COMMITTEE MEMBERS
David W. K. Acheson
James D. Anders
Dane T. Bernard
Robert L. Buchanan
James S. Dickson
Catherine W. Donnelly
Stephanie Doores, Pennsylvania State University
Michael P. Doyle
Mel W. Eklund
Daniel L. Engeljohn, Ph.D.
Michael G. Groves
Michael L. Jahncke
John M. Kobayashi
Earl G. Long
Roberta A. Morales DVM, Ph.D.
Nancy E. Nagle
Marguerite A. Neill
Alison D. O'Brien
Michael C. Robach
Leon H. Russell, Jr.
Skip Seward II
William H. Sperber
William H. Sveum
Bala Swaminathan, Ph.D.
Robert B. Tompkin
AGENCY REPRESENTATIVES
Janice Oliver, Deputy Director, Center for Food Safety and Applied Nutrition, FDA
Dr. Susan Alpert, Director, Center for Food Safety and Applied Nutrition, FDA
Arthur P. Liang, MD, MPH, CDC Liaison
LeeAnne Jackson, FDA Liaison
E. Spencer Garrett, Commerce Department Liaison
LTC Scott Severin, Defense Department Liaison
Dr. Karen Hulebak, Executive Secretary
Jacque Knight, Advisory Committee Specialist
ALSO PRESENT
Dr. Larry Beuchat, University of Georgia
AGENDA ITEM
MS. OLIVER: Once again, my name is Janice Oliver.
I'm Deputy Director of FDA's Center for Food Safety and
Applied Nutrition, and I'm going to be chairing the meeting
today. Dr. Wachsmuth is unable to be with us again and
sends her regrets. Dr. Karen Hulebak may be here later
today, but Dr. Engeljohn is here in her absence this morning
from USDA.
I want to take care of a few housekeeping things
and some other things first, and then we'll go into a
follow-up to yesterday's meeting, if we could.
First, I'd like to introduce Dr. Susan Alpert, who
is FDA's new Director--Susan, if you'd stand--FDA's new
Director of Food Safety at the Center for Food Safety and
Applied Nutrition. She's taking--you know Morrie Potter,
and Morrie Potter was previously Director of the Food Safety
Initiative, and that is part of Dr. Alpert's job right now.
She was formerly the Director of the Office of Device
Evaluation at our Center for Devices and Radiological
Health. Prior to that, she was a medical officer in the
Division of Anti-Infective Drug Products at our Center for
Drug Evaluation and Research. She also served as the
supervisor for anti-infective and dermatological drug
products, so she has a broad background there. But her
background, she has a degree in biology and she has a Ph.D.
in microbiology, so she has a strong background in micro.
She has an M.D. and is a pediatrician, and she completed her
training also in pediatric infectious diseases, so that she
has a broad background in those areas, and Dr. Alpert will
be here with us today and most of tomorrow also. So she
wants to meet some of you and talk with you and I'm sure
will be interacting with you in the future. So, welcome.
The next thing I'd like to do for the record,
since this is being transcribed, is once again have the
members and our guest expert introduce themselves. And
first I'd start with Dr. Beuchat, who is our guest expert.
DR. BEUCHAT: Larry Beuchat, University of
Georgia.
MR. RUSSELL: Leon Russell, Texas A&M University.
MR. SVEUM: Bill Sveum, Campbell's Soup Company.
DR. DONNELLY: Cathy Donnelly, University of
Vermont.
MR. JAHNCKE: Mike Jahncke, Virginia Tech.
DR. KOBAYASHI: John Kobayashi, Washington State
Health Department.
DR. O'BRIEN: Alison O'Brien, Uniformed Services
University.
DR. GROVES: Mike Groves, LSU.
MR. DICKSON: Jim Dickson, Iowa State University.
DR. SPERBER: Bill Sperber, Cargill.
DR. BUCHANAN: Bob Buchanan, FDA.
DR. SWAMINATHAN: Bala Swaminathan, CDC.
DR. MORALES: Roberta Morales, Research Triangle
Institute.
MR. ANDERS: Jim Anders, North Dakota Health
Department.
MR. EKLUND: Mel Eklund, Mel Eklund Associates,
from the peaceful city of Seattle.
[Laughter.]
LTC SEVERIN: Scott Severin, DOD.
DR. LIANG: Art Liang, CDC.
MS. JACKSON: LeeAnne Jackson, FDA, CFSAN.
DR. TROXELL: Terry Troxell, FDA, CFSAN.
DR. ENGELJOHN: Dan Engeljohn, USDA, Food Safety
and Inspection Service.
DR. DOYLE: Mike Doyle, University of Georgia.
DR. DOORES: Stephanie Doores, Penn State
University.
MR. ROBACH: Mike Robach, Conti Group Companies.
MS. NAGLE: Nancy Nagle, Nagle Resources.
DR. KVENBERG: John Kvenberg, FDA.
MR. ACHESON: David Acheson, New England Medical
Center and Tufts University.
DR. NEILL: Peggy Neill, Brown University, in the
city for the little TV show, Providence.
MR. SEWARD: Skip Seward, McDonald's.
DR. BERNARD: Dane Bernard, National Food
Processors Association.
DR. LONG: Earl Long, CDC.
DR. TOMPKIN: Bruce Tompkin, Armour Swift-Eckrich.
MS. OLIVER: Good. Thank you very much.
The next thing I'd like to do is, an agenda, a
draft agenda was passed out for today, and what I'd like to
see is if the Committee agrees with the agenda, has any
questions about the plans for the day.
DR. SPERBER: I notice there's no time on the
agenda. Do you have any rough idea of timing for today?
MS. OLIVER: The draft agenda we had before was to
possibly adjourn around 2:30. What I'd like to do is see
how the meeting goes, and depending on how the deliberations
and discussion goes in the morning, we may adjourn earlier
or we may adjourn a little later.
We're planning on having a break an hour and a
half to two hours into the morning. I will play it by ear
so that depending if we're in the middle of a discussion on
one point, we can break a little earlier or later. Is that
helpful?
DR. SPERBER: Sure.
DR. TOMPKIN: I would like to know, are we going
to focus on fresh juice today, or are we going to be talking
about juice in the more broader sense? I'd like to know
where we're going.
MS. OLIVER: Okay. I'm going to go over that when
we focus on what the day's discussions will be. Okay?
Anything else?
[No response.]
MS. OLIVER: Okay. With that, what I'd like, is
there a motion to adopt the agenda?
DR. DONNELLY: So moved.
MS. OLIVER: A second?
DR. NEILL: Second.
MS. OLIVER: Okay. Fine. That's done.
Now, the next thing I'd like to do is get--look
at--ask everybody, you have a copy of the draft minutes that
were supplied you from the meeting from September 21st to
24th. They're included as tab B in your notebooks. I'd
ask, is there any discussion at all on the minutes?
[No response.]
MS. OLIVER: No discussion on the minutes. Do I
hear a motion to adopt?
DR. GROVES: So moved.
MS. OLIVER: Second?
MS. NAGLE: Second.
MS. OLIVER: Does everybody agree?
[No response.]
MS. OLIVER: Okay. Now, let's go and talk now
about the focus of today's meeting, and I think that's where
everybody is concerned about. But what I'd like to do first
is I'd like to clarify some things that came up yesterday,
either questions that came to me from the Committee or from
members that were presented or the audience or questions--
some things that I'd like to clarify based on comments that
were made yesterday, clarify for the Committee.
The first has to do with an understanding of the
process that FDA is undergoing and where this fits into our
process.
Dr. Troxell told you yesterday that we had
proposed a juice HACCP rule which you're all familiar with.
We're in the process of rulemaking. The comment period had
closed for the juice HACCP period. In reviewing the
comments that came in, there were several comments that
dealt with the possibility of infiltration of pathogens into
citrus. There were other comments, as he said, that dealt
with where does the 5-log start, and there were questions of
interpretation.
In response to that, FDA did some research. That
research was presented here, and you heard comments on the
research and on research that other people did yesterday.
What we're doing is we're asking the Committee for input on
specific questions relating to the infiltration or
internalization of pathogens into citrus juice, and we're
also asking questions that deal with where does the 5-log
start. And we're dealing with fresh juice.
Now, what we will do is, following this meeting,
we're transcribing the meeting, the transcript will be
turned around--within about 24 hours we'll get it, and we
will send it to our docket. It will be a part of our--the
comments in the docket, and it will be placed on the Web.
That should happen fairly shortly, so that the transcript
and the results of this meeting will be used in the
evaluation as part of our rulemaking process, and we'll take
the advice and look at this as advice from the Advisory
Committee.
What we will be doing and what the juice HACCP
rule will or will not look like or finalization or comments
to the proposal will not be done at this meeting. Some
people had misinterpreted that, that the finalization will
happen here.
The comment period was reopened on November 23rd.
The comment period will remain open until January 24th.
Therefore, individuals have a chance to comment on what has
already been placed in the docket, which includes the
research that we presented yesterday, and that is a part of
your booklet from FDA. Individuals will also then have the
opportunity to comment on the deliberations from this
Committee as this will be made a part of the official
record. So just to clear that up and focus that part.
There were a number of other questions that arose
yesterday on outbreaks. The focus of this meeting is not on
outbreaks but on the questions we have, but there were some
questions that arose that if we had the results of certain
things or you needed certain information, it would be
helpful to have certain information in order for you to
respond to us.
The first thing is Laurie Girand's slides
yesterday did not appear and did not work on the overhead.
They were made and distributed to you yesterday afternoon.
Dr. Ismail also had slides dealing with outbreaks.
He provided a copy of that this morning. We are copying
that, and that will be given to you this morning. But if
you have questions, that will be given.
We have also, FDA has also provided a summary of
outbreaks to you this morning. LeeAnne Jackson can answer
any comments that you might have on that if you have some
later.
There were also comments that were made yesterday
on the causes of various outbreaks, and there was some
confusion in my listening to the comments and the
presentations and the questions. There could be some
confusion that the current recall that is underway by Sun
Orchard is associated with outbreaks. So let me just go
through a few things.
There was an outbreak associated with Sun Orchard.
That was earlier this year, and there was a recall
associated with that. There currently is a recall by Sun
Orchard. That recall was not associated with an outbreak
that we know of. The recall was based on Sun Orchard's
sampling, their finding of Salmonella in the product, so
that Sun Orchard did the sampling and entered into a
voluntary recall.
There are a number of questions that have been
asked about, and I think Dr. Tompkin made a comment
yesterday that knowing the cause of the various outbreaks
would be very beneficial for this Committee in your
deliberations.
Let me go through a few things and tell you what I
know and what I don't know, and let me start with the most
recent.
The recall by Sun Orchard of Salmonella in orange
juice that is currently ongoing is currently under
investigation, still under investigation by the firm, by the
states, and by FDA. We do not know the cause at this time,
and it would be purely speculative to go into anything. And
since it also is under active investigation, it is not
something that we would be able to further discuss.
The previous outbreak that--there were a number of
comments made by different people saying or intimating that
the cause was definitively found for the previous outbreak
on Sun Orchard. We, FDA, did not find or do not know the
definitive cause for the previous outbreak on Sun Orchard.
There were samples that were taken. We have positive
samples for Salmonella. We also had a positive sample that
showed multiple serotypes of Salmonella from a tanker that
was taken that was incoming into the country to go to Sun
Orchard.
There was never a final determination as to that.
There were comments made yesterday about ice, and the sample
that FDA took of the ice did not come out as a positive for
Salmonella. And I'm looking at John to verify that. It was
negative. So I think I just want to put that on the record
so that you have some of these facts in doing the
deliberations. So the definitive cause was not known.
I think to try and speculate all of that is not
worth talking about a whole lot of discussion when it's not
known, but those are the facts that go with that.
The outbreak in Florida, I would leave that to
someone from Florida if they wanted to add. Dr. Parish, I
know, is very much involved. I do not know if he happened
to be--yes, he happens to be here this morning. If you
wanted to say what the cause of the outbreak in Florida was?
DR. PARISH: There was never--
MS. OLIVER: Could you come to--you can use this
mike right here.
DR. PARISH: Mickey Parish, University of Florida.
The so-called smoking bullet was never found.
Specifically, we did not find the exact serotype that caused
the illnesses in any part of the plant. However, Salmonella
strains were isolated from unopen bottles of juice from the
plant. Salmonella strains were found in amphibians that
were in close proximity to some of the equipment and in
close proximity to the plant.
In one case, there was a Salmonella Hartford which
caused most of the illnesses, a Salmonella Hartford found on
an amphibian outside the plant. However, it was not the
exact same serotype.
MS. OLIVER: Thank you.
We can come back and ask questions, but I just
wanted to clarify some things from yesterday.
Another discussion that was related throughout the
day dealt with the Florida program, sometimes calling it a
HACCP program, sometimes not calling it a HACCP program,
saying that it is a mandatory program, some saying that
there were requirements and some confusion.
What I'd like to do is to--Dr. Troxell talked to
Dr. Martha Roberts last evening to clarify some of that, and
then somebody from the State of Florida can add to that to
clarify any that you have so that you know what the program
actually is. And we can reference what has been supplied in
your book so there's a clarification there.
DR. TROXELL: Thank you. Yes, Martha Roberts
indicated it is a not a HACCP plan. This plan, I believe,
is in your notebook under tab E, under sub-tab (c). And
among the features there, it indicates that this plan does
not apply to gift fruit shippers, retail processors, and
roadside stand operators engaged in the production of fresh
squeezed unpasteurized juice and who squeeze less than
30,000 boxes annually.
On the next page, you will see that as far as the
wash area there are items like acid wash and so on, 200
parts per million, hypochlorite, brush rollers and so on.
And there is further quality control checks indicated in the
plan under item D indicating that there is micro-monitoring
required using a standard plate count, coliforms and E. coli
as indicators of the process, and I don't believe we heard
any data on generic E. coli testing yesterday.
Martha indicated that the oversight is divided
between USDA and the Florida Department of Ag. USDA has
oversight over the large producers. She had indicated over
40,000 boxes squeezed a year, maybe it's 30,000, but,
anyway, in that ballpark. And Florida Department of Ag has
oversight over the smaller juicers.
They have been monitoring the smaller producers
for E. coli and coliforms and have found no generic E. coli
and only a few coliforms early in the--positives early in
the program.
The other thing she pointed out is that while the
micro quality of juice squeezed on site under this program
was good in her view, this program, this code does not
preclude transporting juice in from outside the state where
the production is out of the control of the producer. And I
believe that's it.
Thank you.
MS. OLIVER: Okay. I would ask Dr. Parish or Dr.
Ismail if you had anything to add to that briefly that you
felt should be clarified.
DR. ISMAIL: I think there are several--
MS. OLIVER: Can you please identify yourself and
go to a microphone just so everybody can hear you? Thank
you.
DR. ISMAIL Mohamed Ismail, Florida Department of
Citrus. There are several plans that have been mentioned
yesterday as the Florida HACCP plan, and they are adopted by
well-established companies, and they are very well
researched. A great deal of expenditure of funds have been
spent on developing these plans, and they are definitely
much stronger than what the regulation in our books
mandates.
There are some discussions as far as bringing in
tanker juice into the State of Florida and the desire to
regulate in some fashion the quality of these arrivals. But
the HACCP plan is indicated in the regulation. You might
see it mentioned as verification through a GMP or HACCP or
quality control measure. I believe--I don't have it with me
right now, but it is indicated as "or a HACCP plan or
quality control or GMP." So HACCP is one of the options
that could be adopted by a juice manufacturer.
MS. OLIVER: Okay. Thank you.
Dr. Parish, did you have anything to add?
DR. PARISH: No.
MS. OLIVER: Okay, fine. Thank you.
With that behind us, then what I'd like to do is
remind all the Committee members that we presented you with
a list of questions yesterday, and the questions are
basically reflective and basically what was in our request
for comments and in our Federal Register notice.
I'm going to read the questions that are presented
for the record, once again, so it is the record--Alison?
DR. O'BRIEN: May I just clarify?
MS. OLIVER: Sure.
DR. O'BRIEN: You said today we will focus on
fresh squeezed juice. You still mean citrus juice?
MS. OLIVER: Citrus.
DR. O'BRIEN: Thank you.
MS. OLIVER: Yes. I want to say a couple of
things. You know, obviously in asking these questions,
FDA's focus is safety and public health, and I want to put
that in the background. And these are the questions that
we're asking the Committee, and there are two groups of
questions: one dealing with internalization and survival of
pathogens, one dealing with application and measurement of
the 5-log reduction standard. I'll go through and read
these questions for the record.
For the internalization and survival of pathogens,
we had four questions:
Is it valid to assume that there is no
internalization of pathogens in citrus fruit?
Is internalization of pathogens into citrus fruit
theoretically possible?
If internalization of pathogens into citrus fruit
is theoretically possible, is such internalization likely to
result in a public health risk?
If internalization does occur and it results in a
public health risk, are there techniques to assure that
internalization of pathogens does not occur? If so, what
are they?
Regarding the application and measurement of the
5-log reduction standard:
At what point in the production process should a
processor begin to measure attainment of the 5-log pathogen
reduction? For example, should fruit be cleaned and culled
before measurement of the 5-log reduction has begun?
Are there limits within which the 5-log reduction
must be accomplished?
Would using cumulative steps that are separated in
time and location impact a processor's ability to achieve
and deliver a 5-log reduction?
Can the safety achieved by the 5-log reduction be
maintained consistently if a processor does not package
product immediately after attaining the 5-log reduction?
They are the questions that we're looking at, and
the two areas, once again, internalization of the pathogens
and application and measurement of the 5-log reduction, and
they're the areas that FDA would like the advice of this
Committee on.
What I'd like to do now is ask the Committee--I
know there were a number of people who did not get a chance
to ask questions of individuals yesterday. The individuals
who were presenters are still here today, and I wanted to
give you that opportunity to ask questions of clarification.
Once again, this is time for the members to ask
any additional questions that they have for those who made
presentations yesterday. It's not for discussion or debate,
but to help clarify what you heard or read, and the
questions are for the Committee to ask. Then there will be
opportunity for the Committee to enter into further
discussions after that.
The other thing is there may be one or two people,
because some individuals felt that they might not have been
able to answer some of your questions yesterday, that might
be here to supplement and better answer some of those
questions. So, with that, I'd like to go and open it for
questions of clarification.
Okay, Bill?
DR. SPERBER: Thank you. I'm Bill Sperber from
Cargill. I have a question for Dr. Strobos. I believe I
saw him this morning.
It seems that many of the juice processors, in
attempting to comply with the 5-log reduction, are putting
heavy emphasis on fruit selection and fruit washing.
However, in your presentation, you made reference to a
reduction in extraction, which was kind of new for me. I
hadn't heard of that previously.
You described an experiment in which fruits were
somehow dipped or treated with a suspension of 106 organisms
per ml, and then I don't know how the fruit was handled
after that. And then when you extracted the juice, you
reported 103 organisms in the juice, and you claim that as a
3-log reduction.
I was wondering if you could perhaps describe that
experiment in more detail so we could understand that.
DR. STROBOS: In part, that's described in some of
the earlier materials as well as it's also--just for your
reference, it's also described in the Florida symposium for
which you have the transcript.
The concept is really how do you--assuming that
there may be some residual small contamination of the
surface, how do you avoid contaminating the juice as you
extract it? Because as I'm sure most of you who have done
hand extraction know, you get juice on your hands and also
on the peel when you use some sort of cone compression
device.
There is a specific extractor, largely put on the
market by FMC, which basically stabilizes the orange, a cold
orange. It stabilizes the orange and then induces a
puncture in the bottom and then sucks the juice out.
The experiment that we did to evaluate the effect
of that reduction method was by, you know, inoculating the
surface of the orange with microbial contaminant, and then
without sanitizing the orange and measuring the levels of
residual organism on the surface of that orange, you know,
calculating basically the--or measuring the amount of
residual organism in the juice itself, you know, using a
contaminated orange. So, in other words, when you have the
orange completely contaminated, so covered with organisms at
a level of about 106, 107 measured, you know, what kind of
residual levels do you get in the juice from that orange?
Does that explain--there's more detail provided in
two sets of documents. One is at tab 3 where there's a
discussion of the experimental protocol, and the other is
at--I think it's--actually, I think that's tab 2, and then
there's tab 3 where the data from that experiment are
actually presented.
DR. SPERBER: Two things. I'm thinking that it's
difficult to extrapolate from surface count per square
centimeter, say, to a volumetric count of extracted juice.
So it might not be accurate to say that you had a 3-log
reduction. Perhaps it is, but there's a difficulty there in
counting.
DR. STROBOS: Well, the way that was done was by
taking a template, swabbing the--a measured template. We
know the surface area of an orange, and we took, you know, a
specific surface area, a known surface area of the orange,
swabbed that, did counts on that, and extrapolated that to
the entire surface of the orange, and then assumed that that
amount of organism had gotten into the juice and used that
as the reduction.
We've also done, you know, sort of start-to-finish
measurements subsequent to that which have verified that,
and then to a certain extent, you know, the data we
presented yesterday also show very similar results.
DR. SPERBER: Thank you.
A further complication of this type of
experimentation might come up more during the discussion
today, and that is, when we're trying to validate a process,
it's hard to do it under artificial laboratory circumstances
where the organisms might not be attached to the fruit the
same as if they had occurred naturally and lived in the
grove on the fruit for weeks or whatever. So it's something
to keep in mind.
Thank you.
MS. OLIVER: Fine. Thank you.
Bob?
DR. BUCHANAN: Thank you, Janice. I also have a
question for Dr. Strobos.
MS. OLIVER: Can you please identify yourself?
DR. BUCHANAN: Bob Buchanan, Food and Drug
Administration. I also have a question for Dr. Strobos.
I was wondering, Janice, if it--since--instead of
making Jur jump up and down and some of the other speakers,
would it be appropriate to find them some seats at some
place close to the microphone.
MS. OLIVER: Well, there's a seat next to me, and
there are some chairs that can be brought up near the
microphone up there for people.
DR. BUCHANAN: Dr. Strobos, you indicated
yesterday that the consortium of four companies that you
represent have all voluntarily--whether they're in Florida
or not--agreed to follow the Florida program. As part of
that Florida program, there is a requirement for testing for
E. coli, generic E. coli, as indicators of process control.
However, you didn't share that data with us yesterday.
Do you have that data available? And could you
share it with us?
DR. STROBOS: Yes, I--as you may be aware, having
reviewed the Florida program, there's a requirement--and I'm
not a microbiologist, so you may have to help me with this.
But there's a requirement for testing what I believe are
referred to as generic coliforms. There's a requirement for
looking at fecal coliforms, and I believe there's a specific
requirement for looking for generic E. coli, as well as a
requirement for looking at pathogenic E. coli.
DR. BUCHANAN: Just so we all know what phrase I'm
talking about, this is in the program, and it says, "The
program must include a microbiological monitoring component
using standard plate count coliform and E. coli as
indicators of process control."
DR. STROBOS: Right. My understanding is that at
this point the two--remember, in the consortium there are
four companies, and as was apparent, I think, from
yesterday's data, the two companies in California have been
gradually coming on line with this sort of complete testing
over the last few years.
My understanding in the California companies is
that they have been doing--and, again, I'm not an aficionado
on the testing, and I could certainly bring someone up from
one of the companies to discuss it in more detail. But my
understanding is that they are doing a generic coliform test
and then there is a way to evaluate fecal coliforms in that
test. But the two California companies at this point are
not specifically testing for generic E. coli.
With regard to the Florida companies, since
they're under the mandatory HACCP, they are, in fact,
testing for generic E. coli. One company informed me that
they had had no positive results. Another company informed
me that they have had, over the entire 7,000 tests they've
performed, about 20 positive results, and none in the last
year. All of those have occasioned some sort of a failure
investigation.
DR. BUCHANAN: And for the California plants, do
you have the fecal coliform data?
DR. STROBOS: No, I don't have that, but I could
probably put that together. I think at this point the
companies don't particularly want to identify themselves, so
I would be a little loath to bring up a particular company
and address that question, but I could certainly respond to
that in terms of the fecal coliform, if you can give me a
few minutes to track that down.
DR. BUCHANAN: Sure.
DR. PARISH: Jan, may I respond to that?
MS. OLIVER: Sure.
DR. PARISH: Mickey Parish, University of Florida.
Bob, as I understand the regulation--and I'm not a
regulator, which is one of the reasons I didn't respond to
your question earlier on regulations. The regulation
requires, as I recall, total counts, yeast and molds,
generic coliforms, and E. coli. There is no requirement, to
my knowledge, for fecal coliform specifically, which, to me
has always been a weakness with that particular regulation.
The--well, that's all I wanted to say.
MS. OLIVER: Okay. I was just handed the
Department of Citrus chapter on the quality control, and it
says, "The program must include a microbiological monitoring
component using standard plate count coliforms and E. coli
as indicators."
Okay. Bala?
DR. SWAMINATHAN: Thank you, Madam Chair. Bala
Swaminathan, CDC. I have two questions, one for Dr. Miller
and one for Dr. Parish and any of the experts on processing.
I will ask my question first to Dr. Miller.
In your manuscript, you indicate that the mean pH
of the orange juice used in the experiments was 3.65. But I
did not see any information on the pH of the oranges
themselves. and also in the manuscript, you indicate that
California Valencia oranges were used exclusively in your
investigation, but I think in your presentation you
mentioned that oranges from Florida and California were
used.
My questions are: Were any pH determinations
made? Of the seven out of 178 that yielded pathogens after
the internalization experiment, were they all predominantly
from one state or the other? And were the ph's measured in
those oranges?
DR. MILLER: This is Art Miller. I may need some
clarification. I've been scribbling these down.
You asked about pH in the juice, which I agree,
that was 3.65. We didn't measure the pH in the orange, and
I would emphasize the fact because of the compart--the way
that you take pH of most products is to make a homogenate,
so in this instance, with this commodity, you take the
commodity and turn it into juice. So we measured the pH of
the juice, not the orange. But I would expect to have
compartmentalization. If you can insert a probe into the
different areas, you'd probably have different pH's.
I'm getting a little bit fuzzy on your questions--
you asked about Valencias. For the first set of studies--
let me just make sure I'm--
DR. SWAMINATHAN: Do you want to repeat the
question?
DR. MILLER: Yes, but I want to make sure that I
have my breakdown properly.
All right. For the dye uptake studies, we used
both California and Florida fruit. For the pathogen uptake
studies, we used California Valencias.
DR. SWAMINATHAN: Okay.
DR. MILLER: I think that was your question.
Then there was another question about pH.
DR. SWAMINATHAN: No. You've answered my question
because my question for the internalization of pathogen was
if you used oranges from California and Florida, of those
seven oranges that were found positive, did they call come
from one place or the other? But since you used California
oranges exclusively, we don't need an answer for that.
Thank you.
DR. MILLER: All right.
DR. SWAMINATHAN: The next question is for Dr.
Parish, and in order to answer the first two questions, we
need to know whether it is possible under any circumstances
to have a 17 degree Celsius difference between the fruit and
the water or the solution in which it's immersed during any
stage of processing, either in Florida or in California. If
you don't anticipate--the second part of that question is:
What is the maximum likely difference in temperature between
the fruit and any water or solution used for immersion
that's likely to be encountered in processing?
DR. PARISH: My name is Mickey Parish. Those are
very good questions. I cannot speak to California
specifically.
In Florida, I would not expect--are you referring
to on-tree in the grove situations?
DR. SWAMINATHAN: Anywhere.
DR. PARISH: Okay. In a grove situation, I would
not expect a 17C differential in temperature due to passing
thunderstorms or rainstorms, something of that nature. I
would not expect that.
In a plant situation with fruit arriving from a
grove that has been picked and then put onto conveyor belts
to undergo washing, the differential there would be whatever
the ambient temperature of the fruit is versus the
temperature of the water.
We could expect fruit to probably come in at
ambient anywhere--let's say an extreme case might be
harvesting in the late part of the season in June where the
ambient temperature may be 33 or 34 C and the--I'm going to
guess--the municipal water temperature in Florida, believe
me, is not nearly as cold as it is around here. It's
sometimes not nearly cold enough. I'm going to make a stab
at that at probably around 80 Fahrenheit, 75 to 80
Fahrenheit, and if you'll do a conversion for me, I would
appreciate it.
DR. SWAMINATHAN: And the temperature of the fruit
was between 33--
DR. PARISH: Let's say the temperature of the
fruit was probably about 95 Fahrenheit.
DR. SWAMINATHAN: So it is possible to have a 20-
degree difference, as much as a 20--
DR. PARISH: Fahrenheit.
DR. SWAMINATHAN: Fahrenheit.
DR. PARISH: Yes.
DR. SWAMINATHAN: Thank you.
MS. OLIVER: Bala, did you have any other
questions?
DR. SWAMINATHAN: No. Thank you.
MS. OLIVER: Okay. Dr. Strobos has some
clarification in answer to Dr. Buchanan's question from
before.
DR. STROBOS: In terms of the fecal coliform
testing being done in California, one California company
hasn't identified any positives. Another California company
had two last year, but has had no positives this year. Last
year's batches that had positive coliforms were destroyed.
MS. OLIVER: Jim Anders?
DR. ANDERS: Yes, I really have two questions.
Part of it was just answered by Swami, so--
MS. OLIVER: Can you identify yourself, please,
for the record?
DR. ANDERS: Oh. Jim Anders, North Dakota Health
Department.
Yes, I have two questions, one for Dr. Miller. I
was also concerned about the temperature that the FDA
studies were done at. Twenty-one degrees Centigrade is
approximately 69 degrees Fahrenheit, I believe, and 4
degrees, of course, is much colder than that.
First of all, I understand why that study was done
because of the differential to see what would happen with
the dye uptake. But from what we're hearing, none of the
temperatures in the processing of these plants are at those
temperatures. So I have a big question about that.
DR. MILLER: Let me mention one point that I think
is important to bring out. In the pathogen uptake study, we
took the oranges and moved them from room temperature to a
4-degree incubator and held them for three hours. So at no
point did they equilibrate at 4 degrees. In fact, when we
measured the internal temperature, it was 11 degrees, so
that differential is not quite as high as just subtracting
the difference between the two extremes, 21 to 4.
I think your question asked what was our
rationale, and simply stated, it was laboratory convenience.
DR. ANDERS: Well, yes, and my point is that none
of those temperatures--either one of those temperatures,
actually--is used within the industry, or at least that's
what we're hearing. I really don't understand why it was
set up with those temperatures.
DR. MILLER: The question really was that we were
trying to address is: Can it happen? And, once again, I
would emphasize the fact that it really wasn't a 4-degree
orange; it was closer to an 11-degree orange.
DR. ANDERS: Okay. Thank you.
My second question is--and I really didn't get--I
did ask Dr. Ismail yesterday, and he said he didn't have the
answer to it. But it seems to me that this is really an
important issue.
In the process of oranges going through--coming
into these plants, the way I understand it is that, by
sight, the worst-looking oranges are immediately sent
someplace else. They're not going through the processes.
So then my question is: Where are the studies to
tell us how many actual pathogenic E. coli or Salmonella
organisms are left on any of the oranges that are left that
are going through the process? Are there any studies? Is
there any information on that that might tell--
DR. ISMAIL: Not that I am aware of. I don't
think anybody has taken the time to do a systematic
evaluation of what is really left on culled fruit,
eliminated fruit. So there is a gap in our knowledge.
DR. ANDERS: Well, it's a tremendous gap because
we're talking about what we need to do here, and we don't
even know if there are any organisms left or what numbers of
organisms are left on the oranges.
DR. ISMAIL: Most likely the predominant organisms
that you would find on eliminated fruit are decay,
pathogenic organisms, plant pathogens, like diploidia,
penicillium, and perhaps yeast and different molds.
DR. ANDERS: And as we discussed yesterday, most
of those are not really pathogenic to human beings--
DR. ISMAIL: No, they are not.
DR. ANDERS: --that are non-immune or don't have
immune problems.
DR. ISMAIL: Correct. In reference to what Dr.
Miller has mentioned, I believe the study by the Food and
Drug Administration raised the temperature. The fruit was
incubated at 37 Celsius, then placed a 4 degrees Celsius for
three hours. The core temperature of the fruit went down to
11; however, the surface temperature of the fruit must have
been much higher. There is a gradient in temperature
decline, and you would find that to be true in any study
where temperature reduction is involved. So the surface of
the fruit definitely, I can say, should have been much
lower.
DR. ANDERS: One additional question, and maybe
you won't know this. So we went through the basic throwing
away of the bad fruit. We got those out of the way, and
assuming that the fresh juice industry now is going to take
the best fruit or some of the very best fruit, there are no
studies then for the oranges that they're starting out with,
there are no studies to show what kind of contamination--and
I'm talking about now pathogenic contamination, E. coli and
Salmonella, on the fruit that they are actually starting in
this process.
DR. ISMAIL: On the fruit that is--
DR. ANDERS: Going into the fresh fruit now.
We're really talking about two things. One was in the basic
process of oranges they are culled and the best fruits are
taken out, and then the way I understand it is that the
fresh juice industry then takes the best fruit and then goes
through the fresh juice process.
Are there studies to show what kind of pathogens
are present--prevalent on oranges as they start that
process?
DR. ISMAIL: I believe there are some studies that
show that there are different mold, bacteria, yeast. Have
they been characterized? I'm sure there has been some
characterization. But there has been no Salmonella or E.
coli 0157 detected on any fruit that is going into either
fresh fruit or juice.
DR. ANDERS: I'm sorry. I keep--it's an important
issue here. Therefore, if there were contamination at the
end of the juice, is that to be inferred, then, that since
there isn't any to start with, you can't come up with
something that--I mean, you can't come out with something if
it wasn't there at the beginning.
DR. ISMAIL: I think this is a fair conclusion.
DR. ANDERS: So it was contaminated in the
process, from an outside source, then, not from the oranges
themselves.
DR. ISMAIL: We believe that most of the problems
associated with the juice contamination in general, whether
it is fresh or not fresh or pasteurized, has been introduced
at some point perhaps during the extraction process, due to
breakdown of good manufacturing practices, or sanitation was
lacking.
DR. ANDERS: Thank you.
MS. OLIVER: Dr. Parish had something he wanted to
add to your question. And if you could identify yourself
fully for the record? If I could remind everybody once
again, when the speakers come up to answer the questions and
the Committee members, to once again just identify yourself
just for facilitating the transcript. Thank you.
DR. PARISH: Mickey Parish, University of Florida.
In answer to your question a little more, at least
in the studies that we did on the plant that was involved in
the salmonellosis outbreak in '95, we did look at surface
microflora before extraction, looking specifically for
Salmonella, and we found none.
In looking at the literature in the past and
trying to find examples of where people have looked for
human pathogens on the surfaces, I found very little
information. There simply is not much information on what
types of organisms can be found on the fruit surfaces. And
as an aside, I applied to USDA NRI last year to do that very
thing and was told that the research was not relevant to
food safety.
MS. OLIVER: John?
DR. KVENBERG: Thank you. John Kvenberg, Food and
Drug Administration.
My question of clarification goes to Dr. Arpaia or
others who spoke yesterday that might be able to help the
clarification, and that is, in a description outside of the
State of Florida, specifically in your presentation on
California, it was described, a situation where the
packinghouse operations and how oranges were treated, are
oranges specifically in California, to the knowledge of
those who spoke yesterday, similarly treated? And is the
same oversight there where--or are there direct contract
oranges that are going to juicing that do not go through a
packinghouse operation?
DR. ARPAIA: Mary Lu Arpaia. If I understand your
question correctly--just let me restate it--you're asking
whether it would be possible for a grower to sell his fruit
to a juice contractor directly. To my knowledge, that does
not occur in California. All the fruit that would be going
to fresh juices would be predom--almost exclusively, as far
as I can tell, would be going directly through a
packinghouse operation in California.
As I indicated, Sunkist packs about 55 percent of
all the oranges, and Mr. Orman told me yesterday that all
Sunkist growers then would send 100 percent of the fruit
exclusively through a Sunkist packinghouse. The other major
houses also would be--are mainly growing their own fruit and
do some contract packing. And, again, usually those
contracts are set up so that you pack--you send 100 percent
of your fruit through the packinghouse.
I'd just like to clarify the question about
temperature differentials. Our navel oranges are harvested
from approximately October through May. Most of the navel
oranges come from the San Joaquin Valley. During the time
of harvesting, the ambient temperatures can be anywhere--
they normally pick them in the middle of the day, and the
ambient temperatures during the winter months can range from
about a low of about 45 to about 65 or 70 degrees
Fahrenheit. We don't pick the fruit when the conditions are
damp or moist, when it's foggy, because when the fruit are
wet, they're very turgid and they're very susceptible to
mechanical damage, and then you can have a lot of losses on
arrival due to rind blemishes. So the practice is not to
pick the fruit unless the fruit is dry on the trees.
We don't like to run the fruit when the pulp
temperature is below 50 degrees Fahrenheit because it's very
difficult to apply a good wax application. Typically they
like to have the fruit warmer, around 68 to 70 degrees,
before they apply the wax. The water temperature, again,
is--the ambient is usually above 60 degrees in California.
During the summer months, when we harvest Valencia
oranges, again, most of the Valencia oranges now are coming
from the San Joaquin Valley, although we have Valencia
oranges coming from Ventura County and in the Coachella
Valley. The Coachella Valley harvest season is from about
the months of February through May. They have much higher
ambient temperatures during that period of time, anywhere
from about 70 degrees Fahrenheit to 100 degrees Fahrenheit.
They have thermal source waters in the Coachella
Valley, so the water actually is usually quite warm. A
minimum temperature of about 70 degrees would be the water
temperature in the Coachella Valley.
In Ventura, they harvest the fruits in the late
summer months because most of that fruit goes to export,
and, again, the ambient temperatures there would be 70 to 85
degrees, approximately, during the day, and the water
temperature, again, is quite warm. They need the water to
be fairly warm, again, for all the solutions that they use,
especially the wax solution.
Then addressing the Valencia oranges in the San
Joaquin Valley, they're picked from about May through
August. Temperatures can range from about a minimum of
about 75 degrees during the day to in excess of 100 degrees.
We don't like to pick the fruit when it's very hot, but
typically the fruit will be brought in and held overnight so
that they can have some cooling. Some houses have cooling
facilities, and, again, the fruit are run--they like to run
the fruit when the pulp temperature is about 68, 70 degrees
Fahrenheit. But we never run cold fruit in warm water, and
we don't run warm fruit in cold water.
MS. OLIVER: Okay. I just want to--this is
another logistics question. I just need to tell everybody
that all the microphones are on so that when we have
discussions at the table, it sometimes is going and it makes
it more difficult for the record, we were told. Also, if
individuals would bring your microphones forward since they
are all on, the volume is not that high, so when you speak,
we need to just assist the recording a little bit.
Okay. Dr. Beuchat?
DR. BEUCHAT: Yes. I have a question for Dr.
Strobos I'm trying to understand the procedure in more
detail that was used for your study with the dye and the
Salmonella. Correct me if I'm interpreting this
incorrectly.
You dipped the oranges in a suspension of cells,
and that suspension contained approximately 106 per ml. Is
that correct?
DR. STROBOS: Yes, with the--we're talking about
the most recent experiments that we did just last October.
Yes, that would be the case.
DR. BEUCHAT: And the baseline against which you
then made calculations in terms of reduction in numbers or
differences in numbers in the juice versus that population,
was that the difference--I mean, did you--I heard you tell
us that you used a swab technique to determine populations
per--was it orange or square centimeter?
DR. STROBOS: Yes, per square centimeter of the
orange surface, but that was done in the earlier studies.
DR. BEUCHAT: Okay. I guess I'm--it's difficult
to--I don't know how many milliliters of juice was extracted
from each orange, so it's difficult to compare surface
versus volume in these studies.
DR. STROBOS: Yes. I mean, that is one of the
experimental--what I think of as the laboratory problems
with these studies, and that is that we're trying to go from
a surface area contaminant to, you know, what the
contaminant is in the volume of the juice.
Now, we do know, you know, on average--we're
doing, you know, relatively large numbers and then juicing
ten oranges at a time, and we do know what the average
volume of the--you know, how much juice you get out of each
orange, which is a fairly, you know, narrow range. And we
do know what the surface area of the oranges is on an
average basis as well.
DR. BEUCHAT: Was there a study done along the way
to confirm, to validate that all of the cells that had
attached to or adhered to the surface of the orange were
indeed extracted using the swab technique?
DR. STROBOS: You mean some sort of a microscopic
examination of the--
DR. BEUCHAT: Well, yes, some microscopic or mass
balance through culling forming units that you could have
extracted using that technique.
DR. STROBOS: Not specifically, although when we
were doing the swabbing technique, the concentrations of
organisms that we were getting--and this, again, I would
have to--I would probably have to refer to the data. But my
recollection is that there was a drop between the
concentration in the contaminating--or the inoculating fluid
and the amount that was recovered through the--you know, the
swab technique. Our assumption was that that was due not--
you know, just to the sticking issue. We did not--other
than that, which is not a mass balance analysis.
DR. BEUCHAT: Another question. You may be able
to answer this, or someone else. The specialized mechanical
device that FMC has on the market and has used, how many--or
what percentage of the fresh citrus juice processors
actually use this particular machine, equipment?
DR. STROBOS: Of the four companies that have been
part of this consortium, all of them use it, and use it
exclusively. My understanding is when you go out into the
rest of the fresh juice industry in Florida that it is the
predominant machine used, but I believe there may be some
residual companies that are using different extractors. I'm
not 100 percent sure on that. I think at this point
everybody has switched. Outside of Florida, I wouldn't know
the answer to that.
DR. BEUCHAT: One last--
DR. STROBOS: Now, I--yes, go ahead.
DR. BEUCHAT: Excuse me.
DR. STROBOS: I had just--there was a
clarification with regard to the question on whether packing
in California that I--let me let you continue your question
because I just wanted to make sure--
DR. BEUCHAT: Either in California or Florida,
over a period of a year or several years, are there citrus
fruit transported by land from east to west or west to east
that are subsequently used in fresh citrus juice production?
And, also, I would extend that further. Are there any
imported citrus fruits that are used in the U.S. for the
fresh citrus juice market?
DR. STROBOS: It would be speculative for me to
answer that, but I can certainly find that out in the next
few minutes and respond to that question.
DR. BEUCHAT: My question is not so much in terms
of perhaps different microflora that may be on these fruits
but, rather, fluctuations in temperature and pressure that
they would be subjected to during this transport, even by
land, across the U.S.
Thank you.
DR. STROBOS: Okay. I can--just in clarification,
I just wanted to be clear that I think we're all aware of
the fact that California does not have the same set of rules
governing fresh juice operations and that it's, you know,
the position of the people I represent that we want to have
that system as a national system.
With regard to the two companies in California,
they buy their fruit directly from the growers. They do not
buy them from packinghouses. There are some fruit that does
come from packinghouses, especially, my understanding was,
last year, when there was some frost issues in terms of the
temperature. Both of the companies, however, do, you know,
complete processing from the arrival of the oranges
basically in terms of, you know, grading, washing,
sanitization, which is why we could say that none of the
fruit used in the fresh juice operations in these two
companies were immersed.
DR. STROBOS: Mike Doyle?
DR. DOYLE: This is Mike Doyle, University of
Georgia. My questions also are for you, Dr. Strobos, so
don't go too far.
I'd like to follow up on E. coli questions. As I
understand it, in Florida, the Florida model requires that
you do E. coli testing. Is that correct?
DR. STROBOS: That's my understanding, yes.
DR. DOYLE: Now, if you do E. coli testing, do you
hold the fresh juice until the testing results are in?
DR. STROBOS: My understanding is that as part of
the regulations that is not required.
DR. DOYLE: So if you come up with a positive for
E. coli, what's the next step?
DR. STROBOS: Well, again, the question becomes
what the companies are doing in terms of what the
regulations require. My understanding is that the way in
which the fruit is distributed, the companies, in fact, have
control over--remember, it has a 17-day shelf life by
regulation. However, the companies have control over the
juice for a period of time after it's been juiced, and many
of the company--first of all, we haven't had, you know,
positive E. coli results recently.
In the circumstances in which positive E. coli
results have been obtained, my understanding is that the
juice has been able to be recalled before distribution to
consumers in those specific settings.
DR. DOYLE: So then if there is a positive E.
coli, the juice would not be sold. It would not be made
available to the public.
DR. STROBOS: You know, we're certainly attempting
here to be responsive to the concerns of the community as
well as the concerns of this Committee with regard to
ensuring the safety of juice. You know, there's a
difference between what the current regulations in
California are and the current regulations in Florida and
national regulations. And we're certainly looking for
recommendations from the Committee on the best ways to do
these things.
When it comes to the issue of release of product
relating to microbial testing and the timing of that, my
understanding is that the companies that were involved here
have generally been able to not distribute product that has
had positive E. coli, generic E. coli testing. They have
been able to do that, but I do not believe as originally
designed--and perhaps Dr. Ismail may want to comment on that
as well, but as originally designed, the concept of the E.
coli testing was as part of, you know, a GMP or a HACCP-type
program, so that the concept was that you would evaluate the
results in light of what your processing was and attempt to
do failure investigations when those events occurred. And
it was not designed to be sort of as a release testing
format, and that it was the concept, I guess--if I
understand, you know, HACCP, it is that you have a series of
controls, not just one control, and that the goal is,
therefore, to use these microbial testings as one in a long
series of controls but not as the sole control with regard
to the processing of the juice.
DR. DOYLE: Would you consider the presence of
generic E. coli to be an indicator of potential pathogens
being present?
DR. STROBOS: I think that the presence of generic
E. coli probably indicates a problem with the manufacturing
of--you know, and requires some sort of an investigation.
Again, I'm not a microbiologist, but my
understanding is that some E. coli are not pathogenic, and,
therefore--and you can probably answer this question better
than I can. But my understanding is that the mere presence
of E. coli doesn't mean that it's a public health issue. It
does seem to me to indicate that because of the origin of E.
Coli there is a problem that needs to be investigated and
identified.
DR. DOYLE: That's all I have. Thank you.
MS. OLIVER: Peggy?
DR. NEILL: Peggy Neill. I'm struggling with
something, and I think I'm probably not alone, and it has to
do with this issue about testing and the results.
It has been a time-honored scientific tradition to
fully describe sampling plans, conditions under which
samples are held prior to testing, the testing methodology,
and in particular, its lower limit of detection, sometimes
called sensitivity. I think in the best interests of the
Committee it would be extremely helpful for us to be able to
assign credibility to the results that have been mentioned
repeatedly by several groups about the testing that has
already been done over the last couple of years, both in
Florida and in California. And to that end I would
appreciate it if those details could be cogently summarized
for the Committee.
I think this is probably best directed to Jur
Strobos, but if John Martinelli or Dr. Ismail or Dr. Parish,
if someone has those level of details, they would be, I
think, fairly helpful for us to be able to look at this
issue
MS. OLIVER: Let me ask a question. Do any of you
have that level of detail that you can respond to now? Do
you need to go off or at break time for a few minutes and
respond back after that? Which would be the best way?
DR. STROBOS: You know, again, not being a
microbiologist, I certainly understand your concerns, and my
understanding is that the test--you know, the test
methodologies that have been used to evaluate the various
different tests that Florida has required are standardized,
and many of them, in fact, when FDA was involved with the
Orchid Island plant, were, in fact, proposed or recommended
by FDA.
Not being a microbiologist, I don't know the
significance of the description or the level of detail that
you would require, so I think it would be better for me to
try to develop a more formal response that you would be able
to understand and evaluate in a cogent manner.
MS. OLIVER: Dr. Ismail?
DR. ISMAIL: Yes, I left my notes here. I'm glad
I came back.
All our scientists--and I'm speaking of the
Department of Citrus, and I think I can speak on behalf of
Dr. Mickey Parish--direct their work to be published in
refereed journals, and we have a very thorough process by
which our manuscripts are reviewed internally at the Citrus
Research and Education Center, University of Florida at Lake
Alfred, and that process is very exhaustive. That's before
even the paper leaves the premises to be sent to the
journal. And the details of the methodology, the
experimental conditions, where the fruit were obtained, how
it was held prior to extraction and so on, are always
recorded and detailed.
You have been provided several manuscripts that
have already been published by Dr. Steven Pao, and the
latest work has been hurried. However, it was exhaustive.
He has worked many times 14, 15 hours a day, weekends,
repeated some of the experiments that you have seen results
of and been extremely cautious, extremely conservative in
putting his results. And he definitely would be more than
happy to provide details on how the fruit was handled
throughout the steps until the final results were obtained.
MS. OLIVER: Okay. I talked to Dr. Strobos for a
minute, and he indicated that if he had a few minutes after
break that if they got together, they would be able to
respond better. So we'll probably break around 9:45, and
then after that, we'll get that response. I think it would
be better if they, you know, could discuss and come back
with that.
Dr. Parish, do you have a response for that now?
DR. PARISH: Just very briefly. The test methods,
as I understand it, vary from plant to plant to a certain
extent. I do know that at least--and with Orchid Island's
permission, referring to what they do, that the test methods
they are using are bam methods. They do sent the test
samples out. The degree of sensitivity, at least for--well,
it's hard to say what the degree of sensitivity is at this
point.
I would point out that with respect to the
requirement in the Florida regulation for total coliforms--
and this is something that I had a disagreement with when
this regulation was being brought up. Total coliforms are
really of little use in citrus simply because there are so
many non-fecal coliforms that do exist naturally that could
potentially get into juice, and I just wanted to point that
out.
MS. OLIVER: Okay. And we'll have a further
response after break.
Peggy, did you have anything else?
DR. NEILL: No.
MS. OLIVER: Okay. Bob?
DR. BUCHANAN: Thank you. I have--
MS. OLIVER: Please identify yourself.
DR. BUCHANAN: Bob Buchanan, Food and Drug
Administration. You'll train me eventually.
I have two questions, and I think they both will
include Dr. Arpaia and Dr. Parish. One was a further
clarification on the temperature differentials that were
discussed. I'd like to know what is the temperature of the
cold rooms that you use in your facilities. Two, what is
the temperature of the oranges before they enter those cold
rooms?
If I can get that from the California and Florida
perspective, then I have another question for both of you,
also.
DR. ARPAIA: The temperature of the cold rooms are
generally set at 5 degrees Celsius. The fruit--most of the
rooms do not have any forced-air cooling facilities or room
cooling, so the fruit will enter the room from the packing
line. They may be on the floor for a while. The
packinghouses are normally run at ambient temperature. So--
DR. BUCHANAN: So we're talking about a 75-degree
Fahrenheit to 5-degree Fahrenheit differential?
DR. ARPAIA: Going into the cold room?
DR. BUCHANAN: Mm-hmm.
DR. ARPAIA: The packinghouses, like the one that
I was in on Wednesday that I took the photographs that I
showed you yesterday, there was very little temperature
differential between the outside temperature and the
temperature of the packinghouse. But it was a warm day, so
it was about 65 degrees outside, and the fruit goes into the
cold room, and the cold room is at 5 degrees Celsius or 41
degrees Fahrenheit.
So the fruit is going in--the fruit does warm up
when it goes over the line, so it would be reasonable to
assume that the fruit would be at approximately the
temperature that the packing--that the main portion of the
packinghouse is at. But that will vary for the time of year
because they will run coolers in the packinghouse during the
summer, and they will run heaters in the packinghouse during
the winter when it's very cold.
DR. BUCHANAN: On average, you're talking about
somewhere about--
DR. ARPAIA: Ambient.
DR. BUCHANAN: --70-degree Fahrenheit
differential?
DR. ARPAIA: Well, 70 degrees going into--70
degrees--
DR. BUCHANAN: Oh, no, I'm sorry. Yes, I--
DR. ARPAIA: Yes, 70 degrees Fahrenheit--
DR. BUCHANAN: About a 20--
DR. ARPAIA: --in the packinghouse facility and
the fruit are generally put at about 41 degrees Fahrenheit.
The fruit does not normally stay in that cold room for very
long. It's loaded on the--they try to get the fruit out of
the holding room. It's basically only holding rooms. It's
not cold storage rooms like you would think for apples. So
the fruit goes into it, typically the fruit will only be in
that holding room anywhere from less than 24 hours through
two or three days.
DR. BUCHANAN: But we're talking about somewhere--
I'm trying not to mix and match my degrees Celsius and
degrees Fahrenheit, but somewhere between a 15- and 20-
degree Celsius differential between ambient temperature in
the packinghouse and in the cold room.
DR. ARPAIA: In the cold room, yes.
DR. BUCHANAN: Okay.
Dr. Parish, are the cold rooms within Florida held
at about the same temperature?
DR. PARISH: Yes, the cold rooms are held at
roughly 5C.
DR. BUCHANAN: And the ambient temperature of a
packinghouse in Florida?
DR. PARISH: I can't answer packinghouse
specifically because I don't work with packinghouses. But
in processing plants, it would be roughly ambient
temperature, that's correct.
DR. BUCHANAN: And that would be--in Florida, what
would be the average ambient temperature?
DR. PARISH: During harvesting season, which runs
typically from about November through May, perhaps October
through June, we're talking a large fluctuation ambient
temperature, anywhere from--well, perhaps as low as 60
degrees Fahrenheit to as high as 90.
DR. BUCHANAN: Okay. So, again, you're talking--
DR. PARISH: That's outside temperature. Inside,
probably more in the range of 75, 80 degrees. I think it
would be very similar to California.
DR. BUCHANAN: So potential temperature
differential between the cold room and the ambient
temperature would be in the range of anywhere from 10 to 25
degrees Celsius?
DR. PARISH: Anywhere from--yeah, I would say it's
very comparable to the California situation.
Let me point out that I know of probably two of
the larger processors that do run fruit through a packing
line so that it is waxed and is then put into cold storage
for extraction at a later date. The majority certainly of
the small people do not do that because they don't have that
sort of facilities, holding facilities. The mom-and-pops,
the roadside stands, would not be able to do that. But a
couple of the larger facilities, to my knowledge, do store
fruit under cold storage. When the fruit is brought out at
that point, Bob, at a later point for extraction, it is re-
washed, re-graded, even though it's already been through a
packing line, it's put through the whole line again just to
make sure that they do take out any fruit that may have
softened or may have some bacterial rots or something.
DR. BUCHANAN: Now, the second part of my question
is an abrupt shift, but it was a question I had yesterday
and didn't have an opportunity to ask.
It was mentioned that the culls go to animal feed,
and I know from visiting Florida and California that you
have a very substantial beef industry in both locations,
animal production. Is there any restriction on the adjacent
location of animal-rearing facilities and growing facilities
for citrus fruit?
DR. PARISH: I'm not knowledgeable--I do not know
that there is any limitation on the placement of growing
facilities for animals and citrus. The vast majority of
groves that I'm aware of do not have fences around them and,
to my knowledge, do not have cattle grazing in them.
I think that there are a couple of instances where
that is correct that that can happen, and one of the issues
that we have tried to push with the people that are
producing fresh squeezed at all levels is that they have to
make sure that the source of their oranges comes from groves
that do not allow that to happen, first of all, do not have
cattle grazing in the groves and do not use raw, non-
composted manure for fertilizer, which does happen on
occasion in Florida. There are some grove owners who do
choose to use chicken manure, and we have asked the people
who are producing fresh juice not to buy fruit from them.
Whether they are or not, I don't know, but we have made that
recommendation.
DR. STROBOS: Let me just clarify here a little
bit because, you know, maybe it wasn't clear--oh, my name is
Jur Strobos. The fruit that is used in the fresh juice
operations that we're talking about is not going through
packinghouse cold storage rooms. It's coming from the
grove, you know, being sanitized by the companies, and then
going into juice. So there's not a cold storage operation
involved here in these particular operations.
MS. OLIVER: Bob, do you have any other questions?
DR. BUCHANAN: Well, I'd like the California
perspective on the collocation or adjacent location of
animal-rearing facilities and groves.
DR. ARPAIA: Like Dr. Parish, I can't
categorically give you an answer. I can give you a
generalization, though. We do have a fair number of poultry
and livestock operations in the San Joaquin Valley where
approximately now 60 percent of the--almost greater than 60
percent of the oranges are cultivated. However, they're
geographically different. The citrus are predominantly
grown on the east side of the San Joaquin Valley up in the
foothills. Most of the feedlots and the poultry operations
are on the west side of the San Joaquin Valley or out on the
valley floor where it is too cold for citrus to be grown.
In the 16 years I've worked for the University of
California and all the groves I've visited, I have never
seen cattle or chickens or anything running through groves.
But that doesn't mean it cannot occur, but to my knowledge,
that is not practice. Most growers in California use clean
cultivation and minimize any traffic through the groves for
many, many reasons. Mainly it's because of liability,
actually. If you have someone come and break a leg in your
grove, of course, you're liable. So people are very
cautious about having anything other than people who work
for the operation in the grove.
MS. OLIVER: Alison?
DR. O'BRIEN: Yes--oh, he's not there.
MS. OLIVER: Can you identify yourself?
DR. O'BRIEN: Alison O'Brien, Uniformed Services.
Dr. Strobos, a question for you.
I'm not going to ask you a microbiological
question. It has do with the consortium that you talked
about, you've been talking about representing, which is, as
I understand it, four companies that try, from what you've
said--and it certainly sounds like it--try very hard to
abide by all possible rules along the way. What I want to
know is how representative are those four companies. How
many other fresh squeezed companies are there, small or
large, out there? And what kind of interaction does the
consortium have with these other companies? What kind of
peer pressure is there to conform to your standards?
DR. STROBOS: My understanding is that--first of
all, I think actually, you know, we have Peter Chaires here
from the American Fresh Juice Council, which is a little bit
of a larger organization which does represent some of these
other companies. But obviously I've had a number of
conversations with companies outside the consortium, and my
understanding is that these practices are not particularly
difficult to follow and that they are being followed.
You know, I can't speak specifically to all of the
particulars that you're addressing questions to, for
instance, you know, the questions about livestock. I know
that members of the consortium don't buy from groves that
have livestock in their groves. Just as an example, I
wouldn't know whether that would apply generally to all of
the growers, but I do know that these kinds of
communications from the University of Florida and from the
Department of Citrus are generally picked up by the
companies in general.
But let me see if Peter Chaires can speak more
particularly about that.
MR. CHAIRES: Again, my name is Peter Chaires.
As far as sheer numbers, we don't have an exact
handle on it. The volume of juice produced by the four
members within that consortium group certainly is a
considerable portion of the volume on unpasteurized juice
that's produced in the country.
Within Florida, most of the--well, I'd say
probably upwards of 95 percent of the fresh juice volume is
produced by either members of the Florida Gift Fruit
Shippers Association or the American Fresh Juice Council
members that are within the state.
Now, in the smaller operations, when I refer to
gift fruit shippers or roadside operations, about 98 of
those are members of Florida Gift Fruit Shippers, and that's
going to comprise a preponderance of the volume of the small
operators. So we have about a hundred there, we have about
23 members of the American Fresh Juice Council that are
scattered around the state, but that's broken up among
vegetable, apple, and citrus.
But one thing that we have found, even though some
of these larger operations obviously in volume and scale are
different than what you would find and what we would call a
non-continuous production facility or a roadside, the
sharing of information and technology and techniques between
small and large, we have found that most of the principles
are transferable down to a small level, even if they may
produce one, two, or three hours in the morning for that
day's sales, and then go through their cleaning and
sanitation procedures, shut down, and then juice again the
next day. They're not a production plant like some of these
larger facilities are.
The transfer of that knowledge and that technology
through workshops that we've been able to put together
through either the Department of Citrus, the University of
Florida, or a combination thereof have been pretty
successful. And the small companies have been very willing
to adopt to those technologies.
MS. OLIVER: We have one more person who wants to
respond to your question and thinks might be able to
clarify, too.
MR. BARNHORN: Brad Barnhorn from Fantasia Fresh
Juice Company in Chicago.
Interestingly, there's not many fresh juice
companies outside of Florida and California. It's mostly
economic-driven; namely, it's--actually, it's a combination
of economics and, ironically, product safety. The State of
Florida will not let certain types of oranges be shipped
outside the state. We can only receive in USDA grade 1
oranges. We can't get anything else out of the state. It
won't be allowed by the inspectors.
So, ironically, being outside the state, just to
answer the questions about Florida and California here, we
are required to have basically store-quality fruit, which,
like I said yesterday when I talked briefly, is what you
would get at any major store chain.
So, to answer the question in terms of safety, A,
in our prerequisite programs, we can't get fruit that isn't
of the quality that is store quality.
Internally, we use an FMC extractor, to answer the
question that was earlier put. We go through sorting,
grading. We go through the microbial washes. We go through
the whole same process. So it's--to be in this industry,
like I said, we were born and began producing 14 months
after the Odwalla incident. We had the opportunity to start
from day one with a HACCP program. There are some things
that we're fortunate being outside the state when we began
operations that led us to incorporate into how we operate a
lot of the safety protocols. So I don't know that there are
juice companies outside Florida and California that exist,
quite honestly, in the citrus side, but speaking for the one
that does that I know of, we do follow their programs and
similar safety protocols, and we are a member of the
American Fresh Juice Council as well, so we're very well
informed.
You know, 14 months before we began operations, we
were at the meetings in December of '96 in Washington, so
we--you know, a lot of that stuff has been built into how we
operate.
MS. OLIVER: Thank you.
Alison, did you have any other--
DR. O'BRIEN: Actually, I did have a
microbiological comment. A comment, not a question.
MS. OLIVER: Go ahead.
DR. O'BRIEN: It has to do with 0157 and testing,
microbiological testing, or being sure that it's not there.
Just to remind everyone that what six months ago was 3
percent of our cattle that has 0157, and now it's closer to,
using better methods, 38 percent, maybe. I'm just saying
that you get what you look for. And if methodology--and
this goes back to Peggy Neill's question. We need to know,
when we say it's not there, what methodology is being used,
and it can change, sensitivity levels can change
dramatically with methodology.
MS. OLIVER: Great. In response to that, when we
take a break, I'm going to allow a half-hour break so that
people can get the answers to that question and compile it
for the Committee for after it on the methodologies and
sensitivities. And that goes to the importance of the
question, too.
Okay, Roberta?
DR. MORALES: Yes.
MS. OLIVER: Please identify yourself.
DR. MORALES: Roberta Morales, Research Triangle
Institute.
I'm actually glad that you are providing that time
to get information on the testing, because yesterday when I
posed that question, there was still some clarification
needed. So that to me is another question that I would like
to follow up on, and I'm looking forward to responses on
that.
But I have another question that's more related to
trying to understand the industry and what some of the
constraints are, and this may be a question for Dr. Ismail
or I guess somebody else, maybe Dr. Strobos. But in
describing the outbreak and the recall, there have been
several individuals who have said they think that this is--
they believe this is a failure in the GMPs. What I'm trying
to get a better understanding of is from the industry's
perspective--and, you know, I can see that there's folks
yesterday that said that they would like to maintain being
able to provide the fresh squeezed juice and differentiate
their product from the ones who deliver pasteurized.
What I'm curious is how would the industry have
thought about how they might have modified GMPs or maybe
improved the monitoring process, both in the past and maybe
in the future, in order to minimize the potential for
occurrence of outbreaks.
MS. SEXTON: You asked how would we regulate the
industry so that this wouldn't happen again?
MS. OLIVER: And if you could identify yourself.
DR. MORALES: Actually, what I'm curious about is
finding out what are the proposals that the industry thinks
would be possible to minimize these things from occurring?
MS. SEXTON: I'm Mary Grace Sexton with the Orchid
Island Juice Company.
What we proposed, and I'm the last person they
wanted to get me to get behind this mike, but, you know, God
is good to me.
What we would like is we would like governmental
regulation. We have USDA continuous inspection. It works
well for us. We want to implement HACCP, mandatory HACCP in
the plants. HACCP and outside biological testing we think
is very, very important. And as far as tests, we would like
your input very, very much as to what procedure or test
protocol you want us to use because we want the same results
you want. So we would like mandatory HACCP in all programs,
we would like mandatory USDA inspection on site continuously
for processors, and I think you see--and as far as what we
have, there is a great deal of peer pressure because the two
people that got people sick have gone and stated publicly
they want to go to pasteurized products because it's easier
for them, but we don't want that. We'd rather have USDA
continuous inspection, mandatory, and mandatory HACCP--
countrywide, not just in Florida.
MS. OLIVER: Roberta, do you have other questions?
DR. MORALES: Yes. I guess I'm curious about how
continuous USDA inspection might be occurring and what are
the components of that kind of a program? Does it include
monitoring of the product at the final--where?
MS. SEXTON: The USDA inspector is on site
continuously. They check the facility, they check the
product, and then they have even become so sophisticated
that they say everything has to be charted and graphed.
They don't care. They want you to have a computer operator
on there that can chart and graph all of your micro results
so they can see the results in numbers and also in a graph
to see any movement at all in your testing, in your
biological testing, for your E. coli 0157, your Salmonella,
your bacteria, everything.
MS. OLIVER: Any other questions, Roberta?
Roberta, any other questions? Because we can come back to
you later if you want.
DR. MORALES: Yes.
MS. OLIVER: Skip?
MR. SEWARD: Thank you. Skip Seward, McDonald's.
My question is regarding raw material
specifications, and I'd just like to--I heard a little bit
from the gentleman from Illinois about his restrictions, but
my question is really whether or not there are regulations
or standards that say that people who are going to squeeze
fresh juice can only use choice or first-grade oranges or
are you allowed, whether you are small or big, in any state
to use any oranges you want to do fresh squeezed or can you
use imported oranges?
MS. OLIVER: What I hear you asking is, one, there
are no federal regulations that--we don't have any
regulations that address that. What I hear you asking is
are there any specific state regulations that restrict the
type of orange that can be used in fresh juice.
MR. SEWARD: Correct.
MS. OLIVER: I do not know the answer. Mohamed,
do you know that?
DR. ISMAIL: I don't know of any requirements.
MS. OLIVER: Okay. Fine.
Is that your only question, Skip?
MR. SEWARD: Yes.
MS. OLIVER: And can you identify yourself.
MR. MARLEA: I'm Dominic Marlea. I"m the director
of Quality Assurance at California Day Fresh Foods.
As the committee looks forward to what they want
to recommend, it's not just saying, okay, this is a HACCP
rule that we want to put forth because anyone can say, "I
have HACCP. This is a rule." But if they don't take HACCP,
and they don't put it down all the way to the employees,
back to the grower, the chances of really this being
successful is going to be difficult. So the industry has to
understand, when they take the HACCP under, as we're looking
at it with the Florida regulation, they say you have to test
here, test there. Also, they have to look at establishing
standards.
In our company, what we do is we have
specifications that are set forth. We hold the majority of
our products from the groves. I go out and deal with the
growers, look to see and make sure that, in no way,
livestock is around these groves. Sure, you're going to
have a deer that's going to run through the orchard. You
can't stop that. But these things have to be looked at by
those companies, and it's the company who has the
responsibility to say this is what we want to do if we're
going to produce fresh juice; if not, then that company
shouldn't be allowed to make fresh juice.
MS. OLIVER: Michael Groves, next.
I want to remind the people that what we're doing
is trying to ask questions of clarification and just answer
the specific questions from the committee.
MR. GROVES: Mike Groves. I'd like to ask Dr. Pao
a question.
We've had a lot of discussion about the Dr.
Strobos data on the surface of oranges. And you gave some
data about yours, and it seems that you got a 2-log
reduction, and you macerated the oranges and counted them,
and then you said you put it in a commercial extractor; is
that right?
DR. PAO: Yes.
MR. GROVES: And you got a 2-log reduction; is
that true?
DR. PAO: Yes. I'm Steven Pao.
MR. GROVES: The methodology there was different.
You macerated the whole orange and counted it afterwards.
MS. OLIVER: Can you identify yourself, please.
DR. PAO: Steven Pao.
At the same time we did a surface count based on
shaking six fruits in a sterile bag, and the count was near
identical. The difference between macerated juice count and
bag shaked surface count is less than a half-log difference.
MR. GROVES: Right. Okay.
I wanted to ask Dr. Miller a question. It seemed
to me that there was a discussion about removing buttons
from oranges so that they were all alike; is that right?
DR. MILLER: This is Art Miller.
That is true.
MR. GROVES: And we'd heard some information
earlier concerning dropped oranges, how could you tell the
difference between a dropped orange and nondropped or
freshly picked is by looking at the button, and there was a
scarring that took place. Do you have any thoughts that the
absorption of a pathogen or dye in a freshly debuttoned
orange would be any different from one that had not had the
button taken off of it or did you test that?
DR. MILLER: We didn't test it, and I certainly
don't claim to be an expert in this area, but I think
intuitively what you are really talking about, in our case,
was that these were oranges that had been through commercial
sorting processing and then shipping. So you are talking
about time, and one of the things that we noticed when we
took them out of the cases that you do see some buttons. So
I think they just dry up.
Now, again, intuitively, I would think you're
changing the morphology and physiology of the superficial
structures when you lose those buttons. So, I mean, you can
speculate all you want, but I think we need to really think
about this carefully. But I think an important point is
that the stem scar is the most vulnerable part of the
orange, so that's where the action is.
MS. OLIVER: Mike Jahncke?
DR. JAHNCKE: Mike Jahncke, Virginia Tech.
I have a--
DR. ARPAIA: I'm certainly not the authority to
get up here and make a comment--
MS. OLIVER: Can you identify yourself.
DR. ARPAIA: Mary Lou Arpaia, University of
California.
I'm not the authority to get up here and talk, but
there has been a lot of work done on wound healing that
occurs in citrus. And there is a wealth of literature both
from Florida, California and Israel showing that
lignification occurs when the fruit are wounded and the
fruit are subsequently held. And I think that also has to
be considered in this removal of the stem scar; that
lignification does occur and that work that Dr. Eckert and I
conducted, and I don't have the data with me so I can't
provide it, but we did look at the incidence of the
Alternaria stem-end rot in lemons that were harvested
without stems versus the buttons that fell off during
storage, and there is a difference, and it can be linked
back most likely to this wound-healing phenomena.
DR. TOMPKIN: Before you leave, I want
clarification. This is Bruce Tompkin.
Does the wound healing occur on the tree or are
you talking about after picking?
DR. ARPAIA: After harvest.
There's certain post-harvest treatments, actually,
that stimulate wound healing, and a lot of work that's been
done in Israel at the Volkani Institute regarding wound
healing.
DR. JAHNCKE: Thank you. Mike Jahncke, Virginia
Tech. Dr. Arpaia, this question will be directed to you.
I know there are diff--yesterday and today--there
are differences between some of the procedures that take
place in Florida versus in California. If I heard
correctly, I believe in Florida there is no immersion of any
of the fruit that's used for fresh juice, and I believe that
it doesn't go through a packing house, but it goes from the
groves directly to the company.
Yesterday on your slides, you showed a slide, I
believe, at a packing house where some of the citrus was in
immersion. It was immersed in water.
DR. ARPAIA: Correct.
DR. JAHNCKE: And then you had also indicated that
there are occasions where that fruit that is immersed in
that water has been used for fresh juice.
DR. ARPAIA: That is correct. As I indicated,
about 30 percent of the orange houses in California have
these tanks. The tanks, there's been a lot of research done
most recently by Dr. Smilonek, who works for USDA in Fresno,
on the efficacy of these tank treatments for decay control.
The tanks are never just chlorinated water. They always
have either soda ash, sodium bicarbonate or somehow--we have
two houses using borax, boric acid or we have a new
fungicide registration that Dr. Smilonek worked on, which is
lime sulfur. So there's always one of those four chemicals
going to be in that tank treatment. Most likely it will be
either sodium carbonate or sodium bicarbonate.
The maximum immersion time, because you want to
minimize fruit damage, is not going to exceed 3 minutes, but
the average is 1.5 to 2 minutes. In the case of borax,
boric acid and the soda ash, the tanks are heated to
approximately 105 degrees. As Mr. Orman indicated, that can
range from 90 to 110 degrees Fahrenheit. but those tanks
are always heated. When you use sodium bicarbonate or lime
sulphur, then you are using ambient water conditions. But,
again, that's going to be 65-, 80-degree Fahrenheit water.
DR. JAHNCKE: Okay. That gets to my point,
especially with the sodium bicarbonate. I think yesterday
it was indicated the pH is around 8, 8.5, something like
that with the sodium bicarbonate.
DR. ARPAIA: Correct.
DR. JAHNCKE: And you have 70- to 80-degree water,
and you had indicated this morning that some of the fruit,
during the year, has also been picked and comes in that I
don't know 45 degrees, perhaps.
DR. ARPAIA: But they don't like to, they won't
dump the fruit on the line when it's 45 degrees because that
fruit is turgid and very susceptible to damage. So you want
to run the fruit warm. And the minimum pulp temperature
they like to run the fruit at over the line would be 50/55
degrees. By the time it reaches the tank, it's already been
on the line maybe two/three minutes. It's gone through one
to two chlorinated water rinses already before it hits the
tank.
And, again, they take a lot of care here because
they know that if they run cold fruit through a heated tank,
you get a lot of rind damage. And so, you know, everything
is geared towards we are a cosmetic industry, and you want
to do everything possible to minimize cosmetic blemishes to
the fruit.
DR. JAHNCKE: But it is possible that fruits
coming in at 50-55 goes into a tank of 70- to 80-degree
water?
DR. ARPAIA: It's possible, yes.
DR. JAHNCKE: And you had indicated yesterday also
that that tank water is changed once a week, maybe even
twice a week?
DR. ARPAIA: No. I was told, on the average, it's
changed every one to two weeks. But, typically, in the
houses that have boilers, that those tanks are heated up to
140 degrees every night.
DR. JAHNCKE: To your knowledge, has there been
any--there's been a lot of talk as far as the process, and
good GNPs and all of these things, and it also gets back
with the tank immersion and also even with the reuse of some
of the water in the sprays and the brushes. Have any of the
companies collected any data as far as microbiological
bacteria, the bacteria present in those tanks or in the wash
or is there is any count, you know, looking at numbers and
types of bacteria, as far as concentrations?
DR. ARPAIA: For human pathogens?
DR. JAHNCKE: Correct.
DR. ARPAIA: Not to my knowledge, but it could
very well have happened, but not to my knowledge. I haven't
ever heard any of that data.
DR. JAHNCKE: One last question. The question was
passed down.
The fruit that comes out of a packing house when
it goes to a fresh juice processor, is it--and I believe the
previous speaker indicated that that fruit is usually
rewashed at the fresh juice place; is that correct? Is that
a correct assumption?
DR. ARPAIA: I would assume so, but I cannot
categorically answer that question.
DR. JAHNCKE: Thank you.
MS. OLIVER: Since Dr. Arpaia is at the mike, and
before she sits down, and before we go to break, did anyone
else have a question for Dr. Arpaia?
Larry?
DR. BEUCHAT: Are the orange groves--
MS. OLIVER: Can you identify yourself.
DR. BEUCHAT: Excuse me. Larry Beuchat,
University of Georgia.
Are the orange groves in the San Joaquin Valley
irrigated?
DR. ARPAIA: Oh, we have to irrigate. We're a
100-percent irrigated industry. We just had a meeting just
recently, and the estimate now is 100 percent of the groves
in the San Joaquin Valley are under some form of low-volume
irrigation. There is no longer any grove that I can think
of that would be under flood irrigation. There may be one
or two still under furrow irrigation, but we are approaching
100 percent of the groves will be under some kind of low-
volume sprinkler or drip irrigation system.
In Southern California, it would be 100 percent.
Because of the cost of irrigation water, it is just not
cost-effective to be doing flood or furrow irrigation any
longer.
DR. BEUCHAT: What is the source of the water?
DR. ARPAIA: The source of the water varies
throughout the state. In the San Joaquin Valley it's mainly
Sierra snow melt water. There is some well water being
used.
DR. BEUCHAT: Are the livestock areas upstream or
downstream from the citrus-growing and irrigated areas?
DR. ARPAIA: They would be downstream because the
livestock and the poultry are down on the valley floor. The
citrus are grown up in the foothills at a slightly higher
elevation. We have very strict, and I'm not an authority,
but we do have some very strict groundwater quality
legislation in California on water quality, et cetera. But
in the San Joaquin Valley, the bulk of the irrigation water
is going to be Sierra Mountain snow melt water.
DR. BEUCHAT: So that runoff water from the
livestock growing areas would be diverted to other purposes
and directions. It would not be used in irrigation water
for the citrus groves?
DR. ARPAIA: As far as I know of, no, but if you
want, I can make some phone calls and get clarification for
that.
DR. BEUCHAT: One last question also on the San
Joaquin Valley. What is the predominant direction of the
air flow, wind, relative to the livestock growing areas
versus the citrus growing areas?
DR. ARPAIA: That's a good question. It depends
on what time of year. Sometimes the wind comes from the
west, sometimes it comes from the north. I would say
predominantly, I'm trying to think, because we published a
paper on a Valencia rind stain, and we had to answer that
question in the review. And I looked at three years of
data, and the predominant wind direction was from the
northeast, which would be then not coming from where the
livestock would predominantly be located. But I will call,
and if I have a different answer, I will call and have
someone look at that manuscript. And if it's a different
answer, I'll let you know.
DR. BEUCHAT: Thank you.
MS. OLIVER: We'd like to go to break now, and
we'll have a half an hour break so that industry and others
can gather the data on the test sensitivity.
Did you have something that was particularly
addressed to the question?
MS. GIRAND: I spoke with Jeff--
MS. OLIVER: Can you identify yourself.
MS. GIRAND: Laurie Girand, Safe Tables Our
Priority.
I spoke with Jeff Ferraro [ph.] last week about--
actually, last month, about irrigation water issues, and he
indicated that Coachella Valley was, in fact, irrigated with
water from the Colorado River and that it hadn't
particularly been tested to any particular quality levels
and that we have in California right now a water recycling
rule that's under consideration which would allow for the
use of largely untreated wastewater on crops. So water
quality isn't quite what it might be.
MS. OLIVER: Thank you.
MS. NAGLE: Nancy Nagle, Nagle Resources.
Yes, canal water and Colorado River water is used
extensively in the southern part of the state. Primus labs
has an extensive database on this water and has shown, out
of thousands of samples, very few positive E. coli results
for this water. I think we can go to their database and
check that out, perhaps, during the break. And some of the
recycled water issues I think we could talk about
extensively later. But I have a lot of information in that.
MS. OLIVER: Okay. Fine. So, if we can get that
at break time, and we'll also get the information for you on
the sensitivity.
And so we'll come back at about 25 after. Thank
you.
[Recess from 9:55 a.m. to 10:35 a.m.]
MS. OLIVER: The first thing I'd like to do is
just mention that we handed out this morning the statement
from CSPI. They were not able to be here yesterday for the
public comment, and so they have a statement that's here in
your packet, and they are represented here by Darren
Mitchell is here today. So I want to call your attention to
it so that you can look at that this morning and take that
into consideration, also.
The next thing I'd like to do is say that there
are a number of you that still have questions. And what I'd
like to do is plan on going until noonish or lunchtime with
questions of clarification that you all have. Around noon
or so what I'll do is if there are people that still have
questions, ask those who think they have questions that are
critical to your deliberations in the afternoon, for those
to be the ones that are asked at that point, but it'll give
you plenty of opportunity.
I gave a little extra time because people were
still working on sensitivity of method and answering method
questions for you all, and some of you gave questions that
you wanted specifically answered, and they were being
responded to. So we have that lined up.
Then, after lunch, what we'll do is we'll have the
committee discussion, and we'll proceed from there. And
I'll poll the committee sometime in the afternoon. I don't
have an exact ending time. I just want to make sure that if
you think there are questions that are critical to your
deliberations, that you have the opportunity to ask that and
do have opportunity for discussion.
So Art Miller is going to discuss FDA's lab
procedures and sensitivity, and I believe Dr. Parish is
going to discuss, from the standpoint of the industry, the
sensitivity and methods that are being used, and then you
can ask questions of them both.
DR. MILLER: Sensitivity has arisen, and this
transparency was alluded to yesterday. My name is Art
Miller, by the way.
The question came up about sensitivity and methods
of choice. And as it was brought out yesterday, that there
were questions about the sensitivity and the ability of the
Salmonella method that was used in the BAM, which included a
step to use lactose broth as a pre-enrichment and to address
this question. This is work by Tom Hammack and Wally
Andrews. And I want to say that it was very recently
presented at an international food microbiology meeting in
the Netherlands just a few months back. This work is now
being finalized for publication. It is the method that we
are recommending and have been making this information
publicly known.
What these investigators did was take three
different Salmonella serovars, prepare stationary phase
cultures and then dilute out to extinction, and the data
that you are looking at shows the ability to recover the
Salmonella at a range of three in a liter up to 231
organisms per liter using the traditional lactose broth for
pre-enrichment versus the universal pre-enrichment broth,
which was developed the ARS Laboratory in Athens, Georgia.
And of a total of 120--a possibility of 120
replicates, and I've really extracted this, the lactose
broth was able to recover 44 percent, and that's across this
whole range, versus 81 percent for the universal pre-
enrichment.
Of course, we need to bear in mind that, as you
start diluting down to extinction, you are really playing
the shell game because not every one of those 20 replicates
will contain Salmonella. So it's very, very difficult to
say where that cut-off point is. But in this instance, we
were looking at three organisms in a liter of--a
concentration of three organisms in a liter of material.
MS. OLIVER: Art, did you want to say when this
was done and when the method was, we were changing it?
DR. MILLER: The research was done over the course
of the past couple of years. It has been finalized in our
laboratories. As I mentioned, it was presented this fall at
an international meeting in the Netherlands and Europe. It
is going to be published. We've been recommending this to
all interested parties, and this is an orange juice, I
should mention at the beginning, it's orange juice specific.
And as most of you are aware, to really squeeze out the most
sensitivity for any method, there have to be modifications
made. You can't just blindly go in and apply a method and
say this is the ultimate insensitivity. So it took a lot of
effort to get us this far.
We've recommended it to all of our field labs, to
the states, to the industry, and we're trying to get the
word out to as many people as possible that this is the
method of choice.
DR. BERNARD: Just for clarification--Dane Bernard
NFPA.
For clarification, how many mls did you sample?
You had three organisms per liter?
DR. MILLER: Yes. What they did it was an MPN
type so they grow up the culture and then fractionated it
and did MPNs.
DR. BERNARD: What was the sample size, though on
Salmonella?
DR. TOMPKIN: How much was pre-enriched?
DR. MILLER: Right. I don't have that. I can--I
actually have the notes, and I can inspect that. I didn't
bring it up with me.
MS. OLIVER: If you can check that then when, you
know, the next presenter, and then come back with that.
John?
DR. KVENBERG: Thank you. John Kvenberg, FDA.
I think, if I can just discuss, Dane, what you are
I think going for is the standard BAM procedure for a
finished food would be a composite sample of 30 for a food
that's radiated versus 15 for a raw commodity. I think for
the recommendation of the method of the BAM procedure,
that'll be the sampling size aliquot that we're going to be
involving; is that true? The methodology itself would
require, as it does in the BAM, that remains unchanged for a
food that's ready to eat.
DR. MILLER: Yeah. The modification is the
substitution of the universal pre-enrichment for the lactose
broth.
DR. KVENBERG: I don't know if that went to Dane's
question or not, but that I think is the point relative to
the application of the methodology for the finished juice
would be the standard BAM procedure for Salmonella doesn't
change.
DR. MILLER: Right.
DR. KVENBERG: Thank you.
MS. OLIVER: Dane, does that answer your question?
DR. BERNARD: It does. If I have a chance to look
at the BAM, I'm sure I can get my answer. Thank you.
MS. OLIVER: Art can look it up and give you that
answer in between.
DR. MILLER: Any other questions of clarification?
MS. OLIVER: Yes, any other questions of
clarification for Art?
Okay.
DR. PARISH: I'm Mickey Parish, University of
Florida, and I have just spent the last several minutes
discussing procedures that are used by the consortium of the
four companies, the two California and two Florida companies
and their testing procedures. So this is very fresh in my
mind, and hopefully I won't make too many errors.
It's obvious that at the four companies they do
things a little differently. They have different sampling
procedures and different test methods. And let me begin by
saying basically the California companies do testing by
pulling a sample from a tank so they test the tanks
themselves. The tank sizes range anywhere from 3- to 7,000
gallons.
This amplifies, as I understand it, when it's
pulled, can range from 100 mls. to roughly 8 ounces of that.
That is--of that sample, then 25 mls. is pulled and is run
through a standard procedure for pathogen testing. The
Florida companies did the same thing for tankage, and they
also do end-product testing. Two of the companies do their
pathogen testing in-house, two of the companies send their
samples out.
The samples are pulled--when they pull the samples
out of the tanks or out of the bottles, they are
refrigerated at the time and they are maintained under
refrigeration or packed on ice so that they are cold. The
ones that ship the samples out, the samples arrive--the
samples are normally pulled during the day, shipped at the
end of the day, and arrive at the lab the next day. So
there's roughly a maximum of about 24 hours before the
samples are begun tested. The in-house folks say within two
to four hours of their samples, they begin testing of their
samples.
For the Salmonella testing, there are two methods
that are used. One is an ELISA method by Tecra [ph.],
called the Tecra Unique System. It is under AOAC review and
will--should be approved by--they are anticipating AOAC
approval within a few days--within a few months. That test
takes roughly 24 hours if it's in-house and 36 to 48 hours
if it's sent out. The other--one of the four uses the BAM
method. They send it out to an outside lab, and the person
at that lab has indicated that it takes her five days to get
results.
The E. coli 0157 testing that's done, two of the
companies use something called a VIP method, which has AOAC
approval, VIP method from Bio-control. It's a visual immuno
precipitate method. It has an AOAC official method approval
number.
One company uses a clinical test that is under
review for testing in foods. The VIP has a turnaround time
if it's in-house--well, the VIP has a turnaround time in-
house of roughly 18 hours; if it's sent out, roughly 36
hours. The other clinical testing method is in about 8
hours.
The fourth company for 0157 uses a compendium
method, and that method again takes roughly 5 days. The
person at the lab reports the Salmonella and 0157 results
back to the company on the same day.
These samples, again, are 25 mls. in size. The
Salmonella testing at one company is a 50-ml sample in size.
They are reported as positive or negative. They have all
been negative up to this point. And if we assume a 25-ml
sample, I'm assuming that perhaps we can say that it's less
than one cell per 25 ml, making that assumption.
The Salmonella Tecra Unique has been tested on 42
different serovars, and the--one of the companies involved
has contracted an outside lab to verify both the Tecra and
VIP testing for orange juice specifically, so they will
begin the process of verification very soon.
That's all the information I have, hopefully.
DR. TOMPKIN: Of course we didn't ask the question
before, but on the E. coli analysis, which looking through
the information, I got the impression that at least one
company was analyzing--this is Bruce Tompkin--analyzing a
10-ml sample for E. coli; is that correct? Are they 1-ml or
10-mls. for E. coli, because we had a lot of negative
results?
DR. PARISH: I'm not sure what results you're
referring to, what company you're referring to, Bruce, and
is that generic E. coli or pathogen?
DR. TOMPKIN: Generic E. coli as part of the State
of Florida requirement for end-product testing.
DR. PARISH: I do not know the answer to that. I
believe some of the smaller plants may actually use the 3-M
petri film method for detection of E. coli, so in those
plants the detection limit would be something in the range
of 1 per ml. The others I don't know. I think some of them
may actually use a traditional test method as in the
compendium, which I believe that's 1 per 10 or 1 per 25.
Yes, Bob?
DR. BUCHANAN: Bob Buchanan, FDA.
Are positive controls run with all of these
analyses?
DR. PARISH: That's a good question, Bob, and I
don't have an answer for you. I assume that--I would assume
that they are not if they're run in-house, if they're
pathogens, because I don't think any of the plants will
handle pathogens in-house.
MR. MARLEA: On ours a positive controls method,
positive/negative.
DR. PARISH: Okay. So at least one of the
companies does run positive/negative controls on their
testing.
DR. KING: The VIP and the tec method both.
DR. PARISH: Okay, two companies do.
DR. KING: The VIP and the tec method both [off
mike] positive controls.
DR. SWAMINATHAN: You mentioned one of the
companies runs a clinical method that takes 8 hours. I'm
very concerned about it because clinical specimens are very
different from foods in terms of the numbers of organisms
that you're likely to find in 8 hours bothers me. Can you
give me some more details?
DR. PARISH: I cannot give you more details.
Unfortunately, that's as much as I know, and I share your
concern. I think that that test method, they--it's my
understanding that test method is being reviewed for food by
the company that makes the test. It is a clinical test at
this point, and I share your concern that perhaps that's not
the most appropriate method to use.
MS. OLIVER: Dane?
DR. BERNARD: Thanks, Dane Bernard.
Is there any reason to believe that we have a
homogeneity problem with say a tank of juice in terms of
distribution of organisms?
DR. PARISH: The tanks are all agitated, so to the
best of their ability, the tanks, we would assume the sample
is homogenous, yeah.
DR. KVENBERG: John Kvenberg, Food and Drug
Administration.
I think, just for clarification purposes, on the
actual drawing of samples for the methodology, is it not
correct that you're basically down to an analytical unit of,
I believe, 25 grams?
Going back to Dane Bernard's comment, the full
utilization of the sampling procedure for ready-to-eat food
would be aliquots that are composited for enrichment. In
other words, 25-gram samples would be composited into a
total of 750 mls. of product in two enrichment broths of
375, 15 each, for convenience. That's not normal industry
practice, and I just don't want to leave the impression that
that's what's being done here. There are individual
aliquots of perhaps 25 grams being run by the procedure that
represent that batch. It's not a combination of the lot.
In other words, if you had--you would be pulling
samples from actually 30 points and compositing them and
enriching them in a full BAM procedure. That's not being
done.
DR. PARISH: That's correct. That's correct.
There is one company that is compositing their samples.
They pull--however, they pull one sample from 6 different
tanks, then composite those samples from 6 different tanks,
but that's correct, they're not compositing from an
individual tank.
MS. OLIVER: Any other questions or clarifications
on the methodology?
DR. DOYLE: Mike Doyle, University of Georgia.
How many of these assays that you are using have
truly been evaluated in terms of determining the sensitivity
of the test for orange juice?
DR. PARISH: As I said, the Tecra and VIP methods
have been--are being contracted, companies contracting to do
that with an outside lab. To my knowledge, they have not
been specifically looked at for orange juice. I believe the
universal pre-enrichment broth type system for Salmonella,
as Art just indicated, is a desirable methodology, and for
the folks who are doing the modified BAM procedure, I make
the assumption that that's what they're doing. I don't know
that that's true.
DR. DOYLE: And has any effort been made to
validate procedures? That is, Dane brought up the point of
sample testing. How good is a 25-ml sample or up to an 8-
ounce sample from a several thousand gallon batch?
DR. PARISH: I'm unaware of anything that's been
done to validate the adequacy, but perhaps Jur can--
DR. STROBOS: My understanding is that there has
been some validation done in acid foods, but not
specifically in orange juice. You know, let me be clear
here. We are certainly seeking the input of this Committee
in terms of what kind of comments and improvements we can
make in this process, and that's part of the reason we're
here.
DR. DOORES: This is Stephanie Doores, Penn State
University. Mickey, what procedure is used for the generic
E. coli?
DR. PARISH: Again, Stephanie, I'm not exactly
sure. It's my understanding some of the smaller companies
may use the 3-M petri film method. Other companies may use
the compendium method, which would be an enrichment.
DR. DOORES: You mean the most probable number
method?
DR. PARISH: MPN, yeah.
DR. DOORES: Does anyone use the standard agar
plating with violet red bio-agar?
DR. PARISH: I have no idea. I don't know,
Stephanie.
DR. DOORES: One of the concerns with the petri
film may be with the volume that's used to perform that
test. You might have some situations where the pH is still
fairly low on that agar to the point where you may not get
visualization of those organisms, where in something like an
MPN or even an agar plating procedure, you may have dilution
of that orange juice to the point where the buffering
capacity allows for a more neutral recovery environment, so
I could see where there might be a possibility that you get
positives in those types of tests but potentially negatives
in the petri-film type of test.
DR. PARISH: I share your concerns. I've wondered
about petri film in the past. And I know that some
companies do, at least early--years ago, when they were
first investigating petri film for E. coli in orange juice,
some companies were diluting 1 to 10, therefore sacrificing
some sensitivity in order to try to balance the pH issue.
MS. OLIVER: Mike?
DR. JAHNCKE: Mike Jahncke, Virginia Tech.
I have a question that relates to John's and
Dane's question on sampling and delivery of the sampling and
things. In the Florida guidelines there are, on sampling
rates there are a recommended number of samples for the size
of the containers. I was just wondering--it sounded from
your presentation now that this isn't necessarily being
followed, and I was wondering why.
DR. PARISH: Well, I think that's a very good
question, Mike. I would wonder why also. I don't know what
the sampling recommendations are in the regulation, in the
Florida regulation. I think that the companies involved
should make sure that they are meeting that regulation and
that's really all I can say to address that.
MS. OLIVER: Any more questions or clarification
on the methodologies? I don't see any more. Okay. Thank
you.
With that, we'll continue on the questions that we
started before. And, Dane, you have a chance to ask your
question.
DR. BERNARD: Thank you, Madam Chairman. Dane
Bernard.
A question for Dr. Pao. I think he's still here.
MS. OLIVER: He's right behind you.
DR. BERNARD: It relates to the discussion we had
yesterday about the dipping in the orange, putting it into
the extraction device, and getting juice and a number of
organisms in the juice. And if I remember our discussion
yesterday, we had 105 roughly, and there was Bill Sperber's
concern this morning about translating a surface enumeration
into a volumetric enumeration of the product. But all that
aside, we had microorganisms on the surface of the orange,
and we had some less--I think you said a 2-log reduction. I
wouldn't necessarily call it a reduction. I would say it
didn't transfer into the juice, but we left 99 percent of
them in the extractor or it went out with the peel or
whatever. And the 1 percent that came through in the juice,
do you have an idea of how that happened, where those
organisms may have been and how they ended up in the juice?
DR. PAO: My name is Steven Pao. And in my slide,
where I show the bars, the first bars are control. That's
based on macerated juice count, so that was not surface
count. Based on--the macerated juice count represent, I
believe, the inoculation level on the fruit surface. From
that macerated juice count to our control juice, from the
extracted juice, and we see 1.9-log reduction, so it's from
juice to juice we have 1.9-log reduction. And if you say
why there are some in the juice, see, in the juice
extraction method alone we not achieve that low a reduction.
Juice extraction technique, commercial juice
extraction, we have--in Department of Citrus we have conduct
30 on at least three companies' juice extractor. We found,
consistently found reduction through their juice extraction.
But I guarantee you there is no 5-log reduction by juice
extraction alone.
DR. BERNARD: I understand that. I was just
trying to understand. I think the material we were
supplied, we had a schematic diagram of the FMC extraction
device, and it talked about cutting plugs, and juice would
be extracted around at least the bottom plug. Is that the
same device or the same function that you used, and could
the 1 percent that was transferred into the juice have been
on a little bit of that plug that gets contact with the
juice?
DR. PAO: Right. There are certain contacts
between--otherwise, the blades would not enter the fruit.
So the reason I demonstrate that in the meeting is I want to
use that as my control to compare to a treatment such as
hot-water treatment can give you 5-log reduction.
DR. BERNARD: Okay, thank you.
DR. PAO: You're welcome.
MS. OLIVER: Dr. Parish had something to add,
Dane, to that question.
DR. PARISH: Mickey Parish. If I could just
elaborate just a moment.
I think the reason that you were seeing some of
the transfer is due to the plug, and that there is a minimal
amount of juice-to-peel contact. According to FMC
documentation that I've heard of, perhaps as much as 3
percent of the peel has the potential to come in contact
with the juice during the extraction method, so that may be
where we're seeing the organisms come that had been on the
outside of the fruit, and again, unlike apple juice where
there is intimate contact between the peel, the milled
apples where the peel is mixed in with the pulp and is
pressed, where there's intimate contact, in orange juice we
want to make sure that there is very minimal contact with
the peel for just a very small amount of time, because of
the fact--for flavor issues, the peel oil has a tendency to
make the juice very--gives you a burning sensation, so it's
an organoleptic reason.
MS. OLIVER: Bill.
DR. SPERBER: Thank you. I'm Bill Sperber from
Cargill.
My question is centered on the FMC extractors, and
to some extent it's already been answered, but I want to
pose my question maybe more for the information of the
Committee, as we deliberate this afternoon.
Three years ago the citrus--fresh citrus producers
were arguing that they shouldn't be lumped together with
apple producers because they were different. Whole apples
were macerated, and any external contamination could end up
in the juice. They were different. Citrus is different
because of the extraction process. There's not intimate
contact between the peel and the juice, and so therefore
fresh orange juice is cleaner.
So my question is centered on the FMC extractors,
that in fact, when you put an orange through such an
extractor, you get four streams coming out. One is the
juice. The second big stream is the peel that generally
goes to animal feed. But the other two factions concern me,
and that is one is the peel oil. In the FMC extractor
there's a small water spray that washes--coves the surface
of the peel and helps extract the oil. That's recovered
separately. And then the core of the orange is cut out
during the extractor, and in conventional orange juice
processing, where the juice is pasteurized or concentrated,
both the peel oil and the core are kept and further
processed, and they end up back in the orange juice
somewhere down the stream.
So I was thinking that if the fresh producers are
trying to claim that their juice is cleaner because they
don't have contact with the peel or even you could argue
that if there are infiltrations through the stem scar into
the core of the orange, that that too would be removed. My
question for the fresh juice processors is what do you do
with the peel oil and the core?
I had one answer from Ms. Sexton from Orchid
Island during the break, but I wonder--she said that they
don't use it, they completely throw it out. Is that true
for the entire industry?
DR. STROBOS: Yes. This is Jur Strobos. The core
and the peel oil is not at any point in contact with the
juice.
DR. SPERBER: So just that mechanical fact of
extraction would indeed differentiate fresh citrus juice
from fresh apple juice in terms of potential contamination?
DR. STROBOS: Yes. Well, yeah, and I think, you
know, just to reiterate Dr. Parish's point too. I mean,
when you crush an apple, you crush the skin with the apple,
and then the entire mixture is sort of mixed up, so there is
intimate contact between the peel and the juice until some
straining operation takes place.
DR. SPERBER: FMC claimed a 3 percent contact with
the peel and the juice. In my experience, commercial
extractors, each contain six heads, and one extracting unit
will process over 500 oranges a minutes, so you end up with
quite a mess. It looks kind of messy. And I'm just
wondering if there's--if the fresh producers operate their
machines that fast, as fast as the conventional producers?
Do you have any idea of your line speed?
DR. STROBOS: I don't know the answer to how fast
they run the machines, but I don't think--I mean, I've seen
them in operation, and I dispute the description of it as
being a mess. You know, the oranges enter the machines and
the juice comes out in a contained system, and the way the
machine works, you know, the peel and the other materials
come out in a different system.
DR. SPERBER: You have to take the cover off to
look on the inside to see what's going on.
DR. STROBOS: Well, if you open the machines in
the middle of the processing, which you don't do, but the
oranges are basically annealed to the surface of these. I
mean, there are pins that come down and grab the orange, and
the surface is annealed as the juice is extracted.
But let me defer to--
MS. OLIVER: Yes. There are two processors
standing behind, so let's see if they have the answers.
MS. SEXTON: No. FMC had different settings on
their machines.
MS. OLIVER: Please identify yourself.
MS. SEXTON: I'm sorry. MaryGrace Sexton, Orchid
Island Juice Company.
FMC is technical enough that they have different
settings on their machines. They also have machines
considered a soft squeeze machine, meaning we don't want the
peel oil in there, and that we do--a fresh-squeeze processor
will run lots slower than a commercial pasteurized company.
We run much, much slower.
And also when they go to say that they put the
three--the razor on that orange and that's the contact
point, I want to reiterate that orange has already received
a 6.7-log reduction before that razor. So that razor is
continuously sanitized by those byproducts that come with
that orange, the sanitizer on the outside of the orange
before that razor hits that orange.
MR. BARNHORN: Brad Barnhorn, Fantasia.
Just to confirm what MaryGrace said, we run much
slower than that. I mean, on the first question, if I can,
about the peel oil and the peel. Most of us here are--I
think probably everybody--are fresh juice companies more
than orange processing companies, so we're not looking to
create byproducts. Everything that comes out that's not
orange juice is thrown out by us.
DR. SPERBER: So you throw out the core too?
MR. BARNHORN: Yes, everything--the only thing
that we maintain is the juice, everything else is thrown out
as waste.
DR. SPERBER: Thank you.
MS. OLIVER: Earl?
DR. LONG: Earl Long, CDC. I have a question on
orange anatomy and physiology. I don't know whether Dr. Pao
would want to answer that. There are two questions. The
first one is: do fluids enter oranges through continuously
open channels in the vascular bundles or through pores in
contiguous cells or through cell cytoplasm?
The other one is: do citrus oils have any
inhibitory effect on microbes?
DR. PAO: From what I can remember, peel oil does
have antimicrobial property. But how effective is that in
this case, there's no direct study.
DR. LONG: I'll tell you why I ask that. Because
I'm concerned that there may be a temporary inhibitory
effect on bacteria that early sampling of the juice would
not show the potential for later growth of microbes there.
DR. PAO: Did I answer all your questions?
DR. LONG: No, that's one. The first question was
how do fluids enter the fruit itself from the plant?
DR. PAO: On the tree.
DR. LONG: No. I'm talking about the vascular
bundle now. Is there a continuously open channel?
DR. PAO: There are--they call it a pit wall in
the vascular bundle. At this time I talk to our electron
microscope technician, and he's also our associate
scientist. He said there are pit wall in the vascular
bundles, so--
DR. LONG: So fluid will--
DR. PAO: --will stopped at the top. That's why
we see lumps.
DR. LONG: So there are pores in the cell walls?
DR. PAO: There are walls.
DR. LONG: I'm asking whether there are pores in
contiguous cells.
DR. PAO: Maybe a fruit person could--I'm a food
technologist. Maybe a plant person can help me. Thanks.
DR. LONG: I'm just wondering whether there is
some mechanism in the cells that could filter bacteria out
or whether bacteria could just flow through channels?
MS. OLIVER: Dr. Arpaia, can you answer that?
DR. ARPAIA: Mary Lu Arpaia. You're asking a
question on whether the vascular bundles--the vascular
system remains functional after the fruit is harvested?
DR. LONG: I wasn't asking that, but yes, I'd like
to know that.
[Laughter.]
DR. ARPAIA: Well, I mean when the fruit is on the
tree, definitely, water goes into the fruit through the
vascular system, and there's a lot of data showing how the
fruit shrinks and expands during the day, depending on the
water requirements of the tree.
DR. LONG: But does the structure of the vascular
bundle act as a filter that could prevent bacteria entering
the fruit?
DR. ARPAIA: To my knowledge, I don't think
anybody has ever, ever really looked at that, but the
vascular system in the fruit, from what I remember from
reading the literature--and this is a while back--is that
it's a typical plant vascular system. It does not have any
specialized cells or cells that are different than the
vascular system in the remainder of the plant. So it would
have the tracheid cells and cells that are typically found
in vascular tissue.
MS. OLIVER: Dr. Parish, did you want to add to
that?
DR. PARISH: Mickey Parish, University of Florida.
And I'm not a fruit physiologist either, and I'm
just going to make a stab at this. We have experts at the
research center in Lake Alfred, who study these issues, and
I'm sure would be glad to comment to your question.
Regarding is the vascular system functional after
harvesting, I asked that question specifically of one of our
researchers. He indicated that upon pulling the fruit from
the stem, that there is a break that occurs internally just
beneath the surface of the stem scar that essentially breaks
what he calls the water column. And, frankly, I don't know
exactly what that means other than to say that the
implication is that you don't get continuous suction or a
forced pulling down completely down into the fruit, but it
does stop at some point. That was my understanding of that
conversation.
Is there a filter? There are pit walls. You have
a tube of cells that come down and there are pit walls in
between them. The fluid can flow through the vascular
bundle, and we have seen, through some of the recent photo
micrographs that the bacteria do--if they enter the vascular
bundle at all, they tend to accumulate at this--will
accumulate at a pit wall. So obviously there is some
filtration effect occurring.
DR. BUCHANAN: Janice, can I--
MS. OLIVER: Bob.
DR. BUCHANAN: I attempted to do a little reading
on fruit physiology before this meeting, and it appears
that--
MS. OLIVER: Could you identify yourself?
DR. BUCHANAN: Bob Buchanan. It's still the same
one.
[Laughter.]
DR. BUCHANAN: Citrus, like other fruits, when
picked, at the stem scar region there is a response where
there is a plug that's established that tends to seal off
the vascular system. Once beyond that plug, as far as I
could determine, the vascular system remains intact. If
there is a sufficient pressure differential between the
inside and the outside of the fruit, that plug can be
overcome, and then once that plug is removed, the vascular
system is again open. That is one of the concerns, and why
you have to have a certain degree of pressure differential
before you can start to get infiltration. It will vary from
fruit to fruit. Some will have a stronger plug than others,
and I gather in some cases the plug may not form totally.
But once beyond that plug, as far as I can tell, the
vascular system remains intact.
MS. OLIVER: Bob, were you done with your
questions? Because you were next anyhow.
DR. BUCHANAN: Bob Buchanan, FDA.
[Laughter.]
DR. BUCHANAN: I just wanted to make sure our
afternoon speakers didn't feel slighted, and so I do have a
question for Bruce Tompkin.
Bruce, in your discussion of validation and
validating processes, you didn't particularly focus on the
role of microbiological testing in that process. Based on
the Florida system, HACCP system or HACCP-like system, they
require, in addition to the steps for surface-treating the
fruit, they also require subsequent microbiological testing.
Could you give us some comments on how such microbiological
testing fits into a HACCP validation process and
verification process?
DR. TOMPKIN: This is Bruce Tompkin.
I wrestled with that question throughout those
slides. Actually, in--the intent of a HACCP system is to
design the system such that you have confidence in the total
system, the total food safety management system, so that you
actually control the hazards. In those situations where you
do not have a sufficient confidence level that the end
product will be safe and meet your own criteria or
regulatory criteria, then some end-product testing may be
appropriate.
In my own case I know of two product systems where
we did do end-product testing. We no longer have those
systems in place, so I would view those situations as being
of an interim nature till you have a better controlled
system.
And so I think in terms of the orange juice system
that we've been talking about, and these 5-log reductions,
the goal is to reach a point whereby end-product testing--
your confidence level is high enough that end-product
testing is no longer needed or productive because the
hazards of concern are below detection levels.
As for the data that we've been hearing with the
E. coli, which is certainly very helpful information, and
useful as a process control--as a means to assess the level
of control of the process, that's very helpful. The
pathogen testing for Salmonella and E. coli 0157, that also
is very helpful data, but the testing is not adequate for
lot acceptance testing, and if we as a Committee wish to get
into that, then we should consider a sampling plan, whether
a sampling plan is appropriate, and John Kvenberg's already
been talking in terms of 30 sub-samples being composited,
for example. Whether you can do it in two 15 sublots,
that's one approach. And then it's a question of the
methodology. We have a lot of work to do in terms of even
coming up with an acceptable end-product testing program.
Does that help?
MS. OLIVER: Did you have any other questions?
DR. BUCHANAN: No.
MS. OLIVER: Okay. Swami?
DR. SWAMINATHAN: Bala Swaminathan, CDC.
I have two comments on specific questions that
were brought up yesterday, and then I have a request for the
chair and a question.
First, responses to the two questions that were
brought up. Dr. Donnelly asked about the CDC method. I do
have a copy of the method now, and I'll be happy to share it
with you, and if someone would make copies, others on the
Committee.
As far as the regulated industry is concerned, my
advice to you is to get the procedure from the FDA, not from
us.
Secondly, Dr. Tompkin yesterday asked me if we had
quantified the Salmonella from any of the outbreaks, and the
answer is yes. We did quantify the numbers of Salmonella in
the Florida outbreak, and it was 2 to 4 CFU per 100 ml.
Third, the request for the chair. I am easily
confused, and I'm thoroughly still confused about the
temperature differential, and I thought after Bob Buchanan's
questions I had things under control and clarified, until
Dr. Strobos pointed out that the oranges that are meant for
fresh juice do not spend time in the cold room. It would be
very useful for us, as we do our deliberations this
afternoon, if one representative from California, perhaps,
Dr. Arpaia, and one person from Florida, would draw a flow
diagram starting from the tree, and give the ranges of
temperatures that those oranges are exposed during the--
until the juice is made, and if at any point the oranges
come in contact with water, a cleaning solution or a
disinfectant, provide the approximate temperature of that
solution at that step. I think that would be extremely
useful to me.
And finally a question for anyone who cares to
answer this question. Is we have primarily focused on the
top four questions that we were given, and we have not spent
any time at all on the 5-log reduction related questions,
and I would like some feedback from persons like Dr. Parish,
Dr. Ismail and so forth, on whether in their opinion the 5-
log reduction can be carried out in different steps at a
different locations or how do they view this? Thank you.
MS. OLIVER: Okay. First I would ask both those
that are here from Florida and California, if you would be
able to draw a flow diagram, each of you, for the Committee
for the afternoon?
DR. ARPAIA: Yes, I'm trying to get a
transparency.
MS. OLIVER: Fine, and we'll get one then for both
Florida and California?
DR. STROBOS: Yes.
MS. OLIVER: Okay. We'll do that for this
afternoon.
Then, Dr. Parish or anyone, can you answer the
second question?
DR. PARISH: Regarding the cumulative 5-log, this
is a philosophical issue that I've struggled with for years,
and the Committee, this Committee did make that
recommendation. I have had a great deal of difficulty
understanding, when we first began, trying to comprehend
what a 5-log reduction meant, especially with regards to the
surface volume--surface area to volume issue. And I queried
FDA folks, my colleagues there for a number of times. They
got tired of me calling, actually, to try to understand
exactly what that meant.
It was my understanding that if you consider one
piece of fruit, and you assume--make an assumption or make a
theoretical thought process, that there would be 105
organisms on that, pathogens on the surface of that one
fruit, that when you juice that one fruit, in that juice
there will be a 105 reduction of those organisms that might
have been on the fruit as to what it gets in the juice.
When you stop and consider the volumes that are
run and the volume of juice that's been produced, the
empirical evidence seems to show that when you use good
quality fruit that's produced properly, that's harvested
properly, that's handled properly in a very well-cleaned and
sanitized facility, and when the fruit itself is well
cleaned and sanitized, that the empirical evidence seems to
indicate that there--that the risk associated with that
product is very low. Now, we don't have a specific number
to put on that risk, and one thing I've tried to come to
grips with is the fact that every bite of food that we take
has a degree of risk associated with it, whether it be the
orange juice I drank yesterday morning, or whether it would
be the wrap I had for lunch yesterday at the counter. And
the question comes in, what is acceptable risk? According
to this Committee, 105 log reduction is an acceptable risk,
and I've just accepted that as being what FDA thinks is
appropriate.
MS. OLIVER: Did anyone else want to respond to
that question? Dane?
DR. BERNARD: Thank you. Dane Bernard.
It's one of these issues that a good idea has many
parents, and a bad one is an orphan. And I'm not sure where
the 5-log falls at this point in time. However, having
been at least associated with the deliberations, the
thought--at least my impression at that time, was that in
the absence of great amounts of data, an operation which
were being run under even fair GMPs should have
produced a juice with a moderate amount of bugs in the juice
and then a process applied to the juice. Conservatively, a
5-log process applied to the juice would reduce the
contaminants that were there to a level where they would not
result in a public health risk. That's my impression of the
thinking that was there.
Now, since this issue has developed, I have to
agree with Dr. Parish, it depends on who you talk to as to
what that number means, how it is to be applied, and when
you begin looking at the fruit and decontaminating the
fruit, and taking credit for a portion of the log reduction
in decontaminating the fruit. I think that that thinking,
while it--theoretically, there's nothing wrong with it, that
probably goes beyond the original concept that we had
discussed when we came up with it. Now, that doesn't mean
it's wrong. It's just that the original thinking was to
apply a treatment to where we come up with a level in the
finished product that is not going to result in a public
health risk. And when you start with, say, 107 or 109,
obviously a 5-log reduction is not going to be enough if
that were in the juice itself.
On the other hand, if you start out with very low
numbers, applying a 5-log is a very conservative number. So
it depends on how you want to look at it, but those were
some of the considerations.
I'd also like to ask, since there is, I think,
still opportunity for questions. We had a presentation by
Laurie Girand, and one of the concerns she brought up was a
concern that their group has over the adequacy of the 5-log
and maybe Laurie would have something to add. Maybe they're
not satisfied yet. There's been some discussion, but maybe
we could get a revisit of the questions that STOP had
regarding the 5-log.
MS. OLIVER: Laurie?
MS. GIRAND: Laurie Girand, STOP.
We distributed yesterday the background on that
slide that was shown to you yesterday in paper, so I think
you now have it in your binder. We had, I believe, 7 points
that we thought called into question the validity of 5 in
particular as the number. The first was that the--one of
the at-risk groups consumes substantially more juice than
the Committee assumed. The Committee's initial assumption
was 100 milliliters per day, and we have statistics showing
that some infants and small children drink as much as 10
times that amount, which seemed to be off by a log, so that
was of concern.
The second point was that it wasn't clear to us
that the number of pathogens in animal feces had been
accurately assumed for both Salmonella and E. coli. We have
information revealed at the November meeting by Jurs Strobos
in particular, that we had a quote from him that said that
the level of pathogenic organisms that you get in fecal
contaminants is 1011 to 1012, and that was quite an order off
from the 104, 105 that the Committee assumed based on the
data that we have. We might be comparing Salmonella to E.
coli, and that might be the difference there, but it was a
pretty substantial difference.
We have gone over different grading issues that we
don't believe the Committee considered in the past, which we
believe contributes to the amount of contaminant or the
potential for contaminant. We've also gone over temperature
changes, which will be considered to be an issue. I think
theoretically one of the questions, as long as you're still
dealing with theory, is why do you see repeated Salmonella
contamination in orange juice? If it was a plant problem
and a processing problem--when I say "plant", excuse me-- a
facility-related problem or a processing problem, why would
you not see other types of contamination in orange juice?
And we're not seeing outbreaks from other types, which
suggests that something from--and I don't know where--it
could still be in the processing plant, but somewhere
between the orange and the plant, something is selecting for
Salmonella as opposed to other organisms.
We are very concerned that the Committee only
really viewed fruit as coming in maybe 1 piece in 100 being
contaminated. Clearly, one of the fundamental problems that
we have, and epidemiologists have in tracing back these
outbreaks, is that the fruit that went to the batch is gone
by the time they get to the site, and in fact, sometimes
even the orchards have been cleaned up by the time the
investigators get to the site. And so when you might have,
for example, as it appeared to be the case in the Odwalla
outbreak, a single orchard shipping off a large batch of
fruit which might have had a significant percentage of it
picked up off the ground, you're not selecting necessarily
for the circumstance. When you talk about 1 in 100, where
an orchard might fertilize--we haven't heard a lot about
chicken manure--but fertilizing with chicken manure, and in
fact, multiple pieces of fruit, more than 1 in 100, would
have been selected, and in fact, FDA studies show that even
growers, apple growers in this case, claim that they use as
much as 10 percent of dropped apples in juice, and that's
again off by a log from where you originally started.
We have concerns about the contamination rate. It
sounds like you have one piece of data which we didn't have
yet, which is that you've seen 2.4 CFU per ml in the Disney
World outbreak, but we don't seem to have data on the
others, and I don't know where that's going to go. We are
seeing isolated examples in multiple FDA related and
outbreak-related data, and actually, Martha Roberts from
Florida's data, where they get a case of more or 100 or more
fecal organisms per ml they found in studies between, I
think, 1996 and 1997, that 4 to 5 percent of samples in
firms in Florida had some level of contamination.
And lastly, we're very concerned about this what
we'll refer to as the pseudo-validation of this with eggs
and salami. Salami is being increasingly recalled for E
coli 0157:H7 contamination, which we believe--and this test
number about E. coli contamination in meat suggests that a
5-log may not in fact be sufficient for salami, and the
pasteurization of eggs, it's my understanding, was formed by
the ARS. It wasn't necessarily scientifically validated.
It was part of bake-offs and marketing that yielded the
current 5-log for pasteurized eggs, which is what the
company was comparing it to.
So along the lines, across those 7 points, there
seem to be enough validation or enough data that suggested
that maybe at least one of these points would undermine 5,
and suggest that maybe 6 would have been safer.
Do you have any more questions? Dane, did I
answer your question?
DR. BERNARD: Yes.
MS. GIRAND: Thank you.
MS. OLIVER: Jur, did you have a comment to that?
DR. STROBOS: Well, yes. She apparently quoted
me, and I just wanted to--first of all, I'm not aware of
where--
MS. OLIVER: Can you identify yourself, please?
DR. STROBOS: Yeah. My name is Jur Strobos. Just
three very small comments.
One is: my assumption--and it's clearly an
assumption--is that the differences between apples and
oranges that we're talking about and the differences between
Salmonella and E. coli have some reflection on the different
flora and fauna that are present in the environments where
apples are grown versus those where oranges are grown,
especially in Florida where there are a fair number of
amphibians, and I think at least in the theme park episode
that was discussed earlier, you know, there was an issue of
potential amphibian contamination that you talked about.
As another point of clarification, I believe your
clarification was 2.4 CFU per 100 ml, not per ml, as she
stated.
Finally, she quoted me as saying that I thought
the contamination of Salmonella was 1011. That was a
question, not a statement.
My question, and it's still a sort of, as far as I
know of, open question is: if there is natural contamination
from let's say amphibian feces on an orange surface, or some
sort of animal contamination of that nature, I'm not aware
of what the concentration of the Salmonella organisms
endemic in amphibians that are present in the environment
is. And my question was whether it is 104 or 1011. I don't
think we really know the answer. If there's anyone on this
Committee that knows the answer, I'd be very interested in
that, but I certainly have no knowledge of what that endemic
level of contaminant might or could be.
MS. OLIVER: John?
DR. KVENBERG: Thank you. John Kvenberg, Food and
Drug Administration.
MS. OLIVER: Can you speak into the microphone,
please?
DR. KVENBERG: John Kvenberg, Food and Drug
Administration.
Back to the issue that Dr. Buchanan had brought
up, and was previously discussed by Dr. Doyle. If I could
have some help from Dr. Ismail on the Florida plan relative
to the utilization of E. coli and what the rules are?
I have been struggling with the Tab D of our
notebooks, trying to make a determination of what exactly
the procedures are and the requirements are within the
Florida program on finished product testing, what--I'm
referring to the section called 3.27, which is Tab (d),
small d, under the Citrus Products Inspectors Instructions.
And I simply can't find out the specifics of how the E. coli
testing is done. Does it depend on the size of volume
that's put out? Who does the testing and what are the
procedures? We don't appear to have that document that
covers the E. coli in this 1996 program that the Department
of Citrus has. And you can help me, Dr. Ismail, on what E.
coli testing protocols and procedures are by the Florida
Department of Citrus?
DR. ISMAIL: Where are you looking?
DR. KVENBERG: I'm looking--I may not be correct,
but what we were provided was under Tab D in our notebook.
It's called 3.27. It starts out, "Unpasteurized citrus
juice inspectors instruction." And I'm looking at--every
page appears to have a letter on it. It appears that the
microbial section, which is 3.2.7(f) begins to talk about
total plate count numbers.
Is there some procedure that we're missing in the
document that speaks to the E. coli testing requirement?
Who does it? Is it associated with volume and production?
How frequently? I just don't see any information on the E.
coli indicator testing procedures in what we have.
DR. ISMAIL: This is Mohamed Ismail, Florida
Department of Citrus. I don't have the specific information
on the type of testing, but MaryGrace Sexton, having a
facility that is under USDA inspection and subjected to
consistent testing in day-to-day operation of this, I would
like to call on her to clarify this point.
MS. SEXTON: MaryGrace Sexton, Orchid Island Juice
Company.
The procedure is that every single day we run,
every single day we have a USDA inspector on site, and every
batch is then tested at an outside lab. If I recall
correctly, it is mandated in those rules that an outside
independent lab test these. This all came down when they
had their--it got very strict when it came--the situation in
Florida, the theme park, and at that time Dr. Parish helped
us interpret the tests that they wanted to use.
Is that true, Dr. Parish?
MS. OLIVER: Dr. Parish, can you interpret?
DR. PARISH: Mickey Parish, University of Florida.
The regulation, John, to my knowledge, does not
specify a test method specifically. It simply says that the
processors shall conduct tests on total counts--help me out
here--coliforms, E. coli, in an effort to try to establish
that the process is somehow under control.
DR. KVENBERG: Let me read to you the specific
that I've seen, and maybe you can help me interpret it.
It's under Section E of the instructions to what you do, and
I assume it's the Florida Department of Citrus through the
contract arrangement with USDA inspection.
Section E, subset 2. "The processor shall have a
microbiological program and the inspector shall verify that
the program includes results from total plate counts and an
absence of fecal coliform and E. coli for whatever
production lot of each day"--let me read it slowly--"for
each production lot or each day's production, whichever is
less."
So how is that done? Is that a simple grab sample
from--that is, the processor shall have this done? Maybe
MaryGrace Sexton can help me. How do you do it?
DR. PARISH: I could not address that. I think
the processors individually do that different ways.
DR. KVENBERG: Maybe you could help me.
MS. SEXTON: And I don't mean to come across as
being ignorant, because I'm not, but the question is, is at
some point when they were getting very sophisticated in the
orange juice testing, this serum was of very much interest
to get the most accurate test. Now, as it has developed and
evolved, I believe the CDC has even had their input in the
protocol of the testing, and every time there's a
governmental agency that shows a concern of any sort, then
there is--it popped up immediately that we then transfer our
testing to what you want. So I don't want you to think I'm
ignorant, but there are serums that--you know, there's the
orange serum that sometimes you want. Then you do a little
bit more study and you bring a different kind of serum. And
we respond to whatever you want.
When the CDC responded this last time, we
immediately called the lab to verify that they were using
the exact protocol the CDC was doing.
DR. KVENBERG: Well, let me try again because this
is a very specific question. I think you can get--
MS. SEXTON: About when we pull the tests?
DR. KVENBERG: No. How do you do it?
MS. SEXTON: Pull the test?
DR. KVENBERG: It's done every day--is it done
every day, and are you required, or do you--
MS. SEXTON: It's taken right off the bottling
line. There are 8-ounce samples, and they are put in a
cooler, and they are overnight-expressed or personally
transported to the outside lab.
DR. KVENBERG: Thank you.
MS. OLIVER: Any follow up?
DR. STROBOS: Let me just--for the record. I
think we--John actually answered that question, and Dr.
Parish, earlier this afternoon, gave sort of a detailed
description of exactly when the sampling was taken, the
batches and so forth, in response to Peggy Neill's question.
Let me reiterate that we are advocating as a
Florida model, what we're asking for is a national system
that builds on that system. It doesn't necessarily have to
be identical in every piece. What we would like to do is
build on that experience and create a national system. So,
again, we are looking for your recommendations in terms of
what the appropriate system is, building on that experience.
MS. OLIVER: What I would like to do is try to
keep our comments related to the questions from the
Committee and focus on the answers that we need.
Bob, you have a follow-up quickly to that?
DR. BUCHANAN: Yes, I just want a clarification.
This is Bob Buchanan from FDA. Also outlined in that
document is a sampling plan based on the number of samples
that have to be taken in correlation with the amount of
juice that's produced.
DR. KVENBERG: Under section K?
DR. BUCHANAN: Under section K. Is that sampling
plan followed? And it's not clear on the size of the
sample.
DR. KVENBERG: Madam Chair, if I could, that was
basically my question, too. My confusion goes to exactly
that point.
MS. OLIVER: Would you identify yourself?
DR. KVENBERG: John Kvenberg, Food and Drug
Administration. Yes, section K basically--I'm not clear in
how this is written, but it doesn't appear that sample size
under this section applies. It looks like a one-ounce
sample per day going back to the other section is all they
do. That's what it looks like.
MS. OLIVER: Okay. Bob, were you looking for a
response?
DR. BUCHANAN: Yes. I'd sort of like to find out
if in practice the sampling plan as laid out in this
document is actually followed or if it's just a single
sample that's taken each day, regardless of the production
of the plant.
MS. OLIVER: Might I might ask does anyone have
that answer from any of the plants that are here if you take
a sample according to the plan there or if it's a single
sample each day?
MS. SEXTON: I'm MaryGrace Sexton, Orchid Island
Juice Company. Are you asking is there a sample taken from
every batch that is processed?
DR. BUCHANAN: In this document, on page 3.2.7K,
there is a chart that says retail fresh juice, all types of
products, containers, sizes, and counts. Then there's a
table that indicates number of gallons produced--I assume
per day. It ranges from 1,500 or less up to 4,200 to 7,200-
-72,000, I'm sorry.
At each of these there are six--five categories.
There's a different number of samples that are required. At
the lowest category, three samples are require. At the next
it's 6, 13, 21, 29. And I just--is there--is this being
used by--
MS. SEXTON: Okay. I would say yes, because what-
-are you--are they stating that--is that a production day or
tank fill? So I'm going to go read that document.
DR. BUCHANAN: Okay.
MS. SEXTON: Okay? Because I would say, yes, it
is being followed.
DR. BUCHANAN: How many gallons do you produce a
day and how many samples do you take a day? That's, I
guess, the way I want to ask it.
MS. OLIVER: I think if you would just--we could
give you the document to go look at and read, and then if
you could even call back to find out if you need to, that
would be--
MS. SEXTON: No, I'll address that.
MS. OLIVER: Okay. That would be fine. We'll
give you--we'll go through other questions and come back to
that. Just let us know when you're ready. Okay?
Jim Anders?
DR. ANDERS: Yes, Jim Anders, North Dakota Health
Department.
My first comment is about the 5-log reduction. I
have a problem with that because that was designed--and I
think Dane kind of hit on that. It was designed in products
in which there was heavy contamination to begin with.
My question yesterday was--
DR. BUCHANAN: No.
DR. ANDERS: Well, there was a connection between
general organisms and pathogenic organisms. There was not?
DR. BUCHANAN: No.
DR. ANDERS: Well, then, there's some question in
my validity--a question of the validity of a 5-log reduction
to start with. But basically yesterday I had asked whether
there was any studies to show that there were any pathogenic
organisms on these--I guess I asked it this morning, and it
was finally answered, that no studies had really shown that
there were any organisms here.
But let's assume that there were organisms here.
Then my question of industry is--because after--some of them
said that they actually did testing that was sent out and--
but the common practice in food processing is to, even if
they're going to test the product, that they release the
product to supermarkets and that type of thing. That's why
we end up with recalls because even when they then test
their product and they find that something is wrong with it,
they've already released it, and then they bring it back.
And in the process, sometimes the public has actually
consumed some of those products.
So my question here is of the industry, since we
don't have rapid tests, we don't have tests that are--
they're working on those, by the way, but since there are
not tests that are due in four hours or so, for those that
are bottling--now, I realize, keeping in mind here now that
if they're producing it today, there's no way they can test
it today, if they're producing it and they're going to drink
it today. But if they're putting it in bottles and then
they are--or packages and they're shipping it out, with the
testing that's being done--and some of them said they were
doing testing on this--are they releasing the product before
they get the results of these tests? Or are they doing this
and then having to recall it if it's got a positive?
DR. BUCHANAN: Janice, can I answer the first part
of that question?
MS. OLIVER: Yes, go ahead.
DR. BUCHANAN: I was chair of the working group,
produce working group--Bob Buchanan, FDA--at the time that
these deliberations took place. The process that was used
after hearing public comment and examining as much of the
scientific information as we had available, the process that
was used was in agreement and in accordance with the process
outlined by Bruce Tompkin. That was there was a
consideration of what was the best data we had on initial
levels. There was a consideration of the number of log
cycles it needed to be in terms of your target level of
protection that was being sought. There was an evaluation
of whether or not the organisms could grow in juice. And in
this case, it was assumed that they could not grow in juice.
So that we specifically went through each of those
four phases of the equation that Bruce put up on his
overhead or his slide. While I can't say that that process
was reduced to a formula such as he had placed it, each one
of those specific items were addressed and evaluated using
the best available scientific information that the Committee
had at that time. And this was, as you--when we solve that
equation, this is what was felt was the appropriate level of
protection based on the information we had on the incidence
and levels of pathogens present on both incoming fruit and
in the juice.
DR. ISMAIL: Mohamed Ismail, Florida Department of
Citrus. In response to Dr. Anders, there is a paper by
Steven Pao and Eldon Brown in which a statement is made that
no E. coli was recovered from fruit at the end of
packinghouse processing and no Salmonella were found on
fruit during the entire processing. You have that paper in
your packet. We provided that, so I would like to say that
there has been some work done on detection of organisms such
as E. coli and Salmonella on fresh fruit going through the
packinghouse, and it was done in a survey of seven
commercial citrus packinghouses.
As far as the specifications on the fresh fruit
that goes into processing, whether it is fresh or--fresh
non-pasteurized or pasteurized, processed, the
specifications throughout the Florida citrus code and the
Florida Department of Citrus rules have a description of the
fruit that must be processed or packed, and it emphasizes
the absence of defects, and wholesomeness. Whether it is
processed by heat treatment or going into fresh, it has to
be wholesome, it has to be sound, and any fruit that is not
sound must be discarded.
So there is a specification. I did say something
this morning or maybe yesterday that we don't have any
specifications for fruit going into fresh juice, but the
fresh juice, including processing and non-pasteurized or
pasteurized, fruit has to be wholesome and absent--have
absence of any defects.
DR. ANDERS: Well, thank you. Just one quick
comment, and that is, a 5-log reduction of nothing is
nothing. That's my comment here.
But, anyway, yes, I'm still asking for the
industry's response to release of a product that has perhaps
not had the results in.
DR. ISMAIL: In general, we find approximately
between 104 and 105 log of colony-forming units of
microorganisms on the surface of the fruit that is harvested
from Florida citrus groves. That's the range we find. We
do not find 109. We don't find 108. We actually have to do
a great deal of our work to test chemicals or heat
treatment, has to be inoculated to bring the level up to
where we can test the efficacy of the treatment.
MS. OLIVER: Catherine?
DR. STROBOS: I believe he wanted an answer about
industry practices with regard to the positives.
MS. OLIVER: Identify yourself and just--
DR. STROBOS: Yes, my name is Dr. Strobos. The
question--remember that the--or recall that the fresh
product has a 17-day shelf life. Obviously there are some,
you know, transportation and storage issues before it gets
to consumers. As we've shown, there haven't been any
positives for pathogenic E. coli or for Salmonella, so there
have been no recalls based upon that.
My understanding is that the few episodes where
generic E. coli have been identified, that based on the test
methodology becoming available or the test results becoming
available relatively promptly, the test methods that were
used, that those particular batches--and we're talking out
of 17,000 batches. We're talking batches numbering on
someone's--you know, the fingers of one's hand amongst these
four companies, or something on that order, that those
batches have not reached consumers and, therefore, have not
technically been recalled. In other words, they've been--
where they have been not released to distributors and,
therefore, not entered the stream of commerce.
Now, that, of course, depends a lot on the test
methodology that is being used. Were one to adopt a test
methodology for which one would not have results for 72 or
48 hours, then the ability to institute that with a product
that has a 17-day shelf life would be difficult.
DR. ANDERS: So am I to understand what you're
saying is--you did mention this morning, now that--in some
of those studies that there were some positives, but those
never reached the market--
DR. STROBOS: That is my understanding.
DR. ANDERS: --by the time that you had the
results of those, as far as you know.
DR. STROBOS: Yes. Based on the test
methodologies being used at the time that those tests were
obtained.
DR. ANDERS: But theoretically now it could reach
the market. I mean, you are not holding that product--
DR. STROBOS: Theoretically--
DR. ANDERS: --before it's released.
DR. STROBOS: Theoretically--and, again, we are
open to suggestions from the Committee about this. But
under the circumstances that are currently taking place in
these plants, the data is being made available in a way in
which timely action can be taking place.
I want to reiterate, you know, Dr. Tompkin's
comments that we're talking about multiple levels of
control, and the microbial testing is intended not as a
release criteria--I mean, that's not why it was adopted. It
was adopted as a method of evaluating the process and the
plant and for taking corrective actions.
So, you know, given the fact that there have been
no Salmonella or pathogenic E. coli identified, there's been
no corrective actions based on that.
When generic E. coli have been identified, the
products have not reached the market, and there have been,
you know, actions taken to review the processes and try and
prove the process that may have resulted in that
contamination.
DR. ANDERS: Thank you.
MS. OLIVER: Catherine?
DR. DONNELLY: I had some questions regarding--
MS. OLIVER: Please identify yourself for the
record.
DR. DONNELLY: Oh, I'm sorry. Cathy Donnelly,
University of Vermont.
I had some questions regarding the model HACCP
program or the voluntary program in which some of the
processors here are participating, and the first question
is: Who has regulatory oversight in that program?
MS. OLIVER: What model HACCP program?
DR. DONNELLY: Isn't Orchid Island and--weren't
there four companies that were participating in a--
MS. SEXTON: We're the FDA pilot program for the
United States.
DR. DONNELLY: That's my question. So the FDA
presumably has some regulatory jurisdiction over this pilot
program. Is that correct?
MS. OLIVER: FDA has regulatory, you know,
jurisdiction over fresh juice manufacturers that we're
talking about and fresh citrus juice manufacturers.
DR. DONNELLY: Great. So then with that, if FDA
were engaged in a pilot program, presumably there were a set
of criteria that FDA was recommending--or maybe--I'm trying
to get at this. It seems like during our deliberations this
morning there are many more questions than there are
answers. And at least the way I operate, I'm assuming if
you run a pilot program, there were a set of criteria that
the regulatory agency would be testing whether these
criteria could be met. But based on our conversations this
morning, simple things like verification procedures for
testing--I don't care whether we're pasteurizing or not
pasteurizing. In the absence of those methods, how can you
verify? And I'm just wondering if someone could comment on
the goals and objectives of the FDA pilot program with these
manufacturers.
MS. OLIVER: John?
DR. KVENBERG: Thank you. John Kvenberg, Food and
Drug Administration. Well, I'll try.
Basically the--well, there are two points just to
avoid confusion. Under tab E of the document you got, the
model HACCP plan for small-scale fresh squeezed non-
pasteurized citrus orange products is a Florida document.
It is not ours. So the material you have is--this is
Florida Department of Citrus documentation.
Our pilot program basically is a study program
that goes through the procedures of how a firm will execute
the HACCP-based program. And, you know, I can speak with
our relationship to Orchid Island and its validation
studies. We reviewed the process that they had externally
done, and it's been explained here, I believe yesterday,
that they used actual pathogen testing on a simulated
system, and we've reviewed that data on how they validated
their system.
Do you have specific questions of our comments on
that?
DR. DONNELLY: Well, I guess so many of the
questions here are relating to methods and sampling and
plans and all the specifics of presumably implementing a
pilot program, and I'm just wondering if there's a written
document that the FDA could share with this Committee
regarding what your instructions to these manufacturers were
for participation in this pilot program. Or was the goal
more to learn answers to the many questions that we're all
asking?
MS. OLIVER: Janice Oliver from FDA. One of the
things I'd like to say is the FDA pilot program was a pilot
program across the industry, across many types of
industries. It was not a pilot program for just juice. It
was not a program--and, John, you can add to this. It was
not a program specifically giving methods of sampling, et
cetera. It was a pilot program to see if HACCP would work
in the industry, what controls had to be in place, the
amount of paperwork, how it could be implemented. And we
did not have specific instructions that were handed out
doing it.
Each firm entered into agreement and a
confidentiality agreement with FDA. FDA went out and did
inspections of the facilities, on-site audits at that time.
John, did you want to supplement that?
DR. KVENBERG: Yes, John Kvenberg, Food and Drug
Administration. That's absolutely correct. We sign a
confidentiality agreement. However--and we seem to be
running her legs off this morning. MaryGrace Sexton, who is
out researching the other issue, has volunteered--you're
back. Okay. She has her other answer, but is basically
willing to share, I think, their validation information.
She can speak to it better than I can.
We have reviewed this data. This is their data
that we have reviewed and critiqued, and she can provide the
information, I guess, on validation, if that's your concern.
DR. DONNELLY: Well, I guess more maybe to put you
on the spot, John, after dealing with this pilot program,
how do you feel the abilities for these fresh juice
manufacturers to implement a HACCP program and its efficacy,
where are we at there?
DR. KVENBERG: Well, the only experience, as I
said in my opening remarks, with juice products within HACCP
programs involved three firms. This was, as you may recall,
Ocean Spray, which can be typified as a very large firm,
that has a corporate structure to it, and two small firms:
Fresh Samantha was involved in out pilot, can be typified as
a small firm in my eyes, as well as Orchid Island.
I guess we're here today talking about Orchid
Island's ability to do a hazard analysis, come up with a
HACCP plan, have it go through the seven steps, and conduct
it. They've done that. And they're typified as a small
firm that can go through that process.
MS. OLIVER: I think if you look at the--Janice
Oliver, FDA. If you look at the questions--yes, I
remembered myself.
[Laughter.]
MS. OLIVER: If you look at the questions we've
asked the Committee, one of the things, I think, in the
basis of doing the 5 log and in the pilot was based that 5
log and where do you start is the question we're having now,
and that wasn't answered definitively before we had comments
dealing with that.
Another thing is we have additional research that
we have done in the meanwhile that has a question or a
possibility of internalization of the pathogens that we're
bringing to the Committee, too.
Another thing is that this pilot is ongoing and
active. We have put out reports, and I think we do have
them here, if you have comments, if you wanted to see the
type of reports that we put out in evaluating HACCP and
doing that, and we can give it to you when we break so you
can look at that and see if that clarifies the questions
that you have or if you have any additional questions of
clarification from that. But the juice one is still
ongoing.
MS. SEXTON: Can I clarify something?
MS. OLIVER: Sure.
MS. SEXTON: It was my understanding that when our
Congressman got the meeting with Dr. Vanderveen, we went in
and they were going to regulate fresh squeezed orange juice,
and that time we asked them, Do you have a pilot program, or
how are you going to regulate this? They said, oh, yes, we
have one, meat and cheese. I said, sir, this is fresh
squeezed orange juice.
At that time I thought a specific program was set
up as a pilot program for the FDA for fresh squeezed orange
juice. I--excuse me--am the pilot plan and I was under no
understanding that it was in connection with other products.
I thought we were supposed to be specifically studying fresh
squeezed orange juice. That's what Dr. Vanderveen had told
us.
The second clarification I have is this document
that you keep responding to, I don't believe--I'm going to
investigate it as I leave. I don't believe this is the
Department of Citrus document that went--that everybody's
referring to. I believe this is the Department of
Agriculture document. So I think that's where people are
getting confused.
DR. KVENBERG: Well, if I could, relative to our
understanding, yes--
MS. OLIVER: John Kvenberg.
DR. KVENBERG: John Kvenberg, Food and Drug
Administration. Your participation in our pilot program was
specifically for studying HACCP applications in fresh
squeezed orange juice. You're absolutely correct.
MS. SEXTON: Okay. That's what I was to
understand.
MS. OLIVER: This is Janice Oliver, FDA, again.
My comment was made that our HACCP pilot program was not
just for fresh juice, that we had other companies in HACCP
pilots that were not fresh juice. It was just part of a
larger program.
MS. SEXTON: You're just talking about your
department.
MS. OLIVER: Yes.
DR. BUCHANAN: Possibly you can help--
MS. OLIVER: Who are you?
DR. BUCHANAN: Bob Buchanan, FDA.
[Laughter.]
DR. BUCHANAN: You can help clear up, I guess,
some of the confusion that's around the table. My
understanding when you say USDA inspection, you are not
referring to the regulatory agency FSIS, but you're
referring to the marketing agency AMS.
MS. SEXTON: Now, that is something you're going
to have to deal with because that's what you define it as.
But as of two and a half years ago, they could shut us down
for safety issues. They can come down and shut us down for
any issue that is a safety issue to a consumer. They have
taken that authority upon themselves, and we have
documentation that they require reports that are not
marketing reports. And I know that you want to make light
of that, but it's very important that I reiterate this,
because when it gets in your field, you want to say it's a
marketing arm, and I am telling you they come in and
severely inspect us.
DR. BUCHANAN: Let me further--
MS. SEXTON: And not just for quality.
DR. BUCHANAN: --ask that question. This is a
fee-for-service. You pay to have these inspectors there.
MS. SEXTON: Right.
DR. BUCHANAN: So you've entered into a
contractual arrangement with them in terms of this
inspection. This is not a regulatory inspection.
MS. SEXTON: It is mandatory in the State of
Florida.
DR. BUCHANAN: It's not mandatory at the federal
level.
MS. OLIVER: Okay. I think there's some confusion
and some question about that. We'll try to get some
clarification if we can at all at lunchtime and we'll see if
it's of necessity to the Committee, and I'll ask that.
MS. SEXTON: And then the third thing that you
asked about is the 5 log, can it be done. We have the
documentation from ABC Research that I hope everyone knows.
It's a well-renowned lab that has the validation of the 6.7
log.
MS. OLIVER: Okay. We'll have that available for
the Committee.
Bruce, you had some questions?
DR. TOMPKIN: Yes, I do. This is Bruce Tompkin.
We had some information then provided--Swami, I
really appreciate it--on the number of Salmonella in the
Florida outbreak. We're talking then about 2 to 4 cells--
and that's just one, probably a few analyses, or maybe even
only one--per 100 ml. And I was interested in knowing
whether any information was available on the Sun Orchard
outbreak in terms of numbers of Salmonella.
MS. OLIVER: Dane?
DR. BERNARD: Thanks. Dane Bernard. Let's take
John's intervention first.
DR. KOBAYASHI: On this testing that we did--
MS. OLIVER: Can you identify yourself?
DR. KOBAYASHI: Sorry. John Kobayashi, Washington
State Health Department.
On the investigation that we did on the implicated
juice, there was one sample that was positive. Our
laboratory quantitation showed that there were 68 Salmonella
per cc. This was serial dilution, so it's possible to have
an order of magnitude difference on either side. Estimating
from an eight-ounce glass, that would extrapolate to about
15,000 organisms per serving.
The other general point of interest might be that
we studied several cohorts of individuals who all drank the
orange juice, and within those cohorts there was a 50
percent attack rate on diarrhea. Extrapolating from the
amount of juice served in Washington State during the
outbreak period, we estimate that there were perhaps 10,000
individuals who became ill related to the outbreak, or a
ratio of 100 to 1 with regards to positive individuals for
Salmonella. For every case of Salmonella reported to us
during the outbreak period there could have been 100
individuals ill with salmonellosis related to the outbreak.
MS. OLIVER: Bruce, did you have a follow-up
question?
DR. TOMPKIN: No, I think that's it. Thank you
very much.
MS. OLIVER: Dane?
DR. BERNARD: Thank you. Dane Bernard.
Further to the 5-log issue, I think Bob has
restated that our intent was pathogenic organisms in juice,
not total count or anything like that. We were looking at
potential for pathogens.
Among the many unique things about the proposed
rule on juice HACCP, there is a second criteria, which is
stated no less than 4 times, possibly more than that, in the
preamble to that rule, which basically lays out the level of
protection that the 5 log is intended to achieve. That is
the real target. Most people don't know how to deal with
that, so the focus has been on the 5 log and where to start
counting 5 log. But within the preamble to the rule--and I
don't want to misstate it so I'm not going to read it here,
but if you're going to look it up, it talks about the
probability of illness per year based on a certain level of
consumption of the same juice. That is the real criteria.
So when you talk about the 5 log and how to apply
it and how to interpret it, if I look at that criterion and
I look at some of the interpretations of a 5-log reduction,
I'm really not too impressed with somebody that starts with
a 7 log on the outside of a fruit, gets it down to 2 log,
and says they've accomplished the intent of the rule. That
was not the intent of the criterion that this Committee
recommended.
MS. OLIVER: We have two, then I'll take these
last two questions before we break for lunch.
DR. LIANG: Art Liang, CDC. I don't know if this
is a meaningful question, but could someone compare and
contrast Sun Orchard's operations to the industry best
practices or to the operations of the consortium.
MS. OLIVER: No, I don't think that--
DR. LIANG: Can't do that?
MS. OLIVER: No.
DR. LIANG: Okay. I'll withdraw.
MS. OLIVER: Are there any more questions? Dane,
do you have another--
DR. BERNARD: No.
MS. OLIVER: Are there any more questions that the
Committee thinks they need answered before this afternoon?
[No response.]
MS. OLIVER: Okay. What we have this afternoon
is--
MS. SEXTON: Did you think we didn't have an
answer--did you think nobody could answer that or did you
just not want an answer?
MS. OLIVER: No, I just didn't think--
MS. SEXTON: You don't want an answer.
MS. OLIVER: Right. I just don't think it's
appropriate to the deliberations of the Committee and the
questions that we're asking.
What I'd like to do is take an hour and 15
minutes, come back at 1:30. That would give industry a
chance to look and put together the flow diagrams in Florida
and California to start off with this afternoon. Then there
could be a couple questions of clarification, and then the
Committee will have discussion amongst yourselves for about
an hour.
[Whereupon, at 12:15 p.m., a luncheon recess was
taken to reconvene at 1:30 p.m., this same day.]
AFTERNOON SESSION
[1:32 p.m.]
MS. OLIVER: We need to start back because we have
a number of people who are going to have early planes this
afternoon, and I want to make sure that I get the input from
the group. I've gotten input from Larry Beuchat that I want
to read after 2:00, but we had asked the industry to present
flow diagrams from Florida and California. Are those people
who are going to present the flow diagrams here?
[No response.]
MS. OLIVER: Might I ask a question of the times
the Committee members have to leave, might I just ask a
question of who has to leave before 3:00? Because I will
make sure that when I am polling the Committee I will poll
those individuals first.
[No response.]
MS. OLIVER: No one has answered for sure. Okay.
Alison?
DR. O'BRIEN: I leave at 3:00.
MS. OLIVER: You leave at 3:00. Okay, fine. And,
Nancy, you may leave early?
MS. NAGLE: Yes.
MS. OLIVER: Okay.
MS. NAGLE: Janice, what time do you think we'll
get done?
MS. OLIVER: We probably will end up getting done
closer to 4:00.
What I'm going to do, I'll tell you the process
I'm going to go through, and I'll ask a question now. I was
going to have the flow diagrams done and give each five
minutes to do it so we could move on from there. And then I
was going to after that read Larry Beuchat's statement to
the Committee and ask if you wanted any discussion before we
ended up and I went around the Committee, and I was going to
poll the Committee individually. And how I was going to ask
the Committee to give me their responses was in two groups:
ask the Committee to--that we've presented you with a number
of questions in two areas: internalization and survival of
pathogens, and the application and measurement of the 5-log
reduction standard. I was going to ask the Committee to
respond individually on internalization and survival of
pathogens, if you could respond to those and just go around
and have you respond as individually in the whole group as
opposed to asking you each and every question, because I
think that would take a long period of time, and then go and
do the application and measurement of 5-log reduction.
A question I had was whether the Committee needed
or wanted any time for discussion before doing that, and you
know better than I. So while we're waiting for those
individuals to come in on the other, what I might ask is:
Does the Committee want discussion?
DR. SPERBER: Madam Chair?
MS. OLIVER: Yes?
DR. SPERBER: Bill Sperber, Cargill. I know I'm
talking less than my colleagues. We have a lot of points we
want to discuss. But I think that a lot of the discussion
will fall out from the questions that have been asked, and
it might just be more productive to go through the questions
first.
MS. OLIVER: Okay.
DR. SPERBER: Then we could come to agreement on
some broader discussion topics.
MS. OLIVER: Okay, fine. In the interest of time,
should I read Dr. Beuchat's statements that he has here and
read them into the record so you all have them, he left his
comment? Okay. Let me do this. This is the comments from
Larry Beuchat. It says, "To NACMCF: The following are some
conclusions and comments offered for the Committee's
consideration in the course of discussions leading to
recommendations on pasteurization of citrus"--he says "on
pasteurization of citrus juice."
"Evidence exists to support the likelihood of
infiltration of microorganisms, including pathogenic
bacteria in tissues and/or on areas of the skin surface that
protect against contact with sanitizers, and, therefore,
removal or inactivation prior to juicing.
"Two, the efficacy of sanitizers for killing
pathogenic bacteria and other microorganisms lodged in
protected areas on the citrus fruit surface has not been
established through appropriately designed experiments.
"Three, information on survival of pathogens on
the surface or internalized in tissues of citrus fruits as
affected by temperature, relative humidity, atmospheric
pressure, and other environmental factors, particularly if
these conditions fluctuate over time, is lacking.
"Four, evidence for preventing cross-contamination
of juice with microorganisms on the surface and/or
internalized in the skin, albedo, or other tissues of citrus
fruits during the squeezing process, either using
specialized FMC or other equipment, has not been documented.
"Five, survival of pathogenic bacteria in orange
juice stored at refrigeration temperature for a period of
time not exceeding its shelf life has been documented in
laboratory experiments and in a commercially processed
product.
"Thank you for the opportunity to contribute to
the Committee's activity." And it's signed Larry Beuchat.
Okay. Might I ask if the individuals who are
going to present the flow diagrams are here yet?
DR. STROBOS: Yes.
MS. OLIVER: Okay. If you could present the flow
charts, I'd like to give about five minutes for Florida and
five minutes for California.
DR. ISMAIL: I will introduce myself again.
Mohamed Ismail, Florida Department of Citrus. This is
definitely a highly estimated, approximate figures on the
temperature change. I assume this is what was the question.
Perhaps somebody can articulate the question.
MS. OLIVER: I thought there was going to be a
flow chart. You might be answering a different question.
There was going to be a flow diagram presented from the
State of Florida and from the State of California on the
processing of citrus juice, fresh citrus juice, taking it
through the temperatures and how it's processed.
DR. ISMAIL: I did not prepare a flow chart. I
did prepare a table, which can serve the same purpose, I'm
sure.
MS. OLIVER: Okay.
DR. ISMAIL: This is an estimate--
MS. JACKSON: Can you speak into the microphone,
please?
DR. ISMAIL: At harvest time, in the wintertime,
you may encounter temperatures as low as 45 degrees and
perhaps 70 degrees, and that would be during the month of
November, December, January. And in the fall and the
spring, the temperature of the fruit at harvest time could
be at 80 to 90--I am not even sure of the 90 because it
could be that the effect of transpiration on the tree can
moderate the temperature in the atmosphere versus the
temperature of the fruit surface itself.
Municipal water, depending on the time of year,
could be between 70 and 75 degrees in Florida. That would
be the water that one would use in a packinghouse situation.
If there are some heating--I don't think we have any soak
tanks that would require any heating of the water.
Fruit in the fall is de-greened at 85 degrees
Fahrenheit. De-greening is like what they do with banana.
They put the fruit, which is green, at 85 degrees with five
parts per million ethylene to stimulate chlorophyll
breakdown and enhance the development of color. And the
fruit leaving the de-greening room could be at 85 degrees,
85 to 90 degrees, maybe.
After washing, sanitizing, and packing in the
packinghouse, during the fall I estimate that it would be
about 85 degrees, and the falls months would be October and-
-September and October, and the winter, maybe about 65, and
during the summer, about 85 degrees.
There are also--this is going through
packinghouses. If the fruit goes from the grove directly to
the juice operation, then it would fall within these ranges
here, 45 to 70 degrees, and as we mentioned, there is hardly
any soak tanks. There may be one or two in the State of
Florida, but it is not a common practice. In juice
operations, no one uses a soak tank, and at some point we
had some packinghouses that had soak tanks that would be
used for treatment against citrus canker, which is a plant
pathogen. And these tanks would require a residence time of
about two minutes. And it is either in 200 parts per
million chlorine or in about 200 parts per million of sodium
orthophenylphenate, which is an antibacterial, antifungal
agent or chemical.
Storage is--we definitely recommend storage as
required by the U.S. Department of Agriculture, about 33
degrees, and grapefruit, we don't recommend 33, but some
industry people, they tell me that it is about 33, the same.
But chilling injury is one of the disadvantages of
grapefruit. Grapefruit is more of a tropical fruit, and it
is very susceptible to chilling injury. Therefore, storage
temperature, now we recommend 45 or even above, but above
that we have a different disorder that can affect
grapefruit. So we settled on 45 degrees.
The harvest for juice operations, even the ones
that keep fruit during summertime for storage, they don't go
beyond May, and at that time there is--this is not the rainy
season in Florida, so they usually go through May.
Harvesting for processing plants can continue into May,
June, and even part of July. And let's say this is a very,
very uneducated estimate, and I think it does reflect the
struggle that you and us are going through, that we don't
have enough information, even some basic things. And if I
have it, I don't have it here.
We didn't exactly know what we are coming here
for, other than to look into the issue of infiltration and
to look at the experiments that the Food and Drug
Administration designed and conducted in the lab under
extreme conditions. So just speculating that it could be--
between the beginning of a thunderstorm and the end of a
thunderstorm, it could be about a 10- to 15-degree drop in
air temperature. That doesn't necessarily mean that the
fruit itself goes down by 10 to 15 degrees.
And, again, I would like to indicate that cold
stored fruit are--whenever it comes out of storage, are re-
washed. They are put again on the line. They are put
through a packing line where they are re-washed, sanitized,
graded prior to juicing. So it goes through an exhaustive
surface cleaning.
Then in the packinghouse, the same thing. We can
attest to the safety of our fresh fruit. It is washed,
sanitized, graded, waxed, dried, and so on, before packing.
That's it.
MS. OLIVER: Thank you very much.
Dr. Arpaia?
DR. ARPAIA: I'm going to have to write on the
overhead as I go because I only just--I had trouble getting
the information.
MS. OLIVER: Does that mike come on?
DR. ARPAIA: I didn't want to get up and give my
best estimates, so I contacted Bob Elliott, who works for
Sunkist, who works in the packinghouses in California so
that I could get a more accurate estimate of orange house
conditions and fruit conditions.
In California, the fruit that go through a
commercial packinghouse, we have navel and Valencia oranges.
They're picked at very distinctive times of the year, and we
also have different growing regions where the temperatures
are slightly different between the growing regions, and so I
wanted to talk to Bob about this. So I'll cover navel
oranges first because I've actually completed the table for
that.
San Joaquin Valley, Sacramento Valley accounts for
approximately about 90 percent of all the navel oranges in
California. The harvest season is between mid-October and
May. The average ambient temperature at the time that we
pick fruit--we don't pick the fruit when it's very, very
cold because normally it's very damp when it's very cold,
and we don't like to pick wet fruit. We estimated that the
average ambient temperature would be between 45 and 75
degrees Fahrenheit because we're talking about mid-October
to May.
The pulp temperature of the fruit coming into the
packinghouse would be very close to what the ambient
conditions are, so, again, 45 to 75 degrees Fahrenheit.
Normally, however, we don't like to run cold fruit
over the line, as I indicated yesterday, and if the fruit
are very cold, typically the fruit will be brought into the
packinghouse and held overnight in a staging area. So the
fruit does sort of moderate the temperature, and the
estimate that Bob had based on some experience in doing pulp
temperatures is that in these winter months in the San
Joaquin Valley, the pulp temperature when the fruit is
actually dumped onto the line would be between 55 and 70
degrees Fahrenheit.
If the fruit have been de-greened, early-season
navels already green, then pulp temperature would be very
close to 70 degrees because we de-green at between 68 and 72
degrees Fahrenheit. The packinghouse average temperature
would be between 55 and 70 degrees Fahrenheit.
Cold room temperatures, Sunkist is recommending 37
degrees. He says some houses run as high as 45, but the
average would be between 37 and 41 degrees. The fruit are
typically in the hold room zero to three days with the pulp
temperature coming out of these rooms--because there's no
forced-air cooling going on, this is all passive cooling--
would be around 41 to 45 degrees if it stays in at the
longer period of time.
Water temperature, again, we only have two to
three rinses on the line. The duration of the fruit under
these rinses is under two seconds. And then if they have a
tank treatment, the tank treatments typically average one
and a half to two minutes. So we're not talking long
durations in the tank.
Mr. Elliott indicated to me that he has done some
testing of the change in fruit temperature in the tank, and
if the fruit was 55 degrees Fahrenheit, he said the core of
the fruit only warmed up one to two degrees Fahrenheit, and
the actual surface of the fruit was somewhat higher but did
not warm substantially, even in a heated tank of 105
degrees.
But, anyway, ambient water temperature would be 50
to 55 degrees, again, less than two seconds under these
sprays. Tank, one and a half to two minutes. If the tank
is heated, it would be 90 to 105; otherwise, for the sodium
bicarbonate tank we like to see around seventy--I didn't
write that down, but it would be 65 to 70 degrees.
Some houses have a heated rinse after the high-
pressure washer, again, less than two seconds under this,
but it would be about 120 degrees to heat that water to.
But, again, the exposure is under two seconds.
If you move to the inland empire--this is a small
percentage of our industry--the harvest season is December
through March, and you can see they're slightly warmer
temperatures. But if you go down through here, the
temperatures are going to be about the same.
Now, if we move to Valencia oranges, which account
for about 25 percent of all the oranges grown in California,
we have a different harvesting season. Here the fruit are
being harvested in the spring and the summer months versus
the winter and spring months. So in the San Joaquin Valley,
harvest is between mid-April and October. The ambient
temperatures here would be 55 to 90 degrees Fahrenheit.
Pulp temperature of the fruit then coming into the
packinghouse would be 55 to 90 degrees. And, again, when
the fruit is run over the line, we like to see--we estimate
it would be 55 to 75 degrees because, again, the fruit are
being held overnight and it's moderated.
After de-greening--and we de-green late-season
Valencias; this would be in the months of August, early
September--it would be 70 degrees Fahrenheit, approximately.
The packinghouse temperatures during this period of time we
estimate would be about 60 to 80 degrees Fahrenheit. Cold
room temperatures would be identical. These conditions
would be identical. And then if we move down into the water
temperature, we estimate at 65 to 75 degrees Fahrenheit.
Fruit coming from the inland empire would be
virtually the same, except the ambient here would be 65 to
100 degrees Fahrenheit, and we have fruit grown in the
Coachella Valley, which is a very warm production area, and
again it would be, we estimate, 65 to 100 degrees
temperature. But these temperatures here would be
approximately the same.
Now, I talked to the two representatives from
California Day-Fresh and Perricone, and we talked about
their conditions. Fruit temperature when the fruit is run
over the juice plant line in the summer months would range
in California Day-Fresh 60 degrees, approximately;
Perricone, 60 to 65 degrees. In the winter--these should be
reversed. Sorry. Sixty degrees because they hold their
fruit in a cold room overnight versus 80 to 85 degrees for
the Perricone plant. In the winter months, we're talking 50
degrees versus about 60 to 65 degrees.
Plant temperature here you can see in the winter
months would be 60 to 65 degrees for California Day-Fresh
versus 50 to 55, and in the summer, 75 to 80 versus about 65
to 75. The difference is because of an elevational
difference. California Day-Fresh is in Glendora. Perricone
Juice Plant is in Beaumont, which is a higher elevation,
about--I'm guessing about 1,500 feet.
The water temperature here in the summer would be
about 75 degrees versus 65 to 70, and in the winter months,
again, about 50 to 55.
So the temperature differentials here, we're
talking probably at a maximum temperature differential, and,
again, the fruit is only exposed to water for relatively
short periods of time, would be a maximum of about 20
degrees Fahrenheit, maximum temperature differential.
MS. OLIVER: Thank you very much.
DR. ARPAIA: You're welcome.
MS. OLIVER: What I'd like to do now is open up to
the Committee for, you know, at least 20 minutes to see if
there are any comments people want to make or discussion you
want to make before I go around and poll the group, because
some of you may think there are some things you want to say
before that. So let me ask that, and if anyone has
anything, we'll put--you know, I'll call on you.
Don't think so. Okay. With that, I'm going to
start on this side since people are leaving early, unless,
Nancy--because Cathy's leaving and there are a number of
people on this side who are going to leave early, so I'll
start going around this way.
What I'd like is for the Committee to respond,
first I'll go around on internalization and survival of
pathogens. Cathy, what time are you staying until?
DR. DONNELLY: I've got leave probably at 2:00,
and I apologize.
MS. OLIVER: Okay. Can I ask you then, before you
leave, to be the first then to respond to both groups of
questions? One is if you could respond on internalization
and survival of pathogens and respond to the four at once,
and then to respond to the application and measurement of
the 5-log reduction standard and what your advice would be
there. Thank you.
DR. DONNELLY: Thank you. I feel a little bit on
the hot seat. I think based--and I'm really going to
restrict my remarks to the scientific data that's been
presented, and that is what we've been asked to do.
I think we've seen data that internalization of
pathogens can occur under laboratory controlled conditions.
Whether I've seen data that that's applicable to a field
condition--
MS. OLIVER: Can you identify yourself?
DR. DONNELLY: I'm sorry. Cathy Donnelly,
University of Vermont.
Do I think that such internalization is likely to
result in a public health risk? I have not seen evidence
that that's the case, and instead, I've seen compelling
evidence that contamination is a result of post-process
contamination that I think can be controlled. And, again,
so that response to D, I think a HACCP program with proper
verification and validation is a way to control risk.
In terms of the next set of questions, again,
because we're dealing with citrus specifically, I think the
5-log reduction based on the scientific evidence that I've
seen, starting with the fruit from the orchard, I think is
an appropriate place to start. And, again, I think
regarding Part B, questions 1 and 2, clearly the less time
that the product has an opportunity to support the growth of
pathogens, the safer the product. And so I think my answer
to both of those questions are--again, I've seen data and,
you know, John's work in the pilot HACCP program. I think
that you can safely achieve the equivalent of a 5-log
reduction through model HACCP programs like that which is
being used in the fresh juice industry.
MS. OLIVER: Thank you.
Is there anyone else that's leaving fairly
shortly? Okay, Nancy?
MS. NAGLE: Nancy Nagle, Nagle Resources.
To keep this brief, I agree with what Cathy said.
Those were the same answers I pretty much had for questions
I, A, B, C, and D. Yes, it's theoretically possible that
they could be there, but we didn't see evidence that there's
really--in the current system that it's really going to
happen. I don't believe that it's truly a public health
risk, internalization of these organisms.
Hello? This isn't working? Okay.
And then as far as the second part, I think there
are some issues that we heard about that the 5D reduction I
believe should start at the point of receiving within the
plant. There is one thing that I think we heard some--
enough data about that we do think--and a few of us over
here were discussing, and actually we have Mike's comments,
too, to give you--that these things need to be linked in
time, these reductions, that there can't be--we felt that
the idea of having some culling and washing at a
packinghouse and counting that and then shipping these fruit
thousands of miles, or whatever, we don't think that's an
appropriate--you have to start from when you receive it at
the place where you're going to juice it.
We also felt that there was a problem of having
the reduction and then putting the juice in a tanker and
shipping the juice somewhere to another location. That
also, we felt, presents somewhat of a problem.
We like the idea that--we do think that the 5D
reduction can be effective, but it needs to be within the
confines of the actual processing environment that is going
to process and package that juice.
MS. OLIVER: Thank you very much.
Okay. Might I ask again if anyone else is going
to be leaving fairly shortly, so we'll take those comments.
[No response.]
MS. OLIVER: Okay. If not, Bruce, can we start
around the table with you then in order?
DR. TOMPKIN: Am I going to answer the whole sheet
or just--
MS. OLIVER: I think if you could go with
internalization, we'll go around on that, and then go the
other way. It would be better for the record, I think.
DR. TOMPKIN: Okay. I'm Bruce Tompkin. Is it
valid to assume there is no internal--no, I don't think that
we can assume that. And certainly it is theoretically
possible for internalization to occur. If it does
theoretically, does represent a public health risk? I say
no. And within USDA framework, what we work by in terms of
significant hazards, it's a hazard which is not reasonably
likely to occur in whole fruit or in the juice as a result
of internalization. And if it does--so then that's the
answer, if I have to answer the fourth, D.
MS. OLIVER: Thank you. Earl, if we could just go
straight around?
It is possible under certain conditions to
introduce pathogens into citrus fruits, but under normal
circumstances, I do not think that poses a public health
hazard.
On the second set of questions, I think the 5-log
reduction is sufficient because--
MS. OLIVER: I think we are just going to go
around on internalization first and then come back. We are
going to go back on the first set of questions.
DR. LONG: Okay, fine. Right.
I do not think it poses a public health risk.
MS. OLIVER: Dane?
DR. BERNARD: Thank you. Dane Bernard.
Internalization. I mean, theoretically, it is
possible. That is what we have been shown. Does it happen
commercially? Probably not. I think the conditions studied
show that it is possible, but in my mind, the commercial
conditions were distant enough from the laboratory
conditions that it is an open question. I do not think at
this point that I am ready to conclude that it is a
commercial reality.
On the third question, if it is possible that such
internalization is likely to result in a public health risk,
again, it is an open question, but if you did have
internalization from Dr. Miller's data, we did not see much
in the way of growth. We got some growth if it was not in
the juice itself, but even then, it was fairly limited. So
that further tells me that if it is a rare event, then we
are not likely to have significant levels of contamination.
However, if we are not correct on that assumption,
the answer to D is obviously there are ways of addressing
it, but it would involve applying some kill step to the
juice itself.
Thank you.
MR. SEWARD: Skip Seward, McDonald's.
I would say under normal processing with choice
grade or higher raw material that internalization is
unlikely to occur, and that there is no public health risk
associated with routine operations as described to me. To
prevent that, it seems like you could very easily keep the
temperature differential under control as a possible control
step to help limit that potential.
MS. OLIVER: Peggy Neill?
DR. GROVES: I do not think people are answering
Question D. I'm sorry, but they are talking around it. I
do not think we are answering.
Dane, with all due respect, they were not talking
about pasteurization of juice here. They are asking about
if there are ways to prevent internalization.
MR. SEWARD: The only thing I would say, Michael,
is that so far, everyone who has spoken said that they did
not consider this to be a public health risk, and,
therefore, that question starts out indicating that if you
do believe it is a public health risk, are there ways to
prevent that.
DR. GROVES: Okay.
DR. NEILL: Peggy Neill.
My observation is in terms of trying to answer the
questions strictly as they are in the paper.
I do not think it is valid to assume that there is
no internalization of these pathogens into citrus fruits. I
think we have seen data to show that a set of conditions
could be defined under which it could occur, and I do not
know whether those conditions, when modified to approach
those that occur in the real world, would result in the same
findings.
I am probably most concerned about my answer to C.
I do not know whether this internalization occurs in the
real world and as such represents a mechanism by which juice
is contaminated.
I am very concerned about an interpretation of
epidemiologic findings that says we are very limited in the
number of outbreaks associated with juice and, therefore,
because there have been so few cases associated with it, it
really must not be a problem.
As Bala has spoken to and I in previous meetings
have pointed out, our mechanism for associating a case with
a mode of acquisition involving a food is very, very
problematic when it is a low-level contamination that is
very diffuse geographically and temporally. For that
reason, my answer to C is I do not know.
My answer to D is probably somewhat similar to
Skip's in that addressing that this is not about
pasteurization, but is about the step of whether
internalization of pathogens can be interrupted. I think
unless we know the conditions under which it occurs in
nature, if it occurs, we cannot talk about an intervention.
DR. ACHESON: David Acheson, New England Medical
Center.
My answer to A is no. I do not think it is valid
to assume that no internalization can occur. So, clearly,
my answer to B is yes.
C, I am stumbling over the word "likely." Of that
statement in C, it is the word "likely" that has got me
thinking in terms of from the data I have heard presented
today, and unfortunately I was not here yesterday, I do not
get the sense that this is likely to occur, but I do have
some element of concern that if as few as ten 0157 organisms
were to make it inside a piece of fruit, that theoretically
could be a lethal dose in a susceptible child.
In terms of D, the only thing I would think of is
that I would agree with Skip. It seems that temperature
equilibration would be a critical issue here, and if that
was addressed, that may solve the problem.
DR. KVENBERG: John Kvenberg, FDA.
My response is to Question A, no, you cannot make
that assumption. Therefore, logically, the extension to B
would be theoretically possible, yes.
Under C, for internalization of pathogens to the
key phrase "internalization likely," I say it is unlikely
given the information I heard relative to temperature data
and the differentials, with the caveat that you have to
assume that risk reduction is taking place as we heard it
relative to good agriculture, good manufacturing practices,
and the application of HACCP-based programs.
Relative to Question D, which the core of it is
are there techniques to assure the internalization of
pathogens not going to a kill step or a reduction, but
rather an exclusion through temperature differentials, yes,
I think the key to the question that they have discussed
here is temperature gradient plays a major role in risk
reduction relative to the internalization question.
That is it.
DR. DOORES: Stephanie Doores, Penn State.
My answer to A is no, but, B, theoretically, it is
possible.
In terms of Question C, where we are talking about
pathogens in citrus fruit, we have primarily focussed on
bacterial pathogens, but I do not know if there is any data
out there to suggest that other organisms could present a
health risk, such as viruses or parasites in this type of a
situation where we are talking about internalization.
So I guess in that sense, it is probably
theoretically possible that there might be some other
situations which we have not been alerted to or not
specifically looked for at this time.
In terms of the techniques, to assure that
internalization of pathogen does not occur, I am not sure
that the techniques out there are necessarily practical at
this point or whether it requires some other intervention
strategy that would not be at the fruit level, but further
on down the line.
DR. DOYLE: I am Mike Doyle with the University of
Georgia.
I would say no to the first question.
Second, yes, it is theoretically possible that
pathogens can get into fruit juice. I believe what Art
Miller has done is valid.
C, I am not convinced that in reality that intact
citrus fruits would be internalized normally, under normal
conditions, but I do have a concern about fruit that may be
punctured or split or not intact, and I consider that to be
a public health risk. So the answer to that is to avoid
fruit that is split, punctured, or not intact.
DR. ENGELJOHN: Dan Engeljohn with USDA.
The answer to the first question, I would say no.
For the second question, I would say yes. It is
theoretically possible.
For C, I have concerns about the most vulnerable
population, but I think the reality is I do not believe it
to be a problem at this time based on what I have heard.
Then, for D, aside from temperature, I do not know
what other interventions would work. I do not know enough
about it yet.
DR. LIANG: Art Liang, CDC.
IA, no. IB, yes. IC, no. ID, not applicable.
LTC SEVERIN: Scott Severin, DOD.
IA, I also would say is no. I do believe it is
theoretically possible. From the standpoint of a public
health risk, probably not, but due to the limitations on
infective dose, I could not rule that out totally. D, I
would say the only thing we are aware of right now would be
temperature control.
MR. EKLUND: Mel Eklund.
For A, I would say no. B, based upon the data
that we have heard today, I would say theoretically
possible, and C, if it does occur, I think it would be very
infrequent. I think Mike Doyle had a good comment to avoid
fruits that are damaged by various means. That could be
greatly avoided. So I do not think that C would be in
practical conditions probably a major concern.
DR. ANDERS: Jim Anders, North Dakota Health
Department.
A is no, but I hope we are not taking that to mean
that we are saying yes if we reverse that. I do not think
we really know. It certainly is possible under B. It is
theoretically possible. I think it is quite unlikely. C, I
do not think it is a public health risk, and D, I guess
temperature control, and I would second on damaged fruit,
obviously.
DR. MORALES: Roberta Morales, Research Triangle
Institute.
A, I would say no, not valid. There is no
internalization. B, theoretically, yes, it is possible. C,
the data may not represent what is really there in terms of
public health, and I do not feel that there is really good
prevalence data on pathogens of public health concern.
However, I would also tend to say that I think it is not
highly likely that this is a public health risk. So D, to
me, becomes irrelevant in that case, but if I was to propose
an answer, I would say yes, I believe there are ways that
can minimize that risk.
DR. SWAMINATHAN: Bala Swaminathan, CDC.
The answer to A is no, but I would go along with
the caution that was raised by Jim Anders that we do not
immediately assume that there is internalization of
pathogens into citrus fruits. In fact, we have very little
data to support either way. For B, the answer is yes. C,
theoretically, it is possible, but the chance probability is
very, very low, and, therefore, D is really a moot point.
DR. BUCHANAN: Bob Buchanan, FDA.
My answers to A would be no, it is not appropriate
to assume that no internalization occurs. B, based on both
the research data presented and the literature on plant
pathogens, yes, it is theoretically possible. C, it would
appear to be a low probability event, but the potential is
high enough where it would have to be considered in a hazard
analysis in developing a HACCP program, particularly in
comparison to a process that started after juice is made or
a process that was limited just to surface inactivation.
I think that there are techniques available.
Certainly, there were some in the research that was
presented here, though I did not hear much data in terms of
controlling insects and other types of market defects, other
than careful selection and culling of fruit that had any
kind of a blemish or a puncture or a cut or whatever.
Thank you.
DR. SPERBER: I am Bill Sperber with Cargill.
I think Questions A and B are not very useful for
the agency because they are phrased such that the logical
answers can only be no and yes, respectively. Question C,
likely not a public health risk. Question D, maybe there is
a control measure. There is one possible measure that has
not been mentioned, and that is if the FMC extractor is
used, the core removal is essentially an aseptic process.
So, if there had been internalization, that could be removed
during the extraction of the juice.
DR. DICKSON: Jim Dickson, Iowa State University.
As previously pointed out, the answers to A and B
can almost only be no, it is not valid to assume there is no
internalization, and, B, yes, it is theoretically possible.
Regarding the result in a public health risk using
the definition of "hazard," reasonably likely to occur, no,
this is not reasonably likely to occur.
DR. GROVES: Mike Groves.
A, no. B, yes. C, no public health risk. That
makes D moot, but the answer to that is probably there are
ways.
DR. O'BRIEN: Alison O'Brien.
A, no. B, yes. C, reading it as the question is
stated, if there is internalization, if it is possible, is
it likely to result in a public health risk, I think it
could. I am not willing to say no, flat out. Therefore, I
have to answer D, and one other point which was brought up
by Mike Doyle, the use of the type of fruit that is actually
used, I would say at least choice fruit be used. It was not
clear to me that was always the case.
DR. KOBAYASHI: John Kobayashi, Washington State
Health Department.
My answer for A is no. B is yes. My answer for C
is unknown, although it appears to me on the experimental
level that the answer is obtainable with perhaps some
cooperation between the various studies and the
investigators that are doing the experimental work.
Epidemiologically, I think that it will be very hard to
identify internalization as the source of an outbreak versus
other causes of contamination, although I will keep that
question in mind when we have our next outbreak.
I think because C is unknown, my answer to D is
unknown, but one comment I have on this Question C, is
internalization likely to result in public health risk, I
guess there is a certain interpretation going on in the word
"likely," and I think that one way of looking at that is
that the Odwalla outbreak and the Sun Orchards' outbreak
could be considered unlikely events considering the amount
of orange juice distributed in the United States, but I
think that that is a publicly unacceptable occurrence of
unlikely events.
DR. JAHNCKE: Mike Jahncke, Virginia Tech.
My answer to Question A is no.
Is it theoretically possible? Yes. I think that
the data and the experiments conducted by FDA indicate that
it is theoretically possible. I think that the information
and the data presented in these last 2 days indicate that it
is unlikely under current industry practices. Although I
think some data is being collected, additional data on some
of the initial conditions of the fruit, of the citrus fruit
on the tree and as it enters into the packing plant needs to
be collected.
For Question C, is internalization likely to
result in public health risk, I am going to tie this in. I
think Mike Doyle hit upon what I found was a very important
aspect. I agree that if you have a fruit that is in good
condition, choice, the likelihood of internalization of
pathogens is unlikely. Therefore, the risk to public health
by that definition is unlikely, but if you have a damaged
fruit, a cut fruit, something like that, the likelihood of
internalization of a pathogen goes up. As David was
indicating, with the 10 cells of 0157:H7, it can result in a
significant public health risk.
In that regard, when we get to Section D, there
was a lot of discussion in the last 2 days how effective it
was for manual culling of these citrus fruits as they go
down the line. Being involved not necessarily with the
citrus industry, but with the seafood industry and seeing
the product go down the product line, I assume that during
the citrus industry, the product moves on pretty quickly.
Yesterday, as one of the presenters indicated, if
you take a look at the number of errors that are associated
with an operation, 88 percent of it can be associated with
human error. I am not convinced that manual culling of
these citrus fruits is 100-percent effective. You are going
to be getting some defective fruits, some damaged fruit
coming through that may have pathogens that have been
internalized.
How do you address this? A couple of suggestions,
perhaps. In one of the presentations in California, they
are still immersing some of this fruit that is used for
fresh juice. I think what ought to be done is adapt the
Florida model where there is no immersion of the fruit. It
is all washed and brushed.
Another potential method--and I do not want to mix
apples and oranges, but I think it is appropriate at this
time--in the apple industry, there is a laser technique that
is used for grading apples, and I think it is also used for
looking at damages, damage on apples. Maybe something like
that could be incorporated into that production line, have a
laser that would go across your fruit, identify potential
damage on the fruit. That may be one way of a technique
that can address that issue.
MR. SVEUM: My name is Bill Sveum, Campbell Soup
Company.
My answer to A is no, and, yes, it is
theoretically possible in B. I do not believe there is a
public health hazard with this particular issue, and with D,
it would be no, but if there was the theoretical
possibility, temperature control, as we discussed, fruit
quality, as was referred to here by Mike, vision systems
could be used over people on these lines to cull out fruit,
redundant systems, and you could take care of your fruit
quality that way.
DR. RUSSELL: I am Leon Russell, Texas A&M
University.
IA, no. IB, theoretically possible, yes. C, I am
also hung up on the word "likely," and "likely" is a
qualitative term. You are trying to answer that with a
public health risk, which should be quantitative. Really, I
had trouble measuring that. So I would rather err on the
safe side like Dr. Acheson. You have got some young kids
out there that may be exposed to a small does. I would
rather err on that side, although I think it is very
unlikely under present conditions, the commercial way to
handle things. So I would say. The last one, I would say
mandatory HACCP and include the things that Mike and Bill
just mentioned, include the latest technology as it goes
along, but mandatory HACCP including temperature control and
sanitizing control, much better methodology in the microbial
analysis and end-point testing.
Thank you.
MS. OLIVER: Thank you very much.
What I would like to do now is to have each
committee member address the question under Application and
Measurement of the 5-Log Reduction Standard that you have
been handed.
Leon, I would like to start around this side
first, just because of the number of people who will be
leaving earlier and it will be very close to that time.
Do we have Mike Robach's comments?
DR. DOORES: Nancy partially gave his.
MS. OLIVER: His comments all deal with the next
question that we have. So let me read them into the record
first.
This is from Mike Robach. I want to be here this
afternoon, but here are my comments. For juice squeezed and
packaged on site, a 5D process under HACCP is acceptable, 5D
from fruit receipt. Juice expressed in one plant and bulk-
transported to another location should be pasteurized or
subjected to a 5D process under HACCP. The problem is one
of GMPs, SSOPs, and loss of control during shipping. There
simply is not any evidence indicating that juice product
from fresh fruit and packaged in the same establishment is
harmful to public health, and that is Mike Robach.
DR. RUSSELL: Leon Russell, Texas A&M University.
At the point of the 5-log reduction being at the
juice plant upon receiving, rather than after washing and
cleaning, and I think it ought to be just before it is
packaged that would be the end point.
MS. OLIVER: Can you repeat that? I'm sorry.
DR. RUSSELL: I jumped from A down to B-2. The
last sampling should be done actually after it is packaged,
taken out of the package sample to see what the reduction is
in the final product as it leaves the juice plant.
MR. SVEUM: My name is Bill Sveum, Campbell Soup
Company.
I believe this 5D-log reduction should begin at
the point of receipt in the processing facility, using the
steps that have been described and that they be linked
tightly together. I have a very large concern if juice is
inter-plant shipped through trucks, if it was brought in
bulk, I would require a pasteurization on that because it is
not done on site.
DR. JAHNCKE: Mike Jahncke, Virginia Tech.
I would agree with the previous two. I think that
the 5-log reduction step should take place at the time of
receipt, and I also agree, as Mike's comments and the
others, much more control. HACCP would be much more
effective if everything is done within the plant. When you
start shipping the juice from one plant to another, I think
it will cause public health problems, and I do agree that
that product should be pasteurized.
DR. KOBAYASHI: John Kobayashi, Washington State
Department of Health.
I agree with the previous comments on Question A
that 5-log reduction should be measured for time of receipt,
although in addition, there appears to me to be a question
of should fruit be cleaned and culled before measurement of
5-log reduction has begun. My answer to that question is
yes, also.
Regarding Question B on 1, would using cumulative
steps that are separated in time and location impact a
processor's ability to achieve and deliver a 5-log
reduction, my answer to that is yes, or I think restating
that in the way that others are saying that it is a problem
with regards to transport of product and having control
measures occur in various locations.
My answer to the Question B-2, can the safety
achieved by the 5-log reduction be maintained consistently
if a processor does not package product immediately after
attaining the 5-log reduction, answering that question as it
is asked, my answer is yes.
The question that I think is more important,
though, is should that be allowed, and I do not have an
answer to that.
DR. O'BRIEN: My answer to A is that we should
start as the fruit enters the plant, and B-1, I think that,
yes, there would be an impact on the 5-log reduction if
there was a separation in time and location as the steps are
being monitored. I agree that unpasteurized or fresh fruit
should not be stored in big bulk containers, and it should
be pasteurized under those circumstances if it is going to
be transported like that.
II-B, I do not think the safety can be achieved.
My answer is no, by a 5-log reduction, without testing the
product package immediately.
DR. GROVES: Mike Groves.
A, at what point in the production process should
the process being measurement, I say at receipt. Part two
of that, for example, should fruit be cleaned and culled
before the measure, the answer, of course, is no.
B, are there limits within which the 5-log
reduction must be accomplished, yes. B-1, would using
cumulative steps that are separated in time and location
impact, yes. Can the safety be achieved without packaging
immediately, I do not know. Maybe.
DR. DICKSON: Jim Dickson, Iowa State University.
I would say for Part A that the 5-log reduction
should be measured at the beginning of receipt of the fruit.
I am reluctant to dismiss cleaning and culling because those
are effective measures of preventing contamination in the
finished product, and personally, I would rather prevent
contamination of the finished product than try to clean it
up later. So I think cleaning and culling are very
important preventive measures in this whole process.
Cumulative steps could be effective. It would
depend on the individual step. Question 2 of Part B, the
safety could be achieved if the product was not packaged
immediately, but clearly that would put the product into a
different category and would probably require some special
handling circumstances.
DR. SPERBER: I am Bill Sperber from Cargill.
Question A has really two questions in it. The
first question is more of a HACCP-type question, and the
second question is kind of a GMP question. I point that out
only to make the point that during this past day, there has
been a lot of distortion of the concept of HACCP, and a lot
of people are confusing GMP procedures with the HACCP
program. So it is important for our continuing discussion.
A-1, if a 5-log pathogen reduction is required, it
has got to be done in a HACCP context, and it would have to
be implemented after juice extraction. It starts with the
juice, not with the fruit.
B, cleaning and culling are GMP steps, not part of
your 5-log reduction. If they are sufficient to reduce the
hazard or eliminate the hazard, we do not need to be talking
about 5-log reductions or HACCP. We can control the problem
simply by enforcing existing GMPs.
You cannot take cumulative steps and apply them at
different times and different geographies and get full
credit.
Two, the answer is no to B-2.
DR. BUCHANAN: Bob Buchanan, Food and Drug
Administration.
II-A, considering the comments that I have heard
around the table about the critical nature of starting with
sound fruit, I would say that you would start counting the
5D reduction after culling, and since culling is almost
impossible to do without some initial cleaning, I would
suggest after cleaning and culling would be the appropriate
start point for the 5D.
I have concerns with any process that the longer
and more complex it is, the easier it is for failures to
occur. While I think that cumulative steps can be
effective, I think that the amount of time between those
steps need to be limited, and I have very significant
concerns about locations, particularly if the juice has been
expressed and is moving from one location to another. I
would have some real concerns about it being recontaminated
at that point.
Thank you.
DR. SWAMINATHAN: Bala Swaminathan, CDC.
The answer for A is it should start at the point
of receiving in the processing plant. The cleaning and
culling should be mandatory requirements for the oranges or
on ingredients that come into the processing plant for fresh
citrus juice.
Are there limits within which the 5-log reduction
must be accomplished? Definitely yes. Under B-1, yes, it
would have a very adverse impact if the steps are separated
in time and location, and for B-2, the answer is no.
DR. MORALES: Roberta Morales, Research Triangle
Institute.
For A, I would say at the point of receipt. For
B, are there limits, yes, there are. My answers for both 1
and 2 are going to be related in that if the cumulative
steps are separated in time and location, the more that
separation is in the cumulative steps, the higher the
likelihood of a failure occurring. So, likewise, the longer
the time between when the 5-log reduction is maintained and
when that product is packaged, also the higher the
likelihood of a failure occurring. There should be limits,
and they should be specified even more stringently if there
are going to be spatial and temporal differences.
DR. ANDERS: Jim Anders, North Dakota Health
Department.
A, I believe that the 5-log reduction should be
after the fruit has been cleaned and culled. That is when
it should start.
Are there limits? There certainly are. With
using cumulative steps that are separated in time, I agree
that that should be limited certainly on how much time it
takes and in between each step, and I have a serious concern
about a separate location. I guess I would have real
problems with tankers and that type of thing.
Can the safety be achieved? I do not think we
have that evidence, one way or the other, there.
MR. EKLUND: Mel Eklund.
On A, I would say yes, that the 5-log reduction
should be at the receipt of the product at the plant, and it
must be done in conjunction with the HACCP plans within the
plant.
For B-1, I would say yes, if they are done
consecutively within the plant, and as other speakers have
said, if there is a delay of time and maybe of an area, then
I would say that part of the answer would be no. For 2, I
would say no.
LTC SEVERIN: Scott Severin, DOD.
For the answer to A, I would say after cleaning
and culling is when you should start your 5-log reduction.
From the standpoint of limits, I feel that as long as time
is minimal between steps, you cannot have cumulative 5-log
reduction. I do not feel you can have a 5-log reduction if
transportation is involved in another location.
I also feel strongly that there should still be a
microbiological testing criteria following the attainment of
your 5-log reduction just to verify that you have achieved
that.
Thank you.
DR. LIANG: Art Liang, CDC.
II-A, after cleaning and culling. II-B, yes,
there are limits. I share the same concerns about steps
separated by time, location, or management, and 2, I do
not know.
DR. ENGELJOHN: Dan Engeljohn with USDA.
For A, I would say at receipt after cleaning and
culling. For B, I think yes, there are ways or there are
interventions that need to be there, but for 1, I would say
no, I think it can be controlled and validated if there is
no growth. Then, for 2, I think, yes, if it is controlled
and validated for no growth and no cross-contamination or
recontamination.
DR. DOYLE: Mike Doyle, University of Georgia.
For II-A, I think it is important that we consider
the cleaning and the culling as far as good manufacturing
practices and do not include that as part of the 5-log
reduction. That should all begin after the cleaning and
culling.
I would encourage the industry to look harder at
the surface steam pasteurization process because the little
work we did no that, if there were splits or holes in the
fruit, the inside of the fruit heated up and it got quite
hot. I think it almost pasteurized that juice within the
orange. So, if there were culls that got through, there may
be a safety factor built in there, but you need to research
that out more thoroughly. I think that could be a key
critical control point for you.
In Section II-B, yes, I do think there needs to be
limits within the 5-log reduction. Relative to the
cumulative steps being separated in time, I agree with what
has been said. It is a real problem to transport juice that
has been processed somewhere else and assume that that 5-log
reduction is still good.
I think you have got to start all over, and I
would not give you any credit for juice that was transported
through the plant.
Then, for II-B-2, can the safety achieved by the
5-log reduction be maintained consistently if a processor
does not package product immediately after attaining a 5-log
reduction, well, I believe you could do that. You would
have to document it, but if you had aseptic conditions for
holding the juice, I believe you could do that safely. I
think the milk industry has big old silos where they put
their pasteurized milk in and hold it there until they can
bottle it. They do not do it immediately after
pasteurization.
So I think it is reasonable to come up with an
approach and especially if you all come up with testing
protocol for a critical control point. You are not going to
get those results back in 5 minutes. You are going to have
to probably hold that juice for a day or two. So you have
got to come up with some way of holding that juice safely
after processing. So you are going to have to think that
one through.
DR. DOORES: Stephanie Doores, Penn State
University.
For Question 1, I favor measuring the log
reduction after cleaning and culling. I think if you do it
before that time, you are achieving part of the reduction
due to a dilution effect, rather than elimination of a
problem, and I am not in favor of diluting out any potential
pathogen load there due to the fact that some outbreaks of
foodborne illness can result from only a few organisms.
In Question B-1, I think that if the juice leaves
the particular location, again, all bets are off. I think
you need to restart the 5-log reduction process there. If
it is separated in time, I would like to know what that time
is and have that defined.
I would also in B-2 like to know for what
particular reasons the product is not being packaged
immediately after processing, why that would or would not be
done, but I think I concur with what Mike says, that we do
have a history with other products under defined conditions.
Furthermore, I would like to add that I am very
concerned that whatever organisms are chosen for the 5-log
reduction, be they pathogens or indicator organisms for
those pathogens, that the methods that are used to assess
that reduction are specific for orange juice and appropriate
provisions have taken into account oranges and their
intrinsic and extrinsic parameters that may lead to
erroneous results and perhaps estimation of a reduction when
it is lack of recovery from the organisms, so things like
terpinols in the orange oil that might be present there or
any other Ph effects that those methods take into account,
those kinds of things that can interfere with estimation of
the reduction.
DR. KVENBERG: This is John Kvenberg, Food and
Drug Administration.
Regarding II-A, my answer is that the point of the
account for the 5-log reduction must be at the point where
the juice is actually processed.
I agree with other statements relative to culling
and cleaning. I feel very strongly that this ought to be a
mandatory point, but it is not a critical control point. It
is prior to a critical control point and, therefore, is not
part of the 5D process.
However, this should not be confused with the flow
diagram of a HACCP program, wherein the culling process may
occur downstream from the initial point of entry into the
plant. You may recall that high pressure does aid in
sorting out and accentuating the fruit for the culling. So
I am saying that the 5-log should begin after the culling
process, as others have said, on through to the end of the
process.
Relative to II-B, are there limits to which the
reduction must be accomplished, I certainly agree with other
statements relative to the cumulative steps being separated
in time and location, are highly problematic, and lend
themselves to recontamination problems. This is a severe
problem that negates the 5-log reduction idea that the
committee originally proposed.
Relative to B-2, can the safety achieved by the 5-
log reduction be maintained consistently if a processor does
not package the product immediately prior to the 5-log,
ideally if the kill step were applied to the juice, there is
no doubt with mechanical measurement that this is achieved.
Therefore, if there is not a full 5-log applied to the
juice, then it may be prudent to consider product testing,
as was suggested by the committee, to assure that the
process that was applied did not result in a recontamination
of the product.
Thank you.
DR. ACHESON: David Acheson.
II-A, one piece of data that I was not made aware
of--maybe this was discussed more yesterday--was the total
pathogen load on this fruit at the point at which it arrives
in the plant. I want to try to separate "begin to measure
attainment" as opposed to "begin to reduce the pathogen
load." The question says "begin to measure attainment," and
to me, just from a purely basic science principle, the
further down the line you begin to generate your 5-log
reduction, the better you are, but that is a theoretic
argument.
So I agree with Mike that a substantial cleaning
and then you begin to look for your 5-log reduction would be
appropriate, but I would like to know how many bugs are on
that to begin with.
II-B, obviously, clearly the transport issues are
important. I would have thought with appropriate
monitoring, this could be undertaken safely, but we cannot
make any assumptions.
The second part of B, theoretically, yes, I would
have thought that this could be maintained consistently,
but, again, I did not see any data to suggest that this has
been done, can be done, but, empirically, I would just feel
that it is of limited likelihood that it could be attained
without some major steps.
Thank you.
DR. NEILL: Peggy Neill.
With the assumption and understanding from the
previous observations that cleaning and culling is a GMP, I,
therefore, think that the answer to A for my response would
be that measurement would begin after the fruit has been
cleaned and culled.
For B, I think that there are limits, although I
do not yet know that we would be able to define them in
terms of time and mileage, be they hours or metric system or
what.
For No. 1, using cumulative steps, I think it
seems reasonable from the totality of the data that we have
cogitated on before the meeting and for the last day or so
that cumulative steps that are separated in time and
location will impact the processor's ability, unless those
steps have clearly been shown to be under the processor's
control and for which there would then be an adequate track
record for measuring that control.
For No. 2, whether safety could be consistently
achieved, I think the key word was "consistently," and
operating on the principle of Murphy's law, my answer to
that then would be no. I do not think it can be maintained
consistently.
MR. SEWARD: Skip Seward.
The first question in Point A, I would believe,
like everyone else, that it is at the point of receipt into
the plant, and my answers for all the other questions are
yes.
DR. BERNARD: Dane Bernard.
Let me first say there was a larger question on
the adequacy of the 5-log. I personally have had no problem
with 5-log as the target as long as it is understood that
the target was identified to produce a finished product that
had essentially the target that was in the proposed rule
which was basically reasonable certainty of no pathogens in
the finished product. So I hope we do not walk out of here
envisioning that 5-logs means you can accomplish--prove that
you started with 7 and end with 2 and we think that is a
safe product. That was never the intent.
So, with that caveat in mind, should fruit be
cleaned and culled, I think we have already heard many times
that that appears to be a very vital part of putting into
the process fruit of quality, good quality, that would have
a potential of low prevalence. So I think the 5-log should
begin after cleaning and culling.
Are there limits within 5-log reduction that must
be accomplished? I have several limits. First of all, the
scientific rigor with which one proves their point that they
have met the performance criteria, I think we have to hold a
fairly stringent yardstick to any process that claims to
achieve that log reduction.
I agree with the previous comments in terms of
keeping the time frame between steps at a minimum. Rigorous
sanitation in the operation appears to be very important to
all of this, and there have also been several interventions
mentioning the necessity of microbiological testing as a
continuing verification of the effectiveness of the
application in the 5-log process.
On B-1, would cumulative steps separated in time
and location impact the ability to achieve and deliver 5-
log, I think we have seen beyond probably any doubt that
there is an impact, and I would agree with previous speakers
who have mentioned that they are very uncomfortable with
seeing large separations in time and space in terms of the
delivery of the 5-log. So I am very uncomfortable with that
as well.
B-2, can the safety achieved by a 5-log reduction
be maintained consistently? I would agree with Peggy that
any separation between achieving 5-log and packaging raises
the possibility of mistakes, not counting Mike Doyle's
caveat regarding aseptic processing. If someone can prove
your point, fine, but if you are not willing to spend the
money to put in aseptic equipment and maintain it and run it
aseptically, then I would suggest that we go right to
packaging after delivery of the process.
Madam Chairman, are we going to have further
comments after answering the questions? Because I really
think we have not addressed the cause of the more recent
outbreaks with any of the questions that we have answered.
MS. OLIVER: I think the questions that we had
were basically the two questions, and I have some questions
of clarification on micro-testing. If the committee feels
they need to make some additional comments, I will allow
that, but I do not want to go too far beyond.
DR. LONG: Earl Long, CDC.
On II-A, I think the measurement should begin at
the point of entry. B-1, yes, and B-2, no.
DR. TOMPKIN: This is Bruce Tompkin from ConAgra.
I think the 5-log reduction that we have had in
place since '96 has been effective in bringing about change.
The question, is it adequate, the comments about whether or
not--well, first, the question--I believe that the 5D
process should be from the whole fruit upon receipt at the
plant. The difference between whether it should be before
or after culling is like adding on another 2-log reduction.
Really, are we talking about a 5-log reduction or a 7- or 8-
log reduction?
As we went through the process yesterday, I am
trying to put myself in the place of a processor and trying
to live with what this committee is going to require. I am
trying to see whether I will be able to produce a fresh
juice with a 5-log reduction beginning after cleaning,
culling, and washing.
You might recall yesterday when we went through
our little HACCP validation here that we picked up about a
3-log reduction just through those steps. Those were very
important steps. So the question is: Do we need additional
kill and to what degree do we need that kill?
I think the system that is in place is working.
It is a matter of bringing everyone else up to the level
where they are at this point in time.
As for B-1, then I would say yes. The process
should occur on site from raw fruit to the juice and avoid
incoming tankers.
With regard to immediate packaging, well,
certainly it is possible to hold product over some period of
time after creating the juice. It is really a matter of
recontamination, and that is a manageable risk.
MS. OLIVER: I have a couple of questions.
Leon, Bill, and Mike, I did not hear your response
to Part 2 of Question A as should the fruit be cleaned and
culled before measurement of the 5-log reduction has begun.
I might have missed it.
DR. RUSSELL: Leon Russell.
It should begin at receipt of the plant before
cleaning and culling.
MR. SVEUM: Bill Sveum.
The same point.
DR. JAHNCKE: Mike Jahncke.
At the time of receipt.
MS. OLIVER: I had another question of
clarification. Several of you mentioned testing in various
ways, John, Mike Doyle, Dane, and someone on this side. I
was wondering if you could clarify what type of testing you
are talking about.
DR. BERNARD: Dane Bernard.
Let me also ask, if I could, because there is some
confusion, at least now in my mind, regarding the cull step,
cleaning and culling. I viewed that more as a receipt step
rather than what was explained as the wash step, which I
think is what Bruce was talking about in terms of claiming
some log reduction. So I was talking my version of cleaning
and culling, if I understood the presentations, is more a
rough clean and getting out and then beginning to count the
5-log.
So I think that we have had several people answer
the question yes and several answer no, when I think they
were thinking the same way. So I would like to have a
clarification on that.
DR. GROVES: I agree with Dane. This is Mike
Groves.
Do people realize it is after the cleaning and
culling, the people who have answered this? Were they
saying we want pasteurization? Because it seems to me that
is what we are talking about. Getting a 5-log reduction
following the cleaning and washing step, if it is the
rigorous cleaning and washing that I saw described, we are
talking about not getting there unless you have
pasteurization. Is that what people that answered that
question meant?
MS. OLIVER: Let me go around and ask individuals
one of two ways.
Go ahead, Bob. What is your comment?
DR. BUCHANAN: Bob Buchanan, FDA.
I guess my comment on initial cleaning and culling
is you get rid of the big chunks. There are some obvious
fruit that just should not be in there, and while I am not
considering this as a rigorous cleaning step, often these
blemishes are not available until after you can give them at
least an initial rinse. So my thought was a gross
separation of the bad fruit out, and if necessary, some kind
of reasonable initial cleaning of the product so you can see
the defective fruit, but then to start it after which with
your rigorous washing and sanitizing steps.
Oh, I would assume that somewhere after the
rigorous washing and sanitizing steps, there would be a
subsequent final call to look for new defects that have come
out as a result of high-pressure cleaning, et cetera.
DR. O'BRIEN: Alison O'Brien, Uniform Services.
The reason I voted for receipt, starting at the
level of receipt, was I do not think they can document later
on that they have had a 5-log reduction. From what I heard
about what the level of organisms, just plain old coli kind
of bugs, were on the fruit and if we forced the producers
into the position where there is no possible way of
demonstrating 5-log reduction, I think that is what Mike
means by pasteurization, unless I misunderstood what people
said about the level of organisms on oranges.
MS. OLIVER: What I Bob say is the cleaning and
culling that we are talking about in the question is
basically your gross cleaning and culling to start with as
opposed to going through your rigorous washing. What I need
to do is be sure that everybody was answering the question
in that way as they went around.
So can I go around the group and ask?
Go ahead.
DR. GROVES: We had better define carefully.
MS. OLIVER: Okay. Bob, I will ask you to define
"carefully."
DR. BUCHANAN: My definition would be an initial
rinsing or washing of the fruit so that you can take a rapid
assessment of the quality of the fruit to see that it is in,
as we described, choice or first-run as opposed to
processing, separate out the processing, then begin starting
with choice or better, start the process then through
whatever sanitation, steam treatments, whatever, to get your
5D, but it would be to get those with obvious gross defects
out of the pool of fruit before you start the process. That
is, start your process with choice or better fruit.
DR. O'BRIEN: Alison O'Brien.
Let me start, then. That was my understanding
that we were starting with a particular kind of fruit, and
most of the time, it is at least choice. I am hoping that
it would not be anything else but that. If we start with
that, then we do the 5-log reduction from there. That is
the way I was voting.
MS. OLIVER: So what I hear as an assumption is
basically starting with choice fruit coming in and then
seeing that is the cleaning-and-culling answer that people
were giving in that response. I would ask, can you go
around and tell me if it is in that context that you gave
your response, choice clean fruit?
Go ahead.
DR. GROVES: I would think what you would like
people to answer is at what step do you think they should
start the 5-log reduction, at immediate receipt, when it has
been given some sort of brief culling and cleaning, or after
the rigorous wash process, to make it very clear what people
are voting for.
MS. OLIVER: Why don't we take a 15-minute break
so that I can clarify the question, get it on a piece of a
paper, and we can make sure that everyone has it because of
the confusion.
The other thing is that there are brownies
upstairs.
[Recess taken from 3:07 p.m. to 3:34 p.m.]
DR. BUCHANAN: Hi. This is Bob Buchanan from FDA.
As we went through and discussed what different
people were trying to refer to at different steps, we came
up with the following flow diagram to try and get a handle
on what we were referring to in terms of cleaning and
culling.
The concept that was seen here was to get
something equivalent to the separation of oranges that we
see in the packing house into what we referred to here,
second quality or oranges that would go to further
processing or into processed products versus high quality
which in California, I guess, was broken into two areas. It
was first run and choice.
The equivalent on this side, going directly from
the orchard or cold storage, to a juicer, a fresh juicer,
would be the equivalent of some sort of gross cull to get
the classification to the equivalent of this, and it was
thought that this would require some cursory washing in
order to be able to see defects that allow a separation in
the basis of quality and then some initial culling to get
the processing quality of oranges segregated.
This was from that point on done under one roof.
That would be the rest of the steps that are currently used
in a fresh juice operation, which would include the normal
washing, intensive washing and brushing, sanitizing steps
and a final culling and then juice formation.
At least the people over there are trying to put a
definition behind cleaning the culling, and the thought was
it would be getting the oranges that are going directly from
the orchard or cold storage to a juicer to the equivalent of
the oranges that would be coming from a packing house into
the final operation.
That is what we are using as a working definition
now.
MS. OLIVER: Of cleaning and culling above the red
line.
DR. BUCHANAN: Cleaning and culling above the red
line.
MS. OLIVER: If I could ask the committee, then,
once again, to respond to the question as to whether fruit
should be cleaned and culled before measurement of the 5-log
reduction has begun.
Dr. RUSSELL: May I ask a question, please? Leon
Russell, Texas A&M.
Under one roof, does that begin where the red line
is? In other words, the wash and cull is outside the
building?
MS. OLIVER: Bob, as I understand it, where you
have receipt at juicer and then under one roof, that that
brief washing and culling could either occur at the
processor or elsewhere, and so that it could all be under
one roof and it could all be the juicer going down, right?
DR. BUCHANAN: It could all be under one roof. In
the case of the packing house, it would be done somewhere
else. The segregated oranges of the appropriate quality
would be then shipped to the juicer.
MS. OLIVER: Bruce?
DR. TOMPKIN: This is Bruce Tompkin.
I just had a question relative to the use. Is
there a wash step prior to culling that is typically used
today? I do not know that I would put a wash step in before
I cull. I would cull and then probably then begin to apply
the wash so that you get rid of all the big junk first, and
then it is a matter of where do you start at that point. It
is a detail.
DR. BUCHANAN: This is Bob Buchanan from FDA.
We were at least told partially that it is hard to
see defects in the oranges without some kind of initial
cursory washing step.
DR. BUCHANAN: I would just ask you for
confirmation of that.
MS. OLIVER: John?
DR. KVENBERG: This is not a snide comment, but
let's call it a "grove" and not an "orchard."
This is John Kvenberg.
I think the important point is that you start at
the grove and may or may not go to cold storage on this.
The important point is at the red line, either outside the
building or inside the building. We are looking at a pre-
cull. That is correct, is it not? The pre-cull is before
you begin the 5D under one roof. Is that what we are
saying?
MS. OLIVER: John, who are you asking the question
to?
DR. KVENBERG: Bob Buchanan.
DR. BUCHANAN: Yes. It is an initial segregation
of the product into the quality of orange that we had
expected to be introduced into the processing step and into
the counter, what you need to start off with before you
start counting the 5D.
DR. KVENBERG: Is the brief wash critical prior to
gross cull, I guess was the point, because Bruce brought it
up and that is when I got a little bit confused. Are we
talking a wash necessary or a cull prior to starting the
process?
MS. OLIVER: John?
MR. MARTINELLI: My name is John Martinelli. I am
with Orchid Island Juice Company.
In the State of Florida and in California, if
California is using packing-house quality of product and
then you want to start the 5D, I think that is pretty much
the process that is in place in California at this point in
time.
In the State of Florida, we use field-run fruit
that has no drops in it. There is not going to be dirt on
it. There is not going to be heavy soil. There is not
going to be all sorts of different defects. There is not
going to be a lot of heavily decayed fruit.
The thing that we mostly grade for during the
season is scratches in the surface of the skin and things
like that.
As far as the brief wash in water and the gross
cull, there is not a lot of rotten fruit in field-run fruit,
and Florida's citrus crop, about 90 percent of it goes to
processors like myself and Cargill and Tropicana. We use
field-run fruit because Florida's crop is mostly used for
processing. So there is not a lot of heavy decay. There is
not a lot of heavy problems with the fruit as it comes in
off of the trucks.
MS. OLIVER: Is there a basic culling when it
comes in, a gross culling?
MS. SEXTON: Yes.
I am MaryGrace Sexton with Orchid Island Juice
Company.
Theoretically, a damaged piece of fruit will not
hang on the tree. So it is not going to get picked. It is
not going to get into your packing house if you are using
field-run fruit.
MS. RAINEY: Charlene Rainey from Nutrition
Network.
I am from California, and there is a culling that
happens prior to harvest in the field. They will go through
and see damaged fruit on the tree, and they will pull that
one or two days before harvest. So that, when you harvest
the fruit from the tree, that you have good fruit. So there
is an initial culling in the orchard.
DR. STROBOS: My name is Jur Strobos.
I think for purposes of trying to simplify the
question, I have a diagram. I may have misunderstood, and
this is a little bit of a simplification. There are some
slight variations, but basically if it is going to go to the
packing house, it will go from the grove to the packing
house. There may or may not be a brief wash for leaves and
stems and so forth. I think it may be relevant to some of
the questions that are going on here, but there may or may
not be some culling that takes place here.
In any event, there is a culling step that takes
place here. Then the fruit goes through the processing, and
then it will go into cold storage.
In California, if I understand it correctly, if
that cold storage fruit is used for juicing, it will go from
there to the juicer, where it will go again through the same
process. Again, it is a little bit of a simplification, but
in Florida, basically we are talking about this process
where it is going from the grove to the juicer. There may
or may not be this step. There is a culling that takes
place right here, and then it basically enters the plant,
goes inside, really, and begins going through the
sanitization, brush washing, extraction, and juice.
I think that may be easier because then the
question becomes whether the 5D should start here or whether
it should start here or whether it should start here. This
may be helpful.
MS. OLIVER: The cull as I see it is before or
after the brief wash, correct?
DR. STROBOS: Yes, and it would depend a lot on
the particular operation.
MS. OLIVER: Basically, what FDA was saying, in
Bob's diagram that he had up there before, was should it
start after the cleaning and culling, including the brief
wash and the culling up at the top before the sanitization,
the brush wash, in either of those phases.
Correct, Bob?
DR. BUCHANAN: Yes. It appears that the two
differences here are whether it starts at the point where
you have on that diagram "juicer" or at the point where it
says "sanitization and brush washing."
MS. OLIVER: Okay.
John?
DR. KVENBERG: John Kvenberg. Thank you.
I think the critical point here that I am aware of
is a juicer may in Florida use California fruit or in
California may use Florida fruit or may use other things.
There is no State boundaries associated with processing
this.
If it is coming from storage or cold storage, two
things can occur. The fruit can get damaged in transit in
the truck or it can deteriorate in cold storage. I think
what we were trying to say on that diagram, that I was, that
the juicer is looking at a pre-cull, and I am not clear
whether there needs to be a wash or not, but there is no
guarantee from the grove to the juicer through the packing
house or its own cold storage operation really is going
through a pre-cull. I think that was what in my mind we
were saying. Prior to starting the 5D reduction process
within the juicer plant, you need to have sound fruit to
begin. That is all, but the count starts in the plant with
that juicer. You are not counting the 5D process coming out
of cold storage either within the juicer's facility or in
the packer's cold storage.
DR. DICKSON: Jim Dickson from Iowa State.
It sounds like, John--and at least I am getting
confused on this cull issue--it sounds like this pre-cull to
me is occurring during the harvesting. Is that not correct?
DR. KVENBERG: May I respond?
DR. DICKSON: Please.
DR. KVENBERG: Not in my mind. Maybe we should
get some clarification.
DR. DICKSON: Okay.
DR. KVENBERG: In clarification, the juicer should
be responsible prior to starting it. That is how I
responded.
DR. DICKSON: Right, but there is a selection step
at harvest.
DR. KVENBERG: Granted.
DR. DICKSON: That is all I was trying to clarify,
John. Thank you.
DR. KVENBERG: Yes, but the point is that the
culling process is the responsibility of the juicer.
DR. DICKSON: Right.
MR. BARNHORN: I know we keep going back to
Florida and California, but we have a process flow which is
a little different. I want to make sure that it is not
monolithic in understanding that.
MS. OLIVER: I agree, but I think that the point
does not matter. It is just us trying to get a
clarification on where we are talking about.
MR. BARNHORN: Let me just make sure. We receive
packing house fruit which has been pre-graded, pre-culled,
waxed, washed, sanitized.
MS. OLIVER: Yes, that is up there.
MR. BARNHORN: It is a little different, then. I
want to make sure that packing house or similar level of
grading, which I think is relevant here.
MS. OLIVER: Do we need more clarification? Does
the committee need more clarification on this?
DR. GROVES: This is Mike Groves.
On one and two up there, are we talking about,
one, that it is the 5-log reduction that begins before
cleaning and culling, like cleaning and culling, and two,
after the brief wash and cull, and two is not meaning that
it is after sanitization and brush washing. Is that
correct?
DR. BUCHANAN: This is Bob Buchanan from FDA.
For point of clarification, number one would be
that you would start the 5D as the juicer received the
oranges, okay?
Number two would be you would start counting the
5D from the moment you start the sanitation, brush-wash
cycle, et cetera. The difference between one and two would
be that you do not count the brief wash, brief cull that is
in between steps one and two. That would be the difference.
MS. OLIVER: Mike?
DR. JAHNCKE: Mike Jahncke.
I have a quick question. If we are going to be
doing this, we have got citrus going through the packing
house, and it is not only getting a brief wash. It is
getting sanitized, brushed, and washed, versus material that
is coming directly from the grove to the juicer. I do not
think we can apply the point of where we are going to start
the 5D. They are two different processes. They are not
equivalent.
MS. OLIVER: Bob, do you have any response?
DR. BUCHANAN: I guess I am a little bit--
MS. OLIVER: John Kvenberg does.
DR. KVENBERG: Yes, let me try again. This is
John Kvenberg.
I think what we are trying to say is the process,
and maybe "culling" is an inappropriate word. We are really
talking about acceptance of fruit that is going to be
processed by the juicer on receipt or removal from cold
storage, either within its own facility or from a packing
house. So what we are saying is acceptable fruit.
The two points may or may not include a brief
wash. I do not know, but basically the sanitation and
brush-washing process in the control of the processor is
where the count should begin.
It may not be total receipt, but there has to be a
grading, if not a culling, given the last point of the
speaker that the thing is coming in crated. It has to go
through something, so you have an initial starting point.
The point we were trying to make was gross cull.
It did not count in the 5D process.
Thank you.
MS. OLIVER: Dr. Troxell?
DR. TROXELL: Thank you. This is Terry Troxell.
What Bob said, I believe, was we are talking about
sound fruit. In my mind, sound fruit involves fruit that is
not damaged and it is fruit that is clean. So that is what
we are talking about. The difference would be that you
would make sure that whether it came from the grove or the
packing house that had the cold storage, that you had
rechecked that fruit to ensure it is clean and sound before
you put it in the process, and then you have your double-
check.
For example, yes, it is supposed to be tree-
picked, but you would have a verification under your control
that everything you are putting into the process is sound;
that is, cleaned and culled.
MS. OLIVER: Dane?
DR. BERNARD: Thank you. Dane Bernard.
I agree with what Terry said. That was my
concept, that whatever goes to step two there is relatively
clean, sound, choice, whatever you want to call it. Then
you push down the button and you say, "Okay, start." That
is where we start counting.
In relation to the other questions that were on
our list, though, there were a number of us who said that
all that ought to be done under a roof, and I think that is
where we started with Bob's red line.
We had an intervention from a juicer who buys
packing-house fruit which has already gone through a lot of
that. My intent would be do it again because we were
concerned about separating of steps in time and space. I
want to make clear that that was my intent there and see if
that is the sense of the committee.
Thank you.
MS. OLIVER: Bob?
DR. BUCHANAN: Dane, that was my assumption in
looking at that diagram that was provided with us.
The juicer is a location, and it was upon receipt
at that location. If you move to another location, based on
our comments and what I thought was pretty much the opinion
of the committee, you would have to start that process over
again.
MS. OLIVER: He is asking you a question, Bob.
Leon is asking a question.
DR. RUSSELL: Leon Russell, Texas A&M.
You mean start the 5-log reduction again if you go
to another place, transport?
DR. BUCHANAN: That was my understanding based on
the answers to Question II-B was that if you were
transporting fruit or juice in between locations that people
seemed to have a great deal of concern about being able to
achieve part of a 5D kill at one location, then the rest at
a second location.
DR. RUSSELL: Leon Russell again.
Should we not use a different criteria? Could you
meet a 5-log reduction, refrigerated, aseptic, if you want
to call it that?
DR. BUCHANAN: I am not sure of your point.
DR. RUSSELL: You are going to start the 5D
reduction again once you go to a new plant, right?
DR. BUCHANAN: Right.
DR. RUSSELL: Is that possible or feasible?
DR. BUCHANAN: 5D, I think there is some confusion
here because I have seen this. 5D represents the degree of
processing that would be needed to achieve a certain level
of reduction, regardless of whether the organism is there or
not. It is a risk-reduction approach.
You can have 103 organisms and give them a 5D.
What that means is you are now down to a probability of less
than 1 in 100 that there is a surviving organism.
We heard earlier commentary about shelf-stable
juice receives a 50,000D. There is no way, since 1013 is
solid bacteria, in the world you could have 1050,000 in any
kind of realistic 1-ml volume, but you can still get that
kind of a treatment just on the basis of continually first-
order kinetics in terms of an activation theory.
MS. OLIVER: Bruce?
DR. TOMPKIN: We are on two points now. Have we
reached a consensus as to where to draw the line first and
begin the 5D reduction for fruit entering a juicing
operation?
MS. OLIVER: Have we reached a consensus? No,
they did not reach a consensus on the other. I am saying
you need a consensus on where to ask the question from.
This is a different thing.
I will tell you what, I am going to ask the
question, and if everybody would just describe from whence
they are saying the 5-log should be in terms of cleaning and
culling and what you mean by it as opposed to understanding
and answer the question in that vein, would that help?
MS. OLIVER: Bruce?
DR. TOMPKIN: It is my understanding that we are
at a point where the 5D reduction begins after the initial
culling upon receipt of the fruit into the operation.
DR. LONG: Earl Long, CDC.
That is my understanding, too.
DR. BERNARD: Dane Bernard.
That is my understanding.
MR. SEWARD: Skip Seward.
I agree with that.
DR. NEILL: Peggy Neill.
I agree with that. I think I might suggest
inserting the words "culling," borrowing from Terry Troxell,
"the culling step to identify sound fruit."
DR. ACHESON: David Acheson.
I agree with that, beginning with clean fruit.
DR. KVENBERG: This is John Kvenberg.
I agree also with the second intervention, sound
fruit.
DR. DOORES: Stephanie Doores.
I agree with that.
DR. DOYLE: This is Mike Doyle.
I also agree.
DR. ENGELJOHN: Dan Englejohn.
I agree.
DR. LIANG: Art Liang.
I agree.
LTC SEVERIN: Scott Severin.
I agree.
MR. EKLUND: Mel Eklund.
I agree.
DR. ANDERS: Jim Anders.
I agree.
DR. MORALES: Roberta Morales.
I agree.
DR. SWAMINATHAN: Bala Swaminathan.
I agree.
DR. BUCHANAN: Bob Buchanan.
I agree.
DR. SPERBER: Bill Sperber.
I agree only for citrus.
[Laughter.]
DR. DICKSON: Jim Dickson.
I agree as well.
DR. GROVES: Mike Groves.
I agree.
DR. KOBAYASHI: John Kobayashi.
I agree.
DR. JAHNCKE: Mike Jahncke.
I agree.
DR. RUSSELL: Leon Russell.
I would not dare not agree. I agree.
[Laughter.]
MS. OLIVER: Thank you, everyone.
Now I have another question that I had started
with before, and that had dealt with microbiological
testing. The testing was brought up by Mike Doyle, by
Stephanie, by John Kvenberg, by Dane, and I do not recall
who on this side, but also someone on this side. I have a
question, as I heard the testing a little bit differently
from each of you. I am wondering what you are meaning by
testing. If I could have a clarification or possible
discussion on that.
Dane, could I begin with you?
DR. BERNARD: Thank you. Dane Bernard.
My intervention earlier referred to finished
product testing. We had a very, I think, convincing
presentation of information from a compilation of the four
processors who are doing microbiological testing.
There was also a lot of discussion about the
methodologies used, how they have changed. All of that
aside, 17,000 negatives is an impressive data set, and I
think they are to be complimented for that.
However, I think that what we need to do is as a
committee give some expression as to the value of finished
product testing with fresh citrus products, what we think
might be appropriate as finished product testing, and on
what frequency. There are those on the committee who are
much more expert than I who might have some opinions on
that, but I would see some type of testing on a lot basis
and an occasional more in-depth testing for specific
pathogens.
One of the criteria that we might want to think
about is how one would react to a positive finding for, say,
E. coli or fecal coliforms, whatever the preferred organism
might happen to be. E. coli would provide, I think, a good
tracking mechanism as to how you are doing in your process.
Since sanitation of equipment, brushes, maintenance of
equipment appears to be a very important factor, I think a
microbiological verification on finished product is a tool
that is probably something that should be used.
I will just open the conversation with that and
let others jump in.
MS. OLIVER: Bruce?
DR. TOMPKIN: This is Bruce Tompkin.
I think that the ongoing practice of testing for
E. coli as a means to assess the control of the process has
considerable value, and that should be continued. The data
should be plotted, as some are now doing.
When it gets beyond that, to impose a lot
acceptance sampling plan on product prior to shipment, I
think it is unnecessary based on the history or at least
based on the data of those establishments that currently
apply to Florida principles of best practice, let's call
them. However, it would be useful in the event of a
questionable lot to have a sampling plan that would be
applicable.
And I know that in the past FDA and others have
established a microbiological criterion or sampling plan
that provides guidance to industry as to how to design and
control its processes. So, for example, it could be 60
samples in the case of that--no, excuse me--30 samples--30,
60 samples based on 25 individual analytical units, and
those could be analyzed as composites or not, depending on
how that data shakes out. But that would not be done on a
routine basis.
MS. OLIVER: John?
DR. KVENBERG: Thank you. John Kvenberg.
I was speaking in the term of sampling in the
context of HACCP verification. I think the sampling
frequency will depend on the confidence of the system that
has been validated, and should be frequent until confidence
is gained and then moved apart. I am not talking
necessarily about lot by lot verification. Speaking to what
to be tested for, I think our history would indicate that
Salmonella may be better than E. coli for this purpose.
MS. OLIVER: Mike Doyle.
MR. DOYLE: Mike Doyle, University of Georgia.
And I saw what FDA did with sprouts, and has set
up a end-product testing for sprouts, and I guess I don't
see the fresh juice situation to be too much different from
that, and if we're going to establish end-product testing as
what I would call the equivalent of a critical control
point, then I would concur with what Dane had to say,
although John has some good points too. If it's found that
there's a strong history of product being microbiologically
safe, then there just needs to be certain tests done on a
verification basis with time. But I think both E. coli and
Salmonella have a place in this--not E. coli 0157
necessarily, but E. coli as an indicator organism.
MS. OLIVER: Okay, Scott.
DR. SEVERIN: Yes. Scott Severin, DOD.
My concept was final product testing, focusing
primarily on Salmonella and E. coli, more a verification of
system processes control, along the lines of what Dane was
describing.
MS. OLIVER: Thank you. Bob?
MR. BUCHANAN: Bob Buchanan, FDA.
My inclination that we're primarily looking here
as a microbiological testing as a verification for a HACCP
program. There are several different sampling techniques
that can be used in conjunction with that. It can be
tailored to the defect rate that you actually are
experiencing or that you have concerns about. It can also
be coupled--if positives come up for whatever organism you
select to be monitoring for organisms.
So, for example, you are dealing with E. coli,
generic E. coli as an indicator organism of process control,
and you begin to have positives on that, or positives beyond
some baseline. You then can move into a more rigorous lot
acceptance criteria as part of your HACCP plan for specific
pathogens such as Salmonella or any of the other organisms
of concern.
I think particularly considering that we have a
process for which we do not have a great deal of scientific
data, and that we had some discussions about potential
concerns, including microbiological testing as part of the
HACCP verification program, is a wise precaution.
MS. OLIVER: Bill?
DR. SPERBER: Bill Sperber, Cargill.
I think two types of microbiological testing would
be required to have an effective program. Pathogen testing
would be useful for verifying the HACCP plan. This is
something that would be done irregularly or maybe on a
weekly basis, something done for a process that's under
control.
But the processor is going to have to do some
other microbiological testing to know that its process is
under control, and do this testing on a regular basis,
perhaps daily, and pathogens are not useful for that kind of
testing, simply because they're so infrequent. So there has
to be some other type of indicator organism, perhaps it's
coliforms, or in the case of juice, yeast might be a better
example because it's more likely to be there if something is
not done properly. So there should be some kind of an
indicator organism that's used to verify process control.
MS. OLIVER: Thank you. Jim?
DR. DICKSON: Jim Dickson, Iowa State.
I guess I'd like to support what's been said up to
this point. The only thing I'd like to add is that when we
talk about testing for specific pathogens, particularly in a
case where we're talking an incidence of what, 3 to 4 per
100 mls., that that doesn't lend itself to setting up a
statistically valid sampling that can be operated on a daily
or a weekly basis.
My concern is that as a food industry, we do an
awful lot of microbiological testing, but when you look at
the sampling plans behind it, basically most of that data
doesn't mean very much, because the plans are not
statistically valid.
I agree with Bill here that there is a role for
some kind of an indicator organism for process control, but
if we're going to do specific pathogen testing, a whole
series of Salmonella negatives from a sampling plan that is
not statistically valid really doesn't mean very much.
MS. OLIVER: Thank you. Mike?
DR. JAHNCKE: No, I'm sorry. Didn't know my flag
was up. Thank you.
MS. OLIVER: All right. Dane?
DR. BERNARD: Thank you. Dane Bernard.
Let me make it clear again we're talking about
fresh citrus juice in this particular context.
MS. OLIVER: Right, okay, thank you.
Stephanie.
DR. DOORES: Stephanie Doores, Penn State.
I would like to address--and maybe I should wait
until this issue is finished--about the methods used to
ascertain the coliforms, and it's related to this, but it
may be different from where other people are coming from, so
I think I'll hold on that until we finish this particular
discussion right now.
MS. OLIVER: Okay. Mike, you have something now?
DR. JAHNCKE: I do have a question now, thank you.
Mike Jahncke, Virginia Tech.
I think it would also be helpful, in the Florida
guidance document, they do have some recommendations as far
as testing and lots and sample sizes. We still haven't
gotten a good explanation of how that's being followed
and/or the logic behind how that was even designed, and why
that type of a program was put in place. You know,
obviously, a lot of thought went into it, probably by the
industry and also by people in the state of Florida, and I
think it would be helpful to get some of that background too
at some point.
MS. OLIVER: Bruce?
DR. TOMPKIN: Bruce Tompkin.
It's not clear what the definition of a lot is,
and that has to be addressed in the establishment of a
sampling plan.
MS. OLIVER: John?
DR. KVENBERG: It's current industry practice, as
I understand it, to track total plate count--
MS. OLIVER: Please identify yourself.
DR. KVENBERG: John Kvenberg, Food and Drug
Administration, slow learner.
[Laughter.]
DR. KVENBERG: It is my observation that total
plate counts are currently used, and it may go to the idea
to determine if your process is in control or moving out of
control. I offer this only as an information that I know.
I don't know about the suitability of that as an indicator.
MS. OLIVER: Bill?
DR. SPERBER: Bill Sperber, Cargill.
I agree total plate counts might be a good
indicator. I mentioned yeast before. I think total plate
counts would be better than yeast.
Also, another possibility better than yeast would
be a lactic acid bacteria.
MS. OLIVER: Thank you. Stephanie, could I come
back to you about your methods, your question?
DR. DOORES: Stephanie Doores, Penn State.
If we're talking about total plate counts or
coliforms or fecal coliforms or E. coli as indicators, I
have several concerns with the procedures that are used to
assess these numbers. If one is doing a total plate count
by the traditional method, i.e., a standard plate count,
generally there is a dilution effect by using the agar in
the plate. Now, this particular product is going to have a
low pH, and it may have other naturally occurring inhibitory
properties, probably dependent upon how much oil is in the
product, and this may vary from manufacturer to
manufacturer.
If one uses something like a petri film, which is
an excellent method, but you have a similar amount that's
added for your sample size, but it does not go through a
dilution effect on that petri film plate, and if I'm
assuming--and this becomes more problematic with the
coliforms, that you have a low number there. You may have
some inhibitors coming over that interfere with the test,
i.e., you're not going to get the organism showing up on
something like a petri film where you may have it in an agar
plating method or most probable number method. So it might
lead you to think that you're having or achieving the
reduction of organisms, but it's an artifact of the method
used.
So what I would like to see--and maybe ARS has
this, these data--is whether these testing methods have been
used specifically with orange juice as a sample, perhaps
using some coliforms that have been isolated from orange
samples too that are indigenous to that particular product,
or that they've looked at the carryover of orange juice into
these sampling procedures to see whether it has an effect.
MS. OLIVER: Thank you. Does anybody else have
any comments before I turn it over to USDA to describe what
we'll be doing tomorrow and then we adjourn for the day, any
specific comments?
DR. BERNARD: Dane Bernard. Considering the
lateness of the hour, maybe we shouldn't even venture into
this discussion, but I do have a good deal of concern about
discussions regarding what we've referred to as HACCP or
GMPs or whatever.
A lot of the success of putting a fresh juice that
presents a minimal risk of pathogens in it appears, as a
result of my education over the last day and three-quarters,
as to how it is done, and we've spoken a lot to that in our
recommendations.
However, saying HACCP does not trigger
automatically high pressure washers and specific kinds of
brushes that are incorporated into the Florida protocol, and
that bothers me a little bit, because I think that if we
look at past problems--and it's been said before by many
presenters, they have not been related--and I think we've
all come to that conclusion--to internal contamination in
the fruit, but to other failures, and I don't that we've
addressed as a Committee the entire scope of the juice
problems that we've had, and I know we don't have time to
solve that today, but we're walking out of here, as far as
I'm concerned, without really addressing some of the nuts
and bolts issues of the problems that have arisen, and what
we mean when we say HACCP, and how do we trigger the kind of
system that is more or less embodied in the Florida plan and
make sure that the California plan and the Texas operators
and the Arizona operators use acceptable protocol. That was
my concern.
MS. OLIVER: Thank you, Bruce.
DR. TOMPKIN: Bruce Tompkin. The Florida best
practices document was written in '95, '96, and the National
Advisory Committee issued its HACCP update in '97. I think
it would be appropriate for the--whatever comes out of this
process, that it should be done with the current '97
advisory committee recommendations relative to HACCP and
prerequisite programs as a guide.
MS. OLIVER: Thank you. Bob?
DR. BUCHANAN: Bob Buchanan, FDA.
I'd also like to echo Bruce's comments. A good
HACCP program is one that not only is implemented and shows
up on paper, but it's also one that is capable of catching
its mistakes. And any program that is initiated and is not
adequately catching its mistakes, having an appropriate
contingency plan on what to do when there are out-of-spec
operations is an incomplete HACCP plan, and so I think there
has to be a lot of attention paid to going back to the sound
principles that we've helped develop here in this Committee
in insuring that they are appropriately applied, which
includes a great deal of contingency planning on what can go
wrong and what will go wrong, and insuring in your HACCP
plan that you're addressing those things, because while I
know that there is some sensitivity about this term, HACCP
takes into account Murphy's Law and does a lot of forward
planning, contingency planning on what should be done and
what can be done to make sure that we catch those problems,
not only in hazard analysis, but also in implementation.
MS. OLIVER: Thank you. Jim?
DR. ANDERS: Jim Anders, North Dakota Health.
Yes, I agree. I think that I'd personally like to
see a mandatory standardized HACCP plan, because everybody
says they have a HACCP plan and everybody's got a different
HACCP plan. In this particular case, we're talking about
unpasteurized juice. It seems to me that there could be a
very clear standardized HACCP plan that could be used in all
the states.
Secondly, I think that you have to validate that
with some testing, and there has to be some validated
testing.
And thirdly, because it's unpasteurized, it would
seem to me that there needs to be some end testing, whether
that's every lot or whatever that is, that it needs to be
some end testing done to at least give some semblance of
safety to the product since it's unpasteurized.
So I guess--and we even ran across a couple of
other things here, and that is on the use of fresh juice.
Something that is bottled for 17 days is hardly in the same
category as something that is--they prepared the juice this
morning and you're going to use it today. So I guess--and
it seems to me that they're using the fresh label for both
of those concepts.
So it seems to me we have a whole series of things
here that's not just--we haven't answered all these problems
today.
MS. OLIVER: Thank you. Seeing no more comments,
I'd like to--before I turn it over to USDA--to thank the
Committee for bearing with us for the full two days.
They've been two long days, and thank you very much for the
advice that you've given us today.
And I also would like to apologize for not having
a better clarification on what we meant in our question on
culling and cleaning, because it did take us a while to
flesh that out this afternoon, and I apologize.
With that, I'd like to just let you know that you
have background materials that have been passed out from
USDA on FSIS on tomorrow's session, and turn it over to Dan
Engeljohn to give a little brief intro into that.
DR. ENGELJOHN: Thank you, Janice.
Dan Engeljohn with USDA.
I just want to remind you all that you do have a
packet which contains the handouts that are going to be used
tomorrow in the description of the FSIS risk assessment for
E. coli 0157:H7 in ground beef.
The modelers will be presenting their sessions on
production, slaughter, preparation and dose response.
In addition, we've invited some subject matter
experts to participate. We'll be seeking your input and
your guidance and comments on the risk assessment as we
present it, and we'll be taking comments on that tomorrow,
as well as for a few weeks after the presentation tomorrow.
So we'll talk more about that and we'll begin at 8:00
o'clock.
MS. OLIVER: Yes. Tomorrow's session begins at
8:00. And thank you all very much, and enjoy your evening.
(Whereupon, the proceedings were adjourned at 4:21
p.m.)