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