UNITED STATES DEPARTMENT OF AGRICULTURE

**NATIONAL ADVISORY COMMITTEE**

**ON MEAT AND POULTRY INSPECTION MEETING**

Columbia Room

Holiday Inn Capitol at the Smithsonian

550 C Street, S.W.

Washington, D.C. 20024

Thursday, November 7, 2002

9:00 a.m.

[Committee Members]{.underline}

DR. GARRY McKEE, Administrator

DR. GLADYS BAYSE

MS. NANCY DONLEY

MS. SANDRA ESKIN

MS. CAROL TUCKER FOREMAN

MR. MIKE GOVRO

MR. MARTIN HOLMES

DR. LEE JAN

DR. ALICE JOHNSON

MS. COLLETTE SCHULTZ KASTER

DR. DANIEL LAFONTAINE

DR. IRENE LEECH

MR. CHARLES LINK

DR. CATHERINE LOGUE

MR. MIKE MAMMINGA

[Participants]{.underline}

DR. JIM DENTON

MR. BUD PAULSON

MS. CHERYL HICKS

DR. PHILIP AMAN

DR. WILLIAM CALLOWAY

DR. PERFECTO SANTIAGO

MS. JEANNE AXTELL

DR. ENGLEJOHN

MR. GIOGLIO

MS. LINDA SWACINA

DR. MURANO

DR. PIERSON

DR. WILLIAM JAMES

DR. KENNETH PETERSEN

MR. LAUREN LANGE

A G E N D A

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

Recap 226

Dr. Garry McKee

Standing Subcommittee Number 1 - Briefing on 228

Wednesday Evening Session

Education and Training of the Field

Workforce to Achieve a Public Health Vision

Dr. Daniel Lafontaine

Briefing on HACCP-based Inspection Models 262

Project (HIMP)

Introduction and General Status Update

Ms. Jeanne Axtell, OM

Dr. Perfecto Santiago, OPPD

Observations from the Field Perspective 276

on HIMP

Dr. Philip Aman, OFO

Dr. William Calloway, OFO

Introduction to Video Presentation 287

Ms. Jeanne Axtell

Review of HIMP Data by National Alliance

for Food Safety

Video Presentation 291

Dr. Billy Marshall Hargis

Questions and Answers 311

Dr. Patricia Curtis (by telephone)

Next Steps for HIMP 320

A G E N D A

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

Questions and Answers on HIMP 328

Presentation - Panel

Ms. Jeanne Axtell, OM

Dr. Perfecto Santiago, OPPD

Mr. Loren Lange, OPHS

Dr. William James, OPHS

Dr. Kenneth Petersen, OFO

Dr. Philip Aman, OFO

Dr. William Calloway, OFO

[Afternoon Session]{.underline}

Standing Subcommittee Number 2 - Briefing on 352

Wednesday Evening Session

Escherichia coli 0157:H7 Developments

Mr. Mike Mamminga

Standing Subcommittee Number 3 - Briefing on 372

Wednesday Evening Session

Procedures for Evaluating State Meat and

Poultry Inspection Programs

Dr. Lee Jan

Remaining Issues and Plans for Next Meeting 384

Dr. Garry McKee

Public Comment 391

Wrap Up and Adjourn 403

Dr. Garry McKee

P R O C E E D I N G S

9:10 a.m.

Recap

DR. McKEE: Welcome back. I\'m glad to see everyone back, especially with
all the material that you had to cover last night and the activity that
we had yesterday. And again, I appreciate all your efforts last evening
on \-- on the different topics that \-- that you were addressing.

I think we\'ve had some very good presentation and discussions. We\'ll
begin today with the reports of the Standing Committee.

But I\'d like to start with a presentation on behalf of FSIS and USDA.
We have several people that will be leaving the committee. And those
individuals \-- one isn\'t back yet this morning.

What I\'d like to do is to \-- we have a certificate of appreciation and
a presentation of a mahogany double pen stand with personal engraving.

This \-- this is what it will be. I\'ve got these in the box. And so
what I\'d like to do is to call your name and come forward and make the
presentation to you.

Ms. Nancy Donley.

(Applause)

DR. McKEE: Dr. Daniel Lafontaine.

(Applause)

DR. McKEE: Dr. Michael Mamminga.

(Applause)

DR. McKEE: Mr. Dale Morse is not here, but he will be receiving one as
well.

And we also have Ms. Carol Tucker Foreman. Is she here?

Well, thank you very much. You know, the committees are \-- are
dedicated, especially when you spend the evenings working on topics that
will help us make decisions and strategy within the Agency. And it\'s an
extremely valuable task for us to be able to have your input and your
recommendations.

We have really appreciated the work and expertise you all have
contributed to the committee. And the secretary has truly appreciated
all of your invaluable recommendations as well. Your input has certainly
been valuable to us.

As you know, we announced in the \"Federal Register\" this past August a
solicitation for nomination for membership on this committee. We
received so many applications from qualified candidates for these five
positions that the selection process certainly poses a major challenge
for us. However, it\'s far better to select from so many talented
individuals than it is being in a position where there are few to choose
from. We expect to have a selection made by March 2003.

And I thank \-- again, I want to thank those of you that are currently
serving and those of you that are going off the committee for your
dedicated service. Let\'s have a round of a hand for those that are
leaving.

(Applause)

DR. McKEE: Okay. Thank you.

This morning what I would like to do is to start with the standing
committee \-- the Standing Subcommittee Number 1, which is Education and
Training of the Field Workforce to Achieve a Public Health Vision. The
leader is Dr. Daniel Lafontaine.

If you would like to start with your presentation?

DR. LAFONTAINE: Thank you, Mr. Chairman.

Briefing - Standing Subcommittee Number 1

Education and Training of the Field Workforce

to Achieve a Public Health Vision

DR. LAFONTAINE: I\'m Dr. Lafontaine from South Carolina. And I was \--
had the honor of chairing the subcommittee.

Before I get into the substance, I\'d like to, first of all, thank my
colleagues on the committee, Mr. Govro, Ms. Logue, and Ms. Eskin.

We even went high-tech, or low-tech if you want to call it, and Ms.
Eskin was with our committee by phone last night because of another
commitment. So that shows her dedication.

Also, we had good audience participation. Mr. Paulson and Ms. Hicks from
FSIS were there to help us. And also, we had representatives from the
inspector union and also the public citizen organizations. So we had a
good, healthy group and discussion.

Also, one other introductory comment. Dr. McKee, we sincerely appreciate
the opportunity to comment on this critical element in any organization.
One way I like to put it is, and this is my own thoughts, training is
certainly the bedrock \-- or a bedrock of any organization. So we
appreciate that opportunity.

(Slide)

DR. LAFONTAINE: We did address the two questions that were posed to us.
And I guess we have those for everyone to \-- to see on the screen here.
So I will run through these fairly rapidly. And then if there\'s \--
I\'ll take question one and then question two. And if there\'s any
comments from the committee members or \-- the subcommittee or full
committee, then we\'ll certainly entertain those.

The first question that we were posed \-- well, first of all, the \--
the issue is education and training of the field workforce to achieve a
public health vision. So we\'re talking about that 80 or 90 percent of
the \-- of FSIS that is in the Office of Field Operations out there on
the frontline doing the day-to-day work in the plants.

The first question was, what does the subcommittee recommend FSIS set as
its top priorities with respect to education and training of its diverse
field workforce, diverse being many different skill levels, many
different types of responsibility.

(Slide)

DR. LAFONTAINE: The first question we asked was, does FSIS really know
what knowledge, skills, and abilities, commonly known as KSAs, are
required to perform the various job functions that its field force
undertakes. In other words, a need \-- needs assessment.

So we need \-- we feel you need to define that or redefine it, if
necessary, by doing a needs assessment to determine what training is \--
is needed to accomplish these KSAs.

The needs assessment should include input from the field workforce about
the areas they feel they need more information or guidance. Also, don\'t
forget in \-- about the state programs. We\'re in this along with you,
and we need to be included in that information-gathering.

So the bottom line there is, make sure you know what your \-- what\'s
\-- what\'s needed as far as training.

Another key thing that \-- we\'re not saying all these things aren\'t
done, but it\'s kind of important to reiterate them.

After training, the Agency should test the participants to verify
they\'ve acquired the needed knowledge, skills, or ability. This
information is also \-- could be used to evaluate the effectiveness of
training as an element of your ongoing quality improvement.

The third item was offered by myself and agreed upon by the
subcommittee. We feel, Dr. McKee and leaders of FSIS, that the Agency
needs to shift the focus of its training to provide more science-based
training as appropriate at each level. We realize that different jobs
and skill levels need different parts of this.

But if you\'re going to be a public health agency, you need to have a
good understanding of meat and poultry microbiology, especially those
foodborne pathogens that we know are emerging. Biostatistics, if you\'re
going to take scientific information and make valid assumptions. Food
technology and \-- and what\'s happening in the food safety
interventions. And let\'s not forget about the basics. Cleaning and
sanitizing and basic hygiene practices.

If I might digress for a moment, I\'ve been with the state programs and
in turn with the FSIS for almost 10 years. And I just haven\'t seen it
happening. I know it\'s being integrated into certain training elements
such as the consumer safety officers, but this is, we feel, needed
across the board as you set your \-- your game plan for the future to be
a solid public health agency.

(Slide)

DR. LAFONTAINE: Also, the Agency should address the barriers to the
delivery of training, such as the Agency requirement the more \--
majority of its workforce be present on the production lines and
wherever possible eliminate those barriers. And my next comment kind of
feeds into this.

The \-- the Agency needs to figure out what funds you need to do your
training plan and build a fence around those so it doesn\'t become a
discretionary fund to use if all else does not go well.

More specifically, maybe a dedicated percentage of the workforce should
be continually in training. This represents a higher level of commitment
to education and training on the part of the Agency.

To give you a possible model to look at would be military training. The
armed forces, we feel \-- I feel personally, is probably the best in the
world because of its bedrock of training. And in most of the services,
they set aside approximately 10 percent of their personnel budget for
having people in training rotation at any one time. And they do not
touch that. So they have this \-- a very \-- and this ties in with, you
know, obviously having enough people that you can release for training.
So it\'s not only the training money but it\'s the \-- the \-- enough
overhead as far as personnel so that you can actually rotate people and
make them available, you know, for your \-- your training game plan.

And then, a final comment for these new training initiatives such as CSO
training. There was also a supervisor\'s course started a few years ago
that\'s a five-week course and a four-week scientific-based course for
inspectors. From the get-go, we \-- we would ask that at least a few
slots be set aside for the state employees \-- from the get-go. What\'s
happened is, we kind of knock on the door and maybe a couple years later
we start to get a \-- a few slots to send people. And we\'re \-- we have
the same requirements and the same implementation needs, and we\'d ask
that as you look at this training situation that you include us in that
initial allocations.

So let me stop here. This is question 1, which was, what are the top
priorities. Any questions from the \-- my colleagues? Dr. Jan? Let me
get Dr. Jan first and then get you.

DR. JAN: Lee Jan, Texas Department of Health. I certainly have no
argument with anything that you\'ve presented. I think it\'s all right
on target.

But I \-- I think the Agency should consider that even before all these
things are put into place, to consider starting with a more educated or
a higher level of education of a workforce by requiring a college degree
or some level of college. I think a public health agency \-- I think the
public expects that the \-- that the persons in that agency that are
looking after them do have a higher level of education.

And \-- and so I think if \-- if that would become a minimum
requirement. Now, it may not be necessary for first \-- on-the-line
slaughter inspectors where they simply do one task and that\'s slice \--
and then they have oversight of some higher level people. Because I know
college is not for everybody. But if you\'re going to move in the \-- in
the Agency \-- move within the Agency and become a person that deals
with these high level industries that \-- being \-- to produce a safe
product, we have \-- they have to have quality assurance people. Those
people generally have a college degree. And being able to communicate
with those people and not be intimidated, I think those people that are
representing the Agency have to be at least equal to that level.

And so I think work that in and make that a mandate, at least at some
level. Perhaps even consider \-- and I don\'t know if there\'s a
national registered sanitary and certification program, but I know each
state has one. You know, perhaps require some certification of a
sanitary status which would indicate that they have been capable of
successfully completing an exam of \-- of their knowledge and then be
certified. And most of those then do require a degree. But I think
that\'s the thing I\'d like to offer.

DR. LOGUE: Just one quick point. You see where you have that word,
\"with emphasis on foodborne pathogens for the microbiology\"? You might
want to consider changing that because that sounds exclusionary to the
other aspects of microbiology. And you need another word, I think,
there.

DR. LAFONTAINE: We\'ll work on that editorially.

Yeah, Mike?

MR. GOVRO: I just wanted to \-- Mike Govro again. I just wanted to
comment on what Dr. Jan brought up.

In addition to the possibility of requiring a degree, there are a lot of
other models that are available out there. For instance, we \-- at the
Department of Agriculture, we require a sanitarian\'s registration. That
does require a degree. There are also other programs, such as manager\'s
certification, that is now required under the model food code. There are
trainings that are given by training organizations that are certified by
an independent third party so that they verify that the training meets
the needs. And also, many states have food handler certification so that
someone coming into a job has to take a basic course.

And I think if you created a requirement such as that, you would find
that there would be third parties that would step up and offer that
training probably all over the country if there was a need.

DR. LAFONTAINE: Nancy? Ms. Donley.

MS. DONLEY: Thank you. Did the subcommittee at all discuss the idea of
\-- of looking at what level of field force is \-- has the most impact
on \-- direct impact, I guess, if you will, or impact on \-- on
achieving public health and that \-- or was any discussion on that there
are gaps or \-- or \-- in this position or there\'s \-- there\'s \--
there\'s \-- there\'s shortages here and that need addressing that would
better benefit the public?

DR. LAFONTAINE: Let me answer your question this way. We did not
specifically look for where the gaps were. But we indirectly addressed
that by saying the very first step is to take a look at each of the job
series and figure what the knowledge, skills, and abilities are needed
in that job to execute a public health \-- your public health mission.

So that \-- in an indirect way, we did that very specifically as the
very first step.

MS. DONLEY: Is there \-- I guess, is \-- is it \-- would it be helpful
if the Agency were to take a look at its field \-- I\'m wondering if the
Agency took a look at its field force and says, okay, we \-- in each
category and we have X number here, X number there, X number there. And
\-- and underneath that classification there\'d be thus-and-thus
function. And \-- and just kind of looking at the whole big picture to
see \-- we need more in this classification and less in this one. And
\-- just a suggestion.

DR. LAFONTAINE: Mike\'s going to answer that.

MR. GOVRO: Again, that goes to the needs assessment. And we felt we, as
a committee, really couldn\'t answer what the Agency needs to do until
they make that determination. And we\'ve asked USDA if a needs
assessment had been done and they said, no, really a comprehensive needs
assessment hadn\'t been. And really, that\'s, I think, where you
determine where you need to provide the training.

DR. McKEE: Do you suggest the \-- the needs assessment include
questions, a test kind of a thing? Or how \-- how would you \-- are you
identifying the perception of \-- needs themselves or are you looking at
what are the weaknesses and do that through a testing kind of a baseline
determination? Or what\'s your recommendation there?

DR. LAFONTAINE: I\'m going to start to answer that, and I\'m going to
let Mike embellish because he was the one opponent.

But what \-- to put it in as simple language as I can, we are asking you
\-- the public are asking the field force to execute certain missions
such as, does industry have an adequate HACCP plant, is there \-- and
are they implementing it properly. Do they have proper interventions to
prevent foodborne pathogens from being in the product, whether it be raw
in the case of 0157:H7 or, you know, listeria, salmonella \--
salmonella.

So the point I\'m leading up to is, when you\'re out there on the front
lines talking to the quality manager or whoever might be involved in \--
in this particular plant, do you have the knowledge, skills, and ability
to execute \-- to communicate effectively, to understand what\'s being
said, to ask the hard questions. That\'s my view of a needs assessment
of asking your workforce, what do you need to do what we\'re asking you
to do.

Mike?

MR. GOVRO: I believe you\'re asking \-- and correct me if I\'m wrong \--
how you would go about making the determination of the level of
competence of the field workforce with regards to how they compare to
the knowledge, skills, and abilities that you defined?

DR. LAFONTAINE: Yes. I think it\'s probably two-pronged. And I\'m
thinking how we can do it possibly at one time. There\'s an issue of
what \-- I feel like I need to do my job but at the same time there may
be issues that you don\'t know you need that we need to identify. And so
how \-- I guess the question is, that can all be done in a needs
assessment. But maybe it\'s a combination of baseline testing
information and a needs assessment by comment or perception as well.

MR. GOVRO: Right. I think you\'re on the right track there. And I \--
I\'m not a training expert, but the times that I\'ve talked to training
experts about the training I need to deliver to my staff, their first
question is always, you know, have you done a needs assessment. And
there are people who are very expert in that and I think could look at
\-- at your particular situation and advise you.

I don\'t know if you\'d want to go outside or if you have people in
staff. I was pretty impressed by the people at USDA last night. Mr.
Paulson seems to have a good grip on it. So I would say, utilize
whatever expertise you can find.

DR. LAFONTAINE: Yes, Ms. Donley?

MS. DONLEY: One thing I \-- I \-- I think might be worth adding to this
is, when it comes to education and training I think you need to have
some sort of a feedback loop or some sort of an assessment done
afterwards to see just how effective the training and education is so
that there\'d be some sort of a follow-up to see if it\'s translated
into actual behavior modification.

DR. LAFONTAINE: We \-- we touched on that briefly in this question by
saying, you know, for those \-- those critical training episodes, it
needs to be tested. You need to \-- you know, and of course, implied in
testing is how effective is your training in accomplishing your training
objectives. So we did touch on that.

And \-- and the second question will \-- will talk more about that also.

Yes?

MR. GOVRO: I was going to say, it\'s in the second \--

DR. LAFONTAINE: Right. That\'s what I was saying. So we\'ll \-- Nancy,
we\'ll get to that in a little more depth in a moment.

Mr. Paulson or Ms. Hicks, do you have any comments on this at all? Oh,
is there a question over here? Oh. Ms. Foreman?

MS. FOREMAN: Thank you. Carol Tucker Foreman with the Consumer
Federation.

If you\'re talking about a vision of public health protection, I think
you have to look beyond the questions that were raised with this \-- at
this meeting. So although you didn\'t ask, I want to talk about.

There are, as I see it, three major barriers to having a workforce that
provides public health protection. One of them clearly is training.
You\'ve \-- you\'re trying to address that. The second one, and I know
you\'re aware of it, is the pay level, which connects to training in the
federal system.

If you\'re at GS-5 \-- you provided us with the salary tables yesterday.
Twenty-five thousand dollars a year for a GS-5 employee, \$30,000 for a
GS-7 employee. Part of the reason that there are vacancies in places
like the New York City metropolitan area is nobody works for that money.
In \-- no competent person can be hired for 25- or 30,000 dollars in
Westchester County or in the metropolitan New York City area. We\'re \--
we\'re still living with an assumption that you\'re going to have people
working who address the problems this industry as they existed 30 or 40
years ago, not today.

So you can\'t even get people you can train if you can\'t do something
about the pay scale. It\'s a good salary out there maybe in rural
Nebraska, but that\'s not where Albany\'s plants are.

The third one is attitude. And I\'ve watched over the past several years
since HACCP was implemented. It\'s not new. It\'s been going on \--
well, it\'s been going on for a long time. It\'s gotten increasingly
worse since HACCP has been implemented. An increasing level of hostility
between the Agency management and the field workforce. I know some of
that was there as long ago as when I was at the department. But it has
just gotten infinitely worse in recent years.

And I \-- I\'d urge you, Dr. McKee, to \-- to do everything you can to
reach out here. As long as there is warfare going on between management
and staff, the public won\'t be protected. I think it has become a
barrier to public health. And as I said yesterday, I think the kind of
language that was in that memo that was released is \-- gee, I hope
that\'s the worst of it. But it exists on a number of levels, and I do
believe that it is a serious barrier to public health protection. Thank
you.

DR. LAFONTAINE: Ms. Hicks?

MS. HICKS: Thank you. What I wanted to add was just something that
somewhat addresses what Nancy Donley brought up about taking a step back
before we would do a needs assessment, but look at the complement of
positions we have in the field and whether those are what we need and
whether the duties that we have assigned to them cover all the bases.
And as I mentioned yesterday, we\'re looking at the frontline supervisor
jobs and what those need to be, and other things we\'re doing to fill in
a gap.

I believe Dr. Johnson mentioned yesterday is we have compliance officers
who have been split between the new organizations here and field
operations. And so we\'re working on defining the job of the compliance
officers that are left with field operations. And one of the things we
want to do is train those individuals so that they can assist the
districts with reviewing the corrective action plans that the plant
submits so that can be turned around in a faster manner than it is now.

And so there are things along those lines that we\'re doing at this
point.

DR. LAFONTAINE: If there are no further comments, we\'ll move on to the
second question.

(Slide)

DR. LAFONTAINE: The second question was, what suggestions does the
subcommittee offer concerning cost-effective delivery of training to
FSIS\'s geographically dispersed workforce.

Before I get into the substance, you \-- you will see some repetitive
language in the second question. And what we did, we had two groups in
the \-- in the subcommittee write the report. And we consciously decided
to \-- to keep the repetition in there even though we \-- I just wanted
you to know we did recognize. You\'ll see some of the same words \--
same ideas twice.

The report reads as, while the committee recognizes that FSIS endeavors
to provide high quality and appropriate training for its entire
workforce, the committee considers there are gaps in this training that
need to be addressed. A needs assessment of the Agency\'s workforce must
be carried out and the individuals identified who can determine gaps in
the existing training.

The committee understands the resource constraints that are a
contributing factor to these gaps. And with that in mind, we recommend
the Agency consider the following.

Training must result in learning. And this goes back to \-- unless it\'s
just general knowledge, it needs to be tested training so that there\'s
an ownership in the process and a measurement, of course, how effective
you\'re accomplishing your objective.

And we say that as \-- I digress because in the distance learning that
I\'ve \-- I shouldn\'t say distance learning. But the training that \--
some of the training that I participated in, it\'s not tested. So it \--
it \-- it\'s fairly effective but it\'s certainly not honed in as it
would if \-- if the individuals were tested and held accountable.

The effectiveness of training, of course, should be balanced with the
costs and benefits. What we\'re saying there is, you know, take a look
at the various modes of training and, to the best of your ability,
figure out what gets the job accomplished most cost effectively, which
of course was \-- was your basic question. So we\'re turning it around,
saying that has to be a key element of this whole process.

We had quite a bit of discussion on the next topic. The \-- the joint
training of FSIS\'s inspection personnel and industry personnel should
be encouraged on appropriate topics. What we\'re saying is, if it\'s a
purely technical issue where both parties need common knowledge of what
we\'re talking about \-- a food safety intervention would be a good
example \-- that would be an appropriate topic. Conversely, if you\'re
talking about FSIS policy or enforcement, then that is not an
appropriate topic.

But you can accomplish an awful lot when you train together, hear the
same information, the same interpretations. It really helps the
effectiveness of what you\'re trying to accomplish.

And another idea \-- excuse me for a second.

(Pause)

DR. LAFONTAINE: Another idea is to consider regional training. And even
went \-- we went so far as to recommend district training officers. Your
Agency is doing that now, and I\'ll just use the recent example of the
IPS Biosecurity training where you had a two-day training block. You
took facilitators to a central location to make sure they understood the
subject material. The subject material was presented by, in this case,
video tapes. But the facilitators were available to answer questions.

And then, in each district they reached out and found training locations
\-- and I was involved in these firsthand in South Carolina, in this
case with joint federal and state personnel \-- and executed the
training. And I thought it was quite effective.

And this answers the question of the diverse workforce and you can\'t
\-- you don\'t have the time or the money to bring everybody in for
face-to-face training in \-- in College Station. But you can have that
face-to-face effectiveness by reaching out in your districts and then
into subunits. So that\'s a \-- a recommendation of the committee, that
you give that a look-see.

The creation of district training officers or whatever title you want to
call them is someone that has that as an integral part of their job
description and responsibilities so that they\'re in the loop with the
training center and other parties concerned on what\'s being developed,
what the essence of it is, and that they know their \-- they are \-- he
or she is responsible not only just to coordinate the training be done
but to be actively involved in it, maybe even be a routine facilitator.
So that you\'ve got that cadre of folks that are accountable for \-- for
doing training or assuring that it\'s adequately executed.

I offer the example of state training officers. We have a system with
our cooperative agreement where the FSIS trains state employees so they
can go back and be trainers at the state level for some of the basic
requirements for accomplishing the mission. So you\'ve got that kind of
a system ready between us and between the states and \-- and FSIS.

You can tell I feel very strong about that. I embellished on it quite a
bit.

Consider alternative technologies for training purposes. The use of the
land-grant colleges and their infrastructure should be considered. Those
land-grant colleges and their extension services have communication nets
to include Polycom and other current technologies out at the county
level. So you \-- you have an infrastructure in almost all states that
you \--that you could possibly plug into so that you can better reach
out to your workforce. In other words, work with the extension service
and with these counties to \-- to have \-- to use their facilities and
equipment for the ability to reach your workforce wherever they may be,
in the middle of Texas or Kansas or wherever.

The next item that we suggest you consider is providing for interaction
on the application of the training. And I touched on this already. Real
face-to-face training is invaluable, especially when you have
complicated or complex issues to work on or the interpretation of what
\-- what this directive or this subject really means as far as the
Agency\'s execution.

FSIS needs to consider options to address the recess \-- resource
allocation personnel to ensure the timely training and maintain
necessary coverage of the inspection duties. One method of this is the
team-based training approach. Once again, you see we\'re coming back to
enough \-- a structure that will allow you to dedicate on an ongoing
basis what \-- have workforce available so you can execute.

Finally, training is an important mandate of the FSIS mission.
Commitment to training and the funds necessary to accomplish this
mission should not be compromised by budgetary cuts. Touched on that
earlier when the \-- locking in or fencing of the funds. Put your game
plan together, figure out how much you need and \-- and lock in those
funds so you can \-- can do that month after month, year after year.

And the final comment is, who is out there to determine what training
the inspectors need. We touched on that a couples times on needs
assessment and figuring out what your gaps are, et cetera.

So with that, I\'ll ask the full committee and subcommittee to offer any
additional comments.

Yes, Collette?

MS. KASTER: Thank you. This is Collette Kaster with \-- Standard Farms.
I think this is an excellent and very comprehensive list, and I\'d
encourage you guys to look very seriously at this. I really like the
idea of the district training officers. I also like the idea of
spreading this out, as we talked about yesterday, to other land-grant
universities. Texas A & M is a great university but it\'s one of the
harder and more expensive places to get to. And I know when our
inspectors leave, it eats up quite a bit of time, including travel time.
It\'s difficult for people to get down there. And there\'s a lot of
other really fine institutions that could be included in this.

And the other thing I\'d just like to add in here is something that does
already happen on a lot of these trainings. But besides joint training,
I\'d also like to add a bullet point where we say that when appropriate,
training materials are shared with industry. For example, the way that
the CSO training was shared with industry, so that we understood the
things that they were going to be looking for and could make sure that
we made the adjustments that we needed to.

So I\'d like to add that as a bullet point. Thank you.

DR. LAFONTAINE: Yes, Ms. Tucker?

MS. FOREMAN: Carol Tucker Foreman with Consumer Federation. I have a
couple of suggestions I\'d like to make. Everybody knows that I have
serious problems with the notion of joint training. However, Dan, as you
\-- as you started out, as you gave the examples, I was more comfortable
with it. Could we include the examples in the bullet, please? So that
\--

DR. LAFONTAINE: Yes. I\'ll do that.

MS. FOREMAN: Thank you. That \-- that \-- that would make it a lot
easier for me.

The second is, using the land-grant college training infrastructure
strikes me as a good idea. As I was looking \-- as you were talking, I
thought, here we\'ve got a force that we\'re really trying to get to
look at their work in a very different way. It\'s a public health
agency. FSIS hasn\'t historically been a public health agency.

I think it would be \-- I think you could implicate that way of thinking
in the Agency workforce faster and more successfully if instead of just
involving extension if you were able to involve the public health
community infrastructure of some of the land-grant colleges, if you
would integrate some public health people into this training. They do
tend to look at things a little differently, think about it a little
differently. And if you would entertain some reference to the \-- the
public health infrastructure there, I\'d appreciate it. Thank you.

DR. LAFONTAINE: Carol, with the permission of the full committee, I\'ll
\-- I\'ll include that also. The \-- words to the effect of, the public
health infrastructure, giving examples of what we mean by appropriate
topics for joint training, and also your comment about, continue to
share the FSIS training materials with industry. So I\'ll put all \--
integrate all three of those in, if it\'s \-- if there\'s no objection.

Have some other questions? Mike?

MR. GOVRO: Mike Govro, Oregon Department of Agriculture. One of the
points that Collette brought up made me think of something. As I\'ve
tried to develop training in our agency for a shift over to the food
code, I\'ve relied on a lot of outside information that I\'ve gathered
from other agencies. One example is a guide that the Los Angeles County
Health Department uses in explaining the use of their inspection form
and their rules and regulations. And it puts it in \-- it takes it out
of the regulatory language that you find in the rules and puts it in
very simple, straightforward language designed to be comprehended by a
lower level person, as you might find working in a food service
establishment.

And I really find that to be an excellent document. And you might use
that as a guide for how you could develop more information to get out to
your field workforce and \-- and the regulated industry as well.

But that brought me to the \-- actually, the next point, which is there
is a lot of information out there that has been developed by other
agencies for the purposes of training. And I think it would be to
USDA\'s benefit to participate with organizations such as the
Association of Food and Drug Officials and find out what they\'ve got
available, what types of approaches they\'ve taken, and avail yourselves
of as much of that information as possible.

One of the things that AFDO is doing is \-- is working on some
collaborative efforts so that everyone is not reinventing the wheel
separately and to try to \-- it\'s called a States Helping States
Program, and I think there may be information there that you could
utilize.

DR. LAFONTAINE: Any other questions, comments? Oh, Nancy? Sorry. Ms.
Leech, let\'s deal with you.

DR. LEECH: Irene Leech. The first thing that I\'d like to say is, thank
you for the staff for having these here on our desks early this morning.
I came in early and was able to read before the presentations, and that
makes me a whole more effective than when I get the information after I
sit down. So that was a big help this morning.

I would encourage you to consider ways to involve key consumer folks in
some of the trainings and so forth as well so that everybody is brought
along together. I think whenever parts are involved and parts are left
out that it breeds mistrust and that kind of a thing. And I think we
really need, with our food supply, to keep the public confident, need to
be sure that we\'re bringing everybody along, particularly in the
situations where we may consider new technology along the way.

So I know it\'s an expense, but I think key consumer leaders could be
involved and that that might be a way to strengthen the whole system.

DR. LAFONTAINE: Let me make a follow-up comment. And I\'ll just go back
to the land-grant college infrastructure and I\'ll use South Carolina\'s
example.

They are the individuals, in our state at least, that really are in
touch with the consumers and the users as far as the food safety issue.
So that\'s not exactly what you\'re talking about, but it\'s certainly
\-- my point is that if you \-- if you do involve your extension folks,
you\'re taking a giant step towards that \-- that effort.

But I also hear what you\'re saying. You\'re talking about the next step
of actual involvement of consumer organizations in \-- in the training
or what\'s actually being put out.

DR. LEECH: To give a further example of what happens on my campus, there
really is no communication between consumer types like myself and our
food science division. We\'re in different colleges, even. Even the
nutrition people who do the food kinds of things are in a different
college from our food safety people. And yes, they\'re extension, but
they tend to have more connections with the traditional agriculture
audiences than the average consumer on the street.

And that\'s why I think we need to ultimately be sure that we just keep
people in the loop. And I know there\'s been some mistrust through the
years, and so I think that\'s a little thing that can be done.

DR. LAFONTAINE: Ms. Donley?

MS. DONLEY: Thank you. This kind of is a general comment about education
and training in general. And one of the things that STOP does, our
organization does, is we are regularly asked to speak to various
companies, organizations, trade associations. Basically, what we do at
these \-- during these speaking engagements is to empower the \--
empower the audience. And we will have anyone from the highest level
company executives down to the \-- the bus boys, if you will, in a \--
in the restaurant situation.

But our goal, our mission, is \-- is to \-- and particularly now that
the Agency is making a very public stance towards going ahead to public
health and safety, I think your inspection force needs to really know
and understand how critically important they are and to be able to have
some sort of an identity or a face or something in their minds to which
they can say, yeah, I really am important, I really do need to do this
job very, very well.

So I just would say that you need to have \-- during all this is to have
some sort of an empowerment message to give to them. Be happy to work
with \-- with FSIS in any way. You know, STOP will offer its support in
any way we can on this.

Doesn\'t have to be your major, major \-- major, major function, but
just something that \-- that reaches out to the inspection personnel and
\-- and gets them to buy into it and get committed to it.

DR. LAFONTAINE: Nancy, that\'s a \-- a very pertinent and important
suggestion. And I\'ll integrate something in here about the, using your
words, the need to include an empowerment message.

Dr. Denton?

DR. DENTON: Thank you, Dan. First, I would like to compliment the
committee on what I think is a very insightful as well as a very
thoughtful response to these questions.

I don\'t want to belabor the point, but in thinking about what Carol
mentioned earlier about including from the health side of the equation,
I mentioned or referred to very generally yesterday our Food Safety and
Quality Program. And as a point to follow up and reinforce that, I\'m
gratified to hear this because I think it validates the approach that
we\'re taking just a bit.

One of the things that we looked at is a basic set of skills that we
feel like people within not only the industry but within the regulatory
community need. We looked at things like basic food microbiology. We
looked at things like statistical process control.

Some of the things that we looked at are outside of what we normally see
in our College of Agriculture, Food, and Live Sciences. We actually
dipped over into our College of Education in the Health Education
curriculum for our modules that have to do with epidemiology and
communicable diseases.

I think the more of this type of effort that we can have in putting in
the expertise from the other areas, and it fits in with what you\'re
saying about the extension service, we think that looking for the
fundamental knowledge, wherever we find that, is going to strengthen
this educational effort. We\'ve worked very hard to put this thing
together not only with three separate universities involved in it but
looking beyond our traditional curriculum with regard to how we approach
these types of things.

And I think that your recommendations should form a very important
guidepost as \-- as we move forward in this. Thanks.

DR. LAFONTAINE: Thank you, Jim.

Other questions, comments?

DR. McKEE: I\'d just like to comment that I think the comments are
exactly right. We need to have the core public health disciplines within
the public health arena. And we certainly need to have that incorporated
as part of the training, whether it\'s technical and so forth, so that
we \-- we can start going in the direction that we understand that is.
That includes epidemiology, communicable disease control, those kinds of
things that are kind of \-- that are basic to public health that we need
to know how that \-- how what we do in the inspection business fits into
that.

And so certainly, that\'s an opportunity. We need to partner with \--
with other folks in public health and schools of public health to do
that. I think it\'s a good point.

DR. LAFONTAINE: Thank you, sir. You know, I\'m going back and plowing
the same ground again, but you need the basic knowledge and skills to
execute what your mission is. And that\'s \-- that\'s the first
important and hard question. So we\'re saying the same thing.

Any other questions or comments?

(No response)

DR. LAFONTAINE: Okay. I will take these four items and integrate them
into question number two and give it to our staff and support staff and
then we\'ll have a second version go out later.

Okay. Thank you, sir.

DR. McKEE: Okay. Thank you.

We have our \-- we have a presentation for the \-- the briefing on the
HACCP-based Inspection Models Project, or better known as HIMP, right
after our break. We will need to be right back on time at 10:30.

Before we go to break, I would like to make the presentation to Carol
Tucker Foreman. We commented earlier about those leaving the committee
and their dedication to the committee and the valuable work that they
have done.

And Carol, I\'d like to present you a \-- this is a pen set that is
engraved. And I believe everybody on the committee has spent two terms
\-- or three terms, which is two year each. That\'s a long time.
Dedicated work, especially the evening work. And we certainly, again,
appreciate it. So if you could come forward, Carol.

(Applause)

DR. McKEE: Okay. I believe we have refreshments outside the door \-- are
you finished, Dr. Lafontaine?

DR. LAFONTAINE: Yes.

DR. LAFONTAINE: And we will \-- that\'ll give us about \-- a little over
20 minutes. So that\'ll make \-- give us plenty of time to be back here
right at 10:30. Thank you.

(Brief recess)

DR. LAFONTAINE: Okay. We can take our seats. It is 10:30.

We do have a long-distance presentation, and so it will be necessary to
\-- to start on time with that.

Briefing

HACCP-based Inspection Models Project (HIMP)

Introduction and General Status Update

DR. LAFONTAINE: This morning\'s presentation on HIMP will be facilitated
by Ms. Jeanne Axtell and Dr. Perfecto Santiago, who have been the \--
the lead individuals in the Agency on this project.

And Jeanne, if you would go ahead and start, why we\'ll do whatever we
need to do on the electronics here.

MS. AXTELL: Okay. Thank you very much, Dr. McKee, and we thank very much
the advisory committee for allowing us to come and brief you on the
status of the HACCP-based Inspection Models Project, or HIMP it is \--
as it is more commonly referred to.

This morning we would like \-- we will be presenting to you the results
of the third party review of the HIMP data that had previously been
collected by Research Triangle Institute, and to discuss our plans for
the HIMP project.

At the last national advisory committee meeting in June, FSIS officials
and the Research Triangle Institute project leader presented data that
had been collected during the baseline and models phase of the project
in young chicken plants. To say that the data presentation and the
ensuing dialogue with members of the committee was lively would be an
understatement.

At the conclusion of the June meeting, FSIS acknowledged that while the
goal of HIMP remained solid, the Agency could and should do more to
assure the public that their confidence in the Agency\'s decision-making
based on the data from this project was well-placed. The quality of the
data, what the data means, and how the data are communicated are
critical issues for assuring public confidence in moving forward with
the goal of HIMP. That is, modernization of inspection.

FSIS committed to having a third party review of the data that had been
collected by Research Triangle Institute for the project after taking
another look at the data ourselves. And we acknowledged that the issue
of increases in the recovery of salmonella during the course of the
models phase of the project would need to be addressed.

With this acknowledgement, FSIS proceeded to an internal assessment of
its management and direction of the project, what we have called
assessing the current reality of HIMP.

With me today are individuals who represent the new face of HIMP. As you
see represented on the panel here today, Dr. Lauren Lange from the
Office of Public Health and Science; myself from the Office of
Management; Dr. Perfecto Santiago from the Office of Policy; two field
supervisors, Dr. Bill Calloway, Dr. Philip Aman; Dr. Kenneth Petersen
from the Office of Field Operations in headquarters; and Dr. Bill James
from the Office of Public Health and Science.

We represent executives from different program areas within FSIS and
supervisors from the field at both the in-plant level and the circuit
supervisor level of the organization.

FSIS is actively engaged in the HIMP pilot. It is our goal to bring the
focus of HIMP back to the original intent of the pilot as stated in the
June 1997 \"Federal Register\" notice which announced this project. It
was at that time and it remains today as the most ambitious and
difficult undertaking for this Agency next to the implementation of
HACCP itself.

With the implementation of HACCP underway, the HIMP proposal was
designed to address the fact that under the carcass-sorting process,
inspectors carry out certain process control activities that are not
inspection activities and thus should be the responsibility of the plant
under close FSIS oversight. This is consistent with the HACCP approach
under which plants are responsible for the production of safe and
wholesome products, including carcass-sorting process control
activities. And FSIS is responsible for setting performance standards
and ensuring those standards are met, thus assuring that no adulterated
product leaves the plant.

With inspectors in these slaughter plants no longer carrying out
activities that should be the plant\'s responsibility, FSIS believed and
still believes that it can better focus on public health concerns.

FSIS believes that there are additional tasks within slaughter plants,
such as verification of the zero tolerance standard for fecal
contamination as well as sampling for pathogenic microorganisms and
verification of HACCP food safety systems, that deserve more focused
attention than they have received. This would permit FSIS to focus
greater attention on products after they leave plants and enter
distribution channels where minimal attention is now paid. And
opportunities do exist for improving food safety and public health.

This is where we began with HIMP. Over time we lost sight of the
project\'s goals, but now we are back on track and intend to move
forward.

Modernizing inspection is the goal and remains the goal for the Agency.
It is about assuring that FSIS meets its food safety public health
responsibilities.

The objectives of this project as outlined in 1997 we have reviewed over
the last several months. We believe them to still be valid objectives
for us to attain.

The first of these is that whatever new approaches we\'re looking at,
that they do not diminish current food safety and consumer protection
achievements.

Second, HACCP, other industry process control systems, and FSIS
inspection activities, all three of these, are complementary and
interrelated but they are independent activities. Taken together, they
enhance the safety of food and earn consumer confidence.

Third, resource redeployment of scarce inspection resources is essential
to assuring food safety and consumer protection objectives throughout
the farm-to-table continuum.

Those are the three objectives with which we began the project and the
three objectives which we believe are still valid today.

To move forward with HIMP, we contracted with an independent third party
since the meeting in June, the National Alliance for Food Safety, to
review and analyze the RTI data and FSIS data. Today, the National
Alliance for Food Safety will be presenting their findings.

Thus far in the pilot, we\'ve seen that HIMP provides benefits to all
stakeholders. It does result in safer, higher quality product for
consumers. It permits industry greater control over the production
process to meet food safety and quality standards set by the Agency. And
it frees up inspection personnel to be redeployed to other areas of
need.

We believe that in the last few years that we\'ve been engaged in HIMP
that we have accomplished what we set out to do, that there have been
benefits to consumers by FSIS\'s ability to focus its attention upon
food safety concerns that otherwise would not have received the same
level of attention.

Among the first 15 plants involved in the project, FSIS was able to
successfully deploy 70 inspectors. These individuals were freed up to
focus on other food safety concerns or were detailed into other critical
slaughter vacancies within the local commuting areas of the HIMP plants
to which they were formerly assigned.

FSIS has not had to request additional resources for program growth
since fiscal year 2001 because this has been possible. In light of
bioterrorism concerns that you heard discussed yesterday, having a
flexible workforce that can be redeployed to areas of need will become
increasingly essential.

At the same time, there have been benefits to industry. Participating
plants have had the opportunity to redesign production practices, line
configuration, and process flow and to introduce innoventions and
interventions that would not have been possible with inspection
personnel at fixed inspection stations midstream in the production
process. Our inspectors, carcass inspectors, are now positioned at the
end of that production process prior to the chill plant.

Despite these benefits, there have been real and perceived problems with
the project. FSIS has not been transparent in sharing data. And
criticisms from many quarters have caused consumers to believe that
products from HIMP plants are less safe than other products.

The project is not perfect. From our own assessments as well as those
from outside groups, we\'ve seen shortcomings in the pilot. As we move
forward with the project, we will build on the important food safety
gains that are already apparent and take the opportunity to address the
shortcomings through ongoing evaluations.

We are at an important juncture in this project. We are working on
strengthening the program and improving the benefits for all
stakeholders.

At this point, I would like to ask my colleague, Dr. Perfecto Santiago,
who has been co-leading this effort with me, to provide you a more
detailed description of the sets that are underway today to address
these shortcomings.

Dr. Santiago?

DR. SANTIAGO: Thank you. Good morning. Like my senior partner Jeanne, I
thank you for the opportunity to \-- to speak to you this morning to
share with you the initiatives we have taken to strengthen the
HACCP-based Inspection Project for young chickens.

Being before you this morning is one of the first \-- another first for
me when I came to Washington in my \-- after spending 32 years in the
field, five years of that as a district manager with one key
establishment under my jurisdiction.

As Jeanne mentioned, we know that HIMP is not perfect, and a few short
comments that we must address as we move forward on this project.

We know that the set of procedures we are operating from in this
project, called Draft 6, needs to be revised for clarity. We know that
the inspection procedures are not being implemented uniformly in the 20
volunteer establishments under HIMP for young chickens. We know that the
\-- the normal supervisory structure in the management of this project.
We know that we need to develop an enforcement strategy for
non-compliance with non-food safety standards, also known as OCPs. And
we know we need to review how we are starting HIMP establishments at the
present time. Lastly, we know that we need to review our communication
strategy with the industry and the inspection personnel in the HIMP
establishments.

To address these shortcomings, we have embarked on the following
initiatives. Engaging the field supervisory structure. In the early
stages of the pilot, HIMP implementation was managed by the New
Initiatives staff in Washington. Technical advisors from headquarters
were assigned \-- HIMP establishments to provide direction on the
implementation of the pilot.

While this arrangement worked well and probably was necessary in the
early stages, disengaging the supervisory structure may have
inadvertently weakened accountability and supervisory control.

As the role of the technical experts were gradually phased out \--
advisors, excuse me \-- it became unclear to the inspectors in charge of
HIMP establishments where they may seek guidance and direction on
implementation problems. Inspection personnel and plant management as
well reported inconsistencies on directions being given by members of
the headquarters staff. Procedures become unclear.

To address these shortcomings, the Office of Field Operations formally
reengaged the supervisory chain of command in the management of the
implementation of HIMP to establish clear accountability and to
strengthen supervisory control. Appeal procedures were also clarified.

The \-- was reinforced in the last National Supervisory Conference in
Dallas by Bill Smith and members \-- members of the Office of Field
Operations.

The second initiative we are taking here is to review and revise Draft
Number 6. In response to the issues presented by HIMP establishments at
the recent meeting with FSIS and as a result of our assessment of, as
Jeanne called it, current reality, we \-- in the HIMP procedures we are
operating from to identify provisions or procedures that need
clarification.

For example, in Draft 6, we are telling verification inspectors that
when doing the eight 10-bird tests for Food Safety 1 and Food Safety 2,
they should not score OCPs or \-- defects but they may find against the
plant\'s performance standards. In the OCP procedure further down this
\-- draft, we are telling verification inspectors to randomly select two
10-bird samples from the eight 10-bird sample sets for food safety and
\-- one and two and use that for OCP verification. Appearance of bias
\-- biased sampling is then most inevitable when these procedures as
written are performed by our inspectors.

We will clarify this procedure in Draft 7. Possibly, \-- a way that all
food safety and non-food safety defects observed in an 80-bird sample
are counted against the food safety and the non-food safety performance
standards.

We do not anticipate major procedural changes, however, but all
procedures in Draft 6 needing further clarification will be addressed
appropriately.

We also intend to incorporate in Draft 7 all other minor revisions made
to Draft 6 after it was first issued. We are actively soliciting input
from inspection personnel and supervisors working in HIMP establishments
in preparing the draft.

In addition to clarifying the procedures in the existing draft, we also
plan to propose in Draft 7 an enforcement strategy for non-compliance
with performance standards for non-food safety processing defects.
Again, those we call OCPs.

We hope to develop an enforcement strategy that will provide guidance to
inspection personnel using statistically based limits on how to
determine when regulatory action will be taken. We expect Draft 7 to be
completed by the end of this month \-- the end of this month.

Another initiative we\'re taking is to conduct sustained and vigorous
correlation activities in the HIMP establishments. Reported
inconsistencies on sampling and other procedures underscore the need for
sustained correlation activities in HIMP young chicken establishments.
Following the issuance of Draft 7, the Office of Field Operations is
committed to conduct vigorous on-site correlation activities with
inspectors and supervisors in the 20 HIMP young chicken establishments
on the new procedures. They expect to complete this activity by the end
of May 2003.

We plan to look at the existing staffing configuration as another
initiative that was initially established for HIMP. We need to ensure
that we have the appropriate level of staffing, including properly
trained relief personnel, to conduct verification activities in HIMP
establishments. The project has had time to make the necessary
evolutionary changes. And roles and responsibilities are now better
clarified for us to make this staffing assessment.

On communication, in the early stages of the project regular conference
calls were made to inspectors in charge and supervisors of HIMP
establishments from Washington, D.C. As the project matured, the \--
became less and less frequent. The technical advisors from Washington,
D.C. and the Technical Service Center that were assigned \-- initially
assigned to every HIMP establishment gradually became less and less
involved in the project. And that particular function has practically
disappeared in the implementation strategy of HIMP at present.

We deem it critical at this stage of the project to ensure that
effective communication is established between the now-engaged field
management structure, the Technical Service Center, and the HIMP
headquarters staff in the management of the project. As Draft 7 is
implemented, we plan to \-- the regular conference calls and explore
other means of establishing effective communication with the supervisory
structure of \-- of those inspections in the HIMP establishments.

We are very confident these initiatives, when fully implemented, will
strengthen the program, ensure the protection of public health, and
maximize the benefits of all HIMP to all stakeholders. Thank you very
much.

MS. AXTELL: Thank you, Dr. Santiago.

Now I would like to introduce two field supervisors who will share their
observations from their perspectives on the HIMP pilot.

The first to speak will be Dr. Philip Aman, who is an inspector in
charge at a HIMP plant. The second to speak will be Dr. William
Calloway, who is a circuit supervisor with supervisory responsibilities
for a HIMP plant within his circuit.

Dr. Aman?

Observations from the Field Perspective on HIMP

DR. AMAN: Thank you, and good morning. I\'m very happy to be able to
comment today on a project which I firmly believe in. My comments will
be based on observations and assessments as a veterinary medical officer
with 16 years of experience in meat and poultry inspection.

I\'m currently assigned to a plant that slaughters young chickens,
approximately 2 million a week. And at the end of next month, I will
have just completed three years in this plant under the HIMP inspection
methodology. Prior to that, I spent 13 years under \-- in plants with
the traditional inspection.

In my professional judgment, the HIMP inspection system is superior to
the traditional inspection system. Given the choice of purchasing
product for my 75-year-old parents or my 11-year-old son, I would choose
to have product from a HIMP inspection plant. Let me explain to you why.

In the traditional inspection, the inspectors, as you\'ve already heard
from previous comments, the inspectors were placed in the middle of the
process, of the evisceration process, in fixed positions. They could
only control what came to them at that point.

With the HIMP inspection method, we remove them from the middle of this
process and place them at the end of the evisceration line where they
are observing and inspecting those carcasses that have been sorted and
washed and trimmed and are supposed to be ready to go into the chiller.
At that point they are better able to determine what the consumer is
actually going to get at the end of the process.

Not only that, but in the previous scenario and traditional situation,
this inspector was pinned to the line for eight to 10 long hours a day
in the same fixed position. With the HIMP, the inspectors are set up in
a rotating pattern such that when one inspector leaves that line
position, another inspector comes and takes their place, allowing that
inspector to go into a different mode \-- they\'re trained in all the
modes \-- where they will be inspecting carcasses. They will be
performing all the other duties that were mentioned.

It allows us to reallocate our resources and better utilize our
personnel resources to a much greater degree than we could ever do in a
traditional plant.

I\'m going to give you a snapshot view of what I\'ve seen in the last
three years in the plant that I\'ve been in. That\'s what I can do
today. And I want to give you some examples of what I\'ve seen happen
with their process.

Initially, this was a plant that had \-- HACCP plant. Had an SSOP plant.
It\'s meeting regulatory requirements. They went into the HIMP
inspection system. And due to the HIMP, they were allowed to see some
areas in their process that could be improved, and they took advantage
of that.

For example, OCP-3, which is the \-- one of the OCPs that we look at
every day for ingesta, when they began under the HIMP system, because of
the tightened performance standards \-- and I can assure you the
standards are tighter and they\'re harder to pass under HIMP than they
are in traditional. Under this new tightened criteria, the plant was not
able to meet this requirement on a daily basis. And they discovered that
even though they had a good written plan for the field needs to meet
this criteria, which primarily consists of proper withdrawal, time of
the feed, where it may be written that X amount of hours you withdraw
the feed from the field. If you\'re a farmer and you are going to get up
at 2:00 in the morning to pull those feeders and you know that no one is
going to come to that farm and verify that you did that, the temptation
would be to, what the heck, go ahead and wait until five or six and pull
it.

But those two or three hours makes a vast difference on that flock when
it comes to the slaughterhouse as to how it will process out and how it
will score out on that OCP-3. The plant had to go back and start holding
people accountable and verifying that those procedures were followed to
the T so that they \-- and at this point they have eliminated that
problem.

Another example that we saw, as \-- as the mission in the HIMP
environment, we do closer scrutinize the product and we do take more
sampling. And the numbers of non-compliances initially with the fecals
did go up. Not the percentage of birds when you scale it out on
percentage, but the numbers went up. The perception of this to the
public is poor because they only see the numbers. They don\'t
understand. And it\'s true that that would be the case.

But the plant did not want that perception. And so they began to work on
their process in that area. They began to better work on their
equipment. The initial equipment that the birds come into that could
cause fecal contamination of a carcass. They had to go to the field and
make corrections.

I will say to you now that in the \-- we are, like I said, almost into
the third year. At the plant where I am, I could almost name on one hand
the number of non-compliances that we see now of fecal contamination in
a shift per month. And we\'re talking over 2 million chickens a month.

The other great improvement that I\'ve seen at this particular plant is
in the OCP-1 category, which is \-- in a young chicken plant, the bulk
of that is going to be airsacculitis. For all my career as a poultry
inspector, veterinarian, in the winter and springtime is when we see
those flocks primarily that come in with the airsac. And they are a
processing nightmare for the plant and for the inspection team, whether
you\'re on the traditional or whether you\'re under the HIMP, either
one. But particularly in the HIMP.

Again, because of the increased or the tightened performance standards,
this plant was not able to consistently meet those standards using the
normal routine as they did in the past. They had to address what flock
\-- they were using for these flocks before they brought them into the
plant. And I can attest to you that in the last year and a half, I have
not seen these flocks coming to the slaughter house. They have corrected
this problem. And therefore, the OCP-1 issue has gone away.

So I think the \-- the \-- what I\'m trying to say is that the \-- in
the environment of the HIMP system, it allows the plant to correct these
deficiencies and improve their process.

The last comment I want to make, because when I told my inspection team
that I was coming here to talk to this group, they told me before I
left, Dr. Aman, please, please tell them that we do not want to go back
to traditional inspection. Our job is more important. We feel like
we\'re doing a better job for the consumer. And we would not want to go
back to the traditional inspection. Thank you.

DR. CALLOWAY: I want to thank the committee for providing me the
opportunity to come and give you my slant on HIMP.

As was noted in the introduction, I am a circuit supervisor. And for
those who might not be quite sure on what that is, I\'m responsible for
the delivery and implementation of inspection operations at the field
level over a relatively large geographic area, mine encompassing
Mississippi and south Alabama.

I have a fairly complex circuit. There are several different types of
federally inspected establishments in my circuit, five of which are
poultry slaughter plants, one heavy fowl plant, four young chicken
plants, one of the young chicken plants being a HIMP plant.

I think for point of clarification, the HIMP plant in my circuit is not
Dr. Aman\'s. He\'s not assigned in my circuit, although I\'d probably
let him work for me if he came down there.

So we are speaking about two separate facilities here.

I\'ve been a circuit supervisor for about four and a half years, and so
I\'ve been a circuit supervisor for the entire time that HIMP has been
implemented. I was an IIC for seven years prior to that, and four of
those years as an IIC was in this facility that went to HIMP. So I have
an approximately eight and a half year knowledge of this facility.

I don\'t pretend to be an expert on the big picture of HIMP. I can only
give you a snapshot of one facility. And so that\'s what I\'m going to
try to do.

I want to try to touch on three points: the product that\'s exiting the
facility, the company and facility itself and what HIMP has done to and
for them, and what HIMP has done for the inspection personnel in that
facility.

As to the product, I have to concur with Dr. Aman. And he\'s covered it
in much more detail and better detail than I can provide you. I can
relate to you that in \-- in the major food safety categories of FS-1,
septox; FS-2, fecal contamination; and OCP-1, diseased animals, there
has been a significant reduction in this plant from the time that it was
a \-- under traditional inspection as opposed to its operating under
HIMP inspection.

I firmly believe that the product coming out of this plant is of better
quality and more wholesome now than it did when this plant was under
traditional inspection.

As to the company and the facility, this is an old facility. It was
built in the early 1950s. And the company is one of the smaller
companies in the industry. To be quite honest with you, prior to HIMP
and during the time pre-HACCP to HACCP implementation, this company was
struggling. They were struggling financially and they were struggling
meeting regulatory requirements. And they selected to go to HIMP with
the full knowledge that they were going to be held accountable to a more
stringent regulatory standard, but they did it with the knowledge and
the hope that by being allowed the freedom to reallocate their very
limited resources that they could do a better job producing their
product and also, at the same time, do a better job meeting regulatory
standards.

And so we embarked on the HIMP road with this company, and it\'s \--
it\'s had its rocky spots along the way. And they didn\'t immediately
turn things around. They didn\'t have a lot of capital to invest into
major renovations to immediately meet some of the changes that HIMP
provided.

But I can report to you that as I sit here today that in the last year
to year and a half, this company has been able to invest a significant
amount of capital into replacement of equipment, to renovation of the
facility. They have been able to install and implement an on-line
carcass antimicrobial system. They have become competitive in the job
market and have gone out and hired better-trained, progressive,
proactive management. They have contacted and hired an outside
consultant to come in and do a full audit on their HACCP and SSOP
systems. And they have conducted training for every supervisor in their
plant in HACCP.

It is my opinion that had they remained under traditional inspection,
these things, these improvements, all that went to better, more
wholesome product, would not have been accomplished.

As to the inspection personnel in this plant, and I certainly don\'t sit
here as a representative of the inspectors, particularly in regards to
their working conditions. That\'s the charge of the NJC, and I respect
that area.

I can relate to you individual conversations that I have had with the
inspectors in this plant. They reiterate what Dr. Aman\'s inspectors
have said. To the person, not one would go back to a traditional
inspection. The inspectors believe they are doing a better job, that the
plant is producing more wholesome product, and they are better serving
the consumer in their role as HIMP inspectors.

I think as a significant sidebar to this, we have all seen and heard and
read the reports that there is a crisis in the federal workforce. We
have an aging workforce. A significant number of experienced inspectors
are retiring and leaving the Agency each year. We have a subcommittee
here, I believe, that\'s addressing some of those issues. It has been
pointed out that we\'re having difficulty obtaining qualified people and
retaining qualified people.

If you think of what we have subjected these people to in a traditional
inspection system where they are tied to the line for eight to 10 hours,
that they can sit or stand only in one position, that they have a
repetitive up-and-down and sideways head motion, a repetitive rotation
of the wrists. We see a large number of traumatic illness-related cases
of workmen\'s compensation associated with neck injury, shoulder injury,
and carpal tunnel syndrome.

I can tell you, in this plant since they went to HIMP, those have gone
away.

I can relate to you a story of two ladies in this facility. One is in
her early 60s, one in her lat 50s. Both have in excess of 25 years\'
experience in inspection. Four and a half years ago they told me that
they doubted they could last another year. I talked to them last week.
They both told me they plan to work another five years and maybe longer
if they can stay healthy.

If we can retain our experienced workforce and extend their life, their
working life, then we have accomplished something and retained a major
asset for the Agency.

In conclusion, I agree. I don\'t think HIMP is a perfect system. I do
believe it is superior to \-- to traditional inspection. And given the
fact that it is driven by HACCP, it is forced to continually adapt and
change to meet the requirements of HACCP. And therefore, the flexibility
it gains from that provides not only that it meet the needs of the
immediate time but also for the future.

I thank you again for this opportunity.

MS. AXTELL: Thank you, Dr. Calloway.

Introduction to Video Presentation

MS. AXTELL: We are at the stage now where we will be preparing to
present to you the report of the National Alliance for Food Safety,
which was the review of the RTI and FSIS data from a baseline and models
phase of the project.

FSIS specified particular questions to be addressed through examining
the data from the 11 plants that have been involved in the project from
the beginning, from the 16 plants whose data was presented at the last
advisory committee meeting in June, and from all 21 plants who have been
engaged in the project at any point in time. When we met in June, we
said 20 plants. The reason we\'re saying 21 today is that one had
dropped out, one came on. And we had a plant enter the project over the
summer.

The questions that were posed to this third party review focused on the
validity of study design and methodology that would permit an
interpretation of the organoleptic and microbial data sufficient to
assess the accomplishments of the traditional and HIMP systems. Again,
this was a crucial question for the Agency since study design and
methodology and a comparison of one system of inspection to another
system of inspection was an inherent feature of the design of the
project.

FSIS awarded the contract to the National Alliance for Food Safety. And
a technical review of bids was submitted through the normal procurement
and contracting process used by the federal government.

As with all outside contractors, the participants on the technical team
identified by the National Alliance for Food Safety completed conflict
of interest statements verifying their impartiality to participate in
this review.

FSIS did not include in the contract a requirement to make an oral
presentation of the findings from the review. Our requirement was simply
to conduct the evaluation, to conduct the review, and prepare a written
report of findings and conclusions.

When the Agency contacted Dr. Billy Marshall Hargis, the team leader, to
request his availability to make a presentation to this committee, we
found that Dr. Hargis had a previous commitment out of the country that
precluded his being here today. Dr. Hargis has indicated that he would
be available at some point in the future should the committee wish to
have him present to address the work of the National Alliance of Food
Safety directly.

What Dr. Hargis did agree to do is to tape the presentation he would
have made had he been here. This presentation will run 30 minutes. It
would be helpful to the members of the committee if you would follow his
presentation with the copy of the report that was placed on your chairs
or at your seats during the break. It has the cover sheet on it with the
cover letter from the National Alliance for Food Safety.

MS. FOREMAN: (Off microphone)

MS. AXTELL: Ms. Foreman, Dr. Hargis was not able to be here, but Dr. \--
but Dr. Patricia Curtis, who is another member of the team, is going to
be available by conference phone. And following the running of the
videotape, Dr. Curtis has agreed to be hooked up in order to answer the
questions of the committee that they have at the moment with respect to
the work of the National Alliance for Food Safety on this review.

MS. FOREMAN: Carol Tucker Foreman from Consumer Federation. This is
extraordinary. First of all, we\'ve been here for two days. My tab
number eight, which covers this material, is shockingly vacant. You
walked in here with extremely detailed material. It was put on my chair
while I was outside on the break. You do not have the author. You\'re
willing to hook up one of the people by conference call.

It is clear that this presentation was brought to this committee in a
way that makes it impossible for us to deal with it. And frankly, there
are no data here. There are none.

So having said that, I want to be on record as objecting. I\'ll have
some other things to say later.

MS. AXTELL: Thank you, Ms. Foreman. Your objection is on record.

We do want to proceed with the playing of the video. Again, there have
been a number of technical difficulties this morning in trying to get
all of this equipment connected properly and to assure that we could get
the printing of the final report done. And in fact, the copies of the
report were not delivered until first thing this morning. I apologize to
the committee for that, but we received the final version of the report
only a couple of days ago.

We will proceed now with the video tape.

Video Presentation

DR. HARGIS: Hello. I\'m Billy Hargis. I\'ve seen a list of folks that
are present here today. And I realize that I know many of you and I wish
I could be here in person to see you and talk with you.

Unfortunately, none of our review team was able to be present for this
particular meeting. It was very short notice. And I believe Dr. Curtis
is going to be able to answer some of the questions by telephone some
\-- some time later after the presentation this morning.

As you know, it\'s my honor to be the lead person on this team to review
the HACCP-based Inspection Models Project that we were granted by the
National Alliance for Food Safety as a technical team, which of course
contracts with FSIS for review of its projects.

The team consisted of some very well-known people: Dr. Pat Curtis, Dr.
Mike Johnson \-- Dr. Curtis is actually the professor and director of
the Poultry Product Safety and Quality Program in the Department of
Poultry Science at Auburn University. Also, Dr. Mike Johnson, who\'s a
very well known food microbiologist at the University of Arkansas in the
Food Science Department. And Dr. J.D. Williams, who is a \--
biostatistician and is one of the best biostatisticians that I\'ve ever
known.

Also, myself. I\'m presently a professor and director of JKS Poultry
Health Research Laboratory at the University of Arkansas. My background
is both in veterinary medicine and in research. Most of my research over
the last few years has dealt with some work with antemortem intervention
strategies and at the interface between pre-harvest and post-harvest
intervention.

Do you want me to start \-- okay. That\'s fine.

As an introduction, the National Academy and others have called for
moving federal regulatory activity away from the traditional
organoleptic inspection and toward a risk-based HACCP approach. In a
subsequent report, the National Academy of Science has indicated that
the mandatory inspection of all carcasses is an impediment to improving
the safety of meat and poultry.

Arguments that have been made that sorting activities should
appropriately be assigned to the plant under FSIS oversight to evaluate
a model system of inspection operating under HACCP principles, the HIMP
project was initiated to evaluate the ability of the HIMP models to
improve the safety of processed animals and poultry.

As I mentioned, the present review has focused on the validity of study
design and methodology to permit an interpretation of organoleptic and
microbial data to assess the accomplishments of traditional versus HIMP
systems. Our team reviewed the differences in food safety performance
data between the inspection systems for young chickens using data from
the Food Safety categories 1 and 2 and also microbial testing, as well
as data from the other \-- Other Consumer Protection categories, one
through five.

The technical review team was selected by the National Alliance for Food
Safety under contract with FSIS. And the review team consisted of
nationally and internationally recognized experts, we hope, in the area
of poultry microbiology, food safety, poultry health, poultry
processing, and statistical evaluation. We reviewed the documents
provided by FSIS.

The \-- a group of documents, about eight inches\' worth. And I\'ve
given them here. We focused on the entire project, the original 11
plants that reviewed for both baseline testing and for models testing,
as well as the replacement five processing plants that replaced the five
plants that dropped out of the program. And we\'ve also reviewed the
FSIS data as well as the other reports and things that others have
written about the data today.

As requested, the primary focus of this review was on the specific
questions by FSIS. We\'ll go through these individually.

The first question was, does the design and methodology of the study
permit an interpretation of the organoleptic and microbial data to
assess the accomplishments of traditional and HIMP inspection systems.

Overall, the review team determined that the design and methodologies
used allow for mutual comparisons of the plant that is measured under
the two systems. The review team noted the enormous difficulties in
accomplishing a comparison of this type under \-- conditions and
restrictions.

The primary \-- design clause related to the fact that the baseline and
HIMP system data were collected at two very different times, potentially
introducing unintended variables. However, when one accepts that the
comparison is between these two systems at these times, then the data
are indeed interpretable.

Large data sets collected on parameters not expected to vary
substantially due to season or time are particularly comparable in the
studies. However, an issue was raised with regard to the salmonella
incidence data, that these data were collected under a very short time
span for each of the systems evaluated.

As discussed in more detail in the report, the review team could not
find any valid reason for discounting the data generated by the entire
RTI \-- RTI data set from the 16 plants under the traditional or HIMP
inspection system. And secondly, comparison of the data provided from
either RTI-generated data set does not alter interpretation of the data
in a meaningful way.

Regarding geographic distribution, the review team noted that the \--
area most represented, which was the southeastern United States,
actually represents the area most responsible for approximately 80
percent of the young chicken production. And we didn\'t feel like that
this was in any way a bias geographically for the design.

The size range of the selected plants were also representative of the
majority of chicken plants. Now, I think the review team does recognize
that extremely small plants might very well fall into a different
category.

No reason was found for rejected the RTI-generated data based on
statistical \-- geographic bias, plant size bias, or non-completion of
the study by five of the 16 originally selected plants. In fact, we
think it\'s rather remarkable than 11 of the 16 originally selected
plants are ready to complete the study. The design and methodology \--
represent the best available choice for most of the plan that is
measured.

However, the compressed time frame, only \-- salmonella recovery data
represent an exception to \-- conclusion. And I\'ll talk about that just
a little bit later.

Our second question that we were asked to address specifically was to
evaluate and characterize the differences in food safety performance
data for current inspection systems for young chickens using data from
Food Safety categories 1 and 2 and microbial testing.

We found that there were clear and important reductions in FS-1 and FS-2
defects, the food safety categories, that were attributable to the HIMP
models system as compared to the baseline data. There were also clear
generic E. coli reductions which were also attributed to the HIMP models
system as compared to the baseline data.

The findings of the review team are generally consistent with those
outlined by the RTI-generated manuscript which was published in
\"Journal of Food Protection.\"

Our third question was to evaluate the aggregate and individual
establishment data by comparing the accomplishments of traditional and
HIMP systems for the 11 establishments participating in both RTI
traditional and RTI models sampling.

And so for this question we were focused only on the 11 plants that
actually completed both phases of the sampling.

An apparent improvement in the average score was noted with \-- process
under the HIMP models system for Food Safety categories 1 and 2 and
OCP-1 and -2. Consistent with these data and the numerical increase in
the percentage of plants which met performance standards for these
categories were noted for FS-1 and OCP-1, -2, -3, with no difference in
the percentage of plants meeting performance standards for FS-2.

The average score for carcasses processed under the HIMP models system
was higher for OCP-3, OCP-4, and OCP-5. However, we also considered that
there is a very real difference between statistically significant
changes and those that are likely to be meaningful.

For example, the average score was reduced in the HIMP models group by
18-fold for Food Safety category 1 and almost five-fold for Food Safety
category 2, almost three-fold for OCP-1, and almost two-fold for OCP-2.
In contrast, the increase in average score in the HIMP models group was
only 10 percent for OCP-3, 15 percent for OCP-4, and 44 percent for
OCP-5 as compared with the baseline data.

It is also important to note that the Food Safety categories are
considered to reflect much more important defects as related to product
safety.

Overall, the review team considered these data to evidence marked
improvement in the organoleptic defect scores of carcasses processed
under the HIMP models system as compared to the baseline data collected
under the traditional system.

Marked and significant reductions from generic E. coli recovery were
reported in carcasses processed under the HIMP models system as compared
to those processed under the traditional or baseline system. However, a
statistically significant increase in salmonella recovery from carcasses
processed under the HIMP models system \-- that was 9.2 percent \-- was
observed as compared to the baseline data, only 4.6 percent. This is
again with the 11 plants that started and completed the study.

However, this observation was not consistent with the overall data of
the combined 16 plants or with the FSIS data, and we\'ll discuss that in
a moment.

Question Number 4. Descriptive analysis of individual establishment
performance in traditional and HIMP systems.

A complete data set provided by the \"RTI Individual Establishment
Data\" was available only for the initial 11 plants for most categories.
But we certainly looked very hard at this data. Review of these data did
not affect the conclusions apparent in the summary data for these 11
plants as discussed, with one exception, which I\'ll mention here in a
moment.

There was no evidence that any \-- that the summary data were unduly
weighted by extreme variations with the exception of some very high
individual salmonella recovery incidence numbers, particularly with two
of the plants in the HIMP \-- operating under the HIMP system.

The aggregate analysis \-- Question Number 5 was to look at the
aggregate analysis comparing the accomplishments of the 16
establishments participating in the RTI traditional sampling to the
accomplishments of the 16 establishments participating in the RTI models
sampling.

And again, we did not \-- we recognized that the model plants had made
many, many changes. They are in fact a apple compared to an orange. And
we \-- we really struggled with the question but don\'t find any real
reason to discard the data from the replacement five plants that \--
that replaced those that dropped out of the study.

Very similar data, though, regardless of how you looked at it. Whether
we looked at the 11 plants that both began and completed the study or
the 16 combined establishments, we pretty much get the same data with
one exception.

We saw significant differences again in issues of each of the
organoleptic parameters evaluated, and this was expected because with
very large data sets, very small differences, they\'re likely to \--
statistically significant.

We saw apparent improvement in the average score with carcasses
processed under the HIMP models system for Food Safety categories 1 and
2 as well as OCP-1 through -3. Consistent with these data, a numerical
increase in the percentage of plants which met the performance standards
for each category was noted.

As discussed above, average scores for carcasses processed under the
HIMP model system were significantly increased by a small factor for
OCP-4 and OCP-5 as compared to the baseline data. But again, these were
small differences.

Overall, the review team considered these data to evidence marked
improvement in the organoleptic defect scores of carcasses processed
under the HIMP models systems as compared to the baseline data collected
under the traditional system.

Marked and statistically significant reductions in generic E. coli
recovery were reported in carcasses processed under the HIMP models
system. And as with the 11 original plants, salmonella recovery was less
noticeably but more crucially recovered from carcasses processed under
the HIMP models system. As mentioned above, this observation was
unexpected given the clear reductions in FS-1 and FS-2 scores and marked
decrease in generic E. coli recovery attributed to carcasses processed
under the HIMP models system.

A pitfall of the microbiological data collected by RTI is the compressed
time frame during the collection \-- collection time. This is \--
compressed into a six-week period per plant.

We know that flocks that have been identified as highly
salmonella-infected antemortem \-- in other words, hot flocks in the
field. These birds have been associated with clearly increased carcass
contamination at processing, and this is very well documented at this
time.

The authors have good reason to believe seasonal and intermittent
patterns of salmonella infection of broiler chickens may be occurring in
the field. We certainly see this with a lot of plants, and there appears
to be a \-- in many reports.

With these \-- considerations in mind, the authors suggest that
salmonella data for this set of 16 plants are inconclusive and that more
seasonally balanced data should be considered, as discussed \-- as I
will discuss in a few moments.

Our last question, we were asked to consider the additional data
provided for this analysis, including the FSIS organoleptic and Pathogen
Reduction HACCP microbial verification data for young chicken
establishments participating in HIMP and national salmonella Pathogen
Reduction HACCP verification data for young chickens.

Our team focused really on the salmonella data. It\'s probably the most
important. We did not have any specific information related to design or
methodology, but I think it\'s pretty clear to the review team that
it\'s pretty much the 21 plants that \-- that continue to compare to the
baseline data from these 21 plants.

The FSIS Pathogen Reduction HACCP data, current to September 30th, 2002,
related to salmonella recovery from 21 establishments operating under
the traditional system and 21 establishments operating under the HIMP
models system were provided by plants and in summary form for review.
These data reflect rolling consecutive sampling dates representing at
least 51 working days which in fact translates to approximately two
months.

Therefore, the potential effect of seasonal bias is reduced by this
expanded time frame of sample collection as compared to the \--
RTI-collected data for salmonella. In this case, the salmonella
prevalence in sampling from plants operated under the traditional
system, eight percent, is not significantly different than the
prevalence in samples from plants operating under a HIMP system, 8.2.

Furthermore, of the completed sample sets, 94 percent of plants operated
under the traditional system and 96.9 percent of the plants operated
under the HIMP system passed the testing criteria.

These data suggest that implementation of the HIMP system does not
affect salmonella recovery frequency \-- that these 21 plants operating
under the HIMP models system be considered with a focus \-- operating
under the traditional system in the near future. This is really the only
\-- category that I think needs to be addressed, and the review team
agrees with that statement.

The experimental design is generally appropriate for a field study of
this nature. And the methodologies employed generally allow for
interpretation and comparison of these systems. Overall, adoption of the
HIMP models system has clearly improved certain scores related to the
more important organoleptic parameters described as FS-1, septicemia and
toxemia, and Food Safety category 2, fecal contamination, and has
markedly reduced contamination of carcasses with generic E. coli as a
generally-accepted parameter related to plant hygiene and process
control.

Adoption of the HIMP models system has also resulted in improvement of
scores related to OCP-1, animal diseases, and OCP-2, miscellaneous
conditions, and OCP-3, ingested contamination \-- ingesta contamination.
That has resulted in slightly increased scores for dressing defects,
OCP-4 and OCP-5.

Salmonella recovery seems to be increased in plants inspected under the
HIMP system when the smallest data set available was considered but less
so when the larger data sets were considered, 16 plants. Although it can
be argued that inclusion of the five replacement plants not included in
the baseline study is a potential bias in the study, there are no
founded reasons to exclude these plants from consideration.

While not impossible, the authors are unable to identify any \-- any
factor \-- we can\'t \-- we can\'t find any factors that we think would
be associated with the HIMP system that could be responsible for
increased recovery of salmonella. And the bottom line is, we don\'t
really think that there is a significant \-- a meaningful \--
salmonella.

Seasonal or random influences affecting the salmonella data set
collected in a single short time frame may provide the best hypothesis
for why we saw an increase in \-- significant increase in salmonella
recovery from the 11 \-- original 11 plants operating under the HIMP
system. This hypothesis is supported by lack of consistency of this data
with the more recently generated FSIS data comparing the 21 plants under
the traditional system and 21 plants under the HIMP system with data
collected over an expanded time frame.

The authors strongly suggest that these data be carefully further
evaluated and considered. And what we\'re talking about there is to,
perhaps, look at the ongoing sampling to select appropriate control
plants based on plant size and geography and make the comparisons with
data that\'s already been collected.

Nevertheless, we feel that the data as presented would argue that
implementation of the HIMP system is not contributing to salmonella
contamination. Conversely, at this time there is no evidence that
implementation of the HIMP system is reducing the incidence of
salmonella recovery from chicken carcasses.

So it may not be all that surprising, if you look at the biology of
salmonella. Where the bird comes into the plant, perhaps this \--
salmonella incidence recovery.

In addition to these \-- the authors also reviewed the Government
Accounting Office document which commented on the results of this
project in 2001. In general, we found the conclusions and
recommendations of this report to be confusing, inconsistent, sometimes
contradictory, and frequently inconsistent with the methodologies
employed and data generated by this study. The bottom line is that we
did not agree with the report at all. And we suspect that perhaps the
people completing this report didn\'t really understand the restrictions
and limitations of doing a field study of this nature.

The first \-- this is a list of a few of the specifics. I pointed out
that, quote, \"The chicken pilot that the USDA designed lacks a control
group.\" The principal criticism here appears to be related to the fact
that multiple factors were simultaneously changed as the HIMP system was
adopted. The review team believes that this criticism does not take into
account the concept that it is in fact a system and that this \-- that
\-- that\'s being evaluated and that constant adjustments to varying
conditions is in fact the goal of a HACCP-based system. There are going
to be multiple factors in terms of comparison.

If it is considered that systems and not who did the inspections were
compared, the controls are indeed appropriate for a study of this type.

The second major GAO criticism is, quote, \"The plant \-- the chicken
plants that volunteered to participate in the baseline measurement phase
of the pilot were not randomly selected, and they did not include plants
from all chicken-producing areas or plants of all sizes.\" The plants
\-- end quote.

The plants selected represent the states supplying the majority of
domestic chicken production. And the size range for the plants included
in the study are representative of the majority of chicken slaughtered
in FSIS-inspected facilities within the United States. We\'re basically
not buying those arguments at all.

The third major GAO criticism of the study is the claim that, quote,
\"The pilot project\'s methodology did not take into account variables
such as seasonal changes and plant modifications that could affect
project results. For example, after the project began, many plants added
antimicrobial rinses and washers, which usually reduce the levels of
microbial contamination,\" end quote.

Indeed, seasonal related salmonella levels and compressed sampling times
for microbial surveillance could indeed be a factor limiting
interpretation of this specific parameter. However, the addition of
HACCP-based interventions during HIMP model implementation was in fact a
goal of the study.

The fourth and final major GAO criticism of the study is, quote, \"The
pilot project did not include features of the modification \-- modified
inspection systems in Australia and Canada that would be important
considerations in ensuring the successful implementation of a modified
inspection system nationwide. For example, during the pilot project,
USDA did not require the training of plant employees.\" While the review
team does think that training is important and we do believe that FSIS
should provide regulatory oversight and to require specific training
for, you know \-- but in terms of answering this criticism of the
project, this statement in terms of no training is not consistent with
the review team\'s understanding of HACCP training that was occurring
prior to and during implementation of the HIMP models system. We know
that there was a lot of \-- of HACCP training that was going on out in
the field.

Nevertheless, if training were inadequate prior to implementation of
this project \-- this is kind of an interesting observation \-- this
would serve to enhance the relative effectiveness of the system and
argue that improvements could be made with increased training.

So we\'re not completely buying the argument, but it would seem that
that argument actually argues for the HIMP models system as compared to
the traditional system.

Of special interest in the GAO report were the responses to the GAO\'s
survey of USDA inspectors and veterinarians as related to this review.
Of the 210 inspectors and veterinarians surveyed, 71 percent indicated
that product safety was the same or better under HIMP \-- under the HIMP
system as compared to the traditional system. And 57 percent indicated
that product quality was the same or improved.

The review team agrees with the majority of USDA inspectors in that
safety and quality of young chickens inspected under the HIMP system was
either the same or improved.

In final conclusion, the review team urges continued FSIS oversight and
continuous reevaluation of HIMP is more broadly implemented. At this
time, no convincing arguments were identified which indicates that
adoption of the modified system under regulatory supervision would
increase risk. And thirdly, the authors find that there are several
lines of evidence that strongly argue for process improvements from the
consumer perspective as related to adoption of the HIMP system.

And that concludes our report. And as I mentioned before, I believe Dr.
Curtis will be available to, hopefully, answer questions that your group
may have for her with regard to the activities and findings of the
review team.

Thank you very much for your attention, and it was an honor to do this.
And I wish I could have been here in person to present this to you.
Thank you.

Questions and Answers

MS. AXTELL: At this point \-- call to connect Dr. Curtis. She had a time
window open between 11:30 and 12:30. So we are \-- we are attempting to
\-- to match her schedule with ours and being able to have questions
from the committee directed to her. It will take a moment just to make
sure that she can hear us.

(Pause)

MS. AXTELL: Dr. Curtis, this is Jeanne Axtell, one of the co-leaders of
the project. Can you hear me from this point in the room?

DR. CURTIS: I can\'t hear very well.

MS. AXTELL: Okay. We\'ll come over.

(Pause)

DR. CURTIS: Yes, that\'s much better. Thank you.

MS. AXTELL: (Inaudible). And in addition, \-- the advisory committee
members here today, there are a number of FSIS and USDA officials. Dr.
Murano. He is the undersecretary for Food Safety. And Dr. Pierson, the
deputy undersecretary for Food Safety. FSIS administrator, Dr. Garry
McKee. The associate administrator, Ms. Linda Swacina, and a number of
other \-- project officials.

Dr. Curtis, are you ready for questions? We have just completed viewing
Dr. Hargis\'s video presentation.

DR. CURTIS: Okay. I\'ll give my best answer to the questions. Don\'t
guarantee I can answer all of them, but.

MS. AXTELL: Thank you very much. First question from the advisory
committee? Ms. Foreman?

MS. FOREMAN: Thank you. Can you hear me?

DR. CURTIS: I can, yes. I can hear you now.

MS. FOREMAN: Okay. The \-- this is Carol Tucker Foreman with Consumer
Federation of America. Dr. Curtis, I\'m \-- I\'m looking at the language
in this report, and I \-- I\'ve never seen a report, a scientific
report, that \-- I don\'t understand the scientific nature of some of
your language, and I\'m going to give you some examples. You describe
the study as, quote, \"quite meaningful and useful,\" close quote, as
having tremendous merit, as being a real-world comparison, these flags
are possibly overcome by, and the \-- determined but the methodology was
generally appropriate.

I \-- I don\'t find that to be quantifiable language. It doesn\'t seem
quite scientific to me.

DR. CURTIS: Dr. Hargis put the report together. The exact language you
would have to address to Dr. Hargis.

The general consideration that the committee had was that the report was
looking at it from \-- that the committee was looking at it from a
practical study. It was \-- you \-- we felt you got much better results
in a real-world situation as far as what was going to happen in the
plants on a day-to-day basis versus what you would have if you had all
the factors controlled like you would in a regular laboratory setting.

MS. FOREMAN: And that \-- that accounts for \"quite meaningful\" and
\"tremendous merit.\" And I do understand that application, \"real-world
comparison. However, do I understand that you had nothing to do with
writing the report, you just did \--

DR. CURTIS: We \-- all the committee members submitted in their
individual reports, and Dr. Hargis put them all together.

MS. FOREMAN: Well, I\'d like to ask him questions but he\'s out of the
country and the committee is unable to address questions to him. Thank
you.

MS. AXTELL: Next question from the advisory committee? Ms. Eskin?

MS. ESKIN: Can you hear me?

DR. CURTIS: Yes.

MS. ESKIN: I was hoping you could address what was identified as, quote,
\"the primary statistical flaw in the data.\" Could you elaborate on
that?

DR. CURTIS: That was Dr. William\'s comment. The \-- the flaw that I\'m
aware of had to do with the condensed six-week collection of the
salmonella tests and the fact that there was two years between the
baseline and the data collection for the HIMP studies.

MS. ESKIN: I believe there was also some discussion of a lack of a
control group. Was that also identified as a flaw?

DR. CURTIS: No. Not that I\'m aware of. Dr. Williams may have identified
it, but I don\'t recall that in our discussion.

MS. AXTELL: Thank you. Next question? Dr. Lafontaine?

DR. LAFONTAINE: Yes. This is Dr. Lafontaine from South Carolina. In your
review of the GAO comments about training, if I understood your
conclusions properly, in essence, you agreed with the GAO recommendation
that there be \-- for the plants that there be a baseline training so
that they can adequately execute their mission. Is that a fair
assumption or fair interpretation of what your group says?

DR. CURTIS: That\'s correct. We \-- we support the training of the plant
personnel. We think that could only improve the \-- the effectiveness of
the HIMP program.

DR. LAFONTAINE: I want to add an editorial \-- not an editorial but an
additional comment that I\'ve made before. And that is, these plants
volunteered, and so one would assume that they\'re proactive in what
they do to include training. And I think it\'s critically important that
if this is expanded to \-- into any mode eventually that that be a
clear-cut element so that all plants involved have a clear understanding
that they have to have an adequately trained group of folks performing
these essential tasks.

So thank you for your comment.

DR. CURTIS: That \-- that is \-- that is what the committee supports, is
\-- is full training. They thought that based on the training they had
\-- the plants had put forth into the HACCP was much more than what was
originally anticipated. They would anticipate that there would be
significantly more training in the HACCP \-- I mean, in the HIMP
training as well.

MS. AXTELL: Thank you. Next question? Dr. Johnson?

(Pause)

MS. AXTELL: The delays you\'re hearing, Dr. Curtis, are people moving
closer to this conference table so that you can clearly hear their
questions.

DR. CURTIS: I appreciate that because some of them it\'s very difficult
to hear.

DR. JOHNSON: Hey, Dr. Curtis. Alice Johnson with the National Turkey
Federation. And I think we do want to \-- thank you for setting up your
schedule and doing this for us. I know it\'s a little hard to hear
sometimes and hear the discussion.

I also think that we need to say \"thank you\" to Dr. Hargis for going
to the effort to do it. It is regrettable he\'s not here, but he did put
together a good video presentation for us.

I just was wondering about some of the comments in the report. We talked
about \-- during the last advisory committee discussion, we had a lot of
discussion over the 11 that were originally \-- the 11 that \-- the 11
that were originally baseline and then the information taken after HIMP
implementation on the 16 plants, that there were \-- the difference
between the baseline that started \-- the plants that started in the
initial baseline and those that remained after HIMP implementation.

Can you make any comments on that?

DR. CURTIS: When we talked to the statistician about that, that was one
\-- one of the questions that we asked. And the conclusion was that,
ideally, you know, it would have been great if you would have had all of
the plants at the beginning and at the end. But in most biological
studies you rarely have in a statistic set all of the things you started
out with. So that was not as big an issue on this.

And we looked at everything. We looked at the 11 plants and we looked at
the 16 plants. And it was the conclusion of the committee that that was
not a problem with the study and the conclusions from that. The only
issues that really come to question when you looked at the 11 and the 16
plants dealt with the salmonella data. And then there were \-- there
were \-- we had other comments to follow up with the salmonella data.

DR. JOHNSON: One more here. Somewhere in here, and I apologize because
it was \-- it was kind of \-- you talked about one of the alternatives
would have been \-- at the project design would be to look at split
lines.

DR. CURTIS: Ideally, that would have been a way to do that. But you\'re
still going to have some changes if you\'re operating in a real-world
HACCP system, as we all know, that if we recognize \-- for a HACCP
system to work when you recognize there\'s an issue, you correct that
\-- that problem.

So we think that there would still have been changes in a real-world
situation with HACCP lines operating. You might have \-- you would
reduce some of the factors by having the split line operation, but you
don\'t have enough of a split line operation possibility, we thought, to
really get the job done as far as the research for \-- for the HIMP
study. We thought that using the different types of plants that were
used added some validity to the study.

DR. JOHNSON: Thank you. I definitely agree. It would be hard to say that
a split line would \-- would reflect the traditional \--

DR. CURTIS: The other plants, yes.

DR. JOHNSON: Yeah, with the changes that we\'ve already made with HACCP
and the changes that just are inherent in the whole process.

DR. CURTIS: The committee thought that the additional plants that were
added just added some additional support from the standpoint of how this
would work in other types of plants and other types of situations.

DR. JOHNSON: Thank you.

And while I have the microphone, I did \-- I think Dr. Aman and Dr.
Calloway, we \-- the committee would also like to thank you guys for
trudging up to D.C. and sitting through this. So thank you very much for
your remarks.

MS. AXTELL: Thank you, Dr. Johnson. Next question?

(No response)

MS. AXTELL: \-- we have any further questions. And we think we are ready
to move on to the next phase of the discussion.

So, Dr. Curtis, if you would like to say anymore to this that would be
able to kind of \-- issue at the moment?

DR. CURTIS: I don\'t think I would be able to hear most of it based on
what I\'ve heard, so at this point I think I\'ll just hang up and \--
and look for the minutes of the meeting.

MS. AXTELL: Thank you very much, Dr. Curtis. Again, we really appreciate
the fact that you made time available within your schedule today and we
do appreciate that Dr. Hargis took the time to put together the video
presentation for the \--

DR. CURTIS: Okay. And I know that Dr. Hargis spent many hours putting
that together trying to get \-- pre-guess what your questions might be
and include them in the presentation. Thank you.

MS. AXTELL: Thank you again, Dr. Curtis.

DR. CURTIS: Bye-bye.

MS. AXTELL: Bye-bye.

Next Steps for HIMP

MS. AXTELL: In terms of the next steps for the HIMP project, I know
there had been a great deal of concern expressed by the advisory
committee at its last meeting in June with respect to the 11 plants that
had been in the project from the beginning and the 16 plants whose data
was presented at the last advisory committee meeting.

I wanted to advise the committee that the additional materials that were
provided today are the summary data for the 11 plants that have been in
the project from the beginning done in two formats. One of the packages
says, \"Aggregate Establishment Data.\" That represents the data
summarized in the same fashion as the data provided at the last advisory
committee meeting for the 16 plants.

The other request that had been made by the advisory committee at its
last meeting is that the data for the 11 plants that were in from the
beginning be profiled plant \-- on the positions on the chart, Plant A
to Plant A, Plant B to Plant B, rather than in the format at which it
was presented at the last meeting, which is best scores to worst scores
for all plants within a group.

So I wanted to let you know that the other handout that has the
individual establishment data in fact compares the data, Plant A before,
Plant A after. And the positions shown on the chart run continuously for
each of those plants.

For clarity purposes, there is also a handout that identifies each of
the plants that are in the group of 11, in the group of 16, in the group
of 21, so that there would be no question about which plants are
referenced in which categories. Even in the group of 11, there is no
identification to plant name or number. Again, RTI had shared all its
raw data for the 11 plants with the National Alliance for Food Safety
for purposes of their conducting their work.

We asked that RTI prepare the summaries, as you see them, in the same
fashion in which they were prepared for the last meeting so that you
would have a complete and comparable display of data from all data sets.
Again, they prepared it. I cannot tell you who Plant A is. And that was
in \-- done intentionally. The data remains blinded to the Agency.

From the Agency\'s perspective, we believe that the review from the
National Alliance for Food Safety, the conclusions of the review,
indicate that adoption of the HIMP models system has shown clearly
improved important scores related to the most important organoleptic
parameters described as FS-1, septemia \-- septicemia and toxemia, and
FS-2, fecal contamination, and also notes markedly reduced contamination
of carcasses with generic E. coli, which is a generally acceptable
parameter \-- or generally accepted parameter related to plant hygiene
and process control.

Further, there were improvements noted in OCP parameters 1, 2, and 3,
and with respect to animal diseases, miscellaneous conditions, and
ingesta contamination.

There were increases with respect to OCP-4 and -5 noted after the
introduction of the HIMP models process in the volunteer plants. And
again, we do have the data with respect to salmonella, that the
salmonella numbers were increased, particularly in the data set for the
11 plants, also in the data set for the 16 plants, although less
noticeably.

Again, the National Alliance for Food Safety noted the issue with
respect to the compressed time frame on the data collection and the
issue of seasonal variation and the issue of the antemortem salmonella
infection rate of flocks being brought in to slaughter, which may be
contributing factors. They did not find a basis to say that the HIMP
inspection process either contributed to reductions or increases with
respect to the salmonella.

I think it\'s important to note \-- the Agency noted in its review \--
and I\'ll be brief because we\'ve only had the report a few days \--
that all of the plants that are operating under the HIMP project have
been meeting food safety and OCP performance standards that were set for
this project that are \-- that are tighter than the standards that are
presently in place for non-HIMP plants.

And even for the OCPs that showed some increase in defect scores from
the baseline to the models phase of the project, still operated within
regulatory requirements for non-HIMP plants. That does not mean we are
satisfied with the direction of the numbers, and we need to know more
about that direction. This is particularly true for the fact of the
increased recovery rates of salmonella on carcasses for all of the data
sets.

(Pause)

MS. AXTELL: What are the things that the Agency is doing in part and
considering doing in part to address the issues that have been
identified and where there are still some questions about the data. Dr.
Santiago, at the beginning of this presentation, mentioned that the
Agency is looking at revising the current instructions for young chicken
plants which are known as Draft 6 and moving to Draft 7.

In part, one of the issues that we will be looking at in that Draft 7 is
the use of statistical process control, which is also a recommendation
that the GAO had provided to the Agency nearly a year ago now, with
respect to having parameters for the Other Consumer Protection
performance standards, the OCPs, in order that we can clearly identify
regulatory actions that can and should be taken when there is \-- are
repetitive non-conformances in those OCPs.

We think that that is an appropriate response for the Agency to make
with respect to making further modifications in the instructions and
guidelines for the project such that we can determine if there are
appropriate means by which we can establish regulatory control over
those activities where the data is moving in a direction still within
existing regulatory requirements but in a direction we would prefer it
not have gone in.

I would also like to say that with respect to salmonella we are looking
at some options. The National Alliance for Food Safety, both in their
written report and in the video presentation, made note of the fact that
the Agency needs to look at controls, perhaps looking at the data from
the 21 plants that have been involved in the HIMP project, looking at a
certain number of other control plants, and examining salmonella data
over time with respect to providing a greater degree of assurance that
the HIMP project itself is not contributing to the increased recovery of
salmonella. That would permit a focus on the issue of seasonal variation
so that we can look at that issue more closely.

Again, the Agency remains committed \-- I should say for the record that
the Agency did not request that the National Alliance for Food Safety
provide a critique of the GAO report. But the GAO report is a public
document and was one of the documents provided to the Alliance for
purposes of its work.

Most \-- of most concern to the committee has been the issue of the \--
of the \-- or to the Agency in this regard had been the question of
study design. Was the study design, conducted as it was in a real-world
setting, a appropriate means by which to make a comparison between the
traditional inspection system and the HIMP inspection system. We believe
that it was, and we were pleased that the Alliance found that as well.

The Agency remains committed to following through on the recommendations
presented by GAO which specifically are that we have appropriate
criteria for plants entering the project; that we focus on the use of
statistical process controls for quality defects; that we look at
mandatory \-- mandating some aspect of formalized training for plant
personnel; that we look at ways to increase communication with
participants in the project with our own workforce and with stakeholders
involved and interested in the project; and that we do in fact have a
basis for the use of this study design as a means of being able to move
forward with the project.

Again, in summary, we are \-- the data are what they are. We recognize
that there are some very favorable data that have come forward from this
project. We have approached this project from the standpoint of saying
it is a comparison between systems, which means that we are looking at
the overall \-- assuring that we do not diminish the accomplishments
overall of the traditional system. And that means that we want to be
able to have a system that has data or data from the system that
demonstrates improvements at least equal to but preferably improvements
in food safety and public health concerns.

There are improvements that are here. We do not wish to turn our back on
those improvements because we believe that they are in the best
interests of food safety and public health for the consumers of poultry
products in this country.

We know that we need to do more with respect to engaging our supervisors
and managers in the project. We need to \-- need to do more with respect
to statistical process control where appropriate, to ensuring that we
have effective tools for accountability for plants participating in the
project and for ourselves.

It has been about assuring that both inspection personnel and plant
personnel understand our expectations for the conduct of the pilot, and
those are principally the reasons we are looking at revisions of the
existing Draft 6 and moving to Draft 7.

At this point, I\'d like to open this up for questions from the
committee. And I believe Dr. Johnson had the first question.

Questions and Answers on HIMP Presentation - Panel

DR. JOHNSON: Alice Johnson, National Turkey Federation. I know that
there are \-- are several industry folks here that are involved in HIMP.
And I think that everybody will admit there\'s no perfect system. But I
just wonder when we \-- when we have our question-and-answer panel if it
would be appropriate to pull some of the folks that are \-- that are in
HIMP facilities into part of the discussion as well?

MS. AXTELL: Is that acceptable? Yes. Yes. I think we are at the
question-and-answer.

DR. JOHNSON: Oh, oh.

MS. FOREMAN: Are these public people who are sitting out in the audience
like those who only got three minutes to speak yesterday?

DR. McKEE: I think what we can do is to hear from the panel with
questions from the \-- from the advisory council. And we\'re running a
little ahead of schedule, so we could have some questions from the
audience that might want to address some of those issues for a short
period of time as well.

MS. FOREMAN: Could that be open to all the members of the audience?

DR. McKEE: Well, we can just address the \-- the members of the
audience, regardless of \--

MS. FOREMAN: Thank you.

DR. McKEE: \-- of where they\'re from.

MS. FOREMAN: Good, good.

DR. McKEE: But this \-- I will limit the time on this.

MS. AXTELL: Mr. Govro?

MR. GOVRO: Mike Govro, Oregon Department of Agriculture. My experience
with HACCP is in a regulatory environment where there is no continuous
inspection. Might refer to that as a self-directed HACCP environment.
And I think it\'s fair to say that HACCP has been more successfully
implemented in firms where there is a high level of commitment to
excellence on the part of management and there is good management.

And I\'m wondering about the farms that were involved in the study and
if there was any screening of those firms or any method by which USDA
evaluated the \-- the level of competence of the firms that participated
in the study? And I \-- and I ask this because if we\'re looking at HIMP
as a possible model for use in the entire industry, I think there may be
varying degrees of success based on the companies that \-- that
participate.

MS. AXTELL: Thank you, Mr. Govro. I\'d like to direct this specific
question to Dr. Ken Peterson and with respect to the criteria for plants
entering the project. And then I would also like to ask Dr. Calloway to
comment with respect to situations where there have been \-- there has
been a need to take enforcement action in a HIMP plant.

DR. PETERSON: What we did for \-- when we requested volunteers \-- this
really goes back to \'97 and \'98. And it was open to any plant that was
interested in participating. They came forward with their name.

And then what we did was look at the \-- several things related to that
plant. We looked at their \-- at the time, their salmonella compliance
history under our Pathogen Reduction initiative. Were they in
compliance. And if not, then we didn\'t consider them eligible at that
time.

We looked at their recent enforcement history. Had there been any
suspension or other enforcement type actions taken related to their
HACCP plant or their SSOP plant. And again, if \-- if \-- if that was
the case, we didn\'t consider them to participate.

When we looked at them, the ones who volunteered knew that criteria. So
I don\'t think we had any volunteers that were \-- that were under those
particular levels of scrutiny.

So, bottom line, we looked at those things. We made sure they were
within compliance. They were. And then they stepped forward and \-- and
we took them in.

MS. AXTELL: Dr. Calloway?

DR. CALLOWAY: Again, I can speak only for my circuit, but all the
applicable rules of HACCP are applied to the plants within the circuit
equitably. Because it is a HIMP plant, it\'s not \-- it\'s not given any
special privilege.

And so there was a time in this facility that we felt that they were
exceeding the FS-2 fecal contamination levels and certainly were
exceeding them above what the \-- the norm within the circuit was. This
resulted in me issuing a 30-day letter to this facility. And had they
not taken appropriate steps to bring the facility back into compliance,
to an acceptable level, we would have progressed on with regulatory
action as applicable under the rules of practice. They did respond
favorably and, as a result of that, did go to installing an
antimicrobial rinse on the lines and to bringing in an expert \--
outside expert to do an in-depth audit on their plan, their HACCP plan,
the implementation of the plan, and to train their supervisors.

So merely being a HIMP plant didn\'t give them any special privilege,
and \-- and they are treated the same even though they do respond to a
higher level of regulatory standard in that plant.

MS. AXTELL: Thank you. Dr. Jan?

DR. JAN: Lee Jan, Texas Department of Health. My question is more on a
technical nature. And it goes back, and maybe I should have known this
several years ago but I need to ask it again anyway.

Regarding the RTI\'s results and looking at the end of the line, I\'m
\-- I\'m satisfied that the results at the end of the line are better
and \-- and the review gives me confidence in \-- in the overall
results. But I \-- I\'m a little concerned and maybe need some
clarification from a technical standpoint on the process for Food
Safety 1. When you move the inspectors to the end of the line \-- and I
don\'t have poultry slaughter establishments in my area so I\'m not \--
there may be a technique that I\'m not aware of.

But it seems to me that when you move the inspector to the end of the
line and you take away the opportunity for the inspector see those
organs that may indicate septicemia or toxemia and then they may not be
able to pick up on it at the end of the line, looking at only a carcass.

Now, I know in red meat and in the livestock portion, the internal
organs are important to identify that disease condition. Is that the
same in poultry? Or how \-- how is that \-- is one assured that it\'s
not being missed in this process?

MS. AXTELL: Dr. James?

DR. JAMES: That question was one that was discussed extensively at the
beginning of the project amongst subject matter experts within the
Agency and outside the Agency.

We had quite a concern that \-- that carcasses when they\'re looked at
at the end of the line and don\'t have the viscera associated with them,
that we had quite a strong level of assurance that our experts, our
inspectors, would be able to determine whether those birds indeed were
septicemic and \-- or toxemic.

And the subject matter experts that were consulted were virtually
unanimous in that in young chickens, a septicemic, toxemic bird could be
identified at the end of the line without the associated viscera. So
that is \-- that is a question that received great attention before the
project was begun at these plants.

MS. AXTELL: Thank you. Ms. Donley?

MS. DONLEY: Thank you. Nancy Donley from STOP. I actually have two
questions, and they\'re two totally unrelated questions.

One is, I believe, Jeanne, I heard you say that \-- that 70 \-- that
because of HIMP that it allowed 70 inspectors to be redeployed to do
other food safety inspection functions within a HIMP plant or to fill
vacancies in a \-- in other slaughter plants. Do you not have the
breakdown of numbers there of what went to what?

MS. AXTELL: No, I do not. I\'m just relating to data from the initial
group of 15 \-- 15 plants that participated in the project.

Again, whether the inspector was \-- was doing other work within the
plant, certainly the work within the plant was redefined by the HIMP
project so that the focus of \-- inspectors\' time within the HIMP plant
is more \-- there is more attention devoted to food safety issues.

Additionally, by being able to redeploy inspection personnel from the
plants, we were able to fill critical slaughter vacancies that were
occurring within the local commuting areas of a number of the HIMP
plants. The poultry industry over the early years of this project has
continued to grow at a fairly steady rate each year.

MS. DONLEY: Okay. I think that\'s \-- it\'s a critically important issue
because at the onset of this project the only reason that, you know, my
organization was \-- were all receptive to the idea of HIMP was with the
understanding that it would \-- it would free up inspectors to do
additional food safety activities within the plant and not to fill
vacancies as they occurred nor would it in any way serve as the tool to
decrease the size of the inspection force.

I \-- this is \-- it\'s an editorial comment with this project, and \--
this is kind of my last hurrah on this since this is my last term. But
our members of Congress see this \-- see this project as an opportunity
to cut back on inspection staff, to cut the numbers, and this will
defeat the purpose of the HIMP project, which was to improve food safety
by increasing food safety inspection functions.

I am very concerned that that\'s the direction that this project is
headed.

Also, having served on this committee from the inception of HIMP, I find
it very difficulty today even to determine what successes that \--
let\'s just say for the moment that \-- that the numbers at the \-- that
have come out of these studies show a clear improvement for food safety.

I have a hard time justifying and rectifying what we heard from Dr. Aman
today and Dr. Calloway that these plants \-- and my own personal visits
to HIMP plants where I have seen incredible plant innovations,
technological innovations. Dr. Calloway, you mentioned that the plant
did \-- did a renovation. And Dr. Aman, you said too that they did \--
that the plant did additional improvements within it.

How do we justify these improvements to a change in the way and the
positions the inspectors are on the line? I don\'t see how you can
clearly separate the success of this project from the way inspection is
being done to the way that the plant is being allowed to perhaps do some
improvements of their own.

And I have said \-- and I have talked to other plant \-- plant \-- plant
managers and \-- and companies that may not even participate in HIMP
right now that just want the opportunity to do some of these innovations
and technologies that we\'ve heard about today. And under the
traditional system, would we still see these improvements?

I\'m also concerned if we open the door to let anyone and everyone who
is into HIMP who wants to be and who don\'t implement these
technologies. And a good majority of these plants, to my understanding,
have implemented some really state-of-the-art innovations. But what
it\'s going to do is just change the inspection and it\'s going to water
down these successes until, frankly, we are going to be in a worse state
than we are under a complete traditional inspection system.

I hope not. I would love to see \-- I \-- I \-- I support innovation. My
organizations support innovations, both technologically, both from FSIS
to \-- to constantly reassess what it is you\'re doing and how can you
do it better. But I cannot, over these \-- these years that I\'ve been
here and over what I\'ve seen today, be able to say \-- and I \-- I
challenge FSIS to say, we can arbitrate all these changes because we\'ve
moved inspectors from this point to that point and that all of these new
technologies that these companies have implemented have nothing to do
with it.

MS. AXTELL: Just one comment before we move on. We have maintained the
level \-- the employment level of inspection resources throughout the
duration of this project. So that \-- there has not been a decrease in
the number of inspection personnel, and that in fact for the inspection
activities in the HIMP plants, many of the food safety tasks are
actually done at an increased frequency level in these plants than we
are able to perform them in a non-HIMP plant. And that is, we believe,
an appropriate redirection of their resources.

Ms. Foreman?

MS. FOREMAN: I\'m Carol Tucker Foreman with Consumer Federation. I have
three issues I\'d like to raise.

The first one, I\'m sorry that Dr. Murano and Dr. Pierson had to leave
because the first one is really not to this issue specifically but more
generally.

We didn\'t get \-- as I complained earlier, this is a very important and
very complicated issue. And we got no advance paper. We got to peel the
plastic off of it. I can think of a lot of reasons why that should
happen. There\'s always a reason why papers don\'t get delivered on
time. But I don\'t know how you can expect the committee to deal with an
issue this important and this substantive when you give us the papers
within the five minutes before presentation begins, do not have the
author of the paper present to give \-- to talk and defend the paper,
and is clearly the primary author.

I found that that\'s entirely consistent with a change in attitude
toward the committee. That\'s why I\'m sorry that your two principals
are not here. You\'ve moved it over to Public Relations. The papers have
become increasingly last-minute sort of thing. And only when pressed do
we get the papers that will make a subject be covered adequately.

I \-- it seems that the Department does not value the work of the
committee as it has in the past.

The second point that I\'d like to make is \-- is also more general. We
hear a lot about FSIS wants to be science-based. We\'re going to have a
science-based system. And as you know, I think that\'s terrific.

This morning I\'ve been hearing a new word \-- a new term called
\"real-world.\" I don\'t find that those two mesh very well. I may see
the world in a very different light than you see the world.
\"Real-world\" is subjective. It\'s not science-based.

I frequently see that victims of foodborne illness are dismissed because
they \-- their comments are anecdotal. But you bring us two inspectors
who give us anecdotal information.

So you\'re either science-based or you\'re real-world-based, and in my
view, real-world is usually subjective. I see it differently than you
do.

Third, since this is my last time I want to offer you some friendly
advice. Nancy and I and some other consumer people have been supportive
of HIMP \-- of HACCP and of HIMP at no small expense to ourselves. In my
organization, we vote on our policy positions, and I have had to defend
HACCP and HIMP in our annual meetings. And it hasn\'t always been an
easy thing to do.

I would like to have a risk-based system so I would really like to be
able to reallocate these resources based on risk. But I can\'t do it,
and my organization won\'t do it. And I think I speak for a lot of other
consumer organizations. When you try to make such a basic change based
on material that isn\'t just without question good data. You can\'t back
into this with data that are challengeable. You can\'t \-- back into it
with a kind of apologetic, \"well, you know, maybe we wouldn\'t have
done it exactly this way ourselves\" sort of review that you\'ve got
from these people. It won\'t fly.

Now, you may think that because of the current political situation you
can push this through the Congress. But I\'m going to tell you that the
Agency\'s credibility with the public is pretty damn low after the last
three months. I think you\'re spitting in your own soup if you try to
push this forward without going back. It would take so much less time
and it would cost so much less money to go back and get it done the
right way before you move forward because the way things are right now,
the next time the inspectors union goes to court and sues on this issue,
Consumer Federation of America will be with them. And I would hate for
that to be the case.

I think those are probably my final words to you.

MS. AXTELL: Thank you, Ms. Foreman. Mr. Link?

MR. LINK: Sorry. I dropped my card. I forgot.

Maybe this isn\'t the right time to ask this question, but I\'m thinking
about moving forward. Can you talk about where you are? You\'ve got 21
chicken plants in the program right now. Are there more waiting in the
wings? What\'s happening in turkey and pork and beef? Are you familiar
with the status on that?

MS. AXTELL: Very briefly, we \-- we do have a couple of plants that are
swine plants that are participating in the project. And in fact, earlier
this week we met with representatives \-- several of us met with
representatives from those plants and from additional plants that are
interested in coming into the project. We are proceeding on \-- on that
side as well.

There also are two \-- two turkey plants \-- correct me if I\'m wrong on
the numbers here \-- that are also participating in addition to the 20
young chicken plants that are in. There were 21 over the total course of
the project, but one has dropped out. So there are only 20 in the
project.

We are hopeful at some point of being able to have five swine plants
engaged in the swine portion of this project and five turkey plants. We
believe that we need, given the size of those two industries, we will
need data from five plants \-- five market hog plants and five young
turkey plants in order to proceed with making determinations on those
two species.

Ms. Kaster?

MS. KASTER: Two questions. My first question is for Dr. Aman and Dr.
Calloway. What was the mindset of your inspectors, excuse me, before you
started into HIMP? Were they apprehensive, as we\'ve heard that many
inspectors are, and then they\'ve become more positive about it, as you
guys described? Or were they always pretty open to it?

DR. AMAN: Any time there\'s a change, you know there was some
apprehension. They knew the duties were going to change. But I think
they were enthusiastic about what they could see. I actually spoke to or
saw several people that came to the plant, initially told them what
their new roles would be, and they became very excited about it. And of
course, that just was a competitive type situation. Had to vie for
promotion to get these positions. So it\'s gone over very well.

MS. KASTER: My second question is, the group from GAO that reviewed the
\-- that \-- in the report that was referenced, what do you know about
the \-- the technical background or makeup or familiarity? You talked a
little bit in the \-- in the response. I\'m wondering about the
familiarity with the group from GAO. Do we know, are they statisticians?
Do they have some familiarity with how this was set up? Just \-- maybe
I\'m the only person in this room that doesn\'t understand how that
goes, but if somebody could just walk us through that a minute, that
would help.

MS. AXTELL: I actually \-- I do not know the academic background of the
individuals who participated in that particular project. I know
yesterday two representatives from GAO were present in the room. I do
not see them here today. So I really cannot comment on the \-- the
background of the individuals who conducted the study.

Dr. Lafontaine?

DR. LAFONTAINE: Yes. Just a brief comment. And I\'m tacking onto Nancy
Donley\'s comment.

In any species in any strata, there is a whole range of performers when
it comes to plants. And I speak from personal experience in my \-- my
state. Those who \-- remember when \-- is to do it right the first time.
Food safety unquestioned.

The other is that usually it\'s less than five percent, maybe \--
whatever your situation is, that you, unfortunately, have to use command
control. It just doesn\'t go away. I don\'t care what system you have.

So my advice to the Agency is, and back to Dr. Petersen\'s comment, the
change based on the GAO report, Dr. Murano publicly stated that it was
no longer a mandatory across-the-board but rather voluntary on the basis
of the plants, to carry that one step further. Use oral type criteria in
making decisions on who \-- who can eventually enter this program if it
continues to progress because I \-- I strongly feel that there is a
subset that are going to need strong government presence and enforcement
action in any species that you\'re involved with.

So put that \-- my suggestion is, mark that down, as we say, as a
must-do as you progress.

MS. AXTELL: Thank you, Dr. Lafontaine. Dr. Johnson?

DR. JOHNSON: I just want to throw something out to the committee. I
think that the comment that it would be good to have had an opportunity
to read the report and absorb it and \-- and be able to talk to Dr.
Hargis is valid, although I do recognize the Agency \-- the whole review
process was a part of the recommendations that were made from this
committee in June, that we slow down and look at the data one more time.
And so I \-- without being too critical of that.

I wonder if the committee would want to try to find when Dr. Hargis may
be coming back into the country. And maybe we could have time to read
the report and have a conference call or something and be able to \-- to
have time to absorb the report a little bit and talk to Dr. Hargis
directly, if that was something that we would want to recommend as a
part of this project.

DR. McKEE: I certainly think that is a doable if the committee would
choose to request that. Okay. I see a lot of nods, so we\'ll \-- we\'ll
plan on that. We can have a conference call and have time to absorb the
material.

MS. AXTELL: Dr. Leech?

DR. LEECH: Irene Leech. My question is about the companies that dropped
out of the project. You know, often in the research that I do, we try to
show that the folks who are particularly in an experimental design where
people are volunteered, to show that the folks who aren\'t in it are not
different from those that are and that kind of a thing.

Why did folks drop out of the project? And were those companies
different from the ones that stayed in?

MS. AXTELL: Dr. Petersen?

DR. PETERSON: Well, briefly, I can tell you what I know about the one
plant in particular that dropped out, which isn\'t much.

They volunteer for reasons of their own. And we don\'t \-- we don\'t
investigate what those reasons are. And so if they drop out, they are
for, presumably, business reasons of their own.

I can say the plant that dropped out was not in any particular jeopardy
in what they were doing within the project. So for whatever reason, it
was not related to that.

DR. McKEE: We \-- we have \-- we were ahead a while ago but are kind of
behind on schedule at this point. What I\'d like to do, I think, is
we\'ll expand the time at the end for public comment and include any
comments that those in the audience might have to make on this subject
as well. There will be a sign-up sheet out front. I think that\'s the
fairest way to do that.

And at this point, we will break for lunch. We\'re scheduled to come
back at \-- at 1:30. That\'ll give us about 50 minutes. So if we can,
let\'s try to maintain our schedule and be back here at 1:30.

(Whereupon, at 12:40 p.m., the proceedings were adjourned for lunch, to
reconvene at 1:30 p.m., the same day.)

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

1:41 p.m.

DR. McKEE: Okay. Are we ready to get started, folks?

(Pause)

DR. McKEE: Yeah. Dr. Lafontaine, if you could point out to the full
committee what changes you have made in the document from Subcommittee 1
so that we could get a final consensus from the full committee?

DR. LAFONTAINE: You bet.

DR. McKEE: And then we can move on to the next issue. Thank you.

(Slide)

DR. LAFONTAINE: We are showing Question 2 because there was no
adjustments to Question 1 except one small typo. So let\'s concentrate
on Question Number 2.

If you start with the \-- the bullets, the first bullet, you know,
\"Training must result in learning.\" There is a new entry, \"Training
should also include an empowerment message for field personnel. The goal
is to assure employees at all levels recognize they are key players in
protecting the public health of consumers.\"

So that was \-- I guess Ms. Donley\'s not here, but that was her \-- her
recommendation on making sure that all levels understand they are
empowered to protect public health.

Let me get my thoughts together here.

In the \-- the next one was unchanged.

Then we get into the additions to joint training. The first sentence
stays the same. And then I\'ve added two sentences. \"Example topics.\"
We\'re talking about job training now. \"Example topics would be
technical issues such as food safety interventions and foodborne
pathogens. Joint training is not appropriate for FSIS enforcement
training.\" So that was the \-- how I modified that.

Going to the \-- the next item, a new entry that was a suggestion. And
that is, \"also encourage continued sharing of FSIS training materials
with industry.\" So regardless of what is being put out, even though in
some cases it\'s not appropriate for joint training, to share that with
industry so they can be aware of what is being taught to the FSIS
employees.

And then, the final change \-- let me make sure I got my thoughts
together. Yeah.

The final change is where we talk about considering alternative
technologies. In addition to the use of land-grant college, we also put
in \"and public health agency training infrastructures should be
investigated.\"

And then also, another sentence. \"Also input from consumer groups
should be considered as you look at the training that you\'re going to
extract from the land-grant colleges and the public health agencies.\"

So those are the \-- the changes. Are there any comments? Yeah, Lee?

DR. JAN: Dan, I have no comment regarding Question Number 2. But when we
talked about Question Number 1 earlier, we brought up a \-- what we felt
was a need to increase the education level of the inspectors
entry-level. And I think it would be appropriate to include in this
document.

DR. LAFONTAINE: Yeah, I \-- Lee, you\'re right, and I apologize. In
fact, my admin assistant reminded me but it still didn\'t get in there.
So we will add a sentence to that effect in Question 1. A recommendation
that we \-- that FSIS work towards increasing the qualifications \--
educational qualifications of their entry-level personnel.

Mr. Chairman, I think that\'s \-- are you going to put it in there?
Okay.

(Pause)

DR. LAFONTAINE: Is that succinct enough? Okay. Good.

Are there any other comments or questions?

(No response)

DR. LAFONTAINE: Okay. I see no comments, suggestions. So let\'s consider
it the full committee\'s consensus.

Mr. Chairman, do you have any \-- Mr. Chairman, do you have any closing
comments on this topic?

(Pause)

DR. LAFONTAINE: Dr. McKee, do you have any closing comments before we
move on?

DR. McKEE: We\'ll make this a final, if that\'s okay with the \--
committee.

DR. LAFONTAINE: Okay. Thank you.

DR. McKEE: Okay. Thanks.

DR. LAFONTAINE: Thank you for the opportunity.

(Pause)

DR. McKEE: Okay. I think we\'re ready to discuss Standing Subcommittee
Number 2, Escherichia coli 0157:H7 Developments. The lead on that
committee is Mr. \-- Mamminga. Excuse me. I\'ll get it right by the time
you leave.

MR. MAMMINGA: Okay. Well, Doctor, you are not alone in not being able to
pronounce my last name. So no offense taken at all.

Briefing - Standing Subcommittee Number 2

Escherichia coli 0157:H7 Developments

MR. MAMMINGA: First, I \-- I would be remiss if I did not thank the FSIS
support staff that assisted us in our committee. I\'m telling you, these
people are essential and they just do a really a good job. And they stay
until it\'s over with. And there\'s \-- I\'m leaving this committee. I
want to make sure that those thanks are handed out.

Dr. \-- leaving as far as the issue, but for those who do flip charts
and write on computers and stuff, without them we would still be in that
room. So my thanks to you on their behalf.

When we first received our agenda and seen that we were going to be
discussing E. coli 015:H7 developments, that\'s kind of a long and broad
subject. And when we looked at the issue paper, however, we found that
FSIS was asking us for a couple of very specific things and that the
in-depth verification review of hazard \-- control point systems at
slaughter and fabrication plants that supply grinding operations with
raw beef materials that have been found to contain E. coli 0157:H7. We
were informed that FSIS has not established a structured process for
systematically assessing the HACCP system that these operations that
supply raw beef material. And of course, we all know that the industry
is being asked to reassess their HACCP system.

So with that in mind, the Agency asked us first, should FSIS target IDV
review resources at slaughter and fabrication establishments. And then
the next question was, if yes, explain; if it\'s no, explain.

So the first thing we did was address that first question. And we felt
that, yes \-- and this starts at the top of our report here \-- that
FSIS should target IDV review resources at slaughter and fabrication
establishments.

We suggested that \-- we know that IDV reviews can be done for cause.
But looking at this issue, we thought that it would also \-- IDV should
become two programs to address this question. Automatically, when there
is a positive sample for E. coli 157:H7 or human illness occurs, both of
which we acknowledge are reactive. However, a random system addressing
these questions might be more preventative or proactive. So we said \--
and a random system which we thought would be preventative.

It was kind of necessary for us to go through all of our thoughts and
processes about E. coli and then keep coming back to this issue. And
even though we weren\'t asked about the next two things, we decided in
good conscience we were going to say them anyway.

And that is, a trace-back system is important to help identify suppliers
of grinders. Moshi\'s already taken that typo out of the report. This is
difficult logistically because grinder use \-- grinders use multiple
suppliers to create grinding materials, as in coarse drying bull meat
\-- trimming.

We went on to say on farm interventions at the producer level should be
done as well as interventions at every step along the farm-to-table
continuum. FSIS and APHIS need a regulatory structure that can address
pathogens that may not affect animal health, in the case of E. coli
157:H7, but do have a human health impact.

And then the committee members went through trying to give you some
specific circumstances that might trigger an IDV review. And you can
take them individually or collectively or \-- or however because all of
these things will play a part. And here we have to compliment committee
members for really thinking and talking it out and putting their heads
together.

But among these things, proactive IDV review triggers, assess more
during the high-risk summer months. We\'re already finding a lot of data
out there that there are certain months of the year where there\'s a
much higher incidence than others. Obviously, look at HACCP plan
deficiencies and NRs. Prioritize testing at larger volume plants or
those that supply multiple grinders. Cross reference the suppliers and
positive E. coli testing in a database. Multiple exposures to the
database would trigger an IDV.

To have a district manager or consumer safety officer process to help
determine IDV appropriateness. The consumer safety officer could review
records and \-- and trigger an IDV review team, another option.

Random plants selected for IDV based on information by \-- gathered by
FSIS. In other words, all the information that you gather. Again, to
focus on the public health risks. We had a very specific proposal about
a standardized testing program and using statistical processes to
monitor the prevalence of E. coli 0157:H7 or other indicator organisms.
Tests on trim or ground products. Develop a program based on plant size
or production volume or based on lot size to determine if a positive
test result is \-- is a natural variation or out of control.

Sample size selection should be based on organism prevalence,
sensitivity testing, and targeted \-- levels. Obviously, that might be
an option that not all plants would buy into, but it would be an option
for them.

Again, going to the other end of the spectrum, target plants that \--
that are without preventative measures. Have scientific data available
to indicate if an IDV is needed.

And on the next point here, might have been the point \-- really, one of
the biggest points that maybe we didn\'t hit it between the eyes well
enough. But the statements is, let the industry know FSIS expectations.
And since then I have been approached to add, public and inspectors and
almost everybody in the process. And that might be one of the more
profound statements that came to me. And I\'ll leave it up to you folks.
If you would like to add public, inspectors, along with industry and all
those other constituents that you have to let them know the
expectations.

And this was brought to us very clearly by a representative of a small
and very small and medium-size meat process association, who, I think
very correctly, observed that when we started, FSIS had a perspective or
expectation. Industry perhaps had a perspective. Inspectors may have had
a perspective. States may have had a perspective. And they have not
meshed together as well as they could have if we would have done a
better job of clearly stating the expectation.

That ties into what Dr. Lafontaine\'s group brought up this morning
about training and the appropriateness of training people together in
the expectations. Then it\'s not a secret.

But that little \-- that one right there probably should be expounded
upon a little bit by at least indicating the constituents that we all
have in this \-- in this process.

And again, the last individual comment, random IDVs could be used to
build benchmarks.

Now, all of these things that we have supplied, keep in mind that any
one or two or three of them together could be what triggers this \--
this IDV review.

But the last statement on here, the Agency should come back to this
committee with the proposed criteria for withdrawing inspections if
timely preventative measures are not put in place \-- into place. Again,
those of us that deal with rules of practice on a daily basis and take
actions based under law and regulation, sometimes for our \-- all of our
constituents, they wonder when does it ever end. When is the last straw.
And so it was put in there not to write your program for you but to tell
you that I think we\'d like some \-- some information from you about
when is the time to withdraw inspections.

Now, Marty Holmes had some ideas, maybe, for finetuning it. And we\'ll
see if we can get them out slow enough that Mr. Dreyfus can \-- can work
them in as we go.

I like that, Mr. Dreyfus. I think that\'s the first time I ever called
you that. Oh, well. Be polite.

Marty, would you like to offer your suggestions up?

MR. HOLMES: I\'d be happy to. First of all, I want to \-- to again with
\-- thank the staff that helped us last night. We were the last group to
finish, and at the very end we were scrambling around to get something
on paper. So as I read through this again today, I \-- I see the \--
there\'s a lot of red herrings that don\'t necessarily all tie together
here.

So I would like to at least make some recommendations here. And we can
kind of shoot them down as we go.

Obviously, you caught the grinder mistake.

The third \-- the fourth paragraph, where it begins, \"On farm.\" What
\-- I\'ve just drafted some \-- some potential language here. Let me
just read it.

\"Intervention \-- intervention research and implementation should occur
every step along the farm-to-table continuum.\" So not only intervention
research but the implementation of \-- of positive outcomes should be
applied, whether it be at the producer level all the way through the
farm-to-table continuum. I think that kind of makes it a little more
concise and a little more \-- we\'re talking about producers here, but
then maybe saying that the \-- and other places along the chain.

So I think I would \-- I would make that one recommendation to \-- to
the committee to change that sentence to read, \"Intervention research
and implementation should occur every step along the farm-to-table
continuum.\" And obviously, just because it\'s research doesn\'t
necessarily mean we\'re going to implement it if it\'s not effective.
But that would be one suggestion there.

The next sentence, I\'ve drafted something here. It says, \"FSIS and
APHIS need better communication and structure that can help address
pathogens that may not affect animal health but do have human health
impact.\" I think that\'s a little more what we were trying to achieve
last night in our \-- in explaining that better.

Anybody have any concerns about changing that to read that way? Would
that make better sense?

(No response)

MR. HOLMES: Okay. I\'ll give you that \-- motion.

In the \-- the proactive IDV review triggers, I think these are more
trigger considerations more than they are triggers. Because as you read
through those, those wouldn\'t all necessarily be classified as a
trigger or fit into that category. So I think that just considerations
for FSIS to look at in making an IDV consideration to send a team in, I
would change that to, \"review trigger considerations\" or even
\"proactive IDV considerations.\" I don\'t know exactly how you want to
term that.

We had some \-- quite a bit of discussion on bullet points three, four,
five, and six. And I\'d like to at least let the rest of the committee
know where we were going with that.

We had \-- some of us had concerns about testing large plants just
because they\'re large. Others felt large plants made sense because
they\'re producing a larger volume of product, means just a multiple \--
multiple customers, that if there was a problem going on there, it could
have a larger impact on public health than \-- than another plant that
might not be as large or producing as much product or have as many
customers.

And so we basically said, well, if you do that, you need to \-- before
you spend all this money \-- we were talking about resources yesterday
and how expensive it was to do an IDV and those kind of things. And
before you go to spend \-- spend a significant amount of time and
resources and \-- and money sending somebody to do an IDV, the CSO or
the district manager, somebody at the district level would probably have
some indication based on NR information or, you know, actual in-plant
experience at that individual plant to know whether an IDV would be
appropriate. You know, they have a good pulse on the \-- on the plant to
know whether or not they\'re \-- they\'re a good operator and \-- or
whether there \-- there\'s a legitimate concern there.

So that\'s basically what those four bullet points were trying to say.
If you do \-- and it also comes down to, based on public health risk.
The \-- the \-- the bullet point says, focus on public health risk. That
is talking about large plants, but realize, just because they\'re large
doesn\'t mean \-- necessarily mean they\'re a public health risk. There
may be plenty of information to \-- before you go to that expense in
resources of sending an IDV team out that you may \-- may say, no, it
doesn\'t make sense to do that in this instance.

So I\'m not sure we\'ve really captured \-- captured that the way it was
intended last night. So I don\'t want to give the \-- at least the
subcommittee\'s impression last night was not that \-- just because it
was a large plant, that would trigger an IDV, although that would be a
public health risk to consider because of the volume and the potential
for multiple customers.

But I want to make sure that the Agency is getting the right
understanding from at least the subcommittee\'s perspective last night.

We also went on to \-- to say that if all plants \-- so that you didn\'t
have a large-small plant confusion here, maybe all plants that are
slaughter operations or fabricators producing trim that are going to be
sold to customers, that all of them test \-- test for 0157:H7 on their
trim to develop some kind of national baseline, for lack of a better
term, of what \-- what is actually occurring. And that just because a
positive is reached by one \-- say, one of my customers, if \-- if I\'ve
got \-- if I\'m creating data that shows I\'m within \-- within whatever
is \-- is normally found, it doesn\'t necessarily mean that I need an
IDV. There may be a large plant that\'s way outside the \-- the national
average or there may be small plants that are way outside the national
average.

But maybe actually testing for 0157:H7 on trim at \-- at both the
packing house and maybe the fabricator level to see what \-- what\'s
going on there. So I don\'t know if I\'m making that clear.

And then, this question about target a plant without preventive
measures. I\'m not sure why we even have that \-- that in there because
if there\'s no preventive measures they wouldn\'t be operating because
we have a new 0157:H7 policy that says they do have to have a preventive
measure in place. I\'m not sure why that bullet point was actually in
there.

And then, the \-- I had made the same comment here. Let the industry and
all \-- actually, let all stakeholders know FSIS expectations, which was
what Mike was just referring to earlier.

So anyway, those are some draft considerations that I\'d like for
anybody on the committee or subcommittee to comment on. And you know, we
could have a subsequent motion to give a revision.

Yes, sir?

MS. DONLEY: Nancy Donley from STOP. And I had to leave, as you were all
scrambling to get the last few things on paper.

But I just want to go to the \-- because I don\'t want to count all of
them \-- big \-- the large \-- on the SPC. We had talked about that as
being something that would be an industry-generated process. And \-- and
that the companies would be \-- be doing their own statistical process
control. And \-- and this is a big \"and\" or a big \"but\" or a big
\"we\'ll see\" \-- that they share this information, make this
information available to FSIS, and that FSIS would have access to this
information to monitor and \-- and \-- and see it.

The plants that choose not to do this type of process would then be
targeted for an IDV. But if \-- if \-- if plants are willing to share
their information and shows that things are all right, they would not be
the ones that would get targeted.

So if we could put in there somewhere that it \-- it\'s the plants doing
this and sharing the information with \-- or making information
available to FSIS.

DR. LAFONTAINE: I have a \-- I don\'t know if you\'d call it an
editorial or administrative change. Not change but comment and change.

In the fourth paragraph, we talk about \"FSIS and APHIS need a
regulatory structure,\" et cetera. That is \-- that goes against the
current law. By law, in the mid \'90s, APHIS was restricted from being
involved in \-- being considered or being involved in food \-- food
safety issues. And in fact, a certain group of people from APHIS came to
FSIS at that time because of that congressional action. The folks who
have \-- currently have on-farm regulatory authority is the Food and
Drug Administration.

So you \-- I just wanted to point out to the full committee that that
statement goes against current congressional law.

And personally, I think APHIS should have that authority, but that\'s
\-- that\'s just a personal opinion.

So you need to \-- if you keep it as you \-- as it is, recognize it\'s
not a \-- it\'s a no-go from a \-- a law viewpoint now. Or statutory
viewpoint.

MR. HOLMES: If I could interject there, that\'s \-- obviously, it\'s not
up there yet, but that was one of the recommendations that I kind of
read a second ago ,realizing exactly your point. And I think I \-- I
said FSIS and APHIS need better communication and structure \-- whether
you want to take out the word \"structure\" \-- but we\'re moving the
word \"regulatory\" there. FSIS and APHIS need better communication and
structure that can help address pathogens that may not affect animal
health but do have a health \-- human health impact.

DR. LAFONTAINE: Marty, no matter how you cut it, you\'re still putting
APHIS in a food safety role. And I\'ll just \-- I\'ll drop it at there.
It\'s \-- it\'s a no-go in the current statutes.

MR. HOLMES: Well, it\'s really not \-- I mean, currently FSIS and APHIS
talk regularly on \-- on these types of things. BSE is one specific
instance I can think of, affects both animal health and human health.
And \-- and I agree with you, there\'s not \-- there\'s not a \-- I
think asking for them to communicate better between each other about
these pathogens that may not be affecting \-- affecting live animals but
they do affect \-- have a human health impact, it\'d be beneficial, even
if we\'re not talking about changing a regulatory authority by any
means. That\'s the only reason they would have done that.

MS. TUCKER-FOREMAN: Yeah. Dan \-- Dan\'s right about that. And I think
since we\'re a USDA committee that maybe the best way to do it is to
limit it to communication and so we\'re not talking about structures.
They\'re not prohibited from talking to each other. Would that be okay
with you, Dan?

DR. LAFONTAINE: Yes, ma\'am. That \-- that would be consistent with what
the current statutory language is.

DR. McKEE: Okay. Do we have anybody else that has an amendment they\'d
like \-- Dr. Jan?

DR. JAN: Lee Jan, Texas Department of Health. I just notice or \-- or
you talked a lot about testing and your first trigger \-- I think
you\'ve changed the heading now. But the first one says, \"Test more
during hot summer months.\" I don\'t see how that\'s a trigger unless
you \-- you\'re testing to identify positives and then those positives
\-- I\'m assuming that may be what you\'re \-- what you\'re testing for,
to \-- to \--

MR. MAMMINGA: I think the object was that if you test more when the
prevalence is highest, then you may find that the interventions,
whatever they are, aren\'t successful. And that could then \--

DR. JAN: And that would trigger an IDV. Okay.

MR. MAMMINGA: That would be a consideration when \-- when you\'re
thinking about doing an IDV.

DR. JAN: Okay. And that \-- I thought that\'s where you\'re going, but I
didn\'t really read it that way.

MR. MAMMINGA: I understand.

DR. JAN: But the other thing, and Marty, you talked about testing trim
and establishing a national level of acceptance or a national occurrence
in trim and some of these other products going to \-- that will be
destined for grinding. I think FSIS Directive 44 dash 02 established a
standard, and that\'s either less than detectable or no detectable
organisms. So I don\'t know that you can recommend that you establish an
acceptable level when they\'ve established that zero is the acceptable
or is the norm.

So I think that \-- that with 44-02, that directive \-- that notice
requiring those type establishments to address that hazard and \-- and
\-- and it almost states \-- and I don\'t think that these words are
verbatim. But basically, it says that it is a hazard reasonably likely
to occur unless you can prove otherwise, I think. So if they\'re going
to have to address that as a hazard really likely to occur and then
control that hazard, then that \-- the only acceptable control is below
detectable levels.

So I\'m not sure that coming out and saying we want to establish a
national acceptance level is appropriate from this committee.

MR. MAMMINGA: The only other thing was \-- other indicator organisms \--
or indicator organisms.

MR. GIOGLIO: This is \-- I would just follow up on that. I think the
discussion also was more centered on how confident the sampling program
was to be able to find the organism. It was \-- it\'s not per se what
the positive rate is but how well you\'ve designed that protocol to find
it if it were there.

So I think that was more the intent that we had as well.

DR. McKEE: One of the \-- go ahead.

MR. LINK: I was just going to \-- this is Charles Link. I think part of
the \-- the intent of that bullet point wasn\'t to establish an
acceptable level for E. coli but more a statistical what\'s happening in
the real world when you\'re out there looking at these samples. If
you\'ve got a sampling program and one out of every hundred times you
find it, and that\'s what typically happens in your facility, then
that\'s \-- becomes your norm.

Now, if all of a sudden you start finding it 10 out of every 100 times,
something happened. And that might be the trigger mechanism to say,
something\'s up, let me go take a look.

And you may find that one out of every 100 times, everybody finds it
except for Plant A over here, who finds it more.

So it wasn\'t necessary to set some tolerance but more just a measure of
what\'s going on out there and if it does tweak up, we see that and we
can address that. If that makes sense.

DR. JAN: Just \-- I know what you\'re talking about and I see where
you\'re coming from. But \-- but if you\'re talking about one out of 100
or one out of 1000 or one out of X, finding 0157:H7, it \-- the plant
still is going to have to take corrective action under 417.3, or
whatever number that is. So \-- so then \-- then that would already be
documented.

I mean, you\'re already going to have records. But that \-- then you
could use that information. So \-- okay.

MR. MAMMINGA: The \-- the challenge that this committee had you have now
experienced because we were asked to \-- to give FSIS some advice on
what conditions, plural. And obviously, with the intelligence of those
folks who are in attendance, either as participants or in the audience,
you can get about as many opinions on very specific items. Very good
opinions. Expert opinions. Excellent opinions.

But we\'re \-- we\'re \-- we\'re kind of charged with painting with a
broad brush to give FSIS some direction on some conditions, perhaps not
all conditions or the only conditions. Better ones may come up.

So we in haste, after a lot of discussion, made this list. It is not
perfect nor all-inclusive nor a mandate to you, obviously, that this is
what you have to do. I think we\'ve had some very excellent suggestions
on fixing a few of the \-- of the sentences to clearly give the
direction that we wanted to give. But it was not our intent to give you
a mandate ready to be put into a directive or a regulation, obviously.

So could we \-- could we do a little finetuning? And I think Marty\'s
doing that now. He\'s really a good wordsmith. And I would have him at
my side at all times because \-- yeah, he\'s triaging the computer as we
speak.

And I \-- I love these things because they\'re really \-- when you get
really smart people together, they \-- they come up with great ideas.
And sometimes it\'s hard to get them on one piece of paper. But we did
the best we could.

And Marty will work with Moshi and fix it. But I \-- give him a few
minutes to do that. Maybe you want to move on and then come back to the
finished document, and then we can submit it to the committee.

And again, thank you all for your considerations in these matters.

DR. McKEE: Okay. I will move on to the Standing Subcommittee Number 3. I
would remind, as we approach the \-- toward the end of the agenda, if
you have public comment, to sign up out front. We will continue to hear
the discussion on procedures for evaluating state meat and poultry
inspection programs.

Dr. Jan?

Briefing - Standing Subcommittee Number 3

Procedures for Evaluating State Meat and Poultry

Inspection Programs

DR. JAN: Okay. Thank you, Mr. Chairman. I will report on this committee.

The issue, as you mentioned, that we were charged with was to evaluate
the \-- to review the procedures for evaluating state meat and poultry
inspection programs. And we began our deliberation. And \-- and we had
part \-- some of the members of the subcommittee were not dissatisfied
necessarily with the document but felt that it \-- maybe it did not go
far enough in that the document addressed the review in the system, the
state inspection system, and not necessarily the outcome when you talk
about the outcome being the product from state inspection
establishments. The outcomes addressed in the document talk about
expected outcomes to meet the requirements of the law, do you have a
program that\'s equal to.

So after much deliberation, we felt as a subcommittee that to address
that issue as well as outcomes related to the administrative management
program that \-- that part of the federal oversight \-- or as part of
the federal oversight, FSIS should take samples of product produced at
state-inspected establishments.

And we considered several options. One of them would be that the states
would just send the product \-- the sample \-- the products to be
sampled to federal labs. And it\'d be that way. It\'d be the one lab \--
the same lab that\'s doing all these testings. The other option would be
that states continue to use the labs that they\'re using but quarterly
or on some statistically sound plan FSIS would collect the samples and
\-- and have them tested. And then that would be used to \-- to then
compare the product standards for food safety to the standards that are
established in federal inspection establishments.

So we \-- we kind of left that open then without any specifics on how to
do that. But we left that at \-- with the Agency then to look at how can
the data that is acceptable to all parties concerned \-- to give them
the confidence that that product is safe. And so we feel that FSIS can
revise that sampling procedure.

Some of the other issues that we thought that might make this a little
better document would be when \-- when the establish \-- when the state
program is required to submit a state performance plan, the document
talked about documentation that is expected.

And the question \-- or the issue that we felt needed to be addressed
would \-- would be that there be a little more delineation of which of
the documents would need to be submitted to Washington as part of a plan
and which of the documents would need to just be available for when
there\'s an on-site review. And obviously, there \-- some of those are
pretty clear which ones need to go to Washington.

But there are some that may be some confusion. And to have it consistent
from state to state, we felt that it would be better that it \-- that
documentation was \-- was broken down to part of STP and part \-- and
then the other part would be just records to be available for review.

We felt that in the section that talks about training, it \-- it
specified that state plants \-- inspectors from state programs needed to
be trained. And it listed certain training. It talked about basic
slaughter, basic processing, but it omitted some of the important
training that we feel states need to be able to receive if they\'re
going to be expected to be equal to. And that \-- and so we want those
\-- or suggest that those be put in the document. That would be consumer
safety officer training and the EVMS or the humane slaughter training
that are new training. And as other new trainings come up, that they be
included in \-- in that process.

And then the state annual report, that \-- that they wanted to clarify
that the state annual report, when they do the self-assessment, that
that report would include a report from the states on each of the
elements that are defined in the document and include outcomes of the
\-- of the evaluation for each of those outcomes.

One area that we actually failed to talk about in the committee meeting
I\'d like to just bring up here and that way we can discuss that. The
document also talks about in \-- on the page three, it says, \"On
occasion, FSIS entered into a separate agreement with state \-- programs
to conduct federal inspection \-- federal inspection activity on behalf
of FSIS.\" These \-- these are outside the scope of this document.

I want to point out that the document recognizes that but is not
addressing that here.

And then there\'s a footnote that says that, \"These agreements are
governed by FSIS Directive 5721, cooperative agreements for federal
activity to be conducted by state employees.\" And then there\'s a note
to that footnote that says, \"To be drafted based on Parts 3 and 4 of
Directive 5720.2, Revision 2,\" which is the document that is currently
being used \-- that state programs use to assess themselves in FSIS \--
state programs.

And I just wanted to go on record as stating that this drafted \-- this
proposed drafting of this, how to \-- how to oversee this first part, be
moved forward as quickly as possible because that \-- those are
important issues as well. And we need to move on with that and not
forget that.

I mean, this \-- this document makes that reference, but when we\'re
finished with this document, I think we need to move on to that as
quickly as possible. And then that would take care of all the oversight
of state programs.

And I open it to the staff to comment and the subcommittee members or
committee members. But before I do that, I would like to \-- our
subcommittee thanks to the FSIS staffers for being there, helping us out
\-- again, without them taking the notes, preparing it as we go, it
takes forever to do it. And also, Mr. \-- and Dr. Leech for providing
FSIS perspective on some of the thoughts that helped us out \--
subcommittee members.

MR. GIOGLIO: Dr. Jan, on \-- on behalf of all the folks that \-- that
were here and \-- and have been throughout the meeting, we appreciate
your kind words and the kind words that were offered by everybody else.
We\'re trying to make this process as quick and \-- and easy as we can
and get through on these important issues.

So thank you. And we appreciate your time very much here, too.

DR. JAN: Okay. There \-- are there any additional comments or questions
addressing these issues that \--

(No response)

DR. JAN: Okay. Either I can \-- oh, you\'ve got one.

MS. DONLEY: Nancy Donley from STOP. Just a quick question. Under three,
training for states to be equivalent to federal standards CSO, NDV, and,
training should be available? Are you just saying it should be available
or do you \-- are you saying that they should take the training?

DR. JAN: What we\'re saying here is that \-- that those training \--
those courses ought to be among those listed in the document that \--
and the document basically states in here, \"Training requirements on
the same basis as FSIS inspectors, VMOs, state inspectors. They must
satisfactorily complete FSIS \-- FSIS-sanctioned instruction appropriate
to job held.\" And then it lists, but it fails to list \--

MS. DONLEY: Oh.

DR. JAN: \-- CSO \--

MS. DONLEY: Okay.

DR. JAN: And so we felt that if it\'s in here, then \--

MS. DONLEY: Right.

DR. JAN: \-- then they would be more apt to allow us to attend, which
state programs have not been able to attend these before.

Any other questions? Comments?

(No response)

DR. JAN: I guess I either did a good job of explaining that or confused
everybody or something, or it\'s getting late in the day. But I\'ll turn
it back over to the chairman.

Thank you, Dr. McKee.

DR. McKEE: Okay. Thank you. Do we need to revisit any of the
wordsmithing that we\'re doing now or would it better to take a short
break and then \-- okay.

Let\'s take about a 10-minute break. Or let\'s take a 15-minute break
\-- and we\'ll come back and they\'ll have the wordsmithing done, I
think. So, 15 minutes would be about 20 till three we\'ll \-- we\'ll
convene again.

(Brief recess)

DR. McKEE: Okay. I think we\'re ready to \-- to proceed. We\'ve got the
wordsmithing done. So if we could find our seats and get started here.

(Pause)

DR. McKEE: Mr. Mamminga, do you want to discuss the \-- the changes in
\-- on the \-- the report, subcommittee report?

(Pause)

(Slide)

MR. HOLMES: All right. I want to call your attention here, intervention
research, at the bottom. Might pull that up a little bit.

\"Intervention research and implementation should occur at every step
along the farm-to-table continuum.\" We added here, \"FSIS, comma, FDA,
and APHIS need better communication and cooperation that can help
address pathogens that may not affect animal health but do have human
health impacts.\"

That\'s just basically a blanket statement. It\'s not \-- certainly not
having regulatory impact.

As you move down, I think \-- let\'s just go through these.

To test more during high-risk summer months. So if you\'re targeting
your resources at one \-- at one place versus another, high-risk months
would make sense.

Look at HACCP plan deficiencies and NRs, to take that into
consideration. It potentially could trigger or \-- for the plants
potentially in a \-- a consideration to think about in targeting
individual plants.

Random plants. Select a variety of these based on information gathered
by FSIS. That\'s similar to \-- to the second bullet point, I believe.

Focus testing on public health risks. That\'s similar to the next point
\-- in terms of \-- prioritized testing at larger volume plants or those
that supply multiple grinders.

I would also make a point there that many times it\'s the larger plants
that have the greater \-- expertise and/or the money to put
interventions in place to prevent them to begin with. So I\'m not sure
that\'s \-- in and of itself is a \-- is certainly not a reason. But we
talked about public health risk and large \-- large customer base.
That\'s \-- I\'m not going to debate that issue. There are differing
opinions on that.

Cross reference the supplier in positive E. coli testing database.
Multiple exposures to the database might trigger an IDV. The district
manager of the CSO process can help determine whether an IDV is
appropriate or potentially inappropriate. If they had been targeted
based on this database, the VM or the CSO could basically say \-- could
look at the information they have on hand to maybe either trigger or
prevent a \-- a \-- an IDV from \-- from occurring at that plant for
whatever the appropriate reason or reason not to do it would be.

The next paragraph is, I guess, where we made the most change. So let\'s
\-- let\'s look at it.

The absence of a standardized testing program conducted by the plant
that meets statistical process control to monitor the prevalence of
indicator organisms on trim or ground products would be a factor or
consideration that might trigger an IDV. Develop a program based on
plant size or production volume or based on lot size to determine if
test results are a natural variation or actually out of control. Sample
size selection should be based on organism prevalence, sensitivity of
testing, and targeted confidence levels. These test results should be
made available to the Agency to confirm that the process is in control.

If the plant does not have the data available or, obviously, the testing
program to begin with, to confirm that the process is in control, the
plant would be targeted for an IDV.

And then we drop down. Those other measures make sense if they were
actually considerations or factors so we added those \-- additional
comments included. But all stakeholders know FSIS expectations \-- could
be used to build benchmarks. And the Agency should come back to this
committee with a proposed \-- for withholding inspection if timely
preventive measures are not put in place.

So does that help?

MR. MAMMINGA: Marty, you\'re a prince.

MR. HOLMES: Thank Moshi. He\'s the one who helped me.

MR. MAMMINGA: Well, so it be. Can we \--

MR. HOLMES: Did we triage that properly?

MR. MAMMINGA: Yeah. We triaged that. Salary increases for all. Someone
will sign off on it.

Do we \-- do we have any other comments before we submit this report
that we can\'t do without?

(No response)

MR. MAMMINGA: I see none, Mr. Chairman, so we\'ll submit this report.

DR. McKEE: Okay. Thank you very much. Good job.

Let\'s look at the Subcommittee Number 3. Was there any changes on
Subcommittee Number 3? No? Okay.

DR. JAN: We did \-- we did add the \-- the one comment regarding
addressing or urging the Agency to proceed with drafting the document
for oversight of state programs when they have agreement to provide
inspection services in a federal establishment. That\'s \-- we added
that in the fifth bullet. And I can\'t read it from here.

DR. McKEE: Okay. I think that says what you want. I think that says what
you intended.

DR. JAN: In fact, I think I can read it. I\'ll just read it to you.

\"Recommend drafting the document for oversight of cooperative
agreements for federal activities to be conducted by state employees
without delay.\" And if anybody has any other comments regarding that?
And if not, we\'ll submit that as our report.

DR. McKEE: Okay. Good. Well, that\'s certainly \-- job in getting those
prepared. And that\'s very helpful to the Agency.

I\'d like to move on with the agenda. The remaining issues and plans for
next meeting.

Remaining Issues and Plans for Next Meeting

DR. McKEE: If you have comments, we\'ll entertain those at this time.

Dr. Bayse?

DR. BAYSE: We will, I hope, continue to be updated on the food supply in
terms of bioterrorism considerations?

DR. McKEE: Okay. I\'d like to move on to \-- oh, sorry.

MS. KASTER: I think I might have asked for this before, and I should
have pressed for it. But I\'d like to hear an update on dioxin screening
because I think that\'s costly for you guys and it\'s costly in some
ways for the plants as well. So I\'d like to hear a little bit of
feedback about whatever information\'s being collected. And then,
possibly along those same lines, some discussion about the \-- of
course, it\'ll probably be a done deal by then \-- but the directive on
AMR hand-testing and those types of materials and where you\'re going on
other CPs and that type of thing.

DR. McKEE: Okay. I\'ll just go down the row there. Dr. Jan?

DR. JAN: I \-- I\'d be interested in including in a future meeting some
information about using irradiation as a control point or as a \-- a
critical \-- as a critical control point and the various options and
where we are with that.

DR. McKEE: Dr. Bayse, did you have an additional comment? Mr. Link?

MR. LINK: I guess this is the time to ask the question. Is there a
formal feedback mechanism, I guess, for committee members to come back
to \-- to you guys on thoughts, concerns, issues with the meeting,
administration of the meeting, or whatever, for future reference?

MR. GIOGLIO: Let me address that, Charles. I don\'t think \-- we don\'t
have a formal mechanism. Certainly, we\'re open \-- my office is open to
hear from \-- from the committee members.

And I would point out that we are, you know, beginning the process of
\-- of rechartering the committee. And it was obvious from today, we\'re
going to have to replace some of the members of the committee. So we\'ll
be looking at that.

I would say, certainly, let\'s keep the channels of communication open
between members of the committee and our office. And if \-- if need be,
we can, you know, have a special conference call or something like that
to discuss any issues that might come up.

DR. McKEE: Are you talking about administrative process issues or how we
run the meeting?

MR. LINK: Yes, how you run the meeting. And I think to Carol\'s point
earlier on some of the paperwork that came in late. Some of it we
didn\'t get till we got here. I mean, just \-- just some things that I
think we could do better.

DR. McKEE: If you want to send us \-- send those items that you\'ve
identified, we\'d be glad to include those \-- certainly, we want to
make this meeting as productive and easy as possible for all the
volunteers. And we don\'t want to add any extra stress that\'s induced.
So we certainly would appreciate those comments.

Dr. Johnson?

DR. JOHNSON: We \-- we\'d talked earlier yesterday about what the
committee had recommended before on certain issues. I was wondering if
it would be possible to include in our \-- our initial information that
we get just kind of \-- the recommendations that were put forth this
time and any type of steps the Agency had \-- had done as far as
following up on the recommendations. I think that\'d be helpful to have
kind of just a reminder of what we did last meeting.

DR. McKEE: Okay. Mr. Holmes?

MR. HOLMES: And that kind of answers one of my \-- the point I wanted to
make \-- follow up on. This committee had suggested doing away with the
retail exemption. I\'m just kind of curious what \-- maybe an update
next time as to where that is and what \-- the Agency \--

MR. GIOGLIO: I think I\'ll make sure that that gets on \-- on the agenda
next time to at least give an update on \-- on where we are within the
Office of Policy.

DR. McKEE: Mr. Govro?

MR. GOVRO: Other than this suggestion period that we\'re having right
now, how does the Agency decide which items will make the agenda for the
meeting? Is it open to suggestions from the public or committee members?
Or how do you go about that?

MR. GIOGLIO: The way we go about that is that within our office and
throughout the Agency, we solicit issues from the other deputy areas and
assistant administrator areas to get to the agenda. We draft up, in
fact, an agenda to try to, you know, get everything on within the
framework that we\'ve established for this meeting. And ultimately, they
go up to the administrator\'s office and \-- and it\'s decided on which
issues will be forth as an issue.

We have certain standing briefings that we\'ve committed to, let\'s say
like the food security and so forth, that we want to continue to do for
the foreseeable future.

And that\'s basically the process that we follow internally.

DR. McKEE: As we identify priorities within the Agency that we would
like to have additional input, especially new initiatives and so forth,
then, clearly, that would be on the agenda for the committee to look at
as well.

Ms. Eskin?

MS. ESKIN: Yeah. I wanted to make a general suggestion but first wanted
to comment on a number of suggestions made here.

When you say \"contact your office by email,\" should we email you
directly, should we email Sonya? What\'s the most \--

MR. GIOGLIO: I think probably the \-- the constant in that equation is
going to be Sonya West. As \-- as \--

MS. ESKIN: So if we \-- we have no \--

MR. GIOGLIO: \-- the committee contact \--

MS. ESKIN: Okay.

MR. GIOGLIO: \-- she is, you know, and going to remain as the advisory
committee specialist.

MS. ESKIN: Okay.

MR. GIOGLIO: And so forth. And then, certainly, we\'ll let you know of
any other updates, if there\'s an easier way \--

MS. ESKIN: Okay.

MR. GIOGLIO: \-- than or a better way to get that done.

MS. ESKIN: So we send her and she can follow up with whoever the
appropriate \--

MR. GIOGLIO: Sonya can collect that information and get it to the folks
that need to evaluate it and respond back to it.

MS. ESKIN: I agree with Dr. Johnson. I think it\'s a great idea that we
have just some follow-up on the specific recommendations made by the
subcommittee in the \-- prior meeting and what\'s been done to implement
those or just to respond to those.

I also think it would be helpful earlier in the process to \-- contact
by email, whatever, the members of the \-- members of the committee and
let us know what your thoughts are as far as the agenda. And we too can
then weigh in because I know it takes a while to \-- to put these things
into play, but I think it\'s really important that there\'s back and
forth.

On the \-- the agenda, I know we didn\'t have time to discuss listeria
and I know that we\'ll have a summit in two weeks to discuss it. I would
definitely like us to have sort of an update on what the Agency has done
in response to developments in this area next time.

DR. McKEE: Mr. Holmes?

MR. HOLMES: One last \-- I assume Moshi is making copies of the final
two revisions?

MR. GIOGLIO: Yes. He\'s going to try to have them available out at the
\-- you know, on the back table there as soon as he can get those copies
made.

DR. McKEE: Okay. Thank you.

Public Comment

DR. McKEE: I\'d like to go on to public comment. We have four
individuals that have requested time. And since we do have \-- we are
ahead of schedule, I will allot up to 10 minutes per person for the \--
instead of 30 minutes.

I\'d like to make a comment that the comments from the public should be
in regard to the agenda items that we\'ve discussed over the last two
days. The purpose of the advisory committee is to assist the Agency in
recommendations and problem-solving, so we want to keep it focused on
the agenda the last two days.

So the first one that I have on the list, I\'ll have Charles \-- but you
can have up to 10 minutes \-- you can have up to 10 minutes. And it
doesn\'t even have to take that long. Whatever you want to do within
that time is fine.

The first one is Charlotte Christian. If you would give your association
or connection?

AUDIENCE MEMBER: Sure. Thank you.

Thank you for the opportunity to speak. My name is Charlotte Christian.
I\'m a senior food safety attorney at the Center for Science in the
Public Interest. And I have a couple of issues that I\'d just like to
ask questions about and comment on.

A question I would have with regard to HIMP. Can you tell us how many
plants currently have antimicrobial intervention in \-- among the HIMP
plants? Do we have a figure on how many plants are using antimicrobial
interventions?

MS. AXTELL: I don\'t off the top of my head. We\'re checking to see if
we have the data with us.

(Pause)

AUDIENCE MEMBER: While they\'re looking, one of the comments I have is
that in the discussion of the HIMP report and the data generally, there
seemed to be some broad conclusions reached about the ability of the
HIMP system to improve food safety. I think the Department needs to be
very careful about making those broad generalizations.

Yes, the data do show some improvements in FS-1 and FS-2. But the fact
is that there are also data which show that there is no improvement or
in fact may be an increase in salmonella recovery in HIMP plants.

Now, I understand that there is a question about seasonality. However,
we are talking about young chickens. We are talking about plants that
are supposed to have tight controls. And at least according to the
report that we saw today, one of the responses to the GAO\'s criticism
with regard to antimicrobial intervention is that in fact many HIMP
plants are using antimicrobial intervention.

I think it\'s too pat of an answer to just try to explain this away by
saying, oh, it\'s just seasonality. I urge the Agency to, number one,
look deeper into the issue for why there may in fact be increases in
salmonella prevalence, and number two, to again be careful in how you
portray food safety measures under this plan because we don\'t know
about salmonella yet. And I think it\'s wrong to say that just because
FS-1 and FS-2 have been improved that we therefore have a plan that\'s
going to improve food safety.

The second comment, and this relates to the agenda and \-- and Ms.
Eskin\'s question about listeria. Just in general, I think that it\'s
important for the Agency to get the input of this committee when you\'re
thinking about important issues that are on the front page of the
newspaper every day. We\'ve got a huge recall. We\'ve got two plants
being investigated, possibly four plants being investigated.

And I think it\'s very important when you\'ve got this august body
together to at least give them an opportunity to give you their insights
in how FSIS might best approach this problem and better protect
consumers. Thank you.

DR. McKEE: Okay. Thank you.

The next presenter will be Dr. Dale Boil.

AUDIENCE MEMBER: Thank you. I\'m Dr. Dale Boil. I\'m executive vice
president of the National Association of Federal Veterinarians. We\'re
\-- we\'re an association of supervisors and managers. Most of my bosses
and most of my customers are veterinarians that are in plants throughout
the United States. So at least in the first part of these statements
I\'m going to be speaking on their behalf.

Rarely do we have a win-win-win-win opportunity. I have listened
carefully. Our organization has been extremely critical. And we have
also been very much a part of the solution of trying to make the whole
process of getting HIMP to work part of what we are about.

We started out as a group who were against. The ones that were in the
plant were the first to see the light. The people throughout the United
States, veterinarians throughout the United States now are all clamoring
to go to the HIMP plants.

What am I talking about a \"win-win-win\"? Well, I think it\'s fairly
obvious to anyone who\'s really taken a look at it without trying to
slant it for this or for that that this \-- that this is clearly a
superior system.

I say that consumers win by getting a safer product. I say that industry
wins by having process controls in their hand. I say that employees win
by having better jobs and a more significant ability to contribute to
public health. I say that taxpayers win by having to pay fewer employee
compensation checks.

So on behalf of our organizations, we encourage the rapid adoption of
HIMP and moving it out.

I think we need to be careful. I think we need to continue to improve.
But this is clearly a better system than the current one that\'s in
place now.

Since I\'ve got 10 minutes, we\'ll talk about another win. Let\'s talk
about microbiological controls.

Microbiological controls are another way we can see a win-win-win. I say
let\'s have salmonella performance standards and let\'s make that a part
of what we commit to. I think listeria species offer real opportunities
for validating how good our sanitation programs are working. I say that
a fecal indicator of some sort be a regular part of our microbiological
controls and that be put into the system.

We\'ve already talked about another one. But this is a win that is an
investment in your future. The win-win of investing in people. The
long-term investing in education and training for FSIS is the only way
that you\'re going to get to that place where you want to be as an
employer of choice and an agency recognized for its excellence.

DR. McKEE: Okay. Thank you.

Okay. Our next speaker will be Paul Johnson.

AUDIENCE MEMBER: I \-- I just have a couple comments, and I\'m not going
to take 10 minutes.

But my first comment is that I believe that this group would benefit by
having a representative of the \-- the inspectors union present at these
meetings so that you can get a \-- I heard the word \"real-world
evaluation\" about what\'s going on. I think it would benefit you to
know what\'s going on out there in the field and what inspectors are
actually tasked with.

We\'d be \-- we\'d be glad to come. And we \-- earlier this year, as you
know or some of you may not know, I\'m the new chairman for the NJC. And
I sent a letter to the secretary telling her that this new union theme
is extending the olive branch. I kid Dr. McKee about it, that I brought
my olive branch to Washington last time we came.

And so we would like to work with the \-- with you folks and \-- and try
to make the best system that \-- that can be provided out there. So that
was my first comment.

One of the \-- a small \-- a short comment on HIMP.

Dr. Aman, your stationed at Carthage, Mississippi, right? I think one of
the things that \-- I heard the comment that the product from the HIMP
plants seemed to be a less quality or a less desirable product to get. I
know that just in the recent few months, an entire load of product came
from the Carthage plant to a plant in North Arkansas that was grossly
contaminated with feed. They may have that under control now. I don\'t
know.

But it\'s not been long that \-- that a load \-- this entire load was
rejected and sent back to Carthage because that \-- it was grossly
contaminated. And when the lids were popped, it had an off condition
odor.

Those things now in the HIMP plant are not considered food safety.
Things like airsacculitis, glucosis, tumors, things that, in my
experience with the \-- the public have been grossly appalled that that
kind of stuff would be allowed to be fed to the \-- the American public.

I think that \-- and also wanted to make \-- make a point that when we
find product that exceeds those tolerances for the OCP, we don\'t have
the right to retain that product. We tell the company that it \-- that
they\'re out of tolerance on it but we don\'t retain it. We \-- we \--
if they want to, they can. We think that that would be an improvement.

I know Dr. Santiago talked about making some improvements to \-- to the
HIMP system. I know Jeanne talks about some. I think that that would add
to your \-- to your system, is to take a look at some enforcement on
those \-- on those type issues. I think those are the things that are,
you know, turning people off against the product that comes out of those
plants.

And this may be an avenue that inspectors that are in the plant could do
those additional tasks, like \-- I forget the lady\'s name. But Donna.
I\'m sorry, Donna. I apologize.

Donna talks about the inspectors doing additional tasks in the plant.
That could be some of the things that they\'re doing, is checking that
cart before it goes out the door, those type things. There\'s additional
duties that could be \-- could be performed by the inspectors that are
not on the line.

We\'d be glad and open to sit down and \-- and take a look with the \--
with you on those things on \-- on HIMP. And let\'s see if we can come
to some kind of a closer agreement of \-- of what would work.

I know we filed an \-- we filed a lawsuit against the Agency because of
the HIMP project. Maybe there\'s some way that we could sit down with
you guys and find \-- find a way that we weren\'t so ready to do that
the next time.

The next thing is on training. I heard some of you guys talk about CSOs
and \-- and the duties that they\'re performing. And somehow I get the
impression that \-- that you\'re giving them more credit than \-- than
\-- than they have got or more responsibility than they\'re actually
supposed to be doing. Because it\'s our understanding that the CSO is
basically focused in on the design of the HACCP plant.

The only difference in a CSO and many of the inspectors that we have out
in the plant is four weeks of training. We \-- we feel like that
there\'s much more benefit in training all \-- you know, and I think the
Agency has made a commitment to train all the veterinarians in the CSO
training.

Why not train the inspectors also that are working in these processing
plants, the IICs that are bargaining unit folks? You have somebody \--
then you have somebody there full-time, not their supervisor, that may
check it. You know, he may be there on the site but may not be checking
that on a regular basis. You have an inspector, though, that would be
there full-time and could check that plan 365 days a year.

When a CSO comes in that plant, he checks it that day or that week when
they\'re there, and they\'re gone. That plant could change 364 times
until they get back. It could change, you know, a numerous amount of
times. But if you \-- if those folks were trained on design, any time
the plant made a change in their plan, they could evaluate it like the
CSO does.

DR. McKEE: Thank you.

I think we do have the answer to the HIMP question.

DR. SANTIAGO: On the question of the number of plants using
antimicrobial, we have 15 plants out of the 20 using antimicrobial. All
of them have passed the salmonella cert except seven, seven are ongoing.
All the others have passed the salmonella. Seven are still ongoing.

DR. McKEE: Okay. Our next speaker will be Tony Corbell.

AUDIENCE MEMBER: Tony Corbell from Public Citizen.

Public Citizen at the outset was a critic of HIMP. And I\'ve attended
now four meetings on this issue, and \-- and nothing has \-- has been
presented today that \-- that is going to modify our organization\'s
position in opposition to HIMP.

I want to give Dr. Santiago fair warning. We \-- we are \-- we ride the
Metro together quite a bit back to God\'s country in Greenbelt,
Maryland. If you see me on the platform, and since you\'re a new face at
HIMP, believe me, I\'m going to have questions for you. So your day is
not going to end when you \-- when you \-- when you leave the building.
So \--

(Comment off mike.)

AUDIENCE MEMBER: Does he?

(Laughter)

AUDIENCE MEMBER: So that\'s \-- I\'m just \-- I\'m just going to, you
know, just end it there, that we still have great concerns over the
program.

And \-- and now, you know \-- the other thing I wanted to \-- to point
out, since \-- since the GAO\'s study has been \-- has been attacked, I
think you\'re going to have to come to some meeting of the minds with
the \-- the folks \-- the so-called experts, the \-- the group you\'ve
empaneled to look at the data along with the GAO folks. Because now the
\-- the muddy \-- the water \-- the water has been muddied even further.

The other thing I \-- I wanted to address is to essentially follow on
what Mr. Johnson just \-- just spoke to. I think you\'re going to have
to include your \-- your inspection force in some way in these meetings.

Dr. McKee, you \-- you addressed the issue of being a quarterback of a
team, and \-- and this is the major portion of your team, your
inspectors.

I sat in the \-- the training subcommittee last night. Dr. Lafontaine
did a tremendous job in terms of including everybody in \-- in that
meeting, including Mr. Johnson, who \-- who addressed some \-- some real
concerns in terms of the \-- the lack of training that are currently
provided to inspectors. He provided invaluable \-- he was an invaluable
resource in terms of what was actually going on out there.

So I would encourage you, if you cannot include him as part of the \--
the committee itself, I think there should be a standing invitation for
the employee representative to be here and to participate in these
meetings. Thank you very much.

DR. McKEE: Okay. Thank you.

Wrap Up and Adjourn

DR. McKEE: Are there any other comments that the committee would like to
\-- to make before we adjourn the meeting? Mr. Magmini?

(Laughter)

MR. MAMMINGA: All right. One time for the record. \"Mamminga.\"

DR. McKEE: \"Mamminga.\"

MR. MAMMINGA: \-- and since I\'m leaving, I\'d just like your indulgence
to thank Sonya West. I\'ve been on the committee for four years. She has
coordinated my getting here and going home and my expenses and my
questions. And while she, like us, live in an imperfect world, she
certainly has my gratitude and I\'m certain on behalf of the members of
the committee.

So, Sonya, thanks a million.

(Applause)

MR. GIOGLIO: Well, see, she\'s probably out there making copies or
running around and \-- or something.

MR. MAMMINGA: It\'d be nice if we could bring her in here and just say
\"thanks.\" It\'s quite a job, I\'m sure.

(Pause)

(Applause)

DR. McKEE: Okay. Thank you.

Hearing no other comments, we stand adjourned until the next meeting.
Again, thanks those \-- to those that are going off the committee for
the yeoman\'s work that you\'ve done over the last several years. Thank
you.

(Whereupon, at 3:25 p.m., the proceedings were concluded.)