditors that will come in and certify that these programs \-- that
these producers are on the program against the criteria, and they\'ll
make recommendations back to the National Association to recommend that
this producer is on or off the program.

Working with that, then we have the third party services which will
provide an impartial audit on a regular basis of the full implementation
right down to the field level of that program, and then providing a
level of oversight to that, then we have the agency, along with the
provinces, going in on a regular basis after the recognition process,
going on on a regular basis to verify that the audits are being carried
out and that the program is administered nationally against the written
program. Then behind all that, we have Health Canada providing the
regulatory standards that these programs will have to meet.

So, just some examples here. I\'m just going to quickly go through some
of the interventions and try and respect time of the various programs,
and this is kind of a real quick walk through the park. In the bovine
species, both beef and dairy, we have certainly interventions with the
use of veterinarian medicines. This is considered a must-do, and it\'s
derived from the CCP and through the hazard analysis. So, there are a
number of steps that the producer must have in place to properly
administer the medications. They also have a full set of records, etc.,
that they have to keep on the farm.

We also have \-- we\'re dovetailing with the animal ID program that has
been recently put in place in Canada for beef and dairy cattle, so that
the two mesh together.

In the poultry sector, we certainly have biosecurity up in front. We
have \-- there was some discussion earlier about the programs have
caused the producers to work with buyer specifications with their
supplier, and again it goes back with the upstream philosophy, and
another dovetail for poultry is the flock information sheets. These will
be a requirement through the Poultry Inspection Programs, but they\'re
based on the on-farm programs and the derived records from that.

For the layer flocks, we have some sanitation and buyer programs, as in
the poultry and biosecurity, and they also have some specifications for
feed and suppliers, etc.

In the pork, we certainly have veterinary medicines as well,
biosecurity, and they are taking \-- they do have a program right now
where they\'re going out and actually sampling barns for Salmonella
prevalence, and in the horticulture, we have the use of agricultural
chemicals is their processes for that, and the use of organic
fertilizers and ground water testing, and there is a point that \-- the
common point between all these is water testing, and it\'ll be
interesting to see over the long run, to see producers regularly taking
water samples.

Some of the things that are coming down the road, certainly we have
medicated feeds regulations that we\'re working on, and they will have
to be dovetailed into the producer programs. We\'re looking at other
points of information transfer, such as where we have the poultry flock
information sheets, we\'ll be seeing that moved into the other livestock
sectors. Animal ID, we\'ll be seeing that moving beyond just the beef
and into the pork and other livestock sectors.

We have a number of vaccination trials going on, and hopefully with some
success, we\'ll see those moved into the process, and on information,
each one of the programs will be running baseline studies at the point
of implementation as a starting point for validation of their programs.

So, I guess in conclusion, we\'re not trying to set the world on fire
with this, but I think if we achieve one major point and that is having
the producers not worry about affecting the things they do as more
importantly we affect the way they think about the things they do, and
if we can achieve that and get them remembering that they\'re producing
food in the final outcome, we\'ll achieve a lot.

Thank you very much.

(Applause)

DR. DICKSON: Thank you, Martin.

Our next speaker is Dr. John Sofos. Bear with me one second while I get
Dr. Sofos\' presentation up. There we go.

Dr. Sofos is a Professor in the Department of Animal Science at Colorado
State University. He has both a Ph.D. and a Master\'s from the
University of Minnesota and also a Bachelor\'s from the Aristotle
University of Thessalonika in Greece.

Dr. Sofos is internationally recognized for his work on meat
microbiology and especially in his efforts with decontamination or
microbiology of fresh red meat products.

I know Dr. Sofos as both a professional colleague and as a friend and
many of you may not realize but you may know him a little closer than
you think. For all of you who read Journal of Food Protection, Dr. Sofos
is one of the scientific editors for that journal.

So, John?

DR. SOFOS: Due to time constraints, I\'m going to skip the joke and go
directly to the presentation, and I\'m going to talk firstly, my
presentation is focused on the reduction of contamination during
slaughter of beef, although much of what I\'m going to say applies to
other species, also.

As Dr. Dickson said, one of the interventions is prevention, and by
doing things before they move out of the hide, we can prevent or not
prevent but reduce the initial contamination that goes from the carcass
that we need to reduce by other interventions later.

So, before hide removal, there may be interventions associated with
animal cleaning and hair removal or the chemical dehairing process, and
after hide removal, there are knife trimming or steam vacuuming
operations, washing or spraying or rinsing of the carcasses either with
water or chemical, and they\'re usually cold or warm or hot, pressurized
steam process, and then that\'s followed by chilling, and often we use
multiple interventions, either combined or in sequence.

Of course, we have the question as to whether how do we deal with
additional contamination that is introduced after slaughter, during
fabrication, and how we control that contamination during distribution,
processing and retail of the product.

This is basically an outline of what I\'m going to talk about in a
little more detail, and we\'ll start with animal cleaning and hair
removal, and there are situations or countries or states where there is
an effort to remove fecal tag and associated hair from
heavily-contaminated animals or to apply washing of the animals before
slaughter, either complete or partial, especially in some countries.
These operations have been found to give variable results in terms of
how much they reduce contamination of the carcass, and they are, of
course, limited in their application by climate and the need for
facilities.

So, alternatives to be used when there are heavily-contaminated or
soiled animals are to segregate those soiled animals and slaughter them
separately and reduce the slaughter speed as well as increase the number
of people working on the line so they can be more careful and take care
of the carcasses to minimize contamination.

The chemical dehairing process is installed in at least one plant at
this point. It is an effective procedure because it keeps the hide
contamination outside of the plant. It uses sodium sulfide to hydrolyze
the hair and hydrogen peroxide to neutralize the sodium sulfide. It is
applied by spraying in sequence or in two or three cycles, and, of
course, it requires capital investment and the issue of waste handling
because you generate all this waste, chemical as well as hair waste, and
how they deal with that is to regenerate sodium sulfide for the use and
to make fertilizer out of the hydrolyzed hair.

Knife trimming and steam vacuuming. Knife trimming, of course, is
required by the zero tolerance directive to remove visible contamination
from carcasses during the slaughtering process. The published results
indicate that may be variable in its effectiveness in reducing
contamination, and sometimes there may be a potential for spreading or
redistributing the contamination during knife trimming, but at least it
is important and necessary to apply, if nothing else, for aesthetics.

Steam vacuuming has been approved and is used in almost every plant as
an alternative to knife trimming to remove visible contamination that is
less than one inch in diameter. It also may have variable results and
that will depend on the equipment maintenance and especially the
diligence of the employees in applying the process, how well they apply
it.

Carcass washing and decontamination processes can be applied to whole
carcasses before evisceration or to half of carcass sides after
evisceration and before chilling of the carcasses. They may be applied
through immersion or flooding or dilution or cascading, depending on the
system and the type of animal. For example, some of these apply more to
poultry than beef or other species, or they\'re applied by spraying or
rinsing, depending on how much pressure is used. Rinsing is the
situation where the pressure is very low, and they are done with water
or chemical solutions.

Important variables that affect their effectiveness include, of course,
the method that is used and the stage and time of their application
during the slaughtering operation, the design and the maintenance of the
equipment, the pressure during spraying operations, and the type of
nozzle, for example, that they use, the temperature of application,
whether they use chemicals, which ones and what concentration, as well
as the duration of exposure of each carcass to these processes.

When spray or rinsing of decontamination is applied before carcass
evisceration, the objective is to apply this treatment as soon as
possible after removal of the hide and initial contamination to reduce
as much of that contamination as possible before it gets attached on the
surface of the carcass.

They may use organic acid solutions in evisceration spraying, but there
are limitations on how much pressure you\'re allowed to use because of
potential weight gain concerns because the carcasses have not been
weighed at this stage, and also in many plants, you need to limit the
temperature of the solution you apply because at this stage of the
operation, you may generate condensation and create problems.

After evisceration comes a final carcass washing treatment with water
and after that comes the more effective decontamination treatments,
including thermal decontamination, either with hot water or with
pressurized steam, the steam pasteurization process, and chemical
decontamination by spraying or rinsing with organic acid solution mostly
for beef at concentrations of 1.5 to 2.5 percent. The acids used are
mostly acetic and lactic. Lactic replaces acetic in most situations now,
and the acids are found to be more effective when they are applied warm
temperatures of about 55 degrees Celsius.

Chemical decontamination also may involve using a variety of other
chemicals, including chlorine dioxide solutions, which apply mostly for
poultry as well as trisodium phosphate or acidified sodium chloride and
some feroxyacidic acid-based products, which are used to lesser or
higher extent. They are approved. Also, there are some other chemicals
that either are approved, proposed or being investigated for use or are
in the process of being approved, including activated lactoferin,
acidified calcium sulphate, hydrogen peroxide, and many others that are
being researched, as well as a number of physical processes, as we know,
are effective in reducing contamination and may be applied to different
situations, not necessarily to carcasses all the time.

Very often in most situations, the industry relies on the application of
multiple interventions in reducing contamination, and those multiple
processes are applied either as combined processes or as processes in a
sequence, one following the other.

Combinations of treatments could be, for example, using warm acetic or
lactic acid or acetic acid solutions because the temperature of the acid
together make it more effective or using steam vacuuming together and
steam vacuuming to remove contamination, and, of course, the complete
sequential application of decontamination sequence would start with
animal cleaning and/or chemical dehairing of the animal before
slaughter, followed by knife trimming of visible contamination or steam
vacuuming of visible contamination of small size, followed by washing at
pre-evisceration, followed by final washing, chemical and/or thermal
decontamination, before carcass chilling. So, that would be a complete
sequential order of decontamination. The rinsing is to produce a carcass
that\'s as clean as possible.

And to prove that I\'m not just talking but I\'m basing off of some
data, I have a few data slides out of the many that I started with, and
this is a set of data that we collected some time ago before E.coli
0157:H7 was an adulterant, in six commercial plants where we had soiled
practices and were analyzed for these pathogens, and we proved the point
here that trimming with a knife reduced contamination, washing with
water reduced contamination, but when carcasses were both trimmed and
washed, the contamination with Listeria and Salmonella was reduced much
more, showing the effectiveness of combinations of treatments.

Another point we can make here is related to a lot of the talk that took
place this morning and yesterday about indicators and what do we measure
and how it can be dangerous to rely on measuring the pathogen that is
not frequent or at very high levels because, as we see when we tested
for E.coli 0157:H7, we found the opposite of what might be expected. Of
course, everything is so low, that you cannot draw any conclusions, but
it is very clear that you have some \-- you have to have something to
measure before you can use it as an indicator of your process
effectiveness in this case.

Are there any concerns associated with washing and decontamination
prevention practices? Yes, there are, and one concern that I always
think about is the great variability we find. We tend to look at
averages, but if we check the data that are published, we\'ll see that
there is what seems to be plant variation, and we don\'t know if that\'s
true plant variation. There is animal lot variation, method of
decontamination variation, variation in different animal type, season of
the year, anatomical site of the carcass, of course, plant site, and
method of sampling may have a major influence on what results we get
when we\'re evaluating the decontamination processes.

Other concerns are, is there a potential for spreading or redistribution
of bacteria, if the process is not applied correctly or is the equipment
is not operating correctly? Could there be penetration of bacteria in
the tissue where we use high pressures? Could we allow formation of
attachment of bacteria and potential formation of biofilms on the meat
later? And the issue of do we get mostly removal in activation, and do
we get any injury of microorganisms by these treatments as well as the
potential for selecting resistant or adopted pathogens after application
of such decontamination interventions?

And again, a couple of data slides to show some variation between animal
types and seasonal variation. Here again, we had commercial samples from
different plants, and we see variation between steer and heifer
carcasses or steer/heifer and cow/bull carcasses, Salmonella prevalence
before decontamination as well as seasonal variation, and this slide
also makes the point how these decontamination interventions reduce the
prevalence of the pathogens after carcass washing and chilling.

Speaking about variation, these are data from the data published by
Elder, et al., in 2000, and they evaluated beef animals for E.coli
0157:H7 contamination in the feces, the hide at pre-evisceration,
post-evisceration, and after washing and decontamination of the
carcasses, and as you can see with all these high numbers here, they
have \-- they found \-- they proved the effectiveness of decontamination
interventions in reducing prevalence of this pathogen, but what I find
interesting is that there were situations of lots of animals where 77
percent of the samples of feces were positive and 11 percent of the hide
samples, 56 percent of the carcasses were contaminated after hide
removal, and eventually zero percent after decontamination.

What is more puzzling is that here, there were no fecal or hide positive
samples but 75 percent of the carcasses were contaminated, and there
were situations where there was no contamination anywhere. So, you can
find all kinds of combinations and all that variation, and we need to
find out why it\'s there. Is it due to plant operations? Is it due to
animal lot variation? Is it due to sampling limitations or could it be
due to something else?

Other concerns associated with application of process to reduce
contamination during slaughter are related to the safety of the
application, such as the toxicological properties of what we use, the
health of the workers, the safety of the product in terms of chemical
residues or other changes, the quality of the products in terms of
appearance, taste, shelf life and functionality, as well as
environmental concerns, such as dealing with waste generated and damage
to the equipment, and, of course, after carcass decontamination during
slaughter, there\'s always the concern of recontamination and whether
there is a need for additional decontamination later on.

During carcass chilling, we don\'t really know exactly what\'s going on
there. There is a lot of research here. We could get contamination
reduction by chilling or we could get microbial growth or we could get
additional contamination. It all depends on chilling rates and chilling
uniformity and sanitary and hygienic practices applied.

Some contamination concerns during fabrication of the carcasses. We
could get new or additional contamination. We could get spreading and
redistribution of the existing contamination. We could get microbial
growth, and all that depends on proper hygienic practices, low room
temperature, and shortness of duration of this process.

As far as applying decontamination interventions at this stage, it\'s an
area that should be investigated and a potential place for additional
reduction of contamination, but we need to figure out technological
issues and labeling issues because this product now goes into the
package.

A couple of data slides from fabrication. In the commercial plant, in a
three-hour period, we found that carcasses coming out of the chiller, as
they were coming out, they pretty much stayed in the same level of
contamination, but very quickly the belts of the fabrication tables
reach high levels of contamination and that was transferred on the
subprimals generated from those carcasses in a very short period of
time, and they were high during the rest of the period.

If we applied decontamination after or during fabrication before product
packaging, we need to do more work on that because we have done some
preliminary work and found that when we took pieces of beef and we
inoculated with Listeria monocytogenes and then we exposed to water or
hot water or lactic acid at 55, acetic acid at 55, and then vacuum
packaged and stored at 10 degrees for 28 days, we see that we got the
initial expected reduction of contamination by these treatments, but
then we found that the control in the control product, Listeria grew
very nicely and very fast, but it also grew in the water-treated
products, especially in the hot water-treated products.

If we think about it, there are reasons for that to happen. So, someone
could say it\'s better to treat with acids because we didn\'t find any
growth during that period of time, but the question there is, could
those survivors become stress adaptive and more difficult to control
later on during preparation and consumption of the product? We need to
find out about those issues.

So, what are some questions, concerns and issues here? The issue of
potential spreading of contamination or cross-contamination, any
contamination that may survive or remain in the product, what happens to
it? We don\'t know how much of that ends up in trimmings or ends up in
rendering or if it is a problem or not.

We need to figure out if there\'s actually animal lot variation in terms
of how much contamination is brought in the plant and why and do things
pre-harvest, and also if there is variation due to plant operations, so
they can be improved.

We don\'t know anything about how much of the carcass surface area is
contaminated. We only have qualitative results from certain areas of the
standardized. So, if someone wanted to really estimate exact levels of
contamination and whether that part of the carcass goes in ground beef
or not, we don\'t know that, and we only have prevalence data, as I
said. We don\'t have any idea about actual populations and changes in
populations during decontamination. We don\'t know how much of the
contamination from the carcass is transferred to the meat. There are
fabrication contamination concerns and potential need for intervention.

We should keep in mind that these decontamination treatments are
instantaneous or of short intensity, and their intensity is inadequate
for complete inactivation. The product is not sterile, and there is a
potential that they may alter the metabolic activity of surviving
microorganisms, that they may change their microbial association in the
plant and the meat and that may select adaptive and cross-protective
microorganisms, and we don\'t know if that makes any difference in the
virulence.

So, in summary, I want to acknowledge the importance of decontamination
during slaughter because it reduces carcass contamination by one to
three logs. It has a major effect in reducing pathogen prevalence and
those things assist plants to meet the regulatory and industry criteria.

However, we should think about evaluating these decontamination
processes for potential and predictable risks, and we need to optimize
them for matching benefits with no risks. We need to consider that
potential long-term effects on interactions of different interventions,
most of them sublethal, on the microbial ecology of plants and raw and
additive products, and then we can select and apply proper interventions
of the right intensity and the correct sequence and the sequence may
make a big difference, it does, we have evidence for that, in order to
maximize the microbial effects and minimize the resistance development.

We need to evaluate further processing concerns in terms of
contamination and reduction of contamination. We need to research new
technologies that apply beyond slaughter. We need to validate these
technologies in commercial situations. We need to find out why we have
variation in decontamination and to avoid that, and we need to remember
that the product after slaughter is not ready to eat until it\'s further
processed or cooked.

However, decontamination during slaughter is useful because it reduces
the probability of illness when product is intentionally or
unintentionally undercooked.

Thank you.

(Applause)

DR. DICKSON: Thank you, Dr. Sofos.

Our next speaker is Dr. John Luchansky. Dr. Luchansky is the Research
Leader of the Food Safety Research, Microbial Food Safety Research Unit
at the Eastern Regional Research Center, USDA, ARS.

Dr. Luchansky has a Ph.D. and Master\'s from Iowa State University and a
Bachelor\'s from Penn State University.

John?

DR. LUCHANSKY: Thank you, Jim.

Good afternoon, everyone. I\'m very pleased as the other panelists to
have this opportunity to talk to you, and I want to thank the organizers
for allowing me to do so.

I\'m going to take a little bit different approach. I knew John would do
a real great job introducing various interventions on the animal side of
things, and many of those same interventions and the efficacy applies to
the product side. So, I thought I\'d spend just a little bit more time
talking about input, questions that one needs to ask as you develop
interventions and how you go about collecting some of that data.

So, I\'m going to share with you some studies that were done by ARS
investigators that have recently been published and hopefully, Jim,
there\'s some studies that have recently been published, some studies
that were just completed, and \--

DR. DICKSON: Dr. Luchansky just broke my computer.

DR. LUCHANSKY: I didn\'t even push a button.

(Pause to fix PowerPoint)

DR. LUCHANSKY: Thanks for the intervention, Jim. Well, sorry for the
delay.

But what I thought I\'d try to do is more or less talk about the type of
questions one needs to ask as you develop interventions and then share
with you a little bit of the research that we\'ve been doing to collect
information that goes into that.

Studies that have just been published, studies that we are just about
ready to present at some meetings this summer, and some on-going studies
that I think you\'ll find of interest.

So, I put together this list. It\'s not meant to be exhaustive by any
means and feel free to add to it during the discussion, but this would
be useful input for developing interventions. What is the targeted
pathogen or indicator, and Dr. Busta this morning or this afternoon made
some nice comments about that. So, we\'ve already had some good
discussions there.

Where does it reside, and how long does it persist or predominate? We
can be talking about on the animal at slaughter or for that matter, we
can be talking within a package of hot dogs, and I\'ll come back to that
in a minute, but is it on the hot dog? Is it in the purge? Is it within
the pack? So, where does it reside is an important question.

How many types are present, and at what levels? So, are all strains that
you find of, for example, Salmonella equally virulent, and if so, what
levels are they at, and what does that mean to the targeted population
that might be ingesting that particular product? How well does your
favorite pathogen or indicator respond to environmental cues? Things
like acid, refrigeration, hot, salt, and what can you do knowing that to
develop interventions? Where did it come from, and where might it end
up?

All too often, this is overlooked. We mind find it in one source, but we
really don\'t know how it got there. A perfect example are livestock.
Are they indigenous to the livestock or did they come in the feed? Did
birds drop it on the farm and the animals ate it? So, we really do need
to have a lot of on-farm microbial ecology and in-plant microbial
ecology.

I think perhaps the most important question, although this is also
arguable, is, what levels and types of the targeted microbe are
tolerable? We talk about zero tolerance for Listeria monocytogenes in
cooked ready-to-eat food. So, for example, what levels are tolerable,
and under what situations for the entire population or for those most at
risk? And knowing that, we can then say, well, geez, how much of a
reduction should our intervention deliver?

So, I just, you know, made an attempt to put this down for talking
points, but it\'s those types of questions that we\'ve developed our
research strategies around to answer as we develop interventions, and so
just very briefly here, we kind of pick it up from where the animal
leaves the farm and arrives at slaughter. We take it through slaughter,
fabrication and processing, all the way to the finished product.

This is some of the work we\'ve been doing. We feel predictive
microbiology \-- excuse me. Predictive microbiology plays a big role in
our interventions, and I\'ll tell you why in a minute. We then feel
there needs to be a known of the magnitude of the problem. So, you have
to be able to detect your favorite pathogen, and we use standard
cultural methods, but we also rely on antibody-based methods and on
nucleic acid-based methods.

An area that I know you\'re going to hear a lot more of in the next two
to five years is the area of genomics and proteomics. Very sophisticated
but it\'s going to be very impactive, and this is really studying the
microorganism right down to the nucleotide level in case of genomics
and/or at the amino acid level in case of proteomics. So, I\'ll share a
little information with you about that.

Then once you know a little bit about how the bug might behave, a little
bit about where it has come from and the genetic mechanisms it uses to
survive in those environments, you can then select your interventions,
be they physical, biological, chemical or mechanical, and again John
Sofos did a nice job of highlighting those that are available.

What I thought I\'d do is spend a little bit now in the predictive
microbiology component. For those of you who are familiar with the
pathogen modeling program, an effort started by Dr. Buchanan and Dick
Whiting a few years back up at Eastern and one which we really picked up
on lately and have taken it to the next level, I feel, we\'re at Version
6.0. This is a copy of our CD-ROM. I\'d be more than happy to get you a
copy of it, if you give me your cards. I\'ll also point you towards our
website where it can be downloaded.

Dr. Mark Tamplen up at Eastern Regional Research Center is our lead
scientist on this program. He\'d be happy to help you out as well.

For those who are not really that familiar with the PMP, it\'s a group
of models that estimate the behavior of pathogens in specific
environments. You can set the temperature. You can select the pathogen.
You can select the salt concentration, and you can see whether or not
that bacterium is likely to grow, merely survive or in some cases
actually decline.

It\'s important to note that there is a user-friendly interface to
access these models. Why did I bring it up for this particular audience?
Because I wanted to give you an idea of how often it is used, to give
you an idea of the impact that it can have. There\'s about 5,000
downloads per year, in addition to the several thousand CDs that we have
distributed. It\'s used by about 30 percent of the food industry to
design HACCP systems, a very useful tool in terms of deciding critical
control points and how much effort needs to go in to verifying and
validating that with the information in the predictive microprogram.

We\'re coming out with Version 6.1 in a couple of weeks. Growth,
Survival and Inactivation Models will be included in that. For those of
you who are interested, there are also dynamic cool-down models for
Clostridium Perfringens that I think you\'ll find very useful. We also
have added a reference database. We can go right from the PMP into the
literature, if you\'d like to get to the original data, and there are
enhanced help functions.

Something you might not be aware of is another effort, a companion to
the PMP that we started within the last, I guess, about 18 months. This
is a collaborative effort with colleagues over at the Institute for Food
Research in Norwich in the U.K., and it\'s a program that we\'re calling
Combase. This is a relational database of predictive micro information,
and what I want to emphasize is whereas the PMP is very user-friendly
and meant to be used by people out in the field, Combase is a very
useful tool for academicians and risk assessors because it actually
contains the raw data. You can get right in there and access the raw
data for which models might not be available.

I think at present, there are over \-- I think there\'s over about
15,000 records/growth curves in this database and we continue to expand
upon that. So, I\'d be more than happy to share some more information
with that after the meeting.

Now, to help us better enhance both the PMP and Combase, up at Eastern,
we\'ve created the Center of Excellence in Microbial Modeling and
Informatics, and if you can read this slide, it says that this brings
together researchers with diverse and complementary talents to advance
the science of predictive microbiology in essence. So, it\'s a
collection of scientists that are looking to add more data to both PMP
and Combase, to find out better ways to analyze these data and better
ways to use that in very practical ways to predict growth and enhance
the safety and quality of foods.

I think this is about six months old, and we\'d be more than happy to
take on any new members or address any problems or concerns you would
have.

So, that\'s a little bit about the predictive microbiology advances
we\'ve been making and how you can maybe use that for HACCP program or
intervention development. It allows you to actually predict the growth,
survival or decline of a microorganism based on statistical estimates
that were done largely in microbiological medium and using that
information, you can then narrow down your choices for what you actually
might validate in a plant or in a product.

I\'d like to move on then and talk a little bit about some studies that
we\'ve done for microbial detection. Three studies in particular which I
think you\'ll find interesting. The ARS/National Alliance of Food
Safety, Downer Dairy Cattle Survey, the NAHMS 2000 Swine Survey. I\'ll
be picking up on comments Dave Dargatz made yesterday, and the Microbial
Surveillance Project. All of these have to do with our efforts to go out
there and look for E.coli 0157:H7.

Beginning with NARMS 2000 or NAHMS 2000, I should say, 17 states, a 160
farms, about 60 samples from each of those farms. It represents 93
percent of the hogs and 92 percent of the producers who have at least a
hundred hogs on that farm.

I\'ll share the results that we\'ve had thus far. Our group was
responsible up at Eastern for looking for E.coli 0157:H7,
Shigitoxin-producing E.coli, Yersinia Enterocolitica and Listeria
monocytogenes, and in addition to prevalence, I want to mention that
we\'re also looking at clonality by ribotyping and pulse field
electrophoresis, and we\'re sharing those isolates with our colleagues
down in Athens who are doing antimicrobial susceptibility testing.

Again, this is a very, very collaborative study, one component of which
was done at Eastern, the other component with the 0157:H7 was done at
Athens, and Jeff Gray is in the audience from Athens who can also help
me address any questions.

Relative to the data, there were about \-- maybe I\'ll try this side
now. There were about 2,500 samples that were tested, and I want to
point out that about a hundred of those or four percent were
0157-positive, but none of those 2,500 samples were 0157:H7-positive,
and the other thing I want to emphasize here, this is feces from the pen
floor, not from an individual animal. This is feces from the pen floor,
and we were unable to find 0157:H7 without a prevalence or a recovery
rate of four percent. We were able to recover 0157.

I want to show you the next slide which looks very, very similar to
this, but there\'s one difference. We actually took fecal samples from
intact colons from a swine slaughter facility. The difference again
being now this is fecal material from the inside of the animal at
slaughter.

Again, now, we have 305 samples, but again about four percent of them
were positive for 0157, and this time, two percent were positive for
0157:H7. We found that quite interesting.

Some of the conclusions. Within the time frame and geographic scope of
this study, the prevalence of 0157 isolates was similar in colon samples
from slaughter and fecal samples obtained on farms and Serotype 0157:H7
isolates were recovered from the colon but not from the feces.

So, because I thought it might be useful in our discussion, I put up
some talking points. What is the impact of collection, storage, shipment
and/or methodology on recovery relative to finding 0157:H7 in the colon
samples but not in the fecal samples? What is the impact of transport
and holding on the shedding and/or viability of this bacterium? Then
lastly, should studies \-- should further studies be initiated to
determine the prevalence of the pathogen in matched animal and fecal
samples from the farm all the way through to slaughter? So, those are
some talking points that perhaps we can visit again in just a little
bit.

I want to switch from pigs to cows and share with you a study we just
recently completed on Downer versus healthy dairy cattle from the Upper
Midwest. This study will in fact be presented in July in San Diego at
the International Association of Food Protection Meeting, and it\'s a
study that was funded by or through the National Alliance of Food Safety
with collaborators at the University of Wisconsin and the University of
Nebraska.

I guess just for definition purposes, we defined Downer cattle as
non-ambulatory. In this sense, the culled dairy cattle or the Downer
animals might contribute to about 17 percent of the meat supply and
almost all of the meat from those animals goes into producing ground
beef. So, you can see that they could have quite a significant impact in
terms of contribution to the meat supply.

We looked at about 200 samples from healthy and about 200 samples from
Downer animals at two slaughter facilities, four visits to a facility
that exclusively handled healthy animals and seven visits to a plant
almost exclusively dealing with Downer animals, from April through
October of 2001.

Now to the results. About six percent of the Downer animals compared to
two percent of the healthy animals harbored E.coli 0157:H7. We retained
several isolates, multiple isolates from a positive sample from both
Downer and healthy, and I\'m not going to show the data because I don\'t
have enough time, but what we were surprised to find was that more of
the isolates from the healthy animals, almost twofold more, were
resistant to antibiotics than those recovered from the Downer animals.
So, again, some interesting points for discussion.

Conclusions within the time frame and geographic scope of this
particular study. There was a threefold higher prevalence of 0157:H7 in
Downer than in healthy, about 1.7-fold higher prevalence of
antibiotic-resistant isolates in the healthy animals compared to the
Downer animals, and via PFGE, we saw pretty much an eclectic group of
isolates.

However, isolates recovered, multiple isolates recovered from a given
animal typically displayed the same profile type. So, we\'ll have a
little bit more information on this in our presentations this summer and
in the ensuing publications.

Talking points from this exclude Downer-suspect animals and those
receiving antimicrobials from the meat supply and/or channel those
animals into cooking operations, conduct additional sampling to address
the impact of methodology, geography and seasonality on the prevalence,
develop further interventions at a variety of points along the line
and/or practice and police more prudent use of antimicrobials. Again,
just for discussion purposes.

We\'re going to switch from the animal to the product and talk a little
bit about hot dogs because we\'ve done a lot of that kind of work up at
Eastern lately. The ultimate handheld food. For those of you who really
don\'t know how many hot dogs we as Americans eat, we eat a lot. 20
billion consumed annually and about seven billion between Memorial and
Labor Day. So, we do ingest a lot of hot dogs.

What I want to share with you are three studies that we\'ve been
involved with over the past year, based on recovery methodologies,
prevalence and optimization of formulation, by beginning with a brief
update on the ARS/FSIS frankfurter shelf life study. This was a very
daunting and challenging project at the outset but one that has run very
well because of our partners in FSIS. I know Karen had a lot to do with
that and Walt Hill, Loren Lange, Jerry Ransom and our industry partners,
largely coordinated through AMI, and I see Jim Hodges here and Randy
Huffman, and many of you in the audience, including those from the NFPA,
Dane Bernard, really brought this thing together in terms of design and
implementation.

It\'s going to be a very impactive study and one that I think will have
a lot of merit academically and for the industry. Very briefly, the
study is designed to determine the prevalence levels and types of LM in
commercially-prepared frankfurters. Each of 12 volunteer manufacturers
are going to contribute 3,000 packages/pounds of product. Those will
then go anonymously to Winmore, Pennsylvania, our facility. We will
sample those within five days of their manufacture and at various time
points over a two-to-three-month period during refrigerated storage.

As I said, the study is basically in the home stretch. We\'ll complete
the prevalence component by July of \'02 and be able to share the data
with you shortly thereafter. I think this will have a lot of utility for
risk assessment and for designing interventions, and I look forward to
sharing that with you at a future opportunity.

One of the outcomes of this was how do you go ahead and sample 36,000
pounds of hot dogs, and so we simply tried to sit down and figure out a
very easy yet sensitive way to do that, compared to the standard FSIS
product enrichment. The standard method would be to open a few packs and
take a five-gram sample from about five franks, combine those five-gram
samples into a 25-gram composite, enrich that, and look for the presence
or the absence of the bacterium.

We thought, boy, that\'s good, but it would be a lot of work dealing
with the volume we need to deal with. So, we said, why don\'t we just
cut open the package, pour in a little diluent, since we expect it to be
surface contamination anyhow. We would then shake the package, pour out
the diluent, and actually sample that rather than the product.

It was a great idea. It has led to a very good publication that came out
about a month ago and made our lives a heck of a lot easier, but was it
effective? Here\'s the conclusion. The package rinse method was about
sixfold more sensitive than the approved FSIS product composite method,
and we feel that is so because the package, the purge and the product
all are tested.

Essentially, we\'re sampling the entire inside of that hot dog package.
The package rinse method requires less hands-on manipulation and this is
good because it minimizes the likelihood of contamination and decreases
the time required for us to sample the product. So, I think this was a
nice outcome of the ARS/FSIS shelf life study.

Just very briefly, I guess this is my one intervention slide. Another
outcome of that was when we were trying to look at the effect of
formulation on recovery, we were comparing the commercially-prepared
franks that did have potassium lactate with those that did not, and here
are the data. If you don\'t have any potassium lactate in the product,
in about two to three months, you get about a four-to-five log increase
in counts of the bacterium during storage in the refrigerator. You put
in either two or three percent and counts of the bacterium do not
increase.

I want to stress the fact that this is the addition of potassium lactate
to the batter as an ingredient. This would be a very effective and, I
think, reasonably-cost effective way, particularly for small
manufacturers, to deal with the problem of LM if indeed it found its way
on to the product or into the package post-process.

Very briefly in the time that I have, I wanted to update you on one
other project, one other large collaborative project that we\'ve been
involved with the past year. It\'s a collaborative effort between or
among a variety of laboratories within the Agricultural Research Service
and through a specific cooperative agreement with TIGR, the Institute of
Genomics Research down in Rockville, Maryland.

Again, at the outset, a very daunting task but one in which that we\'ve
completed quite well. We simply wanted to know what makes Listeria
monocytogenes tick at the molecular level. So, we decided to send the
Jalisco cheese strain to TIGR and have them elucidate the entire base
pair sequence of that bacterium.

We completed that task a couple of weeks ago on April 16th. We now know
every base pair on the circular chromosome of the Serotype 4-B strain of
Listeria monocytogenes responsible for the 1985 outbreak. It\'s about
2,874,000 base pairs. I\'m not going to show a slide listing those base
pairs. You\'ll have to take my word for it. We are now confirming some
single coverage areas, and we\'re assigning the genes to their proper
location on that circular arrangement, and in fact, I\'m pleased to say
that we are now going on to do some comparative genomics.

We\'re going to look at three or four more strains of this bacterium at
the DNA level to try to get some insight on what makes this thing better
able to survive in people and their foods. We have a manuscript in
preparation for the biotechnology buffs in the audience. You can also
access the sequence on the TIGR website, tigr.org.

What are we going to do with this information now that we have it? Just
a few suggestions here. We\'re going to study the regulation of
phenotypes of interest. For example, how the bacterium is tolerant to
salt, pH, increased water activity, refrigerated temperatures and
modified atmospheres. We really want to look particularly at the
comparative genomics to see what allows this bacterium to persist in
foods and/or food processing plants and what allows it to survive in
animal and human hosts, and for the purposes of this, once we get
insight on that, we\'re going to be able to use that information to
develop more effective management strategies, both biological, chemical
and thermal interventions.

So, we really are now down to the nucleotype level of understanding a
bacterium like LM. We\'re going on. The Western Group is doing
campylobacter. We\'ve got a little bit of work going on with E.coli
0157:H7, and I really think this will pay big dividends in the genomics
and proteomics approach to food safety, and we\'re pleased to be a part
of that.

So, I hope I\'ve given you a little bit of an idea of some of the work
we have on-going and how that can fit into the development of
interventions. Although it\'s our intention to get rid of the bacterium,
I think we have to look at it from the bacterium\'s perspective. The
goal of every bacterium is to become bacteria, and we as scientists have
to do our very best to outwit it.

Thank you very much.

(Applause)

DR. DICKSON: Thank you, John.

I\'d like to introduce our final speaker for this afternoon in the
formal presentation of the panel, Michael Ollinger.

Michael is an economist with USDA, ERS, Economic Research Service, and
has been with them for the past 11 years. He\'s worked with food safety
issues for the last five years. I think of particular interest to this
group is that Michael is working with the costs of HACCP and the use of
food safety methods and technology, and he hopes to publish or at least
have that information available on the website some time this summer, I
believe, Michael.

MR. OLLINGER: This summer, I believe.

DR. DICKSON: Excellent. Thank you.

Michael?

MR. OLLINGER: Thanks a lot, Jim, and thanks to John and Martin, and I
have a lot to talk about because they set me up for, you know, what I\'m
about to present.

I also want to thank Karen Hulebak for inviting me to the conference. I
feel honored to be here, and thanks to all of you for sticking around. I
know it\'s about 2:30, and a lot of people left and you were going to
listen to one more. So, thanks for staying, and there\'s really one
other guy I want to thank, and he\'s not here and his name is Lalow.
Lalow was a friend of mine when I was a Peace Corps volunteer in the
Philippines, and Lalow used to come over to my house every day and he\'d
drink coffee, and he was addicted to coffee.

So, I knew he\'d come every morning, and I had a sick chicken one day,
and I said to Lalow, \"Lalow, that chicken looks sick. I think I better
kill it and throw it down the outhouse hole.\" And Lalow said, \"No, no,
don\'t do that. I\'ll take it. I\'ll get rid of it for you. I\'ll save
you the trouble.\" So, the next day, Lalow didn\'t come back at the
normal time. He was a little late, and it happened to be market day that
day, and I saw him coming back from the market. He had a big smile on
his face, and I said to Lalow, \"Lalow, what did you do with that
chicken?\" He said, \"I got rid of it for you.\" And I said, \"Lalow,
what did you do?\" He said, \"I sold it.\" I said, \"You were supposed
to throw it away, Lalow.\" Then he says, \"Well, I got 12 pesos for
it.\"

And the market rate for chickens at that point was about 18 or 19 pesos.
So, what the market did, it discounted that chicken because it looked
sick, and it discounted it by about seven pesos. So, the market worked,
but the problem is the market didn\'t work well enough because that
chicken shouldn\'t have been sold. It was sick. So, that was my
introduction to economics and the food safety of economics.

As far as firms go, they\'re going to invest in food safety technologies
up to the point where it\'s profitable. As soon as it becomes
unprofitable, they\'re not going to invest. So, if quality sends a clear
signal to the consumer or to the ultimate buyer, then the market is
going to work, but if there\'s no clear signal of quality, then there\'s
going to be some kind of a market failure and perhaps a need for
government intervention.

So, what does private industry do or what do they use? What kind of
tools does private industry use, and what kind of tools do government
regulators use to determine what a profitable investment is or what a
good investment is? And what the private market or what a firm will use
is a net present value calculation, and what the government\'s going to
use is something very similar, a cost-benefit analysis.

And the purpose of each type is the same really. They\'re both going to
serve as gatekeepers to keep out unwanted projects and they\'re also
going to allow you to select from a collection of alternative
investments or alternative approaches.

And the calculations are also very similar. A lot goes into each, but
basically the amount you invest has to be less than the amount of return
you\'re going to get and that return is going to be the non-food safety
profit. There may be some kind of a labor reduction or a material
savings or something like that out of an investment, and then there\'s
also maybe some kind of a market value of food safety, and what about in
cost-benefit analysis?

Well, then there\'s a government intervention and that\'s the G.
There\'s some kind of investment and some kind of maybe an industry
investment motivated by government, and on the other side, there\'s
going to be certain public health benefits that are going to be \-- that
are going to include society as a whole. Those are the calculations that
each party makes, and you can see that they\'re quite similar.

Okay. I broke market mechanisms. What I\'m going to do is I\'m going to
outline some market mechanisms, some market approaches that work, that
are going to generate profits to firms, and then I\'m going to really go
over some of the things that people have discussed here for the last two
days on why these may not always work. Then we\'ll talk about three ways
that FSIS has regulated, and then we\'ll summarize then.

Okay. So, the first market mechanism or market approach to controlling
food safety is some sort of an unintended consequence investment. Maybe
a chicken poultry plant\'ll invest into some kind of a poultry transfer
mechanism. It reduces the amount of labor on the production lines. So,
they have a savings in labor. That may be why they make the investment,
but they also get a savings in, say, bacterial contamination because
there\'s less employee handling of the chickens or the turkeys. So,
that\'s sort of an unintended consequence of a normal investment
decision.

Now, there\'s another way in which a seller can recover all of the or a
lot of the profit from a food safety intervention and that is something
like irradiation where you can communicate directly to the consumer that
the product is free of some harmful pathogens or at least there\'s a
pretty strong evidence or support for your claim.

So, there\'s a market premium on that. I think a newspaper in
Minneapolis quotes a price of about 10 to 15 cents a pound on beef,
irradiated beef. So, there\'s a market premium that goes to various
players in the market, and it\'s profitable to provide food safety.

Now, the final way that the private markets are going to work is through
contractual mechanisms, and one type of sort of \-- well, it\'s a
quasi-contractual relationship in which there may be a single supplier
of, say, beef products to a major retailer, and suppose that products
from that retailer happen to be implicated in a food safety outbreak or
a food safety problem. The consumers go back to the retailer, the
retailer goes back to the meat provider. They know who the meat provider
is. It\'s only one source. So, they know who caused the problem.

So, here you can have a linkage in liability and because of that
linkage, this single source supplier is probably going to make a greater
investment in food safety-type technologies. They may use the multiple
intervention approach that John Sofos was talking about, okay, or some
other proven way to provide food safety.

Another way is through branded product. If a consumer gets sick, and
they see somebody\'s name on the package, they know who to blame, and so
these producers of branded products have a lot to lose by providing an
unsafe product. So, they\'re going to make maybe a little bit more
investment in food safety to ensure they don\'t lose their market.

And then, a final way is through explicit buyer contracts. McDonald\'s
makes contracts with its suppliers to provide greater quality, and it
does, I think, with all of its food providers, and on top of that,
McDonald\'s is going to ensure that it heats its hamburgers up to, I
think, a 160 degrees through an automated cooking process. So,
McDonald\'s is going to ensure that nobody\'s going to get sick on their
account in their restaurants because as soon as an outbreak occurs,
their brand name is lost and their sales drop considerably. This is not
just true for McDonald\'s, by the way. All the major fast food
restaurants and the major restaurant chains are \-- have these type of
contracts.

I\'ll just show you how \-- an example of one or the way one might look.
Say, suppose with no contract, a supplier contracts to sell product to
McDonald\'s for a dollar a pound, and say it costs them 80 cents a pound
to produce that pound. Okay. They can make about 20-cent margin on that
and say they sell 10 million pounds a year to McDonald\'s. They\'re
going to make a profit of about two million pounds. Okay. Now,
McDonald\'s comes back to the supplier and says, well, if you increase
your \-- if you do this, this and this and this for me, that\'s going to
add some costs maybe to your production process, but we\'re also going
to increase how much volume we\'re going to buy from you, and we\'re
going to guarantee you that market.

So, now they\'re going to sell 12 million pounds and they\'re still
going to make a profit. These are all cooked numbers. So, it\'s all
going to work out, but the point is that it\'s profitable to do this.
Otherwise, they\'re not going to enter into a contract. Okay. So, those
are some ways that private markets are going to accommodate food safety
concerns.

There are some problems, though, and those are the problems that were
outlined earlier today. Well, first of all, in the case of a retailer,
there can be and there often is more than one provider of meat products
to that retailer. So, then you don\'t know who produced the product that
made a person sick. Okay. The source of the foodborne illness may not be
identified, and a consumer illness may not be even recognized as a
foodborne illness.

So, there\'s lots of problems and probably you guys can think of a bunch
of other ones. Okay. So, that\'s why there\'s a call or at least a
reason for FSIS intervention, and I\'m going to outline three ways in
which, you know, they\'ve sort of intervened. Okay. First of all,
they\'re going \-- one approach they\'ve used is shift responsibility
for quality to industry, and they do this by \-- well, their incentive
or their interest is to increase food safety investment, private
investment.

Back in the \'80s, they tried a voluntary approach which had at least on
paper some similarities to a HACCP plan and that was called a total
quality control plan or whatever and those were completely voluntary and
there was about five percent adoption on that. There were a few benefits
given to producers for adopting this quality control program, but it
really wasn\'t that popular. So, then in the 1990s, they came up with
HACCP. That was mandatory, and it did require a lot of investment.

Okay. Now, another way that FSIS has tried to increase food safety
investment is better investment of its own resources, meaning its
allocated budget, and if it can shift some of its responsibilities to
private industry, then it has more of a budget that it can devote to
public health concerns.

Okay. So, back in the \'80s, they introduced the new line speed
inspection system which allowed poultry producers to increase the line
speeds as they took over some of the more mundane tasks that their
inspectors used. So, what would happen in a situation like this is that
some plants may be producing at the FSIS-mandated level of, say, 70
birds a minute and you\'ll have some producers that may just be able to
produce 70 birds per minute, others that may be able to produce a 120
birds per minute.

So, what I did here is I thought of an example and again these cooked
numbers, but say that you have a plant with a capacity of, say, 70 birds
per minute, and you have 10 workers on that line. The productivity of
that plant or that line is going to be about seven birds per worker per
minute. Okay. If they can\'t increase their speed and FSIS comes back
and tells them that, okay, you can increase your speed \-- okay. If you
can increase your line speeds if you add two workers to remove some of
the birds off our inspectors, well, their productivity dropped, but if
it happens to be that a plant can increase its line speed to what FSIS
is now going to permit, then they\'re going to use their own workers.

So, they\'re going to voluntarily inspect some of their own products,
and they\'re going to do it because it\'s profitable to do it.
Productivity is increased. So, they\'re going to make that shift but not
everybody\'s going to make the shift. They\'re going to have some that
just aren\'t going to find it profitable to do it. So, any kind of a
voluntary program, you\'re going to have some plants adopting the
technology or making the switch and some not, and it could be based on
their own technical reasons, like the plant size or the line speed. It
might be based on a market relationship they have with providers. So,
those are going to be the two key things that are going to encourage a
plant to make a switch voluntarily. Okay. Now, another way FSIS has
tried to encourage investment is by \-- you know, I think it was in \'97
or \'98 or so, they started taking, I think, a bigger sample size for
their E.coli 0157:H7 tests, their Listeria monocytogenes tests. So, what
they did is they sort of increased the sensitivity of that test, at
least that\'s my understanding from talking to the few people, and so
when they do that, the number of recalls should go up if that\'s what
happens, if I used that term correctly.

But what they also do or what inherently happens when you test for a
certain type of pathogen, like E.coli 0157:H7, which was mainly, what,
prevalent in beef is you favor certain industries over other ones. So,
that\'s going to favor poultry and hog producers over beef producers
because those are the ones that are least affected. Poultry and hogs are
less affected than beef producers.

In the same sense, Listeria monocytogenes is going to favor slaughter
plants over processing plants because that\'s where it\'s going to be
more commonly found, is the processes. So, that\'s a second way, and the
final way is just a new regulation, and it seems like we\'ve heard a lot
about performance standards, and I just really want to present an
example. I don\'t want to, you know, enter into the argument on
performance standards, but the reason that economists like them is that
it grants a lot of flexibility.

Suppose that we have four plants that are affected by a regulation with
a target pathogen. Two meet the standard. They don\'t do anything.
Plants A and B, they have to change, and one plant, Plant A, maybe
produces 500,000 carcasses or animals a year, Plant B produces about
5,000. There\'s two ways to reach their goals. One is through steam
pasteurization and I outlined some of the costs there. It\'s going to be
a lot more expensive for a small plant to use this steam pasteurizer.

Option 2 is better dehiding methods. Maybe you have to invest in
training, and I just made up some numbers to make it work out right, but
there\'s greater worker turnover at the larger plants, so they lose
their investment every time the dehider leaves. So, their dehiding costs
are actually going to be higher than for the small plants.

I made it work out so that the net result was about 40 cents a head for
Plants A and B, but one chooses a steam pasteurizer and the other one
chooses the dehiding approach. So, the technologies can work. It may be
that different size plants just choose different types of technologies
to reach a certain point.

So, let me go through an example of a process standard. It\'s just a
mandated technology and an example of one using a time process standard
is outlined below. A lot of it gets cut off there. Okay. So, suppose
that plants are expected to clean hand tools once per hour. Okay. Plants
A and B process a 105 animals \-- one produces a hundred animals, the
other produces five animals per hour. So, you can see that at least for
the mandated process standard, the number of cleanings per \-- the
number of animals per cleaning is a lot greater in one plant, meaning
that the cost is going to be a lot lower for that plant. In this case,
it\'s the higher volume plant.

That was the kind of approach that FSIS took in the preliminary HACCP
study. They used some process standards along that line, I think, for
generic E.coli testing. Now, how does it change if you use per unit of
volume standards? Well, if you use a per unit of volume standard, and
you say one cleaning every five animals, then productivity or at least
the costs are the same, whether you have a small plant or a large plant.
So, the volume standards are going to have less distortion than the time
standards.

The problem with process standards is you don\'t know whether you\'re
getting the results that you really want. So, we\'d prefer a performance
standard if we can have one and that you guys\' job.

Okay. So, I just want to summarize some things and leave a little bit of
food for thought. Okay. Four ways in which markets work were mentioned
earlier. One is through irradiation. Another one is contracting directly
for improved food safety quality. Three is food brand names, and four is
inadvertent contract. That\'s where you have a single source supplier.

Okay. And the incentives offered by FSIS is (1) to try to shift
responsibility for quality to industry. Second is to raise food safety
costs by increasing regulatory stringency, and third is impose new
regulations, either performance standards or process standards. They\'ve
used both.

Now, just an assessment. Markets need our information to function
properly. FSIS has \-- most of its regulations have been cost
impositions or, you know, maybe changes in regulations to encourage
adoption of the technology. Yet FSIS does have a lot of information. It
has information on performance of HACCP. It has information on
Salmonella standards. It has information on generic E.coli tests, and
one possibility is to somehow permit a label or somehow to rate plants
on their performance and let the market decide which one of those plants
is a good plant. Anyhow, I want to leave that thought with you and maybe
we can talk about it a little later.

Thanks for listening to me.

(Applause)

DR. DICKSON: Thank you, Michael.

We\'re scheduled for a break, and Dr. Hulebak has asked us to all be
back by 3:00. I currently have 2:45. So, if we can take about a
15-minute break, and on break, why don\'t you think about some
discussion issues and questions to bring up for us?

Thank you.

(Whereupon, a recess was taken.)

Panel 4 - Discussion

DR. DICKSON: Here it comes. First question. I would invite anyone who
would like to ask questions to come up to the microphone and again
identify yourself and your organization.

MS. ROBERTS: Tanya Roberts from the Economic Research Service in USDA.

Actually this was for Martin Firth. I wanted to hear a little bit more
about two things that seemed kind of unusual and different from the U.S.
and Canada. One was that the requirement that you had to include
academics in your HACCP plan, if you\'re a company, if I understood you
correctly, on farm. You don\'t have it?

MR. FIRTH: What I was referring to \-- is this on? What I was referring
to is the process that we\'re going down the road with on farm is that
the hazard analysis, etc., is done through a technical committee.

MS. ROBERTS: Hm-hmm.

MR. FIRTH: So, on that technical committee, which represents a National
Association, on that technical committee, we\'re asking for a number of
specialists through academia, through in terms of livestock, veterinary
specialists, etc., that comprises or make up this technical committee.
So, it\'s for the development of this program.

MS. ROBERTS: Okay. So, this is to identify the HACCP across the whole
industry?

MR. FIRTH: For that commodity.

MS. ROBERTS: Is that what you\'re saying? For that commodity.

MR. FIRTH: Yes.

MS. ROBERTS: Okay. And so, then each company then would say okay,
you\'ve already done the hazard identification part for me, and \--

MR. FIRTH: Each producer would \-- what happens is this hazard analysis
takes place. They come up with this generic hazard model.

MS. ROBERTS: Hm-hmm.

MR. FIRTH: From that analysis, etc., they develop what we call producer
manuals. So, the control measures and the CCPs that were identified
through the hazard analysis get translated into these producer manuals
which are then implemented by individual producers.

MS. ROBERTS: Okay. And who pays for the consulting of the academics? The
industry or \--

MR. FIRTH: The association, yes.

MS. ROBERTS: \-- the association? Well, the other thing that seemed
different, the second thing, was about the third party audit, and was
this each individual on-farm thing that the HACCP plan is working as
planned or is this at the association level? Maybe I misunderstood that.

MR. FIRTH: No. There\'s two different levels.

MS. ROBERTS: Hm-hmm.

MR. FIRTH: For the delivery of that national program, they are \-- the
association is required to contract an independent third party to come
in and carry the full systems audit of that program as it\'s delivered.

The second level of auditing is at the farm level.

MS. ROBERTS: Oh, okay.

MR. FIRTH: Now, that on-farm level of auditing takes place like inside
the structure of that program. So, you have described in the program
that there will be a person come on to the farm on a stated frequency.
They\'ll evaluate the producer against given criteria in an audit
manner. So, you have two different levels of audit there.

MS. ROBERTS: Hm-hmm. And what happens to people if they don\'t make the
audit?

MR. FIRTH: They get to take the sign off their mailbox in the laneway.
They\'re off the program. That\'s basically it. Now, there\'s some
significance to that, too, though. We\'re seeing \-- the perfect example
is in the pork sector, where we have a large number of \-- well, a
couple of large in Canada is a couple.

A couple of large processors that are now requiring farmers to be on the
national program in order to sell their product to the processors.

MS. ROBERTS: And that\'s what you hope for, right?

MR. FIRTH: Exactly. I guess for the economists, the marketplace is
taking care of itself.

DR. DICKSON: Thank you.

For those of you who do have questions that you\'d like to write down,
we do have cards over here.

Rosemary?

MS. MUCKLOW: I can\'t write, so I have to use the microphone.

I would like to say thank you to Dr. Ollinger for his exquisite example
of discounted diseased chickens and to explain to him very clearly that
that\'s why the industry is very strongly supportive of ante- and
post-mortem inspection. Something that has been decried by politicians
but is one of the fundamental assurances of the Federal Meat Inspection
Act and is probably as important today as it was restated in the 1967
law and is extremely important. So, thank you for the story. It had a
wonderful moral to it.

A couple of other minor things, if I may, while I\'m here. Dr. Sofos did
a great job on all of the various interventions, and once again
lactoferin was mentioned, and somebody mentioned that yesterday. I\'d
just like to tell you all that lactoferin was first identified in
February 1998 at our convention in San Francisco, and it\'s now four
years and three months later, and it\'s still in the trial stages and
not actually implemented.

It takes a long, long time, even by those who work very hard to move
interventions forward, and we had this discussion yesterday about the
other interventions that came along and overcoming very longstanding
inhibitions about anything other than a knife to remove contamination.
There are some really great opportunities, and if we could only find
some way to speed up the process, it would really be wonderful.

The final thing, Dr. Ollinger talked about TQC programs and how they
didn\'t achieve a great deal. I don\'t know if he is aware how many PQC
programs, partial quality control programs, there really were practicing
in the industry, and they had an enormous impact, probably much, much
greater than the originally-intended TQC programs and were very
effective, and they\'ve kind of fallen by the way now, but they were a
major, major preemptive effort towards where we are today. So, it
wasn\'t all lost. It wasn\'t just five percent on the TQC. Lots and lots
of PQC programs that were enormously beneficial.

Thank you.

DR. DICKSON: Thank you, Rosemary.

Dr. Wagstrom?

DR. WAGSTROM: I\'m Liz Wagstrom with the National Pork Board.

I just wanted to kind of give an update on what we\'re doing with pork
quality assurance after the questions about the Canadian Assurance
Program. Canadian Quality Assurance is doing a wonderful job, and in the
United States, we do have a voluntary pork quality assurance plan.
However, we do have a committee that has planned that pork quality
assurance plan that has academics, veterinarians, producers, processors
and several experts. It\'s about, I believe, over 20 members on that
committee.

The program that has come out of that committee is a program that is a
HACCP-based program. We just have a new book that was published. The
second edition was published this Spring, and it takes the producer
through all the HACCP principles and how to identify critical control
points on their farm, and while it\'s a voluntary program, virtually all
of the federally-inspected plants in the United States as part of their
HACCP program require that their producers are certified in pork quality
assurance.

So, even though we don\'t have as much government input into the program
and we don\'t have a government overseeing the program, we do definitely
have a program that I\'m not sure we could actually call voluntary
anymore if you want to sell your animals to an inspected plant.

Then the other statement I was going to make is this, I wanted to let
you know that we also have a trichinae intervention program. We\'re not
sure it\'s really required because our last NAHMS sample, we had one
weekly positive sample out of all of the market hogs that were sampled
under NAHMS which was about 1,600, but again that is an auditable
program with third party verification. So, there are some
auditable-verified programs that are happening at the farm level in the
United States.

DR. DICKSON: Thank you.

MR. ROACH: Hello. I\'m Steve Roach with FACT.

Again, my question is going back again to on-farm intervention programs,
but also I want to kind of link it to some what happens at slaughter as
well.

So, my question is just what is the role of microbial testing in on-farm
control programs? Because control programs that I\'m aware of that are
most effective, probably the one in the U.S. would be the PCAP Program,
really is strongly based on having on-farm microbial testing, and the
other one, I know, I am aware of that seems to have worked is the Danish
Salmonella and some of the other European control programs.

So, what is the role of on-farm microbial testing in terms of
controlling pathogens on farm level, and then the second level question
is, is there any way you can link microbial testing at slaughter with
farms? So, when doing microbial testing at slaughter, it seems to me
that it would be a good idea to know which farm and kind of linking it
back to what happened on farm and what lot it came from. So, I just had
some questions about does that seem to work with what you all understand
about on-farm interventions and also kind of understanding what\'s
happening at slaughter and afterwards?

MR. FIRTH: It\'s basically \-- to answer that question, you almost have
to go commodity-by-commodity, but I guess where all the sampling right
now that\'s taking place is in the chalet or the layer barns, and
they\'re starting to introduce the idea of environmental sampling in
some of the other poultry sectors.

As a control measure, it\'s more of an indicator. What these programs
are \-- for control measures, what they\'re looking at is enhanced
biosecurity, proper cleaning of the barns, farm sanitation between
flocks or between, you know, as they move the animals out. So, they
aren\'t looking at, you know, testing as a control measure per se. It\'s
more of an infrequent indicator of how effective their other measures
are happening.

In terms of linkages between, you know, prevalence at the farm and at
the processors, that\'s wonderful research. Those things have been
identified. It\'s just a matter of getting \-- that\'s \-- it sounds
great, but when you sit down and work out the mechanics of the sampling
regime to effectively look at that, it\'s pretty difficult. So, it\'s
going to \-- you know, there will be some work towards that, but it\'s
going to \-- it won\'t be happening tomorrow.

DR. DICKSON: I will also ask John and John to make any comments, since
both of you have some research that might possibly relate to that
question.

DR. SOFOS: Microbial testing can be very useful in identifying sources
of contamination, developing interventions, validating the
interventions, to reduce contamination, but microbial testing is as good
as sampling, and with pathogens that are not present at very high
levels, and even if they are present at very high levels, why test? We
know they are there.

Those that are present at very low levels, we need extensive sampling to
find them. So, I don\'t recommend it as a control procedure. I would
spend that money instead of testing in interventions that would reduce
contamination.

DR. DICKSON: John, I guess I was thinking more about your Downer cow
study. If you guys had any thoughts about linking slaughter house data
with production sites, animal production sites.

DR. LUCHANSKY: Couple of points. Yeah. I think that that\'s useful and
something that can begin to be introduced into the experimental design
of any kind of survey that anybody might want to do. The real challenge
is to have some groups serve as a repository for that information, so
the database can continually be added to, maintained and that way,
everybody can make use of it.

So, specifically to the Downer cattle, we\'d like to go back and
initiate those types of studies, both for antimicrobial susceptibility
and DNA fingerprinting profiles. I think John and Martin already did a
nice job of addressing the utility of on-farm testing, and I was talking
to somebody over the break and mentioned a slide that I often use, too,
from Phil Olsen and that\'s why should you test, and it was pathogens
are a lot like babies. Until you know where they come from, they just
keep coming.

DR. DICKSON: I\'ll have to remember that one, John. Thank you.

Yes, ma\'am? Question?

MS. DONLEY: Nancy Donley from STOP.

Just actually a couple observations, and I do have a final question. But
I found it very interesting, the five percent compliance number that was
mentioned as far as for voluntary types of programs, and I think it
points out the very real necessity to have very strong governmental
regulatory programs in place when we\'re talking about something as
basic as food safety, that we cannot rely just on voluntary actions on
the part of plants. Some plants are excellent in being very progressive,
but we should expect the same level of protection in our food from all
plants, not just the good players because we frankly don\'t know. We
can\'t identify necessarily where our food does come from.

And with the motorcycle helmet that was mentioned earlier today, the
fact that, you know, do you wear a motorcycle helmet or not? Is it
something that\'s mandated or not? Riding a motorcycle is totally \-- is
a discretionary act. You don\'t have to ride a motorcycle, period. We
all do have to eat.

Also, another cost-benefit analysis, Dr. Tauxe yesterday mentioned that
\-- I don\'t have the exact figure, but it\'s upwards in the
neighborhood of \$7 billion expense per year in the cost of foodborne
illness, treating it, lost productivity. I think that we could \-- \$7
billion a year goes a long way into strengthening food safety programs,
that plants \-- if we had \$7 billion to spend every single year on food
safety, I think we would probably not have a problem any longer.

And then last is that this conference was titled, you know, \"Pathogen
Reduction\", and my question is, we\'ve been talking about the successes
that we\'ve had to date and they\'re wonderful. I think some of the
successes that industry and FSIS and consumers can be very happy about
is the \-- some of these new numbers that have come down as far as
Salmonella prevalence.

My question is, what\'s next? This is \-- it\'s pathogen reduction.
We\'ve shown that it can be done. We have reduced levels of pathogens.
So, what\'s our next step? I don\'t think we should stop here. I think,
I\'d like to hear, and I\'m hoping that maybe Dr. Pierson will be
mentioning this in his comments, where do we go from here? What do we do
next? How do we make it even better?

DR. DICKSON: Thank you. And I think I speak for all of our panelists in
saying we hope that this is a beginning and not an ending of pathogen
reduction.

Any comments from the panel?

(No response)

DR. DICKSON: Thank you.

I do have a number of questions that have been submitted in writing.
Some of these are fairly straightforward. So, I hope anyway. I\'ll take
a couple at random.

For Martin. Does the Canadian Food Inspection Agency require HACCP plans
for farm-raised game, such as elk and deer?

MR. FIRTH: I actually discussed this with the individual and he had to
leave. So, I\'ll fill the rest of you in on our discussion.

The first point is we\'re not requiring HACCP to any farm. There\'s no
regulatory requirement in this program. But to answer the wild game,
there are a number of smaller national associations that are coming to
the table, such as, as I mentioned, the Cervic Council, the National
Wild Boar Association. So, there\'s a number of these smaller groups
that are actually taking interest in them.

But once again, this is \-- it\'s an industry-led program. So, it\'ll be
voluntary in terms of the uptake, but again the marketplace will
certainly assist, I\'m sure, in the long run.

DR. DICKSON: Thank you.

For Michael Ollinger. Mike, it\'s your panel. So, I\'m not letting the
panel off the hook here.

If one way to make markets function properly would be to publish
performance ratings, why hasn\'t the USDA used its own data in selecting
suppliers from whom to purchase for its school lunch and commodities
programs?

MR. OLLINGER: That\'s a good question, and I\'m probably not the person
to ask because I have no control over the school commodities purchasing
program. So, I can\'t answer that question.

DR. DICKSON: Is there someone here from Ag Marketing Service? I suppose
I should have asked that first before I read the question. But I think
the point\'s well taken. I personally don\'t have an answer to that.

If anybody does have any knowledge, I would invite you to take advantage
of one of the microphones here in the room. I personally don\'t have any
knowledge of it, but I think the point is well taken. That is, if the
driving force is in fact performance, then, you know, what is the
rationale, if you will, for selecting suppliers for school lunch
programs?

MS. MUCKLOW: AMS has very prescriptive specifications on which they buy
product. Those are published in their specifications and are slightly
different from FSIS specifications, and in order to know that, all
you\'ve got to do is go to their website and see them.

DR. DICKSON: Thank you, Rosemary.

Okay. John Luchansky. Here we go. USDA says a product is \"fully
cooked\" at a 148 degrees Fahrenheit. At this temperature, can we be
assured that Listeria monocytogenes will be destroyed? If not, is there
a temperature to destroy Listeria without destroying the product? Sounds
like a prelim question, but John?

DR. LUCHANSKY: I think I\'ll answer the way Bob Buchanan answered one
this morning and say it depends. It does sound \-- it sounds like you\'d
need a little bit more information about strain-to-strain variation. I
don\'t think all strains would be similarly in \-- under those
conditions. You\'d need a little bit of information about the uniformity
of the cook and the starting levels of the bacterium.

So, I guess without additional information, I only would know if they
were totally eliminated or there could be spurious survivors.

DR. DICKSON: Okay. Thank you. Any other comments from the panel?

DR. SOFOS: Also, the product, what type of product we\'re talking about.
Is it on the surface or is it throughout the product?

DR. DICKSON: Thank you.

I have a question here for Martin. A two-part question. What are the
risk factors for E.coli 0157:H7 on farms in Canada, and the second part
of the question, what kind of regulations or standards does Canada have
to control E.coli 0157:H7?

MR. FIRTH: That\'s a really good question. That\'s why we have
scientific and academia on these technical committees. I am not the
person to answer that kind of question. Sorry.

DR. DICKSON: John Sofos. Oh, Lord. I hate getting old. Most studies in
intervention methods are done in the lab using \-- oh, I\'m sorry. An
exterior square area of the carcass.

Can you give some guide to processors as to how they can adapt these
methods to whole or half carcasses so it will have the same reduction
efficiency?

DR. SOFOS: Obviously, they are done in the lab because that\'s where we
can use pathogens to inoculate the product. In the plant, you have to
use an indicator type of contamination or a surrogate type of
microorganism, and you have to rely on that, I guess, in terms of
validating the process, and then the product can also be tested for
pathogens over time to see if there is a problem there, but you cannot
rely on testing, for example, for E.coli 0157:H7. First of all, you
cannot introduce it in the product, and second, you\'re not going to
find it enough to see an effect of the process.

You have to use indicators to validate the intervention and then
pathogen testing the finished product over the period of time to see if
you have high levels.

DR. DICKSON: Thank you.

John Luchansky. Your group does some process validation as well. Do you
have any comments you\'d like to add on that?

DR. LUCHANSKY: I would just concur with John. I mean, I think having
better control over it in a laboratory situation, working out things of
the experimental design in terms of physiological state, levels,
concentration and even more the sort of the engineering aspects, you
know, of heat transfer or so forth before you go out and pilot scale up.

DR. DICKSON: All right. Thank you.

I have one more question here, and again I\'m at the end of my cards, so
that if you do have further questions, please take advantage of the
microphone.

Last question for Mike Ollinger. USDA refers to farm-to-table. However,
controls seem to stop at processing establishments. Are there any steps
the USDA plans to take to assure food safety from the time products
leave USDA plants until those products reach the table?

MR. OLLINGER: That\'s a good question, also. I don\'t believe that FSIS
has jurisdiction over what goes on after the processing plant. So, you
know, I wouldn\'t be aware of any plans, and if somebody out there
knows, perhaps they can step to the mike on the floor there and respond
to this question. But I don\'t know.

DR. DICKSON: I believe that\'s correct. I believe FSIS\' jurisdiction
ends at the processing plant, and if there\'s anyone here from FSIS that
would like to address that question in more detail, I think I saw Dan
Engeljohn here a little earlier. There he is.

DR. ENGELJOHN: This is Dan Engeljohn with USDA. I would say it\'s true,
we don\'t have jurisdiction in the individual\'s home. The way the
Federal Meat Inspection Act laws work is that product as labeled still
cannot be adulterated throughout its life.

So, if in fact we were to find 0157 in product at any point in time for
which that product was labeled, then that puts us into a situation where
we can make some determinations about adulteration, but with regard to
intentions for where we\'re going in the future, I would say that the
agency, along with FDA, has had considerable concern about the
transportation of products once it leaves the federal establishments and
goes into distribution channels, particularly to retail, and that we had
advanced notice of proposed rulemaking back in 1994-95 for which we
sought input as to what the agencies could and should be doing to
control the environmental handling of product once it leaves the
federal-inspected facilities as well as the handling from the
temperature standpoint because we know that organisms grow in conditions
where the temperatures are elevated.

I would say that\'s still high on the agenda for both agencies to be
looking at. FSIS isn\'t particularly interested in transportation. It\'s
not something that we\'re going to be working on in the near term, but I
think as the science develops with regard to handling and transportation
and predictive microbiology, that we will in fact be looking at
performance standards that may be put in place to control the growth of
organisms once they leave the federal establishments, but that would be
a long-term effort.

DR. DICKSON: Thank you.

I believe we have some questions back here. Yes, sir?

MR. CORRIGAN: I\'m Philip Corrigan. I\'m from the Embassy of Australia,
and I represent the Australian Federal Department of Agriculture, and I
also represent Australia, which is a major livestock-producing and
processing and exporting country.

Last year, Australia exported meat to a 132 different individual
countries, and it\'s the second-largest exporter of meat after Canada
into the United States.

I just want to take this opportunity to compliment and congratulate FSIS
and USDA and the U.S. industry for putting on a symposium such as this.
I want to commend you on your transparency in this country. This debate
is going on in Australia as well, and it\'s well down the track, and
we\'re following very closely the debate here, but really you are to be
complimented on your transparency and openness that allows
representatives, I\'m not the only one here from the diplomatic
community here in Washington, that can come and participate and listen
and report back, and we will be watching the further evolution of this
issue very closely, and we wish you very well.

Can I commend and congratulate the quality of the presentations
throughout the whole symposium and now I get specific, particularly this
panel? I thought the information provided this afternoon has been
excellent really.

I\'d just say over the whole symposium, we\'ve had a lot of researchers
and a lot of economists here. Just a personal observation of mine is
that researchers and economists provide you with tremendously good
accurate information, but then they all come to the depend factor.
You\'re always told, well, then the next stage depends on what, and also
the final conclusion is always more research is required. That seems to
be a lot of reports.

Could I ask a specific question maybe of Professor Sofos? You gave
detailed intervention strategies. I presume it was a beef slaughtering
plant. I wasn\'t a hundred percent clear on that, but \-- and then, in
the end, you outlined a lot of research that needs to be done in the
future and a lot of sort of limitations on the knowledge of distribution
of microbes, etc.

But the real world is comprised of risk managers really and risk
managers, both in industry or in the government, have to make management
decisions today and whether their management decisions are on a plant or
regulatory decisions, and my question to you is, could you outline \--
could you give us your advice what to risk managers today for, say, an
average beef plant with your average livestock coming in for
intervention strategies and for government verification and validation
of a system in place to ensure that safe food is being produced in that
system?

DR. SOFOS: My presentation was centered mostly towards beef, and based
on what we know today, I think we\'re doing the right things in applying
these interventions in the sequence. In some places, you can have more
in the sequence than in others. I know in Australia, the washing of the
animals overnight before slaughter is very common and that helps. In
other places, they use chemical dehairing and so on.

As far as helping with risk assessments, we do really need the research
that I indicated should be done. For example, it\'s not easy to estimate
how many cells of the pathogen will be in how many ground beef patties
when we only know that we have one percent of the carcasses
contaminated. So, that kind of information is really missing, and we are
not going to have the best ways of assessing risk without that
information.

DR. DICKSON: Other comments? Yes, sir?

MR. SHIRE: I\'m Bernie Shire with the American Association of Meat
Processors, and I have a question, I don\'t know if one of you can
answer it or maybe somebody else here, concerning the agency\'s testing
for \-- that it carries out for E.coli 0157:H7 in ground beef.

Earlier this year, a plant underwent that test and the E.coli sample
turned up positive, and anyway, the situation ended up in a recall, and
after that situation happened, about a period of 30 days went by, and in
this 30-day period, the plant went back to processing and processing
thousands of pounds of ground beef as it turned out.

As you know, under that procedure, the plant has to undergo a 15-day
period, 15 times in a row, where it\'s tested for E.coli 0157:H7. There
was a one-month period that went by where the plant was allowed to go
back to its normal ground beef processing and then it started its 15-day
testing in a row procedure.

Could you or somebody from the agency explain the logic and the thinking
behind the way this process is carried out?

DR. DICKSON: Well, if you\'re specifically asking me to explain it, no,
sir, I can\'t. However, I\'m hoping that someone from the agency would
take the opportunity to address this issue. Thank you, Dan. You\'re
going to quit coming to these meetings if we keep calling on you to
answer questions.

DR. ENGELJOHN: I\'ll try to address the issue. I\'m not familiar with
the situation that you raised, Bernie, in particular, but the agency\'s
policy has been for many years that once a positive result is found in
an FSIS sample, as an example, for E.coli 0157:H7 in ground beef, the
agency would in fact take follow-up samples, 15 of them, after that
action.

We also had in place a policy that if a positive was found at any time
in the six months prior to a sample collection coming forward into that
facility, that FSIS would take the sample. That particular policy was
put together prior to the implementation of HACCP, and the controls that
we believe are in place with HACCP with regard to process control and
the preventive system, and through a series of public meetings over the
last couple years, the agency has identified the 15-sample follow-up and
the six-month trigger as being potentially outdated types of policies
that may in fact provide disincentives for the industry to actually do
more testing of their product with regard to process control, so that
there could be greater preventative systems in place.

So, with regard to where the agency\'s going on that particular issue,
we have raised the concern in public meetings that we are looking into
the potential for removing those provisions and relying upon the HACCP
plan, corrective action provisions, that would be in place if in fact a
plant were to find a positive sample.

So, my assumption would be in this particular case that, in this
particular situation, the plant itself was undergoing corrective action
to put in place procedures that would limit the potential for 0157 being
present in the product that it was producing, and then after a period of
time, the agency would schedule that sampling. But that happens to be
the existing policy that we have in place and that policy is under
review.

MR. SHIRE: Thank you, sir.

I\'d like to make a comment just to follow up on that, Dan. Thank you.

That very well may be, and the plant was in fact undergoing \-- making
some changes in the way it did things, but to \-- the question was
raised because it seemed a little strange that the plant would be able
to go \-- in view of this 15-test requirement that follows up, that the
plant would be able to go back to business somewhat as usual and to go
through and to make thousands of pounds of ground beef while it was
making some changes in its HACCP plan, to go back to that and in fact
the inspector was asked by the plant manager about this, why they were,
you know, \-- the fact they could go back and put out one month\'s
production and then the inspector would come back in and start taking
the 15 samples, and the inspector kind of just shrugged his shoulders as
if to say that\'s life.

Thank you.

DR. DICKSON: Thank you.

I do have one more \-- one final question, and we do have a final
speaker for the day. This is for Martin. Again, two-part question. What
makes the program you described attractive to on-farm producers, and the
second part is, do you have a goal for participation that you would call
success? In other words, what percentage of producers do you need before
you consider your program to be a success?

MR. FIRTH: What was the first part again?

DR. DICKSON: The first part? What makes the program you described
attractive to the producers? Why would the producers do it?

MR. FIRTH: A lot of it is present market conditions. We\'re seeing \-- I
mentioned the pork, but we\'re looking at the hort sector and other
areas that the demands are increasing for them to be on these programs.
That\'s probably the primary one, plus I think there\'s a higher level
of conscience on behalf of the producers to be part of this process.

The second half of the question is the targets for success. Again,
there\'s 17 different commodities, and there\'s a lot \-- well, you
know, Canada as about 214,000 farms that we\'re talking about, a
population base. If we could get 50 percent of those in five years,
we\'d be doing really well and again that\'s going to vary according to
commodity.

DR. DICKSON: Thank you.

And with that, I will close the discussion section of Panel 4 and turn
the program back over to Karen Hulebak.

I would like to say again from my own perspective and certainly the
perspective of my panel members that we appreciate the outstanding job
that Karen and her staff have done on organizing this meeting and, one
word, professional at least as far as our dealings with them in all the
technical details of bringing us in and getting us here.

Thank you.

(Applause)

DR. HULEBAK: Thank you very much.

Administrative Matters

DR. HULEBAK: My final duty to close this symposium is to introduce to
you our final speaker, Dr. Merle Pierson, Deputy Under Secretary for
Food Safety at USDA, sworn in by Secretary Ann Veneman in February of
2002.

In his position, Dr. Pierson will work with the Under Secretary for Food
Safety, Dr. Murano, to oversee the policies and programs of FSIS, and he
also has as a big part of his portfolio the direction and high-level
substantive involvement in U.S. international activities which is Codex
Alimentarius.

Dr. Pierson brings extensive experience to USDA. He\'s internationally
recognized for his work in HACCP and his research on reduction and
control of foodborne pathogens. He\'s authored or co-authored more than
a hundred journal articles and given numerous workshops on HACCP and
food safety. He\'s also authored or co-authored at least five books, and
I won\'t read you all their titles.

Before his appointment as Deputy Under Secretary, he was Professor of
Food Microbiology and Safety at Virginia Polytechnic Institute and State
University, where he served as head of the Department of Food Science
and Technology, at one point acting superintendent of the Center for
Seafood Extension and Research, and he has also been actively involved
in various capacities throughout his career with Codex Alimentarius
Commission.

Dr. Pierson got his Bachelor\'s of Science in Biochemistry from Iowa
State University and his Master\'s of Science and Ph.D. in Food Science
from the University of Illinois, and I have to say that one of the
things I\'ve \-- one of the important discoveries I\'ve made through
this symposium is that there is an Iowa State University Mafia in our
midst. I didn\'t fully appreciate that before hearing all these bios but
it\'s remarkable.

So, Dr. Pierson?

Closing Remarks

MR. PIERSON: Thank you, Karen.

I have my remarks on the computer because I know that our speech people
will say you better turn it in. The other thing, I can\'t do this with
my computer. Frank, I can\'t do like you did with my computer. They get
pretty upset with me when I do that with my presentation, okay, because
you see the university stuff that I haven\'t gotten all out of me, you
know. A university person will stand up here with a bunch of slides, and
they\'ll just start talking and whatever comes next, they\'ll say
something. So, I\'m used to that mode, and I have to stick more to
script now, see.

Talking about being off a script, Bernie, I can tell you one thing
that\'ll happen, and you\'re going to make the people in our policy area
nervous because they know as soon as I get back, I\'ll call Andrew and
I\'ll say, \"Andrew, I want to see some people, and I need to have an
explanation relative to this E.coli testing\", and so we\'ll have a
briefing and all those sorts of things. That happens, doesn\'t it,
Warren? Yeah.

Okay. That\'s all right. Let\'s get this thing over with. Get into all
those big equations and everything. Man alive, you can see who took
statistics at Iowa State University. You know, they\'re known for
statistics. I never did take much statistics there.

Anyway, okay, back to the script.

This \"Symposium on Pathogen Reduction: A Scientific Dialogue\" is the
second of eight that are being sponsored by USDA/FSIS over the next few
months, and I would like to thank the organizing committee headed by
Karen Hulebak for their excellent job in developing this program and
execution of the conference. I don\'t mean execution in the sense of,
you know, whack, it\'s a dead dog, but, you know, in the sense that it
happened, it all happened.

Our thanks to the speakers for developing their excellent presentations
and thoughtful comments. I\'d like to thank all of you for your
interest, for being here, for participating in the dialogue, and in
addition to all this, yesterday, there was inaugurated a very special
recognition and that is to a pioneer in the area of food safety and
HACCP, Howard Bauman.

Now, why is USDA/FSIS sponsoring these conferences? I might say
something. You see, being the Deputy Under Secretary or Under
Secretary\'s Office, you can write all these comments out and then we
have to live with those things, but you see, when Loren writes a speech
and then turns it in, then we get to change it and all those sorts of
things, right? So, the changing, I guess, ends in our office. So, I
guess I\'m held accountable for all this stuff.

Well, Elsa\'s not here, is she? No, she couldn\'t be here right now. So,
if we keep all this secret, we\'re going to be okay. Just between us,
because I found out in Washington, D.C., that happens all the time, you
know, just keep it between us. You know, nothing gets out, does it,
Dane? Absolutely nothing. You know, actually, a lot of stuff, I know it
before I know it. Okay. You know, well, I won\'t get into all these
speculation things. Anyway, when you have two science types \-- I know
it before Dane tells me about it. That\'s it. Okay. No, Dane, you\'re
not the source.

When you have two science types in the Office of Food Safety, as you can
expect, you know, collectively with several decades of professor
experience behind them, you can expect that we\'re going to be talking
science and, you know, that was the basic premise of this meeting, was
the science.

We\'re committed to science in our policies and our policymaking
process, and it\'s dialogue such as we had today and yesterday that are
very, very important to providing that scientific information and having
that scientific interchange to help develop policy.

Now, what we need to do is to assure that we have the best available
scientific information, that it\'s used correctly, it\'s used
accurately, you know, it\'s used effectively. It has to all be used in
the right way. There can be very, very serious misuse of science.

You know, Scott, I remember, you know, some of Deming\'s precepts. One
is, what is the most dangerous type of information? It\'s that which you
think you know, you think you know correctly but actually it is
incorrect. You can dig a pretty big hole by doing that sort of thing.

Now, this conference has provided an excellent forum to discuss our
current understanding of four important areas of pathogen reduction in
foods. Well, meat and poultry products in particular. We talked about
hazards from farm to table, impacts of HACCP systems and approaches,
including prerequisites and good manufacturing practices, talked about
performance standards and microbial testing and intervention strategies,
including verification effectiveness, and being a HACCP person, I was
really tempted to start answering these questions, you know, about
validation and all those things, but I\'m going to leave that alone.

You know, I won\'t attempt, and you\'re going to say whoo, man, I\'m
glad of that, I won\'t attempt to summarize all the presentations, but
I\'d just like to give you just a few brief observations. You know, I,
too, recall early attempts to introduce microbial criteria for foods. I
don\'t go back quite as far as Frank Busta in that regard. Well, we got
what, an eight-year difference in that, didn\'t we, Frank? Something
like that. Exactly. Let\'s put it this way. You can date me back to the
Oregon standards. Okay. That\'s kind of my starting in the food safety
area.

Now, there\'s been much progress over the years with the advent of new
surveillance methodologies. You know, we know all the things that have
been happening through these surveillance sites and the like. Microbial
identification techniques, the development of those over the years, the
license systems, etc. We have new processing technologies, intervention
strategies, new approaches to food safety management, and the
industry-wide adoption of HACCP. You had no choice in that, though. You
know, it gave a good opportunity for implementation of HACCP.

Also, we see the recent CDC reports on foodborne illness and trends
indicating significant declines in foodborne illness.

Nancy, you know, you\'ll enjoy this. Nancy wrote this part of my script.
That\'s not good enough, is it, though? It\'s not good enough. We need
to be doing more. We have to move forward. You know, we can\'t just say
oh, wonderful, things are fine. You know, we\'ve gone this far. We
really have to move forward and find out where those areas of importance
exist and how to effectively address them.

You know, it\'s clear that adoption of HACCP as a food safety management
system has been important in improving our food safety supply, and it
needs to be recognized that HACCP is only a food safety management tool.
You know, it\'s no better than what you use to apply that tool and how
you function within that tool.

It has to be supported by essential scientific information and ideally
other frameworks for addressing food safety, such as risk analysis.
Off-script thing here. For example, we have to take a much stronger look
at raw meat and poultry and how we can provide more effective
interventions to do a better job in that regard. You know, we need to do
a better job in truly applying HACCP to fresh meat and poultry, and as
an example for pushing that in that direction, Dan, when is that
directive coming out? Where are we at on the directive on ground beef?
Soon. Okay. No, I\'m not going to have another meeting with you
tomorrow. Okay. Yeah.

But we\'re coming out with a directive on ground beef that will talk
about interventions, you know, and recognizing that there is a stimulus
that is needed in that area, and we\'re looking towards interventions
for ground beef to take things the step further and to do better.

It\'s clear that there\'s still many critical scientific questions that
need to be answered. We need to have a clear understanding of the
relationship of food safety policy and hazard management to public
health outcomes. Our performance standards, and, you know, you said it,
Loren, is that, they\'re based upon, you know, a hope of a positive
public health outcome by reducing the level of incidence, but those
performance standards were not based upon, you know, knowing public
health outcomes. Okay. We need to better know that relationship.

You know, what is the relationship of specific levels and incidence of
pathogens, such as Salmonella, on raw meats to foodborne illness? To
what level can these pathogens be reduced in raw meat and poultry, and
what is the associated impact on public health? Are there certain
serotypes or biotypes and associated ecological niches that have the
most significant contribution to foodborne illness? How should
performance standards be used, and how do they relate to public health
outcomes? What are the most effective intervention points and strategies
for pathogen reduction and associated impact on public health?

The occurrence of foodborne illness is also impacted by factors, such as
handling practices, at all stages of the food system, not just
consumers, all stages of the food system. What are the practices that
have the greatest impact on food safety, and how can they be improved?

It is clear that we need multiple strategies or approaches to addressing
food safety and to reducing foodborne threats. These strategies must be
appropriately targeted. We must clearly know their impact. Of course,
there\'s many more questions that I could ask, and this is just a sample
of the questions, and I need to give a disclaimer and for those people
that I did not encompass within the questions or my questions and
comments, I \-- my apologies. Pass me a note next time and maybe I can
turn it in or, you know, go to the speaker just before I\'m ready to say
something and I\'ll say it maybe. I won\'t promise it, though.

You have to remember food safety is a responsibility of every person
involved in the food system. All the way from primary production to the
final end user, there\'s a responsibility. We all then share a common
goal and we have a common goal of food safety, safe food. The difficult
question is how do we get there? How is it accomplished? That\'s
accomplished, quite frankly, not just by government regulation. It\'s
not accomplished by just cooking your hamburger correctly. It\'s not
accomplished just by some intervention at production. It\'s accomplished
through a multiplicity of efforts and a cooperative effort to produce
safe food products. Okay. You know, it\'s not a pointing the finger at a
specific segment, but it takes a vast cooperative effort.

You know, for example, HACCP offers a commonly-understood approach to
food safety, food safety management in particular. Risk analysis now
offers a commonly-understood set of principles relative to food safety
policy, and it\'s through conferences such as this that we can exchange
the essential information that is needed to identify areas where we need
to make progress, and we should then take this and move forward towards
producing safer food products, and I hope that you\'re able to attend
the future conferences and be a part of the dialogue at those meetings,
and again thank you very much for being here.

It\'s been great having you. I look forward to seeing you in the future.

Thank you.

(Applause)

DR. HULEBAK: Thank you, Dr. Pierson, again and thank all of you who came
and stayed. Appreciate it.

Good night and safe travels.

(Whereupon, at 4:05 p.m., the meeting was concluded.)