PUBLIC MEETING TO RECEIVE )

COMMENTS ON FSIS REGULATORY )

PROPOSAL CONCERNING )

READY-TO-EAT MEAT AND )

POULTRY PRODUCTS )

Pages: 1 through 187

Place: Washington, D.C.

Date: May 9, 2001

THE UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

PUBLIC MEETING TO RECEIVE )

COMMENTS ON FSIS REGULATORY )

PROPOSAL CONCERNING )

READY-TO-EAT MEAT AND )

POULTRY PRODUCTS )

Federal Hall

The Washington Plaza Hotel

10 Thomas Circle, N.W.

Washington, D.C.

Wednesday,

May 9, 2001

9 a.m. - 4 p.m.

PARTICIPANTS

[From FSIS]{.underline}:

Margaret Glavin, Moderator

Dr. Daniel Engeljohn, Director of Regulations and

Directives Development

Philip Derfler

Kaye Wachsmuth, Administrator

[Commenters]{.underline}

John Drozd, Babcia Food Corporation

Jenny Scott, National Food Processors Association

Katie Hanigan, Farmland Foods

Kim Rice, The American Food Institute

Bernard Shires, American Meat Processors Association

Dr. Katherine Swanson, The Pillsbury Company

Stan Emerling, Consultant to NAMP

Dr. Dane Bernard, Keystone Foods, LLC

Dr. Robert Tompkin, ConAgra Refrigerated Preferred Foods

John Kobayashi, Washington State Health Department

Joe Harris, Southwest Meat Association

Dr. William Sperber, Cargill, Inc.

PARTICIPANTS: (Cont\'d)

[Commenters]{.underline}:

Dennis Johnson

Dr. Larry Beuchat, University of Georgia

John Gross

Dr. Tsegaye Habtemariam, Tuskegee University

Erika Voogd, OSE Industries, Inc.

Caroline Smith DeWaal, Center for Science in the Public

Interest

Charlotte Christin, Center for Science in the Public

Interest

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

(9:08 a.m.)

MS. GLAVIN: Thank you all for coming and getting to your seats so
quickly. My name is Margaret Glavin and I\'m going to the moderator
today. I appreciate the fact that you all are here and ready to
participate.

We wanted to have this public meeting in order to provide an opportunity
for later communication and understanding and particularly to gather
comments on the proposed regulation that we have out for comment on
performance standards for the production of processed meat and poultry
products.

Yesterday many of you were able to be here for the technical meeting and
that was very interesting and I think will help to inform some of the
discussion today. This meeting is consistent with an approach we\'ve
taken over the last several years and also with Secretary Veneman\'s
pledge to ensure that our food safety policymaking process continues to
be transparent and that the public continues to have the opportunity to
provide input and to be fully involved.

As you know, the proposed rule for ready-to-eat meat and poultry
products was published on February 27th and that was after the new
Administration had an opportunity to review that rule and make a
decision that it should be put out for public comment.

The proposed rule is intended to ensure that all categories of
ready-to-eat meat and poultry products are covered by a safety
performance standard and also to give establishments the incentive and
flexibility to adopt innovative science-based food safety processing
procedures and controls and provide objective measurable standards that
FSIS can verify.

These standards are part of our effort to reform our regulatory system
for meat and poultry safety. Science-based processors with proven
effectiveness developed by establishments and subject to Agency
oversight will improve food safety and make better use of government
resources.

Many of you were here yesterday and will today speak on the importance
of using sound science to establish our food safety priorities and to
guide our program and policy decisions. I\'d like to reiterate our
belief that sound science must underpin all of our food safety efforts.

Pathogen reduction performance standards play a key role in our
science-based food safety efforts. Pathogen reduction performance
standards have proven to be effective in reducing the prevalence of
pathogens on meat and poultry products and ultimately food-borne
illness.

Our most recent data for the salmonella performance standards show
significant reductions in the prevalence of this pathogen across all
meat and poultry product categories. The Centers for Disease Control and
Prevention are reporting continued reductions in foodborne illness
associated with meat and poultry products.

We must continue to build on these successes and the proposed rule on
the performance standards for processed meat and poultry products is a
step in that direction.

At the time we developed the proposed rule we used the best data
available to us. However, we recognize that additional data is needed
and we\'re hoping to gather information that we can use to review and
improve upon our approach to improving the safety of processed meat and
poultry products.

I\'d like to briefly mention the data needs we\'ve identified in the
Federal Register \-- . Specifically we\'re seeking information on
appropriate environmental testing specifically through contact surface
testing which we believe is effective in reducing the risk of post
lethality contamination by Lm and data on the potential growth of Lm in
the product after the product leaves the Federally inspected
establishment.

Before I review the agenda I\'d like to emphasize that this public
meeting \-- and I said this a little bit yesterday for those of you who
were here. This public meeting is to receive comments.

We have set it up that individuals from the staff will make
presentations on particular aspects of the proposed rule and then we
will ask \-- you will have a brief opportunity for any clarifying
questions to clarify what the presenter has put forth and then we will
ask for comments. And if any of you have signed up to make comments and
we\'ll go through that list \-- through that assignment list and if
there are any additional comments either from people who didn\'t sign up
or because additional comments are raised by the earlier speakers we\'ll
go through those.

So this is an opportunity for you to give us your comments but it\'s
more particularly an opportunity for us to hear your feedback and to
gather additional data and information related to the proposal. We are
still collecting data and other comments through the written comment
process and we weigh all of the information before deciding how to
proceed.

I\'d also like to note that we\'ve extended the comment period for the
proposed rule. The new comment closure date is June 28th and that was to
ensure that everyone has ample time to prepare comments based on the
discussions at this public meeting. The original comment date came very
soon after this meeting and you felt it wouldn\'t provide an opportunity
for things that are raised in that meeting can be reflected in your
comments. So we\'ve extended it to June 28th.

We found that we really wanted to get this meeting scheduled. Every date
we had, someone else had something on the books. So it took us a little
longer than we had originally anticipated.

So now let me briefly review the agenda for \-- actually for the two
days. First of all, Dr. Daniel Engeljohn who is the Director of our
Regulations and Directives Development staff will introduce the morning
session on lethality and stabilization performance standards and that
ought to wake everybody up.

Following the morning session we\'ll break for lunch at about 12:30 and
return about 1:30 to introduce the subject of requirements for the
control of Listeria monocytogenes. We anticipate ending by no later than
5:00 this afternoon.

Tomorrow we will start again at 9:00 with a session on revisions to the
regulation governing the elimination of Trichina from pork products and
governing commercially stored canned products.

Paul Uhler and Dr. Mimi Sharar and the Office of Policy Program
Development and Evaluation will lead this session. We\'ll break again
for lunch at about 12:30 and will begin in the afternoon with a session
led by Dr. Felix Spinelli, an Economist with our Regulation and
Directives Development staff, on the economic impact of the proposed
regulations and cost benefit data needs. Again we will plan to wrap up
by about 5:00.

On both days we will have breaks and I get to run the breaks, so
depending on how good you\'re being we\'ll have more or fewer breaks. So
are there any questions or concerns about the agenda before we get
started?

(No response.)

Okay. When people have either questions or comments it\'s real important
that you come up to one of the microphones and that you state your name
so that the reporter can both hear what you\'re saying and know who is
saying it.

For those people who are making comments I would particularly urge you
to come up and sit at the table. There are a lot of places with
microphones. I think that will make it easier. If it\'s just a question,
you\'re more than welcome to sit at the table but you could also just
come up and use the microphone briefly and then go back if that\'s more
appropriate for you. So with that, since you all have the agenda and
understand the agenda I\'m going to ask Dr. Engeljohn to proceed.

DR. ENGELJOHN: Thank you. Can everybody hear me? I have two microphones
on. Oh, now you can hear, okay, great. Thank you very much. I\'m glad to
have the opportunity to walk you through the lethality and stabilization
performance standards of meat poultry products.

As Maggie mentioned, I\'d like to remind you that this is a \-- this
session this morning is associated with a public docket that we have on
record in the docket room with FSIS. That room is available to you, the
public, Monday through Friday 8:30 to 4:30. If there are copies of
documents that you need we do have a process you can go through that we
can make that available to you through our Freedom of Information
activities.

I\'d also point out that all the presentations made at these meetings,
and my comments included, are intended to be posted on the FSIS webpage
as quickly as we can get them there. So for copies of what I say this
morning as well as other presenters that have prepared remarks, our
intention is to make them available as quickly as we can. That should be
within a matter of days.

This is Docket No. 97-013P, the performance standards for the production
of processed meat and poultry products. It is a proposed rule. I\'ve
given the Federal Register citation and as was stated earlier, the
comment period was extended through June 28th.

I\'ve had several questions already this morning about how comments can
be submitted for the official record and within the document itself, if
you have access to it, it explains that. Otherwise, please see me or
someone else from FSIS and we\'ll be glad to try to help you get the
information you need to submit your comments.

With regard to lethality, I\'m going to walk you through the specific
components of the proposed regulation that I think \-- and you just need
to be reminded of and maybe will trigger some thought or some comment
that you want clarification on.

We\'re proposing to add a new section to nine coded Federal Regulations,
this would be Section 430. For those of you familiar with how they\'re
doing our regulations now, all regulations that are combined
requirements for meat and for poultry are now in our new Section 400.

Because these lethality performance standards are crosscutting between
meat and poultry, we\'re adding them to this new section. So what that
means is that the old Section 9 CFR 318-17 for roast beef, as an
example, or 9 CFR 318-23 for cooked meat patties or 9 CFR 381-150 for
cooked poultry, will no longer be contained in those sections of the
regulations but will be removed from there and put into the new Section
430, and that would be once we issue a final regulation.

We began the new section with a definition section to provide some
clarity as to what we mean by fermented product, ready-to-eat product
and worst case product. The fermented products are made ready-to-eat by
bacteria enzymes acting to lower pH and microbial inhibition.

Also contained within the definition section are other definitions that
will be discussed tomorrow that are applicable to canned thermally
processed product. There, for an example, we have an acidified product
which is different than fermented products. So for purposes of the
lethality performance standards, fermented product is defined very
specifically.

For ready-to-eat product we are putting in a new definition within the
regulations that make it specific to ready-to-eat meat and poultry which
means that this product is safe to consume without further cooking or
application of some other lethality treatment to destroy pathogens.

In worst case products for purposes of developing the lethality
performance standard are very specifically defined within the new
Section 430.2(a)(1) for meat and poultry. For beef, this would be a
fermented beef product, 430.2(b)(1) and that would relate to the e-coli
standard.

I would also like to point out for those of you who need a little more
background, within the preamble section of the proposed rule, and this
would be on pages 12592 through 12601, where there\'s specific
discussion about how we derived the definition for a worse case to
establish lethality.

I would just point out that for worse case raw poultry that would
contain 6.7 logs of salmonella in any 143 gram sample. This was based on
our national baseline study.

For worse case for raw meat products the level for salmonella was
determined to be 6.2 in any 143 gram sample. We then, as I will explain
later, went on to derive a lethality performance standard for the
finished ready-to-eat product that takes this raw number and converts it
for ready-to-eat product.

In the new Section 8 CFR 430.2(a) we\'re proposing for lethality that
you either achieve a probability of survival, meaning that there would
be no greater than a specified salmonella \-- level of salmonella
organisms in any 100 gram of finished product. That\'s assuming that the
end product in the meat product is worse case. Again, I just gave you
the numbers for the raw numbers. We added a safety margin to that raw
number to derive the finished lethality performance standard.

For those of you who aren\'t familiar with the lethality performance
standards, in this case we are identifying that for the meat products
this would be a survival of greater than zero organisms in any given
product of 39.4 percent, greater than one organism of 9.06 percent,
greater than two of 1.45 and so on. But we have made available the
probabilities that we believe are necessary for establishing the safety
of the ready-to-eat product if the processor chose not to use the log
reduction mandatory requirement.

So you\'re given an either/or situation. So you can either determine a
probability of survival based on the worst case in your product or you
can base it on the worst case that FSIS has given you that we made our
assumptions for this proposed rule. Or you can do a log reduction.

In this case it\'s given that for meat products that would be a 6.5 log
reduction for salmonella and for poultry products that would be a 7.0
log reduction for salmonella.

In addition, the lethality performance standards specifies that there
can be no detectible viable salmonella organisms in the ready-to-eat
product, otherwise it would be determined to be adulterated. So although
we\'re giving you a probability of survival or we\'re giving you a
lethality log reduction, you still have to achieve no viable detectible
salmonella in the finished ready-to-eat product in order to determine
that that product is not adulterated.

Salmonella was determined to be our target organism in this case because
of their relatively high numbers and we believe that there is sufficient
data to establish lethality for it, and that it can be used as an
indicator that other organisms, likewise, will be reduced if you reduce
the levels of salmonella.

For Section 9 CFR 430.2(b) we note specific requirements for
ready-to-eat beef products that are fermented. This would be any product
containing beef that is fermented. It can be a poultry product with a
minimal amount of beef in it that if that\'s product\'s fermented then
in addition you have to meet the additional performance standard for
lethality.

For E.coli 0157:H7, it can be no greater than a given number of
organisms in 100 grams of finished product or a log reduction of five.
This is consistent with the current policy that the Agency has had since
1994 on fermented beef products with regard to a five log reduction for
e-coli.

But for the ready-to-eat products today if you have \-- we\'re proposing
that if you have fermented \-- a fermented process with beef that now
you would have a regulatory requirement to meet, an additional E.coli
0157 requirement as opposed to just the salmonella requirement.

We also are giving \-- to the proposed rule. The level of surviving
organisms for that probability statement and for 0157 greater than zero
organisms there\'s 22.2 percent and greater than one organism would be
2.67 percent.

In addition, any detectable viable E.coli 0157 in the finished product
would adulterate that product, so you would also have to ensure that it
is taken care of at that level.

For proposed Section 9 CFR 430.2(c) we go on to state that in addition
to the target organisms that we\'ve identified, that means salmonella
and E.coli 0157, reduction of other pathogens and endotoxins or toxic
metabolites also have to be dealt with and validated to prevent product
adulteration.

In new Section 9 CFR 430.2(d) we\'re proposing that the lethality
performance standard needs to be maintained throughout the product shelf
life and that it should be validated under the conditions to which the
feed is stored, distributed and held.

I\'d like to give you a little more background about the determination
of worse case levels. In the absence of a specific risk assessment to
help derive how we establish the lethality performance standards we have
constructed a worse case approach, which is what we used in the raw beef
and poultry rules that went into effect in March of 1999.

In general, the Agency did baseline nationwide studies for the various
species and classes of products. We used the highest most probable
number results from those surveys. I point out that those survey samples
were frozen and the samples were also the companion to those that were
used to test for salmonella as a qualitative test for the performance
standard determination.

We also made conservative assumptions in determining our worse case
levels. Some of those assumptions are, again we adjusted the most
probable numbers for recovery. We used the upper 97.5 percent confidence
\-- for statistical majors and we assumed that the levels of the
organisms were uniformly distributed throughout the 143 grams of raw
product. We also assumed a 70 percent yield going from the raw product
to the finished product.

This is an example of the data that were collected in the nationwide
baseline. This happens to be for the levels of organisms in ground
poultry. As an example, for poultry products the most probably number,
the highest number, was 2,300 per gram, this is actually for ground
poultry products. For red meat it was actually 720, the most probable
number per gram.

FSIS pulled the sample results for this species. So for the ground beef
and the beef carcass data from the nationwide survey, we pulled the data
from those two sets in order to determine a worse case level and the
same holds true for poultry.

I mentioned that we added a safety margin onto the worse case level that
we had derived from the raw products, the .3 log for each of those
levels resulting in the performance for poultry at 7 and for red meat at
6.5. Again, the probability \-- if you were to use that approach the
probably of any viable surviving cells that is greater than zero is
39.4.

For 0157 we went through the same process, also adding a safety margin.
Instead of a safety margin of .3 as we added for the salmonella
performance standards, we added a safety margin of .6 for E.coli 0157:H7
in fermented beef products.

I\'ll move on to stabilization. Stabilization as we define it for
ready-to-eat meat and poultry products is actually the same as cooling.
We chose to use the term

\"stabilization.\" It\'s the same term we used in 1999. We\'re certainly
open to comments on that particular term, but as we refer to it,
stabilization means cooling and it generally implies cooling from the
thermal process, from the cooking.

In our new Section 9 CFR 440.3(a) we\'re proposing that the processing
methods such for ready-to-eat meat and poultry products that prevent the
multiplication of toxigen microorganisms, the organisms that we\'ve
identified include C. botulimon and C. perfringens. We allow no
multiplication for C. botulimon. We did have specific questions in the
Preamble asking for information about how much multiplication could
occur before toxin formation would occur. And we\'re certainly open to
assess the way we\'ve written this performance standard, if we can have
more informed information about the development of toxin which is
actually what we\'re trying to prevent from occurring in ready-to-eat
products. For perfringens, we have kept the same performance standard
that we issued for cooked roast beef and for cooked poultry, which is
that there can be no more than one log growth of C. perfringens.

In new Section 9 CFR 430.3(b) we\'re proposing that the processing of
all heat treated not ready-to-eat meat and poultry products also must
meet these performance standards for toxin and for C. botulimon. So we
know we have partially heat treated products out there. There seems to
be our indication the cooked meat patty regulation which specifically
has partially cooked meat patties as a component and we have some
specific revisions for partially cooked poultry with any additional
performance standard first stabilization for the partially heat treated
products.

New Section 9 CFR 340.3(c) then goes on to say that processing of
products are applicable to this Section A and B. They must be validated
to maintain the stabilization performance standards throughout the
product shelf life under the conditions in which the product is stored,
distributed and held. This is an example of the baseline data that we
pulled together to establish the performance standard for stabilization.
This represents the levels of perfringens in whole red meat products.

For determination of the worse case levels for C. perfringens, again we
used the baseline data. We had no values greater than \-- a fifth per
gram. The worse case is it seemed to be \-- C. perfringens per gram.
That could become heat shocked, germinate and after a live period,
multiply as vegetative cells.

I\'ll point out that in ground beef out of 1,687 samples only one sample
result was greater than 10 to the fourth. In chicken, the level was at
11,000 per gram. We also have the data for raw meat carcasses, but we
did, in fact, pull these samples.

Then finally, I want to point out that we have made available on our
website draft compliance guidance for ready-to-eat meat and poultry
products. We\'ll be happy to answer questions on that today if you\'ve
had an opportunity to review them. We announce them through the
constituent update on Friday. They\'re available at our website. I have
made two copies available out on the display table. I didn\'t bring
enough copies for everyone, it\'s 59 pages long. I would encourage you
to take a look at them. If we can answer questions on them, that\'s what
we want to be able to do as well as to provide you with some clarity as
to your concerns.

The guidelines themselves include new information related to the
specific processes of cooked, fermented, salt-cured and dried meat and
poultry products. We also add for the first time, time and temperature
combinations for cooked poultry. For those of you who are familiar with
the cooked poultry current regulation 381-150, we\'ve provided only the
160 degrees as being sufficient for safety. We\'ve now provided, based
on data soon to be published, in a peer review journal article, time
temperatures for common meat and poultry products, that means from one
percent fat up to 12 percent fat. We would welcome your comment on those
time temperature performance standards that are included there, as well.

That concludes my prepared remarks and I\'ll be glad to answer any
questions or give clarity at this time.

MS. GLAVIN: Are there questions for Dan on what he\'s presented, or in
the areas where you\'d like a little further explanation before we move
on?

A PARTICIPANT: \-- .

MS. GLAVIN: Can you come up to the mike, please?

JOHN DROZD: Doctor, you said that this incorporated 381.150 \-- the
regulation stated that the cooking of poultry was at 160 but there is
another part of it, 381.150, that allowed the cooking of poultry to 155
with the addition of nitrites. Now is that also going to be included
into this or had that changed?

DR. ENGELJOHN: I would say, yes, that it is included in this proposed
rule. Just so you know, we have removed the specific requirement that
381.150 currently has with regard to the 160 and 155. We now have it as
a performance standard and have the 155 for cured poultry products or
160 for ready-to-eat poultry products in our compliance guidance. So
that is something that you can continue to do. This proposal would not
change those provisions.

MS. GLAVIN: Could I just ask you to give your name for the reporter?

JOHN DROZD: John Drozd.

MS. GLAVIN: Thank you.

JENNY SCOTT: Jenny Scott from National Food Processors Association. Dan,
would you elaborate a little bit. You said that manufacturers could meet
the probabilities of the performance standards by looking at their own
worst case product and developing a \-- what type of information would
satisfy you in terms of establishing worse case that is different from
the worse case in the baseline?

DR. ENGELJOHN: Okay. As is provided in the current cooked poultry
regulations as an example, this proposal does not change the intent,
which was we wanted to provide flexibility to industry so you didn\'t
have to meet a flat lethality requirement. That you should be able to
use innovative lethality or control the number of organisms on your
source materials such that the profile of those organisms, the levels
and types of organisms may, in fact, be lower than those that FSIS has
assumed for the baseline.

If that\'s the case, then you should be able to in your procedures of
how you would document your control over the level of incoming
perfringens, how you\'ve established the microbial level in profiles of
that and maintain that, and establish your own worse case. That
information would be made part of your documentation for your hazard
analysis that you would ultimately use for your HACCP plan.

So that the intent of the proposal is clearly to allow you the
flexibility to achieve different levels of cooking and lethality, in
fact, but still achieve the same probability of survival so that we have
a level playing field for the objective outcome. But you can achieve it
in whatever manner you are able to document as being equivalent. That
would be something we would expect you to have on file on file as part
of your hazard analysis documentation.

We have not prepared a great deal of guidance at this time on what we
would believe to be the absolute components of that type of
documentation other than what\'s presented in the technical paper that
was made available as part of this proposed rule, which described how
the Agency determined its worse case. It has a great deal of
mathematical modeling in there.

That was how we determined our worst case. We believe we built in the
flexibility that you should be able to establish your own methodology
for that and verify and validate that that, in fact, is sufficient. If
we need to provide more information on development of that type of
guidance that would be the type of thing we would want you to
incorporate into your comments.

MS. GLAVIN: Katie?

MS. HANIGAN: Katie Hanigan from Farmland Foods. I have a question on
heat treated products. My question is if a processor would decide to
process a product that is normally considered heat treated, that they
had processed it to a temperature that basically makes it a ready-to-eat
product based on lethality performance standards from a regulatory
standpoint, do I now have a fully cooked product as far as the HACCP
program is concerned or is this still \-- can it still be called heat
treated, not shelf stable for a HACCP program? How do all of these
regulations come into effect here, or proposed regulations?

DR. ENGELJOHN: I don\'t recall that we had a discussion about the issue
of designating products ready-to-eat or not ready-to-eat in the
proposal. There was certainly some \-- a limited discussion about that.

The intent of this proposed rule was not to define what products are
ready-to-eat and which ones are not ready-to-eat. That would be a
different rulemaking that the Agency would choose to pursue at some
later date. There are certain products that the Agency believes that it
has defined in the same identity or composition as being ready-to-eat
and there would be no opportunity to review those \-- to modify that.

As an example, a hot dog. We consider that under the standard of
identity and composition to be a cooked sausage and, therefore, a
ready-to-eat product. That is within the Agency\'s policy on that.

This particular rulemaking was not intended to define which products
were ready-to-eat or were not. To answer your question or to give you
some guidance \-- and I encourage you to also write that down and put it
into a comment so that we are sure to address it \-- that you as the
industry should have the opportunity to determine through your hazard
analysis what category of products you believe your process should be
in.

Depending on how you choose to label that product, if there are no other
limitations for you in terms of if there is no standard of identity or
composition that would limit you as to what that product should be, then
if you chose to identify that as heat treated not ready-to-eat product
or a heat treated, not shelf stable, I think that should be a
determination you have. As far as how the Agency implements that,
that\'s an issue that we need to be made aware of so that we can also
address that in how we implement our ready-to-eat sampling program.

But right now, if you choose to apply a lethality to a product that\'s
greater, you\'ve chosen to do that for a variety of reasons but are
choosing to label that product as a not ready-to-eat product. We don\'t
have a regulation that would prohibit you from doing that and marketing
that product as a non ready-to-eat product.

We do have concerns, however, about how the consumer interprets the
information contained on that label and how they handle it. But again,
as I said, that would be another issue we would choose to pursue in
another rulemaking. I encourage you to put that question forward in your
comments.

MS. HANIGAN: Just for further clarification and I\'m not trying to put
anyone on the spot, but let me make sure I understand what you\'ve just
told me. If I use the neckbones as an example, are you saying that they
would not be \-- they should not be sampled then by FSIS for listeria
because they \-- under the Agency definition, they are not considered a
ready-to-eat product regardless of what our lethality process is? Is
that what \-- was that partially what you just said to me?

DR. ENGELJOHN: That\'s partially what I said. Again, I think this is an
issue of clarity on how we implement the policy to date versus the
proposed rule. So I think if we can address this in another format then
we certainly will take this back into consideration. I know we get
questions about how the Agency institutes it\'s sampling program but we
are dependent in part on what the establishments do for labeling of that
product and how they\'ve defined it in their master plan.

We have established criteria that we use for how we direct our sampling
program. Again I think the Agency is interested in information on that
issue and we\'ll do what we can to try to clarify it, but I think
that\'s separate at the moment from this proposal.

MS. HANIGAN: Okay. Thank you.

MS. GLAVIN: Back here?

A PARTICIPANT: \-- from Mcdonalds. I have a question. Normally if
you\'re going to establish an equivalent lethality to \-- a certain log
reduction as you indicated. That\'s dependent I think on a D value or a
Z value for the specific organism that you\'re measuring the lethality
against. Is somewhere there that you consider to be a representative D
value or Z value for the different organisms as someone who was working
through the lethality calculations to see whether or not their process
meets the log reduction or is that up to the company to, you know, do
their research and pick a number?

DR. ENGELJOHN: I would say on that, again, that would be an issue that
we as an Agency I believe had intended to provide the greatest amount of
flexibility to the industry to use their data that they believe to be
valid information to support their processes.

We have provided our compliance guidance based on published literature
as well as information that we have available to us. Where possible
we\'ve tried to make that part of or cite that information within the
compliance guidance themselves, so that you know what information we
used to derive our performance standards in what D values and Z values.

An example would be with the cultured ones that we have included in the
labor compliance guide. The information that\'s soon to be published is
not yet available. It was conducted by the Agriculture Research Service
as a submitted publication. It represents, we believe for the first time
published data on poultry that hasn\'t been available before. But if you
have your own data and that\'s what you use as your documentation for
your facility then that should be sufficient for you to use.

A PARTICIPANT: Thank you.

MS. GLAVIN: Can you speak into a microphone please.

A PARTICIPANT: I\'m \-- from the \-- Research Center. Dr. Engeljohn had
mentioned about the kind of \-- contamination and \-- is going to be
published in the International Journal of Food Microbiology, hopefully
in a month. But I do have at this time a draft copy of it. I\'d be
willing to give you a copy of that.

DR. ENGELJOHN: Thank you.

MS. GLAVIN: Thank you very much. That\'s a very generous offer. Jenny?

A PARTICIPANT: I have a follow-up question. Once you publish D values
for salmonella in poultry for food safety, I haven\'t looked at DJ\'s
(phonetic) work yet. I don\'t know if our D values are comparable but
let\'s assume that there is a difference, and companies see a
difference, and the R values are supposed to be greater, vice versa and
they happen to be lower, what is the the Agency\'s position going to be
if they published data that may not be the same?

DR. ENGELJOHN: It\'s a valid point that needs considering the
development of the compliance guide that we put together. Where possible
we try to take all of the available information and if we\'ve made
assumptions in terms of deriving our outcome of what we actually put in
there, we try to make it known as to how we have either summarized the
two data points or whether or not we\'ve chosen the more conservative.

Where possible we try to \-- we will change \--update the data in the
compliance guidance as frequently as we possible can, make them
available to our inspection field force but, most importantly, to the
small businesses who really will have a great value derived from them.

So as the information becomes available and there are differences, I
would guess that our technical staff would try to look at them, try to
resolve differences between the two or explain which ones you use and
the limitations of them. If they can provide both of them and believe
them both to be adequate in terms of the \-- then there\'s no reason why
we wouldn\'t publish both of them in our guidance.

A PARTICIPANT: Excuse me. I\'d like to make a comment. Two weeks ago in
the Journal of Food Science, we published a paper in which we screened
more than 50 strains of salmonella. That \-- different \-- species and
the CDC and we have industries from all over the US and after that paper
was published we selected several types of salmonella that we had
decided to use as a \-- we decided to use in our studies with \-- and
\-- ..

The paper that is going to appear \-- was and that was \-- those issues
that \-- talking about isolated \-- species as \-- were used. Currently
we are working on developing a different model also by \-- also \-- for
salmonella and, of course, \-- that we had \-- what strains to use. So
that was the result of this paper which was published in the Journal of
Food Science.

MS. GLAVIN: Thank you. Are there other questions? Kim? Could I ask you
all to let me know if someone behind me would like to speak?

MS. RICE: Sure.

MS. GLAVIN: Thank you.

(Laughter.)

MS. RICE: I\'m Kim Rice with the American Institute for Food. I want to
go back to Katie\'s question on the definition of a non ready-to-eat
versus a ready-to-eat product. I think it\'s important that the Agency
do that at the same time or in conjunction with this rule because that
has been the biggest issue, as you all know, because you get more phone
calls than probably anybody else on that specific issue as it relates to
the directive and what products are considered ready-to-eat and
not-ready-to-eat, especially when it comes to the small and very small
facilities and whether they\'re going to meet these requirements or not.

So I think you really need to think about doing that at the same time,
not separate, after, or later.

DR. ENGELJOHN: Just let me get some clarity on that Kim, you\'re asking
that we define which products are ready-to-eat versus which ones are not
or make clear of the conditions under which we\'re going to sample a
ready-to-eat product?

MS. RICE: I think \--

DR. ENGELJOHN: Which is the issue?

MS. RICE: Both. Who and what these requirements apply to and don\'t
apply to.

MS. GLAVIN: It seems \-- one moment, it seems to me that that comment
would \-- written comments would be extremely helpful if you provided
some proposed definitions.

MS. RICE: Okay.

MS. GLAVIN: It would be more helpful than \'just do it.\'

MS. RICE: We intend to.

MS. GLAVIN: Yes, okay. Thank you. I\'m going to go to Bernie. He\'s had
his hand up for a while and then Katie.

MR. SHIRES: Bernie Shires, American Association of Meat Processors.
Basically I just wanted to reinforce what Kim just said. This is a big
issue for us. We\'ve gotten loads of calls about this, as well. We are
planning to provide some examples and some possible suggestions.

But this \-- again this is going back to the directive. It\'s a major
problem and it seems that this would be a good \-- it seems to us that
this would be a good place to do this in the rule if that\'s \-- you
know, because if the rule comes to be that\'s, you know, basically to
replace the directive I think anyway, the way it stands. So it just
makes sense, common sense, to do it.

MS. GLAVIN: Phil?

MR. DERFLER: I would encourage people to speak your comments to the
rule, but if there are problems with the directive now, speak right to
me, okay. I mean you try \-- you try \-- I don\'t know if we\'re getting
closer or further away, but I mean if there are problems, let us know.

MS. GLAVIN: Okay. I\'ve got Katie lined up next. Katie?

MS. HANIGAN: Just as a follow-up on that, Dan. I think the confusion
that we felt accompanies that statement that comes in on the partially
cooked. I don\'t mean to keep beating this thing to death, but that
statement that comes in or does it appear to be fairly cooked by the
consumer?

I mean there comes a point in time when the consumer needs to read the
label and see if it says it\'s fully cooked or not. I think that\'s
where part of the confusion comes in with some of this partially cooked,
fully cooked and does appear to be partially cooked. I thought maybe you
could just make a note on that and I will comment on that, as well.

DR. ENGELJOHN: Okay.

MS. GLAVIN: Thank you.

MS. SWANSON: Katie Swanson from Pillsbury Company. One of the
definitions that should be considered for ready-to-eat for harmonization
purposes might be in the food code. That would help manufacturers that
are subject to both USDA and FDA regulations in the same processing
facility.

Work with one definition in addition to harmonizing across state and
local agencies throughout the country. That is something the Agency
needs to be working on at this point because people need a common
system.

DR. ENGELJOHN: Thank you for bringing that up. I would ask though that
if you do in fact submit those in written comment, could give us a
specific issue as to why they aren\'t comparable? Okay.

MS. GLAVIN: Again, my understanding is that we\'re dealing with two
connected but different issues. One is the definition for the purposes
of this regulation and to what it applies, and the other one is the
question of our sampling program.

MR. BERNARD: Dave Bernard. I\'d like a couple of clarifications, if I
may. See if my notes were correct.

Dan, were you saying that you\'re proposing a different performance
standard for fermented beef items than for cooked beef items?

DR. ENGELJOHN: For fermented beef items, any product that contains any
meat and fermented beef, meaning a poultry product that is fermented and
has some beef in it.

In addition to the salmonella \-- standard, we also would have to
address E.coli 0157:H7. So for fermented products containing beef and
that are fermented will have an additional performance standard \-- than
just salmonella. All ready-to-eat products would have to address
salmonella, but those products containing fermented beef would also have
to address E.coli 0157:H7.

MR. BERNARD: If I were to make an all beef summer sausage would I have
the same performance criteria to meet as if I were cooking a hamburger
patty?

DR. ENGELJOHN: If you were making an all beef fermented sausage, if that
was your question, versus an all beef cooked patty?

MR. BERNARD: Yes.

DR. ENGELJOHN: For an all beef fermented product you would also have to
also address 0157:H7 specifically as a performance standard. You would
not address specifically as a performance standard 0157 for a beef
patty.

MR. BERNARD: We\'re going to have to address salmonella for the summer
sausage?

DR. ENGELJOHN: Yes. All ready-to-eat meat and poultry products address
salmonella. Both containing fermented beef would also address 0157.

MR. BERNARD: Okay. Regarding the stabilization standard, you\'re
proposing that the stabilization standard be continued throughout the
transportation shelf life of the product?

DR. ENGELJOHN: Yes. If I could just go over that slide just so that
you\'ll see. Could I have this slide turned on for a second?

MS. GLAVIN: Okay.

(Pause.)

DR. ENGELJOHN: For stabilization, the performance standards must be
validated to maintain the requirements throughout its shelf life under
the conditions in which the food is stored, distributed and held.

To get a \-- in part we have been made aware since we\'ve issued the
previous final rule, situations where ready-to-eat cooked and cooled
cooked products have been sliced and then reheated either nominally or
completely. So the issue was then to address the performance standard,
if you\'re in that situation where you have control over both of them,
to address whether or not you\'re meeting the one log growth of
perfringen rule combination process.

MR. BERNARD: I\'m trying to understand and I thank you for that
clarification. If I am a processor, for example, I\'m going to pick a
species \-- let\'s see, it\'s a whole muscle piece that is to be sold to
a distributor for further distribution. Where does my burden as the
primary processor end, with regard to this performance standard?

DR. ENGELJOHN: While you have control over the product \-- operation and
you\'re applying the heat treatment or in some fashion having to deal
with the stability performance standard so that you cool that product
properly. While it\'s under your control, you would have the obligation
to meet these performance standards.

So once you \-- as an example, once you heated it, cooled it and then
when you open it out of the package and slice it and then pour gravy on
it and then repackage it and then cool it, you would deal with that as
an entire process and ensure that you are meeting this performance
standard.

Once you\'ve cooled it down sufficiently so that microorganism then
becomes an issue, then the intent would be that that goes on into
distribution and wherever the next point is, whoever has control over it
at that point would deal with the performance standard at that point.

MR. BERNARD: Okay. And as a final question, do we have any information
regarding \-- that would lead us to believe that products produced in
current convention in terms of performance standards or whatever the
current convention is. If the product is properly cooked according to
current convention, have we had health problems due to survivors?

DR. ENGELJOHN: Did you mean for the organism stabilization or for the
lethality, as well?

MR. BERNARD: For the lethality? For example, using the current, I
believe it\'s five log inactivation for fully cooked patties? If someone
has met that, does that result in any problems?

DR. ENGELJOHN: The Agency, before the proposal, we had a discussion
about the modification or the proposed modification to the cooked meat
patty requirements. For those of you not familiar with cooked meat
patties, we presently have a prescriptive requirement for cooked meat
patties for in that they have to meet a very specific time/temperature
combination to make them ready to eat and that we believe to be a five
log reduction for salmonella.

This proposed rule would change that and make it a \-- we\'re proposing
a six and a half log reduction for cooked meat patties. We do not have
evidence or reason to believe that the current processes are inadequate
but the proposal goes through the discussion, and I would encourage you
to specifically look at the discussion in the Preamble, that identifies
that in order to establish our worst case, which we are using the
national baselines for raw beef, the same materials used to make the
roast beef products or other roasted or cooked beef products are also
used to make the cooked meat patty products.

Because we\'ve established the worse case on the highest, most probable
number we have then determined that the roast beef category and the
cooked meat category should have the same performance standard, which is
a six and a half log reduction instead of a five. The Agency is
specifically looking for comment on that issue and whether or not the
assumptions that the source materials are the same and should be derived
differently.

I did mention that in order to determine the worst case for the meat
products for lethality we pooled the results from the ground beef
baseline surveys and the carcass surveys and made them into one sample
set. If for your analysis and your belief that they should be maintained
separately, that is what the Agency is seeking comment on, so that we
can make the determination that there may need to be different
performance standards for different categories of product.

MR. BERNARD: Thank you.

MS. GLAVIN: Stan Emerling.

STAN: Stan Emerling representing the American Meat Processing
Association. I guess for clarification in listening to the requests of
definitions of what we\'re talking about; are you considering going in
the direction of putting things that are cooked, fully cooked,
ready-to-eat into different categories for each one of those? I remember
back from years ago, there was a big confusion as to what beef products
\-- .

DR. ENGELJOHN: I would \-- just so that you formulate your comments on
that issue. The Agency doesn\'t specifically \-- was not specifically
looking for comments on how we should define products as what\'s
ready-to-eat and what\'s not ready-to-eat in terms of what goes in the
product label.

Although that certainly can be a comment that you

register for this rule, since definitions as to what they apply to for
the lethality standard versus what they apply to for consumer
distinction. And I would encourage you to continue to think about those
issues.

I will say that the Agency through the Listeria reassessment that we had
years ago and had the issues on \-- relating to not ready-to-eat versus
ready-to-eat \-- we did provide guidance in the directive that we issued
to our employees as to some of the criteria that can be used to make
some distinctions of when a product is ready-to-eat and when it\'s not.
Some of that relates to how the product was labeled and whether or not
that\'s distinctive enough for the consumer to be able to discern
whether or not they need to handle this product differently if it\'s not
a ready-to-eat product.

MS. GLAVIN: Katie and then Bruce.

A PARTICIPANT: Katie \-- from the National Food Processors Association.
I have a stabilization question for you. In your guidance document you
indicate that several steps can be done to demonstrate that someone\'s
meeting the performance standards for cooling is going to get cool \--
and you indicated \-- you said that \-- that was because it grows faster
than C. botulimon and \-- yet in the Preamble the suggestion that under
certain circumstances there may be \-- . Can you clarify this?

DR. ENGELJOHN: I would say that the Agency \-- that the Agency made some
assumptions in the Preamble on the issue of stabilization that C.
perfringens generally grows faster than botulimon and that under most
circumstances there are other inhibitors there that could be addressing
botulimon. Through your validation studies it may not be necessary to do
so.

What we would look for is if you as a company were to address this issue
would be to assume if this were to be a final rule, or if you\'re making
the poultry products and the roast beef products today that you would
still need to address the issue of botulimon because they are regulatory
performance standards.

So in your hazard analysis of what areas that you\'re doing you would
still need to address that particular organism or any other \-- that
may, in fact, be there as part of the toxins or toxin compatibytes that
could grow out.

But specifically for stabilization, perfringens is the one that we were
most concerned about because of the inhibitors that we\'re aware of for
botulimon. We would expect you to have that type of documentation on
file as part of your HACCP program.

MS. GLAVIN: Katie.

MS. SWANSON: I\'m Katie Swanson with the Pillsbury Company. I have a
related question. I\'m not aware of \-- I\'d like the Agency\'s comments
on the types of methods or validation that they would expect to have
with respect to botulimon growth because the technology in that area
really isn\'t available. I mean how do we do it?

(Laughter.)

DR. ENGELJOHN: I have no help.

(Laughter.)

I\'m sorry. In terms of the question you\'re asking, if you were an
industry member and you wanted to do your own validating studies to
address those services the stabilization performance standards \--

MS. SWANSON: Mm-hmm.

DR. ENGELJOHN: And you\'re asking for guidance. I haven\'t indicated it
today but I will make it \-- I do know that people that work on our
technical compliance guidance are here and we\'ll get together and we
will, in fact, take up that issue specifically in terms of the
compliance studies that we put together.

I\'m hearing that we need to provide more guidance on doing validating
studies and I can tell you that within the Agency, validation
determinations are something that we are actively working on as a
separate issue.

But in terms of the compliance guidance, I clearly will make a note of
that. I do believe that we can and should be making more information
available to you. We\'ll be seeking from you, the industry and academia,
assistance or guidance and input as to what would constitute sufficiency
for those issues.

MS. SWANSON: Okay.

A PARTICIPANT: Excuse me, I\'d like to make a comment. C.botulimon, if
you recall about 10 years ago, Dr. Weingarten (phonetic) published a
paper regarding the requirements or the guidelines for \-- studies in
C.botulimon.

Traditionally \-- toxin production that has always been a concern and
all the publications in the past have been related to that kind of toxin
production. And of course, as Dr. Engeljohn mentioned, there is nothing
available as far as the minimum number of what \-- cells of C.botulimon
or the extent of growth that is required to produce a particular level
of the toxin, and this is documented in the research on the kind or the
germination of C.botulimon cells.

MS. GLAVIN: Bruce and then Joe.

MR. TOMPKIN: If I may \--

MS. GLAVIN: First can you introduce \--

MR. TOMPKIN: My name is Bruce Tompkin and I\'m from ConAgra. First I\'d
like to know, at this point in the deliberations we are just asking
questions for clarification of what was just presented, correct?

MS. GLAVIN: Yes.

MR. TOMPKIN: Okay. With regard to C.botulimon we have had an extensive
botulimon challenge testing program in place and companies for which I
have worked, going from about 1955 through \'85 and we are no longer in
that business. Quite frankly, the policies with regard to having mice in
facilities is very strictly controlled.

The number of laboratories available in the United States for conducting
botulimon research is very small, and historically I\'m hard pressed to
come up with an example of a meat or poultry product that has been
implicated in botulism \-- was produced under Federal inspection and
that goes back through decades.

So I think we\'re lacking epidemiology \-- concern for the pathogen and
suggest that we delete it from consideration in this proposal and that
we focus on the target organism of concern and that is C.perfringens.

My third \-- if I can switch to the third topic \--

MS. GLAVIN: Sure.

MR. TOMPKIN: \-- it relates to an entirely different thing and I don\'t
know that you can \-- anyone can give us the answer today but I would
like to see the Agency pursue the answer to this question.

In the baseline studies the data are presented in terms of number
samples and number samples positive and for those samples that were
positive, quantitative measurements were made. The values were recorded
as log mean and geometric mean.

A footnote states, \"Estimates, these estimates for log mean and
geometric mean\" \-- estimates, they\'re estimates \-- \"and they are
weighted by weekly production with an adjustment for the non-responders
and non producers.\"

I don\'t know what that means but it almost sounds like they biased the
data or slanted the data based on weekly production in the facility and
that was a single sample. So I\'d like to know whether that was true or
not and what that did to the data?

DR. ENGELJOHN: That would be something that need to address in our
analysis of comments that come in. If we can do something ahead of that
time if there is another opportunity for us to have a follow-up in any
case in a public way then we\'ll be \-- we\'ll try to have an
appropriate response for that, as well.

MS. GLAVIN: Joe?

JOE: Good morning, Maggie. Thank you. Dan, I want to revisit the
citation that you have up right now. They raise some questions at least
in my mind when you were talking about it.

It was clear enough that if you have a one log target during chilling or
cooling with the stabilization of the product and if you heat it again
you have to you have to hit at that target again. But the way this
reads, it says that, I cook my product, I stabilize it, I meet the
target and then I put it into distribution, my warehouse. If I have a 16
week shelf life product. If this goes out during that 16 weeks I fail.
Is that the intention?

DR. ENGELJOHN: Part of the way the performance standard for this
particular issue is written is that in the identification of your hazard
analysis and your HACCP planning, you would be developing your program
to address the expected handling practices of your product. If, in fact,
you\'re going to \-- if you have identified that this is going to have a
long distribution or it\'s going to be held under fluctuating
temperatures, our expectation is, it\'s written that would address those
in the way you\'ve address your survey \--

JOE: Part of the discussion that\'s come up during listeria, shelf life
and outgrowth and what not, but as this was originally proposed I
understood it to give a different type of target, a process control
target here and it seems to imply something different now.

DR. ENGELJOHN: At least the way it\'s worded.

JOE: Excuse me?

DR. ENGELJOHN: I would just \-- if you could just in your written
comments, if you could just make it real clear as to the differences of
how you think it\'s being interpreted now versus what you thought it was
before.

JOE: Well, I can do that real quick. On your conditions in which food is
stored, distributed and held your prior discussion with Dane was clear
enough, if it changes hands, it\'s no longer my problem, it\'s somebody
else\'s.

But I\'m holding it in my warehouse and it\'s already met the target
temperature, stabilization temperature, without allowing one log
outgrowth of C.botulimon which is specified.

But the way this is written right now it\'s open-ended so that if
outgrowth were to occur even though I\'ve hit all of your defined
targets, your standards, I can still fail.

DR. ENGELJOHN: Okay. We will reassess this language and see if we can
make it more clear.

JOE: Okay. Thank you.

DR. ENGELJOHN: Thank you.

MS. GLAVIN: Yes?

MS. RICE: That same language I believe appears in the lethality section,
as well.

DR. ENGELJOHN: Yes. The language is exactly the same in lethality. I can
tell you on the lethality in part it\'s \-- the issue here is that it\'s
maintaining. The lethality is in part to prevent recontamination while
it\'s under your control. So in part, that\'s what this deals with. But
clearly we will look for whatever input that you give us on this and we
certainly will take this under advisement for clarity.

MS. GLAVIN: I\'d like to suggest if people are amenable that we take a
brief 10 minute break for people to collect their thoughts. There has
been alot of good discussion.

(Off the record at 10:20 a.m.)

(On the record at 10:40 a.m.)

MR. DERFLER: Does anybody have any remaining questions? Does anybody
have any remaining questions about the presentation this morning? Come
right up Stan.

MR. EMERLING: I\'m Stan Emerling. I\'m having a serious problem with how
plausible some of the issues that were brought up are, concerning how
far do we go in checking? I can\'t even see how a distributor who takes
a fully cooked product is responsible for maintaining the parameters, if
you say. First of all, I\'m not sure how the \-- first are vilified.

You would have to guess under a HACCP plan, you could decide whether
it\'s even further distributed \-- which would be a compliance issue.
But then I\'m having trouble because if it goes down one way it\'s
written, whether it\'s in the refrigerator of the consumer at home, and
let it rise above what \-- you can go in and check their fork \-- this
is just out of the top of my head, but I\'m having trouble with the way
it\'s written, if that\'s the way it could be interpreted but also how
would you identify it \-- ? Thank you.

DR. ENGELJOHN: I thank you for your comments and I think we got the
message that the language may need some tweaking just to make clear that
while this product is under the control of an establishment they have
certain responsibilities for it. Once it leaves their control that
responsibility changes somewhat.

Although, if you don\'t have a \"keep refrigerated\" statement on there,
you don\'t have the types of controls in place that give the purchaser
of that product some indication of how to properly handle it, then that
is a concern. This was not intended the way it was written to change the
current practices that are in place. It was just intended to make clear
the obligations in meeting the performance standards.

So if it still is confusing to you I would encourage you to make more
clear your concern about this in your written comments.

A PARTICIPANT: Okay.

MR. DERFLER: Any other remaining concerns about the presentation you
heard today?

MS. SCOTT: Jenny Scott, National Food Processors Association. Dan, I\'d
like you to clarify something with regard to cooked product that is
subsequently reheated. Where there\'s language in there that suggests
that two cooling steps combined should yield no more than one log growth
of C.perfringens.

But if you\'re receiving a fully cooked item from another manufacturer
and then heat it yourself and cool it down, are you expected to go back
to that manufacturer and get data on whether you\'ve got one-half of log
growth of perfringen \-- so that you can adjust your cooling? Is that
the intention?

DR. ENGELJOHN: There\'s a certain way that it\'s written up in terms of
the premium on the discussion on this performance standard, was that we
waived the issue of multiple processing status. And that we really
didn\'t get from industry and academia on the issues related to how we
applied this performance standard.

I would say that the way that it\'s written there would be in part that
you have the obligation to look at it in a cumulative manner. We brought
up that discussion in the Preamble so that we could get comment on that,
but it was also intended to raise the issue of could this performance
standard for stabilization be more clearly written, written in a manner
to provide you some greater flexibility. You don\'t have flexibility
with it right now, it\'s a flat one involving growth and \-- we have
received suggestions before and we are expecting to receive written
supportable comments on the issue of maybe making the performance
standard more flexible.

MR. HARRIS: I\'m Joe Harris with Southwest Meat Association. I have a
question about the \-- on the stabilization performance standards. In
your presentation today on the proposed rule, cured products really
didn\'t specifically address relative to the stabilization and the
potential growth of particular C.perfringens.

In some of your previous rulemaking, there was a provision for a delayed
chilling, a slower chilling process with cured products. I guess my
question is do you remember similar provisions being provided? Secondly,
how does the Agency go about determining that?

I\'m really not aware of any process \-- problem with outgrowth of
perfringens on cured product. Almost \-- chilling or lack of chilling
conditions. So I guess I\'m just interested in how the Agency is
approaching that.

DR. ENGELJOHN: I would suggest that when you have the opportunity, look
through the rule and if you can \-- also look at the compliance guidance
that\'s sitting out on the table in the lobby.

We haven\'t changed our provisions with regard to stabilization for the
ready-to-eat products, those that have been cooked and that contain
cure, and that in the Appendix B to the final law on roast beef and
cooked poultry, we did include additional guidance for ready-to-eat
products that have been cooked and then cooled, but contain a minimum
level of nitrites to control those C.botulimon and to control the
perfringens.

So the current \-- compliance guide, Appendix B, does contain some
examples of sufficient cooling procedures or stabilization procedures
for cured products but they\'re also dependent upon a minimum level of
nitrite.

The Agency is open to additional new data or information that would
support additional or alternative cooling for cured products. If you
make that information available to us and it would necessitate a
modification of the compliance guidance, that would be what we would
want to do. So I would encourage you to provide that.

The Agency has made the determination though that all ready-to-eat
products, in this proposed rule anyway, will need to address the
performance standard for stabilization whether or not they\'re cured.

MR. HARRIS: Okay.

MR. DERFLER: Go ahead.

MS. SCOTT: Jenny Scott, National Food Processors Association. With
regard to the lethality performance standard, this is proposed for meat
and poultry products. But if you\'re starting with a fully cooked item
where the meat or poultry product has already met the performance
standard, is it the Agency\'s expectation that when you combine this
with other \-- you need to give it the same lethality step again, or
could an alternative be designed based on what you feel might be
necessary with the ingredients that you are adding to the product?

DR. ENGELJOHN: Again, there was a very limited discussion about this
issue of entrees and application to this lethality performance standard.

If you\'re simply assembling products, that\'s one issue for which the
Agency is seeking comment as to how the Agency should apply the
performance standards to products that are just simply formulated as
opposed to processed, in which the lethality is \-- or is necessitated.
So I would say that we are looking for input on that issue.

We do see a distinction between formulating or just assembling versus
actually applying an additional process that would impart some type of
lethality. In any case, we believe that the alternative probability
that\'s provided there, should provide the flexibility to address that
issue.

MR. DERFLER: Anybody else with questions for clarification?

A PARTICIPANT: On the \-- on the cured meat product, we have just
completed \-- in my lab we have just completed the studies regarding the
fate of C.perfringens in the cooling of cured meat products, and the
conclusion was that C.perfringens is not \-- of one fifty-six parts \--
types and all the cured beef, pork and poultry and \-- .

The study will be submitted in a few months and once it is published in
the journal we will share the data with you. Thank you.

DR. ENGELJOHN: Thank you.

MR. DERFLER: Are there any other questions?

(No response.)

Okay. Okay. Now we\'re going to shift to the second part of the meeting,
the second part of this phase of the meeting anyway, which is to get
your comments on the proposed rule. There is an opportunity to sign up
although there will be plenty of opportunity to volunteer. We\'ve only
got one name on the sign up list. Dr. Tompkin, the floor if yours.

DR. TOMPKIN: It\'s a critical distinction to be the only one. My name is
Bruce Tompkin. I am with ConAgra Refrigerated and Prepared Foods. I will
be submitting comments in writing when I have that opportunity to get
those together.

This proposed rule has significant implications internationally. For
example, I\'m only going to discuss a cooling phase in the regulation,
proposed regulation. I know that Australia has \-- the UK both have
adopted some requirements specific to food. We compared them to see if
they illicit our experience or not.

What I have to say will be a result of some work from Martin Kowenoski,
Peter Bodner, Jennifer Smelder (phonetic), and now Peyton Pruitt to some
degree. But Robin will be presenting information in the poster session
at the IAFP. So some of this will appear at that meeting.

I will be addressing solely the stabilization portion, which is \--
cooling. As we all know, C.perfringens certainly is a public health
concern and one that we all have to be addressing. It\'s most commonly
associated with cooked meat and poultry products and stews and a variety
of products in which meat and poultry are added.

To help me out, Caroline Smith DeWaal gave me this last night, and I was
able to then go through and pull out the information relative to
outbreaks that have occurred since 1990 and there are some miscellaneous
ones but relative, and actually they are primarily meat and poultry
products, as history would tell us.

Mexican food \-- there were only 39 outbreaks, reported outbreaks that
is, in the booklet since 1990. Of course, it doesn\'t have complete
information for the last few years. We\'re still waiting for the CDC for
that.

But there\'s just isolated cases of dairy products, tuna salad. Mexican
food is 11 out of the 39; beef, 13; corned beef, which is cured, two;
chicken and turkey products, seven; and pork, three. So really it is a
meat and poultry issue, but we must not think only in terms of roasts or
whole turkeys. We\'re talking about Chicken a la King, etcetera. So
there\'s \-- the reporting is not clear as to the specific foods.

So we certainly do recognize this pathogen as being a public health
concern but the question is, as has been puzzling me; has an outbreak
ever been traced back to a cooling defect in any state or Federally
inspected facility?

I don\'t recall that any of these were associated with that, just as I
remember. Normally if we hear that some of us had a problem, we would
know about it. And the thing is, to go back to maybe a handful that \--
that may have occurred.

Historically, if I may, I\'ve been in the business for 37 years and I
have never been associated with a cooling defect that led to a C.
perfringens problem. I can assure you that power outages did not start
in 1995.

(Laughter.)

So there was a tremendous amount of product being produced over these
years and this never did really surface. Certainly that doesn\'t mean
that we can\'t be cautious and concerned about this possibility.

But I am concerned as to why FSIS has become increasingly concerned
about the rate of chilling in cooked meats and poultry products. I think
it really comes back to the use of challenge tests and the resulting
predictive models. Now please do not misread what I\'m saying. I am not
against the use of challenge tests in predictive models because I
recognize the value they can provide. I\'ve used the predictive models
and they have great value to us. I don\'t think that\'s really where the
issue lies, however.

Now I began \-- for example, that this pathogen multiplies very rapidly
in the range of 90 to 120 degrees fahrenheit and, yes, sodium nitrite
does have \-- has virtually no effect on that rate of growth based on
the studies that we have done, also, in cooked poultry to do that. So
essentially our challenge studies verify what has just been mentioned
just a while ago. They\'re quite in agreement with ARS.

The FSIS estimates derived from the baseline study do lead to a worst
case scenario of 10 and one-fourth per gram of C. perfringens in raw
meat \-- . So for that reason after cooking there is a one log increase
and some of the product would exceed 10 to the fifth.

In fact, it\'s stated, and this is a quote, \"What the amount of product
that would exceed 10 to the sixth would not be significant.\" Well, if
you get a two log increase instead of a one log increase, there\'s
clearly a deviation. In the worst case scenario, we would have people
sick because \-- is generally considered the value with the associated
risk of C.perfringen illness.

So certainly the conclusion that FSIS reached, that cook products under
Federal inspection could be as high as 10 to the fifth per gram and
nearly 10 to the sixth under normal conditions, is really a scary
thought. That\'s why I was wondering why the Agency has created the
guidelines and the recommendations to the industry, particularly in the
last five or six years. Under that scenario we could not tolerate larger
than a one log increase.

So again based on experience over the years and knowing that cooling
deviations have occurred historically in the past and we haven\'t really
seen a problem, the question then is why haven\'t we been experiencing
actually numerous outbreaks from this pathogen with products produced in
Federally inspected facilities? Certainly history shows this is not
true. The question then is why? Why haven\'t we experienced outbreaks of
this nature? That\'s a question that I think the Agency would have asked
itself before issuing it\'s cooling guideline requirements.

As a little side note, I really \-- question \-- I really wonder how
much money has been spent in the past five years knowing what we\'ve
done in our own case to meet the tighter requirements because they have
become \-- are becoming increasingly tighter. I\'m certain that large
quantities of food has been destroyed because the chill rate was beyond
the one log increase predicted by the model. That is reality, also.

I also suspect that the impact has been greatest among smaller producers
who have lacked the technical support to challenge the Agency\'s
determinations as to whether a lot is or is not safe.

Well, to get back to the science. Our lab has been conducting studies to
determine why these products from these plants have not been or have
been rarely implicated in illness as a result of \-- cooling. I\'d like
to summarize and go through some things on what we have learned. First
I\'d like to start with the baseline data. The baseline studies
conducted by the Agency did not look for the number of C. perfringen
scores. And that\'s a very important factor because the real issue is
what is a store population of raw meat going into the cook step because
it\'s that population which will survive, germinate and then multiply.

The Agency assumed that the C. perfringen counts reported in the
baseline studies for raw meat and poultry, also would apply after
cooking. The analysis does not include confirmation for C.perfringens.
So the numbers presented were not really confirmed as C.perfringens and
certainly it was not known whether they were spores. Essentially all
white colonies surrounded by a 2.4 \-- were assumed to be C.perfringens
and counted. So, to summarize, in the baseline data that were used to
reach the worst case scenario, really are not valid and have no true
meaning in terms of arriving at an acceptable or safe cooling guideline.

So what is the actual spore level in meat and poultry? Well, I\'d just
like to give you one example. In cases of baseline study for raw and
ground turkey, there were 296 samples analyzed with 28.1 percent being
positive with a standard error of 3.3. The seven \-- positive samples
were then subjected to a quantitative analysis and there are done at the
same time. I\'m not sure how that was done. But they came up with a
large mean value of 2.08, something over 100 per gram.

So we\'ve been doing studies over a number \-- the last few years,
anyway. We produce ground turkey meat in three plants and so we have had
samples come in to us and we have examined 154 of those. We\'re talking
about samples coming in over a period of months, if not years, certainly
months. What we did was to take the ground product and place it into a
bag and heat it to 160 fahrenheit just as you would the product you
would produce and then analyze it for C.perfringens assuming that
anything we would detect would certainly be spores. All 154 samples were
non-detectible and at a less than three spore per gram count.

To take you back a little bit in history, in 1964 or \'65 we did a
year-long survey for the true effects of anabolic spores in raw meat,
poultry and chicken. This had to do with a \-- contract to determine the
baseline level for pH spores to see if they could arrive at radiation
treatments for food that would ensure their safety. This was focused
towards C.botulimon but the data and the analysis would also have
mentioned the presence of C.perfringens.

It was slanted in a way that the samples were from the bloody neck area
of hogs and beef carcasses. What we took from chicken I don\'t remember.
But out of the 22,358 samples 77 percent had three or fewer spores per
gram and the remaining, 2.8 spores per gram. We too, have had some
deviations which were 180, I think you mentioned other than that
unfortunately, but we represent a variety of producers, but we had 53
that we\'ve examined over the last \-- I don\'t know \-- four or five
years past. We had been looking for the prevalence and number of C.
perfringens.

Initially we were analyzing for any \-- plate count and \-- plate count,
thinking that an \-- plate count would be adequate. I wanted to know is
the product safe or not? But the Agency had difficulty dealing with the
manner of plate count and they wanted a perfringens count. So we\'ve now
started doing that, too.

We have growth on anaerobic plate count of 582 analysis across those
lots. 425 were less than 100 and 55 showed some growth between 100 and
10,000 per gram. Then we did have two that were in the range of 10,000
to 20,000. But that\'s just anaerobic growth. They could also have
picked up lactics and anything else that survived the process and then
multiply.

Specifically, C. perfringens they analyzed 340 samples and 336 were
negative and two were in the range of 11 to 100 and two had greater than
100 per gram and those were 110 and 140 per gram. So it would appear
that at least they\'re not selective in terms of \-- deviation. There
were deviations outside the guideline and we wanted to know what is the
acceptability of this product and what should we do with it?

Well, another thing that we found, this is what Peter Bodner found. That
is not perhaps the sole answer, so in his studies and the Chairman\'s
study is do we inoculate cooked ground turkey, essentially it\'s a
turkey breast formulation to which perfringen spores have been added
prior to being cooked and then subjected to different cooling
temperatures, 90, 100, 120, and so on.

We essentially followed the rate of both and matched what we\'ve been
hearing. Then we put some packages into the refrigerator and analyze
them over time. After one \-- after a 24 hour hold in the refrigerator,
there was a one log reduction. After seven days in the refrigerator
there was a two log reduction. It didn\'t matter whether they were held
at 33, 40 or 50 degrees fahrenheit, the rate of death was comparable in
all three temperatures. So essentially we have an unexpected, perhaps
\-- but it\'s in the literature \-- we shouldn\'t be surprised at this,
but it was an unexpected benefit that Clostridium perfringens does die.
So without extensive growth, we have, perhaps that could help to explain
why there has been no issues.

So I\'m going to go through a few conclusions and then a few
recommendations. The conclusions are that the guideline, the cooling
requirements, are really not based on your solid scientific basis and
that is important for us to deal with. The wording within the FSIS
material with regard to cooling is not warranted. It\'s quite scary and
\--in a way, you know, as I read it and it certainly communicates
concern for this one log increase, to the one log increase. In essence,
it\'s certainly understandable considering the data that they had \--
I\'d like to also suggest that \-- this is kind of a bold statement \--
that C. perfringens is not a hazard that is reasonably likely to occur.
Now I don\'t know that I\'m going to go that far, but I said it.

(Laughter.)

So that raises the question do you really need a CCP for cooling? Of
course. I would suggest that the majority of Clostridium perfringens
outbreaks actually occur at food service and at home where the product
is heated and held at wrong temperatures and then consumed while a high
population is still present. Perhaps in the past where we have had
perfringens growth in some products, perhaps some die off over the time
between production and when the product is actually prepared for serving
or consumed that, in fact, the population may have been low enough \--
and this is speculation, of course \-- that the product was not
hazardous.

So then we can come to some recommendations. It\'s one thing to say what
I\'ve just said and then stop, but I think we need to address the
potential for a public health issue. Certainly the no more than one log
increase is not appropriate, but what would be? The Agency had assumed
10 to the fourth was the worst case so it would almost suggest that we
have up to 10 of the four to work with but I don\'t know that we\'ll go
that far.

That should be considered, whether it\'s a three log increase or not is
one possibility. Another way of looking at this is that the performance
standards should be such that product will not have greater than 500 per
gram at the time that the product is released for shipment.

At the current time the Agency is of the opinion that the risk of
illness is best controlled through processes that are based on challenge
tests and predictive modeling. Those two tools are very important to us
but I would suggest also that more is needed, and that is a reality
check that is based on historical commercial experience and critical
review of the epidemiological experience data. Where do these outbreaks
occur and why do they occur?

I would also propose that in the event of a deviation the product could
be sampled. I know that the guidelines discourage that. We have been
doing it for quite some time because we find it very helpful.
Incidentally, we have found lots that we have destroyed. We have found
lots where we just say, \"Don\'t bother sampling.\" You know, there is a
point in time. It\'s not our intent to save every count \-- our intent
is to produce and make sure that the products that are released and
shipped are in fact, safe poultry. So this is not a means to avoid that
responsibility.

I would suggest that a sampling plan and criteria could be 10 samples
and this is going to be working from \-- approach and would equal 10.
Little \"c\" would equal three \"m\" 100 per gram and large \"M\" 500
per gram. These values would be based on the current methods as
currently used in the compendium of methods and in the microbiology
laboratory guidebook. So in the event of a deviation, our sampling plan
should be an acceptable sampling considering the pathogen and it\'s
relative severity.

So, finally, there\'s one other part and there have been questions here
this morning that dealt with that; is what do we do with these products
that are cooked, chilled and then reheated? For example, for smoking,
browning, caramelizing, searing and charring and in some cases
post-pasteurizing? Which is of course intended to address listeria. But
the Agency is almost saying we have to add those times and temperatures
to our calculations. I would suggest that historically these also have
not been associated with microbiological issues of a public health
nature, anyway, and that they should be permitted to proceed as
traditionally has been done. Thank you.

MS. GLAVIN: Thank you. I\'m sorry I missed the beginning, but that was
very thoughtful of you.

DR. TOMPKIN: That\'s what I did last night.

(Laughter.)

MS. GLAVIN: I would assume that there are questions and comments for Dr.
Tompkin. Anybody either at this table or in \--

MS. HANIGAN: Kim Hanigan, FarmLand Foods, just going back to the
question that Katie from Pillsbury asked that also ties in with Bruce\'s
presentation. FarmLand did contract to have a large challenge study done
in cooling, very costly, very \-- to what Bruce said. Companies have to
make a lot of changes here when these chilling requirements kept
tightening down. Particularly in our large volume areas, and we\'ve
spent significant dollars having our processes replicated and an outside
commercial lab for C. bot. and C. perfringens and the findings from the
outside laboratory that we contracted with support everything that
Bruce\'s work showed here today.

I think also that probably helps Katie over at Pillsbury as to how you
do these studies. We did not do these studies in-house. To get someone
in to replicate your process, and move that to a different lab, and to
get your product over to the lab, and have it inoculated is extremely
costly to the company to have that done.

DR. ENGELJOHN: I would suggest that if possible that that information
should be made available as part of the public process it would greatly
help us inform our office how to move forward as well as how to
redevelop performance guidance.

MS. WACHSMUTH: Bruce, did you anticipate \--did you expect anything to
be any different with botulimon?

DR. TOMPKIN: OK, the question is whether or not I run tests that may
indicate different with regard to Clostridium botulimon. Our experience
here of course, we really did work with the effectiveness of sodium
nitrate and Clostridium botulimon. But as was pointed out earlier, our
endpoint was time swelled, we did not look for rate of growth as I
recall. I have to go back two months, I\'m trying to recall a lot of
data over a lot of years, and I mean I don\'t recall that we really
followed growth rates, germination and growth rates.

But I would \-- one thing, sodium nitrates effect, according to the work
done some time ago by Mike Forrester, was that it actually interferes
with germination. So it has an early effect on the public health risk
potential. Then once its germination starts to multiply, other factors
enter in such as salt concentration and so on. So with the presence of
the amount of iron, there\'s a whole host of factors that enter in.

But I would think that with regard to Clostridium botulimon we do have a
margin of \-- in looking for Clostridium botulimon in a variety of foods
when that was of interest. The prevalence rate was quite low for raw
meat and poultry.

DR. ENGELJOHN: This is Engeljohn. If I could add, while you\'re thinking
about it in your comments and looking back at your data, one of the
issues for which would help us particularly would be if there is any new
information, any specific information, that identifies the specific
level of nitrite needed to eliminate germination and new growth. I think
that is some information that, as we moved into ready-to-eat type
products, we now have to be concerned about what the minimum level of
effectiveness is? For nitrite, along with the other safety factors that
control things after germination, of course, would be \--

DR. TOMPKIN: If I could add one thought about Clostridium perfringens,
Robin is now contributing to pursue this idea. We want to better
understand the effect of salt, 100 percent salt, on Clostridium
perfringens. So we\'re looking at different formulations and different
salt levels, mainly at 110 fahrenheit because we get a pretty good

probe there. So we\'re looking at different formulations, in the case
that it is product specific.

In the case of Cotto salami, for example, we got

no growth. I don\'t exactly know why that is, yet we\'ll try to figure
it out, because I think what we\'re going to get to is there may be some
\-- out there in terms of relative risk depending on the type of
product. A lot of the early work was done with a turkey product because
it\'s high moisture and low salt and certainly ideal for perfringens
growth, and turkey has been in the literature in terms of being
implicated in cases. So we know that bacteria grows rapidly there, but
as you go through the spectrum of a wide variety of processed meat and
poultry products, if you have increasing levels of salt and other
factors that could interact, it could have an impact. So I think we want
to pursue that.

It would suggest also that Mexican foods and the

\-- seems to place those in a little different category. I don\'t know
why we haven\'t found in our case, C. perfringens in those samples. The
epidemiology does suggest that Mexican foods, whether it\'s the spicing
and other things that are inherent in the product, whether those have
any effect on the level that\'s in the food.

MS. GLAVIN: Is there a question here?

MR. KOBAYASHI: My name is John Kobayashi, Washington State Health
Department. I just have some comments with regards to reporting of
Clostridium perfringens food poisoning.

I definitely appreciate the importance of having documentation. The
problem before regulations with regards to the particular issue of \-- .
One warning that I would have with regards to the absence of certain
types of

C. perfringens outbreaks is that at least in my opinion there might be
different types of foodborne outbreaks that we have. C. perfringens
outbreaks are a little more difficult to document and are documented
less frequently than many others such as 0157 listeriosis and so forth.
You don\'t have that sort of stuff with C. perfringens.

While it\'s possible to have a very severe illness with C. perfringens
and colitis, at least what we see in the United States, it\'s something
that\'s right on the lines of viral gastroenteritis. When you have
diarrhea of relatively short duration, it\'s very difficult to convince
people and the department investigators that it\'s worthwhile to collect
the necessary source specimens to document that

C. perfringens has occurred.

I completely agree with Dr. Tompkin\'s assessment that the type of
outbreaks that we\'ve found involving local outbreaks, at least with the
ones I\'ve seen, didn\'t have the flagrant, you know, temperature and
cooling abuses \-- on the other hand, I\'m not sure that I could say
that widespread outbreaks have never occurred. It may be that they\'ve
occurred in the same way the listeriosis outbreaks have occurred, but we
just didn\'t have the tools to identify them at this time. It might be a
good idea to get some input from the CDC folks as to how confident they
are with regards to the absence of widespread outbreaks of listeriosis
and

C. perfringens.

Having said that, I think that it seems to me that the big problem is
not on the regulatory side, but it\'s, I think, the academic
epidemologists who \-- the tools that we have with regard to C.
perfringens investigations.

MS. GLAVIN: Thank you.

DR. TOMPKIN: This might be a good one to give to the National Advisory
Committee.

MS. GLAVIN: Well I think the members are here.

(Laughter.)

Question up here?

MR. SPERBER: I\'m Bill Sperber with Cargill. I didn\'t have the time to
prepare a formal comment, but I will organize some of our data and put
some of it in writing.

I certainly would like commend Bruce for his formal comment that
reinforces my opinion and that of my colleagues that \-\-\-- leading
foodsafety microbiologists on the planet. Incredible!

(Laughter.)

MR. SPERBER: But I would just like to say, as a way of reinforcing his
comments, though I don\'t have all of our data on this; in our own
cooked turkey operations, in order to comply with stabilization
requirements of 1999, we have looked at thousands of samples of cooked
turkey and never found C. perfringens. All of the samples were less than
10 per gram.

In the cooked beef side of things, we were concerned about the remote
potential of C. botulimon growth during extended \-- and in an effort to
comply with the food growth regulations; and this supports Katie
Swanson\'s request to harmonize according to and across the agencies.

We did an incidence study of C. botulimon in cooked meat products. The
actual incidents in terms of percentages was very low. I don\'t remember
the number, whether it was less than one percent. The spores per gram in
positive samples was very low, talking in terms from a barely detectible
amount which is generally around 3 spores per 100 grams. We did further
characterization of those and found that all of the \-- botulimon which
claim to be unable to grow below 50 degrees fahrenheit and we in fact
confirmed that.

The concern of C. botulimon in a lot of \-- in the refrigerated areas is
the potential for non \-- strains to be able to grow during the extended
refrigerated shelf life. But there never has been a reported case of
botulimon from non \-- C. bot. in such products, and our data so far
have confirmed that. We don\'t even find alot of spores, quite likely
because they are quite heat sensitive and we kill them in the normal
cooking process. Thank you.

MS. GLAVIN: Thank you.

DR. TOMPKIN: That sounds fine. In the challenge studies that we did do
with clostridium botulimon, and there are many. Using a canned ham
model, we added salt and so on, essentially formulating a canned ham,
canned minced ham, and we had zero, 50, 100 and 150 parts per million of
nitrite. Even in the cans to which nitrite was not added, as I recall,
it took from 100 spores per gram and it took about two weeks for them to
multiply to such a level for the can to swell and become toxic.

All of that data is readily available still, despite not being on the
Internet, but all of that data are available on clarifying any concerns
relative to clostridium botulimon outgrowth, and that was in \-- that
was in the absence of nitrite.

MS. GLAVIN: Other questions or comments on this presentation? Dane?

MR. BERNARD: Thank you. It\'s a difficult problem in the plants for the
food microbiologists and I certainly echo their sentiments there. Two
observations though if I may. I heard one of our former colleagues once
say, that a microbiologist would rather use someone\'s else\'s
toothbrush than their methods.

In the discussion regarding D values and Z values, echoes essentially
that comment. I prefer seeing that when we get into \-- not really so
much substantially, but could significantly bog down the process here. I
can assure that if one goes through the literature and searches for D
values and Z values and salmonella in various products, you\'re going to
end up with quite a range of differences in those numbers. Many of those
differences will be related to the methodology used at the time. I
personally have my favorite in terms of the methodology to be used, but
that is something we can \-- we can share.

But I just caution and bring up the note that we are going to find a lot
of differences in the published nature of what people may submit. I\'m
not sure that focusing greatly on those differences is going to be very
fruitful because there are ways to get around that, and that deals with
verification and validation and information generally which kind of
brings me to my second point.

When I asked Dan earlier whether we had any indication that current
cooking practices were, in fact, leading to public health problems,
specifically that question is, first all we have is survivors of
pathogens based on current cooks. And echoing John Kobayashi\'s comment,
maybe we don\'t know. I recognize that our data simply isn\'t accurate
for us to be able to tell when we have a widespread outbreak, but to the
best of my knowledge having been a food processing authority for much of
my career, I do not recall a single incident where a well-established,
implemented and accurately executed food processes proved to be the
problem.

If one looks at the outbreaks that we have and then John can echo this,
the one outbreak I think that stands out in people\'s minds is a
restaurant-associated outbreak where undercooking was the problem. We
had gross undercooking. The problem was not missing our target 155
versus 158. We\'re talking about temperatures of 120 to 130 versus 158.

So in my estimation, rather than focus greatly on if the target is the
right target, our money and time would be better spent in focusing on
how we achieve the targets. How we implement, how we design and how we
verify that we\'re achieving the targets should be more beneficial than
reexamining the targets themselves. Just some observations.

Thanks.

MS. GLAVIN: Thank you, Dane. Other questions or comments? Are there
other people \-- as you know, Dr. Tompkin was the only one who was brave
enough to sign up to make a comment.

(Laughter.)

But are there other people who would like to comment on this section of
the program? That is the \-- the presentations on lethality and
stabilization?

(No response.)

Okay. Then what I would suggest is that we ask Dr. Engeljohn and his
colleagues, I gather on the second one, to walk us through \-- they\'re
not here yet? Do we need them? Because we can take an early lunch and
come back.

DR. ENGELJOHN: We can go.

MS. GLAVIN: You can go? All right.

DR. ENGELJOHN: Yes.

MS. GLAVIN: Dan\'s \-- Dan\'s ready to go ahead. This is requirements
for the control of listeria.

DR. ENGELJOHN: I just need some help here with the computer first, I
locked it up somehow.

MS. GLAVIN: If you\'ll hold for just a few minutes while we get our
computer working.

(Pause.)

DR. ENGELJOHN: Okay. I\'m going to walk you through the portion of the
proposed rule that deals \-- deals with the Listeria moncytogenes and
the listeria species testing requirements. I\'ll remind everyone that
this is Docket No. 97-013P. You have the opportunity to submit written
comments and we\'d be more than happy to help you if you have questions
about how to do that as an individual or as an organization. The actual
references in the Federal Register which published on February 27th \--
and again the comment closing date has been extended now to June 28th.

In the new \-- in the proposed rule, Section 9 CFR 433.4(a) we identify
the controls for proposed testing for listeria species. This is an
either/or condition with regard to the requirement. Either control is
through HACCP systems of preventive controls, which would identify
Listeria moncytogenes as a hazard reasonably likened to occur after
lethality treatments but before final packaging.

This control for Listeria moncytogenes is non \-- HACCP system, then it
needs to be controlled by listeria species for testing of the food
contact surfaces. So the requirement would be that you would test food
contact surfaces using the sanitation standard operating procedures for
listeria species. There\'s a mandatory requirement for the SSOP
verification activity for listeria species. For large plants there would
be a minimum of four tests per line per month. For small plants it would
be two tests per line per month and very small plants will be one test
per line per month.

For those of you not familiar with the size requirements, a large plant
would be an establishment with more than 500 employees, 500 or more. A
small one would be 499 or less or fewer employees, but more than 10, and
a very small plant would have 10 or fewer, or less than \$2.5 million in
annual sales.

Sanitation SOP testing requirements for listeria species, in Section 9
CFR 430.4(b) results of listeria testing would be used to verify
sanitation SOPs. This would be for preventing direct product
contamination or adulteration of the product and the results must be
made available to FSIS for review. This is the regulatory language
contained within the proposal. In Section 9 CFR 440.4(b) this is a
positive listeria species result. Establishment must take corrective
actions under 9 CFR 416.15(a) and (b), this is the sanitation SOP
section of the regulations, to determine and demonstrate that the
effective lot or lots are not adulterated with Listeria moncytogenes.
You do this to determine which lot or lots are effected. The
establishment would hold sample and test products for Listeria
moncytogenes and would have procedures in place for disposal of effected
product. That\'s the listeria testing requirement section.

MS. GLAVIN: All right. Any questions or comments on this section?
Perhaps, any food microbiologists from the plant?

DR. TOMPKIN: Well, I\'d prefer to wait until after lunch, whatever I am.

(Laughter.)

The Agency has assumed that relevant to plant size that the larger
facilities would certainly have greater impact with regard to the amount
of exposure and the number of individuals affected and that\'s not
questionable.

However, the majority of listeriosis in the US and elsewhere, is really
associated in isolated cases. If we think through, what does that mean?
One of the cases that \-- just had recently was franks of 101 cases, and
yet we\'re thinking in terms of approximately 2,500 per year. What
really counts for the rest? If they are isolated cases, I\'m not
certain. While the focus for this Agency in our discussions is on, of
course, meat and poultry products, I think we should think in terms of
foods in general. But I\'m not certain that we could really reach a
conclusion that size of the establishment really has a relationship to
rate of exposure in these isolated cases.

MS. GLAVIN: Thank you. Other \-- Kaye? I think Kaye had her hand up. Go
ahead.

MS. WASHSMUTH: I just have a comment on Bruce\'s comment. If we have a
smaller population, a susceptible population, that would be \-- that
could develop listeriosis, then exposure would be in relation to the
amount of contaminated product in the market. If something happened, if
we had a catastrophe at a large plant, than the consequences could be
much worse.

DR. TOMPKIN: That\'s certainly correct.

MS. GLAVIN: Katie?

MS. HANIGAN: Katie Hanigan, Farmland. One concern I have when I see the
portion under listeria control via an SSOP program. I have walked
through in my mind what this would do to one of Farmland\'s plants. Just
to keep the numbers simple, if you will. If you\'re a plant that has 20
packaging lines and you have four different lots of product going down
it each day, because we are under listeria going from clean up to clean
up, we no longer have this two hour window of military coding
(phonetic), and I know we\'re all up to date on that. But you could
literally have four lots of product go over each one of those lines. So
on any \-- if you\'ve got 20 lines and you\'ve got four lots of product
coming off of each line, already your at 80 lots of product and now
we\'re going to do this four times a month, each line is going to be
sampled four times a month. I\'m making the assumption here, I\'m a
large plant. I have 320 lots of products that I would want to hold in
the event that my product contact surface was positive for listeria
species positive.

The concern I have is we physically don\'t have the capacity to hold
that type of product in-house at the plant. We don\'t have the storage
room. We wouldn\'t have enough trailers to put it on to keep them on the
premises. So then if you\'ll try to ship it off-site to a public
warehouse, then pretty soon I\'m going to be in violation of the 1996
Pathogen Reduction Act because I shipped it off-site. I\'ve now put it
into commerce by the definition that we\'re now using of going into
commerce.

So now I have an invalid I would assume, HACCP program, or an inadequate
HACCP program, if I ship this product to a public warehouse to store it
while I\'m trying to hold on and wait for my environmental results. I\'m
just wondering if the Agency has considered how companies are going to
implement this? If you look at a company that has multiple plants like
myself, I have 11 plants. When we start tagging up all this product all
over, from all these plants, I don\'t think there\'s enough
refrigeration capacity in the United States in warehousing to hold all
this.

Of course, I don\'t think a company would be willing to send the product
out into the marketplace and run the risk of getting a positive
environmental on product contact, and then try to take corrective action
to prove the product coming off of that line is negative. I mean you
just couldn\'t run that risk.

DR. ENGELJOHN: Thank you for the comment that you\'ve described. I say
that it really is important for you to address that in your written
comments, particularly the economic impact issues of that. The Agency
did consider the issue of storage and holding the product while testing
does occur.

I do want to just make one clarification statement that you did say that
if you were to ship this product into a warehouse \-- you would not be
allowed to do that. I just need to clarify that the Agency has provided
some clarity in the past in parts of the regulation directive that we
did issue, that the definitions of shipping and produced may have
different connotations. You can still have control over the product and
you haven\'t completed the shipment in your records. So that you still
have control of that product and have not completed the shipment
records, and you want to store it in a warehouse off-site while you\'re
getting the results \-- that way, that\'s perfectly acceptable. If that
does appear to be a problem with how it\'s being addressed, then that\'s
something that we need to know to make sure that we are communicating
that informally today.

So I just want to clarify that one issue. Did you mean that you had
completed your shipment reviews when you shipped it out, or you had not
completed them?

MS. HANIGAN: I meant that we have all the CCPs which were applicable to
this product would be within the establishment. My understanding, Dr.
Engeljohn, of what you just said was that only applies if I have a CCP
located at this warehouse and that would not be the case. I\'m saying
for us all our CCPs would be located within the establishment. Are you
saying that even though they\'ve all \-- they\'re all located within the
Farmland establishment, you can still ship that product without doing
record review? I don\'t think that\'s the current interpretation. I
think the last CCP would have to be at the warehouse. So if you\'re
talking about a warehouse located 200 miles from you, going over to look
at this CCP and do a record review, that in itself presents a whole
other facet to this.

DR. ENGELJOHN: We\'ll make a special point of looking into the issue to
see how we are implying this. I would say that it is not our intent to
have you to do a CCP elsewhere. If you still have control of the
product, similar to your own status in which you can pull that product
back, that was again the consideration that the Agency had, but we will
certainly follow up on that issue.

MS. HANIGAN: And you want me to comment on that, as well, as to what the
definition of in transit \-- into commerce means? You want that included
in the comments?

DR. ENGELJOHN: Well, yes we would like that as part of the record of
what you\'re going to submit, but we can \-- I will look into this other
issue as well meanwhile.

The Agency did make clear that we are looking for economic impact data,
particularly with regard to what the plants do with present practices
and what alternatives or suggestions that you would have for how to deal
with the issue of listeria species positives and the handling of that
product.

If we are presented with sampling plants that are based on science with
regard to how such a program should be devised, that\'s the type of
information also that we\'re looking for.

MS. HANIGAN: Katie Hanigan still at \-- still with Farmland. One other
thing that I think would be helpful, if the Agency could provide some
guidance material as to really what is a scientifically or
statistically-based sampling program, because those questions continue
to come up more and more for those of us out in the field.

Once you look at if you do have a generic positive for listeria species,
if you get into a sampling plan that\'s involving thousands of cases of
product how much testing is enough?

DR. ENGELJOHN: It\'s a very good point. When you recognize that the
guidance available to the industry, in particular small businesses,
it\'s critical. We do want that kind of information. We did not have
access to such information when this rule was pulled together.

I do want to just make it clear because I know there may be some
misunderstanding of the intention of the proposed requirements for
listeria species testing. FSIS has proposed the minimum testing
requirements that we deem necessary to have documented within the
control programs that you have for verification of SSOPs. Those \-- the
level or frequency of \-- was not determined to be based on scientific
efficacy of an appropriate SSOP. So that was the piece that we did not
have and that we made \-- we tried to make clear in the Preamble that we
were seeking information. If we had that information, as quickly as we
have it, we can make it available today for comment and guidance as part
of our compliance information. It also would inform us on how we should
proceed with \-- completion on this issue.

A PARTICIPANT: Charles from \-- I guess I\'m a little bit confused
because I\'m looking at this document that not everybody has seen yet.
But to Katie\'s point, if the samples surface, and we get a positive,
and hopefully that product\'s in the warehouse. But this document here
says, \"Results and follow-up based on product contact surfaces.\"

It says, \"Once the product contact surfaces found is positive for the
number of samples indicated in the HACCP plant for listeria species, the
next modified \-- sample and test \-- .\" So that indicates to me that
if my HACCP plants tests \-- positive twice in a row, for example, then
maybe I\'m testing \-- I\'ll have to test the next lot. But now what you
were saying is that if I find any positive at all, I\'ve got to go back
and test the lot.

Basically in the conversation yesterday I think we resolved that there
is no really a true coloration of listeria species. There was in some
cases and in some cases not. So I just look for some clarification on
exactly where we\'re going with this?

DR. ENGELJOHN: Again, part of where the Agency was coming from that the
issue here is to be able to make a determination that product that
potentially is effected by the listeria species positive on a product
contact surface already the product is not adulterated. The issue is to
make a determination from the justifications and the type of reasoning
that you as an establishment would have to determine why your product
would not be adulterated. You can look for guidance of whatever it is
you want to see in the compliance guide and programs that we put
together as to what would be helpful.

MS. RICE: Kim Rice with the American Food Institute and Dan you may want
to answer this question after lunch when your other colleagues get here.
There were a lot of \-- and you indicated in answering some of these
questions \-- a lot of requests for data in this session. And the Agency
was up front that they didn\'t have data to justify a lot of what they
were proposing. It would be helpful to us in preparing our comments if
the Agency could at least review this afternoon, and perhaps later
provide us with exactly how they need that data to make a decision,
because we\'ve been down this road where you ask for data and we give
you data that\'s not exactly how you may have wanted. So we\'ve got to
go and redo the data oftentimes.

So I would just ask that if you want to handle that right now, we can do
that or if you want to wait until after lunch that would be very helpful
for those of us who are trying to pull information together from our
members and for those companies that are doing it on their own, as well,
to know exactly how the Agency wants it and what they\'re going to need
to make those decisions to justify what you\'re planning to do.

DR. ENGELJOHN: I think we can try to come up with some thoughts on what
we think would be \-- can you tell me what issue you\'re addressing
though? Are there specific issues that you are referring to?

MS. RICE: I\'m talking about this particular section of the rule.

DR. ENGELJOHN: Right.

MR. DERFLER: Are there any more questions?

MS. HANIGAN: I have one more.

MR. DERFLER: Oh, I\'m sorry. Go ahead.

MS. HANIGAN: Perhaps you could answer this this afternoon. But as I
understand it \-- SSOP program that there was, if you will, the way it
was proposed, there was no option at the first listeria species positive
on the product contact surface meant I had to, if you will, prove the
product coming off the line was not adulterated. This is where I get
confused. I thought if I had it in my HACCP program based on what these
compliance guidelines are written, that if my HACCP program says I\'m
going to look for a trend on the product contact surface that we would
take action based on what my HACCP program is saying. Is that \-- is
that not correct?

DR. ENGELJOHN: I\'ll just make some clarity there. There is a slide that
I showed you that gave an either/or situation. You control Listeria
monocytogenes through your HACCP plan as a exposure for ready-to-eat
meat product post lethality treatment \-- control it that way how you
deem necessary in your HACCP plan. And you follow up through your HACCP
plan as to how you\'re going to propose your corrective and follow-up
action and how you\'re going to deal with a listeria positive result as
part of your HACCP ongoing verification.

If you don\'t address Listeria moncytogenes in the HACCP plan, but it\'s
used to deal with the sanitation SSOPs, we would have to follow the
requirements that are listed here, meaning that we would sample at the
frequency \-- listeria species. If you get a positive result, the
establishment has to take corrective action to determine and demonstrate
that the effected lot or lots of product are not adulterated with
Listeria moncytogenes. So if I answered your question correctly, if you
have a HACCP plan controlling Listeria moncytogenes, you would identify
in your HACCP plan what you wanted to do with regard to \-- with regard
to listeria species and so forth. That\'s true, that was our intention
when we wrote this rule.

If you chose not to deal with it in the HACCP plan but through the SSOP,
you have to follow these requirements as a minimum. Our expectation
would be that your sanitation SSOP would have more complete procedures
for your daily ongoing procedures, but at a minimum you would have to
have this level of testing and have this follow-up action if you have a
positive result, but that\'s if you address it solely through the SSOP
and not to HACCP. Did I clarify that?

MS. HANIGAN: Very well. Thank you.

MR. EMERLING: Stan Emerling. The concern I think I have having listened
yesterday \-- and probably I should first disqualify myself as a
science-based person because I am not. I haven\'t had that type of
training but I listen to what I hear here. There seems to be no
consensus whatsoever of any correlation between listeria species and Lm

And I\'m wondering if we support strongly food safety measures, I mean
because it\'s in our best interest that what we put out is safe for
consumers. But I\'m wondering if whether we\'re not putting alot of
people\'s lives, because I think it\'s even affecting lives \-- with all
the species testing that is the requirement from you that actually may
be of no use. Because if there is not a correlation between that and Lm,
then why are we doing it as I heard yesterday, we have all kind of
different serotypes, sometimes even the ones that have been damaging to
public health. Other times that serotype is not.

And so I\'m wondering whether we\'re just putting layer upon layer of
regulatory performance standards on top of the industry when we\'re not
affecting the public health. I would really suggest that some parameters
for it would be better served \-- these types of programs would be more
appropriate \-- performance standard and particularly with the species
applications that you\'re asking for.

DR. ENGELJOHN: Thank you for your comments. It would be very helpful to
the Agency if you could identify what some of those alternatives would
be to a regulatory proposed requirement and that would help us inform
our decisionmaking.

As pointed out in the Preamble, the Agency has made the determination
that there is a lack of control for Listeria moncytogenes in
ready-to-eat meat and poultry products. For that reason the Agency
identified a number of reasons as to why we deemed it necessary to
address either through the SSOP or through the HACCP programs.

We did have a discussion in both the front part of the Preamble as well
as the economic impact analysis before we discuss tomorrow afternoon
with regard to the impact on very small, small and large establishments.
And what we believe to be the level of control of listeria species types
of programs in place in the various types of establishments.

We recognize that there is an economic impact, but we also believe that
it\'s necessary as we propose to put in place some mandatory
requirements that also require records to be made available to the
Agency to be able to verify what the establishments are doing.

MS. GLAVIN: Kaye and then Bernie.

MS. WACHSMUTH: I\'ll begin by saying I am not a food microbiologist.

(Laughter.)

But we have quite a few knowledgeable people in the room and what I\'d
like to do is just present my understanding of why species is a way that
we should go and see if the food microbiologists disagree with this.

There\'s no direct one-to-one correlation which was provided in the data
yesterday. But the fact that you found species when you had very low
numbers of moncytogenes would seem to me that it might be a more
sensitive indication that you could have a moncytogenes problem that you
might even miss just going from one moncytogenes.

I was also under the impression that species testing would be a result
that you could get faster and cheaper than going from moncytogenes. So I
would \-- I would have thought that these would have been advantages to
species testing. We\'re not talking about drains, we\'re talking about
product contact surfaces. Is this notion wrong?

MS. GLAVIN: Bruce, Bernie, we\'re going to hold just a second on yours
if you don\'t mind.

A PARTICIPANT: That\'s okay. I\'m \--

MS. GLAVIN: Okay.

A PARTICIPANT: \-- I think I\'ll stand.

MS. GLAVIN: Okay.

DR. TOMPKIN: I\'m sorry, Bernie. This is Bruce Tompkin from ConAgra.
There are a number of reasons why we are in the situation of testing for
listeria-like or listeria species, but we do that and in the case of
cost, for example, and timeliness you can do an analysis for
listeria-like and essentially in the second day looking for black tubes
(phonetic) as the first clue.

The first day is enrichment and the second day is for black tubes and
then the third day, whether you have listeria-like on the plates. So,
essentially two days or three days here you\'re working with something.
We\'ve been doing that on environmental samples and the cost is about
\$4.00 per sample.

Now the key to this using listeria-like or listeria species is what do
you do with the data? I know that we have stated that, \"Well, it\'s an
indicator or an index or whatever it\'s called.\" So it gives us some
indication as to whether we have control or not on that particular line
and that gives us the information we need to make a judgment to bring
about control, fix something. So it\'s a rapid, relatively cheap way to
go. The key thing, however, is there\'s been a misunderstanding of what
to do when you have a positive listeria species. Do not ignore it. If
you ignore it, you can, in fact, be jeopardizing consumer health because
some of those species may, in fact, be Lm and lead to food-borne
illness. So the key is, we have an indicator that\'s cheap, but you must
respond to every positive. If you don\'t respond that\'s when the
problems really arise. Does that help?

MS. GLAVIN: Yes, thank you. Bernie, thank you for your patience.

MR. SHIRES: Bernie Shires, American Association of Meat Processors. I
had a question for Dan, really a clarification question I guess, in what
you\'re talking about there as a response by the plant to a positive
test result for listeria species, is that right? Where you get into the
fact, when we get to talking about making a determination as to whether
there\'s an adulteration with Lm or not. How, for example, do you
envision a small plant, a very small plant, taking that positive result
from Lm and then determining the lot or lots that would be affected and
how much would have to be held and sampled for Lm?

DR. ENGELJOHN: Bernie, I think the issues that you raised are issues for
which the Agency really would like an informed scientific reason for how
to develop guidance from the very smallest establishments.

The number of samples necessary to take and which products and how
frequently to do that, all those issues are things for which we do need
information that we can then pull together to make available to small
businesses. Had we had that information on how much sampling and at what
frequency and at what locations we would have made that available as
part of the document to be commented on for the rulemaking process. That
is specifically what we\'re asking the scientific community to come
forward with, with their best expert judgment or guidance maybe from the
International community that would help us put together guidance for
plants.

MR. SHIRES: Okay. Because many \-- the reason I raise it is part of the
reasons that many \-- for many of us who run very small plants, as you
know, we\'re making a multitude of products, anyway. That\'s another
issue that I was going to raise and question that maybe this is
something \-- maybe this is something we need to comment on as well.

There\'s large numbers of products that they\'re making compared to
lines how many \-- how many tests will we end up having to do? That\'s a
\-- that\'s a question we have as well.

DR. ENGELJOHN: To just simply state, if you\'re doing the SSOPs, then it
would be four production lines from where the meat product had contact,
those lines if you\'re a large plant, two tests if you\'re small and one
if you\'re very small.

The details as to the specifics of how you ration that out across
product lines, that\'s what we would be seeking comment for or have you
ask questions for clarity in the comments that you submit to us.

MR. SHIRES: Okay.

MS. GLAVIN: Yes?

A PARTICIPANT: If a plant decides to go ahead and put this in their
HACCP program or as an SSOP I mean \-- excuse me \-- as a CCP, will we
have an opportunity to have it reviewed by the Tech Center or will we be
at the mercy of an inspector at the plant?

DR. ENGELJOHN: I would \-- could we get your name for the record?

A PARTICIPANT: Sure, my name is Bill Gates.

(Laughter.)

DR. ENGELJOHN: I didn\'t mean that. So I\'d follow-up with you.

(Laughter.)

A PARTICIPANT: I\'ve been around for a long time, too. I don\'t bruise
that easily.

(Laughter.)

DR. ENGELJOHN: The Agency has received prior to us publishing this
proposed rule, various proposed processes for which establishments are
looking into doing just to get feedback from the Agency. The Technical
Service Center does have a group of experts that are there to provide
you guidance.

We are not going to be looking at a renewal to give you an approval or
acceptance of that procedure but we certainly can give you guidance on
what we think is things to be concerned about and to think about, but we
have done that on a case-by-case basis. We really are looking for as
much information on this issue as possible so that we can where
possible, condense the data and put it into the final compliance
guidance that we can make available as quickly as possible so that
industry can use it. So as we have information that comes forward that
establishments or institutions are willing to share, that would be the
kind of information we would \-- if we look at it and we think it is
sounds reasonable, that would be the kind of information we would want
to put in our compliance guides.

MS. GLAVIN: Katie?

MS. SWANSON: Katie Swanson, Pillsbury Company. Yesterday during the
scientific presentations that were made, there were several speakers
talking about intervention strategies to prevent listeria growth through
preservation

\-- preservatives and that kind of thing.

The risk assessment that was \-- the draft risk assessment that was just
published suggests that growth of the organism is a risk factor that \--
or it magnifies potential risk. As I\'m reading this, however, I just
want clarity. This requirement does not seem to have an alternate
approach for preservatives, for example, that would be added probably
before cooking or, you know, inventions like freezing that would prevent
growth after packaging to provide a different approach on this listeria
monocytogenes. Would that be something that would be or should be
entertained?

DR. ENGELJOHN: I think the Agency would welcome input and any clear
examples of what it is that you\'re expecting or thinking about doing.
If you\'re going through the HACCP program, as the proposal is written,
if you\'re addressing that issue through HACCP you have considerably
more flexibility there than you do if you\'re solely going to address it
through the sanitation SOP.

The sanitation SOP does not give you the flexibility to look at other
than listeria species. For instance, if there\'s something else you want
to use as an indicator, the SSOP, as proposed, does not give you that
flexibility. We need to ponder on the appropriateness of that
requirement.

But in the HACCP plan, we did recognize that there are situations where
interventions may be available, available today and then how the
language to the proposal should be treated to allow for that
flexibility. So that if you can document that you have this pathogen
controlled, then you should be allowed to address that through your
HACCP plan. So we would be looking for specific examples that would be
very helpful to us.

MS. SWANSON: Okay.

MS. GLAVIN: Dennis? And I think I have two people back here, is that
right? You both? Okay. Let\'s go, Dennis, and you two can fight it out
as to who\'s next.

MR. JOHNSON: Dennis Johnson. I\'m probably the world\'s worst
microbiologist \--

(Laughter.)

\-- but I am a lawyer.

(Laughter.)

I do have a question. Dan, what I\'ve heard today is very encouraging. I
like the words you\'ve been using. The HACCP plan addresses Listeria
monocytogenes and I understand that you can\'t flip back to a slide
earlier, but one of the slides, that the alternatives are, you have
determined that a food safety hazard isn\'t likely to occur or are you
doing it under the SSOPs?

If you read the regs, once you have determined that a food safety hazard
isn\'t likely to occur you have to have a CCP. CCP\'s are a lot
different than address, you can address for verification, you can
address through hazard analysis. So I\'m kind of curious if you\'re \--
that language would mandate a CCP but if we\'re supposed to have the
flexibility to handle this and put it on our plans how we deem best,
which is it? Is it the language which gives you the mandatory CCP which
you guys don\'t mandate, right?

(Laughter.)

Or are we saying we have to address it, which is really what I think you
were gunning for?

DR. ENGELJOHN: This is the actual language contained in the proposal
which makes it very, very specific that you have to address it as a
hazard. If you\'ve identified it as a hazard reason not to occur, that
would result in a CCP as the regulation is currently written and as the
language here would propose. The Agency is seeking input on how to treat
this language or to address it differently if you see that to be
appropriate. I mentioned the issue about maybe other ways to control
Listeria monocytogenes that we believe are valid and so this is the
language proposed. We\'re open to input as to how we can make it more
flexible or to maybe change the tone or direction of it.

MR. JOHNSON: Okay. Just was trying to see whether or not \-- because
there\'s a bit of a dichotomy between control and CCP.

DR. ENGELJOHN: As we \--

MR. JOHNSON: \-- and the CCP.

DR. ENGELJOHN: \-- we made the determination that for ready-to-eat
products that are handled post-lethality prior to final packaging, that
it\'s reasonable that there would be a hazard \-- that\'s the
determination we made. But we did go one step further to say, \"However,
you may be able to address that, some environmental issues in the
sanitation SOP\'s also.\" So we did provide the flexibility with regard
to HACCP and SSOP\'s. If you have other alternatives you want the Agency
to consider we are clearly open to that through the comment phase.

MR. JOHNSON: Thank you.

MS. GLAVIN: I think we\'re next here.

A PARTICIPANT: I think he made my point, I won\'t have to.

MS. GLAVIN: All right.

MR. BEUCHAT: Thank you. Larry Beuchat, University of Georgia. A comment
on the discussion relative to non-Listeria monocytogenes species versus
monocytogenes.

There is data that you shared with us today, I think largely if not
entirely were from samples taken from locations in plants other than the
surfaces themselves, the food contact surfaces. The ecology, the
environment, in the drains and the floors are quite different than it
would be from the contact \-- food contact surface and could therefore
result in different results and the predominance of different species,
could. That I think we need to consider.

The question I have in trying to better understand the rationale for the
mandatory frequency, the differences large, small and very small. If,
for example, a very small plant has the very same line as does a large
plant and that very small plant is running at 100 percent capacity, but
the large plant the same line runs at 50 percent capacity, would it \--
would the results that would come out of the testing at these
frequencies really exceed the degree of confidence relative to the risk
of the product per consumer consumed by the public?

I\'m trying to understand the rationale in terms of establishing a level
or degree of risk, if you will, if the frequency of testing the lines
and that being whether the plant is large, small or very small?

DR. ENGELJOHN: Thank you, Larry, for bringing that up. I just at this
point, just to provide some more information and maybe trigger some
thoughts for comment.

On the first issue with regard to, again the listeria species in product
contact surface versus just environmental sampling, for the SSOP
requirement as listed here in the proposed rule the plant may, in fact,
be doing environmental testing and choose to do environmental testing.
But if they\'re addressing listeria species through the SSOP in lieu of
HACCP, as contained in this proposal, it would have to be food contact
surfaces.

So this does not give flexibility to environmental sampling. That may be
something that you \-- that the plant is doing and that we would expect
to be doing, but as far as the requirements of the proposal the
requirement is that we have to at a minimum have evidence that you\'re
testing for verification of SSOP on the food contact surface.

With regard to the distinction between the large, small and very small
in the product sampling frequencies, there was not intended to be some
level of confidence associated with that degree of sampling and the
risks that would be associated with it. The issue here was that there
would be \-- if handled through the SSOP there would be a minimum level
of testing that had to occur for which the records would be available
and we just made the distinction between large, small and very small
because of the economy of size within the plant and that it gave some
economic relief with regard to the amount of testing that had to occur.
It was not intended to imply that there would be a greater degree of
confidence that if listeria was there, it would be found.

Had we had that kind of information to base the rulemaking that would
have been formulated as part of the proposal. That is the type of
information we\'re seeking. We did make the public health judgment that
large plants produce more product, you bring up the point that they only
produce a quarter of capacity or 50 percent capacity. But we just need
the distinction so that there would be some economy of cost here with
regard to the amount of mandatory testing, not intended to imply some
verification of confidencing risk. If we \-- that\'s the type of
information we truly would like to have. It may not be made part of the
regulation, but certainly could be made part of compliance guidance for
how to meet an appropriate or approving and SSOP and HACCP program.

MR. DERFLER: This is Phil Derfler. There\'s something I\'d like to add
to that. I mean we\'ve said that what we\'re trying to do is make our
regulations as consistent as possible with sound science and common
sense. There\'s also other statutory mandates that we work under
including the SBEFA, which is the Small Business Economic \-- I don\'t
know \-- Fairness Act, which essentially says that we have to take into
consideration in doing rulemaking the size of plants and the economic
impact on them and stuff like that. In the absence of what we felt was
adequate data, we developed this in consideration of trying to minimize
the burden on small and very small plants and yet at the same time try
and accomplish what we \-- what we were trying to accomplish.

If there is scientific data that will help us do that in a more
effective way we really welcome it. I mean that was a question I asked
of Dr. Wiedmann yesterday and he kind of blew me off. So I mean we need
\--

(Laughter.)

\-- we need that kind of data. Thank you.

MS. GLAVIN: Thank you. Ah, you got up to the front of the line.

(Laughter.)

MR. GROSS: Sort of reorganized.

(Laughter.)

John Gross. Dr. Engeljohn, there\'s \-- there\'s something I just don\'t
understand and probably everybody else in the room does understand it,
but if somebody could take just a minute to explain it to me. If you
identify Listeria moncytogenes as a hazard likely to occur in your HACCP
plan you\'ve done a risk assessment and you say, \"Okay. It\'s probably
going to happen.\"

Regulations of the SSOP 416(a) says, \"All food contact surfaces
including food contact surfaces of utensils and equipment must be clean
and sanitized as frequently as necessary to prevent the creation of
unsanitary conditions and the adulteration of product. If you identify
for your HACCP plan Listeria moncytogenes as likely to occur, aren\'t
you saying that the SSOP doesn\'t work?

DR. ENGELJOHN: Now I would just clarify that. With regard to this
proposed rule and with regard to the way the HACCP regulations are
written, you have identified Listeria moncytogenes in this case, as a
hazard reasonably likely to occur from which you can have in place at a
critical control point, some treatment or measure that will control by
reducing it or eliminating it, or preventing it from occurring.

The SSOP requirements are a bit different in that you\'re dealing with
direct product contamination and the sanitary operation of the plant. We
view the SSOP, in essence, as a prerequisite program. It\'s something
that should occur with regard to daily sanitation and operation of the
facility.

In the case of ready-to-eat products that have a post-lethality \--
prior to the packaging the consideration that has to be given is, is
there opportunity there for a pathogen to be introduced to that product
such that it\'s critical that we can reduce, eliminate it or control it?
In this case, the establishment would need to make that decision as to,
is there the potential that on handling my ready-to-eat product
post-lethality, prior to packaging, such that I need to control Listeria
moncytogenes?

If so, then our expectation would be that not only are you addressing it
in some fashion in the environment through the SSOP but you have your
HACCP plan specifically addressing at the control point how you\'re
dealing with this particular hazard. Does that help clarify the issue?

MR. GROSS: I \-- I \--

DR. ENGELJOHN: We \-- let me just put it this way, with Listeria
monocytogenes, we recognize the fact that it is a \-- it is truly an
environmental contaminant that is ubiquitous throughout the environment
inside and outside of the plant. It\'s different than the \-- pathogens
that come in on the product, for the most part. This means airborne. It
frequently can be there and just simply flying in the air on things, or
on the floor and the water. It presents a different situation.

For those products that are going to be handled after lethality
treatment before packaging our issue is you need to make special
consideration as to does that present a hazard reasonably likely to
occur, so it would need to be addressed in HACCP. If not, then if
you\'re handling ready-to-eat product that meets the criteria of this
proposed rule, then you at a minimum would have to address your minimum
sampling components in your SSOP; so handling this particular pathogen
in HACCP differently than most other pathogens that we have out there.
The other pathogens that we are aware of at the moment that we consider
to be appropriate to be handled either in the SSOP or in the HACCP plan.

MR. GROSS: Okay. Thank you.

MR. SPERBER: Thank you. I\'m Bill Sperber from Cargill. I mean no
irreverence on this first comment, but I have an atheist friend who
says, \"Nothing fails like prayer.\" In the context of food safety I
would say when it comes to assuring food safety nothing fails like
product testing. In this case of the sanitation SOP, if you find
listeria species and your corrective action drives you to product
testing, you\'re eventually testing for \-- you really don\'t have a
prayer of a chance of finding it in the finished product because of the
statistics of the saturation. It would be an unusually grossly, heavily
contaminated product to have an incidence of listeria of one percent of
finished packaged product, but even at that very high incidence you
would have to analyze 300 samples to have a 95 percent chance of finding
one positive.

So what does that do for small and very small plants? That would be an
enormous burden for a large plant but what about the smaller plants who
are producing a dozen products? They can\'t sample hundreds of finished
products to be able to find a positive.

In the last couple of years there have been two large foodborne
outbreaks of listeria attributable to hotdogs and to cooked turkey
products. In each case it was extremely difficult to find Lm in those
finished products.

So if you\'re going to try to manage this in the second section by
sanitation SOP\'s you really don\'t have a prayer of a chance of
controlling the Lm hazard by that.

If you have products that are potentially hazardous because they can
support the growth of Listeria moncytogenes during refrigerator shelf
life, you\'re going to have to rely on process control and not product
testing. If you extrapolate that to your proposed rule you will for most
products need to have a CCP in your HACCP plan and not rest your case or
try to base your strengths on sanitation sampling.

DR. ENGELJOHN: Thank you. I would really encourage you to write that
down and give some more description as to the appropriateness of, if the
issue is that SSOP\'s are not an appropriate alternative for this
proposed rulemaking, then I think that\'s something that you truly need
to put in writing and submit as your comment.

MR. SHIRES: Bernie Shires. The question I wanted to raise with you, Dan,
basically had to do with CCP\'s. From the discussions and the
presentations that were made yesterday and from talking to scientists at
universities and other sources, basically all the plants have these two
choices that you\'ve outlined for us this morning.

The critical control point, if you\'re going to say that it\'s a hazard
reasonably likely to occur and so it has to be handled through a HACCP
plan, for small and very small plants, the CCP\'s that they would have
to come up with to make this part of the HACCP plan seem to be few and
far between. I just wonder if there is some kind of \-- if the small or
very small plants are not going to have the same opportunity because of
cost and other economic factors, to come up with critical control points
that \-- that the larger firms would have? This is something I think \--
what one of my comments is about. I think this is something the Agency
needs to consider especially in looking at your economic factors.

The other point I wanted to make is that in terms of \-- another person
raised it here kind of \-- the numbers that you came up with for
testing. I mean I can think of plants, small plants, that would maybe
doing \-- small and very small plants that might do one hundredth or one
two hundredth or one five hundredth of the product. For example, let\'s
say a large facility might do. So how do the numbers 402 and one come
out? Did you shake some dice or \--

(Laughter.)

\-- I\'m sure that\'s not the case, but what was the \-- what was the
justification for those particular numbers? Because you\'re really not
going to necessarily get the same correlation here.

DR. ENGELJOHN: Again as we explained in the Preamble to the proposed
rule, the numbers were devised simply to give some flexibility in terms
of economy of scale or the burden on large versus small versus very,
very small. They are not based on determination of efficacy or on
prevention of risk or confidence.

If you have other suggested sample frequencies that would be more
appropriate such as one test per order, or whatever, we would welcome
that. We\'d also like some justification that you would have as to why
you think that would be more appropriate than the numbers that we\'re
proposing?

We\'re truly looking for a more scientific basis for having the numbers
there. Right now they\'re simply as minimum levels for verification of
the SSOP. Our expectation is that the plant would be doing many other
things on a daily basis, on a hourly basis, with regard to control of
pathogens in their products. At a minimum this is what we are proposing
to require as having documentation available to FSIS.

MS. GLAVIN: We have someone at the table here?

MR. TOURJE: Yes. Tom Tourje. Just one comment. Several times you\'ve
mentioned \-- after lethality, before packaging; and issues have come up
there. In operations where that\'s not the case, where the product was
packed at lethality, it doesn\'t look like there\'s any option to
address that. It just looks like we\'re being forced to pick as a CCP
just out of \-- you know, the easiest way out but, in essence, the
product being packed at lethality should not be required to be picked as
a CCP nor should it be required to have an elaborate testing program.

DR. ENGELJOHN: I will say that the way that the rule is written again
that the issue here is \-- oh, I\'ve punched the wrong thing \--

(Laughter.)

\-- I have to stop pressing these buttons.

(Laughter.)

I would say the issue is the Agency was concerned about product that are
manipulated. They may be cooked in a bag and then removed from the bag
and exposed to the environment and then repackaged. Those products that
\-- canned products, for instance, which are in a container for which
there is no opportunity for external contamination the Agency identified
that as \-- as an issue and wanted comment on how we could tweak the
language or make sure that we address the language so that this part for
which lethality is sufficient and there\'s no opportunity for a
re-contamination or post-process contamination then we\'re looking for
comment on \-- as to what we should do about this proposed rule in
either addressing them or not addressing them.

We agree that if you have produced a product in a bag for which it\'s
not going to be contaminated after \-- after it has been cooked that
there probably should be some different considerations given. So we
would welcome input on that.

A PARTICIPANT: Thank you.

MS. GLAVIN: Yes, sir?

MR. HABTEMARIAM: Thank you. It\'s not by design that I ask the question
\--

MS. GLAVIN: Okay. Can you give your name?

MR. HABTEMARIAM: Yes. Tsegaye Habtemariam from Tuskegee University. I
wanted to comment on Dr. Swanson\'s comment earlier which I did think is
very important. It\'s a very important premise and rationale and I\'m
glad

Dr. Swanson is back, too. There\'s a point that she made that listeria
species is literally \-- if I use the word intentionally, an indicator
for Listeria monocytogenes and if listeria species cannot be that
representative within the same series (phonetic), I can\'t imagine what
other organism could come close to that.

The other point is about the cheap and easy \--which could be done. It
sounded to me, very rational. I\'m not a microbiologist but an
epidemiologist. It made a lot of sense.

The problem, the fundamental problem, that we saw yesterday and based on
Dr. Weidmann\'s report, if you remember the results that listeria
species do not correlate with Listeria monocytogenes; you find one and
correct it. But it was based on pilot studies. There are several pilot
studies out here reporting. Now pilot studies, if they\'re conceptual,
can provide very useful data, \-- test but really not conclusive,
definitely not powerful to make inferences that are significant, such as
in this case. I think what would really be useful, especially to look at
listeria species on product as well as Listeria monocytogenes. If you
really have an appropriate sample size, a larger sample size and, in
fact, then do a correlation analysis and then you see the correlation
\-- that would have been I think, more substantive and more conclusive
in my opinion.

But I think this is clearly \-- to really end up with this very
significant and very important conclusion that the species is not
indicated for the other Listeria monocytogenes maybe to me, is a little
premature, but I think it is a very important rationale in terms of what
you\'re proposing to do, in my opinion anyway.

MS. GLAVIN: Other comments or questions?

(No response.)

Let me get a sense of the group. We are scheduled to return after lunch
and I would like to know are there people who want to, have comments to
make and have additional questions to make on the two subjects we have
covered so far? The answer is one?

A PARTICIPANT: Yes. Behind you.

MS. GLAVIN: Okay. Then \-- then my suggestion is that we take a lunch
break and return at 1:30. Okay. Thank you.

(Lunch break at 12:33 p.m.)

(Meeting resumed at 1:44 p.m.)

MS. GLAVIN: Good afternoon. Thank you for coming back so timely. Before
we broke for lunch we were still on the requirements for the control of
listeria and then a number of you indicated that \-- that you had
further questions or discussion or comment. So I don\'t know who is
ready to go first.

MS. GLAVIN: Dan tells me he\'s prepared to answer a question that arose
this morning. So why don\'t we let him do that.

DR. ENGELJOHN: Dan Engeljohn with USDA. The question was asked about the
format for submittal of data particularly related to listeria type of
data. So I have Walter and Victor Cook prepared to answer questions
about their needs in terms of looking at it from a microbiological
standpoint and then Warren Lang is going to speak to the issue of the
statistical types of information that we would be looking for.

A PARTICIPANT: Thanks, Dan. It makes sense to me that any materials that
you submit to us would be more or less in a draft form.

A PARTICIPANT: We can\'t hear you.

A PARTICIPANT: I\'m sorry.

A PARTICIPANT: I can\'t hear you right here.

A PARTICIPANT: It seems to make sense to me that any information that\'s
submitted to FSIS as far as scientific findings is concerned, would be
in a form of a draft in the format somewhat similar to what you would
submit to a scientific journal for publication, that is, it would have
materials in different sections and interpretation of data and \--
interpretations of data and some conclusions and any additional
reference materials that you\'d like to include as well. And I think
that there was also some talk about the actual \-- data solution.

A PARTICIPANT: When I think of data, I think of certainly \-- submitted
or one of the things about \-\-- and that\'s to sort of focus on what
question, you know, what is really the answer. If the issue is, as what
was discussed this morning, what is the correlation between listeria
species and Lm and if that \-- if that would be an important issue, then
it\'s certainly \-- sort of have information that sort of \-- and that
relationship and that is the HACCP process, specific products that were
\-- you know, the size of the establishment and other things that people
think might \-- might be available that would \-- that could possibly
have caused in one establishment, you know, for that relationship to be
different than others.

I mean \-- things like environment \-- or not or was that \-- maybe
these characteristics \-- the extent to which the product had been
exposed to the environment the time or something. You know, it\'s really
hard to \-- now that\'s a specific question and trying to get an answer.
Is that relationship \-- I mean other than that \-- devices, that
you\'re presented with would even \-- this \-- this information helps
answer this specific question and why. I mean, it is hard to know
without really knowing what \-- what question you\'re trying to answer,
it\'s \-- how far is someone involved in the data analysis. Until you
really get to folks on what question you\'re trying to answer. It\'s
really hard to get more specific answers than you are. Which data
variables do we think could be effecting the relationship of trying to
measure \-- and answer the question right?

MS. RICE: Well \-- this is Kim Rice with AMI. Since I\'m the one who
asked the question \-- with the variations between the establishment\--
my membership and some of the other food associations that are \-- I
assume will be trying to answer some of these questions and collecting
them.

The facilities themselves have so many different variables and on top of
that the frequencies at which they test, how they test, the methods they
use, etcetera. All of those things are going to be there so I would ask
if you don\'t answer it today, I would ask that you provide some
direction on how we can take current data that may or may not exist and
basically reconcile it to help you answer the questions that you\'ve
asked.

Maybe the members who are microbiologists will be able to help me do
that, but unless we\'re all going to go out and just do like some huge
investigational protocol to go find the data to answer your questions,
you know, we need some direction on how to reconcile all of those
different issues. So I\'d just ask that if anyone would like to, you
know, work that out, get some direction.

MS. WACHSMUTH: I was thinking that Dan and Walter and some of the people
who know the data and the needs, might be able to come up with some
data-needs document to go through the proposal \--

MS. RICE: I think we know \-- Kim Rice again. I think we know what the
questions are and how I would answer them. But because I would provide
the information one way that doesn\'t necessarily mean that that is the
information you want. I\'m asking for that before we go out and do that
I\'d like some direction on exactly what it is you need and how you need
to see it? You asked a lot of questions asking for \-- and you asked for
a lot of data so before we go out and compile the data \--

DR. ENGELJOHN: I would say \-- this is Dan Engeljohn. we will put some
thought into that and see if we can come up with a document or come up
with a format and make that available on the website to say, \"Here\'s
what it is that we\'re looking for\" and we\'ll specifically try to
share that with you just so we can effectively get back the information.

MS. GLAVIN: Katie?

MS. HANIGAN: Katie Hanigan with Farmland. Going back to one of the
points raised this morning which was the division of small, very small
and large plants, the sampling came through well under the SSOP. I refer
to my written comments and I think you need to go back and consider not
the size of the establishment but how many lines the establishment has.
The reason I think you need to go back and look at that is some of these
very large facilities, and we have five within Farmland, we have the
majority of those employees \-- these are the plants with over 500
employees \-- those facilities are located on \-- and boning operations.
Those large plants of ours \-- we have two ready-to-eat slicing lines or
packaging lines, if you will.

When you go back to what I call a medium-size plant, those with 10 to
499 employees, we can use seven and eight packaging lines in those and
they\'re in that smaller group of plants because they don\'t have a
slaughter facility attached to it. When you start looking at which
plants turn out more product, etcetera, it\'s the medium-size. So I
think you may want to go back and say, \"The sampling scheme needs to be
based on how many lines are in the plant.\" The other thing is regarding
the very small folks, if you get in an industrial engineer, basically
the staffing that it takes to run a packaging line is very similar.

I mean it comes with recommendations from the company how many staff
people you need to run this line, etcetera, so I don\'t see that as
being a big issue between a very small plant, a medium sized plant and a
large plant.

DR. ENGELJOHN: I appreciate the comment. I would say related to that,
Katie, and one issue that the Agency struggled with was production data
in terms of the amount of product produced, and that would be very
helpful in that decision process. So again, in terms of you evaluating
the information that you have access to, if that could be a component in
this issue regarding the amount of production, and the trade
associations have access to a variety of establishments, that\'s
helpful.

We made a slight public health decision that the size of the plant had
some reasoning for why we would have a different sampling from them. In
this case it was based on burden and not on an efficacy issue. If, in
fact, production volume has an impact on risk, that\'s an issue for
which we would look for science to help support that as well.

MS. GLAVIN: Bernie?

MR. SHIRES: Bernie Shires. I guess I\'m pushing to \-- to get an answer
to a question raised earlier before lunch. We were talking a little bit
about the \-- testing requirements or the number of lines. I guess if
you\'re talking about facilities that have a lot of different products,
whether they were made from the same species or varied species, various
types of seasonings, for example, and what \-- what you would consider
\-- what the Agency is considering to be a line in that instance?

DR. ENGELJOHN: Bernie, I would follow-up on that. We didn\'t define line
within the Preamble itself and clearly that would be something we were
hoping to get input on as to how you would define that.

MR. SHIRES: Okay.

DR. ENGELJOHN: \-- to define that specifically, but you raised the issue
and we can certainly consider that.

MR. SHIRES: Okay.

MS. GLAVIN: Yes?

MS. VOOGD: Erika Voogd, OSE Industries, In keeping with the same type of
question that Bernie just asked about, what is a line? When Katie was
talking earlier this morning and she was talking about performing a
number of tests I\'m not sure \-- I have not had a chance to read the
guidance material that just came out, but I\'m a little unclear. When I
first read this proposal and it said, \"Number of tests\" I\'m thinking
like a test of sponge, so four tests means four sponges for one line in
a large plant. I\'m thinking, okay, does that mean one sponge per week
for four weeks? Does that mean four sponges today and nothing the rest
of the month? So I don\'t know if there\'s any \-- any information
available. If that is in the guidance, perhaps you can tell me that.
What is a test or, you know, or is a test also possibly, anything I test
today is

Test No. 1?

DR. ENGELJOHN: Again on that issue in particular, the Agency did have a
limited amount of discussion in the Preamble. We did not define what a
test was. We knew that was five composites making up the tests or just
one test or that that was one sponge once a day for four days. We did
not define that and was looking for input on that. Again, the issue was
that we did not base the sampling frequency on the efficacy or on a
specific risk reduction or a confidence level. Had we had the science
behind that to establish that, then we would have been able to give more
descriptive information.

We are looking from the science community information about what would
be appropriate and effective sampling programs. That would then help
inform us as to how we go forward with the proposal, the final as well
as with the compliance guidance.

MS. VOOGD: Okay. Clarifying that would be very important to us. Again,
our interpretation was entirely different just that quickly. In going
forward and trying to decide how we would test, that clarification is
very, very critical to understanding what it is that is expected of us.

MS. GLAVIN: Caroline.

MS. SMITH-DeWAAL: Thank you. I\'m sorry, at this morning\'s presentation
I was following your agenda that had this whole discussion starting
after lunch so I\'m sorry if I repeat questions that other people asked
this morning.

What is the level of confidence that you expect to achieve with the four
tests a month requirement? We had petitioned the Agency for a
statistically valid sampling program. It\'s unclear from the Preamble
that we\'ve got one and so I\'d really like to know what \-- how you
came up with the four tests \-- four tests a month? I know the question
immediately before me went to this issue as well as, what do you really
mean by that? But I also want to go into kind of what \-- what does it
mean statistically?

DR. ENGELJOHN: On that particular issue with regard to the sampling
frequency specific to the sanitation SOP\'s, the Agency did not
establish a confidence around those \-- they\'re meant to be minimum
testing requirements based on plant size if the plant is doing product
contact testing through SSOP\'s in lieu of the HACCP plan. So there is
not a confidence associated with it or a determination that a reduction
of risk would be achieved or a certain effectiveness would be \-- result
in a \-- program if the plant followed that testing regime. It was
strictly mandatory minimum testing that had to be available for review
by the Agency. The Agency\'s expectation would be that the plants would
have ongoing sanitation programs that address its entire environmental
program that may be \-- but at a minimum this is the information that
\--

MS. DeWAAL: Well \-- highly problematic. As you can see, there are
industry lawyers as well as industry scientists sitting here. I\'m sure
they\'re already working on their briefs to shoot this as not being, you
know, statistically meaningful to the plants. I think in the final rule
we do need something that provides some level of assurance that the
conditions for which you\'re testing, which is that listeria subspecies
is in the environment and, therefore, could survive \-- that Listeria
moncytogenes could survive in that environment which is, in fact, what
you\'re, I think trying to prove with this testing program.

That \-- that you have some level of confidence that if \-- if it\'s in
the environment on that surface that you are, in fact, finding it and I
think four tests a month isn\'t going to provide us much in terms of
assurance that if it is there, you\'re finding it.

DR. ENGELJOHN: I will just follow up with that by saying that is the
charge that we have to the scientific community. That we don\'t believe
that information was available to us to be able to come up with that
type of criteria for the proposed rule and, therefore, did not establish
those sampling statistics based on reduction risk or effectiveness, but
based on the minimum testing requirement that we thought had to be
available to us.

MS. DeWAAL: So do you mind if I follow-up on this?

DR. ENGELJOHN: No. Go ahead.

MS. DeWAAL: So are you saying that the \-- your expectation is that in
the final rule you will have gathered this additional data and you will
have a testing frequency should plants choose not to go the HACCP route
that will \-- that will be more solidly based in statistics?

DR. ENGELJOHN: I would say that if you were \-- if the Agency were to
receive scientific data and information from expert panelists on what
would be appropriate sanitation procedures? That that would inform our
decisionmaking as to how we would go forward with modifying the final
rule if we were to go forward with the final rule.

How we would \-- how we may revise the regulatory requirements in terms
of making a different standard and make it a more general standard and
provide that specific sampling data that was important for the plants in
the form of compliance guidance, that this would be the prudent way to
do it.

Again, the lack of information at this time caused us to put it in the
rule the way that we did and then ask for the scientific community to
come up with a more science-based approach that would inform how we
would go through \--

MS. DeWAAL: I get nervous though that, you know, all the science in the
hands of the industry \-- and they may not necessarily want to give it
to you for whatever reason, maybe like they haven\'t been properly told
the format or something, but they may not want to just give it to you.

So I think you need to think beyond that. I think it\'s not only what
the scientists bring to it, which is, you know, which will give you some
information but also to know what is the best in the industry doing?
What is the industry already accomplishing? How much testing\'s going
on?

Based on the public hearing on this topic was it two years ago now? A
year and a half ago? We \-- I mean it seemed clear that industry was
doing more testing as a general rule than what is being required in this
proposal. So I think you need to \-- to provide yourself another vehicle
to get to that result, that if you can\'t get the exact scientific
things that you need that you were using information that was already in
your hands. And I thought that \-- this proposal, that it represents
industry \-- current industry practice?

DR. ENGELJOHN: If I could just follow-up there. We will take into
account all the information available to us. Our true goal here is to
have an impact on public health and to put the motivations where they
need to be, that are most effective and that, in fact, have some
qualifiable determinants on the impact on the size of the establishment,
which is an issue that you have to account for in the rulemaking
process. So we do believe that we will get information to help us move
forward.

MS. GLAVIN: Katie?

MS. HANIGAN: I\'m just going to keep asking until I\'m clear. This is
Katie with Farmland, Katie Hanigan with Farmland. Can we just talk about
listeria now for those who opt to put it in the CCP? Well, I\'ll try to
keep this short and not to confuse myself.

Yesterday we saw many, many outstanding presentations. The one thing we
never did see yesterday was the cost of this intervention would be,
whatever, \$25,000 and you would need one of these units for each one of
your packaging lines. You know, that\'s one thing that nobody ever
talked to the industry or to the Agency about yesterday. Or, if you want
to formulate this compound into this item it\'s going to be X number of
cents per pound and then the labeling is going to come in, etcetera. So
we still have that whole unknown.

So I\'m sitting here today thinking to myself, okay, so now let\'s \--
we put that in the SSOP and let\'s look at it from a CCP point.
Everybody knows that the Tech Service Center in Omaha is going to be
hounded with calls of, \"So what is the CCP that belongs here after the
lethality study?\" And they know pretty well that the Agency came out
and said, \"You need to have a CCP at the final round on the slaughter
floor for fecal.\"

You know the same question is going to come, so what is the CCP you\'re
wanting after lethality? Because we all sat through this meeting
yesterday and nobody agreed to anything, which is right and which is
wrong, there are a lot of opportunities out there. I think you need to
be prepared to address just what is the CCP that\'s going to be
acceptable.

The other questions I have is, for instance, if a company would do
something like put their CCP\'s in personal hygiene, and I\'m not
recommending anybody does that, but if somebody would do that and all of
a sudden you have a positive product \-- and understand this is a CCP
now \-- and I\'ve got a positive product, whether it\'s in the field,
not in the field, however you want to look at it.

Have I just taken down the entire fully cooked, not shelf stable
processing category under the HACCP rule or what have I just done to
myself as a company? Have I just created an inadequate HACCP system for
that entire processing category, or have I just affected only the
bologna line where this employee was seen not following personal hygiene
procedures? Just what happened here?

I think we need to have a dialogue as to what did just happen, because I
don\'t think anyone in the room knows.

MS. GLAVIN: Are there contributions to this?

DR. TOMPKIN: This is Bruce Tompkin from ConAgra. Actually this is one of
the comments that I wish to make relative to that is that the proposal
does indicate that guidance documents for the establishment of CCP\'s
and sampling procedures and the corrective actions would be provided
with a final action on the rule. So your answer I believe will be
forthcoming and the final rule provided by the Agency and so I don\'t
know that there is an answer right now.

DR. ENGELJOHN: I would just follow-up with that and say we clearly will
provide the guidance within the final action but our goal at the moment
is as the information becomes available to us, that we believe is of the
quality that should have public input or at least have some dialogue on
the content of the guidance that we put together, we will make that
available and announce it to the constituent update and any other type
of format that we can, which is what we did last Friday with the
compliance guidance which came out in draft form. We\'re looking for
input to modify it and we will continue to modify it and update it as we
get more information that comes in that we need to provide.

So I wouldn\'t say that we\'re only going to provide \-- that\'s \--
that can be some time away. Our goal is to make available information
that is at least of enough quality in terms of \-- and listeria testing
behind it, that it would be supportable to put out there for the public
to comment on.

MS. GLAVIN: Yes?

DR. TOMPKIN: Bruce Tompkin from ConAgra. I think that the guidance
documents are very important in terms of our ability to understand how
this rule will be applied.

With that information not being available for review during the comment
period essentially we\'re \-- we\'re being asked to buy into a new
direction and we don\'t know how we\'re going to be \-- how the rules
are going to be put in place. It\'s difficult for us to assess the true
impact of those rules for that reason.

MS. GLAVIN: Caroline?

MS. SMITH-DeWAAL: May I just comment as well? I mean Katie raised the
issue of the cost of the HACCP \-- of implementing one of the HACCP
CCP\'s, whether it be the clean room technology or the steam technology,
whatever you wanted to do. If you\'re dealing with a sampling program
that is so \-- I wasn\'t here this morning but I heard a rumor that the
estimate of cost per test is what? Four dollars?

A PARTICIPANT: Yes.

MS. DeWAAL: What? I mean \--

A PARTICIPANT: That\'s what it costs \--

MS. DeWAAL: I mean I think that\'s in-house tasking but potentially a
fairly minimal cost for the testing. You need to have \-- you need to
have some relationship between the costs of these various programs. If
you have a very inexpensive program that the expense of which is borne
by either a food-borne illness outbreak or a recall when it doesn\'t
work I mean that\'s not \-- that\'s not tremendously valuable to the
industry, either. I think it would be \-- because the costs are all
borne \-- borne at the back end rather than then at the front end.

So if you\'re driving people towards adopting this in a HACCP system,
you need to make the testing system also reflective of the cost. We
know, although we\'re not covering this until tomorrow, that the
economic costs of illness and death are very high in this \-- what this
rule is supposed to cover and, therefore, the cost of the regulation can
be somewhat higher than what you had put in at least in the testing
portion.

MS. GLAVIN: Dane?

MR. BERNARD: My question is one that Katie asked first about CCP\'s, but
just for clarification \-- and the CCP if you decide that you want to
put this in your HACCP program, is the language specific to \--
lethality treatment in packaging. I mean if that \-- and if that is so,
would that preclude the flow technology that we discussed yesterday \--

DR. ENGELJOHN: Let me clarify. The language in the proposed rule was
that you had to address in the HACCP plan, that your process involved
post-lethality handling of the product prior to the final packaging. So
to the degree that the product is going to be manipulated after
lethality, and it\'s going to get packaged. It doesn\'t say where that
where that CCP has to be, but that is the portion of the process that we
believe needs to be addressed in the HACCP critical control point.

So I would venture to say that the flow technology that we heard about
yesterday which is the packaged \--product, would be an appropriate way
for us to address that issue.

MR. BERNARD: Dane Bernard. If I were to look at that technology, would I
have to meet a lethality performance standard, or could I just say that
this is a listeria control CCP and leave it at that?

DR. ENGELJOHN: I think that would be the type of thing we would want you
to address in your comments to say, \"I think this should be addressed
in the regulatory language.\"

MS. GLAVIN: Yes?

MS. HANIGAN: Can I make a comment just for clarification? At this time,
Dr. Engeljohn, you\'re not \-- you\'re not able to answer my question as
to if it is a CCP

\-- I just want to make sure I understand this, if it is a CCP, at this
time we\'re not sure if that would take down that entire processing
category as described under the 1996 packaging, the entire fully cooked,
not shelf stable? I mean we don\'t know what that would do yet?

DR. ENGELJOHN: I\'m not \-- I\'m not answering that portion of the
question in the sense that I think that is what we would expect you to
have addressed in your HACCP, in your hazard analysis as to how you\'ve
designed your critical control point and what that has as an impact in
terms of the product and the processing.

I believe that the way the HACCP regulation is written is that you have
some ability to be able to define what is affected when you have a loss
of control in the CCP. So I think that is an issue that you need to come
up \-- come to terms with. In the course of your comments, if you want
to lay out some scenarios of this is how \-- these are some of the
options of how you think this may be handled either by yourself or by
the Agency and then a recommendation for what you think it should be
based on HACCP principles. That would be a good way to get this issue on
the table.

MS. HANIGAN: Thank you.

MS. GLAVIN: Okay. Any other questions along this line of inquiry? There
are a number of people who have signed up for comments and I\'ll just go
in the order in which they\'ve signed up.

MS. SCOTT: Thank you. I\'d like to present this comment on behalf of the
members of the National Food Processors Association. We produce
ready-to-eat meat products that are subject to listeria testing. We did
have a couple of comments to submit.

The food industry has a strong interest in programs that will assure the
continued safety of our food products. We will support government
efforts to develop and implement science-based food safety strategies.
We believe in sound science. We need innovative solutions to be able to
respond to food safety challenges.

First, we believe that the Agency should take into account the fine
rules of the FDA and the FSIS Listeria monocytogenes Risk Assessment in
this rulemaking initiative. Specifically, the key finding that not only
do the food products present the same level of risk to the consuming
public. There is also risk assessment that clearly shows that those
products that do not prevent the growth of Listeria moncytogenes and the
attendant conditions of \-- do not present the level of risk associated
with products that do.

The primary goal of the Listeria moncytogenes Risk Assessment was to
identify those products for which additional industry and regulatory
measures might yield the greatest public health benefit. Based on the
findings of the Lm Risk Assessment, we believe that foods containing
inhibitors to growth presume a low risk. Products that are intended to
be heated or cooked present less risk than those intended to be consumed
without further preparation. Foods that are frozen so that there\'s no
Lm growth, and then thawed or heated and eaten, present low risk.

We believe that control measures for such products presenting low risk
can differ from control measures for other products, rather than a
one-size-fits-all approach. For example, we believe that environmental
sampling programs can be structured differently for products in which
Listeria monocytogenes cannot grow.

We believe that testing of food products based on a single finding of
listeria species on the food contact surface may not be warranted.
Sporadic contamination of the environment, including food contact
surfaces, may occur and have little or no impact on product. You heard
that from Dr. Weidmann yesterday.

The real problem occurs when Listeria moncytogenes finds \--
contamination of the product, the persistence that Dr. Weidmann was
talking about. Our leading food safety microbiologists on the planet
will concur with that.

(Laughter.)

Only through rigorous testing of the environment that such harbor sites
can be discovered. Thus we don\'t feel that it would be appropriate to
require product testing based on a single positive listeria species on a
food contact surface. Investigation of any positive on food contact
surfaces should be done. Additional testing that may include product
testing, should be limited to additional positives on the same surface
or in the same area. This appears to be the approach that the Agency has
outlined in the recently released guidance document on performance
standards. The industry would support this position.

The proposed rule would not require food contact surface testing in
establishments that identified Listeria moncytogenes as a hazard
reasonably likely to occur, and consequently established more and more
critical control points or a HACCP plan after the lethality treatment.

However, industry and academic experts will tell you that with so many
products, it\'s impossible to identify one or two scientifically sound
critical control points if you have a big Listeria moncytogenes
contamination.

Dr. Marsden provided some examples yesterday for some procedures for
which scientifically sound critical control points can be developed.
However, these procedures are not applicable to all ready-to-eat
products.

Since listeria is the cause of \-- the industry\'s done quite a bit of
work in developing and implementing effective listeria control measures.
Keep in mind that there\'s no silver bullet for processing steps that
can be applied at the end of the line, to go to zero tolerance for
Listeria moncytogenes in all ready-to-eat products.

As Dr. Weidmann pointed out, keeping listeria out of food processing
areas requires constant vigilance, because the microorganism is commonly
found in ingredients such as raw meat and other products, \-- water and
shoes and clothes, \-- nooks and crannies in the plant. Therefore,
industry combines a number of different control tools to keep Listeria
monocytogenes from getting into processed foods.

For example, today\'s processors focus on the importance of designing
and maintaining equipment so it can be cleaned effectively. Designing
production facilities so that employees who run the equipment do not
spread bacteria from room to room. Teaching employees to use good
manufacturing practices without exception. Using sensitive detection
programs to monitor the effectiveness of the processor\'s control
systems in reassessing detection and control programs based on actual
results \-- involving science. We know from experience that effective
food safety systems must be tailored to each processors work practices,
manufactural situations, and final product attributes.

As has been noted time and again, as Bill Sperber so eloquently pointed
out, finished product testing has significant limitations. The most
obvious \-- packaged the product. Finding pathogens in products where
contamination levels are low and organisms are not \-- distributed
requires extensive sampling and he gave you same numbers related to
that.

Industry\'s experience has led us to conclude that testing processing
areas and equipment is both more sensitive and more efficient. We feel
that with the proposed testing requirements, existing environmental
monitoring programs have been modified in ways that would make them less
effective. As a result of the regulation establishments are likely to
feel compelled to hold products inside if a food contact surface is
tested and establishments may also feel compelled to hold other products
produced in other lines that day because of the potential for the test
results to be applied to these products. You\'ve already heard Katie
Hanigan talk about the potential costs involved with something like
that.

Therefore, some establishments will elect to do the minimum level of
food contact surface testing because of the expense of the proposed test
programs. The aggressive environmental testing programs that many
establishments employ today to effectively reduce Listeria moncytogenes
contamination, may actually be scaled back with a likely negative impact
on public health.

If FSIS requires food contact surface testing as a final rule we urge
the Agency to create alternative options that recognize the efforts of
firms that do more than minimal testing. As an example, FSIS
microbiological sampling directive, currently has issued some proposed
rules referring to specific environmental end-of-product testing to be
subject to reduced \-- product. This could be one alternative, and other
alternatives should be explored.

In summary, what you administer is key to protecting public health with
respect to listeriosis is emphasized in the need for manufacturers to
develop and implement listeria control programs. The Essential Component
Control Program is aggressive environmental testing with a disciplined
root cause analysis collective action program to address the results of
the monitoring program. We believe that such programs are best promoted
by regulatory policies that encourages rather than discourages firms to
test for foreign \-- for the growth of pathogens. Manufacturers should
also note possible design products that inhibit the growth of Listeria
moncytogenes. Ultimately, improvements in food safety must be designed
into food processing systems.

As a practical matter it\'s not possible to test every single product
defect of the food supply. That\'s why a regulatory system that
encourages intensive \-- and self-audits that protects the
confidentiality of the associated records is so important for Lm
control. Thank you.

MS. GLAVIN: I wanted to ask if in your written comments you were able to
\-- you made a comment that \-- part of your comment was that the final
rule should encourage rather than discourage companies to look for an
eliminate pathogens in their plants. Are you able to include in your
written comments suggestions on specific changes or alterations to the
proposal that \-- that would do that? I mean it\'s pretty hard to argue
\--

MS. SCOTT: Yes.

MS. GLAVIN: \-- that that\'s not a great idea.

MS. SCOTT: Right. We will do that.

MS. GLAVIN: Okay. Great. It would also be useful to have some discussion
of what it is in the proposal that leads to a discouragement of that. So
that would hopefully help and not just for your comments, but because I
keep hearing not just here, but in other places, this concern that in an
attempt to improve things, a rule might make things worse by
discouraging plants from doing things that they\'re already doing and
causing them to scale back, not scale up.

MS. SCOTT: Right.

MS. GLAVIN: Okay. Can you come to the mike? Thank you?

A PARTICIPANT: John \-- I think that question almost answers itself.
Anytime the government gets involved \-- as a plant manager, I\'m more
concerned about what my product is for my customers than I am if I\'m
going to pass a test for an inspector. But I\'ve got inspection
personnel coming in and wanting to review my test records as \-- as are
required by this proposal. What\'s FSIS \-- what\'s FSIS going to do
with the information they get?

I\'ve got an article from the newspaper that there was a plant that
probably had a recall. This paper was dated March 23rd and the product
was supposedly produced March 19th. We heard yesterday that it takes 48
to 72 hours to get even species test results, and yet the newspapers got
information for these several products that had been produced that were
being recalled.

The problem I think that everybody\'s concerned about is that, yeah, we
want to take care of our own products. That, you know, being mandated by
a government agency to do it \-- Dr. Weidmann said yesterday that he
could find listeria in this room. He could also not find listeria in
this room. If FSIS is going to come in and want to look at my records,
there\'s never going to be a positive for it. But I will have positives
for myself. I will check my own records and make sure that my equipment
and my product is going to my customers safe. But I\'m more worried
about what FSIS actions would take, if I came back with a negative
report.

We\'ve got the finest minds in USDA sitting here today and they have all
kinds of questions. Dr. Engeljohn\'s continually asking questions, \"How
do we do this? How do we implement it? We need more information.\" This
is your proposal, this is your regulation. You\'re not sure how to
implement it. When it gets out to the field and finally gets to
inspection personnel, it\'s going to be implemented subjectively. I
don\'t know about everybody else in the room but as a plant operator it
bothers me. It worries me to no end that one inspector will come in and
do things one way and another inspector will come in and do things
another way. One set of information is going to be read in one way and
one set of information will be read another way. And the control that
FSIS takes will be implemented differently, just as much as everybody in
this room has a different opinion about the whole proposal. Thank you.

MS. GLAVIN: Thank you.

MS. HANIGAN: Can I make one \--

MS. GLAVIN: Yes, please.

MS. HANIGAN: Katie Hanigan with Farmland. I was sitting here just
chicken scratching the CCPs I\'ve got here, just for example, so
everybody understands the point I was trying to drive home. I said
\"chicken\" scratching.

(Laughter.)

Doodling. I should apologize to Jenny, doodling during her presentation.

(Laughter.)

But I had to do this.

(Laughter.)

As a comparison, if you use the CCP that we have for fecal and
slaughter, if you get going along and all of a sudden you have fecal on
carcasses we\'re going to go back to your last acceptable check, and
you\'re actually going back and looking at those carcasses for something
that you can see, which is fecal. For those sitting in the room that
have metal detection as a CCP \-- not that I\'m advocating that, either
\--

(Laughter.)

\-- but I\'m just saying if you have metal detection as a CCP and you
get rolling along and all of a sudden your metal detector\'s not
working, the way it\'s supposed to be, you\'ve got your product and you
fix the metal detector, you recalibrate it or whatever you need to do.
And you start running the product back from the last acceptable check
back through and that\'s fine, that\'s good.

Now we get to this listeria CCP for those in the room that opt to do
this, and I just wrote down here \"application of sanitizer to the
line\" or whatever. I mean I was just writing one of these down and I\'m
thinking, okay, so you agree here that you\'re going to apply sanitizer
to the line at a level that is documented significant to destroy
listeria, so whatever. Say it\'s 150 parts per million and I\'m not
saying it is, I\'m just saying whatever.

(Laughter.)

You get to the end of first shift and you go to verify the concentration
of the sanitizer, which is coming out of this unit you have mounted on
the wall which is guaranteed not to ever malfunction \--

(Laughter.)

\-- we all know how that works.

(Laughter.)

And all of a sudden, the sanitizer concentration that\'s being delivered
from this unit has dropped down to 75 parts per million and the last
time we checked this was at noon and it\'s now 4:00. All of a sudden
we\'ve got about four hours worth of production that was packaged during
this timeframe when the sanitizer apparently sometime dropped down to 75
parts per million.

If I have to go back to the last acceptable check with this packaged
product what am I doing? Going to reopen all these packages? It\'s not
like I\'m going to see the listeria. I mean I get \-- sitting here
saying, \"So what\'s my corrective action? I\'m not going to see the
listeria. I mean I\'ve got the product held because the level of
sanitizer here dropped off. What corrective action will be taken on this
product to make sure under the rules, it\'s not hazardous to the health?
I mean we\'re just going to run ourselves in a circle.

Clearly if you would buy one of the interventions that we saw yesterday,
but as I said we don\'t know the cost of those interventions and that
cost is much more significant than the \$4 attachment. I think it\'s two
totally different things. But it would be one thing if you did have the
intervention where you could run all the packages back through it again.
But I think nobody in this room has got those interventions right now,
and I don\'t think anyone\'s going to have those interventions in the
next three to six months.

I mean, we\'re kind of at a stop. It\'s not like we \-- we want to do
the right thing but we\'re kind of locked up here. I recommend, the best
of the best I\'d say is at the Omaha Technical Center. I think more
scientists need to sit down and say, \"So just how do you lay out the
CCP so that when it fails, the corrective action goes back to the last
acceptable check and how do you do this because the product is already
packaged and you can\'t see the listeria?\" Because you sure don\'t want
to go reopening all of that stuff. And repackaging it again means a lot
of issues with cross-contamination if we start reopening packaging. Just
food for thought. I\'ll try to summarize that and put it in written
comments, as well.

MS. GLAVIN: Good. Thank you. Appreciate it.

Yes, Joe?

A PARTICIPANT: Dan, before you tell me to put in my comments, I will.

(Laughter.)

We were talking about the cost of this thing, and what it may or may not
cost. I want to put this in perspective and I didn\'t chicken scratch, I
turkey scratched this.

(Laughter.)

Roughly, if you would take a line and some may run fast and some may run
slower, but say you pack four cases per minute. That\'s about 240 cases
per hour and on an eight hour shift, we\'ve got 1,920 cases at 40 cases
per pallet, so we\'ve got 48 pallets per line. Okay. Let\'s say you have
five to 10 lines in the plant. That\'s another 240 to 480 pallets per
week. If you take those and store those in a warehouse where you have
eight slots, three deep and three high. It would take 48 walls to store
this in. That\'s about 10 miles of warehouse space. At \$15 for handling
per pallet, one time charge hopefully, and \$1.50 storage per month,
you\'re talking about \$3250.00 per week, just because you took a
contact surface swab. That\'s what we\'re talking about. That\'s
significant. But that\'s what it comes down to. And that\'s per week.

Now if you do that four times a week, you really turn it every two
weeks. You can always wait until you get your results back. But you\'re
roughly talking about \$16,500 per month of charge to comply. That\'s
part of the problem, to keep it in perspective. Thank you.

MS. GLAVIN: Yes?

MS. SWERBER: I\'m Bill Swerber with Cargill. Just to remind you on
Katie\'s CCP. One easy way to think about whether something should be a
CCP or a JMP, is to determine whether or not you can take action against
the product when a deviation occurs. A HACCP plan, if you have a
deviation on the CCP, you must control the product. Sanitation steps are
not good CCPs, so sanitizing your line really wouldn\'t shouldn\'t be on
a CCP.

So if you\'re looking to develop an example for a CCP under this rule,
there\'s \-- or something like \-- that would be a good example and you
would control that by formulation controls. For some reason you don\'t
have it, then you go back to the affected product and it has to be
detained, reworked or destroyed. Other CCPs could be \-- processing
steps identifying the packaged product which would be easily monitored
by going through records or \--

MS. GLAVIN: Thank you. Dane?

MR. BERNARD: Dane Bernard. Just to continue on with what Bill said and
to harken back to Jenny\'s remarks.

There\'s a significant value of product that\'s packed, that is not
amenable to the place to package further processing. There\'s a great
deal of products which are manufactured and provided for other multiple
uses. It simply is not amenable to that sort of technology.

So there are challenges and when one thinks of the problem products
we\'ve had \-- and as a company I really think we can post-package treat
things and then incorporate that with technology, but that\'s not the
answer to everything that this rule addresses.

MS. GLAVIN: Caroline, you signed up for \-- do you want to wait?

MS. DeWAAL: Yes. I\'ll wait.

MS. CHRISTIN: Hi, I\'m Charlotte Christin. I\'m senior staff attorney at
CSPI. It\'s been more than two years since the Sara Lee outbreak
sickened 101 people and killed 21 others. Last year CSPI filed a
petition to require both environmental and product testing and labeling
requirements for ready-to-eat products because we were very concerned
about what happened in the Sara Lee outbreak.

We\'re glad at this point that we finally have a proposal, but it has
been more than two years. So it\'s taken us a long time to get to this
point and we need to continue to work with expediency in getting a final
rule going.

With regard to the issue of testing frequency, we agree with Jenny. Alot
of firms are doing a lot of \-- a lot more testing than what their
proposal would require. A lot of firms do have aggressive testing
programs. We\'re concerned that firms might scale back because they
perceive the proposal as some sort of a shield. While it may not
necessarily be legally a safe harbor, there certainly is an issue of
whether there would a ways to the bottom.

We also believe that more testing would save more lives. There is a
public health consequence to reducing Listeria monocytogenes
adulteration. We think that all plants should sample all lines at a
minimum of once a week. We\'re also concerned because it appears that
the proposal would allow the bundling of testing.

The point was raised earlier about what the Agency means by testing. The
way I read the proposal, a large plant presumably could perform all four
of the \-- tests within a very short period of time and then not test
and yet still be in compliance with this proposal. We think the
regulation should be modified to change, for example, the four times a
month requirement for large plants to one time a week, for example.

Finally, with regard to the issue of the listeria species versus
Listeria moncytogenes and what organism should be tested for, we support
the comments made earlier by Kaye Wachsmuth and Bruce Tompkin regarding
the value of listeria species testing. One additional comment would be
that, for those of you who are concerned about the presence of listeria
species, in that it might not correlate to the presence of Listeria
moncytogenes, we have this alternative \-- test for Listeria
moncytogenes. However, the ramification of that, is that Listeria
moncytogenes is an adulterant.

I guess \-- I\'m sorry, one last comment, with regards to the \-- to the
HACCP alternative to the SSOPs, there\'s been a lot of discussion about
that and there were a lot of good questions \-- questions raised by
Katie and others. I think that the proposal focuses a lot on the SSOP
alternative, however, I think a lot more needs to be fleshed out with
regard to the HACCP alternative. For example, the language in the
proposed regulation itself does not provide any specifics about the
required validation. Presumably the Agency does intend that validation
would be required but, for example, nowhere in the section on listeria
species testing is there any mention of the validation for HACCP. So I
think that\'s a large gap that needs to be filled. Thank you.

MS. GLAVIN: Okay. Other comments, questions, discussion?

Bruce?

DR. TOMPKIN: I\'m Bruce Tompkin from ConAgra. My comments will
eventually be submitted in writing so I\'m working from something that I
wrote some time ago and I\'m trying to figure out where it\'s all going
to go. But I would like to remind us all as we head forward, at the
bottom line of all of this exercise is improved consumer protection.
There\'s a discrepancy as to what the actual goal will be in terms of
improved public health. The discrepancy really falls within the Federal
Register notice where 167 cases are estimated to be attributed to
ready-to-eat meat and poultry products and yet the FDA/USDA draft risk
assessment sets this number at 1,660. So there\'s about a 10-fold
difference.

Well, there are probably a number of reasons why that may be the case
but, you know, it would be desirable to have a better fix on what that
number should be, specifically, so that we know where we\'re going. What
is the estimated reduction in \-- in food-borne listeriosis that can be
expected from this particular proposal, relative to what we have in
place today which is the directive. The directive which was issued in
December already does address a number of the issues we\'ve discussed,
and it\'s a question of what further reductions in illness would this
provide?

I think that in reading through the document, we do test aggressively in
our company. We do test on a weekly basis from every line. Cost, as I
mentioned, was \$4 but that does not include the sampling time and cost
as well as the shipping costs. So a few dollars is okay for us because
we\'re high volume.

We\'re looking very hard for this pathogen and actually for an indicator
of the pathogen and the conditions under which we are operating. So we
have been able to have some economies of scale.

However, the way this proposal is set forth if you do test product
contact surfaces, and do detect a positive for listeria whatever,
species or the like, it will require that we place the product, or
actually go after the product and test it. This is going to diminish our
desire, I just know it will, to do this. It\'s critically important for
us and for our level of confidence and our degree of control to test as
freely as possible.

The financial costs in terms of placing product on hold has been
described just a little bit ago and it\'s a very real \-- it\'s a very
real factor. In addition to placing product on hold, there is definitely
a financial cost associated with that. And also, we short customers, and
that\'s really not a very happy experience. So there are a number of
factors that enter into the mechanics and whether or not this is really
a practical thing.

As a matter of policy, our company says that any time we sample a
product for a pathogen, the product will be placed on hold. That means
that not only in the four weeks, the four sampling times per month, but
any other time that we sample a product contact surface, we will place
the product on hold. And that\'s a negative feature.

The idea of incorporating one or more CCPs into the HACCP plan for
control of Lm between lethality and packaging in lieu of testing, I
think, is an easy way to do it to avoid all this pain. But actually what
that means is that leads the industry to test less. And it places CCPs
which, quite frankly, I think there\'s a general consensus that there is
no such CCP between lethality and packaging.

Anything \-- and we have done this before on other issues, but there are
no CCPs that we can put in place that will ensure or control or prevent
contamination with a Listeria organism. That again really comes down to
post-packaging processing as the means to \-- as we heard yesterday,
that would be a true, valid CCP.

The idea of adding additives has considerable public health value, but
it does not get around the issue of a positive product. We would still
be in violation even though we feel that the product would be safe
through the shelf life and \-- and until the product gets consumed.

There is a question, a number of questions, but I think I added it up
and there were 26 questions or more in this proposed rule. Trying to
respond to all of those questions and all of this stuff and listeria
risk assessment from FDA/USDA all at one time is a bit much. But one of
the questions in there, was this relationship between listeria species
and Lm. I suggest that the Agency could actually go into its product
testing, look at the data and find out what number of samples test
positive or suspect, let\'s say, of a listeria species state, a
listeria-like organism \-- such as that, and then determine how many of
those confirm \-- confirm out as Lm? You could \-- that would be one
indication for what that relationship might be, at least in product, and
that could be of interest to us.

The proposed rule does not address the issue of risk of the product in
terms of whether growth can or cannot occur. I think that this is a
feature that should be built into it. I know the current policy states
that, in fact, the presence of Lm is an adulterant and it\'s \-- and
it\'s \-- the product is subject to recall and destruction. However, as
we progress through the risk assessment process and become more familiar
with the public health issue, then perhaps the future version of this
could take into account, growth versus no growth.

I would actually suggest that if you think in terms of this whole
process as we\'ve gone through it since 1987, I believe, at least in the
meat and poultry industry, we\'ve gone through a number of stages where
it was thought to be a concern, it was confirmed to be a concern with
the \-\-- franks situation. Then we had gone from a one gram sample to
25 grams. Alot of things have been going on. We\'ve been changing and
tightening up and that\'s \-- that\'s okay. That\'s not really the
issue, but it\'s a matter of how fast can we move this industry to an
aggressive program as defined in the proposed rule, in terms of sampling
every four weeks, you know, four weeks per month? Four times per month
has just been suggested.

I think that we\'ve reached a point where the directive that was issued
in December of last year, as being a very positive step forward and here
now we\'re already talking about leaving that behind and moving on to
the next one. I think that the directive that was issued is practical,
workable, and does increase the level of testing that industry should be
doing in terms of product testing in particular. It does allow for
environmental testing as an alternative.

I think that that directive should be modified so that when a product is
sampled at whatever \-- is used, the product contact surfaces also be
sampled. Through that means, you would develop the data that your seeing
in terms of a relationship between product contact surface sample
results and the product. Also, we can also use that same experience of
data to address the question of listeria species and its relationship to
Lm. And we would take those samples all the way to Lm.

DR. ENGELJOHN: Can I ask a follow-up question? When you say if \-- if
you\'re talking about the FSIS coding sample, the sample that we would
take from listeria on the ready-to-eat product?

DR. TOMPKIN: No, that\'s \--

DR. ENGELJOHN: the same time \--

(Multiple voices.)

DR. TOMPKIN: \-- and I wasn\'t thinking of what you folks were going to
do. That\'s right. You can do that.

DR. ENGELJOHN: Okay.

DR. TOMPKIN: The product is going to on hold or if it\'s positive it\'s
going to be subject to recall, anyway, so there\'s an opportunity from
experience and information, whereas in the other \-- in our case where
we sample once per month per HACCP plan in each of our plants, we would
certainly, when our products are on hold, we could just as easily sample
the packaging lines at the same time. By pulling that, data actually the
data would add up rather quickly.

As we\'ve been hearing each other talk, I think we\'re all concerned
with testing as really the backbone of our control program, in terms of
assessing the level of control, and then it\'s what we do after we find
the positive. That\'s another issue.

But there is a real problem, a real financial problem and so on, with
regard to smaller operators. They do not have the resources and they do
not have the financial backing to enable them to be as aggressive as
larger plants. There has to be some consideration given to providing
education and help to those operators so that they understand the
problem, what they could be doing in terms of minimizing this risk.

I think there should be a means by which \-- I\'m getting into somebody
else\'s area, but the private laboratories that do the analyses, someone
should be negotiating with them for a better price. It can be done
cheaply. You don\'t have to know the final \-- the final number or
answer. What you need to know is whether you have listeria-like or
listeria species. That is lower cost, and that does provide the
information that allows a processor to direct their energy to a
potential problem. Whether that\'s done through them or it would be done
through the Agency or through some other mechanism, through land grant
colleges and so on, I think something should be done to enhance the
educational component of this whole package.

There is a parallel example that\'s gone on recently with the FDA rule,
it\'s a final rule now, for fresh juice that really relates specifically
to fresh citrus juice where a processor can find an alternative
procedure other than food pasteurization or pasteurization; let\'s say
for a five year reduction. And they do have a program in place for
sampling for E.coli as an alternative to sampling for the pathogen of
concern. In the event they do find the cause of E.coli it\'s all spelled
out exactly what has to be done with that, from a corrective action
standpoint.

If it were in our case, testing for listeria species, the product is not
in jeopardy, just as in the case for fresh juice, \-- is not in
jeopardy. However, it has to go through the corrective actions and then
I believe as you resume sampling or producing, then you move on. If you
have in their case, a couple of positives, then you move toward product
testing. So we have the rule, it\'s a parallel to us that offers I think
some alternatives to where we are now. Thanks.

MS. GLAVIN: Okay. Thank you.

MR. DERFLER: It\'s Phil Derfler. I have a question.

MS. GLAVIN: All right.

MR. DERFLER: We have an aggressive testing program but we\'re worried
about, when you test for the listeria species on food contact surfaces,
but does not necessarily lead you to test the product. I think that\'s
what you suggested earlier in your talk.

DR. TOMPKIN: Exactly, yes. We\'re sampling every line every week, 230
something lines, plus we\'re running over 60,000 samples per year. So I
think, and what\'s in the official program, we encourage our floor
people in the plant to go beyond that because we want them to find the
problem if there is one.

MR. DERFLER: Okay. Do you worry \-- okay, you get a food contact surface
positive, do you worry that \-- about what that represents for the food?

DR. TOMPKIN: Well, that\'s a good question and we\'ve wrestled with it
many times and \-- well, we have also looked at the data recently and we
find that these are isolated positives, and by a large number. I have
the data and we shared that a little bit a little while ago. But, by and
large, those are isolated positives, rather than repetitive positives.
It\'s the repetitive positives that we heard yesterday where a niche is
formed. And as Jenny had discussed, that was the greatest concern and
that leads to the biggest issues.

MR. DERFLER: So if you had a repetitive positive you might start doing
\--

DR. TOMPKIN: Oh, absolutely. That\'s \-- that\'s a real red flag. Now we
have considered as a \-- a product contact surface sample holding the
product and it\'s not manageable. The impact to functioning, to the
business, is so tremendous. So to work on that \-- on that scenario, is
very difficult and, essentially, it immediately has a direct impact on
your desire to go out and sample.

MR. DERFLER: Okay. Let \-- Let me just ask one more question.

DR. TOMPKIN: Sure.

MR. DERFLER: Then do you weigh that from a product \-- I mean do you
think about the costs and benefits from a product liability standpoint?
I mean to a certain extent you are taking a chance there.

DR. TOMPKIN: I recognize your legal background.

(Laughter.)

MR. DERFLER: Yes. Your answer will be \--

DR. TOMPKIN: It\'s not \-- I worry about it from a consumer protection
standpoint first. I also then worry about the legal issue. If or whether
we do have a problem, that original data is just going to kill us in
some ways.

Now the other way of looking at it is that we have a very good story to
tell in terms of that we have been aggressive \-- I don\'t know what the
legal term is

but \--

MR. DERFLER: Due diligence?

DR. TOMPKIN: Thank you.

(Laughter.)

If we have a problem, it won\'t be because we haven\'t been trying to
find it and cope with that. So that\'s \-- that\'s our defense from the
legal standpoint is that we\'re really trying to find \-- I guess from
the Agency\'s standpoint that sort of indicates it\'s a very real one.
That\'s for sure.

MR. DERFLER: Thank you.

DR. TOMPKIN: It\'s where you try to get the balance. It\'s really a
matter of what can you do practically and still achieve the public
health.

MR. DERFLER: Through your experience, have you ever developed like an
odds ratio or something like that or some sort of data that would
suggest what the relationship is between surface positives and consumer
complaints or anything like that that would give you some sort of
long-term handle as to how successful you\'ve been \--

A PARTICIPANT: Or how you define a spike or just that random positive
that you had? Do you have some parameters for that?

DR. TOMPKIN: I mean we used to look at our data closely and respond to
those lines where we had two consecutive positives or three in the last
seven. We no longer do that.

MS. WACHSMUTH: Do you ever do product testing follow-up? I don\'t mean
of the same product, just on the day you took your sample?

DR. TOMPKIN: Okay. I can \-- we do not on the first \-- on the first
time. When we have a suspect \-- we\'re testing for listeria-like in our
situation, and so if we find a listeria-like, then we will essentially
go through our corrective actions and truly mark it Lm. Then we will
resume production and then if we \-- then we will sample the line two
days in a row. We want to verify that, in fact, we have had \-- we have
brought that condition under control.

So whereas we used to look for patterns and focus on two consecutive or
three out of the last seven, now we treat every \-- every positive as a
concern and we go through that step. If we find in the course of that
event a series of three another positive on the line then we will go
through the corrective actions, start up again, and continue for the
three consecutive negatives on the \-- on the packaging line. And in
addition, the product is on \"hold and test\" and we test the product.

We have had situations where we have had definitive positives and
definitive issues, the product is placed on \"hold and test, we\'ve
destroyed product as a result of this program, on the basis of a
listeria-like finding without confirming to Lm when there\'s \-- that\'s
one of the quirks of the current policy, because if you find Lm that\'s
a failure of the HACCP plan and that\'s not really constructive.

Then we have to go through reevaluating the HACCP plan. And we know with
reality, that\'s not going to \-- it\'s not really addressing the issue,
and so on. We\'re getting into all these other things, but from a public
health standpoint, there is a program that can be put in place that\'s
manageable that would address those concerns. But it is not taking
action on the first positive product contact surface.

DR. ENGELJOHN: Let me see if I can follow-up. When you sample the
product is there an ICMF stratified sampling scheme that you\'re using,
or how are you determining the product\'s sample size? Do you have a
comment for that?

DR. TOMPKIN: Yes, that could be done and \-- but at this point in time
we have been simply using the USDA sampling frame \-- now we have had a
situation where we

did \-- we were concerned about \-- we had a positive on the product.
And we went in and sampled that lot with an ICSS sampling plan on 30
sets of five samples each by packages and analyzed those. That\'s 30
separate analysis. They were all negative. So that gives you some idea.
There was one positive and we had those 30 sets negative. We analyzed
those at the end of code date; again 30 sets and they were all negative
for Lm.

So it\'s not much data, but in terms of what is the relationship between
the product contact surface and the product sample; I don\'t know that
there\'s any data. We \-- there was a time when we used to sample
product every two hours from every packaging line and record it and we
used to take those out certainly to listeria species at that time and
that\'s been discontinued because of all of the issues that come up now.

So we really lost an opportunity. We\'ve been losing opportunities for
generating the data that we all need as a result of the adulteration
issue and if we had some \-- some relaxation of that \-- I know that\'s
going to make some people very nervous when I say that \--

(Laughter.)

\-- but there should be some way that we can arrive at a mutually
desirable way to \-- to sample the equipment where necessary and the
product to verify HACCP and CCP and the SSOP, and still allow for
aggressive testing. It doesn\'t matter how we get there. This proposal
is \-- is not the answer.

A PARTICIPANT: After five years I didn\'t think I was going to be
sitting at this table again but I\'m back again on this topic. So you
really asked two questions, and the reason I came back up here was to
try and give you some comment as to what disincentive is and what used
to be, and what we found out when we could keep sampling.

We used to have a definition of a non-intact sample as not being a
sampling in which regulatory reaction would take place. Industry had an
opportunity to police itself, at least it\'s own operations. And we did
that, and we sampled a lot. We\'d sample contact surfaces and we\'d
sample our product in a manner that gave us information to improve our
operations without shutting down the plant.

Pretty much \-- didn\'t find much of a correlation from what I recall,
from the contact surface of the product.

But after the definitions changed as well, it\'s kind of hard to say
right now, we stopped taking those samples. We don\'t have them any
more. We can\'t afford to take those types of samples that we did in the
past. That\'s a disincentive from the regulatory scheme of the past.

I have to agree with Bruce on this, the more that you try to encourage
with a strong arm, industry, into taking sampling plans \-- I don\'t
know if we said it yesterday, but I have to agree \-- there are ways of
sampling and meeting regulatory requirements without looking and finding
nothing and that\'s not what you want, I don\'t believe.

But to answer your question, as I recall there was not \-- there was no
correlation between actual contact surface positives product or product
positives.

DR. ENGELJOHN: Just for the record, this is John Engeljohn. John, you
mentioned intact versus non-intact. Because we dealt with the issue
yesterday of intact versus non-intact, but in a different context, just
for the record, what I believe you meant was, there was original
microbiological sampling program in which we\'d find an intact sample as
one being inside an enclosed container, so that is not exposed to the
environment.

A PARTICIPANT: Yes, that\'s correct. Most of the contact surface
positives were subject to \-- they\'re outliers. Whenever we had
repetitive issues, if we had a repetitive issue it \-- it didn\'t really
correlate well with the product at that time, but whenever we did get a
positive we could go back to a repetitive contact making more sense in
the long run. That\'s what we do now. As we move from past experience.
But just a single contact positive, no.

MS. DeWAAL: John, thank you. I think a lot of good ideas have come out
in this discussion. I do think that USDA holds some of the key in its
own hands, and that is when you are taking food samples it would make
sense to have the government take some product contact samples at the
same time to give you some data on correlation.

I think what we\'ve heard today are two different approaches to the
liability issues. I think Bruce has laid out an excellent example of how
a lot of people thought the industry would respond in a responsible way
to the zero tolerance on listeria, which is we sample \-- we may not
sample for Lm but we sample like crazy for listeria-like and we take
action even against product.

We\'re just \-- you know, that\'s our defense. If something happens,
it\'s like we\'re really looking and that is a responsible approach.
Unfortunately, the industry didn\'t do that. Because of legal advise
given to the industry that said, \"Your best bet is not to know. Put
your blinders on and don\'t test this product.\" That is, in fact, in a
sense, why we\'re here today.

But I need to remind the audience, if not the regulators, that the
Bilmar plant did run samples. They did find positives. They didn\'t know
what to do. There wasn\'t a mandate, their advice from lawyers had been
scared. So they \-- instead of dealing with the product issues, they
just stopped sampling. They didn\'t want to know. They put the blinders
on, they listened to the lawyers and they didn\'t do the responsible
public health thing.

So we really need to move forward with regulations in this area and I\'m
happy to see the government doing that. But I think there are two
approaches, and I think Bruce has really outlined one very well. And I
think the issue I\'m going to go home and think about is the issue of,
we need more than four tests a month, whether it\'s done once a week or
four tests in a month. That\'s not enough for a large plant. That might
be the minimum needed for a small plant, which I think is what Charlotte
was trying to say, but we definitely think that more testing is
required. The thing that I\'m going to go home and think about is what
Bruce has raised, the issue of what \-- what happens after the first
positive?

I think the data that will be beneficial to the Agency and I\'d love to
see it too, is what percentage of random positives for Lm-like as
opposed to repetitive positives? Because that\'s \-- that\'s an
interesting new concept that we should certainly think about. But at
some point, we do need to move on to look at the products and \-- and
you may need to move into the holding-test sampling system. The bottom
line is this isn\'t going to be a free \-- the public \-- the public
health benefit here isn\'t going to be \-- there are some \-- for the
industry. This is going to cost the industry something to improve their
products. Luckily, many of these meats are very inexpensive to purchase,
and they\'re produced in very high volume and so the cost to the
consumer, I think, from making these improvements will probably be
minimal, if even noticeable in the family budget.

So I think it will cost the industry something to comply. We need to
make for compliance whether it\'s a testing regime or a HACCP type
regime. They need to be related so there is some incentive to move to
the HACCP type system, you know. I just would urge the Agency to proceed
quickly, to work out these details and to move this forward. Thank you.

MS. GLAVIN: Do people want to break or do you want to keep going?

MR. JOHNSON: Well, can I just have the last word?

(Laughter.)

MS. GLAVIN: Go.

MR. JOHNSON: Dennis Johnson again. Sitting next to Caroline, I noticed
she mentioned lawyers. Without naming names, I assume she was talking
about lawyers other than me.

(Laughter.)

\-- and I appreciate that. I\'m going to sort of answer to the liability
question, if I could. This is the advice I\'ve given publicly, this is
the advice that I\'ve given to every one of my clients, and here it is.
If you do not control listeria in your plant, you\'re going to end up
with a problem. You\'re going to end up with harborage. Your harborage
is going to increase the amount of products you have positive, which
thereby exposes your risk tremendously.

I\'ve had clients who have had positive rates of up to 30 percent, back
when they hired me they had 30 percent. Because it\'s long and short. If
you don\'t look for it, it\'s going to get you. It\'s what you don\'t
know that will get you in trouble. So in the case of listeria, you need
a very aggressive program recognizing that maybe, you might have a
liability, because maybe one time \-- but I\'d rather eliminate the
possibility of having widespread outbreaks, where you have multiple
Plaintiffs. The better way to go is to eliminate it right in the bud.
Therefore, from a liability standpoint, I tell my clients not to worry
about an isolated incident, it\'s best to prevent the outbreak as it
goes along.

The question here \-- and this is what Bruce has raised and what I have
also talked about \-- is we don\'t want to have an automatic, on
thinking, regulatory reaction to a single isolated positive. The
regulatory issue should not be, did you find it? The regulatory issue
should be, what are you going to do about it to make sure you don\'t
find it again? The one big bite of the apple \-- the follow-up to see
what you do to handle it, as if it were a crisis from the word go.
That\'s where the Agency should be. That\'s where I advise my clients to
be from a product liability standpoint. And if you have automatic, on
thinking, regulatory response to a single isolated positive you\'re
going to get people to go underground.

I\'ve seen it and, notwithstanding, all my legal advice, they\'re still
going to do it because they\'re more afraid. They have to be able to go
ahead and find it. If you discourage them from finding it by saying,
\"The first time you find it, your HACCP plan\'s inadequate. We\'re
going to close you down.\" By the way, that is the answer, Katie. They
will close you down for an inadequate HACCP plan. I make a good living
on that.

(Laughter.)

But all kidding aside, we have to have that encouragement, the
cooperation of the Agency, \"Okay. Go ahead. Try to find it. We\'ll let
you try to find it. We\'re not going to punish you if you find it and
take action.\"

Now if I could extend my break time for just one other second because I
don\'t know when this is going to fit in. On Listeria moncytogenes
control, listeria species is not enough, Listeria moncytogenes is not
enough any more. If you find a positive Lm, you really need to know the
pattern, the ribotyping, the PFG, or whatever you want.

Dr. Weidmann yesterday, made that point real clear. I would hope that
the Agency has full access to all our records. I mean my advice to
clients when the FDA says, \"Do you have any PFG\'s? Can we see them?\"
My advice is, \"They\'ll get a subpoena and get it anyway, so you might
as well share it.\"

But the Agency has data. The Agency runs the PFG\'s, from the way I
understand it, from all the positives. You have full access to all our
records, primarily. Maybe with a subpoena \-- oh I\'m sure you\'re going
to get them. But we can\'t even get anything out of the Agency in terms
of a PFG. Maybe that\'s part of why I feel like this or maybe I\'m \--
maybe I\'m uninformed.

MS. WACHSMUTH: Share the \--

MR. JOHNSON: If we wanted to do ribotyping, could you do ribotyping for
us?

MS. GLAVIN: If you arrange it.

MR. JOHNSON: Okay. Well, then that solves that problem.

(Laughter.)

Now who do I get the rest of it from?

(Laughter.)

Thank you very much, Maggie.

MR. DERFLER: I just want to ask one question and nobody necessarily has
to answer it right now, but I really wish you\'d address it in your
comments and that is what is the repetitive finding of Listeria
moncytogenes on your food content \-- I mean a listeria species on your
food content? Is it listeria-like, is it two? Is it three? Is there \--
is there a scientific basis in which we \-- in which we could reasonably
draw that line? Because, otherwise, we\'re going to wind up in the same
spot where we are, because how many times did we test for Lm? I\'m not
complaining. I\'m merely honestly asking for help.

If you\'re going to consider going down this or consider going down
this, I\'d like to do it in a \-- with a rational basis in a defensible
way and so that\'s why I really would like comments.

MS. GLAVIN: And can I suggest that everyone consider that question and
go have a cookie \--

(Laughter.)

\-- and come back with an answer.

(Laughter.)

(Break at 3:22 p.m.)

(On the record at 3:45 p.m.)

A PARTICIPANT: We\'re down to the hard-core people here.

A PARTICIPANT: As long as we have the leading microbiologists on the
planet, why not continue?

MS. GLAVIN: We anointed during this meeting \-- what did we say? It was
the leading \--

A PARTICIPANT: The leading \-- microbiologists on the planet.

MS. GLAVIN: \-- microbiologists on the planet and someone referred to
the greatest minds in the government.

(Laughter.)

(Multiple voices.)

Okay. We still left a question on the table in terms of \-- and I\'m not
sure that it really is one to answer right now, but I do know that it
will be given due consideration, and some help given in the comment
period. And that had to do with what do you \-- when you have your
company systems consider trends, what are some reasonable parameters, or
what are ways of thinking about that?

I was involved in a discussion just a minute ago during the break, about
a company that considers two a trend and the inspector argued that it
should be three. That two is not a trend because it\'s not scientific.

(Laughter.)

So that would \-- that isn\'t very helpful. But if you do \--

(Laughter.)

\-- if you can share maybe not the specifics that you use but your
thought process. That might be helpful for guidance material because I
think it is real important to think about the very wide range of plants
and the wide range of expertise we have with respect to some of these
very complex issues. So if guidance material can help you give us a
thought process, that\'s probably one of the most useful things we can
do. Comments, questions?

MR. HANIGAN: Yes.

MS. GLAVIN: Okay.

MS. HANIGAN: Katie Hanigan with Farmland. I almost hate to make this
comment with Caroline not here, but she\'ll come in and then she\'ll
want to talk about it. While we\'re talking about things that need to
occur, I know Dr. Hulebak is working with ARS and is doing the component
of shelf life studies as it relates to listeria. So I hope you don\'t
mind if I bring this up, but it has to do with listeria.

MS. GLAVIN: Mm-hmm.

MS. HANIGAN: I thought Bruce just did an outstanding job of talking
about some changes that need to occur. One of the things I struggle with
day in and day out is, as a company, I have a tremendous amount of
ready-to-eat products on shelf life testing and then I am unable based
on the current guidelines, rules or whatever, to do any testing on that
product for listeria. I know the Agency needs the information and I know
the industry needs the information to know whether or not listeria is
growing during the course of that shelf life. So when I have a product
that\'s coded for whatever, 60 or 70 days, there has to be some way that
when that product is past its shelf life date from whatever it is, May
5th or May 15th or whatever, that if I have packages, there\'s got to be
a way to let me test that for listeria so we can get the information we
need because I think the project ARS is doing is outstanding, I honestly
do.

But when it\'s all said and done I\'m not sure what it\'s going to tell
us as an industry and as individual companies and as individual plants,
because I think yesterday they said there was 12 plants that were
involved in that. Well, I have 11 plants and they\'re not all involved
in that but, you know, that\'s a small volume of what\'s out there.

So when you\'re considering maybe ways that we need to move things
around, it would seem to me that allowing a company to test a product
that they\'re holding on shelf life and part of the product is out in
the field \-- I want to make sure you understand that \-- part of this
lot is shipped out and I\'ve kept X number of cases for my own testing.
It sure would be helpful if once the product is gone by its code, it
could be tested for listeria so we could gather the information that
everybody needs to have.

DR. ENGELJOHN: Katie, could I follow-up on that just to get some
clarity. When you\'re doing your shelf life testing on your product, are
you moving it at conditions that you would think reflect what is going
to occur in the marketplace, or are you moving it ahead just regularly
for duration temperatures? Could you give me an idea of how you\'ve
constructed that?

MS. HANIGAN: Mm-hmm. We try to hold ours at the worst case scenario, and
so most of ours is being held before \-- between temperatures of 38 to
42 degrees assuming that there\'s no product storage at all between 28
and 34 degrees. I think that\'s probably incorrect because we do have
part of our product sitting in warehouses, but the shelf life testing
I\'m doing now, I\'ve got it under the worst case scenario, 38 to 42
degrees the entire time.

DR. ENGELJOHN: I think there\'s an opportunity for us maybe to sit and
internally talk about this issue and try to put together some thought
process on how we could come to grips with this issue. It was important
for me to know what temperatures you are holding that at, whether it\'s
refrigeration temperatures that you\'re recommending or are those that
are at temperatures above \-- in this case above 42 degrees. So I think
that\'s an opportunity for us to talk internally to see what we may be
able to do about that.

MS. HANIGAN: Okay. And I just \-- just for clarification. I do
understand why if you\'re half way through a product\'s code, testing at
that time for listeria and finding a positive would be extremely serious
because clearly you\'ve got product out on the market that\'s only half
way through the shelf life, etcetera. I understand that, but I did
wonder what Bruce Tompkin\'s thoughts were on this. I don\'t know how
much testing, shelf life testing, his company\'s doing. But I wonder,
Bruce, what your thoughts were on this?

DR. TOMPKIN: Thanks for that, Katie.

(Laughter.)

MS. HANIGAN: That\'s why they have chairs between us.

(Laughter.)

DR. TOMPKIN: I\'m Bruce Tompkin from ConAgra. We did actually run
analyses on shelf life samples some years ago, that was something we
did. We found the prevalence rate to be very low. I don\'t remember
exactly what it was, but it is a source of information that could be
generated that could help each facility better understand its level of
control because that would be more reflective of what is in the
marketplace or what \-- what may have been in the marketplace. Whether
you test it for listeria species or go all the way to Lm and that kind
of thing, is a question that has to be sorted out.

MS. GLAVIN: Okay. Kim?

MS. RICE: I promised myself that \-- Kim Rice with AFI \-- I promised
myself and the members that I wouldn\'t talk much but I do \-- I think I
need to say something.

It\'s unfortunate that the entire industry is getting painted with the
broad brush that no one is testing because that is not true. We have a
lot of members and we have a project that we\'ve undertaken that Randy
Huffman described yesterday with our listeria intervention and control
workshop that we have been conducting. It has been conducted by industry
people.

The foundation \-- as a trade organization we pulled the people together
in a room \-- the company members \-- they all came to the table with
their best practices. And we put together from start to finish,
everything from facility design to equipment sanitation practices,
etcetera, all the things you need to do to control listeria, including
how to put together a testing program, how to look at your data, how to
go about doing an investigation and corrective action. We are teaching
it on a regular basis and, in fact, our next one is in June in
Philadelphia. You know, stuff like that.

But this is \-- this is one of the first times in my short experience in
this industry that I\'ve seen people like Bruce and \-- company and the
\-- and the Krafts and all the other ones that are participating, come
to the table and share with their colleagues in the industry what it
takes to do this right.

One of the concerns I have when we do get people who come, is that the
way we start the course, or try to start the course is, it doesn\'t
matter what you folks on that side of the table are going to do, that\'s
not important, it is but it\'s not, put that aside. What we\'re going to
teach you for the next two days is what\'s the most important thing that
you need to do. And the industry is taking the rap. I think that that
needs to be rewarded and not just sort of passed over because not
everybody\'s doing everything they should be doing, because a lot of
people are out there doing what they should be doing.

MS. GLAVIN: Bruce, did you have a comment that we missed, on something
that what brought up earlier?

DR. TOMPKIN: I just thought I might respond to Phil Derfler\'s question.
I\'m Bruce Tompkin from Conagra. The question related to repetitive
positives. I went through our data not long ago for two years, 1998 and
the year 2000 to see what kind of tallies that we do have. There were
7,000 in one case and 8,700 plus samplings in each of those years.

Of course, you\'ve got so many samples in each sampling set, but what
that could say is that 63 percent and 69 percent were single, isolated
positives in 1998 and the year 2000. There were two consecutive
positives that were 20.5 percent and 16.4 percent in the two consecutive
positives only and then the rest, the other 15 percent, were three or
more consecutives. So, essentially, what that was saying is that it\'s
84 to 85 percent roughly of the samples. The product either was an
isolated positive, or at worst case two. Okay.

MS. GLAVIN: Okay. Thank you.

DR. TOMPKIN: Eventually with information and some other things I\'m
doing will appear in a manuscript on listeria control. And the idea that
I mentioned and all that sort of information that can be helpful to you
in a draft \-- I\'ll give you a draft \--

MS. GLAVIN: That would be terrific.

DR. TOMPKIN: \-- of what we have.

MS. GLAVIN: That would be wonderful. Thank you. We really appreciate
that. Caroline?

MS. DeWAAL: Thank you. Caroline Smith-DeWaal, CSPI. Bruce, I have lots
of questions. When you say two consecutive positives were you doing
those tests on the same day or what was the \-- what was the time lag
between tests?

DR. TOMPKIN: Well, it would have been no greater than a week, but in the
past year, in the year 2000, every positive we had \-- as soon as we had
notification of a positive, the plant went through a corrective action
and then it was resampled when it was started up.

MS. DeWAAL: So you would have one positive \-- if you had a single
positive you would do a corrective action. So for 100 percent of these
you did corrective action? Then if you found \--

DR. TOMPKIN: \-- positives.

MS. DeWAAL: And then when you found the second positive is when you
moved into the product \--

DR. TOMPKIN: That\'s correct.

MS. DeWAAL: \-- the holding test?

DR. TOMPKIN: That\'s correct. And this again is still listeria-like.

MS. DeWAAL: Okay. And there would be \-- you said a week between each
test? And was that one test \--

DR. TOMPKIN: Well, I think \--

MS. DeWAAL: \-- or was it a \-- it was a group of five tests?

DR. TOMPKIN: It would be a minimum of \-- I\'d say a minimum of three
days you go through the \-- you go through the measurement, the second
day measurement, then you \-- and all we\'re looking for is
listeria-like, so you don\'t use your super-sensitive method for Lm in
this case. What we were trying to find, is a listeria-like organism
present?

MS. DeWAAL: And does \-- I\'m sorry to keep bugging you, but that five
\-- it\'s five tests in a sample set. So you would run five tests per
week?

DR. TOMPKIN: On each line it\'s \-- we use as a rule of thumb five
samples per line. However, that depends on the complexity of the line.
In some cases where it\'s just a bulk packing station, all you have is a
table and somebody with gloves. So in those cases you may have two
samples.

MS. DeWAAL: Okay.

DR. TOMPKIN: But if it\'s a slicing line, it\'s typically at least five.

MS. DeWAAL: Okay. Thank you.

DR. TOMPKIN: And those are analyzed as individuals with the exception of
a couple of plants where the control level has reached a point where,
you know, for them to run all of those samples individually it\'s just
\-- the lab work would just be too great and they still composite.

MS. DeWAAL: Okay. Okay.

MS. GLAVIN: Other questions or comments?

MS. HANIGAN: This is Katie Hanigan with Farmland. I was just hoping to
ask why is two consecutive positives a trend and not one or three? So
let me just \-- for clarification, if you\'re taking your samples on
Monday and if you don\'t have your labs on site, which we don\'t have
all our labs on site, some plants have them and some plants don\'t. So
some of the plants are shipping samples over to other labs to get them
analyzed. So those samples are not starting until Tuesday morning, if
you will. So by the time those negatives, if you will, come back, or at
the first sign of a presumptive positive, you\'re already heading into
Wednesday and possibly Thursday. Well, by that time I\'ve already
sampled my lines again, so I mean I\'m already into my second set of
samples before the first set of results are back. I mean it gets very
difficult and complex to try to explain this to inspectors.

I\'m just wondering, also, if there shouldn\'t be some consideration as
to exactly who in your organization at the establishment has access to
these results and to the interpretation of these results? Is it limited
to the IIC? Is this limited to the IIC and the inspector that\'s over
the processing end of the plant or, also, can you also have your
slaughter people asking to see them, too? If they want to see them why
do they need to see them?

You know, it really does get more complicated once you get it out there
and you start trying to figure all the details of this out, because
there\'s a big difference between whether you\'re talking to your
management staff or your \-- or the Agency\'s management staff. People
who really need to know what the data is versus people who just want to
know so that they have something to talk about, if you will.

We\'ve limited our access within Farmland as to who in our management
team gets to see our data, and I think there should be some
consideration given from your Agency as to who is considered an Agency
official to look at this data at the establishment. Because I don\'t
think slaughter inspectors should be looking at listeria data. I don\'t
understand the need for that or why they have to have that.

MS. GLAVIN: Okay. Thank you.

(Pause.)

Okay. Tomorrow\'s agenda will cover first of all, the revisions
governing trichina in pork products and the revisions governing
commercial sterile canned products. Following that discussion, the
economic impact of the proposed regs and the cost benefit data needs.

Today we found that we moved through the morning session somewhat ahead
of schedule and we moved into the afternoon session. So I will urge
those people who are particularly interested in the afternoon session to
attend at least in the late morning in case that happens again.
Obviously, we can\'t predict that, but if that\'s your particular
interest I would suggest you might \-- might want to be here before
1:30, before the lunch break, in case we move into the second subject
more quickly. Are there any other things for today that you want to say?

(No response.)

Okay. Well, thank you for being very attentive and very hardworking all
day and for all of your good input.

(Whereupon, at 4:00 p.m., the hearing in the above-entitled matter was
adjourned.)

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CERTIFICATE OF REPORTER, TRANSCRIBER AND PROOFREADER

[Public Meeting to Receive Comments on FSIS Regulatory Proposal
Concerning Ready-To-Eat Meat and Poultry Products]{.underline}

Name of Hearing or Event

[N/A]{.underline}

Docket No.

[Washington, D.C.]{.underline}

Place of Hearing

[May 9, 2001]{.underline}

Date of Hearing

We, the undersigned, do hereby certify that the foregoing pages, numbers
1 through 186, inclusive, constitute the true, accurate and complete
transcript prepared from the tapes and notes prepared and reported by
Marcia Logan, who was in attendance at the above identified hearing, in
accordance with the applicable provisions of the current USDA contract,
and have verified the accuracy of the transcript (1) by preparing the
typewritten transcript from the reporting or recording accomplished at
the hearing and (2) by comparing the final proofed typewritten
transcript against the recording tapes and/or notes accomplished at the
hearing.

[5/9/01]{.underline}

Date Maria Hester

Name and Signature of Transcriber

Heritage Reporting Corporation

[5/9/01]{.underline}

Date George McGrath

Name and Signature of Proofreader

Heritage Reporting Corporation

[5/9/01]{.underline}

Date Marcia Logan

Name and Signature of Reporter

Heritage Reporting Corporation